Medicine and Law 0198082886, 9780198082880

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Introduction

SCOPE OF THE SUBJECT Medical law is for doctors who may like to know the laws that regulate their conduct. To legal practitioners, it forms the bedrock on which they may advise and defend doctors as well as the public on legal and ethical issues of medical practice. For the general public, it concerns the whole range of all that happens in the journey through life till death and even beyond death. They are not mere philosophical considerations1 to argue about but the actual concerns of how to grapple with topics like consent for treatment, confidentiality and disclosure in matters of personal illnesses, the right to one’s body and its organs, and how one may deal with them during life and after.The apex body that sets the medical and ethical code for practice is the Medical Council, which also prescribes the course content for medical education. Medical practice is one of the several professions that are ennobled by an exalted service to humanity as the driving spirit but are being undermined in their efficacy and public perception in many ways. First, the growing commercialization shifts the focus of attention from what is appropriate and just for the patient to what is economically profitable. Second, in India, cultural issues, illiteracy, poverty, and the population explosion are concerns of utmost importance that patients of the opulent West2 may not have to deal with. For instance, in matters of consent to treatment, culturally, patients in India may place a greater degree of trust on the medical practitioner and be willing to place their lives in the doctor’s hands. Their own poverty may deny the choice of what is best for their medical condition and may force them to donate their Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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organs to overcome financial difficulties. A vast multitude of people expose themselves to greater medical risks of a congested, overpopulated city or town lifestyles. A package of new problems peculiar to India are caused by medical camps conducted by Non Governmental Organizations (NGOs) and the government for minor surgeries like sterilization, cataract surgeries, and immunization programmes with none too ideal conditions of hygiene and administration of drugs that may have already passed their expiry dates. Third, corporate hospitals do not merely offer professionalism in medicare but have also pushed up costs of treatment sky-high. Escalating costs are justification enough for the entry of the insurance business. Fourth, government spending for public health is not a priority issue in India, where it is less than 1 per cent of the Gross Domestic Product (GDP) despite the World Health Organisation’s (WHO’s) suggestion that every country spend at least 5 per cent of its GDP for optimum healthcare. Fifth, access to justice by resorting to legal remedies is mired in inexorable delays in disposals due to, in popular opinion, an inefficient judicial system. And all this makes for a whole new and varied subject for study. This book will address all the above issues with a global perspective with specific reference to India. Ethical issues relating to organ transplants, euthanasia, abortion, and confidentiality are common to all countries, but their perception of deontological issues will vary, conditioned as they will be by the diverse cultural underpinnings of each country. The judgments from various regimes from the West to the Orient will therefore have to be read and understood in their diverse cultural and geographical contexts. The utilitarian aspects of medical ethics of the ends justifying the means in optimizing happiness will also have to be seen in a distinct Indian context considering the predisposition of an Indian who sees the sufferings in the present birth as karmic results of deeds in past lives, and is willing to suffer in silence rather than press for rights against a doctor even for proven acts of medical malpractice. Sometimes, aside from ethical considerations, the subject of doctor–patient relationships is read from moral high ground of what accords with the patient’s affordability to medical expenses; whether a patient wants treatment at all or prefers to be left alone; a traditional understanding of the doctor as a godsend who knew the best for the patient and the latter’s ability to secure a net benefit over harmful effects of medicine.

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SHIFT FROM TRADE TO HEALTHCARE: THE CONSTITUTIONAL IMPERATIVE Pre-Constitution enactments spelt out no more than the imperial interest to protect trade, and if there were health concerns, they were incidental. The Opium Act, 1878, the Poisons Act, 1919, and the Dangerous Drugs Act, 1930, had control mechanisms that addressed issues of production, licencing of drugs, and the like. The Lt Col. Chopra Committee, set up in 1931, recommended drug control machinery that led to the establishment of a Central Pharmacy Council, Provincial Pharmacy Councils, and a Central Drugs Laboratory for data standardization (with smaller laboratories in the provinces). This led to the enactment of the Narcotics Drugs and Psychotropic Substances Act, 1940, which repealed the Opium Act and the Dangerous Drugs Act with more stringent provisions. The committee recommendation was again the raison d’être for the enactment of the Pharmacy Act, 1948. The Constitution of India declares in its Directive Principles of Policy through Article 47 the duty of the state to raise the level of nutrition and the standard of living and to improve public health. The article declares that the ‘State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption, except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.’ Medical care is an important facet of the right to life, and the Supreme Court has delivered several decisions underscoring the obligation of the state to provide quality health services to its people as a guarantee secured through Article 21 of the Constitution.3 Even while recognizing the constitutional imperatives, the Supreme Court has permitted the state to formulate its policies to suit its financial resources.4 Hitherto, the regulation of the medical profession itself had been left to the uncodified law of torts, and post Constitution with the setting up of the medical councils at the central and the state levels, the autonomy of the profession is still preserved by leaving the registration requirements and de-registration, if necessary, to the medical councils. The Medical Council of India (MCI) constituted under the Act is to (1) maintain standards of medical education; (2) give permission to start colleges, courses, or increase the number of

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seats; (3) recommend the recognition of medical qualifications; (4) register doctors and maintain the All India Medical Register; and (5) regulate the profession of medical practitioners. The mushrooming growth of medical colleges, where the government flouts even the Medical Council Regulations, is a serious threat to the dilution of standards in medical education and the quality of medical care. The Supreme Court in P.C. Kesavan Kuttynayar v. Harish Bhalla5 has adversely criticized the governmental vetoes of MCI recommendations and even restrained it from granting further permission to any other college without the recommendation of the MCI.The Indian Medical Council Act, 1956, has been amended four times in 1964, 1993, 2001, and 2005. New provisions to improve accountability have been proposed without utilizing provisions within the existing act, such as the power of the Central Government to constitute a commission of enquiry. Health policies are shaped by the Ministry of Health and Social Welfare and the Act of 1956 with subsequent amendments seeking to bring about a balance between regulation and autonomy of medical professionals. Over the years, there have been clinical establishments, big and small, some run as corporate entities, some run on a partnership basis, and mostly at micro levels by doctors with a modicum of in-patient facilities.Various attempts have been made to lay down strict norms of regulated practice by barring the private practices of doctors working in government hospitals.To draft the services of talented doctors with private practices, there is a class of specialist doctors attached to government hospitals in an honorary capacity, and as teachers in government medical colleges attached to government hospitals. The first attempt at registration and regulation of clinical establishments has come through the enactment of the Clinical Establishments (Registration & Regulation) Act, 2010, which aims to be model legislation for states to secure the constitutional goal of healthcare for its people that is at once affordable and quality-assured.6 DIVERSE ASPECTS OF LAW The wide gamut of issues fall under two broad categories: civil laws and criminal laws. There may be a hybrid type, such as consumer actions through consumer fora offering redress for deficiency of service as well as defective goods and claims against insurance companies for delayed

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settlements or inadequate reparations. The regulatory mechanisms of the MCI will add the further dimension of the ethical considerations of medical practice to the study. In his Issues in Medical Law and Ethics, Derek Morgan notes that beyond this amalgam of tort, contract, and criminal law, it also encompasses administrative law, procedural law, conflicts of law, labour law, and aspects of personal and intellectual property law.7 It is impossible to miss the inter-disciplinary approach that the subject properly demands.

Torts Medical law essentially tracks the civil liability of doctors and hospitals for negligent treatment. It falls within the realm of civil wrong, when a patient is caused undue suffering. A doctor is bound to apply a particular standard of care that befits his standing as an expert in the field. He may attend to the patient himself or through his subordinates, team mates, or colleagues. He has to diagnose properly by clinical examination or subject the patient to investigation tools of modern gadgetry. Relief from illness and alleviation of pain shall be the predominant tasks. Saving life in case of emergency is the ultimate task for a medical practitioner. Administering appropriate drugs to the patient after due advice on the effects, after-effects, and side-effects of medicines are the most obvious duties of the doctor. Doctors, whether they are physicians or surgeons, can only deliver what they are capable of. They are not guarantors of perfect health or manufacturer of sanjeevani 8 potion against death. The results of diagnosis and treatment will be tested on the touchstone of what accords with standard medical practice and whether the prescriptions and treatment conformed to that benchmark. This is so because the same treatment for one patient may not prove effective for another patient with the same illness. Evidently, in such circumstances, the doctor’s care and competence will not be tested on the result of the treatment alone or by the failure of the treatment. In English law of tort, the Bolam9 test is the rule that is used to determine the issue of professional negligence where the defendant has represented himself as having more than average skills and abilities. In essence, this test expects standards that must be in accordance with a responsible body of opinion, even if others differ.

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Determination of quantum of damages to the affected patient or his representatives is a daunting task. The issue of whether the patient was apprised of the prognosis of the illness and the inherent risk involved in the type of treatment is crucial. The patient’s failure to follow the instructions could be a relevant determinant as a mitigating circumstance for determining the full liability. The expenses incurred for medicines, bed, and hospital charges, the costs of hiring an attendant’s services, the pain and suffering undergone by the patient, and the loss of earning capacity or the actual loss of earning due to hospitalization may all go into the final computation of damages.

Breach of Contract A patient contracts with a doctor when he pays him his fee and bargains for treatment. This does not ensure success at all times, nor is the failure of treatment to be construed as a breach of contract. This may happen in borderline cases, where the doctor is a specialist and certain results are guaranteed when the patient seeks the doctor’s medical or surgical intervention. In a Canadian case, La Fleur v. Cornelis (1979),10 the claimant made a contract with the defendant, a cosmetic surgeon, to reduce the size of her nose. The defendant assured her that there would be no problem but did not warn her of a 10 per cent risk of scarring.The claimant was in fact scarred as a result of the surgery, and subsequently, used for breach of contract. The court said that a cosmetic surgeon was in a different position to a normal surgeon because he was carrying out a special service; he agreed to do a particular thing and failed. In another case,11 Patricia Thompson made a contract with Sheffield Fertility Clinic to provide in IVF and implant two embryos.The clinic implanted three and Patricia had triplets. She sued the doctor for breach of contract and the court awarded £ 20,000 as damages. In the US, Australia, and Canada, a patient-centred approach is taken, and this approach is usually what is meant by the phrase ‘informed consent’. Informed consent in these jurisdictions requires that significant risks, as well as risks that would be of particular importance to that patient be disclosed. They are particularly relevant when surgical intervention is considered necessary.The ability to give informed consent is governed by a general requirement of competency to contract. In India,

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the age is eighteen. In common law jurisdictions, adults are presumed competent to consent. This presumption can be rebutted, for instance, in circumstances of mental illness. The manner of securing consent in such cases may be prescribed in legislation or based on a commonlaw standard of inability to understand the nature of the procedure. In certain legal regimes, in cases of incompetent adults, informed consent from the patients or from their families is not required. Rather, the medical practitioner must simply act in the patient’s best interests in order to avoid liability on the ground of negligence.The National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999, makes provision for appointment of a guardian before a board constituted under the act and commits the guardian of a person with disability with duty, wherever required, either have the care of the person with disability and his property or be responsible for the maintenance of the person with disability.12 ‘Minors’ are generally presumed incompetent to consent. In some jurisdictions (as in much of the US), this is a strict standard. In other jurisdictions (for example, England, Australia, and Canada), this presumption may be rebutted through proof that the minor is ‘mature’ (the ‘Gillick standard’13). In the case of incompetent minors, informed consent is usually required from the parent (rather than following the ‘best interests standard’) although a parens patriae order may apply, allowing the court to dispense with parental consent in cases of refusal.14

Criminal Law The doctor is bound to apply adequate professional care in treating a patient. If death15 or injury16 is caused by a rash or negligent act by an individual that also involves the action of a doctor, it will expose that doctor to criminal liability as well. But the rules of general defence17 outlined under the Indian Penal Code (IPC) protects the medical practitioner substantially against prosecution in case where the act is done with proper care and caution or by consent in good faith for the patient’s benefit. The basis of criminal law is intention or mens rea, and to that extent mere negligence will stand outside its purview. The negligence factor alone is not sufficient for proving a tortious claim but a notch higher that places a superior degree of proof beyond reasonable doubt. For fixing criminal liability on a physician

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or surgeon, the standard of negligence required to be proved should be so high as can be described as ‘gross negligence’ or ‘recklessness’. It is not merely lack of necessary care, attention, and skill. When a patient agrees to go for medical treatment or a surgical operation, not every careless act of the medical personnel can be regarded as ‘criminal’. It qualifies only when they exhibit a gross lack of competence or inaction and wanton indifference to the patient’s safety and which is found to have arisen from gross ignorance or gross negligence. If a patient’s death results merely from error of judgment, no criminal liability should be attached to it. Mere inadvertence or some degree of inadequate care and caution might create civil liability but would not suffice to hold the medical personnel criminally liable. This approach of the courts in the matter of fixing criminal liability on the doctors in the course of medical treatment given by them to their patients is necessary so that the hazards of medical personnel in medical profession being exposed to civil liability may not unreasonably be extended to criminal liability which may result in them being imprisoned for alleged criminal negligence. For every death during medical treatment, the Supreme Court has stated, the medical personnel concerned cannot be proceeded against for punishment. Criminal prosecutions of doctors without adequate medical opinion indicating their guilt would be a great disservice to the community for if the courts were to impose criminal liability on hospitals and doctors for everything that goes wrong, the doctors would be more concerned about their own safety than giving the best treatment to their patients. This would lead to shaking the mutual confidence between the doctor and patient. Not every mishap of misfortune in the hospital or clinic of a doctor qualifies as an offence of culpable negligence.18 In a subsequent case, Jacob Mathew v. State of Punjab,19 the Supreme Court laid down elaborate guidelines to govern prosecution of doctors. They are: •   A private complaint may not be entertained unless the complainant  has produced prima facie evidence before the court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor. •  The investigating officer, should, before proceeding against the doctor accused of rash or negligent act or omission, obtain an independent and competent medical opinion, preferably from a doctor in

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government service qualified in that branch of medical practice who can give an impartial and unbiased opinion (applying a prescribed test to the facts collected in the probe). •   Unless arrest is necessary for furthering the investigation or for collecting evidence, or unless the investigation officer feels satisfied that the doctor proceeded against would not make himself available to face the prosecution unless arrested, the arrest may be withheld.

The essence of the judgment is that intention and lack of proper care are important factors to beconsidered before initiating criminal actions against medical professionals. In Martin F. D’Souza v. Mohd. Ishfaq,20 a recent case falling under the Consumer Protection Act, the Supreme Court said: whenever a complaint is received against a doctor or hospital by the Consumer Fora (whether District, State or National) or by the Criminal Court, then before issuing notice to the doctor or hospital against whom the complaint was made, the Consumer Forum or Criminal Court should first refer the matter to a competent doctor or committee of doctors, specialized in the field relating to which the medical negligence is attributed, and only after that doctor or committee reports that there is a prima facie case of medical negligence should notice be then issued to the concerned doctor/hospital. This is necessary to avoid harassment to doctors who may not be ultimately found to be negligent. We further warn the police officials not to arrest or harass doctors unless the facts clearly come with the parameters laid down in Jacob Mathew’s case (supra); otherwise the policemen will themselves have to face legal action.

This direction was found in a subsequent judgment in V. Kishan Rao v. Nikhil Super Specialty Hospital and Another 21 as not laying down the correct law.22

Consumer Protection Law The majority of actions against medical practitioners have come to public gaze only on the complaint of ‘deficiency of service’. Several factors have contributed to this trend. The Consumer Protection Act creates a more informal atmosphere, shorn of procedural paraphernalia, enabling the party or his agent, who does not necessarily have to be a lawyer, to prosecute a complaint against the doctor. The time and

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money spent in consumer fora are relatively lower. The doctors unsuccessfully challenged this provision on the ground that the services rendered by the medical practitioners are not intended to be included in the expression ‘service’ as defined in Section 2(1)(o) of the act. That contention was negatived by the Supreme Court in Indian Medical Association v. V.P. Shantha.23 They also said that proceedings involving negligence in the rendering of services by a medical practitioner would raise complicated questions that required the evidence of experts to be recorded; further, the procedure followed for determination of consumer disputes under the act is summary in nature, involving trial on the basis of affidavits, and is not suitable for determination of complicated issues. The Supreme Court, however, said that it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency in rendering services by a medical practitioner. There may be cases where such complicated questions do not arise, and the deficiency in service may be due to obvious faults that can be easily established, such as removal of the wrong limb, operation on the wrong patient, administering drug to which the patient is allergic without checking the out-patient card containing the warning (as in Chin Keow v. Govt of Malaysia [1967] 1 WLR 813 [PC]), use of wrong gas during anaesthesia, or leaving swabs or other items of operating equipment inside the patient during surgery. The issues arising in the complaints in such cases can be speedily disposed of by the procedure that is being followed by the consumer disputes redressal agencies, and there is no reason why complaints regarding deficiency in service in such cases should not be adjudicated by the agencies under the act. In complaints involving complicated issues that required the recording of testimony by experts, the complainant can be asked to approach the civil court for appropriate relief. Over a period of time, the consumer fora have assumed jurisdiction over every aspect of medical jurisprudence, including cases involving analysis of evidence from experts and dealing with complicated issues.24 Initially, they were unwilling to call the doctors as witnesses—in some cases, they said that the evidence could be adduced through affidavits and cross-examination done through counter affidavits—till recently in Malaykumar Ganguly,25

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when the Supreme Court suggested video conferencing as a method of recording medical evidence. Parading the doctors in the dock at the consumer fora is, however, still a regular spectacle. INDIAN MEDICAL COUNCIL REGULATIONS In the exercise of the powers conferred under Section 20A read with Section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the MCI, with the previous approval of the Central Government, established the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, for registered medical practitioners. They are arranged chapter-wise, and deal with the Code of Medical Ethics, duties of physicians to their patients, duties of physicians in consultation, responsibilities of physicians to each other, duties of physicians to the public and to their paramedical profession, and unethical acts. There is an exclusive mechanism for punishment and disciplinary action. The coming into force of the Consumer Protection Act and the imminent prospects of litigations through complaints before the various consumer fora brought together the leading members of the medical profession and representatives of over 55 leading consumer organizations at Thiruvananthapuram on 12 September 2004, for a workshop on ‘Accessibility and Affordability of Medical Services in India’. It yielded to the Thiruvananthapuram Declaration, which assigned duties jointly and singly to the Indian Medical Association (IMA) and the Consumer Coordination Council (CCC). The declaration underscored the need to foster a good relationship between the medical fraternity and patients and their family by organizing formal education on this in medical schools, holding refresher courses by the IMA, encouraging the concept family physician, evolving a code of conduct for doctors as well as patients, and recognizing that healthcare should be given a priority sector status at the Central and state levels.26 MEDICAL RESEARCH AND PATENTS RELATED ISSUES These are two distinct areas of study. Under the term ‘medical research’, for the purpose of this book we will concern ourselves with the recent developments in the field of genetics and how ethical issues

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of cloning are addressed. Much of the research is in the field of understanding the anatomy and physiology of humans for identifying the causes of various diseases. Microbiology is another subject of serious study. The extent to which they pose legal issues for resolution will be a matter of interest for us. The pharmacological research attracts a whole branch of industry, both through state and private enterprises for massive investments. The novelty in discoveries and the patentrelated issues will be broached along the peripheries to introduce to the reader the concepts, which incidentally go to make this branch of intellectual property rights the most lucrative area of practice for legal professionals. ALTERNATIVE SYSTEMS OF MEDICINE Alternative medicine means alternatives to Western medicine, or allopathy, or orthodox medicine. This term is loosely used to cover all forms of medicine except allopathy. The most popular forms of alternative medicine are Ayurveda, homoeopathy, Unani, Siddha, naturopathy, Yoga therapy, acupuncture, acupressure, magneto therapy, shiatsu, medical herbalism, meditation, aroma therapy, Bach flower remedies, gem therapy, chromo therapy, hydro therapy, and diet therapy. There are more than 100 systems of alternative medicine still in practice all over the world. Every country or region has its own traditional system of health and medical care: for the Chinese it is acupuncture; for the French, magnetic healing; for the Germans, Heilpraxis;for the Sfitish, Herbatism; for India, Ayurveda; for the Islamic nations, Unani; for the southern part of the country, Siddha; for Japan, Shiatsu, etc. These forms of medicine are known as traditional medicine (as most of these have been practiced from time immemorial), complementary medicine (as these medicines often supplement the allopathic medicines, as they differ from orthodox medicine), holistic medicine (most of the alternative medical systems consider the human body as a complete being comprising physical, mental, social, and spiritual dimensions), ethno-medicine (as these traditional healthcare systems are closely associated with the life and culture of the masses), and natural medicine (as these methods of treatment are based on the laws of nature and natural substances are used to treat the patients).

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Law Applicable to Indian Medicine Homoeopathy, Siddha, and Ayurvedha have well-established regular courses of study, research, and education, established and regulated under the Indian Medicine Central Council Act, 1970. Many of the government hospitals, including rural health centres, provide for separate counters for treatment by these different systems. The basis for legal claims is the same for all branches of medical practice, but there are hardly any cases reported from the courts as regards the practice of these systems. They are not dealt with independently but incorporated in various chapters depending on their relevance. The Department of AYUSH (acronym for Ayurveda, Yoga–Naturopathy, Unani, Sidha, and Homoeopathy) operates under the Ministry of Health and Family Welfare. AYUSH has a fairly large infrastructure of about 7,00,000 registered practitioners, 3,000 hospitals, 21,000 dispensaries and over 450 undergraduate and postgraduate teaching colleges with an admission capacity of nearly 30,000 students.27 Chapter 5A of the Drugs and Cosmetics Act empowers the Central Government to create the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board, and brings the pharmaceutical preparation, storage, and distribution of medicines under these systems under the umbrella of the parent act, namely, the Drugs and Cosmetics Act and its Rules. The prohibition and inspection of drugs under this act are vital for regulations of these systems of medicine. Schedule I, under the act, sets out the various names of drugs that fall within the control regime. The 1970 Act has been amended by the Act of 2010 to include Sowa-Rigpa, a system of medicine practiced in the sub-Himalayan region, as falling within the definition of Indian Medicine, and the practitioners of this system to be enrolled in a separate register so as to develop it and its practices within the legal framework. NOTES 1 Margot Brazier argues that philosophy does count in medical law ‘unless the law can settle upon some coherent and defensible definition of illness, the elasticity of the concepts of illness may snap and the concept of medical law with it.’ See Margot Brazier, ‘Does Medical Law Have a Future?’ in P. Birks (ed.), Law’s Future (Oxford: Hart, 2000).

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2 This generalization does admit exceptions as well. The inability to afford private medical care afflicts a large section of the population in the US, as the debates on medicare bill for people unable to afford medical insurance show. In the UK (the National Health Services [NHS]) and in many parts of Europe, medical care continues to be publicly funded but there is pressure to privatize. 3 See Chapter 2. 4 State of Punjab v. Ram Lubhaya Bagga (1998) 4 SCC 117. 5 (2003) 8 SCC 490. 6 Since medicine and health services is a state subject in the constitutional scheme, the Centre could legislate only on the resolution of the respective states.The act has been passed to be applicable after the assembly resolutions to the following states: Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim. Section 56 of the act details the respective legislation that regulates clinical establishments in some states. They are: 1. The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002 2. The Bombay Nursing Homes Registration Act, 1949 3. The Delhi Nursing Homes Registration Act, 1953 4. The Madhya Pradesh Upcharya Griha Tatha Rujopchar Sanbabdu Sthapamaue (Registrikaran Tatha Anugyapan) Adhiniyam, 1973 5. The Manipur Homes and Clinics Registration Act, 1992 6. The Nagaland Health Care Establishments Act, 1997 7. The Orissa Clinical Establishments (Control and Regulation) Act, 1990 8. The Punjab State Nursing Home Registration Act, 1991 9. The West Bengal Clinical Establishments Act, 1950 In respect of the states where the above acts are applicable, they could also adopt the 2010 Act under Article 252(1) of the Constitution. See also Chapter 2 and Chapter 8. 7 (Cavendish Publishing Limited, 2001). 8 Sanjeevani translates as ‘one that infuses life’. It is a lythophytic plant with medicinal properties and grows on the hills of tropical areas, particularly the Aravawali mountain terrains from east to west in India. In Hindu mythology, it was believed to resurrect even a dead person. This herb is mentioned in the Ramayana when, Ravan’s son Indrajit hurls a powerful weapon at Lakshmana that nearly kills him. Hanuman fetched this herb from the mount Dronagiri. 9 The test is derived from Bolam v. Friern Hospital Management Committee (1957) 1 WLR 583. The Bolam test determines the standards against which to measure the legal quality of the services actually delivered by those who claim to be among the best in their fields of expertise. 10 Brendan Greene, Understanding Medical Law (Cavendish Publishing, 2005), p. 6.

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11 Reported in Telegraph.co.uk, dated 17 November 2000. 12 Sections 14 and 15 of the act. 13 The standard is based on a decision of the House of Lords in the case Gillick v. West Norfolk and Wisbech Area Health Authority (1985) 3 All ER 402 (HL).Gillick competency grants the child the ability to consent but does not affect the power of the parent. If a child is Gillick competent, both she and her parent will be able to consent. As a result, a child can be legally treated in circumstances where they refuse or resist treatment. 14 In a case decided by the High Court of Australia in Secretary of the Department of Health and Community Services v. JWB and SMB [1992] HCA 15; (1992) 175 CLR 218 (6 May 1992), Marion (the pseudonym of the teenager), who was 14 years old, suffered from mental retardation. Her parents applied to the family court of Australia for an order authorizing performance of a hysterectomy and an ovariectomy (usually referred to as oophorectomy for humans and ovariectomy for lab animals) on Marion; alternatively, a declaration that it is lawful for them to consent to the performance of those procedures. A hysterectomy was proposed for the purpose of preventing pregnancy and menstruation with its psychological and behavioural consequences; an ovariectomy in order to stabilize hormonal fluxes with the aim of helping to eliminate consequential stress and behavioural responses. The question, the court said that whether these operations were in Marion’s best interests was not before it.That inquiry continued before the family court.This court heard an appeal from the answers given by the full court of the family court to a case stated to the full court by Nicholson CJ on 28 May 1990. As amended, the questions stated were as follows: (1) Can the applicants as joint guardians of the child (Marion) lawfully authorise the carrying out in the Northern Territory, of a sterilization procedure upon the said child without an order of a court? Ans: No; (2) If no to question 1, does the family court of Australia have jurisdiction: (a) to authorise the carrying out of such a procedure; Ans: Yes; or (b) to enlarge the powers, rights or duties of the applicants as guardians of the said child to enable them to lawfully authorise the carrying out of such a procedure: Ans: No; or (c) to approve the consent of the applicants, as guardians of the said child, to the proposed procedure to make the procedure lawful? Ans: No; (3) Which (if any) of the steps referred to in (a), (b) or (c) of question 2 is required by law? Strauss J. answered at pp. 78, 313, 462 of the FLC: ‘(1) Yes. However, the sanction of the family court should be obtained before the operation is carried out. It follows that questions 2(a),(b) and (c) do not arise.’ McCall J. said at pp. 78, 329, 481 of the FLC: ‘(1) Yes. (2) If an application is brought by parents as

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in this case, the court has jurisdiction to make an order in terms of question 2(a). (3) None.’ 15 IPC, Section 304 A. 16 Ibid., Section 279. 17 Ibid., Section 80: ‘Accident in doing a lawful act: Nothing is an offence which is done by accident or misfortune, and without any criminal intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and caution.’ Section 88: ‘Act not intended to cause death, done by consent in good faith for person’s benefit: Nothing which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harm.’ 18 Dr Suresh Gupta v. Govt of NCT of Delhi & Another (2004) 6SCC 422. 19 (2005) 6 SCC 1. 20 (2009) 3 SCC 1. 21 (2010) 5 SCC 513; 2010 (3) RAJ 240. 22 See Chapter 5 for further commentaries on the relevant judgments. 23 (1995) 6 SCC 651. 24 See the cases beginning with Dr J.J. Merchant and Ors v. Shrinath Chaturvedi AIR (2002) SC2931 till the recent decision in Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others (2009) 9 SCC 221, (2009)(4) RCR (civil) 14, (2009)(4) RCR (crl) 2, (2009)(5) RAJ 405. 25 (2009) 9 SCC 221. 26 See the full text of the declaration in the article published by Indlaw Communications Pvt. Ltd. 27 Annual Report of the Department of Health and Family Welfare, 2008–09.

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Medical Education

GENERAL The interface of law with medical education brings to the fore a range of topics starting from establishing educational institutions to securing admission, from setting standards of medical education not merely of students passing out of colleges established in India but also to appraising persons who have graduated from foreign universities before being granted the licence to practice in India. They are essentially monitored through regulations issued by the Medical Council of India (MCI). Medical education is not just a matter of personal preference of a candidate but the State also takes considerable interest in the field of healthcare to ensure that medical personnel are well versed to administer quality medical attention to the sick and needy. It is the assured standard of education that makes possible a constant supply of competent doctors to the corporate hospitals placing India in the destination map for many a patient from the Middle East for the relatively cheap and state-ofthe-art medicare. Among the most important cases of the Supreme Court in its formative years of drawing the contours of fundamental rights were issues particularly with reference to reservation to backward classes for admission to medical colleges. Regulation of legal education through law also grapples with issues of curtailment of commercial exploitation by prescribing scales of fees and securing commitment from the students to devote time to the rural healthcare. The missionary zeal of establishing hospitals by minority communities and the constitutional provisions recognizing autonomy for Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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minority-run educational institutions have brought open confrontations with central laws that a minimum benchmark for admission and the state laws that describe the extent of reservation and the fee structures for admission to regular course study.

History of Medical Education The Western system of medicine came into India perhaps with the advent of the Portuguese in the early 1500s but it was the British East India Company that established a permanent medical facility to attend to the British soldiers of the garrison in a small rented premise at Chennai (erstwhile Madras) in 1664.1 In 1827, a hospital training Europeans, Eurasians, and Indians in the practice of medicine was undertaken in Madras2 but the first institute imparting formal medical education was established only in Calcutta during the times of Lord William Bentinck.Thanks to his efforts and long persuasion, a government order had been passed setting up a medical college in Calcutta which was known as Calcutta Medical College. As the resolution was passed on 28 January 1835, this day is observed as the foundation day of the college. Madhusudhan Gupta is reported to be its first student.3 In Madras, that is, present Chennai, William Mortimer, the medical superintendent of the hospital was instrumental in using the facilities in the hospital for a medical college and the project got underway by then Governor of Madras, Sir Fredrick Adam through an order issued on 13 February 1835. Indians were admitted from 1842. It was christened Madras Medical College in 1850, and in 1852 the first batch of students passed out.4 Initially, medical education enabled the students to obtain the licentiate qualification in medicine and surgery (LMS), and later a formal degree as Bachelor of Medicine and Master of Surgery (MBCM)5 was granted. The medical colleges established at Calcutta, Madras, and soon thereafter at Bombay were affiliated to the respective universities in the states. The Indian Medical Services was formed in 1896 that led to the establishment of the MCI in 1933 which brought medical education directly under its control for maintaining uniform standards of medical education. The first World Medical Education Conference held in London in August 1953 reviewed the requirements for entry into medical schools, the aim and content of the medical curriculum, the technique and method of

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education, and the importance of preventive and social medicine in the training of physicians. The Medical Education Conference organized by the Government of India in 1955 after the World Medical Education Conference recommended major reforms in medical education in India. This conference made several suggestions in regard to selection of students, entrance qualifications, including premedical studies, curriculum of medical education, examinations, fulltime teaching units, and so on.6 ADMISSION NORMS

The Constitutional Position regarding Medical Education All fields of education, including medical and technical education, fall within the concurrent list after the 42nd amendment of the Constitution effective from 3 January 1977.7 By this exercise, both the Centre and the states can legislate on the subject of education without, in any way, creating any inter se conflict. This has also relevance to testing the constitutional validity of state legislation in so far as they may seek to advance specific state interest, such as preference of candidates residing within the state, the classification of castes or classes for the purpose of their identification to provide reservation, etc. Clash of objects have been witnessed in states’ endeavour to bring populist measures to remove any benchmark of academic attainments for admission to medical colleges or to reduce the minimum standards set by central legislation by invoking Article 15(4) that allows for the state’s power to frame laws for the purpose of advancing the cause of backward classes. MCI Regulations (MCIR) prescribing minimum standards have been sourced to the power of the Centre under the Indian Medical Council Act, and the Supreme Court has had difficulty in reconciling the fundamental cleavage of views on whether reservation compromises merit or not. The constitutional privilege to minorities under Article 30 to establish educational institutions without state interference has actually heightened the friction of the level of autonomy that they enjoy in matters relating to conducting common entrance tests for admission on an all India basis and how to bring the minority run institutions within the central regulatory ambit.

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Indian Medical Council Act

statutory provisions The Indian Medical Council Act, 1956, was enacted by the Parliament to provide for the reconstitution of the MCI, maintenance of a medical register for India, and for matters connected therewith.The act sets out schedules of universities and medical institutions of India and abroad which are recognized. No person other than a medical practitioner enrolled on a state medical register shall hold office as a physician or a surgeon under the government or under any other institution maintained by a local or other authority. He shall also not be entitled to practice medicine in any state nor shall he be entitled to issue any certificate or give evidence in any matter relating to medicine. The act empowers the council to withdraw recognition in case ‘the courses of study and examination to be undergone in, or the proficiency required from the candidates at any examination held by any university or medical institution’ do not conform to the prescribed standards. Recognition can also be withdrawn where ‘the staff, equipment, accommodation, training and other facilities or instruction and training’ provided in such institution do not conform to the prescribed standards.8 Section 33 also specifies the several matters which can be provided by regulations. The matters so specified include ‘the courses and period of study and of practical training to be undertaken, the subjects of examination and the standards of proficiency therein to be obtained, in universities or medical institutions for grant of recognized medical qualifications.’ The Supreme Court went as far as to say that state legislation providing for relaxation of merit consideration at the stage of admission ought not to be material since the guarantee of quality lies in everybody passing the same final examination in Ajay Kumar9 but this was overruled by a five-member bench of the Supreme court in Dr. Preeti Srivastava v. State of M.P.10 The observation in Ajay Kumar that quality of education is guaranteed at the exit stage elicited a counter response in Dr. Preeti Srivastava,‘the final pass marks in an examination indicate that the candidate possesses the minimum requisite knowledge for passing the examination. A pass mark is not a guarantee of excellence. There is a great deal of difference between a person who qualifies with the minimum passing marks and a person who qualifies with

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high marks. If excellence is to be promoted at postgraduate levels, the candidates qualifying should be able to secure good marks while qualifying.’ The latter judgment of the Supreme Court also overruled the former to hold that the standards of postgraduate medical education prescribed by the MCI were not merely directory but the universities were bound to comply with the standards prescribed. In a subsequent judgment in Veterinary Council of India v. Indian Council of Agricultural Research,11 the Supreme Court reiterated that the process of selection for admission has a direct impact on maintenance of the standard of education in medical colleges, and has perforce to recognize the primacy of regulatory bodies to prescribe enforceable standards for entry into medical education.

Indian Medical Council Regulations

graduate courses The lofty objective declared is to train for a medical profession to achieve a national goal of ‘health for all’. It sets out the minimum educational qualification for gaining entry as an intermediate course in higher secondary education with qualifying marks which till recently provided shall not be less than 50 per cent both in board exams as well as the competitive entrance examination in physics, chemistry, and biology, relaxation being provided to candidates belonging to scheduled castes, scheduled tribes, or backward classes prescribing a bench mark of 40 marks, and the number of years of study as four-and-a half years that includes clinical training. The regulations prescribe also the subject-wise curriculum for each phase of pre-clinical and paraclinical and clinical studies. They are structured to inculcate the goals set, the objective to be realized, such as the acquisition of knowledge, skills to be acquired and the level of integration to be achieved with other branches of study and their relevance to community. There are elaborate provisions also with reference to the manner of appraisal of students in the examinations that would include viva voce, and the persons who would conduct the examinations. There shall be a compulsory internship, as a phase of training wherein a graduate is expected to conduct actual practice of medical and healthcare and acquire skills under supervision so that he may become capable of functioning independently. A provisional degree certificate that will be

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given on the completion of studies will culminate in the regular degree certificate as Bachelor of Medicine and Bachelor of Surgery (MBBS), and registration of practice only after completion of the 12th month of internship. Amendment to the regulations in 2009 provided for a horizontal reservation to the extent of 3 per cent of sanctioned intake for admissions to candidates who suffer from loco-motor disability of lower limbs between 50 per cent and 70 per cent, and if not available, relaxable for disability up to 40 to 50 per cent, with reduced qualifying marks as 45 per cent against 50 per cent marks for general candidates. It is a common feature many a time to hold up admissions by court interim orders for some defects in admission, or due to delays in filling up state quota and management quota, and courts themselves have laid a condition carried through an amendment in 2009 that in no case will any admission be made in the MBBS course after 30 September. This was so after the Supreme Court ruling in Medical Council of India v. Madhu Singh12 that the MCI should ensure that the examining bodies fixed a time scheduled specifying the duration of the course, the date of commencement of the course, and the last date for admission. The court said that there was a necessity for specifically providing the time schedule for the course and fixing the period during which admissions could take place making it clear that no admission could be granted after the scheduled date, which essentially should be the date of the commencement of the courts. In the amended notification issued on 21 December 2010, it was provided that there shall be a single eligibility-cum-entrance examination, namely ‘National Eligibility-cum-Entrance Test (NEET) for admission to MBBS course’ in each academic year. The overall superintendence, direction, and control of NEET shall vest with the MCI. An all India merit list as well as state-wise merit list of the eligible candidates shall be prepared on the basis of the marks obtained in NEET, and candidates shall be admitted to MBBS course from the said lists only. In a further amended notification issued on 15 February 2012 to be effective from the academic year 2013–14, it shall be necessary for a candidate to obtain minimum of marks at 50th percentile in ‘NEET to MBBS course’ held for the said academic year. However, in respect of candidates belonging to Scheduled Castes, Scheduled Tribes, and Other Backward Classes, the minimum marks shall be at 40th percentile. In respect of candidates with loco-motor disability of lower

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limbs terms of Clause 4(3) above, the minimum marks shall be at 45th percentile. The percentile shall be determined on the basis of highest marks secured in the all India common merit list in ‘NEET for admission to MBBS course’. In Christian Medical College, Vellore v. Union of India,13 the amended notifications of the year 2010 were challenged as ultra vires by minority institutions as impinging on their institutional autonomy guaranteed to minorities, by the deemed universities and unaided, non-minority private managements as constituting interference with fundamental freedom guaranteed under Article 19(1)(g) to carry on any occupation, trade, or business, and by the States of Tamil Nadu and AP as having their own laws to guide admissions rejecting the idea of common entrance exam and state law enacted cannot be trampled by an inconsistent central notification. The Supreme Court by a 2:1 majority upheld the objections on a sweeping statement that the extent of protection of rights of minority institutions against state intervention have been set forth in earlier decisions in Ahmedabad St.Xavier’s College Society case,14 St. Stephen’s College case,15 T.M.A. Pai’s case,16 Islamic Academy case,17 and P.A. Inamdar ’s case18 and the present notifications were in violation of the judgments and the constitutional guarantees of minority protection that they espouse. The majority approved an argument made by one of the counsel appearing on behalf of the minority institutions that ‘Article 30 of the Constitution must be deemed to have the right to reject a candidate having suprerior marks as against a candidate having lesser marks.’ This conforms to the beliefs, aspirations, and needs of the institution for which it was established. From a practical point of view, it accepted the contention that there are diverse streams of educational courses with different standards and syllabi conducted by different state and central boards, and the CEET cannot provide a level-playing field. The majority reasoned: ‘The practice of medicine entails something more than brilliance in academics, it requires a certain commitment to serve humanity.’ It seemed to suggest that CEET would operate against ‘less meritorious persons’ who could otherwise gain admission into unaided minority institutions, privately managed unaided colleges, and deemed universities prescribing their own admission criteria, and state intervention shall not be justified so long as there are no mismanagement and commercial exploitation.

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postgraduate courses As per the regulations of 2000, postgraduate medical education in broad specialties shall be of three years in the case of a degree course, two years in the case of a diploma course after MBBS, and in the case of super specialties the duration shall be three years after MD/MS. However, a postgraduate diploma holder shall have only two years of training for MD or MS and in case of super-specialty in neurology and neuro surgery, if the institution has a five-year course, it shall continue to be so. Apart from setting out the objectives and goals, the regulations prescribe the curriculum and the eligibility of institutions which could operate the courses after permission from the Central Government in the manner prescribed under the MCI Act. The admission to the course shall be only on merit determined on the basis of a competitive test conducted by the state government or by a competent authority appointed by the state or by the university to which the course is affiliated or a competitive test held at the national level or on the basis of performance in MBBS examination, if such examination is passed from the same university or a combination of any of the above modes. In all private medical colleges, 50 per cent of the total seats shall be filled by the competent authority and 50 per cent by the management on the basis of merit. The rationale is not far to seek: a student who could not gain admission on merit in a government run college cannot come through the back door by obtaining admission in private colleges otherwise than on merit. The regulations prescribe minimum bed requirements in the clinical establishment of the institution, outpatient facilities, staff strength, lab, and research facilities, etc. to ensure that the standards are sufficient to equip students, inter alia, to emerge as effective leaders of health teams engaged in healthcare, research, or training. In the notification issued on 23 March 2006, the regulations also provide that the universities and other authorities concerned shall organize admission process in such a way that teaching in postgraduate courses starts by 2 May and by 1 August for super specialty courses each year. There shall be no admission of students in respect of any academic session beyond 31 May for postgraduate courses and 30 September for super specialty courses under any circumstances. Any admission made beyond the said period will result

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in not merely the student getting discharged, it would invite penal sanctions against the institution guilty of such deviance. The notification dated 25 March 2009 provides for reservation for persons with disability the same way as it provides to the graduate courses. A more recent notification dated 21 July 2009 allocates 50 per cent in postgraduate diploma course for medical officers in the government service, who have served for at least three years in remote and difficult areas with a condition that such a candidate shall continue to serve for two more years in such remote or difficult areas. The admission shall be on the basis of merit only with minimum marks of 50 per cent and 40 per cent, respectively for general and SC/ST/ OBC classes in the graduate course. In determining the merit and the entrance test for postgraduate admission weightage in the marks may be given as an incentive at the rate of 10 per cent of the marks obtained for each year in service in remote or difficult areas upto the maximum of 30 per cent of the marks obtained. The 2010 regulations that mandated a single eligibility-cum-entrance examination at a national level with power of superintendence with the MCI and prescription for minimum marks at 50th percentile in ‘NEET for postgraduate courses’ in 2012 regulations have been struck down in Christian Medical College, Vellore case (as mentioned earlier).

migration The provisions relating to migration are important because, there are differential standards of medical education and fees payable, besides varying criteria for selection. Migrations were initially legitimized through court orders but when there grew large scale abuse of this power, the regulations declared that migration from one medical college to other could not be a matter of right from one college to another but permitted only if sanctioned by the MCI on compassionate grounds19 and with stringent conditions. A migration from foreign medical university to Indian university would not be possible,20 though a college established in foreign country and affiliated to Indian University will stand on a different footing.21 Migration during clinical course of study shall not be allowed on any ground.

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vision 2015 statement The MCI has prepared an ambitious ‘Vision 2015’ document titled ‘Implementation of Reforms in Undergraduate and Postgraduate Medical Education’. The document makes important curriculum reform recommendations, including a proposal to provide early clinical exposure to students, reduce the duration of the MBBS degree programme from four-and-a half to four years by making subjects such as forensic medicine, ophthalmology, and ENT optional; introduction of electives such as bio-informatics, tissue engineering/processing, computer applications, immunology, permission of flexible learning options in the curriculum; adoption of contemporary education technologies such as skills laboratories, e-learning solutions, simulation; and establishing regional learning facilitation centres to enhance continuous faculty development programmes, etc.

Apportionment of Marks in Examination and Viva Voce Examinations are the accepted mode of determining merit. Grading or assigning marks have come to be the yardstick for determining merit.22 Assessment through viva voce only would undeniably admit of arbitrariness. How much could be the apportionment between competitive written tests through objective type multiple choice questions (MCQs) and how much could be the marks assigned for interview have been the subject of several decisions? In A. Periyakarupan v. State of T.N.,23 the court expressed disapproval of the earmarking of 75 marks for the interview out of 275 marks. 50 out of 150 for interview was found excessive in Nishi Maghu24 and allotment of more than 15 per cent for viva voce was held bad in Ajay Hasia v. Khalid Mujib.25 Not merely the marks, even the average time for interview at less than 4 minutes was found to be hardly sufficient to assess merit in Arti Saru v. State of J & K.26 RESERVATION

Content of Reservation

the constitutional mandate Reservation in the field of education is a method of correcting a skewed position of imbalance in society. Social, educational, and economic

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backwardness dampen ability to compete at all levels; and the interventions have necessarily to address issues of extent of reservation in terms of number of seats to be made available, lowering benchmark to gain admission and reducing cost of education by prescribing differential rates of fees for the seats offered. If special provisions through law27 for empowerment of weaker classes are understood as fundamental rights guaranteed in the Constitution, can it be restricted to reservation only in government and state aided institutions? The autonomy that minority run and self-financing private institutions enjoy take them outside the ambit of state control to enforce rule of reservation.This was sought to be corrected through the 92nd amendment to the Constitution. The state has a right to insist that reservation for SCs/STs shall be of fixed percentages through regulation governing admission or grant of recognition to not merely government run medical institutions but also to privately run non-minority medical colleges. Consequently, a society administered by army personnel reserving 100 per cent right of admission to children of army personnel alone was held to be invalid. Any student that does not fall within the category but who claims admission on merit or a person who wants enforcement of the reservation policy applicable in the state could successfully challenge the admission criterion prescribed by the management as not valid.28 Even a private institution, which is not a minority run institution, does not have a right to choose its own source of general pool by earmarking eligibility only to a sub-class of society, without reference to merit. How the rule of reservation has been enforced in matters of admission to medical colleges, whether private or government, be it a minority-run institution or otherwise as regards expression of preference on the basis of domicile or as a past student of a particular educational institution has also fallen for consideration in several cases before courts.

the basis The issue of reservation is invariably spoken in the context of a deviation from a homogeneous application of admission criteria on the basis of marks, domicile, caste, religion, and backwardness. The debate throws up everlasting conflicts of pitching merit against reduced standards for accommodating persons with lower marks. Reservation has relevance typically when the forces of demand and supply present a lopsided scenario with the former far outstripping the number of seats

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available and hence there is a clamour for privileges to corner the limited number of seats. Economic forces also help us understand as to how they contribute to the spiraling costs of medical education. Seen in the constitutional backdrop of equality, reservation is an attempt to restore the balance that simply does not exist in society; an inequality wrought through generations that assured privileges only to certain communities for access to education. Just in the same way as what shall constitute the basis of reservation in public appointments is a contentious issue, so it is in the field of education.

Caste versus Class Article 15 prohibits the state from making any discrimination on grounds of religion, race, caste, sex, or place of birth. Under cultural and educational rights, while setting out the protection of interests of minorities, Article 29(2) declares that there shall be no denial of admission into any educational institution maintained by the state or receiving aid out of state funds on ground only of religion, race, caste, language, or any of them. The protection under this article made possible for a Brahmin candidate seeking admission in medical college to successfully challenge the Communal GO, which had been issued by the then Madras government setting out certain number of seats for different castes and religions. The candidate claimed that she was denied admission only because the quota reserved for a particular caste had been exhausted, although she was more meritorious than another candidate of a different caste/religion. The Supreme Court upheld the Madras High Court decision and struck down the GO as ultra vires Article 29(2), and it did not require examining the applicability of Article 15. The Nehru government brought the first amendment to the Constitution by introducing Article 15(4) that allowed the state to make any special provision for the advancement of any socially and educationally backward classes of citizens or for the SCs/STs. What the framers of the Constitution clearly avoided was brought in by specifically identifying backwardness of class along with SCs/STs to be privileged for their advancement. Caste soon was held to be a relevant factor for determining social backwardness. M.R.Balaji v. Mysore29explained that as an exception to Article 15(1), the reservation that Article 15(4) provided could not justify even a total reservation of

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seats for such classes. A cap on 50 per cent being the outer limit of reservation has stood on to this date.30 Through the 93rd amendment to the Constitution, the time limit for extending reservation was enlarged. It also added beneficiaries and the applicability of reservation in private non-minority educational institutions. In Ashok Kumar Thakur v. Union of India31 one of the judges almost sounded despondent: Did the original Framers intend to provide caste-based reservation in education to the lower classes? No, the original Framers did not. Soon after the Constitution was adopted, the very same Framers acted quickly to permit reservation for SC/ST/SEBCs in education by adding Article 15(4), vide the First Amendment, to the Constitution. In doing so, they deviated from their own goal-the casteless society would have to wait. In Sawhney (I ),32 the Court upheld this decision (of abolishing a casteless society) and bound us to a certain degree on this point... Instead of moving to remove reservations, the Parliament has gone the other way… Preferential treatment was, if at all only to educational grants; rather than reservation, originally the preference was an emphasis on free/compulsory education. We have none of those ideals left now.

effect of conversion SC status would be available only to Hindus (since caste divisions do not theoretically exist in the other predominant religions like Islam and Christianity) and a person on conversion to other religions will lose the right to claim reservation. The effect of reconversion to Hinduism was considered in Guntur Medical College v. Mohan Rao.33 There, the person had been born to parents who were originally of Madiga Caste (SC) but had converted to Christianity by the time of child birth. He applied as a backward class Christian candidate and was rejected. Later, he converted to Hinduism and sought for a seat on reserved quota. The Court followed an election case34 relating to a candidate who had contested from a ‘reserved constituency’and held, if on re-conversion, the person had been accepted by the caste members as one of their class, such a person is entitled to be treated as belonging to the SC category. The petition was admitted to the reserved seat. How the litigant secures proof that he is admitted by the caste people on re-conversion is anybody’s guess!

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rural and urban bias If it has been so difficult to get medical attention and treatment that the rural India deserves, cannot identification of the class of people in villages to be admitted to medical education be a panacea? So it would seem, though not much of data is available to bring support to the view, that if students from villages are picked up, they would go back to the villages to serve their people; there is also no material to suggest that there are not enough people with rural background seeking admission. What would seem so much as obvious was still not sufficient for Court to uphold when reservation was made in the State of Uttar Pradesh35 and still later in the State of Jammu and Kashmir36 when preference was given to persons domiciled in villages, and the Supreme Court held the law as constitutionally invalid. Earlier in Nish Maghu v. State of J & K37 reservation of seats for students from rural areas to correct regional imbalances was held bad as vague and without empirical data. To quell this objection, the state government attempted to identify certain villages as socially and educationally backward for rectification of imbalance in Arti Sapru.38 The Supreme Court was not impressed and said that there was no rational basis for determination of economic backwardness. It said that a pass from IX to XII between students studying in rural schools and urban schools could not make a difference. Distinction between rural area and urban area education alone could not mark a rational distinction for reservation39 but in Pradeep Jain v. Union of India,40 the SC noticed the distinction between place of birth (that was prohibited for public appointments for favourable discrimination) and residence. It said residence in a particular place as a qualification is a distinct expression that would not fall foul of the constitutional scheme of equality. The Court was averse only to total reservation on the ground of residence but having regard to socio-economic disparities and inequalities, reservation of certain percentage of seats as an interim measure, in case of admission to MBBS/BDS courses was held valid, although admission on an all-India basis should be the ultimate goal. Allowing for flexibility for institutional preference and residence, the court fixed 70 per cent to be the maximum permissible extent subject to review by the MCI, but for the admission to postgraduate medical courses even a partial reservation based on residence requirement shall not be permissible; institutional preference would be tolerated but it

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shall not still exceed 50 per cent. It is difficult to gauge before hand what percentage of reservation would qualify for court’s approbation.

domiciliary preference to state candidates If no preference could be given to persons from rural areas, there is still no fear, as we have seen above that it should be understood that the courts do not approve of place of residence as relevant criterion for giving weightage to admission for a person domiciled in the same state, where the college was situated. Here, in Sanjay Ahlawat v. Maharishi Dayanand University41 the weightage of 10 marks for a resident of the State of Haryana for a medical college established in Haryana was upheld on a reasoning that the local doctors would, after obtaining medical degrees, remain in Haryana and their services would be available to the people of the state. An outright reservation only on the basis of residence may be bad but if it is coupled with other considerations such as grant of institutional preference for persons having studied in a particular college and also domiciled in the same state, the criterion would be valid.42

lower marks for reserved candidates If the quota is not filled within the percentage of reservation, is it all right to reduce the minimum benchmark already fixed as necessary for selection? Yes, asserted State of M.P v. Nivedita Jain43 on a reasoning that a person who gains admission initially on relaxation does not get any further relaxation in the course of study, either as regards the curriculum or the marks he had to secure to qualify for a pass. Ajay Kumar Singh v. State of Bihar44 approved of this but a five judges bench in Dr Preeti Srivastava v. State of M.P. 45 overruled this reasoning: We cannot agree with the observations made in that judgment (Nivedita Jain) to the effect that the process of selection of candidates for admission to a medical college has no real impact on the standard of medical education; or that the standard of medical education really comes into the picture only in the course of studies in medical colleges or institutions after the selection and admission of candidates. We cannot agree with the proposition that prescribing no minimum marks for admission for SCs and STs would not have an impact on the standard of education in the medical colleges.

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Lower percentage for reserved category is not anathema but fixing no benchmark and relaxing it totally to accommodate a particular percentage of reservation would be bad.

other privileged classes considered Right to equality is not breached if the discriminatory treatment is founded on intelligible criteria that bear nexus to the object sought to be achieved. It would seem that careful drafting of criteria could save the day and insulate admission criteria that are still not based on merit. In Chitra Ghosh v. Union of India46 a five-member bench was prepared not to mind the right to nominate admission of students of certain percentage of seats for the government because it had established it and undertaken its funding. The nominees were persons who were residents of Union Territory other than Delhi; sons and daughters of the servants of the Central Government posted in Indian missions abroad; and children of scholars of Jammu & Kashmir. The Supreme Court strained its reasoning to find a justification for preferential treatment but it was still a period when there was no fierce competition into admission for medical colleges. It is doubtful, if the same criteria could pass the test in the present times as valid. Unnikrishnan47 case frowned upon any form of preference to be given to any nominee of a person who may have played a part in establishing the college. The idea was to remove the commercial element in the manner of establishing a college to secure preference in admissions. Consequently, when in State of Gujarat v. M.P. Shah Charitable Trust,48 the government withdrew, through a resolution, the right of nomination of certain number of seats for admission to a person who had contributed substantial funds as donation for establishing a college after extending such a privilege in the initial years after donations, the Supreme Court refused to interfere in favour of the donor. In Kerala v. R. Jacob49 stipulation of certain seats for children of registered medical practitioners was found to be arbitrary.

Manner of Applying Reservation

general If the basis is predominantly caste ridden, the principle of reservation is applied by apportioning certain minimum numbers for the

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particular class of persons and lowering marks for eligibility subject to prescribing the minimum bench mark.What shall be the percentage of reservation? How does one assuage the sense of outrage that prevails to other sections of community, against whom the rule of reservation operates, and who argue that reservation is anti-meritarian? There are several theories that introduce different types of reservation as vertical and horizontal and identifying a creamy layer among the identified classes who do not qualify for reservation. How do you understand these concepts?

percentage of reservation Reservation as antithetical to merit has pushed towards theories looking for what percentage of reservation shall constitute as legally acceptable. Horizontal reservation in excess of 15 per cent for special categories was held in Anil Kumar Gupta v. State of UP 50 to be impermissible. Dr Ambedkar in his speech at the Constituent Assembly said that the reservation must be ‘confined to a minority of seats.’ M.R. Balaji51 struck down 68 per cent reservation for SCs/STs and Backward classes and held that reservation in excess of 50 per cent would result in Article 15(4) exception eating into the provisions of the fundamental right to equality given to all citizens. Even as regards minority run institutions, the Supreme Court laid down in St. Stephen’s College v. University of Delhi 52 that 50 per cent quota system, that is, the right to fill up 50 per cent seats by the government and the balance 50 per cent only by the management has to be observed. The correctness of the said ratio of 50 per cent seats has since been reappraised in T.M.A. Pai Foundation v. State of Karnataka,53 as ‘The basic ratio laid down by this Court in St. Stephen’s College case is correct.... However, rigid percentage cannot be stipulated. It has to be left to authorities to prescribe a reasonable percentage having regard to the type of institution, population and educational needs of minorities.’ The current position of law is that while the thumb rule is 50 per cent, the quantum/number of such seats can be modified by the government, according to the local needs and different percentage can be fixed for minority unaided and non-minority unaided and professional colleges. Many states have passed legislation/regulations fixing the number of seats to be reserved under various categories. Jagdish Saran v. Union54 would, however, show what this percentage basis is all about, for in that case, the graduate medical students went on a fast

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unto death demanding an increase of quota from 50 per cent to 70 per cent exclusively for Delhiites and the remaining 30 per cent being open to all including Delhi students for admission to postgraduate courses. They were pleading for a protective discrimination in their favour on the ground that many other universities were excluding students from open competition on account of their domicile being Delhi.The court allowed the surcharged atmosphere outside the court to dictate its result to allow for such increase but left the case with an effete observation that the Delhi University should set their house in order and granted two months’ time to appoint a committee to investigate in depth the justification for and the quantum of reservation at the post-graduate level. That nothing changed is matter of history.

vertical and horizontal reservation Reservation that is set apart to a specific section of society as socially and economically backward class by relaxation of conditions as are otherwise applicable to class of persons of general category is vertical. Reservation that ensures a minimum of a particular percentage as falling both within the particular class and the general class is horizontal. To illustrate, in the field of education, reservation made to SCs/STs and other backward classes pursuant to Article 15(4) shall be vertical, and reservation made for physically handicapped persons, women, persons domiciled in particular region, and persons to whom institutional preference is given, obtain horizontal reservation. Vertical reservations therefore imply that a certain percentage is first of all set aside for the specified category, while horizontal reservation cuts across vertical reservation.55

overall horizontal reservation and compartmentalized horizontal reservation Interpreting Indra Sawhney, the Supreme Court held that a reservation providing for 50 per cent vertical reservation to SCs/STs/OBCs and 50 per cent to general category with 15 per cent horizontal reservation to freedom fighters’ children, handicapped persons, etc. and provide for a compartmentalized allocation of 30 per cent seats to women in each category to be not bad in Swati Gupta v. State of UP. 56

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The decision was rendered after the initial mistakes in the notification were purported to be corrected. In the ultimate manner of its application, there were still problems and the Supreme Court, when confronted with this problem in Anil Kumar Gupta v. UP 57 had to explain the concept of how, if within horizontal reservation, the proportion for all categories, such as SC, ST, OBC, and OC (open competition) are maintained, that is, compartmentalized, we will be heading for a hybrid type. The Supreme Court ruled that it was essential that the notification prescribing horizontal reservation itself specified whether it is ‘compartmentalized’ or it is ‘overall’.

caste status on migration from one state to another The classification of caste through presidential order is particular to each state and a person belonging to an SC status in one state shall not avail the same status in another state on migration. It may seem harsh but the result is inevitable if the basis of classification itself is permitted to be done on statistics relating to economic and social deprivation existing in each state and brought through numerical elucidation. Hence a person who belongs to SC category in one state will not carry the status outside his own state even if the same caste name is treated to SC category in yet another state.58 This is so, because, in the constitutional scheme of things, the President notification is made under Article 341 or 342 after consulting with the respective states. Considerations for specifying a particular caste or tribe or class for inclusion in the list of SC/ST/BC in a given state would depend on the nature and extent of disadvantages and social hardships suffered by that caste, or tribe or class in that state which may be totally non-existent in another state to which persons belonging thereto may migrate. Mere congruity of caste names in any two states could still not make any difference.59

creamy layer The expression ‘creamy layer’ with a frothy skimmed milk product as an imagery to the elitist among the ‘backward class’ is the result of no churning or shaking up taking place in any particular community. As a legal expression, it is imprecise but it has come to stay while explaining

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the need to keep off the wards of a privileged class of bureaucracy and economically rich from vying for any quota in the field of education. In Kumari Jayashree v. State of Kerala,60 the state government prescribed an aggregate annual income less than Rs 10,000 among Ezhavas to qualify for status as socially and educationally backward. The commission that made the recommendation purported to have made a study that showed that (1) the rich, though uneducated were able to move up in society without discrimination; (2) the rich cornered the benefit of existing reservation to the exclusion of poor in the same community; and (3) that the wealthy did not have any caste or communal disabilities. The challenge to the government decision was repelled by the Supreme Court holding that social backwardness was largely the result of poverty and a means test a relevant one at that. Who has not heard of a ‘rich backward’ and ‘poor forward’? But the indignities and innuendos of social exclusion of the rich amongst lower castes are real and that is justification enough not to apply this test to SC/ST communities. This has come to be applied only to OBCs. The majority opinion in Indra Sawhney I 61 made the exclusion of creamy layer as mandatory and Indra Sawhney II 62 went as far as to say that non-exclusion would violate basic structure. Ashok Kumar Thakur v. Union of India 63 directly confronted the issue, while dealing with the challenge to the validity of Central Education Institutions (Reservation of Admission) Act, 2006, which did not provide for exclusion of creamy layer among socially and educationally backward classes. The court quoted Indra Sawhney as laying down a mandate for exclusion. It interpreted Section 2(g) of the act that defined ‘backward class’ to exclude the creamy layer. Following Indra Sawhney I, the Central Government has issued a notification dated 8 September 1993 specifying the four categories: (A) Children of holders of constitutional posts;64 (B) Service category;65 (C) Professional category;66 and (D) Property owners.67

institutional preference Jagdish Saran v. Union68 was a case where 70 per cent of the seats in the postgraduate medical course in at Delhi University were reserved in favour of Delhi University graduates keeping the remaining 30 per cent open to all including the graduates of Delhi University. The Court said rather unconvincingly:

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The student has become familiar with teaching techniques and standards of scholarship, and has adjusted his responses and reactions accordingly. The continuity of studies ensures a higher degree of competence in the assimilation of knowledge and experience. Not infrequently some of the same staff of Professors and Readers may lecture to the postgraduate classes also. Over the undergraduate years the teacher has come to understand the particular needs of the student, where he excels and here he needs a special encouragement in the removal of deficiencies.

It would seem then that this principle could be justified only for postgraduate courses in the same institution but not for first-time entry in a graduate course. In Pradeep Jain,69 institutional preference to a limit of 50 per cent was approved and the court suggested that there shall be a review of the percentage once in three years by the MCI and further clarified that the preference shall be in the same medical college or university. The court did not approve of any form of reservation to super specialty courses. A later judgment further clarified that institutional preference could not be college-wise preference but must be university-wise.70 The judgment in Dinesh Kumar(II)71 restricted it to 25 per cent but with Saurabh Chaudri v. Union of India,72 not merely the principle but also the percentage of reservation to 50 per cent stands fully re-affirmed.

working the principles The proper and correct course is to first fill up the OC quota (50 per cent) on the basis of merit; then fill up each of the social reservation quotas, that is, SC, ST, and BC; the third step would be to find out how many candidates belonging to special reservations have been selected on the above basis. If the quota fixed for horizontal reservations is already satisfied—in case it is an overall horizontal reservation—no further question arises. But if it is not so satisfied, the requisite number of special reservation candidates shall have to be taken and adjusted/accommodated against their respective social reservation categories by deleting the corresponding number of candidates therefrom. If, however, it is a case of compartmentalized horizontal reservation, then the process of verification and adjustment/accommodation as stated above should be applied separately to each of the vertical

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reservations. For every allocation made to either the general quota or vertically reserved quota, the lower most people in the merit list in that quota would miss out.73 It is sometimes difficult to operate these principles as it was experienced in State of Bihar v. M. Neethi Chandra,74 where in the matter of allotment of seats in various branches of the postgraduate medical courses in the state of Bihar, some candidates in the reserved categories found themselves in a disadvantageous position. The candidates in various reserved classes who could qualify on merit were treated at par with the general candidates and were allotted branches which would fall to them on merit-cum-choice basis. This led to the allotment of such courses, which because of their low position in general merit, were not of their choice while the course/college of choice was available to a candidate qualifying for the reserved seat although they were lower in merit position.

Is Reservation Antithetical to Merit? In R. Chitralekha v. State of Mysore,75 Janki Prasad Parimoo v. State of J&K 76 as also in Balaji 77 it seems to have been assumed that reservation necessarily implies selection of less meritorious persons but a slightly different perspective obtained in the expression of majority judgment in Indra Sawhney78 in the following words: The relevance and significance of merit at the stage of initial recruitment cannot be ignored. It cannot also be ignored that the very idea of reservation implies selection of a less meritorious person. At the same time, we recognise that this much cost has to be paid, if the constitutional promise of social justice is to be redeemed. We also firmly believe that given an opportunity, members of these classes are bound to overcome their initial disadvantages and would compete with—and may, in some cases, excel—members of open competition. It is undeniable that nature has endowed merit upon members of backward classes as much as it has endowed upon members of other classes and that what is required is an opportunity to prove it. It may not, therefore, be said that reservations are anti-meritarian. Merit there is even among the reserved candidates and the small difference that may be allowed at the stage of initial recruitment is bound to disappear in course of time. These members too will compete with and improve their efficiency along with others. (SCC p. 751, para 836)

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In Ajay Kumar Singh v. State of Bihar,79 the Supreme Court attempted to rationalize that since reservation was only at the stage of entry and not at the stage of exit when they emerge as one single class passing out the same examinations, there was no compromise on merit but this reasoning was soon dropped, as we have seen above in Preeti Srivastava.80

Summing Up the Principles (1) A provision for reservation must be within reasonable limits. (2) There can be a reasonable classification based on intelligible differentia for the purpose of Articles 15(1), 15(4), and 29(2). (3) There can be reservation for persons belonging to areas which are socially and educationally backward. (4) A rural area is not a class by itself and cannot be considered to be socially and educationally backward merely because it is a rural area. (5) Admission to postgraduate courses should be strictly based on merit. (6) The merits of the candidates seeking admission to higher educational courses shall be judged by a uniform standard and for that purpose holding an entrance examination is the best method. (7) There shall be no dilution of standards in higher educational courses and in particular, postgraduate courses.81 The renowned constitutional law expert Seervai, in his book on constitutional law,82 would deduce five circumstances when reservation has been supported in the field of education: (1) reverse discrimination permitted for (i) socially and educationally backward classes and (ii) members of SC and ST community; (2) state-wise discrimination based on geographical classification, that might fall outside Article 15(1) and (4) but might still be supported under Article 14 on the ground that state has to contribute for the running and upkeep of institutions and it would not be unreasonable that the benefit should accrue to the state not only by encouraging education but by providing trained doctors, many of whom would serve the State;83 (3) geographical classification reasonably related to the object providing better opportunities for students coming from backward areas in a state; (4) protective discrimination on the ground that since every other university discriminated

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against students of other universities, protection is to be extended to students of the same university; and (5) institutional preference. MEDICAL COLLEGES

General So long as the medical colleges were all established only by the government, the cost of medical education never gained popular attention. When private participation became inevitable by compulsions of demand and supply, the government could not have expected charity from the private players to absorb the costs in offering education. Of non-government medical colleges are ‘minority-run’ and also nonminority private management institutions. Kasturba Medical College established at Manipal was perhaps the first of the private medical colleges that introduced the concept of ‘capitation fee’ an expression that has come to mean a fee above the fee prescribed in government colleges and what are believed to be reasonable. It is in recognition of two factors: first, that the management that established a college could charge a fee more than what is approved for government colleges and second, the management would have a certain degree of autonomy for regulating its admissions. Inevitably, the corollary was that the admission could be otherwise then on merit and the price for admission was settled purely on economic considerations of market forces. This trend led to legislative and judicial activities as well; the former, in its bid to lay down a state share of admission after a common entrance examination minding issues of merit and at the same time prescribing percentage of reservation and the latter, by regulating the fees payable and settling contentious issues of the extent of autonomy that privately managed minority and non-minority institutions could exercise.

Judiciary as Watchdog: A Case of Excessive Regulation

capitation fee: a major irritant Reference to capitation fee was first raised in D.P. Joshi v. State of M.B. 84 in the context of state law allowing for differential rates of tuition fees for residents of the state and a higher fee for students from other states.

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In Mohini Jain v. State of Karnataka,85 the Supreme Court restricted D.P. Joshi to justify a classification only on the ground of residence and held that the capitation fee as a consideration for admission was not admissible under the scheme of the Constitution.The plea on behalf of the college that the fee for ‘government seat’ for meritorious students at a rate specified for a government college took care of merit and a higher fee was only for persons that did not have merit was rejected, when the court said: This practice strikes at the very root of the constitutional scheme and our educational system. Restricting admission to non-meritorious candidates belonging to the richer section of society and denying the same to poor meritorious is wholly arbitrary, against the constitutional scheme and as such cannot be legally permitted. Capitation fee in any form cannot be sustained in the eyes of law.The only method of admission to the medical colleges in consonance with fair play and equity is by ways of merit and merit alone.

The court still did not attempt to say as to how the college must bear the expense of education of a student, if the fee for a ‘government seat’ was subsidized. It did not also attempt to say if the government must indemnify the college management for the fee in excess of the fee prescribed by the government for admission in government run medical colleges. Unnikrishnan, J.P. v. State of A.P.86 partly overruled Mohini Jain when it approved of dichotomy between government colleges prescribing their usual fee and a private unaided recognized/affiliated educational institutions that could charge a higher fee which shall not be called a capitation fee, but a fee which will still be regulated by the state. It observed that the state prescribed limit may not still cover the costs and said that they have to meet the cost of imparting ‘from their own resources—and the main source, apart from donations/charities, if any, can only be the fees collected from the students’. This judgment therefore recognized a new genre of colleges called as self-financing institutions. The court was still unconvincing in spelling out how the element of charity could come from private institutions and it attempted to device a method of assigning to the state some beneficent role, such as providing grants or aid. The aid, it said, could take several forms; it could also be in the form of permitting private medical colleges to avail themselves of the services of a government hospital for the purpose of the college, free of charge.

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directions in unnikrishnan The two-tier educational system that the court approved resulted in bringing in new concepts like ‘government seats’ and ‘payment seats’. The former, also called ‘free seats’ were those over which the government or the university would have a right to dictate for selection strictly on the basis of merit upto 50 per cent. The remaining 50 per cent of the seats were to be called the ‘payment seats’ to which candidates willing to pay the higher fee would be allotted on inter se merit. The Andhra Pradesh law allowing for power to management to admit students who qualified in entrance exams irrespective of their ranking in the exams was struck down. The respective legislation of Karnataka, Maharashtra, and Tamil Nadu that did not give such privilege to the private managements was held intra vires the constitution. The activist role was at its acme, when the court was regulating admissions with its directions: (1) there shall be no management quota; (2) reservations were permissible (this came in by a recognition that the private institutions were actually performing an action of the state and therefore amenable to the dictates of Article 14); (3) competent authority alone shall conduct all admissions/common entrance examinations for entire state; (4) number of seats for intake of students shall be prescribed and made subject to terms of affiliation/recognition; (5) decision regarding fee to be determined by a committee or competent authority; (6) only recognized/affiliated colleges that subscribed to the scheme shall be permitted to participate in the admission process and send the applicants through the colleges to take the entrance exams; (7) 5 per cent seats shall be admissible to NRI students in the quota for ‘payment seats’ on the basis of merit to be judged by the college concerned and not on the basis of entrance examination at a fee specifically provided in the scheme; and (8) for minority educational institutions, the quota of 50 per cent other than the ‘free seats’ could be filled up from persons belonging to the minority community on the basis of inter se merit. Having set down elaborate procedures of regulation through a scheme formulated by it as applicable to all institutions other than colleges run by the government or university, the court retained to itself the power to implement the scheme. The court expected a statutory evolution to the scheme by the state machinery incorporating it in rules under appropriate state enactments.

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t.m.a. pai foundation on unnikrishnan’s rubble Unnikrishnan was waiting to be busted both at the legislative and the judicial levels. For one thing, the judiciary had literally laid down directions on how professional colleges shall be established and run. The scheme that it floated was an extensive piece of judicial legislation. The court invoked Indian ethos of charity, a lost quality, as a norm that should guide private players to self-finance institutions to promote the cause of education without so much looking for returns. By raising a question whether to receive education is a fundamental right, the court was simultaneously raising a question in corollary, whether right to establish an educational institution was a fundamental freedom guaranteed under Article 19(1)(g). The minority-run institutions began to flex their muscles to assert their autonomy and the non-minority private institutions were livid that they faced an unfair deal in comparison to minority institutions. The court’s interpretations of Articles 29 and 30 had allowed minority run institutions to have autonomy even if their institutions promoted only secular education and did nothing for language, religion, or culture that the particular minority purported to foster.There was a well-entrenched political class that had enough money in their hands who could launder their black money through the medical colleges that brought respectability to their social standing as builders of modern India. Unnikrishnan rocked the apple cart violently and the Supreme Court delivered the denouncement in T.M.A. Pai Foundation v. State of Karnataka through four decisions,87 attempted to give effect to the judgment by setting up committees to determine fee structure as well as regulate admissions in Islamic Academy of Education v. State of Karnataka88 and declared in P.A. Inamdar89 that Islamic Academy wrongly interpreted the issue of state control in enforcing rule of reservation for minority institutions. Phase I Unnikrishnan was demolished brick by brick. In the first phase, the problem was in the manner of implementing the fee structures which according to the managements were unrealistic. Of the four states in south India, Karnataka had the lowest rates for payment seats; Maharashtra and Tamil Nadu were relatively higher. In Andhra Pradesh there was no attempt to prescribe any. Kerala had been left unhooked, since the private colleges were run as minority institutions.

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The non-minority private management vented their grievance that minority institutions did not go through the rigor of the unviable fee structures. Kasturba Medical College found a method of beating the regulations by filling up 50 per cent of the payment seats with foreign students. The court winked at the deviance as minor and increased the NRI intake from 5 to 15 per cent. The Supreme Court began with stipulating fees payable, a la settling prices of commodities in local markets. It directed that the medical colleges shall be categorized into three classes for the purpose of fixation of fee payable by the payment students. Category (1) shall comprise medical colleges which have their own hospital facility. Category (2) shall comprise medical colleges partly utilizing the facilities of the government hospitals and partly their own hospitals and Category (3) shall comprise those medical colleges who do not have their own hospital facility but depend entirely on the government hospitals for training students. For Category (1), it determined the fee payable at Rs 1,40,000 per annum, for Category (2) at Rs 1,20,000 per annum, and for Category (3) Rs 1,00,000 per annum. Here, Unnikrishnan was approved, explained but modified. The percentage of admission to NRIs that had been raised to 15 per cent was reduced to 10 per cent for the year 1994–590 and again raised to 15 per cent.91 Phase II The die had been cast, when unfair treatment of non-minority of private educational institution was expressed in T.M.A. Pai Foundation (I ). Just not the fee structure but the autonomy that minority institutions enjoyed in the manner of picking up 50 per cent of minority students raised eyebrows of apprehension on the correctness of the decision in St Stephen’s College case.92 It wondered: So long as the minority educational institution is permitted to draw students belonging to that minority to the extent of 50 per cent seats even by going down the merit list, we see no reason why the state/affiliating university cannot stipulate that the general students as well as minority students must all be drawn only from the common merit pool and that even the minority community students must also be admitted on the basis of inter se merit determined on the basis of common/ joint entrance test. Article 30, in our opinion, does not clothe a minority educational institution with the power to adopt its own method of

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selection of students. It is not a part of the minority character of the institution. The said requirement is but a piece of regulation which the state/affiliating university can prescribe in the interest of fairness and maintenance of standards.

When a seven-member bench was constituted, the court wanted to examine whether the scheme framed in Unnikrishanan was itself applicable and whether the rules and orders made by several state governments on the basis of the decision were tenable. It reframed one of the questions to examine a more fundamental question as to what the expression minority educational institution would connote and signify. Every year college managements, government, and public bodies were approaching the court for directions and there seemed no consensus on any issue relating to fixation of fee structure, percentage of intake of NRI students and the degree of control of states for unaided, nonminority private colleges and aided and unaided minority colleges.93 Phase III The 11-member bench of the Supreme Court in T.M.A. Pai v. State of Karnataka94 most famously said that the scheme framed in Unnikrishnan was unconstitutional except where it held that primary education is a fundamental right. A right to administer an educational institution shall also be a fundamental right protected under Article 19(1)(g). Imparting education is a useful activity, whether for charity or for profit and is an occupation; even though an occupation, it cannot be equated to a trade or a business. The principle that there should not be capitation fee was therefore also held as correct but there could be reasonable surplus to meet cost of expansion, and augmentation of facilities does not however amount to profiteering. It recognized the importance of private unaided educational institutions by citing dismal figures that while the number of government colleges in certain states had remained stagnant, private institutions had constantly mushroomed. In case of unaided institutions the regulatory measure of control should be minimal, though conditions of recognition and of affiliation have to be complied with. Fees charged by unaided institutions cannot be regulated but they cannot charge capitation fee. In Islamic Academy, the Court took notice of the several statutes and regulations made in various states fixing the fees and directed that in each state, a committee headed by a retired high court judge shall be nominated

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by the chief justice of that state, with other members being a chartered accountant of repute, a representative of the MCI or All India Council for Technical Education (AICTE), and secretary of the state government in charge of medical education or technical education as secretary of the commission. The committee should be free to nominate/co-opt another independent person of repute, so that the total number of members of the committee shall not exceed five. Each educational institute must place before this committee, well in advance of the academic year, its proposed fee structure. Along with the proposed fee structure all relevant documents and books of accounts must also be produced before the committee for their scrutiny.The committee shall then decide whether the fees proposed by that institute are justified and are not profiteering or charging capitation fee. The committee will be at liberty to approve the fee structure or to propose some other fee which can be charged by the institute. The fee fixed by the committee shall be binding for a period of three years, at the end of which the institute would be at liberty to apply for revision. Once fees are fixed by the committee, the institute cannot charge either directly or indirectly any other amount over and above the amount fixed as fees. If any other amount is charged, under any other head or guise, that is, donations, the same would amount to charging of capitation fee. The person or persons establishing an educational institution who belong to either religious or linguistic group who are less than 50 per cent of the total population of the state in which educational institution is established would be linguistic or religious minorities. State would be the unit which would be the criterion for determining the minority status. But the question whether followers of a sect or denomination of a particular religion could claim minority status even though followers of that religion are in majority in that state was left undecided.The issue of whether the indicia for treating an educational institution as a minority educational institution shall be on the basis of the minority status of person(s) who established and administered the institution was also left unanswered. The minorities’ rights, it said, include a right to establish educational institution but the state shall have the power to prescribe norms for selection on merit basis. It could also direct that a reasonable number of non-minority students to be admitted which the state could stipulate having regard to the type

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of institution, the courses of education, population, and educational needs. Rigid percentage spelt out St. Stephen’s case was modified to that extent without affecting the basic ratio of that decision setting out the contours of autonomy. Even unaided minority institution cannot ignore merit. In case of aided institution, the state can regulate the admission which has to be merit based subject to reservation policy of the state qua non-minority students. Article 30(1) is subject to Articles 29(2) and 28(3). To effectuate Article 30(1), minority educational institutions, while giving preference to students of that minority may admit students of non-minorities up to 50 per cent based on their inter se merit, subject to actual requirements of minorities. Even though the words of Article 30(1) are unqualified, certain other laws of the land pertaining to health, morality, and standards of education apply. The right under Article 30(1) is therefore not absolute or above other provisions of the law. By the same analogy, there is no reason why regulations or conditions concerning, generally, the welfare of students and teachers should not be made applicable in order to provide a proper academic atmosphere; as such provisions do not in any way interfere with the right of administration or management under Article 30(1).95 As regards non-minority unaided private institutions, a ‘certain percentage’ of students shall be permitted to be admitted by the management and the rest of the seats shall be filled up by the students after joint entrance exam conducted by the state and after counseling. As regards minority-run unaided institutions, a ‘different percentage’ for the management to admit students of their own community/language in preference to a student of another community and in both cases, the percentage shall be fixed by the state on the basis of local needs of each state. The expression relating to percentage and how the respective management will fill up their quota was again clarified in Islamic Academy. The management could select students, of their quota, either on the basis of the common entrance test conducted by the state or on the basis of a common entrance test to be conducted by an association of all colleges of a particular type in that state, that is, medical, engineering, or technical, etc. The common entrance test, held by the association, must be for admission to all colleges of that type in the state. The option of choosing between either of these tests must be exercised before the issuing of prospectus and after intimation

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to the concerned authority and the committee set up herein after. If any professional college chooses not to admit from the common entrance test conducted by the association then that college must necessarily admit from the common entrance test conducted by the state. In P.A. Inamdar, while reiterating T.M.A.Pai that minority unaided and non-minority unaided private institutions could legitimately claim an unfettered right to choose the students to be allowed admission, the procedure for such admission shall be fair, transparent, and nonexploitative. If the admission procedure adopted fails this test, the state could itself substitute a procedure. Till regulations were framed for a centralized single window procedure, the admission committee could oversee admissions in these institutions so as to ensure that merit was not a casualty.

capitation fee saga continues The scourge of capitation fees has not abated,notwithstanding legislation brought in almost every state to curb the practice and the decision in T.M.A. Pai Foundation. National dailies are replete with news that the price of an MBBS seat is anywhere in the region of 35,00,000, while the admission cost for postgraduate course is 70, 00,000 to 1.5 crores.96 The union cabinet is reported to have approved amendments to the Prohibition of Unfair Practices in Technical Educational Institutions, Medical Educational Institutions and Universities Bill, 2010, as per the recommendations made by the Parliament Standing Committee on Human Resource Development that proposes to impose a fine of Rs 1 crore against the institution charging capitation fees.97 Politicians, including MPs and MLAs, are themselves the founders of many an institution and it is most likely that it does not become law or if it does, there is very little likelihood that it will be enforced. The Supreme Court for the first time in the P.A. Inamdar case after the Modern School case98 discussed the concepts of revenue expenditure vis-à-vis reasonable surplus, reiterating its earlier stand, but this time, backing it with a cogent reason for the institutions to earn reasonable surplus in the following words: ‘Equally, a reasonable surplus should be permitted so that the fees charged cover the entire revenue expenditure and in addition leaves a reasonable surplus for future expansion. This alone would prevent the clandestine collection of capitation fees and would result in entrepreneurs investing in new medical colleges.’

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FOREIGN UNIVERSITIES AND MEDICAL EDUCATION

General Given the high cost of medical education and extermination of merit as criterion with a large slice of reservation quota, it is not surprising that candidates started looking beyond Indian shores for admission into foreign universities. Entry into universities in the UK or the US or any of the English speaking countries were still out of bounds owing to relatively higher costs and extracting standards of merit assessment.The erstwhile Soviet Union was emerging as a viable option for pursing medical courses. The breaking of Soviet Union and relaxation of state control from every sphere encouraged several racketeers from eastern European countries to thrive by soliciting admissions to institutions of doubtful merit. Students were also prepared to try getting admissions in China, Nepal, Philippines, and Caribbean countries purely on economic considerations of lower cost of education. The Government of India intervened with advisory that students purporting to have completed graduate courses in medicine cannot register as practitioners without undergoing eligibility test. The rigour got firmer with directions from the Supreme Court to the MCI to frame regulations. There have been periodical regulations from 2002 onwards that set norms for screening tests except for medical courses in Australia, Canada, the UK, the US, and New Zealand which are per se recognized by the MCI for registration as a medical practitioner in India.

Medical Council Regulations The Medical Council of India Screening Test also known as Foreign Medical Graduates Examination (FMGE), is a licensure examination conducted by the National Board of Examinations (NBE). The test is one of the mandatory requirements for an Indian citizen, who has a medical degree from a college affiliated to a university outside India, to practice medicine in the country.99 The other requirement is a compulsory one-year internship at an Indian hospital attached to a medical college (teaching hospital) at the MCI recognized hospital or even outside India but internship completion certificate has to be attested by the Indian mission embassy or consulate office. These regulations applied to any Indian citizen who is desirous of taking admission in an undergraduate medical course abroad on or after 15 March 2002.

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Eligibility Requirement Regulations and Screening Test Regulations, both of 2002, were formulated under the directions of the Supreme Court100 and upheld as enforceable by the MCI as a competent body to prescribe the norms of medical practice in India.101 The requirement of screening test is mandatory to any student from any foreign university, other than the foreign universities from the five countries mentioned above and there shall be no exception from the applicability of this regulation even to persons qualifying from universities expressly stated as recognized by the MCI.102 The degree from the institute of study in a foreign country shall also be one which is recognized in the foreign country, which is the primary medical qualification for taking the screening test.103 The results in the screening tests in 2009 to 2011 gave a poor pass percentage of 16.2 per cent to 26 per cent, which is an indication that a degree from a foreign university is not to be assumed as superior to a degree from Indian universities. NOTES 1 A plaque in the General Hospital reads thus: ‘Madras General Hospital was founded in the year 1664, rebuilt in 1692, demolished and rebuilt in 1711, removed in 1753, extended in 1858, 1874, 1884, 1894 and 1897’. 2 The National Medical Journal of India, 23(2)(2010). 3 Available at http://www.medicalcollegekolkata.org (last visited 27 December 2012). 4 The National Medical Journal of India, 23(2)(2010). 5 Bachelor of Medicine is represented by the letters ‘MB’ and Master of Surgery is represented by letters ‘CM’, which in Latin is Magister Chirurgiae. 6 Ministry of Health and Family Welfare (MOHFW). Report of the Health Survey and Planning Committee, 1961. Available at http://nihfw.org/NDC/ DocumentationServices/Reports/Mudalier%20%20Vol.pdf. 7 Schedule 7, List C, Entry 25 of the Constitution of India. 8 Section 19 of the act. 9 Ibid. 10 (1999) 7 SCC 120. 11 (2000) 1 SCC 750. 12 (2002) 7 SCC 258. This position was reiterated in the subsequent rulings as well. See Mridul Dhar v. Union of India (2005) 2 SCC 65; Vikran Dhillon v. State of Haryana (2007) 9 SCC 408. In a still recent judgment in Priya Gupta v. State of Chhattisgarh (2012) 7 SCC 433, the Supreme Court outlined the adverse consequences of non-adherence to the prescribed schedules, and

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condoning delayed admission as resulting in (1) principle of admission on merit would be defeated and meritorious students would not get college/ course of their choice and preference; (2) midstream admission and extension of periods of admission would delay commencement of course and thus lower standard of education and give scope for adopting impermissible practices; (3) inequities would be created which would be prejudicial to both students and colleges; and (4) highly competitive standards for admission to such colleges would stand frustrated. 13 T.C. (c) No 98 of 2012 dated 18 July 2013. 14 (1974)1 SCC 717. 15 (1992) 1 SCC 558. 16 (2002) 8 SCC 421. 17 (2003) 6 SCC 697. 18 (2005) 6 SCC 537. 19 (1) Death of a supporting guardian; (2) illness of the candidate causing disability, and (3) Disturbed conditions as declared by the Government in the medical college area. 20 Medical Council of India v. Silas Nelson (1993) 3 SCC 184. 21 Soham Mayankkumar Vyas v. Union of India (2010) 13 SCC 137. In this case, a student having passed from dental college established in Mauritius and affiliated to Bhavnagar University, Gujarat, with permission from the Central Government and the Dental Council of India was held not required to pass screening test that was otherwise necessary for a student from a foreign university. 22 In Jagdish Saran v. Union AIR 1980 SC 820, the SC said, ‘We are aware that measurement of merit is difficult and the methods now in vogue leave so much to be desired that swearing by marks as measure of merit may even be stark superstition. But, for want of surer techniques we have to make do with entrance tests, and at any rate, save in clear cases of perversity or irrationality, this is ordinarily out of bounds for courts.’ 23 (1971) 1 SCC 436. 24 (1980) 4 SCC 95, AIR 1980 SC 1975. 25 (1981) 1 SCC 722, AIR 1981 SC 487. 26 (1981) 2 SCC 484. 27 Such law could be through legislation or an executive order or rule or regulation, see Article 12 for the meaning of law. Also, M.R.Balaji v. State of Mysore AIR 1963 SC 649; Comptroller and Auditor General of India v. Mohan Lal Mehrotra AIR 1991 SC 2288, Indra Sawhney v. Union of India AIR 1993 SC 477. 28 Indian Medical Association v. Union of India (2011) 7 SCC 179. In this case the challenge to the admission policy of society was made by the Indian

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Medical Association itself, apart from a prospective student who was not a ward of any army personnel. 29 AIR 1963 SC 649. This judgment must be read along with Heggade Janardhan Subbarye v. Mysore AIR 1963 SC 702 and R.Chitralekhav. Mysore AIR 1964 SC 1823. The former ‘clarified’ Balaji to say that reservation on the basis of caste was not to be invalidated; the latter ‘explained’ Balaji by saying that though caste was a relevant test for determining the social backwardness of citizens, it was not obligatory to apply that test and a determination of social backwardness was not void merely because it ignored caste if such determination was based on other relevant criteria. 30 For further commentaries on the percentage of reservation see Chapter 1. 31 (2008) 6 SCC 1. 32 Indira Sawhney v. Union 1992 Supp (3) SCC 217. 33 AIR 1976 SC 939. 34 C.M.Arumugham v. S.Rajagopal (1976) 3 SCR 82, AIR 1976 SC 939. 35 State of U.P. v. Pradip Tandon (1975) 1 SCC 267, (1975) 2 SCR 761. The Supreme Court said, ‘Poverty in rural areas cannot be the basis of classification to support reservation for rural areas.’ 36 Arti Sapru v. State of J & K (1981) 2 SCC 484, AIR 1981 SC 1009. 37 (1980) 4 SCC 85, AIR 1980 SC 1975. 38 See note 19 earlier. 39 Suneel Jatley v. State of Haryana (1984) 4 SCC 296, AIR 1984 SC 1534. 40 (1984) 3 SCC 654. 41 (1995) 2 SCC 762. 42 Magan Mehrotra v. Union of India (2003) 11 SCC 186. In this case the 15 per cent reservation of residents of Delhi for persons who competed on all-India basis was found to be bad, but the court held that if this reservation were to be made on the basis of institutional preference as explained in Pradeep Jain (Dr) v. Union of India (1984) 3 SCC 654 it could pass the test of legality. 43 (1981) 4 SCC 296, AIR 1981 SC 2045. 44 (1994) 4 SCC 401. 45 (1999) 7 SCC 120. 46 (1969) 2 SCC 228. 47 Unnikrishnan v. State of UP (1993) 1 SCC 645. 48 (1994) 3 SCC 552. 49 AIR 1965 Ker 1628. 50 (1995) 5 SCC 173. 51 AIR 1963 SC 649. 52 AIR 1992 SC 1630, 1991(2)SCALE 1217, (1992)1 SCC 558. 53 (2002) 8 SCC 481. 54 (1980) 2 SCR 831, AIR 1980 SC 820.

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55 A principle approved and explained in Indra Sawhney v. Union of India AIR 1993 SC 477. 56 (1995) 2 SCC 560. 57 (1995) 5 SCC 173. 58 Marri Chandra Shekhar Rao v. Seth G.S. Medical College (1990) 3 SCC 130. 59 Action Committee on Issue of Caste Certificate to SCs/STs v. Union of India (1994) 5 SCC 244. 60 AIR 1976 SC 2381. 61 AIR 1993 SC 477. Justice Ratnavel Pandian said that the exclusion was not keeping in with the constitutional mandate. According to him, since the socially and educationally backward classes have common attributes it would not be possible to further classify them using a means test. He maintained that varying salaries every year and the prospect of government servants deliberately slicing down the number of working days to receive less salary within the limit could cause confusion. 62 AIR 2000 SC 498. 63 (2008) 6 SCC 1. 64 President of India,Vice-President, Judges of the Supreme Court and high courts, Chairman and members of UPSC and State PSC, CEC, and CAG. 65 Children of parents, Group A Class I officers of All India Civil Services and State Services (direct recruits) where both or one of the parents are Class I officers, subject to certain conditions; Children of Group B/Class II officers of the Central and State Services (direct recruits), subject to certain conditions. 66 Children of those in professional class or those engaged in trade and industry beyond a particular income limit. 67 Owners of agricultural holdings, plantations, vacant land or buildings in urban areas or urban agglomerations holding property beyond a particular extent as being outside Backward Classes. 68 AIR 1980 SC 820 69 (1984) 3 SCC 654. The Supreme Court purported to lay down an All India criterion for admission in this case, where the challenge was to an admission notification in Delhi University, the Union Territory of Delhi but it is important to remember that so far as there is no central legislation laying down uniform criteria throughout India. However, most of the states have now local legislation providing similar criteria including provision for reservation upto 50 per cent by way of institutional preference and the Supreme Court seemed to recognize the inherent fallibility in the type of directions issued in Pradeep Jain and in Saurabh Chaudri v. Union of India (2003) 11 SCC 146 exhorted the Parliament to make necessary legislation in that regard taking into consideration the special needs of some small states having regard to their backwardness.

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70 Municipal Corporation of Greater Bombay v. Thukral Anjali Deokumar (1989) 2 SCC 249. 71 (1986) 3 SCC 727. 72 (2003) 11 SCC 146. 73 Anil Kumar Gupta v. State of U.P. (1995) 5 SCC 173. 74 (1996) 6 SCC 36. 75 AIR 1964 SC 1823. 76 (1973) 1 SCC 420. 77 AIR 1963 SC 649. 78 1992 Supp(3) 217. 79 (1994) 4 SCC 401. 80 (1999) 7 SCC 120, see note 30 above. 81 Narayan Sharma (Dr) v. Pankaj Kr. Lehkar (Dr) (2000) 1 SCC 44 82 H.M. Seervai, Constitutional Law of India: A Critical Commentary, Vol. 1, 4th edition (Nagpur: N.M. Tripathi Pvt Ltd,1991). 83 D.P. Joshi v. State of M.B. AIR 1955 SC. 84 AIR 1955 SC 334. 85 (1992) 3 SCC 666. 86 (1993) 1 SCC 645. 87 Two five-member benches of the court reported in (1993) 4 SCC 276 and (1993) 4 SCC 286, seven-member bench decision reported in (1994) 2 SCC 734 and an 11-member Bench in (2002) 8 SCC 481. 88 (2003) 6 SCC 697. 89 P.A. Inamdar v. State of Maharashtra (2005) 6 SCC 537. 90 (1994)4 SCC 728. 91 (2005) 6 SCC 537. 92 See notes 43 and 44 earlier. 93 There were directions literally every year till a larger 11-member bench was constituted: see, for instance, TMA Pai (1995) 4 SCC 211; (1995) 5 SCC 220; (1996) 5 SCC 8; (1998) 9 SCC 477 (direction against college in Maharashtra from claiming double the fee from non-residents for payment seats as fees paid for the same category from students of Maharashtra). 94 (2002) 8 SCC 481. 95 Notwithstanding this law, a Full Bench of the Punjab and Haryana High Court in Gurleen Kaur v. State of Punjab (2009) 3 RCR (Civil) 324, (2009) 5 SLR 690 approved of the decision of a ‘minority sikh institution’ running a medical college the admission norms denying the right to be considered in minority quota of any male claiming to be sikh who trimmed his beard or cut his hair and any female sikh who tweezed her eye brow! The judgment was the result of raising a wrong question of what constituted the essential tenets of Sikhism, instead of the question whether such a mode of determining admission criteria was relevant to admission for a medical college.

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96 TheTimes of India, 12 April 2012. 97 The Hindu, 16, November 2011. 98 Modern School v. Union of India (2004) 5 SCC 583. 99 The location of the college in a foreign country alone is not relevant.The affiliation of the college shall be to a foreign university. In Soham Mayankkumar Vyas v. Union of India (2010) 13 SCC 137, a student having passed from dental college established in Mauritius and affiliated to Bhavnagar University, Gujarat, with permission from Central Government and the Dental Council of India was held not required to pass screening test that was otherwise necessary for a student from a foreign university. 100 Medical Council of India v. Indian Doctors from Russia Welfare Associations (2002) 3 SCC 696. 101 Sanjeev Gupta v. Union of India (2005) 1 SCC 45. 102 Yash Ahuja v. Medical Council of India (2009) 10 SCC 313. 103 Mohd.Ibrahim v. Vinayaka Mission University (2012) 4 SCC 190.

2

Medical Ethics

Ethics is a discipline in the realm of moral philosophy. It is now common to refer to ethical judgments or to ethical principles where it would once have been more accurate to speak of moral judgments or moral principles. In earlier usage, the term referred not to morality itself but to the field of study or branch of inquiry that has morality as its subject matter. In this sense, ethics is equivalent to moral philosophy. It deals with what is right and what is wrong and, as a dialectical principle in the field of medicine, examines what actions are appropriate for the doctor, what is good for the patient, and what is acceptable by the society. It is not a set body of rules, though a supervisory body may periodically issue directions to regulate the conduct of doctors vis-à-vis their relation to patients, amongst themselves, and in medical research. These regulations shift along with changing mores and have an intimate bearing with the epistemological construct of what life is all about. The doctor–patient relationship, organ transplant, medical termination of pregnancy, assisted reproduction, surrogacy, cloning, euthanasia, etc., shall gain our immediate attention, as they are central to the ethical concerns of the professional practice of medicine though we will also examine what is appropriate in biotechnology, medical research, and clinical practice. In short, the subject of ethics consists of the fundamental issues of practical decision-making, and its major concerns include the nature of ultimate value and the standards by which human actions can be judged right or wrong.1

Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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HISTORICAL PERSPECTIVE Medical ethics find expression through physician Hippocrates (460– 377 bce), in whose name doctors take an oath to inculcate the qualities of a good physician, with an emphasis on healing the patient. Healing suggests a holistic approach than the present terminology of curing a patient. ‘Heal’ derives from old English ‘haelen’, meaning to become whole or sound. ‘Cure’ derives from the Latin ‘curare’, meaning to get rid of disease. Curing is associated with disease, whereas healing is associated with illness. Benefiting the sick and doing them no harm is the Hippocratic refrain, and the oath resounds with advice to the physician to ‘follow the method of treatment which, according to my ability and judgments, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous’. Beneficence and non-maleficence are the first articulated ethical precepts that set the physician–patient framework. The medical practices of ancient India had a similar approach to healing the patient, rather than merely prescribing a cure for the disease. Ayurveda calls upon the physician to treat the patient as a whole: ‘Dividho jayate vyadih, Sariro manasasthatha, Parasparanz tavorjanma, Nirdvadvam nopalahhyate.’ (‘Diseases occur both physically and mentally, and even though each part might be dominant, they cannot be compartmentalized.’) Ayurveda treats man as a whole body, including the mind and what is beyond the mind. The earliest protagonists of Indian medicine, such as Atreya, Kashyapa, Bhela, Charaka, and Susruta have based their writings on the foundations of spiritual philosophy and ethics. But the teacher of Ayurveda who established the science on the foundation of spirituality and ethics was Vagbhata, the author of Astanga Hridaya. Vagbhata says, ‘Sukarthah sarvabutanam, Matah sarvah pravarthayah, Sukham ca na vina dharmat, thasmad dharmaparo bhavet.’(‘All activities of man are directed to the end of attaining happiness, whereas happiness is never achieved without righteousness. It is the bounden duty of man to be righteous in his action.’)2 The dominant belief was that all diseases could be seen as manifestation of imbalance in one or the other or the combination of one or more of vada, pitha, kapaha, and vayu. It is doubtful that this gives a complete answer to all the complexities of present-day diseases

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that scourge humanity. In the West, philosopher and physician Galen (131–201 ce) believed that disease resulted from an imbalance of the four humours of the body—blood, phlegm, yellow bile, and black bile. Later, the Jewish philosopher and physician Moses Maimonides (1135–1204) carried on the Hippocratic ethical tradition but followed physiological teachings of Galen. Vesalius (c. 1500) understood human anatomy, better and with Harvey’s (1578–1657) findings on the circulatory system, medical science took a giant leap that saw many advances in human anatomy, physiology, clinical medicine, and surgery. Thomas Percival (1803) used the term ‘medical ethics’ and expanded the ideas of Hippocrates and Maimonides to a broader social ethics of medicine, emphasizing in particular the professional responsibility of physicians and responsibility to the community at large, apart from basic beneficence and non-malfeasance.3 Ideas of medical research with human subjects went from the mere paternalistic approach of ancient times to the patient’s right to know the risks of experimentation and the right to decide on the type of treatment that might be administered. Consent and autonomy became the bywords in ethical medical practices. In the wake of Nuremberg Trials of 1947, which uncovered the inhuman horrors of medical experimentation in the ostensibly scientific research done by Nazi doctors in the concentration camps, the Nuremberg Tribunal formulated ten basic principles that came to be called the Nuremberg Code of 1947.4 Henry Beecher, who was Harvard Professor of Anethesiology, exposed clinical investigations involving human subjects that were unethical. In 1964, the World Medical Association formulated the Declaration of Helsinki, which distinguished between clinical research that is essentially therapeutic for a patient and clinical research that is essentially scientific and without therapeutic intent. By now, autonomy emerged as the most important ethical principle grounding biomedical ethics. Informed consent as articulated by Justice Cardozo5 found a firm judicial utterance in Salgo v. Stanford,6 which ruled that the physician must disclose to the patient the nature of the illness, the risks and benefits of the proposed procedure and its alternatives, as well as the consequences of refusing treatment.Veatch and others underscored deontologtical principles such as respect for autonomy, not killing, justice, and fairness in meeting different patients’ needs. Now all the four principles constitute necessary and sufficient conditions of explanation

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and justification for decisions and actions in all areas of medicine and biomedical research. THE FOUR FUNDAMENTAL PRECEPTS In their seminal Principles of Biomedical Ethics,7 Beauchamp and Childress have formulated four basic principles that form the bedrock for ethical medical practice: autonomy, beneficence, non-malfeasance, and justice.8

Autonomy

for a fully competent patient The right of autonomy is variously described as the right of self-determination, the right to privacy, liberty, and the right to be let alone.The principle of patient autonomy or self-determination gives a competent patient an absolute right to refuse treatment offered by a doctor.9 The doctor’s common law duty is to assess which clinically appropriate treatment options to offer, and then to explain them to the patient, who will decide which to accept. Thus, the competent patient decides what is in his best interests, taking into account the doctor’s advice and any other factors he considers relevant. What the patient cannot do is require the doctor to provide a particular form of treatment that the doctor does not consider to be clinically appropriate, even though it is in accordance with a responsible and competent body of relevant professional opinion.10 There must be a fair balance between the individual’s autonomy and the doctor’s ethical duty to treat the patient in accordance with his own medical judgment. When treating a competent patient, it is not the doctor’s duty to find another doctor who will provide whatever treatment the patient requires.11 The patient has a legal right to accept or refuse treatment, making his own assessment of his own best interests, with no legal or moral obligation to give reasons for his choice.12 The medical team must accept that choice. There are two limits to patient autonomy. First, a patient cannot compel a doctor to provide treatment either against his clinical judgment or which the doctor considers not to be in the patient’s best interests. The ‘best interests’ test allows doctors to take into account all relevant

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circumstances and is thus the most flexible and appropriate test. Second, where the patient is motivated by a desire to commit suicide, he cannot make the doctors complicit by determining the course of treatment provided. There is an almost universal prohibition on assisted suicide.13 Intentional killing, by act or a planned course of omissions, is wrong and unlawful. Suicide remains contrary to public policy as expressing an inadmissible valuation of self and of human life under various adverse conditions. The Supreme Court of India held in Gian Kaur v. State of Punjab14 that right to life did not include right to die. Article 21 of the Constitution of India provides for protection of life, a right to live with dignity up to natural death, including a dignified procedure of death. But it does not comprehend extinction of life that amounts to an unnatural death.The right under Article 21, ruled the Supreme Court, which has a negative aspect of not being deprived by others of continued exercise of right to life, cannot be construed to include the positive aspect of right to die. Freedoms guaranteed under Article 19 are, on the other hand, positive in nature and include negative aspects also, as they require no positive or overt act to be done (for example, the freedom of speech includes freedom not to speak) but that analogy cannot be applicable to Article 21.

advance directives Advance directives can help people implement their desire to have life-sustaining treatments withdrawn or withheld when these treatments only serve to prolong death. Advance directives are generated when individuals execute living wills or durable powers of attorney. All 50 states in the US have enacted a living will statute. These laws enable competent individuals to exercise their right to refuse healthcare prior to their own incompetency. Under a living will, treatment decisions are difficult to make in advance, because most people cannot predict their future medical conditions. A durable power of attorney, on the other hand, establishes an agent who can respond to developing medical conditions. The patient who executes a durable power of attorney is assured that the healthcare provider will consult his agent before initiating medical treatment. Living wills cannot be expected to anticipate all situations or all changes in attitude. This suggests that durable power of attorney should be given more serious consideration as a mechanism for facilitating the patient’s autonomy.15

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There are many reasons why physicians may not initiate advance directives.16 First, in emergency situations, it may be difficult to locate the agent or proxy the patient has designated to make decisions on their behalf. Second, the agent or proxy may choose to implement directives that contradict the patient’s previously expressed wishes. Third, patients or families may change their minds about implementing advance directives. Fourth, the initial preference expressed by the patient might be too restrictive to allow the type of care that the physician believes is appropriate. Fifth, physicians may not be aware that patients have executed advance directives because a copy of the living will or durable power of attorney is not attached to the patient’s chart. Finally, advance directives are often ambiguous in specific medical situations, and prompt compliance with a patient’s desires may hinge upon the healthcare provider’s personal or institutional policies. Advance directives do not exert enough influence on either the patient’s ability to control medical decisions or the physician’s behaviour with respect to such issues in hospitals, emergency rooms, and nursing homes. There remains a considerable gap between the acceptance of advance directives and their implementation by healthcare providers. All too frequently, physicians are reluctant to withdraw aggressive treatment from hopelessly ill patients despite clear legal precedent. In Strachan v. John F. Kennedy Memorial Hospital,17 the parents of a suicide victim maintained a cause of action for negligence and emotional distress against a hospital and physician for refusing to disconnect their son’s life support systems despite their explicit instructions to do so.The hospital tried to convince the parents to donate their son’s organs, and successfully delayed the termination of life support for three days despite a unanimous conclusion by several doctors and neurologists that the young man was dead.The court held that as the emergency room physicians had pronounced the boy brain dead almost three days before his respirator was disconnected, the hospital and physicians were negligent in withholding the victim’s body from his parents. Termination of life support was clearly appropriate, even though the hospital attempted to save another life by utilizing the victim’s organs.The courts are likely to continue upholding the right to refuse medical treatment, and impress upon healthcare providers that the simple ethical mandate to sustain life must be qualified because it conflicts with a very strong and older ethical duty, the duty to relieve suffering and accept death.

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for a fully competent person in critical condition It is the patient, not the doctor, who decides whether it is in the patient’s best interests to receive life-saving treatment. That decision must be followed, whether communicated orally or by advance directive, and whether any or no reason is given. A physically disabled patient who is competent has the same right to personal autonomy as a physically able person with full mental capacity. Lack of resources is not a legal reason for refusing a patient basic food and water. In Regina (Burke) v. General Medical Council (Official Solicitor and Others Intervening),18 the claimant had suffered from a congenital degenerative brain condition that would inevitably result in his needing artificial nutrition and hydration. It was expected that he would remain competent until the final stages of his condition. He was concerned that before those final stages a decision might be taken by the medical practitioners responsible for his care to withdraw artificial nutrition and hydration despite his wishes and regardless of his pain or suffering. In order to obtain clarification as to the circumstances in which treatment might lawfully be withdrawn, he claimed judicial review of the guidance issued by the General Medical Council by way of declarations to the effect that it was incompatible with his rights under common law and under Articles 2, 3, and 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms.19 The Court of Appeal held that that once a patient was accepted into hospital, the medical staff were under a positive common law duty to care for him, a fundamental aspect of which was the duty to take reasonable steps to keep the patient alive. Where that necessitated artificial nutrition and hydration, the duty of care would normally require it to be supplied. Although the duty to keep a patient alive by administering artificial nutrition and hydration or other lifeprolonging treatment did not apply where a competent patient refused such treatment or where it was not considered to be in the best interests of an incompetent patient to be artificially kept alive, if a competent patient made it clear that regardless of pain, suffering, or indignity they wished to be kept alive, the positive duty to take reasonable steps to do so persisted. To deliberately bring about the death of a competent patient by withdrawing life-prolonging treatment contrary to his wishes would infringe his rights under Articles 2, 3, and 8 of the convention. Accordingly, the doctor with care of the claimant would be obliged,

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so long as the treatment was prolonging the claimant’s life, to provide artificial nutrition and hydration in accordance with his expressed wish. In the US too the issue of advance directive of a patient in grave illness has obtained immense relevance. Immediately following the Supreme Court’s ruling in Cruzan v. Director, Missouri Department of Health, mechanisms for documenting a competent person’s choice about terminating life-sustaining treatment became popular. Many states enacted statutes that provided for advanced medical directives such as living wills and durable powers of attorney for health care. Congress responded by enacting the Patient Self-determination Act of 1990. The act requires healthcare providers to furnish information to patients regarding advance medical directives, institutional protocols, and current state laws. In addition to living wills, people may formulate advance directives by appointing an agent or proxy under their state’s durable power of attorney law. A ‘durable power of attorney for healthcare’ is a written legal instrument whereby an individual appoints an agent to perform certain acts or make authoritative decisions on their behalf about medical treatment. There are currently thirty states that have enacted durable power of attorney statutes.

for a patient who becomes incompetent on account of illness When a patient who has made an advance directive becomes incompetent, and has not foreseen the unbearable pain their illness will bring, then it is for the doctor to decide what is in his best interests. He shall have no right to cede the decision-making power to even a relative in such a circumstance, so that if the relative takes a decision to stop treatment, he shall not be prosecuted for assisting suicide.20 Where the advance directive meets the circumstances that arise, the patient remains determinative of his own best interests. It is only in the final stage of the patient’s life, when death is imminent and it would be futile to administer artificial nutrition and hydration, that the doctor shall have a right to do what in his opinion is in the best interests of the patient. In cases of disagreement as to the patient’s best interests, there is a legal obligation to seek a ruling from the court to protect the patient’s rights.21 In Delio v. Westchester Country Medical Center22 case in the US, there was a definite advance directive to withdraw life-saving treatment,

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but hospital refused on the ground that it was against its policy. The dilemma was as follows: the court confronted the issue of terminating artificial hydration and nutrition through an advance directive from a previously competent individual. The plaintiff ’s husband had been put in a chronic vegetative state as a result of complications from a routine surgical procedure. Prior to his incompetency, he had told her that he considered life-sustaining treatment to be degrading and demeaning. The court upheld his right to refuse medical treatment in light of the clear and convincing evidence presented by his wife. The court stated that the hospital could either directly comply with the wishes of the victim’s wife or facilitate his transfer to another healthcare provider who would be willing to carry out his wishes.The hospital was unwilling to withdraw the feeding tubes on the ground that it would constitute a deliberate act that would cause the patient's death, and the termination of life support was ‘contrary to its mission as a hospital to preserve life.’ After a ‘heart wrenching search’ for another hospital, he was finally transferred to a facility who allowed him to ‘die with dignity’. In Canada, an attempt to commit suicide is not an offence, but assisting suicide is. Rodriguez v. Attorney General of Canada23 dealt with the case of a patient that was similar to what the House of Lords were dealing with in Regina (Pretty) v. Director of Public Prosecutions (Secretary of State for the Home Department Intervening),24 and suffered from a disease legally indistinguishable from that which afflicted Mrs Pretty. She sought an order that would allow a qualified medical practitioner to set up the technological means by which she might, by her own hand but with that assistance from the practitioner, end her life at a time of her choosing. The Supreme Court of Canada, in a divided judgment ruled by majority, stated, ‘Given the concerns about abuse that have been expressed and the great difficulty in creating appropriate safeguards to prevent these, it can not be said that the blanket prohibition on assisted suicide is arbitrary or unfair, or that it is not reflective of fundamental values at play in our society’. It disallowed the relief sought.

when the patient is a minor or otherwise incompetent The court’s directives also assume significance in cases where the patient is a minor and has no capacity to decide, or if he has such a capacity, is suffering from such illness that he cannot make a rational

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decision. In NHS Trust v. T (Adult Patient: Refusal of Medical Treatment), a patient suffering from borderline personality disorder who had several episodes of self-inflicted cuts and bloodletting was found incompetent, and even if she refused to undergo treatment, the court would have been justified in making an interim declaration for transfusion treatment to be started when her condition had deteriorated.25 In In re W (A Minor) (Medical treatment: Court’s jurisdiction), [Court of Appeal], the patient was suffering from an illness called anorexia nervosa. It is a peculiarity of this disease that the condition itself creates a wish not to be cured, or only to be cured if and when the patients decide to cure themselves, which may well be too late. In such cases, the court may decide the nature of treatment even against the consent expressed by the patient.26 Here, no question of a minor consenting to or refusing medical treatment arises unless and until a medical or dental practitioner advises such treatment and is willing to undertake it. Regardless of whether the minor or anyone else with authority to do so consents to the treatment, that practitioner will be liable to the minor in negligence if they fail to advise with reasonable skill and care and to have due regard to the best interests of the patient.27 A minor of any age who is ‘Gillick competent’28 in the context of a particular treatment has a right to consent to that treatment, which again cannot be overridden by those with parental responsibility, but can be by the court. Unlike the statutory right, this common law right extends to the donation of blood or organs. No minor of whatever age can, by refusing consent to treatment, override the consent from someone who has parental responsibility for the minor and a fortiori consent by the court. Nevertheless, such a refusal is a very important consideration in making clinical judgments and for parents and the court in deciding whether to give consent. Its importance increases with the age and maturity of the minor.The effect of consent to treatment by the minor or someone else with the authority to give it is limited to protecting the medical or dental practitioner from claims for damages for trespass to the person. In the US, certain regulations by the Department of Health required posting of informational notices for cases when consent was withheld by the guardian of a handicapped person governed by the Rehabilitation Act, and empowered state child protective agencies to prevent instances of unlawful medical neglect of handicapped persons.

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They were later found to be invalid and their enforcement injuncted on the ground of unsustainability of Federal intervention to what was well regulated by state- administered decisional processes.29

autonomy and compulsory vaccination policy The health policies of the government and, sometimes, the directives of international health organizations like the WHO may dictate the adoption of vaccination against polio, smallpox, etc. The massive scale of the operation this involves may include administration of drugs at school, at railway stations and many other public places with a degree of persuasion that the recipient may not be able to resist.30 In some cases, the drug administration may not require that recipient of the drug give any consent that may seem to violate the fundamental precept of autonomy. In the earliest case before the US Supreme Court in Jacobson v. Massachusetts,31 the issue was the adoption in response to concerns about smallpox of a regulation in 1902 by the Board of Health in Cambridge, Massachusetts, that ‘all the inhabitants of the city who have not been successfully vaccinated since 1 March 1897, be vaccinated or revaccinated.’ Massachusetts law designated such ‘boards of health of a city or town ... [to] require and enforce the vaccination and revaccination of all the inhabitants’ and to ‘provide them with the means of free vaccination.’ The regulation stated that any adult ‘over 21 years of age and not under guardianship [who] refuses or neglects to comply with such requirement shall forfeit five dollars’, while ‘children who presented a certificate, signed by a registered physician that they are unfit subjects for vaccination’ were exempt. Jacobson, an adult resident of Cambridge, refused to be vaccinated and pleaded not guilty at his arraignment. In 1904, only 11 out of then 45 US states had compulsory vaccination laws, with thirteen states excluding unvaccinated children from public schools. No state employed ‘forcible vaccination, while Utah and West Virginia expressly provided that no such compulsion shall be used.’ It was noted that states with mandatory vaccination laws were ‘not any more afflicted with smallpox than those which compel vaccination’, citing that ‘even New York, which imports the major part of the immigrants who annually enter this country, has not undertaken to force it upon the people.’

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In foreign countries, Holland had ‘recently recommended the repeal of the compulsory vaccination laws’, and vaccination laws were nonexistent in New Zealand. Switzerland had abolished compulsory vaccination, and riots erupted in Brazil in 1904 from ‘attempts to enforce vaccination’. English law provided only for the vaccination of children. Jacobson claimed that he had ‘suffered seriously from previous vaccination’, as did his son, suggesting a genetic predisposition ‘to rebel against the introduction of the vaccine matter’. In challenging the mandatory vaccination law in the Massachusetts Supreme Court, Jacobson was not permitted to offer medical testimony that vaccination ‘might even be deadly in its effects’, thus making the law, in his opinion, ‘oppressive and unreasonable.’ This argument was matched with State’s ‘unquestioned power to preserve and protect the public health’, which permits the state legislature to ‘determine whether vaccination is effective in preventing the spread of smallpox or not’, and, if so determined, could ‘require doubting individuals to yield for the welfare of the community’. It was noted that ‘the legislature has large discretion to determine what personal sacrifice the public health, morals and safety require from individuals....’ Compulsory vaccination was cited as ‘a proper exercise of the police power’. Since the state’s ‘police power’ enables it to enact ‘health laws’ reflecting dominant medical beliefs and those of the majority of society, the opinion of the minority should not subvert the opinion of the majority. The US Supreme Court affirmed, explaining that they were ‘unwilling to hold it to be an element in the liberty secured by the Constitution ... that one person, or a minority of persons ... should have the power ... to dominate the majority when supported in their action by the authority of the State’, or to ‘permit the interests of the many to be subordinated to the wishes or convenience of the few.’ Furthermore, the court asserted that ‘upon the principle of self-defence, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members’. In enacting compulsory vaccination laws, the court assumed that the Massachusetts legislature was aware of and rejected opposing, minority medical viewpoints. Maintaining that safety and health measures of Massachusetts are ‘for that Commonwealth to guard and protect,’ and ‘do not ordinarily concern the National Government’, the court held that the compulsory vaccination legislation had not ‘invaded any right secured by the Federal Constitution.’

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While disposing of the rival contentions, the court re-emphasized ‘that the police power of a state, whether exercised by the legislature, or by a local body ... may be exerted ... so arbitrary and oppressive in particular cases as to justify the interference of the courts to prevent wrong and oppression.’ The Massachusetts legislature presumably ‘intended exceptions to ... avoid’ the situation in which vaccination ‘would be cruel and inhuman in the last degree’ due to ‘a particular condition of [a person’s] health or body’. However, the court found ‘no such case’ with Jacobson, in that he did not show ‘with reasonable certainty that he [was] not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death’. Acknowledging that the vaccination issue was controversial, in that ‘some laymen, both learned and unlearned, and some physicians of great skill and repute, do not believe that vaccination is a preventive of smallpox’, public health policy should reflect the ‘common belief ’ of society that smallpox vaccination is effective. Even though vaccination is ‘not accepted by all, it is accepted by the mass of the people, as well as by most members of the medical profession’, and ‘in a free country, where the government is by the people ... what the people believe is for the common welfare must be accepted as tending to promote the common welfare, whether it does in fact or not.’ Exemptions to Compulsory Vaccinations The state legislatures have granted three types of exemptions from compulsory vaccination, with the availability of each type varying depending on the state. Such exemptions are not absolute in that if the local department of health declares a public health emergency, the exemptions can be cancelled. A physician may certify in writing that the vaccine may be harmful, or is contraindicated. Religious exemptions are available in 47 states, some requiring that a person’s religion be disclosed, while others are worded more liberally. Mississippi and West Virginia provide no religious exemptions but only medical exemptions.32 The third type of vaccine exemption is the so-called ‘philosophical exemption’, which, depending on the state, allows the parent or student to assert in writing that they have another reason to object to vaccines. As with religious exemptions, each state’s philosophical exemption provisions are worded differently. These can range

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from objections based on ‘personal’, ‘philosophical’, ‘moral’, or ‘other’ beliefs. As recently as 1990, 22 US states provided a philosophical exemption for vaccines. However, encouraged by state departments of health, whose immunization departments are usually staffed by federal civil service centers for disease control and prevention (CDC) personnel, several state legislatures have deleted philosophical exemption provisions in their state codes. For example, Missouri, Indiana, and Nebraska lost their philosophical exemptions in 1992, 1993, and 1994, respectively. Organized citizen opposition was credited with reversing this trend by defeating legislative attempts to delete philosophical exemption provisions in Utah, Pennsylvania, and Michigan in 1992, 1993, and 1995, respectively. The Nevada State Senate passed legislation in 1995 that would have added a philosophical exemption provision in that state, but the bill is predicted to have little chance of final passage, due to its subsequent assignment to a lower house committee. Similar legislation to that of Nevada was introduced in both houses of the New Jersey legislature.33 The newly licenced varicella (chickenpox) vaccine, in its product package insert, Merck warned of the uncertainties surrounding this new product. Examples of such statements include the following: (1) ‘The duration of protection ... is unknown at present and the need for booster doses is not defined’; (2) ‘...broad use of the vaccine could reveal adverse reactions not observed in [prelicensing] clinical trials’; (3) ‘There are insufficient data to assess the rate of [vaccine] protection against the complications of chickenpox...’; (4) ‘The completeness of this reporting [of post-vaccination herpes zoster incidence] has not been determined’; (5) ‘Post-marketing surveillance studies are ongoing to evaluate the need and timing for booster vaccination’; and (6) ‘Limited data from an experimental product containing varicella vaccine suggest that [chickenpox vaccine] can be administered concomitantly with [selected other vaccines].’

Individual Predilections must Suborn to the Larger Public Good Since Jacobson v. Massachusetts34 was decided by the US Supreme Court in 1905, all challenges to state compulsory vaccination laws have failed based on local governments’ police power to protect the public health. Even religious exemptions hold little weight if the local department

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of health declares an emergency. Whereas only the smallpox vaccine was available in 1905, children today are now recommended to receive one vaccine at birth, 10 vaccines administered in multiple doses before their second birthday, four to six vaccines before entering kindergarten, and in some states, three to five vaccines before entering the seventh grade or college.The US Supreme Court in Veronia School District v. Wayne Action35 recently compared random drug testing of student athletes to compulsory vaccinations, describing the latter as a ‘constitutionally reasonable’ breach of privacy inflicted upon children ‘for their own good and that of their classmates’, calling them ‘blanket searches of a sort’. Parents wishing to enrol their children in school or day care, and feel uncomfortable about vaccine safety and efficacy, are left with few choices. If the family resides in a state with a philosophical exemption or a broadly worded religious exemption provision, the child may likely forego vaccination. However, for a family not living in such a state, the child may be forced to receive all government recommended vaccines. Although the road to a disease-free world may be paved with good intentions, the practice of injecting multiple vaccines, with known and unknown risks, into healthy babies appears unethical if proper informed consent is dismissed in the process.36

Beneficence The actions of the doctor shall be only for the benefit of the patient. The treatment for the betterment of the patient shall be the primary concern, and any possible benefit to the doctor (monetary or researchbased) shall be only incidental. This principle shall still suborn to patient’s autonomy, since the perception of what is good to a patient must also be viewed as such by the patient in the ultimate choice of whether or not a particular treatment is acceptable to the patient.

Non-malfeasance

life-saving treatment There is an a priori assumption that life is very precious, and which is incapable of admitting another viewpoint. Scalia J said in the US Supreme Court in Cruzan v. Director, Missouri Department of Health: ‘The point at which life becomes “worthless”, and the point at which

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the means necessary to preserve it become “extraordinary” or “inappropriate”, are neither set forth in the Constitution nor known to the nine justices of this court any better than they are known to nine people picked at random from the Kansas City telephone directory.’37 When considering whether life-saving treatment should be given or continued, three separate questions have to be answered: first, whether the contemplated treatment is futile; second, whether it is in the best interests of the patient; and third, whether resources should be deployed to provide it. In re A (Children) (Conjoined Twins: Surgical Separation), Court of Appeal,38 the Court of Appeal was considering the dilemma of saving one of conjoined twins39 by a surgical operation, knowing full well that the other child would be lost in the process.40 J and M were the conjoined twin girls who were born to devout Roman Catholic parents. They were joined at the pelvis and each had her own brain, heart, lungs and other vital organs, as well as their own arms and legs. The medical evidence was that J, the stronger twin, sustained the life of M, the weaker twin, by circulating oxygenated blood through a common artery, and that M’s heart and lungs were too deficient to oxygenate and pump blood through her own body. If they were not separated J’s heart would eventually fail and they would both die within a few months of their birth. However, if they were separated, the doctors were convinced that J would have a full life, although M would die within minutes. The parents refused to consent to the operation on religious grounds. It was accepted that M, despite having a severely impaired brain, heart, and lungs, was alive and that the twins were two separate persons. On the hospital’s application for a declaration that it could lawfully carry out separation surgery, the judge saw that separation would enable J to lead a relatively normal life, and that the few months of M’s life, if not separated from J, were worth nothing to her, and were a serious threat to her. He held that, although regard had to be accorded to the parents’ wishes, the proposed operation was not a positive act, which would be unlawful, but rather, by analogy with the situation where a court authorized the withholding of food and hydration, represented the withdrawal of M’s blood supply, and therefore could be lawfully performed. On the parents’ application for leave to appeal, the Court of Appeal held that notwithstanding the conflict of duties the doctors owed to each twin in respect of her right to life and the impossibility of undertaking any relevant surgery on one without

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affecting the other, the proposed operation was an act of necessity to avoid inevitable and irreparable evil. Its purpose was to preserve the life of J and not to cause the death of M, and it was inappropriate in the unique circumstances to characterize foresight of M’s accelerated death as amounting to criminal intent. The protection of a person’s right to life in Article 2 of the Convention for the Protection of Human Rights and Fundamental Freedoms did not import any prohibition, additional to that under English common law, to the proposed operation, and ‘intentionally’ in its ordinary and natural meaning applied only to cases where the purpose of the prohibited action was to cause death. In essence (per Ward LJ) there was no difference between resort to legitimate self-defence and the doctors’ actions in J’s defence by removing the threat of fatal harm to her presented by M’s draining her lifeblood. Accordingly, the operation could be lawfully carried out. The court further added that the proposed operation was a positive act of invasive surgery and not a withdrawal of treatment or an omission, and, although clearly in J’s best interests (per Ward and Brooke LJJ), could not be in the best interests of M as it could not ensure any other improvement to her condition, would bring her life to an end before its natural span, and deny her inherent right to life. Given the conflict of duty the court faced in considering the best interests of each twin, its task was to strike a balance between each and do what was best for them by considering the worth of the proposed treatment having regard to the actual condition of each twin and the advantages and disadvantages that flowed from the performance or non-performance of that treatment, and not to balance the quality of life of each in the sense of considering the worth of one life compared with the other, since that would offend the principle of the sanctity of life, and is therefore unlawful. The prospect of a relatively normal life for J was counterbalanced by an acceleration of certain death for M, so that, in the unique circumstances of the case, the court was obliged to consider the manner in which each twin was individually able to exercise her right to life; the balance was heavily in favour of J as the best interests of the twins was in giving the chance of life to the twin whose actual bodily condition was capable of accepting the chance to her advantage, even if that had to be at the cost of the sacrifice of the life that was so unnaturally supported. Therefore, the least detrimental choice, balancing the interests of M against J and J against M, was to

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permit the operation to be performed.There was a strong presumption (per Robert Walker LJ) that the proposed operation, consent to which did not require the court to value one life above another, would be in the best interests of each twin, as its purpose would be to give J a reasonably good prospect of a long and reasonably normal life, and, although M’s death would be its inevitable consequence, she would obtain bodily integrity and human dignity which was her right. Her death was not the purpose of the operation; she would die because her own body could not sustain her life, and her continued life, whether short or long, conferred no benefit on her except possible pain and discomfort, and was to her disadvantage. ‘The court is a court of law, not of morals, and our task has been to find, and our duty is then to apply, the relevant principles of law to the situation before us—a situation which is quite unique.’ More questions than answers have arisen since the court’s decision. Is death inherently evil? Are we not all destined to die? Is it not more important how we live than how long we live? Is interdependence a good thing, even to the point of ensuring a conjoined twin’s survival? Isn’t choosing the lesser of two evils still choosing evil? If sanctity of life is the ultimate value, can murder now be excused if done to save the life of another? Can law be utterly divorced from morality? Did the court exceed its jurisdiction by ‘playing God?’ The court assumed the greatest happiness would be that one live child was better than two dead ones. The court looked to the short-term consequences of the potential benefits to Jodie and to her parents. Whatever spiritual consequences would flow from the taking of Mary’s life was not relevant to the decision. Would saving Jodie in this manner really make her happy? Would she wish she would have died with her sister, considering the special intimacy twins share, the numerous operations ahead, and the possibility of severe disability?41

PVS The PVS state of a patient is one condition where the doctor may not wish to continue treatment but to allow the patient to die.42 It is not the same as assisted suicide. Here the patient has no capacity to exercise the choice between life and death. The doctor may prefer the latter for the patient. In death, is there anything that could be consid-

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ered in the best interest of the patient? Perhaps it is the principle of non-malfeasance at work. In Airedale NHS Trust Respondents and Bland Appellant,43 the House of Lords was considering the case of a patient, then aged seventeen, who was very seriously injured in the disaster that occurred at the Hillsborough football ground on 15 April 1989. His lungs were crushed and punctured, and the supply of oxygen to the brain was interrupted. As a result, he sustained catastrophic and irreversible damage to the higher centres of the brain, which had left him in a vegetative state since April 1989. The medical opinion of all who had been consulted about his case was unanimous in the diagnosis, and also all were agreed on the prognosis that there was no hope of any improvement in his condition or recovery. At no time before the disaster had the patient indicated his wishes if he should find himself in such a condition. But his father, in evidence, was of the opinion that his son would not ‘want to be left like that’. With the concurrence of the patient’s family and the consultant in charge of his case and the support of independent physicians, the authority responsible for the hospital where he was being treated, as plaintiffs in the action, sought declarations that they might (1) lawfully discontinue all life-sustaining treatment and medical support measures designed to keep the patient alive in his existing PVS state, including the termination of ventilation, nutrition, and hydration by artificial means, and (2) lawfully discontinue medical treatment to the patient except for the sole purpose of enabling the patient to end his life and die peacefully with the greatest dignity and the least of pain, suffering, and distress. The House of Lords ruled that the object of medical treatment and care was to benefit the patient, but as a large body of informed and responsible medical opinion was of the view that a PVS was not a benefit to the patient, the principle of the sanctity of life, which was not absolute, was not violated by ceasing to give medical treatment and care involving invasive manipulation of the body of the patient that they had not consented to and which conferred no benefit upon them. The doctors responsible for the patient’s treatment were neither under a duty nor entitled to continue such medical care. Since the time had come when the patient had no further interest in being kept alive, the necessity to do so, created by his inability to make a choice, and the justification for the invasive care and treatment had gone. Accordingly, the omission to perform what had previously been a duty would no

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longer be unlawful. The court further said that the interests of the protection of patients and their doctors, the reassurance of the patients’ families and that of the public render it desirable that, until a body of experience and practice has been built up, application should be made to the family division in any case where it is considered by the medical practitioners in charge of a PVS patient that continued treatment and care no longer confer any benefit upon them. The House, speaking through Lord Browne-Wilkinson and Lord Mustill, said that it was imperative that the moral, social, and legal issues of the present case should be considered by the Parliament. In the Matter of Nancy Ellen Jobes, a case that appeared before the Supreme Court of New Jersey,44 the respondent filed an action in the lower court to obtain authorization to remove a jejunostomy tube from his wife, which was keeping her alive and in a vegetative state after an automobile accident. The court affirmed the portion of the judgment of the lower court authorizing respondent husband to do so, holding that a competent person, or an incompetent person’s family or friends, had the right to refuse continued medical treatment.The court also reversed the lower court’s decision that allowed appellant nursing home to refuse to participate in the withdrawal of the tube. In Guardianship of Jane Doe45 the Supreme Judicial Court of Massachusetts, Norfolk, similarly held in a case of a patient who had been in a PVS state that the decision of the trial court to terminate the treatment through substituted judgment was to be affirmed because the appellant’s family supported the withdrawal, and was acting in good faith, appellant’s religious beliefs did not prohibit the action, and she would not suffer the effects of the dehydration. The court also found that the state’s interest in keeping appellant alive did not outweigh her right to refuse treatment through substituted judgment. It held that, in assessing whether the appellant would choose to terminate treatment, the trial court properly applied the standard of preponderance of the evidence with an extra measure of evidentiary protection by reason of specific findings of fact after a careful review of the evidence. This term ‘persistent vegetative state’ is criticized by some as driven by masked intentions. It is argued that if a profoundly impaired person is not imminently dying from a disease process, denying food and water causes him or her to die of dehydration and starvation. When provision of food and water does not create excessive burden (such as

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extreme pain and discomfort), and if the food and water can be digested and absorbed, denying such nourishment is immoral and unethical. Under these circumstances, this denial (by commission or omission) is motivated by a real intention to cause death, whether or not that intention is explicitly recognized.46 It is suggested that the ‘quality of life’ judgments so predominant today in medical ethics are a recasting of the notion that some people are better off dead. Is that not what is really being said in such arguments, that a person’s life is so miserable that they are better off dead? Wolfensberger has made a strong case for the elimination of the term ‘quality of life’ as a hopeless, useless term that has lost all relevance and meaning.47 Quality-of-life judgments are based on inexplicable, subjective criteria that judge one life as having more value than another, or one state or stage of life as having more value than another. Space does not permit detailed exploration of this issue here. Suffice it to say that while analysis of benefits and burdens of medical treatments can be valid, quality-of-life judgments subjectively assess the value of a person’s life, rather than maintaining focus on the benefits and burdens of the treatments themselves. In India, in Aruna Ramachandra Shanbaug v. Union of India48 the Supreme Court dealt with a poignant case of a nurse raped and rendered to PVS state by a blandishment by a dog chain on her head by the rapist. Her condition was described in the judgment thus: Aruna Ramachandra Shanbaug was a staff nurse working in King Edward Memorial Hospital, Parel, Mumbai. On the evening of 27th November, 1973 she was attacked by a sweeper in the hospital who wrapped a dog chain around her neck and yanked her back with it. He tried to rape her but finding that she was menstruating, he sodomized her. To immobilize her during this act he twisted the chain around her neck.The next day on 28th November, 1973 at 7.45 am a cleaner found her lying on the floor with blood all over in an unconscious condition. It is alleged that due to strangulation by the dog chain the supply of oxygen to the brain stopped and the brain got damaged. It is alleged that the Neurologist in the Hospital found that she had plantar’s49 extensor, which indicates damage to the cortex or some other part of the brain. She also had brain stem contusion injury with associated cervical cord injury. She was now 60 years of age, after 37 years of being in this state. She was featherweight, and her brittle bones could break if her hand or leg were awkwardly caught, even accidentally, under her lighter body. She has stopped menstruating and her skin is now like papier mâché

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stretched over a skeleton. She was prone to bed sores. Her wrists were twisted inwards. Her teeth had decayed causing her immense pain. She could only be given mashed food, on which she survives. The prayer of the petitioner was that the respondents be directed to stop feeding Aruna, and let her die peacefully. It came to the court for appropriate directions after 37 years of the incident for withdrawal of all tubular feeding and withdrawal of life support by a social activist, Pinky Virani, who had been visiting her at the hospital at Bombay and who had written about her plight in a book, Aruna’s Story. The doctor’s report about the condition of the patient examined all the clinical aspects.50

After examining the report of the doctors and the global approaches to euthanasia, active and passive, the Supreme Court held that it was not in the best interest of the patient to let her die. A PVS state in this case was not still entirely hopeless. The court observed that the patient recognizes that persons are around her and expresses her like or dislike by making some vocal sound and waving her hand by certain movements. She smiles if she receives her favourite food, fish and chicken soup. She breathes normally and does not require a heart lung machine or intravenous tube for feeding. Her pulse rate and respiratory rate and blood pressure are normal. She was able to blink well and could see her doctors who examined her. When an attempt was made to feed her through mouth she accepted a spoonful of water, some sugar and mashed banana. She also licked the sugar and banana paste sticking on her upper lips and swallowed it. She would get disturbed when many people entered her room, but she appeared to calm down when she was touched or caressed gently.

Fairness or Justice

general Decision-making on issues of treatment must be transparent. Doctors must not conflate best interests with resource issues. A patient cannot compel the deployment of government resources in favour of a particular treatment he wants, but if a lack of resources is the reason for the decision made, the patients should be informed so that they can evaluate their options. Where decisions are made by doctors in respect of incapacitated patients, it should be borne in mind that a disabled individual may place a high value on their

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life even though someone without a disability may regard such a quality of life as intolerable.51 This principle evolved in 1961, when hemodialysis was invented by Dr Belding H. Scribner, which was invaluable for people with renal failure. The life-saving technology was, however, very expensive and limited, and the issue of allocation of scarce medical resources with due regard to patient affordability became relevant matter of some concern. In the Indian context, withdrawal of life support for poor patients in a government hospitals, where the demand often outstrips supply, is a major issue. Admission to hospital, securing MRI scans, administration of costly drugs, performance of surgery to be undertaken without delay, etc. are areas that are very open to corruption. It is important that government hospitals that dispense free treatment display data on these matters, so that the patient and their relatives feel confident that no discrimination is practiced. It is also imperative that there is a well-established protocol for withdrawal of life support, and made available at the hospital’s reception counters so that there is not the slightest suspicion that a precious life became a casualty only because the patient was poor and unjustifiably denied of medical treatment till the last breath.

Constitutional Imperatives

healthcare and state initiatives Under the constitutional scheme of things, the states are entrusted with the task of legislation in respect of ‘Public health and sanitation; hospitals and dispensaries’ under Entry 6 of List II of the State List in the Seventh Schedule to the Constitution. The Parliament has power to make a law for the state (apart from the provisions of Articles 249, 250, and 252 of the Constitution) under Article 252 of the Constitution, where the legislatures of two or more states pass resolutions in pursuance of Article 252 of the Constitution, empowering the Parliament to pass the necessary legislation on the subject, and a bill may be introduced in the Parliament. The State Legislatures of Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, passed such resolutions and, consequently, the Parliament has now passed the Clinical Establishments (Registration and Regulation) Act, 2010.52

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clinical establishments and regulation through law The salient features of the act as delineated in the statement of reasons and objects are as follows: (i) the legislation provides for the constitution of a National Council consisting of representatives of Medical Council of India, Dental Council of India, Nursing Council of India, the Pharmacy Council of India, the Indian Systems of Medicines representing Ayurveda, Siddha, Unani and Homoeopathy systems, the Indian Medical Association, the Bureau of Indian Standards, the Zonal Councils set-up under the States Reorganisation Act, 1956, the North-Eastern Council, etc.; (ii) the function of the National Council shall be to determine the standards for the clinical establishment, classify the clinical establishment into different categories, develop the minimum standards and their periodic review, compile, maintain and update a National Register of clinical establishments, perform any other function determined by the Central Government, from time to time; (iii) the function of the State Council shall be to compile, maintain and update the State Registers of clinical establishments and to send monthly returns for updating the National Registers. The State Councils shall also publish reports on the implementation of standards within their respective states, annually; (iv) the concerned State Governments shall, by notification, setup an authority to be called the district registering authority under the chairmanship of district collector for registration of clinical establishments; (v) no person shall carry on a clinical establishment unless it has been registered in accordance with the provisions of the proposed Bill.The legislation would not apply to the clinical establishments of the armed forces; (vi) it is proposed that clinical establishments already in existence may be allowed for provisional registration to carry out their business. There shall be no prior enquiry for provisional registration. But the authority shall have power to make enquiry in accordance with such rules as may be prescribed; (vii) the clinical establishment having provisional registration shall fulfil the standards which may be notified for the purpose. The provisional certificate shall not be granted or renewed beyond a period of two years from the date of notification of standards;

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(viii) any clinical establishment may apply for permanent registration in such form and shall pay such fee as may be prescribed by the state government. A detailed procedure for permanent registration is being provided in the proposed legislation; (ix) the authority shall have power to cancel the registration of the clinical establishment which fails to comply with the conditions prescribed by the Central Government. The authority shall have power to inspect a registered clinical establishment. Any person aggrieved by an order of the registering authority shall prefer an appeal to the State Council; (x) the clinical establishments shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment; (xi) the certificate of permanent registration issued by the authority is valid for a period of five years from the date of issue; (xii) there shall be register of clinical establishment at the district level, state level and the national level; (xiii) if any person contravenes any provisions of the proposed legislation or any rules made thereunder, he shall be punished with fine.The maximum penalty being provided is Rupees Five lakh; (xiv) conferring power upon an authority to levy monetary penalty for violation of the provisions of Sections 41 and 42 of the proposed Bill; (xv) any person aggrieved by the decision of authority may prefer an appeal to the State Council.

relevance and scope of telemedicine Telemedicine has the potential to change the relationship between patient and healthcare provider. Hitherto, the patient had sought the doctor; with telemedicine, it is healthcare provider who waits at the door, as it were, to provide information on everything, from FAQs to heal-yourself advice through the Internet and telephony. It is difficult to say if it is all altruism at its best or advertisement to entice the patient in the long run but it will be fair to assume that there is a mixture of both motives. It is the ease with which medical information could be accessed that holds the key to its popularity. From desktops to laptops and now to smart phones, Internet connectivity brings home a certain immediacy

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and privacy that all the books and magazines or personal visits to doctors cannot give. The individual can get second opinions through an expert, or the family doctor’s advice could be cross-checked through the Internet information.The medical opinion is available for free. No traffic snarls on the way to hospitals or clinics, nor long waits for the doctor’s consultation. Even pharmacists are prepared to deliver medicine at the door step on a phone call if you read out the prescription.There are privately hosted sites, such as Medindia.com (or .net), that provide a range of services to both healthcare consumers and the medical professionals. Meanings of ‘Telemedicine’,‘Online Medicine’, and ‘Medical Profiling’ The gift of science and the novelty that telemedicine assures is the new mode of communication between the doctor and patient, and the improved medical care that is possible even for the remotest areas. According to the WHO, telemedicine is defined as ‘The delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities’. By ‘online medicine’ we mean developments in digital technology, largely involving the Internet, that offer new ways for individuals to obtain and share health advice, diagnosis, and medication; and provide new possibilities for storing, accessing, and sharing health records; monitoring individuals’ health status; and communicating with health professionals and other patients. By ‘medical profiling’ we mean new services offering direct-to-consumer body imaging (such as CT and MRI scans) as a health check and personal genetic profiling for individual susceptibility to disease.53 Objective It is difficult to believe that telemedicine was a deliberate innovation for improving medical care. In communities where literacy rate was high and use of information technology was prevalent, telemedicine became a new tool of obtaining medical advice and treatment. India has embraced information technology in all walks of life, and state governments are promising laptop and Internet connectivity to every student in every village. If rural medical health must obtain qualitative

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improvement while there is increased polarization of medical personnel in big cities and towns, telemedicine could provide that missing link by enabling a patient to access expert medical advice, if not directly, at least through doctors manning the rural medical centres. To that extent, it slices through distant barriers and makes possible the sharing of information and medical advice from any part of the world to any other remote corner. Traditional Methods and New Possibilities Tabulating the differences, the report by Nuffield Council of Bioethics, 2010, gives essentially 5 new approaches: Seeking health information: Consultation with a family doctor or general practitioner, newspapers and magazines, and the informal experience of family and friends have been the traditional source of information on healthcare. Use of online search engines, quality assured websites, other websites that mix advertising with information, exchanges with others with same condition in online communities, and user-generated content reference sites will be the approaches of the future. Records of health history and status: Hospital or general practitioner records, traditionally in paper form, are non-interactive and, until the widespread enactment of data protection laws in the 1990s, were often not directly available to the patient. The use of online personal health record facilities accessible to and in some cases managed or modifiable by individuals to keep all of their data in one place are capable of automatically alerting pharmacists, patients, or healthcare professionals to new discoveries, developments, and products. It also facilitates potentially easy use in research. Obtaining medication: Prescription by medical professionals and medication is normally obtained in person or by mail. Pharmaceuticals shall henceforth be available to purchase directly by users via the Internet and in some cases through online prescription by health professionals. Various aspects of diagnosis, health monitoring, and management: Travel to and receiving care within hospitals or medical centres

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for those in remote and inaccessible locations, and the use of radio, telephone, or other forms of communication will be obsolete. The use of online or other modern information communication technologies (ICT) for remote consultations, diagnosis, monitoring of health status indicators or patient activities, drug delivery, and some other forms of treatment will soon be widespread. Indian Telemedicine as Tool for Better Rural Health Service Telemedicine is not just for computer-savvy doctors and patients with Internet connectivity. The Ministry of Health and Family Welfare has released several ambitious projects to bring sophisticated treatment to patients in rural areas through the Indian Telemedicine network.54 The Integrated Disease Surveillance Programme network, which will connect all district hospitals with medical colleges of the state to facilitate tele-consultation, tele-education (training of health professionals), and monitoring of disease trends. The National OncoNET Project anticipates that under the National Cancer Control Programme 27 regional cancer centres will be linked with 100 peripheral centres for primary prevention, early detection, treatment, and rehabilitation of cancer patients. The ministry is reported to have approved teleophthalmology project to provide eye care specialty services to the patients of rural and remote areas of Punjab, Uttar Pradesh, and West Bengal through tele-ophthalmology mobile van. The National Task Force on Telemedicine, set up by the union ministry, plans to establish a national grid on telemedicine for networking of medical colleges. A few tertiary-care academic medical institutes from different regions of the country will be identified as Medical Knowledge Resource Centres (regional hub), each connected to medical colleges (nodes) in that region. One of these regional hubs, it is claimed, will be identified as the central hub, which will be responsible overall to coordinate the National Network in addition to providing the infrastructure for the Central Content Development Centre. The National Medical Library’s Electronic Resources in Medicine (ERMED) consortium is an initiative taken by the Director General of Health Services (DGHS) to develop nationwide electronic information resources in the field of medicine. Thirty-nine centrally-funded government institutions (including 10 under the DGHS), 28 laboratories of the Indian Council of Medical Research, and All India Institute of Medical

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Sciences (AIIMS) libraries are selected at the initial stage as its core members. The MoH&FW aims to provide the funds required for the purchase of electronic journals under this consortium project. Much of this is in the development stage, for the ministry admits that the National Rural Telemedicine Network (NRTN) Project under the National Rural Health Mission (NRHM) is in the planning phase. What is not implemented still gives an idea of what is the potential in this branch of medicine for rural outreach that assures quality medical care to the poor in India.55 There are initiatives through established chain of private hospitals also and just as well as they satisfy the social service quotient, they go to enlarge their patient base from the rural areas for their city based hospitals. It may raise serious ethical issues in allowing for a covert form of advertisement to the facilities available at the hospitals and cultivate a clientele directly from the houses of the patients.56 Imaging and Genetic Testing If reference to a specialist on the basis of symptoms and risk by a family doctor or general practitioner (also with the possibility of genetic counselling in the more recent past) is modern enough, one will soon know and experience individual purchase of directly marketed imaging and genetic testing products that are delivered on demand as a commercial product. Confidentiality and Data Protection While reduction of travel, costs, and time are significant advantages, tele-consultation is impersonal and exposes the threat of data piracy. Storage and transmission of patient information includes a serious risk of interception of data by those who are not the intended recipients. The Information Technology Act, 2000, has been enacted to provide legal recognition for transactions carried out by means of electronic data interchange and other means of electronic communication, commonly referred to as ‘electronic commerce’, which involves the use of alternatives to paper-based methods of communication and storage of information to facilitate electronic filing of documents with government agencies and further to amend the IPC, 1860; the Indian Evidence Act, 1872; the Bankers’ Books Evidence Act, 1891, and the Reserve Bank of India Act, 1934, and for matters connected therewith or incidental

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thereto. The General Assembly of the United Nations by resolution A/RES/51/162, dated 30 January 1997, adopted the Model Law on Electronic Commerce adopted by the United Nations Commission on International Trade Law. The resolution recommended inter alia that all states gave favourable consideration to the said Model Law when they enact or revise their laws in view of the need for uniformity of the law applicable to alternatives to paper-based methods of communication and storage of information. The enactment was thus to give effect to the said resolution and to promote efficient delivery of government services by means of reliable electronic records.57 A doctor or a hospital or a healthcare institution is expected to secure the privacy of ‘sensitive personal data or information’, which could include ailments or personal information of the patient stored in electronic form, and any leakage will be an actionable wrong, liable for compensation.58 Publication or transmission of even an image of a person without their consent, under circumstances violating the privacy of that person, is an offence punishable with imprisonment for a period up to three years.59 Even a person securing access to confidential information will be guilty of an offence punishable with imprisonment up to two years and be liable for a fine up to Rs 1,00,000.60 The act makes liable a person guilty of the contravention of the provisions by an act committed outside India by use of a computer, computer system, or computer network located in India.61 Honouring Medical Prescriptions through the Internet Prescription of medicines and forums for resolution of disputes could turn out to be complex issues. While the Information Technology Act itself legitimizes documents sent in electronic form, the danger resides only in checking the authenticity, accuracy, and the competency of the person generating the prescription. MEDICAL COUNCIL REGULATIONS The Indian Medical Council Act, 1956, establishes the MCI. The council has the exclusive right to grant recognition to medical colleges, new or higher courses or training, or to increase the capacity in the training or course qualification granted by universities or medical colleges in India.62 Registered medical practitioners are entitled to practice the allopathic system of medicine.63 Instructions are given

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for recognition of medical institutions and to monitor and maintain standards of medical education.64 The council has made regulations calling for standards of professional conduct, etiquette, and a code of ethics that should be observed by medical practitioners.These are mandatory and followed by all other state medical councils.65 The Indian Medical Council (Professional Conduct, and Ethics) Regulations with regard to professional conduct, etiquette, and ethics were notified in 2002. To the extent to which the MCI regulates the practice of only the allopaths, it is obvious that we have to look elsewhere for the practitioners of other systems of medicine. The Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) was established as the Department of Indian Systems of Medicines and Homoeopathy (ISM&H) in the Ministry of Health and Family Welfare in March, 1995, and was renamed the Department of AYUSH in November 2003.66

Character of Physicians Physicians shall uphold the dignity and honour of their profession,67 with the prime objectives of rendering services to humanity, with rewards or financial gains being subordinate.68 No person with qualifications other than the modern system of medicine (allopathy) would be allowed to practice it. Physicians should continuously try to improve their medical knowledge and skills, and should affiliate themselves with reputed allopathic organization and attend continuing medical education programmes, at least 30 hours every five years. They should maintain the medical records of the patient for three years, which may be made available whenever required.They should also maintain a medical certificate register, entering relevant information about the person for which certificate has been issued. Physicians shall display their registration number in their clinic and on every prescription, certificate, etc., they shall display only recognized degrees, diploma memberships, and honours as suffixes to their name. They shall prescribe normally only generic names of drugs. Physicians should also display their fees in their chamber, and announce their fees before rendering service rather than after or during an operation or treatment. They should be cooperative in the observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provision of the state acts like the

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Drugs and Cosmetic Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic Substance Act, 1985; Medical Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986; Prenatal Sex Determination Test Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995; and Biomedical Waste (Management and Handling) Rules, 1998; etc.

Duties of Physicians to their Patients In case of emergency, a physician must treat the patient, if not, he may refuse treatment and refer the patient to another suitable physician. Confidences concerning individual or domestic life entrusted by patients to a physician and defects in the disposition or character of patients observed during medical attendance should never be revealed unless required by law. Physicians should also determine whether their duty to society requires them to reveal confidential information about patients. They should neither exaggerate nor minimize the gravity of a patient’s conditions in communicating with patient or relatives. The breach of some of the duties may result in legal action for negligence, some may go as complaints to medical council for disciplinary action and some may result in criminal prosecution.

doctor’s duty to treat Therapeutic Privilege The physician is generally believed to have the privilege of choosing when to inform the patient about the gravity of his illness such as not to traumatize the patient. This, however, does not accord with the modern emphasis on patient autonomy and informed consent. This privilege could be really put to test in a situation where the attendants on the patient or near relatives of the patient do not want the information of serious illness or poor prognosis for cure to be revealed to the patient. The theory of therapeutic privilege was brought into question in Canterbury v. Spence,69 which involved a 19-year-old paraplegic after an exploratory laminectomy, and the patient was so ill and distraught that disclosure would have hindered treatment or posed psychological damage.

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Pearce and Another v. United Bristol Healthcare NHS Trust,70 was a case where the patient was expecting her sixth child. The expected date of delivery was 13 November 1991. The baby had still not arrived on 27 November 1991, when the plaintiff saw the consultant responsible for her care at the respondent hospital, the United Bristol Healthcare Trust. She was very distressed during the consultation, and begged to have an induced labour or a caesarean section.The consultant, however, thought it appropriate to let nature take its course, and for her to have a normal birth without any medical intervention. He explained that it would be very risky to induce the birth, and that it would take longer for her to recover if she had a caesarean section. She accepted this advice. The baby died in utero sometime between 2 and 3 December, and the delivery of the stillborn baby was induced on 4 December.The following issues were raised at the trial: (1) Should the consultant have advised the plaintiff that there was an increased risk of stillbirth as a result of the delay in delivery between 13 November and 27 November? (2) If the consultant should have so advised, would his advice have altered the decision made by the plaintiff to have a natural birth? Applying the tests in Bolam v. Friern Hospital Management Committee71 and Bolitho v. City and Hackney Health Authority72 in a case where the plaintiff complains of being deprived of the opportunity to make a proper decision about treatment, if there is a ‘significant risk’ attached to a particular treatment or course of action that would affect the judgment of a reasonable patient, then in the ordinary course, the doctor is responsible for informing the patient of that risk. The doctor has to take into account all the relevant considerations when deciding how much to tell a patient, including the patient’s physical and emotional state at the time, and his or her ability to comprehend information. However, in this instance, the risk involved in waiting for labour to begin naturally, even after the expected date of delivery, was so small as to be insignificant. Had the patient been informed of the risk she would, as far as could be ascertained from the evidence, reluctantly have agreed to follow the advice of the doctor and wait for a natural labour and delivery. The Court of Appeal took note of the fact that earlier during the pregnancy, the risk of the child being stillborn would have been greater than the

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figure with which the court was concerned after 13 November and 27 November 1991. If the patient’s distressed condition was borne in mind, one could not criticize the physician’s decision not to inform the patient of that extremely small additional risk.The court took note of the fact that the doctor would know that the baby was not large, which would also mean that the risk would be reduced. This was a case where, in the court’s judgment, it would not be proper for the courts to interfere with the clinical opinion of the expert medical man responsible. Telling the Truth Lying to a patient is indefensible. Honesty in diagnosis, prognosis, and treatment shall inform the best medical practices of a physician. They are complementary to the duty of care, which is an important precept that every practitioner adopts in his practice. If the truth is concealed, the element of trust takes a beating as well. Hippocrates had different advice for physician, who shall perform his duties calmly and adroitly, concealing most things from the patient while you are attending to him. Give necessary orders with cheerfulness and sincerity, turning his attention away from what is being done to him; sometime reprove sharply and emphatically, and sometimes comfort with solicitude and attention, revealing nothing of the patient’s future or present condition.

This probably sums up Indian cultural traditions as well73 but newer practices seem to indicate the opposite trend. The problem would be slightly different if the physician knew of some risk but did not share the information with the patient. Obligations to the Sick Though a physician is not bound to treat each and every person asking his services, he should not only be ever ready to respond to the calls of the sick and the injured, but should be mindful of the high character of his mission and the responsibility he discharges in the course of his professional duties. In his treatment he should never forget that the health and the lives of those entrusted to his care depend on his skill and attention. A physician should endeavour to add to the comfort of the sick by making his visits at the hour indicated to the patients. A physician advising a patient to seek the advice of another physician is acceptable;

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however, in case of emergency a physician must treat the patient. No physician shall arbitrarily refuse treatment to a patient. However, when a patient is suffering from an ailment that is not within the range of experience of the treating physician, the physician may refuse treatment and refer the patient to another physician. A medical practitioner having any incapacity detriment to the patient or which may affect his performance vis-à-vis the patient is not permitted to practice his profession. Ezekiel and Linda Emanuel detail four models74 of the physician– patient relationship: (1) The paternalistic model, which corresponds to the Hippocratic tradition of the physician acting in the best interests of the patient, who surrenders decision-making about the treatment to the doctor; (2) informative model, which gives the patient ultimate responsibility for decisions about treatment, where the physician is the expert giving necessary medical information; (3) the interpretative model, which sees the physician as taking the patients values and preferences into account in determining the treatment that will best serve the patient’s needs; (4) the deliberative model, in which the physician is engaged not only in presenting information to the patient but also in making recommendations about treatment in accord with patient’s values and preferences. There are, however, objections to all of these models. The paternalistic model could be justified in an emergency situation but could hardly be defended in the context of the modern need for the patient’s full complicity for courses of treatment based on informed consent. In the informative model, the physician lacks a caring approach and endorses the trend towards specialization and impersonalization within the medical profession. The interpretative model includes the possibility of favouring the physician’s value systems under the guise of articulating patient’s values. Advice for ‘safer sex’ for an HIV infected patient is not for the welfare of the patient but an appeal for the patient to assume responsibility for the good of others.The deliberative model may easily become unintended paternalism. After all, the nature of the moral deliberations between physician and patient, the physician’s recommended interventions, and the actual treatments used will depend on the values of the particular physician treating the patient.

confidentiality This norm is a facet of the recognition of a right to the patient’s privacy. We are examining it only in the context of the patient–doctor

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relationship and do not discuss the extent of such privacy issues visà-vis press freedom.75 Conversations between a patient and a therapist and the notes taken during their counselling sessions are protected from compelled disclosure. There are no specific legal provisions of professional privilege in India, except as a rule of evidence provided under the Indian Evidence Act. A physician cannot be compelled to disclose matters relating to the patient, but there are well-known exceptions to this privilege. The waiver of right to confidentiality when he places his physical or mental condition into issue in litigation is one. Another exception could be when any legislation places the duty on a physician to report the occurrence of child abuse revealed during therapy. A third exception is the duty of the physicians to warn potential victims of the violence threatened by their patients. Other jurisdictions might also exclude the use of the privilege in a criminal proceeding when the patient is charged with homicide or inflicting injuries on another human being. Disclosure in the public interest is yet another exception. This branch of law is particularly very relevant in cases of psychotherapists, where the patient disclosure depends greatly on the underlying presumption that the information given is kept confidential. Criminal Proclivities of Patient The public interest always makes an exception for disclosure of confidential information in the case of some psychological tendencies of a patient that could be harmful to society. In W v. Edgell76 the Court of Appeal dealt with a case of a plaintiff suffering from paranoid schizophrenia who shot and killed five people and injured two others. At his trial, his plea of guilty to manslaughter on the ground of diminished responsibility was accepted and the court ordered that he be detained without limit of time in a secure hospital. In 1986, the plaintiff ’s responsible medical officer recommended to the secretary of state that the plaintiff be transferred to a regional secure unit that could eventually lead to the plaintiff returning to the community. The secretary of state refused. The plaintiff then applied to a mental health review tribunal and to support his application for a transfer to a regionally secure unit he sought a report from the defendant as an independent consultant psychiatrist. The defendant’s report did not support the plaintiff ’s application. It disclosed that the plaintiff had a longstanding and continuing interest in home-made bombs, and did not accept that the plaintiff was no longer a danger to the public. The

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plaintiff withdrew his application to the tribunal and refused to consent to the defendant’s disclosure of the report to the medical officer at the secure hospital. Concerned that the report should be known to those treating the plaintiff, the defendant gave the report to the medical officer and copies were subsequently sent to the secretary of state and the Department of Health and Social Security. The plaintiff learnt of this when the secretary of state, in accordance with Section 71(2) of the Mental Health Act, 1983, referred his case to the mental health review tribunal in 1987. The plaintiff issued writs claiming, inter alia, injunctions restraining the defendant from communicating the contents of his report and requiring him to deliver all copies.The Court of Appeal affirmed the decision of the trial court and held that although the plaintiff had a personal interest to ensure that the confidence that he had reposed in the defendant was not breached, the maintenance of the duty of confidence by a doctor to his patient was not a matter of private but of public interest. The public interest in maintaining that confidence had to be balanced against the public interest in protecting others against possible violence. The nature of the crimes committed by the plaintiff made it a matter of public interest that those responsible for treating and managing him had all the relevant information concerning his mental state before considering his release from hospital. The information in the defendant’s report was relevant and the public interest in its restricted disclosure to the proper authorities outweighed the public interest that the plaintiff ’s confidences should be respected. The defendant’s disclosure had been properly made both in the public interest and in accordance with Rule 81(g) of the General Medical Council’s guidelines on professional conduct. In a curious reversal of fact situation in Carrie Jaffee, Special Administrator for Ricky Allen, Sr, Deceased, Petitioner v. Mary Lu Redmond et al.,77 where the police shot dead a person believed to be dangerous, and in an action for damages by the representative of the deceased, the notes of the doctor maintained during the police officer’s counselling sessions, were sought to be produced. The Supreme Court upheld the claim of privilege on grounds of doctor–patient confidentiality. However, the constitutionality of the New York State Controlled Substances Act of 1972, NY Pub. Health Law § 3300 et seq. (1976), which required that records be kept of all prescriptions for controlled substances with a potential for abuse, was upheld by the Supreme Court in Whalen,

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Commissioner of Health of New York v. Roe et al.,78 while still conceding that there was a constitutionally protected zone of privacy that included the interest in avoiding disclosure of personal matters and the interest in independence in making important personal decisions. The court held the law adequately protected privacy when it limited access to the lists and granted protection from disclosures. The court also held that there was not sufficient evidence to establish that the law had affected any decision-making abilities. Finding that the law was the product of an orderly and rational legislative decision, the court reversed the judgment and upheld it. In Crystal M. Ferguson, et al. v. City of Charleston, et al.79 the US Supreme Court dealt with the case of a state hospital’s policy setting forth procedures to be followed by hospital staff to identify pregnant patients suspected of drug abuse. Pursuant to the policy, hospital staff members tested pregnant patients for drug abuse and reported positive tests to the police. The women who received obstetrical care at the hospital and were arrested after testing positive for cocaine sued respondents, alleging that the warrantless and allegedly non-consensual drug tests were unconstitutional searches. The federal appellate court found the searches to be reasonable as a matter of law under the ‘special needs’ doctrine. On certiorari, the court reversed the judgment. Given the primary purpose of the programme, which was to use the threat of arrest and prosecution in order to force women into treatment, and given the extensive involvement of law enforcement officials at every stage of the policy, the case simply did not fit within the closely guarded category of ‘special needs’. Therefore, US Const. amend. IV’s general prohibition against non-consensual, warrantless, and suspicionless searches necessarily applied to the policy. The court, held that the drug tests performed by the hospital were not excluded from the prohibition against non-consensual, warrantless, and suspicionless searches based on ‘special needs’. Scalia J’s dissent is interesting. He said: The conclusion of the court that the special-needs doctrine is inapplicable rests upon its contention that respondents ‘undertook to obtain [drug] evidence from their patients’ not for any medical purpose, but ‘for the specific purpose of incriminating those patients’ (emphasis in original). In other words, the purported medical rationale was merely a pretext; there was no special need. See Skinner v. Railway Labor Executives’ Assn., 489 US 602, 621, n. 5, 103 L. Ed. 2d 639, 109 S. Ct. 1402 (1989). This

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contention contradicts the District Court’s finding of fact that the goal of the testing policy ‘was not to arrest patients but to facilitate their treatment and protect both the mother and unborn child.’ App. to Pet. for Cert. A-38.This finding is binding upon us unless clearly erroneous, see Fed. Rule Civ. Proc. 52(a). Not only do I find it supportable; I think any other finding would have to be overturned.

In the Indian context, the dissenting view would accord with the correct statement of law. Although there is constitutional guarantee against self-incrimination,80 the courts have consistently permitted medical examination, blood tests, breath analysis for alcohal, urine sample for narcotic substance use, etc. as legitimate tools of police investigation, and the non-disclosure of doctor’s report would have never been protected. Communicable Diseases If the patient is a threat due to a communicable disease that he may have contacted, the patient will have no right to insist that the information not be divulged by the doctor. Here the public interest would demand that the confidentiality itself does not become a source of danger. In Mr X v. Hospital Z, in two decisions between the parties, one against the decision of the National Consumer Disputes Redressal Commission81 and another by way of clarification of the first judgment in a writ petition filed by the same appellant,82 the Supreme Court examined the issue from the point of view of the fact that although the Hippocratic Oath and the Medical Council Regulations provided for the duty of the physician to maintain confidentiality, the corresponding right of the patient to enforce confidentiality is subject to an important exception of public interest. More so, if the information relates to communicable disease, the information divulged to a prospective spouse is not actionable because the Hindu Marriage Act itself provides that the affliction of sexually transmissible disease as a ground for divorce, and a person who negligently transmits a contagious disease commits a criminal offence under the IPC. Therefore, if a person suffering from HIV/AIDS, knowingly marries a woman and thereby transmits the infection to that woman, he would be guilty of offences indicated in Sections 26983 and 27084 of the IPC. These two sections spell out two separate and distinct offences by providing that if a person, negligently or unlawfully, performs an act which he knew was likely to spread the

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infection of a fatal disease to another person, then the former would be guilty of an offence punishable with imprisonment for the term indicated therein. The above statutory provisions thus impose a duty upon the appellant not to marry as the marriage would have the effect of spreading the infection of his own disease, which obviously is dangerous to life, to the woman whom he marries apart from being an offence. The court noted that even in England it is provided that the exceptions to this rule permit disclosure with the consent, or in the best interests, of the patient in compliance with a court order or other legally enforceable duty, and, in very limited circumstances, where the public interest so requires. Circumstances in which the public interest would override the duty of confidentiality could, for example, be the investigation and prosecution of serious crime or where there is an immediate or future (but not a past and remote) health risk to others. It further pointed out that the General Medical Council of Great Britain in its guidance on HIV infection and AIDS has provided: When diagnosis has been made by a specialist and the patient after appropriate counselling, still refuses permission for the General Practitioner to be informed of the result, that request for privacy should be respected. The only exception would be when failure to disclose would put the health of the health-care team at serious risk. All people receiving such information must consider themselves to be under the same obligations of confidentiality as the doctor principally responsible for the patient’s care. Occasionally the doctor may wish to disclose a diagnosis to a third party other than a health-care professional. The Council think that the only grounds for this are when there is a serious and identifiable risk to a specific person, who if not so informed would be exposed to infection ... A doctor may consider it a duty to ensure that any sexual partner is informed regardless of the patient’s own wishes.

Doctor as a Witness against His Patient Can a doctor be summoned to testify against the patient who he is treating? This question arose in Dung Ngo v. Standard Tools & Equip., Co.,85 in which a claim for damages had been made by a person against an elevator company for a defect in the functioning of an elevator that had caused the person some injuries. The person had been treated for these and filed a suit for damages against the elevator company. The company sought to subpoena the doctor to give evidence of all

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medical records pertaining to the plaintiff to substantiate its defence that that the plaintiff had not suffered any genuine injury as a result of the alleged occurrence. The plaintiff sought for a restraint on the ground that the doctor would breach the confidentiality that he owed him. The District Court of Maryland held that regardless of the near fatal quality of the testimony, the defendant was entitled to present such evidence. As the plaintiff ’s physician possessed factual information obtained during the course of treatment and not as a result of a consulting expert, there was no prohibition on the doctor’s testimony at trial. Fairness also required allowing the defendant to call the physician as a witness. In Sally McCormick v. Kent England, MD, and Michael Meyers,86 in a divorce proceeding by a husband and for custody of their children, the doctor treating the wife was summoned to give evidence about her emotional status. The physician sought leave of absence, but issued a certificate ‘to whomsoever it may concern’, suggesting that the wife was suffering from ‘major depression and alcoholism, acute and chronic’. Further, he stated the children had experienced school difficulties due to the family discord caused by the wife’s drinking. He stated it was his medical opinion that the wife was ‘a danger to herself and to her family with her substance abuse and major depressive symptoms’, and concluded that she required hospitalization. The medical records were not disclosed, and the certificate had been issued without any particular court order. The wife brought a suit against the doctor for negligence, libel, invasion of privacy, outrage, breach of confidence, and civil conspiracy against the doctor and her husband. The Court of Appeals said there existed no common law principle that protected confidentiality between doctor and patient but said: The belief that physicians should respect the confidences revealed by their patients in the course of treatment is a concept that has its genesis in the Hippocratic Oath, which states in pertinent part: ‘Whatever, in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all such should be kept secret.’ ... The modern trend recognizes that the confidentiality of the physicianpatient relationship is an interest worth protecting.

The court therefore found that an actionable tort lies for physician’s breach of the duty to maintain the confidence of their patient, but it

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was not unexceptional. It said that the public policy protecting the welfare of children through disclosure by physicians was recognized in all legal systems, and directed the trial court to consider whether circumstances existed for such disclosure or if they were privileged. Confidentiality and the Right to Information Act The disclosure of confidential information is enjoined by the provisions of the Right to Information Act on the ground of public interest. In Surupsingh Hrya Naik v. State of Maharashtra through Additional Secretary, General Administration Deptt and Ors,87 the Bombay High Court held that the confidentiality required to be maintained of the medical records of a patient, including a convict, considering the regulations framed by the MCI, cannot override the provisions of the Right to Information Act. The pronouncement of the court was in the context of a contention that the larger public interest requires that the information regarding patients who, with the intention of avoiding prison, orders of detention, remand to police custody, judicial remand get themselves admitted into hospitals with the connivance of officials. The public justifiably has a right to know as to whether such a person was admitted for genuine reasons or merely to avoid punishment or custody and thus defeat judicial orders. The court held that normally the information sought about the medical records of a convict and the like must be made available, yet it is possible that in a given case, a party may give sufficient reasons as to why the information should not be revealed. Legal Basis for Action for Breach of Confidentiality One approach that plaintiffs use when there has been a breach of confidentiality is through contract law. The weakness of a contract cause of action for breach of confidentiality between therapist and patient is that, generally, the contract cannot be a rigid one. The more common approach is the law of torts. As a first requisite, the doctor–patient relationship must be established. In Doe v. Roe,88 a psychiatrist and her psychologist husband published a book about a wife and her late husband eight years after the couple terminated psychotherapeutic treatment with the psychiatrist. The book reported extensively and verbatim about the patients’ thoughts, feelings, emotions, and fantasies, and about the disintegration of the plaintiff ’s marriage. The plaintiff

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sued for breach of contract, and in tort, for both violation of a statute establishing a public policy of confidentiality between physician and patient, and for invasion of privacy. The court held that the defendant psychiatrist had entered into an agreement with her patients to provide medical attention. The contract was one between private parties to retain in confidence matters that should be kept in confidence. As a breach of contract action, that might protect confidential relationships are muddled and unclear, the courts will stretch to find liability. In Doe v. Roe, the psychiatrist who treated the plaintiff and her husband was held liable on the basis of breach of contract, but her psychologist husband, who was a co-author and an ‘avid, co-violator of the patient’s rights’, was not in a contractual or physician–patient relationship with the plaintiff. The court held him equally liable as a co-violator. In MacDonald v. Clinger,89 the plaintiff sued his psychiatrist for disclosing personal information to the plaintiff ’s wife without his consent. The court held that the parties had a relationship that gave rise to an implied covenant which, when breached, was actionable. The court found the breach of contract action of the plaintiff inadequate for a recovery from his mental distress, loss of employment, and deterioration of his marriage. The court, however, found that the defendant psychiatrist had an additional extraneous duty that sprang from the contract that he had with the plaintiff, and the duty was actionable in tort. The more common approach for a plaintiff wanting to sue a psychotherapist for breach of confidentiality is to bring an action in tort. The tort of breach of confidentiality is an ‘unconsented, unprivileged disclosure to a third party of non-public information that the defendant has learned within a confidential relationship.’90 Most professional liability claims are made under the law of unintentional torts or malpractice (negligence). Malpractice is a special case of negligence. We all have a basic duty to exercise reasonable care to safeguard others, and professionals have an obligation to adhere to a higher standard in the course of their work. The actual damage suffered by the patient by the disclosure caused that does not comport to the standard practice is a necessary ingredient of proof in a tort action. The MacDonald court recognized that sometimes the line of demarcation between torts and contracts is not clear, and that the essence of a tort consists in the violation of some duty due to an individual that is different from a

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mere contractual obligation. Especially when the duty grows out of relations of trust and confidence, the tort is more easily separable from the mere breach of contract. Very often, plaintiffs who sue for breach of confidentiality also sue for invasion of privacy. This fact leads to more confusion in the courts’ decisions. It is necessary to identify each action, that is, breach of confidentiality and invasion of privacy, and to deal with them separately. It is also important to label each properly. An action for invasion of privacy is a tort with four subcategories: intrusion, appropriation, publicity that puts the plaintiff in a false light in the public eye, and public disclosure of private facts. Generally, public disclosure of private facts is the cause of action most closely related to breach of confidentiality by psychotherapists. This is publicity ‘of a highly objectionable kind, that gives private information about the plaintiff, even though it is true, no action would lie for defamation.’91 There are limitations on this branch of the right of privacy.The disclosure of private facts must be a public disclosure, and not a private one; there must be publicity; the facts disclosed to the public must be private facts, not public ones; and the matter made public must be one which would be offensive and objectionable to a reasonable man of ordinary sensibilities. The other limitation is, so long as the identity of the patient that could connect the disclosure to the particular patient is not revealed, there could be no cause for complaint. Therefore, the doctor or pharmacist obliging a drug company by disclosures of anonymous information about the general prescription patterns with details of identity and quantity of drugs prescribed cannot be said to constitute breach of confidentiality.92

Duties of the Physician in Consultation Physician can get a consultation only when it is justifiable and in the interest of the patient. Laboratory tests of any kind shall be carried out judiciously. Consultants should observe the utmost punctuality and will never try to blame the treating physician or disclose any diagnosis in front of patient or their relatives without discussion with the treating physician. When a patient is referred to a specialist by the attending physician, a case summary of the patient should be given, who should communicate his opinion in writing to the attending physician.

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Responsibilities of Physicians to Each Other Physicians should consider it a pleasure and privilege to render gratuitous service to all fellow physicians and their immediate family dependants. There should not be any discussion in the presence of a patient or their representatives that may affect the confidence of the patient in the treating physician. No physician or consultant shall criticize the referring physician. While another physician treats the patient during the absence of their physician, the utmost consideration to the interest and reputation of the absent physician should be made.

Duties of Physician to the Public and to the Paramedical Profession The physician engaged in public health work should enlighten the public concerning quarantine regulations and measures for the prevention of epidemic and communicable diseases. At all times the physician should notify the constituted public health authorities over every case of communicable disease under his care, in accordance with the laws, rules, and regulations of the health authorities. Physician should recognize and promote the practice of different paramedical services and should seek their cooperation whenever required. UNETHICAL ACTS

Advertising Any violation of code of conduct, unethical act, or misconduct shall lead to the removal of a physician’s name from the register permanently or temporarily, and their name shall be publicized in the local press as well in the publications of different medical associations, societies, and bodies.93 Professional misconduct or infamous conducts include the following: Soliciting of patients directly or indirectly, by a physician, by a group of physicians or by institutions or organizations is unethical. A physician shall not make use of them (or their name) as a subject of any form or manner of advertising or publicity through any mode, either alone or in conjunction with others, which is of such a character as to invite attention to him or to his professional position, skill, qualifications, achievements, attainments, specialties, appointments,

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associations, affiliations or honours, or of such character as would ordinarily result in the physician’s self-aggrandizement. A physician shall not give to any person, whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report, or statement with respect to any drug, medicine, nostrum remedy, surgical, or therapeutic article, apparatus, or appliance, or any commercial product or article with respect to any property, quality or use thereof, or any test, demonstration, or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode. Nor shall he boast of cases, operations, cures, or remedies or permit the publication of report thereof through any mode. A medical practitioner is, however, permitted to make a formal announcement in press regarding the following: (1) On starting a practice. (2) On change of type of practice. (3) On changing address. (4) On temporary absence from duty. (5) On resumption of another practice. (6) On succeeding to another practice. (7) Public declaration of charges. Printing of their own photograph or any such material of publicity in the letter head, or on the sign board of the consulting room, or any such clinical establishment shall be regarded as acts of self-advertisement and unethical conduct on the part of the physician. However, printing of sketches, diagrams, picture of the human system shall not be treated as unethical. The IMA had itself been guilty of this misconduct when it signed a Rs 2.25 crore deal with PepsiCo, allowing the company to use the IMA logo on two of its products, Tropicana and Quaker Oats. The MCI in November 2010 ruled that the IMA had violated its own ethical norms as well as the Code of Ethics through product endorsements. The MCI ordered that the names of the then IMA national leaders who had authorized the endorsement of the products be removed from the Indian medical register for six months. In addition, it sent letters of censure to the entire IMA top brass.94 Hospitals do what a doctor cannot. Advertisements of a quick and efficient cure for pin-hole spinal surgery, eye care under the guidance

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of leading ophthalmologists, knee replacements surgeries, etc. are adroitly displayed in flashy billboards and newspapers as advertisement for facilities available in hospitals. Doctors who are not in the forefront get behind the technology mask, as if to suggest that they seek no publicity for their professional skills but for what the product of science could do for the patient. In addition to curative medicine, cosmetic surgeries, Botox administration, hair reconstruction, orthodontistry, etc. are a class apart, where advertisements are made mostly without any compunction of indulging in unethical practice. There has been little effort by any of the central or the state medical councils to take serious note of this violation or even consider hospital advertisements as violations.95 Legally it is possible to plead that a corporate hospital registered as a company is a juristic person distinct from the doctors who practice in such hospitals or who may even run such hospitals, and the medical regulations that sets rules to individual doctors do not yet control them. Doordarshan and All India Radio have released a code for commercial advertisement that contains a bar to advertisement for hospitals, but it is couched in a language that offers easy scope for brazen violation.96 The West has a realistic approach that in a consumer-oriented market, advertisements are necessary tools, and patients as consumers of healthcare could be wooed to opt for what and where the best services are available.97

Patent and Copyrights A physician may patent surgical instruments, appliances, and medicine or copyright applications, methods, and procedures. However, it shall be unethical if the benefits of such patents or copyrights are not made available in situations where the interest of a large population is involved.98

Running an Open Shop (Dispensing of Drugs and Appliances by Physicians) A physician should not run an open shop for sale of medicine for dispensing prescriptions from other doctors or for sale of medical or surgical appliances. It is not unethical for a physician to prescribe or supply drugs, remedies or appliances as long as there is

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no exploitation of the patient. Drugs prescribed by a physician or brought from the market for a patient should explicitly state the proprietary formulae as well as generic name of the drug. The practice, however, is to run a pharmacy attached to a private clinic and to make its services available as a sales outlet for the general public too. The Pharmacy Act enables only certified pharmacists to dispense medicines in a pharmacy. The act itself does not contain any express stipulation barring a physician from owning a pharmacy. However, many a legal battle have been fought over ownership issues of a pharmacy by medical practitioners in the US.

ownership of pharmacy The Pharmacy Act, 1948 This central enactment was to make better provision for the regulation of the profession and practice of the pharmacist, and establish Pharmacy Councils at the centre and at the states to formulate education regulations, approval of courses of study and examinations, qualification criteria for pharmacists, registration procedures, etc. While the act makes it an offence for dispensing medicines by unregistered individuals,99 it does not expressly prohibit doctors from owning pharmacies. The prevalent practice is that many medical practitioners own pharmacies that are attached to their private clinics or hospitals and have a ‘registered pharmacist’ attached to the pharmacy. It could be perfectly tenable for the central or state legislative bodies to bar pharmacy ownership by physicians without offending the fundamental freedoms guaranteed under Part III of the Constitution of India, and justify the embargo on the ground that the restrictions are reasonable, but this has not come before the Indian courts. The examination of the physician–pharmacy relationship below is drawn from American experience.100 The physician was also originally the dispensing chemist. By the early nineteenth century, the pharmacy began to break away from the practice of medicine, and medicine began to move from the apothecary into private offices.101 The physician with a pharmacy ownership interest receives a fee split, rebate, or kickback for every prescription that is filled in his outlet. Such self-referral arrangements encourage overutilization of medical services and create a conflict of interest

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problem for physicians. Recognizing this built-in conflict, numerous states have proscribed physician ownership of medical facilities in the US. Pharmacies are a profitable investment for a businessman. Because a patient is a captive customer who is told what to buy, what amount to buy, how fast it must be consumed, and how much must be paid, they are caught in a monopolistic squeeze between the pharmacist and the physician. For a doctor to interfere with the patient’s free choice of pharmacies would be tantamount to granting a physician a complete monopoly over the patient. Although the ownership of pharmacies by doctors has waned, it is now on the rise again. The Examination of the Physician–Pharmacist Relationship The pharmacist and physician share a unique relationship. It is the doctor who manipulates and treats illness or injury through surgery, therapy, or the prescription of medications. The doctor orders medication for the patient and the pharmacist interprets and evaluates the order. The pharmacist is completely at the control of the physician because they must supply what the physician orders; the patient is likewise under the doctor’s command because they receive those drugs prescribed by the medical professional in good faith that the medications will correct their ailments. In this type of arrangement, demand is controlled by the supplier (doctor), not the consumer (patient). The physician retains extraordinary control over drug consumption habits because a patient realizes that failure to follow the prescriber’s regimen may be detrimental to their health. In short, there is, in fact, no other product or service necessary to the maintenance of life that so completely escapes the exercise of consumer sovereignty as does the prescription drug in the circumstances under which it is sold today. When a physician owns a pharmacy, he will always stand to profit by directing his patients to it. Thus a temptation is always present for a medical practitioner to influence his patient to have his prescription filled at the pharmacy in which he has an interest. Such monetary inducements may result in increased overutilization of services through greater prescribing habits, increased prices, poor quality of care, and decreased competition in the overall pharmacy marketplace. Because the abuse potential is high for the fraudulent doctor who seeks rebates or kickbacks through his own pharmacy, the issue has come under scrutiny by Congress and professional organizations.

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More ingenious plans that have been employed include stocking only one brand name of a drug and prescribing that drug with ‘DO NOT SUBSTITUTE’ marked on the prescription (invariably forcing the patient to visit the ‘fully stocked’ physician-owned pharmacy); overprescribing to welfare patients and receiving a double windfall when the pharmacy filled the prescriptions; suggesting or directly referring the patient to the pharmacy; and using drug ‘samples’ acquired from drug manufacturers to fill orders. In North Dakota State Board of Pharmacy v. Snyder’s Drug Stores102 the statute in question required that a pharmacy permit applicant must be ‘a registered pharmacist ... or a corporation or association, the majority stock in which is owned by [a] registered pharmacist’. A non-pharmacist-owned corporation issued six shares of stock at a nominal sum to a registered pharmacist-employee to comport with the ownership requirement. The Board of Pharmacy denied the permit and the State Supreme Court of North Dakota agreed with the Board, allowing a piercing of the corporate veil to discourage fraud. Two years later, the same company challenged the constitutionality of ND Cent. Code 43-15-35(5) in Snyder’s Drug Stores v. North Dakota State Board of Pharmacy.103 The North Dakota Supreme Court found the statute unconstitutional. On certiorari, Justice Douglas, speaking for the US Supreme Court, reversed the decision and stated that states have the power to legislate against what are found to be ‘injurious practices’. The Snyder’s decision gave states free reign to legislate pharmacy ownership restrictions and other state courts welcomed analysis of those statutes. Even apart from the focus on due process, the right of a medical professional to have a financial interest in a drug store has been considered in some cases. In Missoula Clinic Pharmacy v. Zimmerman,104 the Montana Supreme Court held that the state pharmacy act does not grant authority to the state board of pharmacy to deny a licence to operate a pharmacy solely on the ground of ownership by physicians. The court took notice of the permissibility of a physician to dispense drugs to his patient, and the anomalous result if one who could prescribe and dispense lawfully could not own the situs where the dispensing occurred. In 1967, two California cases dealt with direct physician ownership of pharmacies. In Warrock Medical Center Hospital v. California State Board of Pharmacy,105 the Court of Appeals of California held that a statute providing that the board of pharmacy

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shall not issue a permit to a licenced physician did not compel the board to deny a permit to a corporate applicant owned in part by physicians. In the companion case of Magan Medical Clinic v. California State Board of Medical Examiners,106 the California Court of Appeals held that a prohibition on physician ownership of pharmacies was constitutional, but that the prohibition did not apply to practitioners who owned stock in corporate pharmacies. Snyder’s and its state counterparts demonstrate that legislatures may pass pharmacy ownership requirements if they are relevant to the important government policy of protecting the public welfare. But as Zimmerman, Warrock and Magan elucidate, the state statute must be scrivened narrowly in order for reviewing courts to interpret them in the way the legislature desired them to be enforced.107 California has retained its statutory scheme of refusing to award pharmacy permits to medical practitioners despite both Warrock and Magan. The California Business and Professions Code restricts the issuance of permits to conduct a pharmacy to any person authorized to prescribe or write a prescription. Moreover, pharmacy ownership by a corporation controlled by, or in which 10 per cent or more of the stock is owned by, a medical prescriber is prohibited. There are three basic types of state statutes that deal with physician ownership of pharmacies. The first type is a blanket proscription on unlawful division, rebate, or refunding of fees when a patient is referred to a business concern of a physician.This type mirrors the federal AntiFraud and Abuse Statutes.The second type of scheme achieves the same result by prohibiting certain actions in which a physician or pharmacist may partake. The third form is a direct prohibition on the ownership of pharmacies by non-pharmacists. The first statutory example usually comes under the heading of ‘disciplinary’ or ‘unprofessional’ conduct. States using this construction subject medical practitioners to disciplinary action if they directly or indirectly receive from any person any fee, commission, rebate, or other form of compensation that tends to influence the physician’s objective evaluation of his patient. In 1972, Congress enacted legislation as an attempt to combat directly fraud and abuse in the federal medicare and medicaid programs.108 In 1977, in response to investigations that uncovered a fraud and abuse explosion, Congress enacted the Medicare/Medicaid AntiFraud and Abuse Amendments, substantially revising the 1972 text.

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The broadly-worded statute was intended to restrict the corrupting influence of profit on a provider in his decision to self-refer patients. Under the amendments, if a healthcare provider files a false claim to the government or solicits, offers, or receives any remuneration in return for referring patients for services covered under medicare or medicaid, he is guilty of a federal crime. Furthermore, the provider is also subject to civil penalties under the Department of Health and Human Services (HHS), state criminal laws against fee splitting, and state disciplinary proceedings. The caveat is that ‘if remuneration flows from one party to another and if referrals flow back, the potential for criminal prosecution exists’. The US District Courts have been flooded by aggressive campaigns to halt the rise of fraud and abuse. In United States v. Greber,109 the defendant physician owned a monitoring service that provided physicians with certain diagnostic readings. The government charged that the defendant had tendered kickbacks to referring doctors. Greber defended that the remuneration to participating physicians was a valid fee for the physicians’ interpretation and consulting services to the patient. The Court of Appeals held that even if the physician performs some service for the money received, the potential for unnecessary drain on the medicare system still remains. There have been a few changes to the Anti-fraud and Abuse Act since 1978, such as the Medicare Patient and Provider Protection Act of 1987. This statute declares that bribes and kickbacks do not apply to discounts if disclosure is made to the patient. Furthermore, the Secretary of Health and Human Services is now authorized to promulgate regulations to describe narrow exceptions to fraud and abuse liability. These regulations or ‘safe harbors’ were enacted because Congress recognized the need to permit practitioners to engage in businesses to encourage competition but they also wished to reduce potential for abuse in these arrangements. These guidelines are the HHS’s attempt to allow investment but to minimize or prevent risks. The Physician Investor Physicians with ownership interests in pharmacies must comport with a series of state regulations, ethical guidelines, credentialing decision-makers, and legal regulations. In the US, the prevalence of self-referral joint ventures by physicians is due to two main factors.

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First, medicaid reforms have barred physicians for profiting from work they refer, but do not directly perform. Second, since 1984, physician fees under medicare have been consistently lowered while service reimbursement, such as laboratory and prescription fees, has remained relatively stable.110 Numerous commentators have discussed two possible solutions to physician referral to owned facilities: disclosure and percentage-based requirements. Disclosure allows the doctor to refer patients to their own business if they reveal their ownership interest to the patient. Such a requirement affords the patient the opportunity to elect a different facility. Unfortunately, given a patient’s reliance on their doctor both as a professional and a friend, as well as the patient’s lack of medical training, disclosure is a weak remedy at best. A second possibility is percentage of ownership requirements, which limit the amount of ownership that a physician may equitably possess when he refers patients to his facility. Numerous states have this provision in place in pharmacy ownership laws. This argument is also problematic because physicians may own a small percentage of a corporation—below threshold levels—yet still recoup a sizeable profit. For physician-owned pharmacies, there are many customs that can be avoided by physicians.These include advertising on the prescription or in the office, ‘coding’ prescriptions, and removing direct phone lines. Also, the physician can disclose to the patient, in writing, his ownership interests and his ownership interest percentage. The doctor can also re-evaluate his current prescribing habits. Moreover, the prudent provider can track his referrals through the use of a pharmacy computer to ensure that levels of such referrals remain low. These procedural safeguards may ensure compliance with anticipated anti-kickback legislation but they may also become an administrative nightmare for the investing physician. Therefore, when practitioners carefully examines the physician–pharmacist relationship, ethical guidelines, state statutes, case law, and state laws, they may decide that physicians and pharmacists should operate independently of one another in tandem for the welfare of the patient. The modern physician is in a precarious position. He has developed medical expertise through many years of schooling but he still may wish to achieve personal and financial goals through business acquisitions. As businessmen invest in businesses, it seems only fair that physician

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entrepreneurs invest in medically-related entities. With a greater-thanaverage income, the medical acumen and training to begin a new healthcare entity, and ‘captive’ patients as customers, the physician stands only to gain by investing in such a venture. Weighed against allowing investment and a physician’s pursuit of the market share are concerns over conflicts of interest with the patient and overutilization of inferior healthcare. Referring a patient to one’s own business may be considered unethical and an exploitation of the patient for pecuniary gain. Physicians should place the welfare of the patient before personal wealth.The anxieties over imbalances in proper healthcare for the public are a compelling state interest. Many jurisdictions have followed this caveat and as they recognize the potential for abuse in referral business schemes developed by physicians. This is a split from the common law dichotomy of separating the ‘healer’ from the ‘medicine man.’ In the US, many state legislatures have passed pharmacy acts that either prevent abuses or act as statutes that lessen the potential for those corruptions. Federal law specifically prohibits such relationships with welfare recipients. With these safeguards in place, fraud by a provider lessens while quality healthcare increases. Since there has never been an outright ban on physician ownership of pharmacies by any governing body, it is up to the state and local pharmaceutical associations, medical associations, and state boards of pharmacy to self-regulate the practice through ethical mandates.

Rebates and Commission A physician shall not give, solicit, or receive nor shall he offer to give solicit or receive, any gift, gratuity, commission or bonus in consideration of or return for the referring, recommending or procuring of any patient for medical, surgical or other treatment. A physician shall not, directly or indirectly, participate in or be a party to act of division, transference, assignment, subordination, rebating, splitting, or refunding of any fee for medical, surgical, or other treatment. This provision shall apply with equal force to the referring, recommending, or procuring by a physician or any person, specimen, or material for diagnostic purposes or other study or work. Nothing in this section, however, shall prohibit payment of salaries by a qualified physician to other duly qualified individuals rendering medical care

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under his supervision. It is widely believed that that physicians who have personally invested in clinical and research labs more often refer their own patients to the labs, imaging centres, and equipment services in which they have an interest.Those who are not doctors also have an interest to see that their centres obtain their patronage from doctors to whom substantial kickbacks are assured. There is no reason to suspect pharmacy referrals would be any different.

Secret Remedies The prescribing or dispensing by a physician of secret remedial agents despite being ignorant of its composition, or the manufacture or promotion of their use is unethical and as such prohibited. All the drugs prescribed by a physician should always carry a proprietary formula and clear name. Even apart from the secret remedies, there is an enactment that bans the use of magic remedies. It is not merely unethical to prescribe a magic remedy; it is illegal to prescribe magic remedies. It is referred to below as making full the statement of law on the subject.

the drugs and magic remedies (objectionable advertisements) act, 1954 The act was passed to prohibit the advertisement for remedies alleged to possess magic qualities and to provide for matters connected therewith. The magic remedy could be a talisman, mantra kavacha, and any other charm of any kind that is alleged to possess miraculous powers for the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals, or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals.111 Distribution or sending out advertisements of drugs within and outside India would amount to publication. The act makes punishable the participation in the publication of any advertisement, which includes the printing of the advertisement, and the publication of any advertisement outside the territories to which the act extends or at the instance of a person residing within these territories.112 The act prohibits advertisement or treatment referring to any drug in terms that suggests (1) the procurement of miscarriage in women or prevention of conception in women; (2) the maintenance or improvements

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of the capacity of human beings for sexual pleasure; (3) the correction of menstrual disorder in women; or (4) the diagnosis, cure, mitigation, treatment, or prevention of any disease, disorder or condition specified in the Schedule,113 or any other disease, disorder, or condition (by whatsoever name called) that may be specified in the rules made under this act.114 It was held in Hamdard Dawakhana (Wakf) Lal Kuan, Delhi and Another v. Union of India and Others115 that the advertisements prohibited by Section 3 of Act 21, 1954, relate to commerce or trade and not to propagation of ideas; and advertising of prohibited drugs or commodities of which the sale is not in the interest of the general public cannot be speech within the meaning of freedom of speech, and would not fall within Article 19(1)(a). As the main aim, object and scope of the act is to prevent self-medication or self-treatment, and for that purpose advertisements commending certain drugs and medicines have been prohibited, it cannot be said that this is an abridgement of the right of free speech. The act also prohibits any person from taking part in the publication of any advertisement relating to a drug if the advertisement contains any matter that (1) directly or indirectly gives a false impression regarding the true character of the drug; (2) makes a false claim for the drug; or (3) is otherwise false or misleading in any material particular.116 The import or export of documents containing such advertisements are similarly prohibited.117 The acts that are prohibited are punishable in the case of first conviction, with imprisonment that may extend to six months, with a fine, or both, and in the case of a subsequent conviction, with imprisonment that may extend to one year, a fine, or both.118 This section shows that before a person is penalized, it is not necessary to show that the contravention brought home to him is habitual; a single proven contravention is sufficient for a person to be regarded as guilty, and that is why the scheme adopted is that it provides for a lesser punishment for the first offence and a relatively more serious penalty for subsequent offences.119 The offences are cognizable offences under the Code of Criminal Procedure(CrPC)120 and may be tried by a court not inferior to the presidency magistrate or the magistrate of the first class.121 The advertisements prohibited under the act do not, however, include: (1) any sign board or notice displayed by a registered medical practitioners on their premises indicating that treatment for any disease, disorder, or condition specified in Section 3, the schedule or the rules

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made under this act, is undertaken in those premises; (2) any treatise or book dealing with any of the matter specified in Section 3 from a bona fide scientific or social standpoint; (3) any advertisement relating to any drug sent confidentially in the manner prescribed under the rules made in the manner prescribed under the act only to a registered medical practitioner; (4) any advertisement relating to a drug printed or published by the government; or (5) any advertisement relating to a drug printed or published by any person with the previous sanction of the government granted prior to the commencement of the Drugs and Magic Remedies (Objectionable Advertisement) Amendment Act, 1963 (42 of 1963). The government may, however, for reasons to be recorded in writing, withdraw the sanction after giving the person an opportunity of showing cause against such withdrawal.122 The act does not envisage action every type of deceitful advertisements unconnected to medicinal effects. Tantric remedies offered by fraudsters to bring back to life a dead person shall not be covered by this act, and in Smt. Aarti v. State of Punjab through Principal Secretary,123 a division bench requested the Law Commission to examine whether there was any scope for reviewing or suitably modifying the scheme of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, so as to bring advertisements that are assuring magic remedies for nonmedical problems within the purview of the legislation. It pointed out that if the advertisements of the magic remedy related to service, business, foreign travel, marriage, education, successes or failure in politics, etc., howsoever outlandish they may be, could not be said to fall within the purview of Section 5 of the act.

Human Rights The physician shall not aid or abet torture, nor shall he be a party to either infliction of mental or physical trauma or concealment of torture inflicted by some other person or agency in clear violation of human rights. It is commonplace knowledge that the tools of investigation adopted by the police for crime detection include physical or mental torture of suspects. Securing vital leads to missing links in its process makes way for active collaboration of the police with medical personnel for administration of certain types of drugs to induce the suspect to provide information during a hypnotic state. The resort to

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medical professionals for their opinions is invariably made while the cause and the time of death are issues in a criminal trial for ‘homicide’ and ‘murder’124 or in cases of injuries voluntarily caused on another with criminal intention. Extra-judicial confession and the maintenance of medical records are also vital tools in criminal cases, for doctors are invited to tender testimony on facts to which they are privy. All these duties have important bearing on human rights issues. Here, the doctors face the dilemma of having to break the doctor–patient confidentiality, when they know that the particular patients are potential dangers to society and when there exist injuries on the persons, the duty to help the investigating machinery of the state by divulging information when sought.

Euthanasia Practicing euthanasia shall constitute unethical conduct. However, on specific occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary function even after brain death shall be decided only by a team of doctors and not merely by the treating physician alone. A team of doctors shall decide the withdrawal of the support system.This team shall consist of the doctor in charge of the patient, the chief medical officer or medical officer in charge of the hospital, and a doctor nominated by the in-charge of the hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organ Act, 1994.

forms of assisted suicide Suicide is an act of criminal self-destruction. While it is not possible to punish a dead person for what he did, if he survived the attempt, he could be proceeded with legally under regimes that make an attempt at suicide an offence. The IPC contains detailed provisions about when an attempt to suicide is punishable,125 when abetment to suicide constitutes culpable homicide,126 and even when the husband or certain classes of relatives could be said to have committed acts of cruelty when a woman commits suicide after marriage.127 We are, however, concerned in this chapter with issues of assisted suicide in the context of medical intervention. Euthanasia, however, is

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more than assisted suicide. The mild variations are treated along the following lines: (1) Passive assistance occurs when a health care provider does nothing to prevent a patient’s suicide. In the healthcare context, however, passive assistance has been an ethical practice for many years. For example, do-not-resuscitate (DNR) orders have been instrumental in forming the current awareness of rights and responsibilities in the area of death and dying. A physician who refrains from attempting cardiopulmonary resuscitation (CPR) on a patient who has made a rational choice to commit suicide is within the acceptable guidelines of the practice of medicine. (2) Facilitation of suicide is the second circumstance in the health care context, and occurs when the healthcare provider renders peripheral aid to the victim. Facilitation of suicide can be distinguished from other types of assistance in that the healthcare provider’s aid only amounts to minimal supportive behaviour. Encouraging an individual to commit suicide, for example, is illegal. (3) Another type of assisted suicide occurs when the healthcare provider supplies the means for committing suicide. Most cases do not involve malicious acts, but do involve ailing victims who have determined that their existence is meaningless and intolerable. Some physicians assist patients who request [suicide assistance], either by prescribing sleeping pills with knowledge of their intended use or by discussing the required doses and methods of administration with the patient. (4) The last type of assisted suicide occurs when the healthcare provider actively participates in the act of suicide.128

active and passive euthanasia In Aruna Shanbaug’s case,129 the Supreme Court said, ‘The difference between “active“ and “passive“ euthanasia is that in active euthanasia, something is done to end the patient’s life’ while in passive euthanasia, something is not done that would have preserved the patient’s life. Assisting patients with suicide comes close to performing an act of euthanasia. Active euthanasia generally involves the administration of some agent or procedure which the physician believes is warranted to end the patient’s life. Passive euthanasia consists of permitting a patient to die by withholding life-sustaining treatment. Passive euthanasia may take many forms. In McKay v. Bergstedt,130 for example, the

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court allowed a competent adult who had been dependent on a respirator for 21 years to discontinue treatment. The court distinguished the plaintiff ’s case from that of a suicidal adult by stating, ‘Unlike a person bent on suicide, Kenneth sought no affirmative measures to terminate his life; he desired only to eliminate the artificial barriers standing between him and the natural processes of life and death that would otherwise ensue with someone in his physical condition.’ In the Netherlands, since the enactment of the Termination of Life on Request and Assisted Suicide (Review Procedures) Act, 2000, nearly 10,000 people die by euthanasia every year at the hands of cooperative physicians.131 The Netherlands has developed criteria that must be met for an act of euthanasia to be considered medically and ethically acceptable. First, the patient’s medical situation must be intolerable, with no prospect for improvement. Second, the patient must be rational, and must voluntarily and repeatedly request euthanasia of the physician. Third, the patient must be fully informed of the procedures and consequences. Last, there must be no other means of relieving the suffering, and two physicians must concur with the request. Although most physicians in the US do not openly embrace the Dutch position, the practice of passive and active euthanasia will continue in the healthcare delivery system.Whatever attitudes society may develop toward assisted suicide or euthanasia, individual physicians will decide for themselves whether to provide suicide assistance or practice euthanasia. There are again no universally accepted norms to justify it. On the contrary, the opinion that euthanasia is morally permissible is traceable to Socrates, Plato, and the Stoics. It is rejected in traditional Christian belief, chiefly because it is thought to contravene the prohibition of murder in the Ten Commandments. The organized movement for legalization of euthanasia commenced in England in 1935, when C. Killick Millard founded the Voluntary Euthanasia Legalisation Society (later called the Euthanasia Society). The society’s bill was defeated in the House of Lords in 1936, as was a motion on the same subject in the House of Lords in 1950. In the US the Euthanasia Society of America was founded in 1938. The first countries to legalize euthanasia were the Netherlands in 2001 and Belgium in 2002. In 1997, Oregon became the first state in the US to decriminalize physician-assisted suicide. On 17 January 2006, in Gonzales v. Oregon,132 the US Supreme Court ruled 6–3 in favour of Oregon,

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upholding the law. The State of Washington’s ban as articulated in Wash. Rev. Code § 9A.26.060(1) (1994) was challenged as violative of the US Constitution Amendment XIV on assisted suicide. Earlier, however, the US Supreme Court had held in Washington v. Harold Glucksberg133 that the Act on its face,134 was rationally related to a legitimate government interest and did not violate the Due Process Clause of the 14th amendment. The court reasoned that state legislation sought to preserve human life and also uphold the integrity and ethics of the medical profession. Additionally, Washington’s statute sought to protect vulnerable groups, such as the poor, elderly, and disabled from abuse, neglect, and mistakes. Finally, the court held that Washington’s ban on assisted suicide effectively prevented a broader licence to voluntary or involuntary euthanasia.135 The potential of modern medical practice to prolong life through technological means has provoked the question of what courses of action should be available to the physician and the family in cases of extreme physical or emotional suffering, especially if the patient is incapable of choice. Passively doing nothing to prolong life or withdrawing life-support measures has resulted in criminal charges being brought against physicians; on the other hand, the families of comatose and apparently terminal patients have instituted legal action against medical establishment to make them stop the use of extraordinary life support.136

the unending, inconclusive debate The subjects of euthanasia and assisted suicide have been deeply controversial long before the adoption of the Universal Declaration of Human Rights in 1948, which was followed two years later by the European Convention on Human Rights and Freedoms (1950). The arguments and counter arguments have ranged widely. There is a conviction that human life is sacred, the corollary being that euthanasia and assisted suicide are always wrong. This view is supported by the Roman Catholic Church, Islam, and other religions. There is also a secular view, shared sometimes by atheists and agnostics, that human life is sacred. On the other hand, there are many millions who do not hold these beliefs. For many, the personal autonomy of individuals is predominant.They would argue that it is the moral right of individuals

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to have a say over the time and manner of their death. On the other hand, there are utilitarian arguments to the contrary. The terminally ill and those suffering great pain from incurable illnesses are often vulnerable. And not all families whose interests may be at stake are wholly unselfish and loving. There is a risk that assisted suicide may be abused in the sense that, in such circumstances, people may be persuaded that they want to die or that they ought to want to die. Further, when one knows the genuine wish of a terminally ill patient to die, they should not be forced against their will to endure a life they no longer wish to endure. Such views are countered by those who say it is a slippery slope or the thin end of the wedge. It is also argued that euthanasia and assisted suicide, under medical supervision, will undermine the trust between doctors and patients. It is said that protective safeguards are unworkable. The opposing views within the disability community on the issue of assisted suicide share a common ground—a recognition of the danger of discrimination to the interests and fair treatment of people with disabilities.137 The countervailing contentions of moral philosophers, medical experts, and ordinary people are endless, and the literature.138

Limitation to the Sanctity of Life Principle A competent patient cannot be compelled to undergo life-saving treatment.139 Under the double effect principle, medical treatment may be administered to a terminally ill person to alleviate pain, although it may hasten death.140 This principle entails a distinction between foreseeing an outcome and intending it. The case of Bland141 involved a further step of the House of Lords, holding that under judicial control it was permissible to cease to take active steps to keep a person in a PVS state alive. It involved the notion of a distinction between doctors killing a patient and letting him die.142 These are, at present, the only inroads on the sanctity of life principle in English law. In this corner of the law, England is not an island on its own. It is true that since the Alkmaar decision of the Supreme Court on 27 November 1984, the Dutch courts have relied on the principle of ‘noodtoestand’ (necessity) and relaxed the prohibition on euthanasia and assisted suicide. The perceived necessity was the conflict between a doctor’s respect for life and his duty to assist a patient suffering unbearably. The Dutch courts

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reasoned that it is necessary to be guided by responsible medical opinion. It is important to note that this line of decisions is not based on the European Convention. The Parliament of the Netherlands has enacted a statute, namely, the Termination of Life for Request and Assisted Suicide (Review Procedures) Act, 2001, which formalizes a relaxation of the law prohibiting euthanasia and assisted suicide previously by judicial decision. Both the case law and the 2001 statute only permit euthanasia and doctor assisted suicide under a regime of ascertaining the wishes of the patient and with considerable medical supervision. It is to be noted, however, that the UN Human Rights Committee in a report dated 27 August 2001 expressed serious concerns about the operation of the system: CCPR/CO/72/NET.

Code of Conduct for Doctors and Professional Association of Doctors in Their Relationship with Pharmaceutical and Allied Health Sector Industry143 In dealing with Pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below: (1) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry and their sales people or representatives. (2) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme, etc., as a delegate. (3) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext. (4) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc. can only be received through approved institutions by modalities laid

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down by law/rules/guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed. (5) Medical research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment/project funded by industry—for being proper and ethical.Thus, in accepting such a position a medical practitioner shall: (i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities. (ii) Ensure that such a research project(s) has the clearance of national/state/institutional ethics committees/bodies. (iii) Ensure that it fulfils all the legal requirements prescribed for medical research. (iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself. (v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s). (vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way. (vii) Ensure that while accepting such an assignment, a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document/agreement for any such assignment. (6) Maintaining professional autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his/ her own professional autonomy and/or with the autonomy and freedom of the medical institution. (7) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors, or in any other professional capacity. In doing so, a medical practitioner shall always: (i) Ensure that his professional integrity and freedom are maintained.

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(ii) Ensure that patient interest are not compromised in any way. (iii) Ensure that such affiliations are within the law. (iv) Ensure that such affiliations/employments are fully transparent and disclosed. (8) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publically. Any study conducted on the efficacy or otherwise of such products shall be presented to and/or through appropriate scientific bodies or published in appropriate scientific journals in a proper way. MISCONDUCT The following acts of commission or omission on the part of a physician shall constitute professional misconduct rendering him/her liable for disciplinary action.

Violation of Regulations If he/she commits any violation of these regulations. (1) If he/she does not maintain the medical records of his/her indoor patients for a period of three years and refuses to provide the same within 72 hours when the patient or his/her authorised representative makes a request for it. (2) If he/she does not display the registration number accorded to him/her by the State Medical Council or the MCI in his clinic, prescriptions and certificates etc. issued by him or violates the regulation providing that physicians shall display as suffix to their names only recognized medical degrees or such certificates/diplomas and memberships/honours which confer professional knowledge or recognizes any exemplary qualification/achievements.

Adultery or Improper Conduct Abuse of professional position by committing adultery or improper conduct with a patient or by maintaining an improper association with a patient will render a physician liable for disciplinary action as provided under the Indian Medical Council Act, 1956, or the concerned State Medical Council Act.144

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Conviction by Court of Law Conviction by a Court of Law for offences involving moral turpitude/ Criminal acts exposes a medical practitioner liable for removal from the rolls.

Sex Determination Tests On no account shall sex determination test be undertaken with the intent to terminate the life of a female foetus developing in her mother’s womb, unless there are other absolute indications for termination of pregnancy as specified in the Medical Termination of Pregnancy Act, 1971. Any act of termination of pregnancy of normal female foetus amounting to female foeticide shall be regarded as professional misconduct on the part of the physician leading to penal erasure besides rendering him liable to criminal proceedings as per the provisions of this act.145 ‘We should not choose the sexes of our children because to do so is one of the most stupendously sexist acts in which it is possible to engage. It is the original sexist sin.’146

signing professional certificates, reports, and other documents Registered medical practitioners are in certain cases bound by law to give, or may from time to time be called upon or requested to give certificates, notification, reports, and other documents of similar character signed by them in their professional capacity for subsequent use in the courts or for administrative purposes etc. Any registered practitioner who is shown to have signed or given under his name and authority any such certificate, notification, report, or document of a similar character which is untrue, misleading or improper, is liable to have his name deleted from the register. A report drawn and evidence given bona fide and in good faith shall, however, be protected against any action for damages in a civil action but will still not impede the regulatory body from taking disciplinary action, if the public interest so demands.147 (1) A registered medical practitioner shall not contravene the provisions of the Drugs and Cosmetics Act and regulations made thereunder.

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Accordingly, a) prescribing steroids/psychotropic drugs when there is no absolute medical indication; selling Schedule ‘H’ & ‘L’ drugs and poisons to the public except to his patient; in contravention of the above provisions shall constitute gross professional misconduct on the part of the physician. (2) Performing or enabling an unqualified person to perform an abortion or any illegal operation for which there is no medical, surgical or psychological indication. (3) A registered medical practitioner shall not issue certificates of efficiency in modern medicine to unqualified or non-medical person. The foregoing does not restrict the proper training and instruction of bona fide students, midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants and therapy assistants under the personal supervision of physicians. (4) A physician should not contribute to the lay press articles and give interviews regarding diseases and treatments which may have the effect of advertising himself or soliciting practices; but is open to write to the lay press under his own name on matters of public health, hygienic living or to deliver public lectures, give talks on the radio/TV/Internet chat for the same purpose and send announcement of the same to lay press. (5) An institution run by a physician for a particular purpose such as a maternity home, nursing home, private hospital, rehabilitation centre or any type of training institution etc. may be advertised in the lay press, but such advertisements should not contain anything more than the name of the institution, type of patients admitted, type of training and other facilities offered and the fees. (6) It is improper for a physician to use an unusually large sign board and write on it anything other than his name, qualifications obtained from a university or a statutory body, titles and name of his speciality, registration number including the name of the State Medical Council under which registered. The same should be the contents of his prescription papers. It is improper to affix a sign-board on a chemist’s shop or in places where he does not reside or work.

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(7) The registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his/her profession except: (i) in a court of law under orders of the presiding judge; (ii) in circumstances where there is a serious and identified risk to a specific person and/or community; and (iii) notifiable diseases. (8) In case of communicable/notifiable diseases, concerned public health authorities should be informed immediately. (9) The registered medical practitioner shall not refuse on religious grounds alone to give assistance in or conduct of sterility, birth control, circumcision and medical termination of pregnancy148 when there is medical indication, unless the medical practitioner feels himself/herself incompetent to do so. (10) Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed. (11) A registered medical practitioner shall not publish photographs or case reports of his/her patients without their permission, in any medical or other journal in a manner by which their identity could be made out. If the identity is not to be disclosed, the consent is not needed. (12) In the case of running of a nursing home by a physician and employing assistants to help him/her, the ultimate responsibility rests on the physician. (13) A physician shall not use touts or agents for procuring patients. (14) A physician shall not claim to be specialist unless he has a special qualification in that branch. (15) No act of IVF or artificial insemination shall be undertaken without the informed consent of the female patient and her spouse as well

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as the donor. Such consent shall be obtained in writing only after the patient is provided, at her own level of comprehension, with sufficient information about the purpose, methods, risks, inconveniences, disappointments of the procedure and possible risks and hazards.149

research on human subjects Clinical drug trials or other research involving patients or volunteers as per the MCIR guidelines can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy is not as per the guidelines shall also be construed as misconduct.150 If a physician posted in rural area is found absent on more than two occasions during inspection by the head of the District Health Authority or the Chairman, Zila Parishad, the same shall be construed as a misconduct if it is recommended to the MCI/State Medical Council by the state government for action under these regulations. If a physician posted in a medical college/institution both as teaching faculty or otherwise shall remain in hospital/college during the assigned duty hours. If they are found absent on more than two occasions during this period, the same shall be construed as misconduct if it is certified by the principal/medical superintendent and forwarded through the State Government to the MCI/State Medical Council for action under these regulations.

punishment and disciplinary action It must be clearly understood that the instances of offences and of professional misconduct which are given above do not constitute and are not intended to constitute a complete list of the infamous acts which calls for disciplinary action, and that by issuing this notice the MCI and or State Medical Councils are in no way precluded from considering and dealing with any other form of professional misconduct on the part of a registered practitioner. Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct which do not come within any of these categories. Every care should be taken that the

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code is not violated in letter or spirit. In such instances as in all others, the MCI and/or State Medical Councils have to consider and decide upon the facts brought before the MCI and/or State Medical Councils. It is made clear that any complaint with regard to professional misconduct can be brought before the appropriate medical council for disciplinary action. Upon receipt of any complaint of professional misconduct, the appropriate medical council would hold an enquiry and give opportunity to the registered medical practitioner to be heard in person or by pleader. If the medical practitioner is found to be guilty of committing professional misconduct, the appropriate medical council may award such punishment as deemed necessary or may direct the removal altogether or for a specified period, from the register of the name of the delinquent registered practitioner. Deletion from the register shall be widely publicized in local press as well as in the publications of different medical associations/societies/bodies. In case the punishment of removal from the register is for a limited period, the appropriate council may also direct that the name so removed shall be restored in the register after the expiry of the period for which the name was ordered to be removed. Decision on complaint against delinquent physician shall be taken within a time limit of six months. During the pendency of the complaint the appropriate council may restrain the physician from performing the procedure or practice which is under scrutiny. Professional incompetence shall be judged by peer group as per guidelines prescribed by the MCI. Where either on a request or otherwise the MCI is informed that any complaint against a delinquent physician has not been decided by a State Medical Council within a period of six months from the date of receipt of complaint by it and further the MCI has reason to believe that there is no justified reason for not deciding the complaint within the said prescribed period, the MCI may— (1) Impress upon the concerned state medical council to conclude and decide the complaint within a time bound schedule; (2) May decide to withdraw the said complaint pending with the concerned state medical council straightaway or after the expiry of the period which had been stipulated by the MCI in

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accordance with para(i) above, to itself and refer the same to the Ethical Committee of the Council for its expeditious disposal in a period of not more than six months from the receipt of the complaint in the office of the MCI. Any person aggrieved by the decision of the state medical council on any complaint against a delinquent physician, shall have the right to file an appeal to the MCI within a period of 60 days from the date of receipt of the order passed by the said medical council: Provided that the MCI may, if it is satisfied that the appellant was prevented by sufficient cause from presenting the appeal within the aforesaid period of 60 days, allow it to be presented within a further period of 60 days. The subject of stem cell research including the ethical issues will be covered at length in Chapters 6, 7, and 8 will deal with ethical issues relating to surrogacy and abortion. HUMAN RIGHTS AND MEDICAL PERSONNEL

Historical Perspective The best known histories of the human rights movement tend to begin with ancient religions and societies.151 The most general histories of public health begin in ancient India, Egypt, Greece, and Rome.152 The human rights movement can trace its roots as far back as one wants to go in the struggle of humans everywhere against oppression and repression. Great moments on the slow road to curbing abuse by political power range from Ashoka adopting tolerance and individual freedom as state policies and abolishing torture in the third century bce, to Antigone, the daughter of Oeidpus in Sophocles’ tragedy, who defied King Creon’s decree and buried her brother out of a sense of justice. Religion and law have an ambiguous role in this historical process.153

Human Rights and International Conventions The UN Universal Declaration of Human Rights clearly stipulates, ‘No one shall be subjected to torture or cruel, inhumane or degrading treatment or punishment.’ The World Medical Association’s (WMA) Declaration of Tokyo, 1975, states:‘The physician shall not countenance,

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condone or participate in the practice of torture or other cruel, inhuman or degrading procedures, whatever the offense of which the victim of such procedure is suspected, accused or guilty, and whatever the victim’s belief or motives, and in all situations, including armed conflict and civil strife.’ The International Committee of the Red Cross (ICRC), Amnesty International, Human Rights Watch, etc. indicate that medical personnel have on many occasions failed to maintain medical records, conduct routine medical examinations, provide proper care of disabled and injured detainees, and accurately report illnesses and injuries, and have falsified medical records and death certificates. It is suspected that medical system has failed to protect detainee’s human rights the world over, and has violated the basic principles of medical ethics and ignored the basic tenets of medical professionalism. Medical personnel and medical information have also been used to design and implement psychologically and physically coercive interrogations. Recently, some sections of the press have claimed that the so-called concerted actions against terrorism have resulted in the torture of particular individuals and groups by the police with the active assistance of the medical professional. Of them, people in detention accused of crimes and undergoing trial are the most vulnerable to such violations, which take place with crude abandon.

Human Rights Violations under Military Regimes An extreme case in recent history occurred in Nazi death camps, where doctors supervised killings and selected which people went into the camps and which were killed. Physicians who interviewed Nazi doctors said that most were normal people who went home on weekends to be fathers and husbands. They were not killers before serving in the death camps and did not continue killing afterward. Those who interviewed US soldiers about atrocities in Vietnam said that an internalization of the ethos of the organization takes place that prompts actions that the individual would not ordinarily perform.154 Since the September 11 attacks, terrorism in the West has been inextricably linked to the public mind to people from Middle Eastern and Muslim backgrounds, generating the type of extreme prejudice that, in a poorly monitored detention environment such as Abu Ghraib and Guantanamo Bay,155 offers moral licence for torturers.156 The result is

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that human rights are allowed to be overlooked and even violated in order to gain information to win the war against terrorism.157 In other words, the end—to win the war on terrorism—justifies any means, including techniques used to gain invaluable information. As a result, military medical personnel face a ‘dual loyalty’ conflict.158 They have to balance the medical needs of their patients, who happen to be detainees, with their military duty to their employer.159

Human Rights and Experimentation Prior to World War II, there were no international efforts to regulate human experimentation. National actions were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Affairs. This was followed by a circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People’s Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an advisory resolution on the procedures for testing new medicinal substances and methods that may present a hazard for the health and life of patients. In 1946, the American Medical Association published its first principles of human experimentation, and in 1953 the US Department of Defence issued its then ‘top-secret’ memorandum on the use of human volunteers in experimental research. In the same year, the Clinical Center of the US National Institutes of Health issued a policy document on clinical research, and the United Kingdom Medical Research Council issued a memorandum on clinical investigations. On 16 December 1966, the International Covenant on Civil and Political Rights was adopted by the United Nations General Assembly, and came into force ten years later, on 23 May 1976. Article 7 was influenced by the events that led to the Nuremberg Code as well as by other inhuman practices during World War II. It lays down that ‘no one shall be subjected without his free consent to medical or scientific experimentation’. This article is clearly binding on the many countries that have ratified the covenant. Reference should also be made to the Declaration on the Human

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Rights of individuals who are not nationals of the country in which they live, proclaimed by the General Assembly on 13 December 1985. Article 6 lays down that ‘no alien shall be subjected without his or her free consent to medical or scientific experimentation’.160 Conventions apart, human experimentation developed in the shadow of horrific examples of abuse such as Nazi experimentation on human beings161 that resulted in the Nuremberg trials. Other examples include the Tuskegee experiments, in which Black men were denied treatment for their syphilis, and the case of institutionalized children at Willowbrook who were intentionally infected with hepatitis and studied to determine the effects of a vaccine. Recent examples, such as the death of an 18-year-old in a gene therapy trial and the death of a nine-month-old given an experimental drug for reflux serve as sobering reminders that using humans as research subjects continues to pose significant risks.162

Narco-analysis, Brain Mapping, Lie Detectors: Tools for Torture? In respect of sensitive criminal cases where the investigating agency cannot make any headway, it resorts to the practice of subjecting the principal suspects to certain medical tests such as narco-analysis163 and brain-mapping164 with the help of doctors. The objections to this have been on the basis that it subjects the individual to testimonial compulsion and is hence constitutionally impermissible.165 After a long line of decisions by various high courts166 leaning in favour of investigating agencies and holding that statements made by people in a trance and the data collected by brain mapping could be admissible, the Supreme Court drew down the curtains in Selvi v. State of Karnataka,167 holding that all the three types of tests, narco—analysis, polygraph, and brain electrical activation profile (BEAP)—are constitutionally impermissible as constituting a violation against the fundamental right against self-incrimination, which is protected against through Article 20(3) of the Constitution.

compulsory blood and dna tests Taking a genetic sample without consent is viewed in Canada as a violation of the individual’s physical integrity. But even this practice was held to be valid when the sample is collected by a healthcare

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professional. In likening the Canadian example to the Indian legal context, the Supreme Court referred to the response of the Privacy Commissioner of Canada to Department of Justice Consultation Paper for Obtaining and Banking DNA Forensic Evidence:168 DNA evidence should not be collected from a suspect unless the information is relevant to a specific crime in question. For example, it would be appropriate to obtain a DNA sample from a suspect where DNA evidence is left at the scene of the crime and the suspect’s DNA is needed to prove the suspect’s involvement. DNA evidence should not be collected from suspects as a matter of routine. To do so causes an unnecessary privacy intrusion; in the vast majority of criminal cases DNA evidence will contribute nothing to the investigation. Thus, it would not be appropriate for Parliament to give blanket authority to collect DNA samples from all persons suspected of indictable offences. DNA should also not be collected from a suspect of investigators have no DNA evidence with which to compare the suspect’s sample. Nor would a DNA sample from the suspect be necessary if the suspect admitted guilt. However, as a practical manner, the DNA evidence might be critically important in getting the suspect to admit guilt in the first place. As well, there should be reasonable grounds for suspecting that the person committed the offence before taking the DNA sample. It would not be acceptable to require all men in a given community to submit DNA samples to solve a specific crime. Broadly-based testing of whole groups within a community would represent an unjustifiable intrusion into the lives of too many innocent people. As a further privacy safeguard, DNA evidence should be collected from a suspect only if a judge authorizes the collection. The list of violent crimes set out in New Zealand’s recently introduced Criminal Investigations (Blood Samples) Bill offers an example of the types of crimes for which DNA testing might be considered in Canada. It may also be appropriate to allow the collection of samples for other crimes, such as conspiracies to commit offences involving violence. For example, it should be lawful for samples to be taken if DNA evidence could help convict someone suspected of planning a terrorist act or murder (perhaps the suspect had left DNA on a stamp he licked and attached to a letter implicated in the crime).

In Goutam Kundu v. State of West Bengal and Anr,169 dealing with a question about the paternity of a child, the Supreme Court took

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note of Section 112 of the Evidence Act, and held that the conclusive presumption of paternity during the marriage of man and wife arising under the provision could only be displaced by a strong preponderance of evidence and not by a mere balance of probabilities. It held that (1) courts in India cannot order a blood test as a matter of course; (2) wherever applications are made for such requests in order to having roving inquiry, the request for a blood test cannot be entertained; (3) There must be a strong prima facie case in that the husband must establish non-access in order to dispel the presumption arising under Section 112 of the Evidence Act; (4) The court must carefully examine the consequence of ordering the blood test (whether it will have the effect of branding a child as a bastard and the mother as an unchaste woman); (5) no one could be compelled to give sample of blood for analysis.

The court will not order a DNA test for ascertaining the paternity of the child on the only ground that there might be scope for rapprochement between husband and wife if the test could positively establish such a fact, especially when there are no allegations by husband in his petition for divorce that the son was born as a consequence of an illicit relationship.170 The law has been re-affirmed in a later judgment of the Supreme Court in Bhabhani Prasad Jena v. Convenor Secretary,171 where it said that when there is apparent conflict between the right to privacy of a person not to submit himself forcibly to medical examination and duty of the court to reach the truth, the court must exercise its discretion only after balancing the interests of the parties and on due consideration whether for a just decision in the matter, the DNA is eminently needed. The court has to consider diverse aspects including the presumption under Section 112 of the Evidence Act, the pros and cons of such an order, and the test of ‘eminent need’, whether it is impossible to reach the truth without it. Even without reference to legitimacy, an offspring born through a relationship that was not legitimate may still want to remove the stigma of being a bastard by seeking to trace the paternity through DNA testing.172 Selvi v. State of Karnataka173 examined the issue whether DNA profiling itself would amount to testimonial compulsion.174 The Supreme Court ruled: The DNA profiling technique has been expressly included among the various forms of medical examination in the amended Explanation to Section 53 CrPC. It must also be clarified that a “DNA profile” is different from a DNA sample which can be obtained from

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bodily substances. A DNA profile is a record created on the basis of DNA samples made available to the forensic experts. Creating and maintaining DNA profiles of offenders and suspects are useful practices since newly obtained DNA samples can be readily matched with existing profiles that are already in the possession of law-enforcement agencies. The matching of DNA samples is emerging as a vital tool for linking suspects to specific criminal acts. In 2007, the Draft DNA Profiling Bill was piloted by the Centre for DNA Fingerprinting and Diagnostics, an autonomous organization funded by the Department of Biotechnology, Ministry of Science and Technology, Government of India. The DNA Profiling Bill looks to legalize the collection and analysis of DNA samples for forensic purposes.175 The bill is pending in parliament.

Narco-analysis, polygraph, and brain mapping are all testimonial compulsions and cannot be used without the patient’s informed consent. The Supreme Court observed in Selvi: The involvement of doctors in the course of investigation in criminal cases has long been recognised as an exception to the physician-patient privilege. In the Indian context, the statutory provisions for directing a medical examination are an example of the same. Fields such as forensic toxicology have become important in criminal justice systems all over the world and doctors are frequently called on to examine bodily substances such as samples of blood, hair, semen, saliva, sweat, sputum and fingernail clippings as well as marks, wounds and other physical characteristics. A reasonable limitation on the forensic uses of medical expertise is the fact that testimonial acts such as the results of a psychiatric examination cannot be used as evidence without the subject’s informed consent.

national human rights commission’s guidelines on lie detector tests The National Human Rights Commission on 12 November 1999 adopted a set of guidelines relating to administration of the polygraph test, or lie detector test. The commission had been receiving a number of complaints that this test was carried out under coercion, without informed consent, and after a certain drug is administered to the accused. As the existing police practice in invoking the lie detector test is not regulated by any law or subjected to any guidelines, the commission felt that it could become an instrument to compel the accused to

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be witnesses against themselves, violating the constitutional immunity from testimonial compulsion.The commission has noted that immunity from invasiveness (as an aspect of Article 21) and from self-incrimination (Article 20[3] of the Indian Constitution) must be read together. The general executive power cannot intrude on either constitutional rights and liberty or, for that matter, any rights of a person. In the absence of a specific ‘law’, any intrusion into fundamental rights must be struck down as constitutionally invidious. It went on to observe that the Lie Detector Test is much too invasive to admit of the argument that the authority for this test comes from the general power to interrogate and answer questions or make statements. However in India, we must proceed on the assumption of constitutional invasiveness and evidentiary impermissiveness to take the view that such holding of tests is a prerogative of the individual not an empowerment of the police. In as much as this invasive test is not authorised by law, it must perforce be regarded as illegal and unconstitutional unless it is voluntarily undertaken under non-coercive circumstances. If the police action of conducting a Lie Detector Test is not authorized by law and impermissible, the only basis on which it could be justified is, if it is volunteered.

However, there is a distinction between ‘volunteering’ and ‘being asked to volunteer.’ This distinction is of some significance in the light of statutory and constitutional protections available to any person. There is a vast difference between a person saying, ‘I wish to take a Lie Detector Test because I clear my name’; and the person [being] told by the police, ‘If you want to clear your name, take a Lie Detector Test’. A still worse situation would be if the police say ‘Take a Lie Detector Test, and we will let you go’. In the first situation the person voluntarily wants to take the test. It will still have to be examined whether such volunteering was under coercive circumstances or not. In the second and third situations the police implicitly/explicitly link up the taking of the test to allowing the accused to go free. The extent and nature of ‘self-incrimination’ is wide enough to cover the kinds of statements that were sought to be induced. The test retains the requirement of personal volition and states that selfincrimination must mean conveying information based upon the personal knowledge of the person giving information. The information sought to be elicited in a Lie Detector Test is always information in the personal knowledge of the accused.

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The commission, after bestowing its careful consideration of this matter of great importance, laid down the following guidelines relating to the administration of the lie detector test: (1) No lie detector test should be administered without the consent of the accused. They must be given the option of taking the test. (2) If the accused volunteers for the tests, he should be given access to a lawyer. The police and the lawyer should explain the physical, emotional, and legal implication of such a test to him. (3) The consent should be recorded before a judicial magistrate. (4) During the hearing before the magistrate, the accused should be duly represented by a lawyer. At the hearing, the person should also be told in clear terms that the statement that is made shall not be a ‘confessional’ statement to the magistrate but will have the status of a statement made to the police. (5) The magistrate shall consider all factors relating to the detention, including the length of detention and the nature of interrogation. (6) The actual recording of the lie detector test shall be done in an independent agency (such as a hospital) and conducted in the presence of a lawyer. (7) A full medical and factual narration of the manner of information received must be taken on record. These guidelines of the commission were circulated to the chief secretaries and DGPs of states as well as administrators and IGPs of UTs by a letter dated 11 January 2000. They were quoted by the Supreme Court in Selvi to hold that lie detectors are again tools of self-incrimination and ruled the practice as impermissible.

Human Rights and Conventions on Clinical Trials In 1995, the WHO issued ‘Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products’. This is a lengthy document, originally published as an Annex to a WHO Technical Report (No. 850). It had originally been envisaged that this would be superseded by a new edition that had tentatively been scheduled to appear in 2004. It has now been decided that there will in fact be no new edition, but instead a comprehensive WHO Health Care Research Handbook, which is intended as an educational tool that could facilitate implementation

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of GCP in clinical trials. The UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases has also formulated ‘Operational Guidelines for Ethics Committees that Review Biomedical Research’. These guidelines have been issued as WHO document TDR/PRD/Ethics/2000.1. For many years now, the WHO Regional Office for Europe has placed a particular focus on patients’ rights. The Declaration on the Promotion of Patients’ Rights in Europe, adopted by a European Consultation held in Amsterdam in March 1994, includes a section that addresses research ethics. The Pan American Health Organization (PAHO), based in Washington, DC (which serves as the WHO Regional Office for the Americas), has developed a series of internal procedures to ensure that ethical considerations are taken into account in research with human subjects. On 11 November 1997, the 29th Session of the General Conference of UNESCO adopted the Universal Declaration on the Human Genome and Human Rights. This was subsequently endorsed by the United Nations General Assembly by Resolution 53/52, adopted on 9 December 1998. Several sections of the declaration deal directly or indirectly with the conduct of research concerning the human genome, notably Article 10 of Section C (research on the human genome).This provides that no such research ‘should prevail over respect for human rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people’. In the course of its 30th Session (in November 1999), the General Conference adopted guidelines for the implementation of the declaration. Several of these guidelines deal with ethical issues; for example, there is a reference to the creation of ‘institutions such as independent, pluralist and multidisciplinary ethics committees’. On 15 November 2002, a working group of the International Bioethics Committee of UNESCO issued a ‘Preliminary Report on the Possibility of Elaborating a Universal Instrument on Bioethics’. The following is an extract from this report, which deals with biomedical research involving human subjects: The increasing globalization of biomedical research has brought to the forefront more ethical issues in the involvement of human subjects. While international collaboration has enabled sponsor countries to conduct research in resource poor communities with greater convenience, coordination and efficiency, the practice has also highlighted a need for greater vigilance to guard against evolving forms of exploitation.

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Although international collaborative research represents laudable efforts to address common health concerns, there is also a danger that the research design and methodology put unnecessary burdens on poor people, poor communities and poor countries. A universal instrument on bioethics can focus on such issues with provisions seeking to promote the recognition of researchers from developing countries as full and equal partners in biomedical studies. It can also underscore the need to raise the standard for benefits accruing to participant communities or countries, promote initiatives for ensuring broad and equitable access, and address approaches for building the capacity of developing country scientists to become full partners in international research. In view of the numerous guidelines that currently exist concerning the practice, a universal instrument on bioethics can provide unity while recognizing the special challenges posed by the unique histories, cultures, politics, judicial systems, and economic situations of the various countries involved especially in relation to ensuring the free and informed consent of research subjects.

HIV/AIDS Medicines and Clinical Trials The Joint United Nations Programme on HIV/AIDS (UNAIDS), a Geneva-based organization that has nine partners, published a UNAIDS Guidance Document titled Ethical Considerations in HIV Preventive Vaccine Research. The document contains 18 guidance points, and the first (HIV vaccines development) states: Given the severity of the HIV/AIDS pandemic in human, public health, social and economic terms, sufficient capacity and incentives should be developed to foster the early and ethical development of effective vaccines, both from the point of view of countries where HIV vaccine trials may be held, and from the point of view of sponsors of HIV vaccine trials. Donor countries and relevant international organizations should join with these stakeholders to promote such vaccine development.

Miscellaneous Organizations Addressing Ethical Issues in Human Genetics On 4 April 1997, the 45-member Strasbourg-based Council of Europe opened its Oviedo Convention on Human Rights and Biomedicine. The Council of the Human Genome Organisation on 21 March

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1996 approved a ‘Statement on the Principled Conduct of Genetics Research,’ which had been prepared by what was then its Ethical, Legal and Social Issues Committee. On March 1999, the HUGO Ethics Committee issued a Declaration on Cloning, which addresses, among other issues, research in this field. On 9 April 2000, the Ethics Committee issued its ‘Statement on Benefit-Sharing’. This includes a recommendation that ‘all humanity share in, and have access to, the benefits of genetic research.’ In 1998, the European Medical Research Councils issued its ‘Recommendations on Gene Therapy in Man’, which of course addresses research in this area. Research in the field of gene therapy was addressed in the ‘Declaration of Inuyama: Human Genome Mapping, Genetic Screening and Gene Therapy’, adopted by a Council for International Organizations of Medical Sciences Conference, held in Tokyo and Inuyama City in July 1990. There are provisions that address ethical issues in research in a 1998 WHO document entitled ‘Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services’.

Miscellaneous Organizations Addressing Ethical Issues in Psychiatric Research On 25 August 1996, the World Psychiatric Association’s General Assembly approved the Madrid Declaration on Ethical Standards for Psychiatric Practice, which contains detailed provisions on the ethical standards for psychiatric research; amendments were approved by the General Assembly, held in Yokohama, on 26 August 2002. The salient features are: Research that is not conducted in accordance with the canons of science is unethical. Research activities should be approved by an appropriately constituted ethical committee. Psychiatrists should follow national and international rules for the conduct of research. Only individuals properly trained for research should undertake or direct it. Because psychiatric patients are particularly vulnerable research subjects, extra caution should be taken to safeguard their autonomy as well as their mental and physical integrity. Ethical standards should also be applied in the selection of population groups, in all types of research including epidemiological and sociological studies and in collaborative research involving other disciplines or several investigating centers.

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On 17 December 1991, the UN General Assembly adopted Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Health Care (Resolution 46/119). Paragraph 15 of Principle 11 (on consent to treatment) is among those provisions that deal particularly with research. It reads: ‘Clinical trials and experimental treatment shall never be carried out on any patient without informed consent, except that a patient who is unable to give informed consent may be admitted to a clinical trial or given experimental treatment, but only with the approval of a competent, independent review body specifically constituted for this purpose.’

Miscellaneous Organizations Addressing Ethical Issues in Reproductive Health In 1992, the WHO published ‘Recent Advances in Medically Assisted Conception’ the report of a WHO scientific group that met in Geneva from 2 to 6 April 1990. This includes a section on ‘Social, Ethical and Legal Issues,’ which, inter alia, discusses research-related issues. In 1997, the London-based International Federation of Gynecology and Obstetrics (FIGO) issued ‘Recommendations on Ethical Issues in Obstetrics and Gynecology’, formulated by its Committee for the Study of Ethical Aspects of Human Reproduction. There are numerous provisions dealing with ethical issues in research; for example, there is a 1990 Recommendation entitled ‘Research on Pre-Embryos.’ At the International Center for Population Studies and Research (Al-Azhar University, Cairo), ‘Ethical Guidelines for Human Reproduction Research in the Muslim World’ were adopted by the First International Conference on Bioethics in Human Reproduction Research in the Muslim World (10–13 December 1991). The Brussels-based European Forum for Good Clinical Practice has issued ‘Guidelines and Recommendations for European Ethics Committees’.The current version is dated July 1997. In January 1981, the International Organization for Islamic Medicine issued the ‘Islamic Code of Medical Ethics’. There are provisions on biomedical research in a section entitled ‘The Doctor and Modern Biomedical Advances.’ In 1995, the Pontifical Council for Pastoral Assistance to Health Care Workers (Holy See) issued a ‘Charter for Health Care Workers’. It includes a rubric on ‘Research and Experimentation’, in Sections 75–82.

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The International Rehabilitation Council for Torture Victims In 1982, the Rehabilitation and Research Centre for Torture Victims (RCT) was founded in Copenhagen by Dr Inge Genefke, MD, as an independent institution with its own premises. However, in response to a growing need for global support and assistance in the rehabilitation of torture victims, the International Rehabilitation Council for Torture Victims (IRCT) was founded in 1985, initially as the international arm of the RCT, and, from 1997, as an international and independent organization. A non-profit global organization with a membership of 147 rehabilitation centres in 73 countries and with over 25 years’ of experience, the work of the IRCT is threefold: rehabilitation of torture victims and their families, ensuring victims’ access to justice, and eradication of torture. The IRCT liaises with key human rights bodies at the international and regional level—such as the UN, Inter-American Commission on Human Rights, and African Commission on Human and Peoples’ Rights—to make the plight of torture survivors more visible in their policies. At the government level, the IRCT lobbies states to ratify and abide by those international instruments related to torture, and increase support for rehabilitation services (either directly or via the United Nations Voluntary Fund for Victims of Torture.) Where possible, the IRCT endeavours to reinforce their messages by partnering with those who share their goals.176

The International Council for Prison Medical Services This body, which was established in 1977, adopted the Oath of Athens on 10 September 1979. It includes a pledge by health professionals working in prison settings not to ‘engage in any form of human experimentation amongst incarcerated individuals without their informed consent.’

The Protection of Human Rights Act, 1993 (No. 10 of 1994) The act provides for the constitution of a National Human Rights Commission, state human rights commission in states, and Human Rights Courts.177 ‘Human rights’ means the rights relating to life, liberty, equality and dignity of the individual guaranteed by the Constitution or

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embodied in the international covenants and enforceable by courts in India.178 The act established a National Human Rights Commission.179 Its chairperson is someone who has been the Chief Justice of the Supreme Court, and of its members, one should be a present or former chief justice of a high court, and two members should be appointed from amongst people having knowledge of, or practical experience in, matters relating to human rights.The Chairperson of the National Commission for Minorities, the National Commission for the Scheduled Castes, the National Commission for the Scheduled Tribes, and the National Commission for Women, shall be deemed to be members of the commission for the discharge of certain functions under the act.

powers relating to enquiries The commission shall, while inquiring into complaints under the act, have all the powers of a civil court trying a suit under the Code of Civil Procedure, 1908.180 The commission shall have power to require any person, subject to any privilege that may be claimed by that person under any law for the time being in force, to furnish information on such points or matters as, in the opinion of the commission, may be useful for, or relevant to, the subject matter of the inquiry, and any person so required shall be deemed to be legally bound to furnish such information within the meaning of Section 176 and Section 177 of the IPC. The commission or any other officer not below the rank of a gazetted officer specially authorized in this behalf by the commission may enter any building or place where the commission has reason to believe that any document relating to the subject matter of the inquiry may be found, and may seize it, or take extracts or copies from it subject to the provisions of Section 100 of the CrPC, 1973, in so far as it may be applicable. The commission may, after recording the facts constituting the offence and the statement of the accused as provided for in the CrPC 1973, forward the case to a magistrate having jurisdiction to try the same and the magistrate to whom any such case is forwarded shall proceed to hear the complaint against the accused as if the case has been forwarded to him under Section 346 of the CrPC, 1973. Where the commission considers it necessary or expedient so to do, it may, by order, transfer any complaint filed or pending before it to

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the state commission of the state from which the complaint arises, for disposal in respect of any matter that the state commission has jurisdiction to entertain.

power to conduct investigation The commission may, for the purpose of conducting any investigation pertaining to the inquiry, utilize the services of any officer or investigation agency of the Central Government or any state government with the concurrence of the Central Government or the state government, as the case may be. The officer or agency whose services are utilized shall investigate into any matter pertaining to the inquiry and submit a report thereon to the commission within a period specified by the commission. The commission shall satisfy itself about the correctness of the facts stated and the conclusion, if any, arrived at in the report submitted to it, and for this purpose the commission may make such inquiry (including the examination of the person or persons who conducted or assisted in the investigation) as it thinks fit.181

statement made to the commission No statement made by a person in the course of giving evidence before the commission shall subject them to, or be used against them in, any civil or criminal proceeding except a prosecution for giving false evidence by this statement, provided that the statement is made in reply to the question that they are required by the commission to answer, or is relevant to the subject matter of the inquiry.182

people likely to be prejudicially affected to be heard If, at any stage of the inquiry, the commission considers it necessary to inquire into the conduct of any person, or is of the opinion that the reputation of any person is likely to be prejudicially affected by the inquiry, it shall give to that person a reasonable opportunity for being heard in the inquiry and to produce evidence in his defence, provided that nothing in this section shall apply where the credit of a witness is being impeached.

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steps during and after inquiry (1) Where the inquiry discloses the commission of violation of human rights or negligence in the prevention of violation of human rights or abetment thereof by a public servant, it may recommend to the concerned government or authority (i) to make payment of compensation or damages to the complainant or to the victim or the members of his family as the commission may consider necessary; (ii) to initiate proceedings for prosecution or such other suitable action as the commission may deem fit against the concerned person or people; or (iii) to take such further action as it may think fit. (2) approach the Supreme Court or the high court concerned for such directions, orders or writs as that Court may deem necessary; (3) recommend to the concerned government or authority at any stage of the inquiry for the grant of such immediate interim relief to the victim or the members of his family as the commission may consider necessary; (4) subject to the provisions of clause (e), provide a copy of the inquiry report to the petitioner or his representative; (5) the commission shall send a copy of its inquiry report together with its recommendations to the concerned government or authority and the concerned government or authority shall, within a period of one month, or such further time as the commission may allow, forward its comments on the report, including the action taken or proposed to be taken thereon, to the commission; (6) the commission shall publish its inquiry report together with the comments of the concerned government or authority, if any, and the action taken or proposed to be taken by the concerned government or authority on the recommendations of the commission.183

state human rights commission There shall also be a state human rights commission for each state. It will consist of a chairperson who has been a chief justice of a high court; one member who is, or has been, a judge of a high court or district judge in the state with a minimum of seven years experience as district judge, and one member to be appointed from amongst people

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having knowledge of, or practical experience in, matters relating to human rights.184 A state commission may inquire into the violation of human rights only in respect of matters relatable to any of the entries enumerated in List II and List lll in the Seventh Schedule to the Constitution. However, if any such matter is already being inquired into by the commission or any other commission duly constituted under any law for the time being in force, the state commission shall not inquire into it. The state commission shall exercise the same powers as the National Commission.185

human rights courts For the purpose of providing speedy trial of offences arising out of violation of human rights, the state government may, with the concurrence of the chief justice of the high court, by notification, specify for each district a court of session—not being a special court constituted for trying offences any other law—to be a human rights court to try these offences.186 For every human rights court, the state government shall, by notification, specify a public prosecutor or appoint an advocate who has been in practice as an advocate for not less than seven years as a special public prosecutor for the purpose of conducting cases in that court.187

Right to be Treated as a Facet of Human Right If a doctor’s duty to treat shall be seen as a fundamental ethical precept, the corresponding right to a patient shall stand elevated to the state of human right. This is so, because the development of law as regards right to life has obtained a new meaning in the broad sweep of Article 21 of the Constitution. The right to health, the Supreme Court has said in CESC Ltd v. Subash Chandra Bose,188 is a facet of the right to life. The expansion of this idea has been significant in recognizing the duty to extend quality medical facilities for prisoners.189 This ought to make the state liable even for its failure to provide medical care to an under-trial prisoner190 or to a mentally ill person in prison.191 A logical extension was to require that the state provide medical aid to children staying with their mothers in prisons.192 As prisoners are a captive working class that are exposed to occupational hazards, it is a

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duty for the employer and the state to extend protection of compulsory medical care to workers.193 The Employees State Insurance Act, 1948, and Factories Act, 1948, are post-constitutional enactments that provide for the employer’s duty to provide medical care in work places. Employees are often compelled to avail of the medical facilities that the employers themselves provide and refuse to reimburse even emergency medical expenses incurred outside the approved hospitals. In State of Punjab v. Mohinder Singh Chawla194 it was held that it was the state’s duty to reimburse the hospital room rent and hospital expenses for emergency treatment for public servants outside the state. The Clinical Establishments Act, 2010, which still has a limited application, makes a bold initiative in requiring every clinical establishment to be mandated to provide such medical examination and treatment within the staff and facilities available as may be required to stabilize the emergency medical condition of any individual who comes or is brought to it.195 A hospital that turned out a patient brought in a serious condition for failure to deposit upfront admission charges was required to pay Rs 10,00,000 for a claim by the parents, who complained of medical negligence arising out of failure of duty to treat in an emergency situation.196 APPENDIX

2.1: THE

NUREMBERG CODE,

1947

Permissible Medical Experiments The great weight of the evidence before us to effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally.The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts: (1) The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and

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(4) (5)

(6)

(7)

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comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached

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the physical or mental state where continuation of the experiment seems to him to be impossible. (10) During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. APPENDIX 2.2: THE DOCTOR’S TESTIMONY ON ARUNA RAMACHANDRA SHANBAUG’S MEDICAL CONDITION She was conscious, unable to co-operate and appeared to be unaware of her surroundings. Her body was lean and thin. She appeared neat and clean and lay curled up in the bed with movements of the left hand and made sounds, especially when many people were present in the room. She was afebrile, pulse rate was 80/min, regular, and good volume. Her blood pressure recorded on the nursing charts was normal. Respiratory rate was 15/min, regular, with no signs of respiratory distress or breathlessness. There was no pallor, cyanosis, clubbing or icterus. She was edentulous (no teeth). Skin appeared to be generally in good condition, there were no bed sores, bruises or evidence of old healed bed sores. There were no skin signs suggestive of nutritional deficiency or dehydration. Her wrists had developed severe contractures, and were fixed in acute flexion. Both knees had also developed contractures (right more than left). A nasogastric feeding tube (Ryle’s tube) was in situ. She was wearing diapers. Abdominal, respiratory and cardiovascular examination was unremarkable.

Neurological Examination When examined she was conscious with eyes open wakefulness but without any apparent awareness. From the above examination, she has evidence of intact auditory, visual, somatic and motor primary neural pathways. However no definitive evidence for awareness of auditory, visual, somatic and motor stimuli was observed during our examinations. There was no coherent response to verbal commands or to calling her name. She did not turn her head to the direction of sounds

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or voices. When roused she made non-specific unintelligible sounds (‘uhhh, ahhh’) loudly and continuously but was generally silent when undisturbed. Menace reflex (blinking in response to hand movements in front of eyes) was present in both eyes and hemifields but brisker and more consistent on the left. Pupillary reaction was normal bilaterally. Fundi could not be seen since she closed her eyes tightly when this was attempted. At rest she seemed to maintain preferential gaze to the left but otherwise gaze was random and undirected (roving) though largely conjugate. Facial movements were symmetric. Gag reflex (movement of the palate in response to insertion of a tongue depressor in the throat) was present and she does not pool saliva. She could swallow both teaspoonfuls of water as well as a small quantity of mashed banana. She licked though not very completely sugar smeared on her lips, suggesting some tongue control. She had flexion contractures of all limbs and seemed to be incapable of turning in bed spontaneously. There was what appeared to be minimal voluntary movement with the left upper limb (touching her wrist to the eye for instance, perhaps as an attempt to rub it). When examined/disturbed, she seemed to curl up even further in her flexed foetal position. Sensory examination was not possible but she did seem to find passive movement painful in all four limbs and moaned continuously during the examination. Deep tendon reflexes were difficult to elicit elsewhere but were present at the ankles. Plantars were withdrawal/extensor.Thus neurologically she appears to be in a state of intact consciousness without awareness of self/environment. No cognitive or communication abilities could be discerned.Visual function if present is severely limited. Motor function is grossly impaired with quadriparesis.

Mental Status Examination

consciousness, general appearance, attitude, and behavior Aruna Ramachandra Shanbaug was resting quietly in her bed, apparently listening to the devotional music, when we entered the room. Though, her body built is lean, she appeared to be well nourished and there were no signs of malnourishment. She appeared neat and clean. She has developed contractures at both the wrist joints and knee joints and so lied curled up in the bed with minimum

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restricted physical movements. She was conscious but appeared to be unaware of herself and her surroundings. As soon as she realized the presence of some people in her room, she started making repetitive vocal sounds and moving her hands. This behavior subsided as we left the room. She did not have any involuntary movements. She did not demonstrate any catatonic, hostile or violent behavior. Her eyes were wide open and from her behavior it appeared that she could see and hear us, as when one loudly called her name, she stopped making vocal sounds and hand movements for a while. She was unable to maintain sustained eye-to eye contact but when the hand was suddenly taken near her eyes, she was able to blink well.When an attempt was made to feed her by mouth, she accepted a spoonful of water, some sugar and mashed banana. She also licked the sugar and banana paste sticking on her upper lips and swallowed it. Thus, at times she could cooperate when fed.

mood and affect It was difficult to assess her mood as she was unable to communicate or express her feelings. She appeared to calm down when she was touched or caressed gently. She did not cry or laugh or expressed any other emotions verbally or non-verbally during the examination period. When not disturbed and observed quietly from a distance, she did not appear to be in severe pain or misery. Only when many people enter her room, she appears to get a bit disturbed about it.

speech and thoughts She could make repeated vocal sounds but she could not utter or repeat any comprehensible words or follow and respond to any of the simple commands (such as ‘show me your tongue’). The only way she expressed herself was by making some sounds. She appeared to have minimal language comprehension or expression.

perception She did not appear to be having any perceptual abnormality like hallucinations or illusions from her behaviour.

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orientation, memory, and intellectual capacity Formal assessment of orientation in time, place and person, memory of immediate, recent and remote events and her intellectual capacity could not be carried out.

insight As she does not appear to be fully aware of herself and her surroundings, she is unlikely to have any insight into her illness. REPORTS OF INVESTIGATIONS

CT Scan Head (Plain) This is contaminated by movement artefacts. It shows generalized prominence of supratentorial sulci and ventricles suggestive of generalized cerebral atrophy. Brainstem and cerebellum seem normal. Ischemic foci are seen in left centrum semi-ovale and right external capsule. In addition a small left parieto-occipital cortical lesion is also seen and is probably ischemic.

EEG The dominant feature is a moderately rhythmic alpha frequency at 8–10 Hz and 20–70 microvolts which is widely distributed and is equally prominent both anteriorly and posteriorly. It is not responsive to eyeopening as seen on the video. Beta at 18-25 Hz is also seen diffusely but more prominently anteriorly. No focal or paroxysmal abnormalities were noted.

Blood Reports of the hemoglobin, white cell count, liver function tests, renal function tests, electrolytes, thyroid function, Vitamin B12, and 1,25 dihydroxy Vit D3 levels are unremarkable.

Diagnostic Impression (1) From the longitudinal case history and examination it appears that Ms Aruna Ramachandra Shanbaug has developed non-progressive

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but irreversible brain damage secondary to hypoxic-ischemic brain injury consistent with the known effects of strangulation. Most authorities consider a period exceeding 4 weeks in this condition, especially when due to hypoxic-ischemic injury as confirming irreversibility. In Ms. Aruna’s case, this period has been as long as 37 years, making her perhaps the longest survivor in this situation. (2) She meets most of the criteria for being in a PVS state. PVS is defined as a clinical condition of unawareness of self and environment in which the patient breathes spontaneously, has a stable circulation and shows cycles of eye closure and opening which may simulate sleep and waking. While she has evidence of intact auditory, visual, somatic and motor primary neural pathways, no definitive evidence for awareness of auditory, visual, somatic and motor stimuli was observed during our examinations.

Prognosis Her dementia has not progressed and has remained stable for last many years and it is likely to remain same over next many years. At present there is no treatment available for the brain damage she has sustained. NOTES 1 See Ethics, Encyclopædia Britannica, 2008, available at http:// www. Britannica.com/eb/article-9106054 (last visited 6 March 2008). They may even fall short of what is legally right or wrong. For this reason, in Cox v. Green (1966) Ch 216, a suit for declaration that the plaintiff ’s practice, which was accused of constituting violation of ethical rules of the British Medical Association, was dismissed as without any cause of action and without justiciable dispute. 2 C.M. Francis, ‘Medical Ethics in India, Ancient and Modern’, IJME 4 (October 1994). 3 See Walter Glannon, Contemporary Readings in Biomedical Ethics (Michigan: Harcourt, 2002). 4 See Appendix 1. 5 Schloendorff v. Society of New York Hospitals 211 NY 125, 105NE 92 (1914). 6 (1957) 154 Cal.App 2d 560, 317 P.2d 170. 7 5th edition (The Free Press, 1979/2001).

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8 The ICMR Code (see Chapter 8) recognizes the same principles for all the research involving human participants. 9 See Airedale NHS Trust v. Bland [1993] AC 789, 816, 864; In re MB (Medical Treatment) [1997] 2 FLR 426 and In Re B (adult: refusal of medical treatment) (2002) 2 AllER 449. 10 See Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582. 11 However, it has been suggested in B v. An NHS Hospital Trust [2002] Lloyd’s Rep Med 265 that the doctor treating the patient must either give effect to the patient’s wishes or hand him over to another doctor who will do so. 12 See In re MB (Medical Treatment) [1997] 2 FLR 426. 13 See Vacco v. Quill (1997) 521 US 793. 14 (1996) 2 SCC 648. 15 Marion Danis, et al., A Prospective Study of Advance Directives for LifeSustaining Care, 882, 887 (1991). 16 Ibid. 17 538 A2d 346 (NJ 1988). 18 [2005] EWCA Civ 1003, [2006] QB 273. 19 Human Rights Act, 1998, Sch. 1, Pt I, Article 2(1): ‘Everyone’s right to life shall be protected by law. No one shall be deprived of his life intentionally’; Article 3: ‘No one shall be subjected to torture or to inhuman or degrading treatment or punishment; Article 8(1): ‘Everyone has the right to respect for his private and family life.’ 20 In Regina (Pretty) v. Director of Public Prosecutions (Secretary of State for the Home Department Intervening) (HL)[2001] UKHL 61 [2002] 1 AC 800, the claimant, who suffered from a progressive and degenerative terminal illness, faced the prospect of a distressing and humiliating death. She was mentally alert and wished to control the time and manner of her dying, but her physical disabilities prevented her from taking her life unaided. She wished her husband to help her, and he was willing to do so provided that he would not be prosecuted under Section 2(1) of the Suicide Act, 1961. The claimant accordingly requested the Director of Public Prosecutions to undertake that he would not consent to such a prosecution under Section 2(4). On the latter’s refusal, the claimant, relying on rights guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms as scheduled to the Human Rights Act, 1998, Schedule 1, Part I, Article 2, sought relief by way of judicial review. In particular, she claimed that Article 2 protected a right to self-determination, entitling her to commit suicide with assistance, that failure to alleviate her suffering by refusal of the undertaking amounted to inhuman and degrading treatment proscribed by Article 3, that without justification her rights to privacy and freedom of conscience under Articles 8 and 9 were infringed, and that in breach of Article 14 she had

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suffered discrimination, as an able-bodied person might exercise the right to suicide whereas her incapacities prevented from her doing so without assistance. She further claimed that if Section 2 of the 1961 Act prevented her assisted suicide or the director’s permission for the undertaking, it was incompatible with the convention. The House of Lords held that that the language of Article 2 reflected the sanctity of life and expressed protection of the right to life and prevention of the intentional taking of life, save in closely defined circumstances. So framed, it could not be interpreted as conferring a right to self-determination in relation to life and death and assistance in choosing death. Although the state had a positive obligation to safeguard the lives of those within its jurisdiction, it had no positive duty to recognize any right to assisted suicide. Article 3 was complementary to Article 2, and required the state to respect the physical and human integrity of individuals within its jurisdiction, but did not engage a right to live or to choose not to live. The ‘treatment’ it prohibited did not bear an unrestricted or extravagant meaning and could not apply to the claimant’s suffering, which derived from her illness and not the Director’s refusal of the undertaking. Although Article 3 imposed an absolute prohibition on states not to inflict the prohibited treatment on individuals within their jurisdictions, their positive obligation was not absolute and the steps which were appropriate or necessary to discharge that obligation would depend on the varying interests and considerations relevant to each member state within the margin of its appreciation. The UK, having fully reviewed the issues and resolved to retain the criminal character of assisted suicide, was not obliged to ensure that a competent terminally ill person who wished but was unable to take his or her own life was entitled to another’s assistance without that other being exposed to the risk of prosecution; accordingly, there could be no infringement of the claimant’s rights under Articles 2 and 3. 21 See Glass v. United Kingdom [2004] 1 FLR 1019. 22 516 NYS 2d 677 (1987). 23 [1994] 2 LRC 136. 24 [2001] UKHL 61, [2002] 1 AC 800. 25 NHS Trust v. T (Adult Patient: Refusal of Medical Treatment) (2005) 1 All ER 387. 26 The facts of the case were: W., who was born in 1976, was placed in the care of the local authority following the death of her parents. In 1990, after unsuccessful fostering and further misfortune, she developed symptoms of anorexia nervosa. In 1991, she was admitted to an adolescent residential unit for treatment. When her condition deteriorated, the local authority decided, contrary to W.’s wishes and the opinion of the consultant attending her, to transfer her to a unit specializing in the treatment of eating disorders.They accordingly

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obtained leave to invoke the high court’s inherent jurisdiction, and by their summons directed to W. and to her aunt (who shared parental responsibility for her), sought the court’s leave for such transfer and treatment without her consent. On the substantive application W., who had attained the age of sixteen, exercised her right to separate representation and resisted the application on the ground that Section 8 of the Family Law Reform Act, 1969, conferred on her the same right as an adult to refuse medical treatment, and thus the court could not override her decision. Thorpe J. found that W. had sufficient understanding to make an informed decision, but held that he had jurisdiction to authorize medical treatment without W.’s consent, and he concluded that in view of the medical evidence he should make the order sought. On W.’s appeal: -Held, dismissing the appeal, that on its true construction, Section 8 of the Family Law Reform Act, 1969 did not confer on a minor who had attained the age of sixteen an absolute right to determine whether or not they received medical treatment, but enabled them, for the limited purpose of protecting their medical practitioner from prosecution or from any claim in trespass, to give consent to such treatment as effectively as if they were an adult; that, although a minor of any age who had sufficient maturity might consent to treatment, their refusal to give consent could not overrule consent given by the court; that in exercising its inherent jurisdiction the court would take particular account of the minor’s wishes, the importance of which increased with age and maturity, but would override them where their best interests so required; and that, having regard to the nature of W.’s illness and to the serious deterioration in her condition, her best interests required the court to direct her immediate transfer to and treatment at the new unit without her consent. 27 Section 8 of the Family Law Reform Act, 1969, UK, gives minors who have attained the age of 16 a right to consent to surgical, medical, or dental treatment. 28 See Chapter 1. 29 Bowen, Secretary of Health and Human Services v. American Hospital Association et al., 476 US 610; 106 S.Ct. 2101; 90 L.Ed. 2d 584; 1986 US LEXIS 87; 54 USLW 4579. 30 See Chapter 3 on consent in relation to vaccination; for product liability against the manufacturer of a contaminated vaccine or the prescriber of the drug, see Chapter 5 on medical negligence, under the heading ‘immunization programmes’. 31 Jacobson v. Massachusetts, 197 US 11 (1905). 32 Minnesota also provides no religious exemption, but does provide a philosophical exemption. 33 See Kristine M. Severyn observes: ‘In response to increasing numbers of lawsuits against vaccine manufacturers in the early 1980s and a perceived

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societal obligation to compensate children for injuries caused by mandated vaccines, Congress passed the National Childhood Vaccine Injury Act (NCVIA).The NCVIA created a new office in the Department of Health and Human Services, the National Vaccine Programme (NVP), whose responsibilities include essentially all aspects of US vaccination policy, e.g., research, development, safety and efficacy testing, licensing, production and procurement, distribution and use, as well as funding and coordination of all federal agencies involved in vaccines. The NCVIA also established another federal advisory committee, the National Vaccine Advisory Committee (NVAC), which advises the NVP director in his/her responsibilities. The NCVIA created a new office in the Department of Health and Human Services, the NVP, whose responsibilities include essentially all aspects of US vaccination policy, e.g., research, development, safety and efficacy testing, licensing, production and procurement. The NCVIA also established another federal advisory committee, the National Vaccine Advisory Committee (NVAC), which advises the NVP director in his/her responsibilities. The NCVIA created a new office in the Department of Health and Human Services, the NVP, whose responsibilities include essentially all aspects of US vaccination policy, for example, research, development, safety and efficacy testing, licensing, production and procurement, distribution and use, as well as funding and coordination of all federal agencies involved in vaccines. The NCVIA also established another federal advisory committee, the NVAC, which advises the NVP director in his/her responsibilities.’ The difficulty of being awarded a settlement from the VICP is reflected in recent government reports. From October 1988 through February 5, 1996 the VICP had received just over 5,000 petitions, of which 3,321 have been adjudicated. Of adjudicated petitions nearly three-fourths have been dismissed (2,408 out of 3,321), with no payment to petitioners. The VICP permits petitioners who brought their cases in ‘good faith’ to be reimbursed for attorneys’ fees. The VICP has awarded 1,052 such attorney-only payments, totaling $ 10.5 million. This latter figure is part of total VICP awards to date: 1,917 (865 petitioner/attorney awards and 1,052 attorney-only) awards totaling $ 624.7 million. Approximately 73 per cent of claims to the VICP are associated with the DPT (diphtheria, pertussis, tetanus) vaccine.’ Civil lawsuits against manufacturers may be filed only after petitioners fail to win compensation in the VICP, or if they find the VICP settlement inadequate. However, plaintiffs rarely, if ever, prevail in the tort system after filing a petition through the VICP due to court precedent labeling vaccines as “unavoidably unsafe,” thereby absolving vaccine manufacturers of liability, unless negligence is proven.’ See ‘Impact on Informed Consent and Vaccine Policy’, The Journal of Pharmacy and Law 5 (1995): 249.

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34 197 US 11 (1905). 35 115 S.Ct. 2386 (1995). 36 Kristine M. Severyn, ‘Impact on Informed Consent and Vaccine Policy’, The Journal of Pharmacy and Law 5 (1995): 249. 37 (1990) 110 S Ct 2841. 38 (2001) Fam 47, (2000) 4 All ER 961 (CA Civ.) (UK). 39 The birth of conjoined twins is a comparatively rare event. In 1975, one expert suggested that they constituted one in 50,000 live births. There has been a more recent estimate of one in 100,000. In 1986 another expert estimated that on the continent of Africa one in 14,000 births were of conjoined twins. Of these, 40 to 60 per cent were stillborn, and a further 35 per cent survived only one day after birth. Conjoined twins are always the product of a single fertilised egg, and they always have the same chromosomal composition and sex. It is believed that they result from an incomplete division of the inner cell mass about fifteen to sixteen days after the egg is fertilized, and about seven days after what is called monozygotic twinning is said to occur. The exact reason for the complex fusion that may result from such late cleavage is still unknown, and it takes a wide range of different forms. The incomplete division of the embryo appears to be associated with a process that inhibits the complete differentiation of the various organ systems. Conjoined twins with fused organs therefore usually undergo incomplete development. This may be manifested, for instance, in conjoined hearts or livers, or conjoined gastro-intestinal and genito-urinary tracts. Doctors give the name ‘ischiopagus conjoined twins’ to twins of this type. The Greek derivation of the first part of this word means ‘pelvis’, and the second part of the word means ‘fixed’. In 1988, Professor O’Neill believed that ischiopagus twins constituted about 6 per cent of the total number of conjoined twins. They are joined, as their name suggests, at the pelvis, and they often possess shared genito-urinary structures, recta and livers. They may possess a ruptured omphalocele—a hernia of abdominal organs through the umbilicus (navel)—and they usually have either three or four lower extremities. They can therefore be categorized as ischiopagus tetrapus (four legs), like the twins in this case, or ischiopagus tripus (three legs). Bipus (two legs) twins also feature in the literature. There may be substantial differences in the way in which the bones and organs of the bodies of ischiopagus conjoined twins develop in the womb. 40 This was not the first case when court intervention had been sought. In 1977, conjoined twins Amy and Angela Lakeberg were separated at a children’s hospital in Philadelphia. A court permitted the surgery to proceed, knowing that Amy would immediately die. No written reasons were released. Angela died 10 months later. See George J. Annas, ‘Siamese Twins: Killing One to Save the Other’, Hastings Center Rep. (April 1987): 27.

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41 Charles I. Lugosi (Visiting Professor, Yale Law School, Barrister and Solicitor, Ontario and British Columbia Bars, Canada), argues that the court’s rejection of the sanctity of life argument has dangerous portents for an argument of the wilful premeditated killing of an innocent human being, justified by the defence of necessity where the victim is a conjoined twin and the death of one twin might benefit the life of the other. Wouldn’t the argument of numbers permit the hospital to kill Jodie and Mary to save nine children who would otherwise die since there would be a net saving of nine lives? The defence of necessity would justify what would otherwise be the murder of Mary and Jodie. He rejects the utilitarian philosophy as suspect and puts out Kantian defence that consequences do not make an action ethically right or wrong. An act was moral only if it originates from a will ruled by a rational moral principle. This is a deontological ethical theory, where the morally decisive factor is the principle upon which a decision is made. What matters is the ‘good will’—the pure moral principle upon which an individual performs his or her duty. Kantian ethics demands that others are treated as moral equals who deserve the same treatment we ourselves would want. See his ‘Playing God: Mary Must Die So Jodie May Live Longer’ Issues L. & Med. 17: 123. 42 See also Chapter 3, under ‘overriding control of court’ for further commentaries in cases relating to PVS states and the court’s jurisdiction. 43 (1993) AC 789. 44 108 NJ 394, 529 A 2d 434, 1987 NJ LEXIS 346. 45 411 Mass. 512, 583 NE 2d 1263, 1992 Mass. LEXIS 10. 46 Adam J. Hildebrand argues that the support for taking life for PVS is a mask of language, mask of presumption, mask of statistics, mask of high technology, mask of response to human impairments, and mask of ‘thanatos’ (a Greek word meaning ‘death personified’). The logic graph that we draw is premised on: ‘People in a “PVS” (or those who have other profound neurological impairments) are typically thought of as having lives not worth living. This thought can be expressed as an intention to cause death. When an intention to cause death is acted upon, one can deceive oneself, or allow oneself to be deceived by masked motivations. The act of denying food and water to people who need them causes them to die from dehydration and starvation. Causing death by commission or omission is a killing act. Engaging in killing acts deadens the moral sensibility of the actors, and enables them to kill again, and to lead others to do likewise. We have fashioned new ways of feeding the hungry and giving water to thirsty people in modern medicine. Yet the moral imperative to “feed the hungry and give water to those who thirst” remains the same. If we allow ourselves to become convinced, however subtly, through the use of mystifying and deceiving masks that some people are not

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fully human, we not only dehumanize them, we dehumanize ourselves.’ See his ‘Masked Intentions: The Masquerade of Killing Thoughts Used to Justify Dehydrating and Starving People in a “Persistent Vegetative State” and People with Other Profound Neurological Impairments’, Issues L. & Med. 16: 143. 47 See generally Wolf Wolfensberger, ‘Let’s Hang Up “Quality of Life” as a Hopeless Term’, in D. Goode (ed.), Quality Of Life For Persons With Disabilities: International Perspectives and Issues (Michigan: Brookline Books), 1994, p. 285. 48 (2011) 4 SCC 454. 49 Reflex response of the toes when a sharp painful stimulus is applied to the sole of the foot. The normal response is curling downwards of the toes. 50 See Appendix 2.2. 51 See In re J (A Minor) (Wardship: Medical Treatment) (1991) Fam 33. 52 See the Statement of Reasons and Objects (SOR). 53 See ‘Medical Profiling and Online Medicine: The Ethics of “Personalised Healthcare” in a Consumer Age’, Nuffield Council on Bioethics 2010, available at http://www.nuffield.co.uk. 54 www.telemedindia.org (last visited 30 September 2011). There are significant initiatives at the instance of the medical community itself. During the National Conference on Telemedicine held in Lucknow in April 2001, the participants resolved to form a scientific society dedicated to telemedicine at the national level and conduct an annual scientific event pending a formal registration. The Telemedicine Society of India was soon born and all the participants signed a resolution to this effect, becoming founding members. The first annual conference of the society was held in Lucknow the next year and all the participants were inducted to the founding member group. In the following two years there was no scientific activity till March 2005, when an International Conference on Telemedicine (INTELMED 2005) was hosted by Indian Space Research Organization (ISRO) at Bangalore. The society was formally registered in 2006 at Lucknow, with its registered office at the Telemedicine Center, Sanjay Gandhi Postgraduate Institute of Medical Sciences. The Telemedicine Society of India is registered under the Societies Registration Act, 1860, and is an independent scientific body operating on a not-for-profit basis and not aligning with any particular political party or religion. IsfTeH, the International Society for Telemedicine and e-Health, has now recognized the TSI as the official national society representing telemedicine activities in India. 55 Telemedicine services at PGIMER, Chandigarh, connect with all the district hospitals of Punjab, and the referrals through doctors help elicit expert opinions from it to clinically manage the patients at the respective district centres themselves. Direct patient–doctor interface through telemedicine services are operationally at a minimal level, and given the levels of illiteracy of

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the rural folk, it is even doubtful if all patients are made aware that the doctors who treat them at district levels have obtained expert opinions from elsewhere. 56 See also Chapter 8. 57 See Information Technology Act, 2000, the preamble. 58 Ibid., Sections 43A and 72 A. 59 Ibid., Section 66 E. The Supreme Court held in Prakaash (Dr) v. State of Tamil Nadu (2002) 7 SCC 759 that even a letter of a woman giving the information of a surgeon making pornographic films from women patients filmed in the nude could be considered relevant material to serve a preventive detention order, apart from proceeding for offences under IT Act, 2000, and Indecent Representation of Women (Prohibition) Act and Arms Act. 60 See Information Technology Act, 2000, Section 72. 61 Ibid., Section 75. 62 Sections 11–13. 63 Section 15. 64 Section 16–20. 65 Section 33. 66 See also Chapter 14. 67 In Tamil Nadu Medical Council Rep by Its President, Dr K.R. Balasubramaniam v. The Chairman, Central Board of Film Certification, The Central Board of Film Certification Rep by Its Regional Officer and The Gemini Film Circuit The Producer ‘Vasool Raja, MBBS’ (WP No. 21527 of 2004, WPMP No. 26041 of 2004 and WVMP No. 1335 of 2004 decided on 06.08.2004) the Madras High Court rejected the contention of the petitioner that the title is per se defamatory. It said that just as in the Hindi version, the words ‘Vasool Raja’ may be the pet name of an individual. The title cannot be considered as per se defamatory and does not suggest that the entire profession of Medical Practitioners are collection agents. The words ‘Vasool Raja, MBBS’ is in the singular. It may at the most mean an individual. 68 This echoes the Hippocratic tradition of paternalistic virtue of healing and care for humanity discussed previously in this chapter. 69 464 F 2d 772 DC Cir (1972). In this case, after undergoing laminectormy, Mr Canterbury fell from his hospital bed and as a result suffered paralysis. He sued his surgeon for falling to inform him of the risk of paralysis. This case expanded the legal requirement for the physician’s duty to disclose and established the ‘reasonable person’ standard of informed consent. 70 48 BMLR 118 Court of Appeal (Civil Division). 71 (1957) 1 BMLR 1, [1957] 1 WLR 582. 72 (1997) 39 BMLR 1, [1997] 3 WLR 1151. 73 The poet Tiruvalluvar states in his Kural 292: Falsehood may take the place of truthful word, if blessing, free from fault, it can afford. ‘Even falsehood has the nature

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of truth, if it confer [sic] a benefit that is free from fault’ English Translations by G.U. Pope, W.H. Drew, John Lazarus, and F.W. Ellis (Tinnevelly: The South India Saiva Siddhantha Works Publishing Society, 1982). 74 ‘Four Models of the Physician-Patient Relationship’ in Walter Glannon (ed.), Contemporary Readings in Biomedical Ethics (Harcourt, 2000). 75 Media reports on prominent personalities’ ill health and treatment given are a distinct subject. The touchstone is what is in public interest. It will be tested under the fundamental freedom of right to free speech guaranteed under Article 19(1) of the Constitution. Under common law and at the European Convention for the Protection of Human Rights and Fundamental Freedoms, the test is again what disclosure will subserve public interest and to balance it with the right to private and family life. In Campbell v. MGN Ltd (2005) UKHL, 2004(2) All ER 995, the House of Lords affirmed the right to damages for a celebrity model who claimed that her privacy was invaded by The Daily Mirror, which disclosed her treatment and therapy for de-addiction from drugs and alcohol. The House of Lords reasoned that a patient would benefit by therapy and the private nature of meetings with therapists encouraged addicts to attend in the belief that they could do so anonymously. The assurance of privacy was an essential part of the exercise and a breach even by the press would be actionable. 76 (1990) Ch 359. 77 518 US 1; 116 S. Ct 1923; 135 L. Ed. 2d 337; 1996 US LEXIS 3879; 64 USLW 4490; 44 Fed. R. Evid. Serv. (Callaghan) 1; 96 Cal. Daily Op. Service 4192; 96 Daily Journal DAR 6783; 9 Fla. L. Weekly Fed. S 678. 78 429 US 589; 97 S. Ct 869; 51 L. Ed. 2d 64; 1977 US LEXIS 42. 79 532 US 67; 121 S. Ct. 1281; 149 L. Ed. 2d 205; 2001 US LEXIS 2460; 69 USLW 4184; 2001 Daily Journal DAR 2839; 2001 Colo. J. CAR 1427; 14 Fla. L. Weekly Fed. S. 152. 80 See Article 20(3) of the Indian Constitution. 81 AIR (1999) SC4 95, JT 1998(7) SC 626, 1998(6) SCALE 230, 1999(1) UJ 232(SC). 82 AIR (2003) SC 664, (2003)(2) ALD 24(SC), (2003)(1) AWC 571(SC), (2003)(1) BLJR 437, JT (2002)(10) SC 214, (2003) 1 MLJ 89(SC), (2003) 1SCC 500. 83 ‘Negligent act likely to spread infection of disease dangerous to life— Whoever unlawfully or negligently does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.’ 84 ‘Malignant Act likely to spread infection of disease dangerous to life— Whoever malignantly does any act which is, and which he knows or has

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reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.’ 85 US District Court for the District of Maryland, 197 FRD 263; 2000 US Dist. LEXIS 19083. 86 328 SC 627; 494 SE 2d 431; 1997 SC App. LEXIS 158. 87 AIR (2007) Bom 121, (2007) (109) Bom. LR 844, (2007)(4) MhLj573. 88 400 NYS 2d 668 (Sup. Ct 1977). 89 446 NYS 2d 801 (Sup. Ct 1982). 90 Alan B. Vickery, ‘Breach of Confidence: An Emerging Tort’, Colum. L. Rev. 82 (1982): 1426, 1455. 91 W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 30, at 185, 187 (5th Ed. 1984). 92 R v.Department of Health, ex parte Source Infromatics Ltd (2000) 1 All ER 786 (CA). 93 See also Chapter 11 for commentary on the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. 94 The Hindu, 7 March 2011 95 The Karnataka Medical Council was reported to have issued a notice to Wockhardt Hospitals, Bengaluru, complaining of the unethical practice in hoardings and advertisements promising the best healthcare (IBN Live, 3 March 2008). The doctors at the national workshop on ‘Redefining Medical Ethics’ organized by the state unit of the IMA are reported to have formulated a charter that restrains hospitals from advertising their specialties, the same way individual doctors are banned from doing so by the Medical Council of India (Hindu, 1 August 2011). 96 Rule 8 in Appendix I reads: ‘No advertisement should contain any reference to doctors or hospitals, whether Indian or foreign, unless such reference can be substantiated by independent evidence and can properly be used in the manner proposed.’ 97 See, for instance, the views of Rick Johnson in Media Health Leaders, under ‘Image Makeover’, www. healthleadersmedia.com (last visited 23 September 2011). 98 See Chapter 8. 99 Section 42 of the Pharmacy Act, 1948. 100 Richard Arden Veon, II, ‘Physician Owned Pharmacies: Lawful Business Ventures or Illegal Business Interest?’ J. Pharmacy & Law 4:1. 101 Alfonso R. Gennaro, (ed. ), Remington’s Pharmaceutical Sciences, 17th edition (1985), pp. 11–12. 102 414 US 156 (1973). 103 202 NW 2d 140 (ND 1972).

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104 454 P.2d 619 (Mont. 1969). 105 57 Cal. Rptr. 85 (Cal. Ct. App. 1967). 106 57 Cal. Rptr. 256 (Cal. Ct. App. 1967). 107 Richard Arden Veon, II, ‘Physician Owned Pharmacies: Lawful Business Ventures or Illegal Business Interest?’ J. Pharmacy & Law 4: 1. 108 Social Security Amendments of 1972, Pub. L. No. 92-603, 86 Stat. 1419, 242(b), 242(c) (1972). 109 760 F. 2d 68 (3d Cir. 1985). 110 Thomas Crane, ‘The Problem of Physician Self-Referral under the Medicare and Medicaid Anti-Kickback Statute’, Jama 268 (1992): 85, 86. 111 Section 2(c), The Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954. 112 See Section 2(d) of The Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954. Dr Yashpal Sahi v. Delhi Administration AIR (1964) SC 784, (1964) 5 SCR 582, (1961) 1 Cri LJ 560. 113 Names of the disease, disorder, or condition as specified in the schedule are: 1. Appendicitis; 2. Arteriosclerosis; 3. Blindness; 4. Blood poisoning; 5. Bright’s disease; 6. Cancer; 7. Cataract; 8. Deafness; 9. Diabetes; 10. Diseases and disorders of the brain; 11. Diseases and disorders of the optical system; 12. Diseases and disorders of the uterus; 13. Disorders or menstrual flow; 14. Disorders of the nervous system; 15. Disorders of the prostatic gland; 16. Dropsy; 17. Epilepsy; 18. Female diseases (in general); 19. Fevers (in general); 20. Fits; 21. Forms and structure of the female bust; 22. Gall stones, kidney stones and bladder stones; 23. Gangrene; 24. Galucoma; 25. Goitre; 26. Heart diseases; 27. High or low blood pressure; 28. Hydrocele; 29. Hysteria; 30. Infantile paralysis; 31. Insanity; 32. Leprosy; 33. Lecuoderma; 34. Lockjaw; 35. Locomotor atoxia; 36. Lupus; 37. Nervous debility; 38. Obesity; 39. Paralysis; 40. Plague; 41. Pleurisy; 42. Pneumonia; 43. Rheumatism; 44. Ruptures; 45. Sexual impotence; 46. Small pox; 47. Stature of persons; 48. Sterility in women; 49. Trachoma; 50. Tuberculosis; 51. Tumours; 52. Typhoid fever; 53. Ulcers of the gastro-intestinal tract; 54. Veneral diseases, including syphilis, gonorrhoea, soft chancre, veneral, granulima and lympho granuloma. 114 Sections 3 and 5, the Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954. Advertisements that talk about cure or remedy falling out of the schedule cannot be regarded as offensive or violative of the act, K.S. Saini and Another v. Union of India AIR (1967) Punj 322. 115 AIR (1960) (SC) 554. 116 Section 4, the Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954. 117 Section 5, ibid.

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118 Section 7, the Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954. 119 Dr Yashpal Sahi v. Delhi Administration AIR (1964) SC 784, (1964) 5 SCR 582, (1961) 1 Cri LJ 560. 120 Section 9A, the Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954. 121 Section 10, ibid. 122 Section 14, ibid. 123 (2009) 3 RCR (civil) 844, (2009) 3 RCR (criminal) 785 (P & H). 124 The IPC makes a technical distinction between murder and homicide not amounting to murder. See Sections 299 and 300 of the code. 125 Section 309 states that whoever attempts to commit suicide and performs any act towards the commission of such offence shall be punished with simple imprisonment for a term that may extend to one year, a fine, or both. 126 Under the provisions of the IPC, there is a distinction between culpable homicide and murder. This has important bearing on the actual sentence meted out. Culpable homicide is not murder, as per Section 300, when the person whose death is caused, being above the age of 18 years, suffers death or takes the risk of death with his own consent. The section offers the example of a minor under the age of 18 who commits suicide and cannot consent to their own death; here the person that causes the death of the minor shall be charged with abetment to murder. According to Section 305, whoever abets the commission of the suicide of a child, insane person, any delirious person, any idiot, or any person in a state of intoxication shall be punished with death (or imprisonment for life), or imprisonment for a term not exceeding 10 years, and shall also be liable to a fine. As regards other classes of persons, Section 306 makes the abetment of suicide punishable with imprisonment of either description for a term that may extend to 10 years, and shall also be liable to a fine. 127 The explanation in Section 498A of the definition of cruelty of husband and his near relative includes any wilful conduct that is likely to drive the woman to commit suicide or to cause grave injury or danger to life, limb, or health (whether mental or physical) of the woman. 128 Michael A. Salatka, ‘The Patient Self-Determination Act Of 1990: Issues Regarding the Facilitation of Advance Directives, Patient Autonomy, Assisted Suicide, and Euthanasia’, The Journal of Pharmacy & Law (1992). 129 Aruna Ramachandra Shanbaug v. Union of India (2011) 4 SCC 453. 130 McKay v. Bergstedt, 801 P.2d 617 (Nev. 1990). Although the plaintiff was able to read, watch television, orally operate a computer, and occasionally enjoy wheelchair ambulation, he despaired over the prospect of life without his devoted father, whose death was imminent.

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131 Raphael Cohen-Almagor regards the lack of hospice care and the fact that there are only seventy palliative care beds in the country as reflections of having the easier option of euthanasia. She concludes on the basis of interviews and the hypothesis that the policy and practice of euthanasia in the Netherlands is the result of undeveloped palliative care, that the entire euthanasia practice could be transformed for the better once nursing-home doctors, specialists, and especially general practitioners are aware of the positive consequences of good palliative care at the end of life. See his ‘Dutch Perspectives on Palliative Care in the Netherlands’ Nat’l Legal Center for Medically Dependent & Disabled, Inc.’, Issues L. & Med. 18 (2002): 111. 132 546 US 243 (2006), 133 521 US 702; 117 S. Ct. 2258; 117 S. Ct. 2302; 138 L. Ed. 2d 772; 1997 US LEXIS 4039; 65 USLW 4669. 134 That holding, the court said, did not foreclose the possibility that some applications of the statute might well be invalid. 135 Kevin P. Quinn, SJ, argues that the distinction between intentionally killing oneself and intentionally letting oneself die is both coherent ‘as a matter of principle’ and morally relevant. This principled distinction then provides a benchmark for courts considering equal protection arguments to distinguish one patient seeking to commit suicide from another wishing to free themselves of unwanted life-sustaining medical treatment, and to conclude that these two individuals are not similarly situated for purposes of the Equal Protection Clause. These two situations are morally distinct—the deaths are caused by different means and those involved have different intentions. The intention of the doctor and patient to hasten the patient’s death is material, and the intention relates to understanding what it means to treat people equally. Doctors who participate in assisted suicide intend their patients to die by their own acts, which is intentional killing. The author concludes that those who ask their doctors to commit assisted suicide and those who forgo treatment are not similarly situated for purposes of the Equal Protection Clause. See his ‘Assisted Suicide and Equal Protection: In Defense of the Distinction Between Killing and Letting Die’, Issues Legal & Medical 13 (1997): 135. 136 ‘Euthanasia.’, sub verso, Encyclopædia Britannica Online, http://www. britannica.com/eb/article-9033299. 137 See Robert L. Burgdorf, Jr, ‘Assisted Suicide: A Disability Perspective’, Issues L. & Med 14 (1998): 273, position paper written for the National Council on Disability, 24 March 1997, Marc Bristo, chairperson. It argues that opposing the legalization of assisted suicide seemingly deprives people with disabilities who face imminent death and severe pain of the only power they can have to decide when and how they will die, an ability to choose that might offer them some control, dignity, and measure of self-determination in an otherwise bleak situation. Such control of one’s own destiny, freedom of

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choice, and self-determination are key principles of the disability rights and independent living philosophies, and cornerstones of the initiatives that the Council has advocated. On the other hand, legalizing assisted suicide seems to risk its likely use, the ultimate manifestation of prejudice against people with disabilities in our society, as a means to unnecessarily end or to force the end of people with disabilities’ lives. People with disabilities know that many in society believe that they would be better off dead, and legalized assisted suicide offers a subtle and sometimes not-so-subtle way to make that judgment a reality. Newly acquired disabilities due to accidents may leave the patients with despondency and depression. They may re-adjust their lives with adequate counselling and passage of time.The existence of a normal period of disorientation and depression following the acquisition of a disability makes it imperative that people in such a situation not try to make long-term or irreversible decisions that may be coloured by temporary depression and disorientation rather than by an exercise of sound judgment. Legal and medical authorities should denounce and prohibit any attempt to pressure, harass, or coerce any individual to shorten her or his life; they should certainly proscribe any action to terminate an individual’s life taken without that person’s full, voluntary, and informed consent, whether it is called ‘suicide’, ‘mercy killing’, ‘letting nature take its course’, or some other euphemistic term. And certainly there should be official condemnation and cessation of practices by which people with disabilities are pressured to sign ‘Do Not Resuscitate’ consent forms, or such forms are hidden within a stack of admission and consent papers in the hope that the individual with a disability will sign them unintentionally. 138 James Bopp, Jr, JD, and Richard E. Coleson, MAR, JD, in ‘Three Strikes: Is An Assisted Suicide Right Out?’, Issues L. & Med. 15: 3. 139 See St George’s Healthcare Trust v. S [1999] Fam 26. 140 Airedale NHS Trust v. Bland [1993] AC 789. Tony Bland’s awful predicament is well known. He was a young supporter of Liverpool Football Club who was caught in the Hillsborough crush, which reduced him to a PVS state. The hospital applied for a declaration that it might lawfully discontinue all life-sustaining treatment and medical support measures designed to keep him alive in that state, including the termination of ventilation, nutrition, and hydration by artificial means. That declaration was granted. In the US, at a hospital in New Orleans, on 1 September 2005, two days after hurricane Katrina left the hospital with no electricity and water from broken levees flooded the surrounding streets, four patients (all black) who had been put in the category of DNR (do not resuscitate) were administered lethal doses of morphine by the medical staff (all whites) to relieve the patients of suffering in adverse circumstances by death. The doctors and nurses that were responsible for the decision were prosecuted for murder.

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141 Ibid. 142 See also NHS Trust A v. H [2001] 2 FLR 501. 143 Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009, Part I, amended by the MCI Notification, New Delhi, 10 December 2009. 144 Dr Prakash, an orthopedician from Chennai, was awarded life imprisonment by a Fast Track Court in Chennai on 6 February 2008 for his involvement in a case relating to taking obscene photographs of women patients and releasing on the Internet. This is the first time that a medical professional has been booked for violation under the Information Technology Act in India.The sentence was passed under the Immoral Trafficking Prevention Act and a fine of Rs 1,25,000 has been imposed on him.The court found Dr Prakash and his accomplices, who were his hospital paramedical staff, guilty under Section 506 (part II), 367, and 120 B (criminal conspiracy) of the IPC and Section 67 of Information Technology Act. The doctor was found guilty of conspiracy and kidnapping, besides other offences under the provisions of the Information Technology Act, Immoral Trafficking Act, Indecent Representation of Women Act and the Arms Act. The court, however, acquitted Dr Prakash from two charges, 307 (attempt to murder) and 376 (rape) of the IPC. The Tamil Nadu Medical Council did not remove him from the Register of Medical Practitioners till after conviction by the trial court and the President of the State Council was reported as saying that he was waiting to know what the appellate court said on his conviction. A somewhat lenient approach was taken in a case reported from Australia. The Sydney Morning Herald (18 March 2008) reported that Fahreed Bahrami, 44, was found guilty in 2002 of rubbing his private parts against a female patient, and of touching the breasts, buttocks, and thighs of another female patient before placing her hand on his private organ. However, the former Iranian refugee was able to continue practising on the condition he have a chaperone present during intimate examinations, after the NSW Medical Tribunal in 2003 found he was unlikely to reoffend. The Queen’s Bench Division (Administrative Court), in Giele v. General Medical Council (2005) 4 All ER 1242 was reviewing a punishment of erasure from practitioners’ list for a period of five years in the case of a plastic surgeon who was found guilty of improper sexual conduct with his patient. Evidence had been given of the surgeon’s great talents and the fact that erasure would deprive the medical world of the services of a uniquely talented surgeon. The bench said that while approaching the question of sanctions the disciplinary panel had to start with the least severe. Even improper conduct with a vulnerable patient must require consideration of the existence of a public interest in not ending the career of a competent doctor.The court said rather unconvincingly: ‘Although

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there were some aggravating features, erasure, which would be likely if not to end his career at least would make it extremely difficult to commence practice again, was not essential.’ It quashed erasure and a suspension for 12 months was substituted with a requirement that there would be a further hearing at the expiration of the period. 145 See Chapter 8 for further commentaries on this subject. 146 Tabitha M. Powledge, ‘Unnatural Selection: On Choosing Children’s Sex’, in Helen Holmes et al. (eds), The Custom-made Child (Totowa: Humana Press, 1981), pp. 193, 196. 147 Meadow v. General Medical Council (2007) 1 All ER 1 (CA). See Chapter 4, on the topic of extent of immunity of the doctor’s evidence. 148 See Chapter 7 for further commentaries. 149 See Chapter 3 and Chapter 6 for further commentaries. 150 See Chapter 8 for further reading on this subject. 151 See P.G. Lauren, The Evolution of International Human Rights: Visions Seen (Philadelphia: University of Pennsylvania Press, 1998); H. Lauterpacht, International Law and Human Rights (New York: F.A. Praeger, 1950). 152 See G. Rosen, A History of Public Health (New York: MD Publications, 1958); D. Porter, Health, Civilization and the State: A History of Public Health from Ancient to Modern Times (New York: Routledge, 1999); M. Paquier, Histoire Illustree de 5.000 Ans d'Hygiene Publique (Paris: Editions Johanet, 2000). 153 Stephen P. Marks, ‘The Evolving Field of Health and Human Rights: Issues and Methods’, J. L. Med. & Ethics 30 (2002): 739. 154 A. Powell, ‘Why Good Doctors Do Bad Things,’ Harvard Gazette (3 March 2005): 1–3, also available at http://www.news. harvard.edu/ gazette/2005/03.03/ll-abu.html. 155 Prison camps under the military control of the US and its allies. 156 D. Silove, ‘Review of Combating Torture: A Manual For Action (London: Amnesty International, 2003)’ in The Lancet 363 (2004): 1915–6. 157 These measures include: ‘sleep deprivation, prolonged isolation, painful body positions, feigned suffocation, and beatings. Other stress-inducing tactics have allegedly included sexual provocation and displays of contempt for Islamic symbols.’ See M.G. Bloche and J.H. Marks, ‘Doctors and Interrogators at Guantanamo Bay’, New England Journal of Medicine 353 (2005): 6–8. See also, Physicians for Human Rights, ‘Break Them Down: Systematic Use of Psychological Torture by US Forces’, Physicians for Human Rights Report (Cambridge, Massachusetts, 2005). 158 Some Pentagon officials have argued that the medical personnel advising interrogators were not bound by ethic strictures because they were not treating patients, but acting as behavioural scientists. See N. Lewis, ‘Interrogators Cite Doctors’ Aid at Guantanamo’, New York Times (24 June 2005).

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159 Peter A. Clark, ‘Medical Ethics at Guantanamo Bay and Abu Ghraib: The Problem of Dual Loyalty’, J. L. Med. & Ethics 34 (2006): 570. 160 Sev S. Fluss, ‘The Evolution of Research Ethics: The Current International Configuration’, J. L.Med & Ethics 32: 596. 161 A history of German politics in the 1920s, 1930s, and 1940s set the stage for the government-sponsored eugenics (so-called ‘racial hygiene’) movement. Early racial hygiene proponents had little association with anti-Semitism, but this changed when racial hygiene extremists merged with National Socialism. Biology became prominent in Nazi ideals, with Nazi leaders referring to National Socialism as ‘applied biology’, reflecting its social Darwinist racial hygiene origins. This ‘scientific’ basis attracted many physicians to Nazism. The National Socialist Physicians’ League was formed in 1929 ‘to coordinate Nazi medical policy, and purify the German medical community of Jewish Bolshevism’. By 1942, about half of all physicians in Germany (more than 38,000) were members of the Nazi party. Hitler was even referred to as the ‘great doctor of the German people’. Nazi racial hygiene goals were carried out through three medical programmes. The Sterilization Law permitted forced sterilization of those with mental disease, epilepsy, Huntington’s chorea, or other various ‘genetic’ diseases. The Nuremberg laws excluded Jews from citizenship and prevented marriage or sexual relations between Jews and non-Jews. Perceived as necessary for the public health, these laws were overseen by physicians. Euthanasia, genocide, and experimentation were also conducted by physicians, who reportedly volunteered for these assignments, feeling them vital to the government’s war effort and ‘racial cleansing’ plans. The crimes included human experiments to test the effects of high-altitude; freezing; malaria vaccination and treatment; mustard gas; sulfanilamide and other drugs; bone, muscle, and nerve regeneration and bone transplantation; ingesting sea water; epidemic jaundice, typhus, yellow fever, smallpox, paratyphoid A and B, cholera, and diphtheria vaccines; various sterilization methods; selected poisons; and bomb materials. A large collection of Jewish skeletons was also maintained and studied for evidence to support the doctrine of Nazi eugenics. General Taylor, who was brought to trial, was reported to have described these crimes as ‘the logical and inevitable outcome of the prostitution of German medicine under the Nazis ... All of the physicians violated ‘the Hippocratic commandments which they had solemnly sworn to uphold and abide by, including the fundamental principle never to do harm—primum non nocere.’ See George J. Annas and Michael A. Grodin (eds), The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (New York: Oxford University Press, 1992). 162 Jennifer Rosato, ‘The Ethics of Clinical Trials: A Child’s View’, J. L Med. & Ethics 28: 262.

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163 The narco-analysis test is conducted by administrating 3 gm of Sodium Pentathol or Sodium Amytal dissolved in 3000 ml of distilled water depending upon the person’s sex, age, health, and physical condition, and this mixture is administered intravenously along with 10 per cent of dextrose over a period of three hours with the help of an anaesthetist. The rate of administration is controlled to drive the accused slowly into a hypnotic trance. The effect of the bio-molecules on the bio-activity of an individual is evident as the drug depresses the central nervous system, lowers blood pressure and slows the heart rate, putting the subject into a hypnotic trance resulting in a lack of inhibition. The subject is then interrogated by the investigating agency in the presence of doctors. The interrogation is recorded on video cassettes. The report prepared by the experts is what is used in the process of collecting evidence. Under the influence of the drug, the subject talks freely and is purportedly deprived of self-control and will power to manipulate answers. The underlying theory is that a person is able to lie by using his imagination. In the narco-analysis test, the subject’s imagination is neutralized and reasoning faculty affect by making him semi-conscious. The subject is not in a position to speak up on his own, but can answer specific and simple questions. In this state, it becomes difficult for him to lie, and his answers would be restricted to facts he is already aware of. His answers are spontaneous, as a semi-conscious person is unable to manipulate any answer. The ECG and blood pressure are monitored continuously throughout the testing procedure. The questions are designed carefully and are repeatedly persistently in order to reduce ambiguities during drug interrogation. After the narco examination is over, the suspect is made to relax for two to three hours. 164 The brain mapping test is also known as P-300 test. In this test the suspect is first interviewed and interrogated to find out whether he is concealing any information. The activation of brain for the associated memory is carried out by presenting a list of words to the subjects.There are three types of words in the list used : Part I consists of neutral words, which have no direct relationship with the case. Part II consists of probe words directly related to the case to elicit concealed information that all suspects have had opportunity to find out during the course of events related to the case. Part III consists of targets, which are not part of the first two parts. The words in this part are based on confidential findings that suspect does not know. The recording of this test is done by acquiring the response through 32-channel EEG-ERP neuro scan cording system. It is carried out by asking the suspect to sit down and close his eyes. The 32-channel electrodes are placed over the scalp directly. This test is conducted twice by presenting each word in three parts randomly.The suspect is instructed to relax and listen to the words presented in the auditory mode. The test does not expect any oral response from the witness. The conclusion

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drawn by the experts after the conduct of the test to indicate the possession of the knowledge about the relevant subject which is helpful in the investigation and collection of evidence. The test determines whether the subject has the knowledge of the crime about which he was questioned. However, there is no way to find out what the lie is, or determine the information stored in the brain of the subject. 165 Article 20(3) of the Indian Constitution reads that ‘no person accused of any offence shall be compelled to be a witness against himself ’. 166 Gujarat High court in Santokben Sharmanbhai Jadeja v. State of Gujarat 2008 Cri LJ 68, (2008) 1 GLR 497; Gujarat High Court in Special Criminal Application No. 1200 of 2003 dated 16.12.2007 in Malav A. Bhatt v. State of Gujarat; Bombay High Court in Ramchandra Reddy v. State of Maharastra 2004 ALL MR (Cri) 1704; Arun Gulab Gavali v. State of Maharastra 2006 Cri LJ 2615; The Karnataka High Court in Smt. Selvi and Ors v. State in Crl Pet No 1964 of 2004; the Madras High Court in Dinesh Dalmia v. State 2006 Cri LJ 2401; the Andhra Pradesh High Court in K.Venkateshwara Rao, S/o K.Vijaya Simha, Hydrabad v. State of AP decided on 30 August 2007 in Criminal Revision Application No. 1402 of 2006; as well as the judgment of the Supreme Court in Jitubhai Babubhai Patal v. State of Gujarat in (2005) (10) SCC 545. 167 (2010) 7 SCC 263. 168 Sharda v. Dharmpal (2003) 4 SCC 493. 169 AIR (1999) SC 2295. 170 Ramkanya Bai v. Bharatram (2010) 1 SCC 85, (2009) (6) RSJ 98. 171 (2010) 7 MLJ 832. 172 On 16 March 2011, the Supreme Court rejected Congress leader and former Governor of Andhra Pradesh N.D. Tiwari’s appeal challenging a Delhi High Court order directing him to submit his blood samples for DNA testing to decide a paternity suit filed by Rohit Shekhar, who claimed to be his biological son (Times of India, 18 March 2011). As it has turned out,Tiwari was compelled to give the blood sample when a team of doctors was reported to have arrived and collected the blood sample on pain of being proceded against for contempt of court, if he had declined. 173 (2010) 7 SCC 263. 174 Testimonial compulsion is a subject in itself and there is a constitutional guarantee against it under Article 20 (3). It is a fundamental right of a person accused of any offence not to be compelled to be a witness against himself. In State of Bombay v. Kathi Kalu Oghad AIR (1961) SC 1808, an eleven-member bench of the Supreme Court was divided on the issue of what it means ‘to be a witness’. The majority ruled that ‘to be a witness’ is not equivalent to ‘furnishing evidence’ in its widest significance; that is to say, it did not include merely making oral or written statements but also involved production of

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documents or giving materials that may be relevant at a trial to determine the guilt or innocence of the accused.’ The Court said, ‘When an accused person is called upon by the court or any other authority holding an investigation to give his finger impression or signature or a specimen of his handwriting, he is not giving any testimony of the nature of a “personal testimony”. The giving of a “personal testimony” must depend upon his volition. He can make any kind of statement or may refuse to make any statement. But his finger impressions or his handwriting, in spite of efforts at concealing the true nature of it by dissimulation cannot change their intrinsic character. Thus, the giving of finger impressions or of specimen writing or of signatures by an accused person, though it may amount to furnishing evidence in the larger sense, is not included within the expression ‘to be a witness’. In Nandini Satpathy v. P.L. Dani (1978) 2 SCC 424, the Supreme Court examined the further dimension of this guarantee by examining whether an accused has a right to silence, and held that such a right would exist when the answer could be incriminatory. If a person claims immunity regarding any question, by refusing to answer the accused without disclosing details briefly states in which case or offence in the offing makes him reasonably apprehend self-incrimination. If after the whole examination is over, the police officer concerned reasonably regards any refusal to answer to be a wilful violation under pretence of immunity from self-incrimination, he will be free to prosecute the alleged offender after studying the refusal to answer. 175 India has both private and public DNA labs. Public labs are sponsored by the government, and use DNA purely for forensic purposes. The Centre for DNA Fingerprinting and Diagnostics (CDFD), located in Hyderabad, is sponsored by the Department of Biotechnology and Ministry of Science. CDFD runs DNA testing for establishing of parentage, identification of mutilated remains, establishment of biological relationships for immigration, organ transplantation, property inheritance cases, identification of missing children and child swapping in hospitals, identification of rapists in rape cases, and identification in the case of murder. Cases are only accepted by the CDFD if they are referred by law enforcement agencies or by a court of law. Only an officer of the rank Inspector of Police or above may forward DNA cases to the CDFD. Copies of the DNA report are released to individuals if they are able to prove their interest in the case through a notarized affidavit. Examples of private DNA labs include DNA Labs India and Truth Labs. DNA Labs India runs paternity testing, forensic testing, prenatal testing, and genetic testing. Truth Labs provides legal services directly, without a court or police order. 176 IRCT Annual Report 2010. 177 Preamble, the Protection of Human Rights Act, 1993. 178 Section 2(d), ibid.

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179 Section 3, Preamble, the Protection of Human Rights Act, 1993. 180 Section 13, ibid. 181 Section 14, ibid. 182 Section 15, ibid. 183 Section 18, the Protection of Human Rights Act, 1993. 184 Section 21, ibid. 185 Section 29, ibid. 186 Section 30, ibid. 187 Section 31, ibid. 188 (1992) 1 SCC 441. Also Rama Murthy v. State of Karnataka (1997) 2 SCC 642. 189 Bibhuti Nath Jha v. State of Bihar (2005) 12 SCC 286. 190 Supreme Court Legal Aid Committee v. State of Bihar (1991) 3 SCC 482. 191 ‘38 yrs in Jail Without Trial’, The Hindustan Times; In re (2007) 15 SCC 18. 192 R.D. Upadhyay v. State of AP (2007) 15 SCC 537. 193 Consumer Education & Research Centre v. Union of India (1995) 3 SCC 42; Research Foundation for Science (12) v. Union of India (2005) 13 SCC 661. Paschim Banga Khet Mazdoor Samity v. State of WB (1996) 4 SCC 37; Gujarat Ambuja Cements Ltd v. Chavi Raj Singh (2007) 15 SCC 632 (liability of industry to compensate people affected by asthma and TB by industrial operations on the basis of polluter pays principle). 194 (1997) 2 SCC 83. 195 Section 12(2), Clinical Establishments (Registration and Regulation) Act, 2010. 196 Pravat Kumar Mukherjee v. Ruby General Hospital & Ors 2005-(002)-CPJ -0035–NCDRC.

3

Consent

INTRODUCTION As an elementary rule, no physician can compel a patient for treatment without his consent. The principle of autonomy that we have seen in Chapter 2 examines the issue of a patient’s liberty to choose wheter or not to be treated as something so fundamental that it could be a criminal offence if no consent is obtained by a physician or a surgeon before undertaking the treatment. As a trespass on a person, it could also lead to a claim for damages in tort. Complex issues arise when the patient is not in a conscious state to signify consent or when the mental conditions due to age or mental or physical illness is such that the patient is not legally competent to consent. The doctor will do what is in the best interest of the patient and what conforms to standard medical practice. Closely connected with how a doctor shall treat a patient is the issue of what information a doctor shall disclose in order to elicit consent, and what a doctor shall divulge in the course of treatment. A doctor is always required to communicate all inherent and potential hazards of the proposed treatment, the alternatives to that treatment, if any, and the likely effect if the patient remained untreated. The standard of disclosure, however, is subject to only two exceptions, namely, if there is a genuine emergency and the information would be harmful to the patient. In cases of patients who are minors or mentally ill, there are specific pieces of legislation like the Guardian and Wards Act and Mental Health Act, which place the guardian as a person competent to signify consent, with a veto being always Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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available to the court to take a decision independent of the guardian in its position as patria parens. This chapter will address the consequences of treatment without consent as well as the predominance of the court’s power to assess the best interests of the patient. In modern medical parlance, the expression ‘consent’ is always used with a prefix ‘informed’, which is loaded with a pregnant meaning that generates many a debate in courts and outside. Here the law in India follows the British approach of the standard medical practice as governing the decisional latitude enjoyed by a doctor, and makes a significant departure from the American practice of what it attributes to the term ‘informed consent’. Yet another area of study that may be relevant is when medical intervention is sought for a court process to determine the age or mental capacity of a patient, or to ascertain the truth as a preliminary in investigative processes where consent could be relevant. Attempts to gather evidence from persons charged with offences of ‘drunken’ behaviour through blood or urine samples, narco-analysis, lie detector tests, and brain mapping of suspects for collecting vital leads on commission of offences may be objected to as constituting acts of compulsion of self-incrimination, against constitutional guarantees. In civil cases, the determination of age or mental health will be relevant for necessity of appointment of guardians, for entering findings on the validity of transactions by minors and the mentally unsound, and for necessary treatment. Here again, the issue of adjudication as a minor or mentally unsound person may be contested, requiring medical intervention. In matrimonial jurisdiction, the possible ill health of a parent in child custody cases, mental unsoundness, or impotence of a spouse could be issues necessary for determination, but the person against whom the allegations are made may be unwilling to cooperate. Each one of these situations will raise issues of lack of consent, not for treatment, but for gathering evidence in an investigative process. However, diagnostic and procedural tools involved in determining minority or ill health are not discussed here. Defences of confidentiality against disclosure of documents by doctors and against their testimony on this ground are dealt with in Chapter 2 as exceptions to the ethical determinants. Only issues arising out of refusal to consent for examination and the exceptions permissible for such consent are the subjects of scrutiny here.

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Real Consent and Informed Consent In Samira Kohli v. Dr Prabha Manchanda and Anr,1 the Supreme Court pointed out that there is a significant difference in the nature of express consent of the patient, known as ‘real consent’ in the UK and as ‘informed consent’ in the US. In the UK, the elements of consent are defined with reference to the patient, and a consent is considered to be valid and ‘real’ when (1) the patient gives it voluntarily without any coercion; (2) the patient has the capacity and competence to give consent; and (3) the patient has minimum sufficiently adequate level of information about the nature of the procedure to which he is consenting. On the other hand, the concept of ‘informed consent’ developed by American courts, while retaining the basic requirements of consent, shifts the emphasis to the doctor’s duty to disclose the necessary information to the patient to secure his consent. ‘Informed consent’ is defined in Taber’s Cyclopedic Medical Dictionary thus: Consent that is given by a person after receipt of the following information: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.

In Canterbury v. Spence,2 the US Court of Appeal, District of Columbia Circuit, emphasized the element of the doctor’s duty in ‘informed consent’ thus: It is well established that the physician must seek and secure his patient’s consent before commencing an operation or other course of treatment. It is also clear that the consent, to be efficacious, must be free from imposition upon the patient. It is the settled rule that therapy not authorized by the patient may amount to a tort—a common law battery—by the physician. And it is evident that it is normally impossible to obtain a consent worthy of the name unless the physician first elucidates the options and the perils for the patient’s edification. [emphasis added] Thus the physician has long borne a duty, on pain of liability for unauthorized treatment, to make adequate disclosure to the patient.

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The basic principle with regard to patient’s consent may be traced to the classic statement by Justice Cardozoin Schoendorff v. Society of New York Hospital: ‘Every human being of adult years and sound mind has a right to determine what should be done with his body; and a surgeon who performs the operation without his patient’s consent, commits an assault for which he is liable in damages.’3 This principle has been accepted by the English courts too. In Re: F. 1989(2) All ER 545, the House of Lords dealt with a case of sterilization of a mental patient, and reiterated the fundamental principle that every person’s body is inviolate, and performance of a medical operation on a person without his or her consent is unlawful. The English law on this aspect is summarized thus in Principles of Medical Law: Any intentional touching of a person is unlawful and amounts to the tort of battery unless it is justified by consent or other lawful authority. In medical law, this means that a doctor may only carry out a medical treatment or procedure which involves contact with a patient if there exists a valid consent by the patient (or another person authorized by law to consent on his behalf) or if the touching is permitted not withstanding the absence of consent.4

The decision in Marshell v. Curry,5 decided by the Supreme Court of NS, Canada, illustrates the exception to the rule that an unauthorized procedure may be justified if the patient’s medical condition brooks no delay and warrants immediate action without waiting for the patient to regain consciousness and take a decision for himself. In that case, the doctor discovered a grossly diseased testicle while performing a hernia operation. As it was gangrenous, posing a threat to patient’s life and health, the doctor removed it without consent as a part of the hernia operation. An action for battery was brought on the ground that the consent was for a hernia operation, and the removal of the testicle was not consented to. The claim was dismissed. The court was of the view that the doctor can act without the consent of the patient if it is necessary to save the life or preserve the health of the patient. Thus, the principle of necessity by which the doctor is permitted to perform further or additional procedure that is unauthorized is restricted to cases where the patient is temporarily incompetent (being unconscious), to permit a procedure that should not be delayed because of the imminent danger to the life or health of the patient.

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It is quite possible that if the patient is conscious and informed about the need for the additional procedure, they would agree to it. It may be that the additional procedure is beneficial and in the patient’s interests. It may be that postponement of the additional procedure (say removal of an organ) may require another surgery, whereas removal of the affected organ during the initial diagnostic or exploratory surgery would save the patient from the pain and cost of a second operation. Practicality and convenience are not relevant; what is relevant and of importance is the inviolable nature of the patients’ right with regard to their body and their right to decide whether they should undergo the particular treatment or surgery. CONSENT IN VARIOUS STAGES OF TREATMENT Clinical practices that are less intrusive than surgery may take consent for granted when the patient seeks advice from the physician. Indeed, a doctor will have little chance of forcing a patient into treatment without consent. It may seem like a greater degree of circumspection is necessary as regards issues of consent whenever surgery is undertaken. Where a surgeon is consulted by a patient, and consent of the patient is taken for diagnostic procedure or surgery, such consent cannot be considered as authorization or permission to perform therapeutic surgery, whether conservative or radical (except in life-threatening or emergent situations). Similarly, where consent by the patient is for a particular operative surgery, it cannot be treated as consent for an unauthorized additional procedure involving removal of an organ only on the ground that such removal is beneficial to the patient or is likely to prevent some danger developing in future, while there is no imminent danger to the life or health of the patient. In Murray v. McMurchy,6 the Supreme Court of BC, Canada, was considering a claim for battery by a patient who underwent a caesarean section. During the operation, the doctor found fibroid tumours in the patient’s uterus. Believing that such tumours would be a danger in case of future pregnancy, he performed a sterilization operation.The court upheld the claim for damages for battery. It held that sterilization could not be justified under the principle of necessity, as there was no immediate threat or danger to the patient’s health or life, and it would not have been unreasonable to postpone the operation to secure

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the patient’s consent. The fact that the doctor found it convenient to perform the sterilization operation without consent as the patient was already under general anaesthetic was held to be an invalid defence. A somewhat similar view was expressed by courts of appeal in England in Re: F.7 It was held that the additional or further treatment that can be given (outside the consented procedure) should be confined to only such treatment as is necessary to meet the emergency, and as such needs to be carried out at once, before the patient is likely to be in a position to make a decision for himself. Lord Goff observed: Where, for example, a surgeon performs an operation without his consent on a patient temporarily rendered unconscious in an accident, he should do no more than is reasonably required, in the best interests of the patient, before he recovers consciousness. There can be no practical difficulty arising from this requirement, which derives from the fact that the patient is expected before long to regain consciousness and can then be consulted about longer term measures.

The question of whether the standard of care that the doctor shall give to a patient regarding the disclosure of risks to a patient who seeks advice for diagnosis and course of treatment is the same as the level of information of risk for a patient who is prepared for a surgery was posed before the House of Lords in Sidaway v. Bethlem Royal Hospital Governors and Others.8 The plaintiff, who suffered from persistent pain in her neck and shoulders, was advised by a surgeon employed by the defendant hospital governors to have an operation on her spinal column to relieve the pain. The surgeon warned the plaintiff of the possibility of disturbing a nerve root and the possible consequences of doing so but did not mention the possibility of damage to the spinal cord, even though he would be operating within three millimetres of it. The risk of damage to the spinal cord was very small (less than 1 per cent), but if it materialized, the resulting injury could range from the mild to the very severe.The plaintiff consented to the operation, which was carried out by the surgeon with due care and skill. However, in the course of the operation the plaintiff did suffer injury to her spinal cord, which resulted in her being severely disabled. She brought an action against the hospital governors and the surgeon’s estate (the surgeon having died in the mean time) claiming damages for personal injury. Being unable to sustain a claim based on negligent performance of the operation, the plaintiff instead contended that the surgeon had

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been in breach of a duty owed to her to warn her of all possible risks inherent in the operation. The trial judge applied the test of whether the surgeon had acted in accordance with accepted medical practice and dismissed the claim. The Court of Appeal upheld the judgment, holding that the doctrine of informed consent based on full disclosure of all the facts to the patient was not the appropriate test under English law. The plaintiff appealed to the House of Lords. In a divided opinion of the bench, it was held (Per Lord Diplock, Lord Keith, and Lord Bridge, Lord Scarman dissenting) that the test of liability in respect of a doctor’s duty to warn his patient of risks inherent in treatment recommended by him was the same as the test applicable to diagnosis and treatment, namely that the doctor was required to act in accordance with a practice accepted at the time as proper by a responsible body of medical opinion. Accordingly, English law did not recognize the doctrine of informed consent. However (per Lord Keith and Lord Bridge), although a decision on what risks should be disclosed for the particular patient to be able to make a rational choice whether to undergo the particular treatment recommended by a doctor was primarily a matter of clinical judgment, the disclosure of a particular risk of serious adverse consequences might be so obviously necessary for the patient to make an informed choice that no reasonably prudent doctor would fail to disclose that risk. When advising a patient about a proposed or recommended treatment (Per Lord Templeman), a doctor was under a duty to provide the patient with the information necessary to enable the patient to make a balanced judgment in deciding whether to submit to that treatment, and that included a requirement to warn the patient of any dangers that were special in kind or magnitude or special to the patient. That duty was, however, subject to the doctor’s overriding duty in regard of the best interests of the patient. Accordingly, it was for the doctor to decide what information should be given to the patient and the terms in which that information should be couched. Since (per Lord Diplock, Lord Keith, and Lord Bridge) the surgeon’s non-disclosure of the risk of damage to the plaintiff ’s spinal cord accorded with a practice accepted as proper by a responsible body of neurosurgical opinion and as (per Lord Scarman and Lord Templeman) the plaintiff had not proved on the evidence that the surgeon had been

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in breach of duty by failing to warn her of that risk, the defendants were not liable to the plaintiff. The judicial approach is an example of medical paternalism that is adopted in Indian courts as well, thanks to the all too popular notion that the doctor knows best, and the propensity of the illiterate to surrender the responsibility of appropriate medical care to the doctor. COMPONENTS OF INFORMED CONSENT

Prime Duty to Inform Beauchamp9 lists the five elements of informed consent: (1) disclosure, (2) comprehension, (3) voluntariness, (4) competence, and (5) consent, meaning that ‘one gives an informed consent to an intervention if and only if one receives a thorough disclosure about it, one comprehends the disclosure, one acts voluntarily, one is competent to act, and one consents to the intervention.’ There is no obligation to accept any medical treatment, and it is remarkable that anyone ever considered it an acceptable practice to treat a person without their informed consent. Physicians have no roving mandate to treat whomever they believe may need their services. While not so emphatically as above, the American Medical Association (AMA) acknowledges the ‘right [of patients] to make decisions regarding the healthcare that is recommended by his or her physician. Accordingly, patients may accept or refuse any recommended medical treatment.’ Similarly, the 1992 opinion of the AMA’s Council on Ethical and Judicial Affairs’ statement on informed consent explicitly states that treatment decisions are to be determined by the patient. Patients admitted to US hospitals routinely receive a list of patients’ rights based on the American Hospital Association’s ‘A Patient’s Bill of Rights’, first adopted in 1973. The most recent revision informs patients about their ‘right to refuse a recommended treatment plan’. In India, routine clinical examination of patients does not introduce this degree of formality. Indeed, by the very fact that a patient goes to a doctor implies the factum of consent to be treated. However, in bigger clinics and hospitals, where the physician gets to interact with the patient at a later stage, it is not uncommon that at the reception the patient is made to sign written forms of consent even for clinical examination and investigative procedures.

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When the issue of consent is the nature of information that is required to be furnished by a doctor to secure a valid or real consent, what conforms to accepted medical practice to sustain treatment even in the absence of consent will pass the test for standard medical practice. In Bowater v. Rowley Regis Corporation10 Scott LJ observed: A man cannot be said to be truly ‘willing’ unless he is in a position to choose freely, and freedom of choice predicates, not only full knowledge of the circumstances on which the exercise of choice is conditioned, so that he may be able to choose wisely, but the absence from his mind of any feeling of constraint so that nothing shall interfere with the freedom of his will.

In Salgo v. Leland Stanford,11 it was held that a physician violates his duty to his patient and subjects himself to liability if he withholds any facts that are necessary to form the basis of an intelligent consent by the patient to the proposed treatment. Canterbury12 explored the rationale of a doctor’s duty to reasonably inform a patient about the treatment alternatives available and the risk incidental to them, as well as the scope of the disclosure requirement and the physician’s privileges not to disclose. It laid down the ‘reasonably prudent patient test’ that required the doctor to disclose all material risks to a patient to show ‘informed consent’. It held: True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make such a decision possible.

Choice regarding Alternatives Due care normally demands that the physician warn patients of any risks to their well being which that the recommended therapy may involve.The context in which the duty of risk disclosure arises is invariably the occasion for a decision as to whether a particular treatment procedure is to be undertaken.To the physician, whose training enables a self-satisfying evaluation, the answer may seem clear, but it is the

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prerogative of the patients, not the physician, to determine for themselves the direction in which their interests seem to lie. To enable the patients to chart their course understandably, some familiarity with the therapeutic alternatives and their hazards becomes essential. A reasonable revelation in these respects is not only a necessity but is the physician’s duty. It is a duty to warn of the dangers in the proposed treatment, and that is surely a facet of due care. It is also a duty to impart information that the patient has every right to expect.The patient’s reliance upon the physician is a trust of the kind that traditionally extends to obligations beyond those associated with arms-length transactions. They are greatly dependent upon the physician for information affecting their well-being in terms of the recommended treatment, and ‘in the fiduciary qualities of (the physician–patient) relationship, it is the physician’s duty to reveal to the patient that which in his best interests it is important that he should know.13 As a part of the physician’s overall obligation to the patient, there exists a similar duty of reasonable disclosure of the choices with respect to proposed therapy and the inherent and potential dangers that the treatment protocol involves.

The Extent of Risk to be Disclosed The patient’s right of self-decision shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The scope of the physician’s communications to the patient, then, must be measured by the patient’s need, and that need is the information material to the decision. Thus the test for determining whether a particular peril must be divulged is whether it is material that the patient has knowledge of all risks potentially affecting the decision. A risk is material ‘when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy’.14 The doctor, therefore, is required to communicate all inherent and potential hazards of the proposed treatment, the alternatives to that treatment (if ) any, and the likely effect if the patient remained untreated.This stringent standard of disclosure, as observed in Canterbury, was subjected to only two exceptions: if there was a genuine emergency, for example, if the patient was unconscious;

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and if the information would be harmful to the patient, for example, if it could cause psychological damage, or if the patient could become so emotionally distraught as to prevent a rational decision. However, it appears that several states in the US have chosen to avoid the decision in Canterbury by enacting legislation that severely curtails operation of the doctrine of informed consent. In Chatterton v. Gerson and Another,15 the plaintiff suffered chronic intractable and unendurable pain in a post-operative scar in her right groin, and was sent for treatment to a pain clinic, where the defendant, a medical practitioner who specialized in the treatment of pain, operated with her consent to block the sensory nerve that transmitted the pain signals from the scar site to the brain. The defendant’s regular practice was to explain to patients before the operation that it would result in numbness over an area larger than the pain source itself, and that it might involve temporary loss of muscle power. He did not later recall what he had said to the plaintiff, but her recollection was that he did not warn her that she would have numbness and perhaps muscle weakness. After the operation, not only did she experience numbness in her leg, but the relief she experienced in the scar site was only temporary. The chronic pain returned and she underwent a repeat operation 10 months later, on which occasion the defendant did not think it necessary to give his usual explanation about the possible effects of the operation, being of the opinion that it involved no more risk than the first.The plaintiff lost the sensation in her right leg after the second operation and still experienced such acute agony in the scar area that she could not bear clothing in contact with it and could only move about with a walking stick. The plaintiff ’s claim, based on trespass and negligence, was that the doctor and the hospital had failed to obtain her consent to the operation. According to the Queen’s Bench, in order to establish trespass to the person, a patient had to show that she did not consent to the operation.Where a doctor failed to explain in broad terms the nature of the operation, the patient could not consent to it and, in such circumstances, any consent given would be unreal and an action would lie in trespass. However, the plaintiff, on her own evidence, understood the general nature of the operation and, accordingly, her consent was a real consent. The duty of a doctor was to explain to the patient what he intended to do and the implications of that action in a way that a

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careful and responsible doctor would in similar circumstances. Where a patient had been given some explanation of the action proposed so that there was real consent to the operation, an action would lie in negligence if there was a failure to inform the patient of the nature of the operation and its implications and the patient proved that, if a proper explanation had been given, she would not have consented to the operation and that since the plaintiff had failed to prove that she had not been given details of the operation and its implications, her action both in trespass and negligence failed. On a principle of judicial review, the bench ruled that it would be very much against the interests of justice if actions based on a failure by the doctor to perform his duty to inform adequately were pleaded in trespass; second, the signing of a pro forma by a patient expressing consent to undergo an operation should be a valuable reminder to everyone of the need for explanation and consent. But it would be no defence to an action based on trespass to the person if no explanation had in fact been given. If even a disclosure would not have made the difference for the patient’s decision, the fact of non-disclosure of a secondary risk would be immaterial and would not render the doctor liable. In Dunn v. North York General Hospital,16 a Canadian case before Ontario High Court of Justice, the plaintiff developed haematoma after cosmetic surgery (a face lift). The skin over the haematoma area died, resulting in a badly scarred face and neck. The plaintiff had originally consulted with the doctor for removal of prior scars, and had then decided to undergo the operation. The doctor had advised her that the face lift would be completed first, and scar removal would involve a second procedure. After the haematoma occurred, the doctor informed the plaintiff that the original scar could not be removed. It was held that the doctor had made a reasonable effort to explain to the plaintiff what was to be done during the first procedure. A risk of haematoma and the resulting death of skin was not a material risk. There was infrequent serious skin loss in face lift operations. The risk was not material even though the surgery was purely elective. The plaintiff would have proceeded with the surgery even if she had known of a potential haematoma.The plaintiff ’s claim against the doctor was dismissed. General damages for scarring, which involved an 11-and-a half inch square above the left ear and a six-inch scar from left ear lobe down cheek, to the left side of the neck, were assessed at $ 22,500. The scarring had a profound effect

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on the plaintiff ’s social life. The husband was awarded $2,000 pursuant to the Family Law Act (Ont.) for involvement in driving his wife to hospital and helping her cope with the haematoma. Chester v. Afshar17 was a failed case of spinal surgery that left the patient with partial paralysis, and the medical opinion was that there was a 1–2 per cent risk of failure. The House of Lords had evidence before it that the surgeon had not indicated the degree of risk. The patient claimed that she would not have consented to the surgery if she had known the risk. The doctor contended that the patient should not only prove that she would not have consented to surgery if the risk had been explained then and there, but also that she would never have consented to the surgery all her life. The House of Lords rejected the contention, saying that there was no such degree of proof, and upheld the finding of professional negligence and the award of damages.

Is the Timing Relevant for Considering the Value of Informed Consent? In Felde v. Vein and Laser Medical Centre et al.,18 the Court of Appeal for Ontario dealt with a case where the defendant doctor had performed cosmetic surgery on the plaintiff ’s lower right eyelid to remove a small, white deposit. At the time of the surgery, the plaintiff was 52 years old and single. She had retired from her lengthy employment as a flight attendant, and it was her plan to enrol in a re-training programme and start a new career in selling cosmetics. Her only sources of income were a small pension and her registered retirement savings plan. The plaintiff claimed that she felt uneasy about a number of things when she met the defendant for the first time on the day of the surgery, including the clothing that he and his assisting physicians were wearing, the nature of the operating room, and the gruff manner in which she was treated by the anaesthetist, but went ahead with the procedure when the anaesthetist impatiently asked her whether she wanted the operation or not. Post-operatively, complications arose, requiring a number of revisionary operations. The plaintiff brought an action against the defendant claiming damages for negligence.The trial judge allowed the action on the basis of an absence of informed consent to the surgery as a result of the defendant’s failure to warn the plaintiff of the material risks associated with the surgery. The trial judge stated,

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‘a reasonable person in her situation, presented with a full discussion of the material risks associated with blepharoplasty, would not have proceeded with the operation that day with [the defendant]. A reasonable person would ... have asked for time to consider whether to proceed with the operation.’ The defendant appealed, arguing that the trial judge’s conclusion on the issue of informed consent was suspect because she applied the wrong test with respect to causation. Referring to the timing of the surgery, the court said: Timing of the surgical procedure may or may not be a significant factor with respect to the issue of causation. Whether it is or not will depend on the particular circumstances of the case. In this case, the timing of the surgery was a factor the trial judge could take into account in determining whether a reasonable person in the plaintiff ’s position would have refused the surgery, had the defendant made her aware of the risks. What the trial judge had in mind in arriving at her ultimate conclusion was not a postponement of the surgery to enable the plaintiff to find a doctor in whom she reposed more confidence and with whom she was as likely as not to proceed with the surgery regardless of the risks. Rather, she had in mind a postponement of some considerable length to enable the plaintiff to stabilize her life and obtain a level of economic self-sufficiency that would better equip her to cope with the type of complications that could arise from the initial surgery. The trial judge made no error on the issue of causation.

In Reibl v. Hughes,19 the timing of the surgery was central to the issue of causation because the plaintiff maintained that had he been informed of the material risks associated with the surgery, he would have postponed the operation for about 18 months in order to solidify his financial position. That explains why Laskin CJ, laid stress on the timing of the surgery in his analysis of the causation issue. As the Chief Justice pointed out: Relevant in this case to the issue whether a reasonable person in the plaintiff ’s position would have declined surgery at the particular time is the fact that he was within about one and one-half years of earning pension benefits if he continued at his job; that there was no neurological deficit then apparent; that there was no immediate emergency making the surgery imperative; that there was a grave risk of a stroke or worse during or as a result of the operation, while the risk of a stroke without it was in the future, with no precise time fixed or which could be fixed except as a guess of three or more years ahead. Since, on the

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trial judge’s finding, the plaintiff was under the mistaken impression, as a result of the defendant’s breach of the duty of disclosure, that the surgery would relieve his continuing headaches, this would in the opinion of a reasonable person in the plaintiff ’s position, also weigh against submitting to the surgery at the particular time.20

Informed Consent v. Bolam Test The stringent standards regarding disclosure laid down in Canterbury as necessary to secure informed consent of the patient was not accepted in the English courts. In England, the standard applicable is popularly known as the Bolam test, first laid down in Bolam v. Friern Hospital Management Committee.21 McNair J, in a trial relating to negligence of a medical practitioner, instructed the jury as follows: (i) A doctor is not negligent, if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art. Putting it the other way round, a doctor is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view. At the same time, that does not mean that a medical man can obstinately and pig-headedly carry on with some old technique if it has been proved to be contrary to what is really substantially the whole of informed medical opinion. (ii) When a doctor dealing with a sick man strongly believed that the only hope of cure was submission to a particular therapy, he could not be criticized if, believing the danger involved in the treatment to be minimal, did not stress them to the patient. (iii) In order to recover damages for failure to give warning the plaintiff must show not only that the failure was negligent but also that if he had been warned he would not have consented to the treatment.

In Hunter v. Hanley,22 a Scottish case, Lord President Clyde held: In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men, nor because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care.

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He also laid down the following requirements to be established by a patient to fasten liability on the ground of want of care or negligence on the part of the doctor: To establish liability by a doctor where deviation from normal practice is alleged, three facts require to be established. First of all it must be proved that there is a usual and normal practice; secondly it must be proved that the defender has not adopted that practice; and thirdly (and this is of crucial importance) it must be established that the course the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care.

In Sidaway v. Bethlem Royal Hospital Governors and Ors,23 the House of Lords, per majority, adopted the Bolam test as the measure of doctor’s duty to disclose information about the potential consequences and risks of proposed medical treatment. In that case the defendant, a surgeon, warned the plaintiff of the possibility of disturbing a nerve root while advising an operation on the spinal column to relieve shoulder and neck pain. He did not, however, mention the possibility of damage to the spinal cord.Though the operation was performed without negligence, the plaintiff sustained damage to the spinal cord resulting in partial paralysis. The plaintiff alleged that defendant was negligent in failing to inform her about the risk, and that had she known the true position, she would not have accepted the treatment. The trial judge and the Court of Appeal applied the Bolam test and concluded that in not informing the plaintiff of the risk of damage to spinal cord, the defendant had acted in accordance with a practice accepted as proper by a responsible body of medical opinion. Consequently, the claim for damages was rejected.The House of Lords upheld the decision of the Court of Appeal that the doctrine of informed consent based on full disclosure of all the facts to the patient was not the appropriate test of liability for negligence under English law. The majority were of the view that the test of liability in respect of the doctor’s duty to warn his patient of the risks inherent in treatment recommended by him was the same as the test applicable to diagnosis and treatment, namely, that the doctor was required to act in accordance with the practice accepted at the time as proper by a responsible body of medical opinion. Lord Diplock stated: In English jurisprudence the doctor’s relationship with his patient which gives rise to the normal duty of care to exercise his skill and judgment to improve the patient’s health in any particular respect in

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which the patient has sought his aid has hit her to be treated as a single comprehensive duty covering all the ways in which a doctor is called on to exercise his skill and judgment in the improvement of the physical or mental condition of the patient for which his services either as a general practitioner or as a specialist have been engaged. This general duty is not subject to dissection into a number of component parts to which different criteria of what satisfy the duty of care apply, such as diagnosis, treatment and advice (including warning of any risks of something going wrong however skillfully the treatment advised is carried out). The Bolam case itself embraced failure to advise the patient of the risk involved in the electric shock treatment as one of the allegations of negligence against the surgeon as well as negligence in the actual carrying out of treatment in which that risk did result in injury to the patient. The same criteria were applied to both these aspects of the surgeon’s duty of care. In modern medicine and surgery such dissection of the various things a doctor has to do in the exercise of his whole duty of care owed to his patient is neither legally meaningful nor medically practicable....To decide what risks the existence of which a patient should be voluntarily warned and the terms in which such warning, if any, should be given, having regard to the effect that the warning may have, is as much an exercise of professional skill and judgment as any other part of the doctor’s comprehensive duty of care to the individual patient, and expert medical evidence on this matter should be treated in just the same way. The Bolam test should be applied.

Lord Bridge stated: I recognize the logical force of the Canterbury doctrine, proceeding from the premise that the patient’s right to make his own decision must at all costs be safeguarded against the kind of medical paternalism which assumes that ‘doctor knows best’. But, with all respect, I regard the doctrine as quite impractical in application for three principal reasons. First, it gives insufficient weight to the realities of the doctor/patient relationship. A very wide variety of factors must enter into a doctor’s clinical judgment not only as to what treatment is appropriate for a particular patient, but also as to how best to communicate to the patient the significant factors necessary to enable the patient to make an informed decision whether to undergo the treatment. The doctor cannot set out to educate the patient to his own standard of medical knowledge of all the relevant factors involved. He may take the view, certainly with some patients that the very fact of his volunteering, without being asked, information of some remote risk involved in the treatment proposed,

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even though he described it as remote, may lead to that risk assuming an undue significance in the patient’s calculations. Second, it would seem to me quite unrealistic in any medical negligence action to confine the expert medical evidence to an explanation of the primary medical factors involved and to deny the court the benefit of evidence of medical opinion and practice on the particular issue of disclosure which is under consideration. Third, the objective test which Canterbury propounds seems to me to be so imprecise as to be almost meaningless. If it is to be left to individual judges to decide for themselves what ‘a reasonable person in the patient’s position’ would consider a risk of sufficient significance that he should be told about it, the outcome of litigation in this field is likely to be quite unpredictable.

Lord Bridge, however, made it clear that when questioned specifically by the patient about the risks involved in a particular treatment proposed, the doctor’s duty is to answer truthfully and as fully as the questioner requires. He further held that a remote risk of damage (at 1 or 2 per cent) need not be disclosed, but if the risk of damage is substantial (at least 10 per cent), it may have to be disclosed. Lord Scarman, in minority, was inclined to adopt the more stringent test laid down in Canterbury. Bringing out the distinction between the American doctrine of informed consent and the British practice, the Supreme Court has observed in Kohli24 that in India, the Bolam test has broadly been accepted as the general rule by pointing out to three earlier cases. In Achutrao Haribhau Khodwa v. State of Maharastra25, it had been held: The skill of medical practitioners differs from doctor to doctor.The nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession and the Court finds that he has attended on the patient with due care skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence.... In cases where the doctors act carelessly and in a manner which is not expected of a medical practitioner, then in such a case an action in torts would be maintainable.

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In Vinitha Ashok v. Lakshmi Hospital,26 the Supreme Court after referring to Bolam, Sidaway and Achutrao, clarified: A doctor will be liable for negligence in respect of diagnosis and treatment in spite of a body of professional opinion approving his conduct where it has not been established to the court’s satisfaction that such opinion relied on is reasonable or responsible. If it can be demonstrated that the professional opinion is not capable of withstanding the logical analysis, the court would be entitled to hold that the body of opinion is not reasonable or responsible.

In Indian Medical Association v. V.P. Shantha27 the Supreme Court held: The approach of the courts is to require that professional men should possess a certain minimum degree of competence and that they should exercise reasonable care in the discharge of their duties. In general, a professional man owes to his client a duty in tort as well as in contract to exercise reasonable care in giving advice or performing services.

Neither Achutrao nor Vinitha Ashok referred to the American view expressed in Canterbury.

Indian Conditions That Dictate Different Considerations The Supreme Court in Kohli justified the application of the Bolam test as the standard for anchoring liability on a doctor as regards a literate lady patient by pointing to the situation of lesser endowed individuals in terms of education and financial resources. The Court found the condition of illiteracy and poverty as contributing to the overly implicit faith in the doctor’s judgment as regards the treatment regimen without so much worrying about of being fully informed about the nature of risk involved in the treatment or the alternatives available to the patient.The Court said: The poor and needy face a hostile medical environment—inadequacy in the number of hospitals and beds, non-availability of adequate treatment facilities, utter lack of qualitative treatment, corruption, callousness and apathy. Many poor patients with serious ailments (e.g. heart patients and cancer patients) have to wait for months for their turn even for diagnosis, and due to limited treatment facilities, many die even before their turn comes for treatment.What choice do these poor patients have? Any treatment of whatever degree is a boon or a favour, for them.

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The stark reality is that for a vast majority in the country, the concepts of informed consent or any form of consent, and choice in treatment, have no meaning or relevance.

The limited resources for costly medicines or investigation procedures in government and charitable hospitals are the further impeding factors for offering viable treatment alternatives to a patient. On the other hand, the treatment costs in private hospitals have risen sky high. There is a lurking suspicion whether all costly investigations are foisted on patients only for commercial profit of the hospital managements that have invested large sums in infrastructure and who hope to reover their costs by hefty billing. Even providing easy access to courts through the Consumer Protection Act for consumer redressals have not helped the patients’ cause in full measure. Doctors themselves are over-protective and adopt to defensive medicine—by relying more on investigation results than their own clinical disagnostic skills.

Effect of Failure to Secure Consent If the physician fails to obtain consent before treatment, it will not always result in commission of the offence of battery or assault. As stated above, the patient that goes to a doctor holds himself open to examination by the physician. It is perhaps never merely a clinical examination that is the cause for complaint. It is the regimen of treatment through drug administration, subjecting a patient to investigative procedures or surgical interventions, or failure to inform about the risks in any of the above procedures that constitutes the central theme for the imperatives of consent. Mere failure to inform the risks of the procedure for treatment or the prognosis is not a valid cause for legal action. To prevail against a physician for lack of informed consent, a patient must show the following: an undisclosed risk has materialized; the undisclosed risk must harm the patient; and if the risk had been disclosed, the patient would have refused treatment. The probability and magnitude of those risks may be matters of medical judgment beyond the knowledge of the lay person, and medical expert testimony must also be presented to establish the significant risks that should have been disclosed to support the plaintiff ’s claim. Requiring expert medical testimony essentially reduces medical informed consent to the practices of other physicians in that locale,

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that is, standard medical practice, some would feel, to the detriment of patient autonomy.28 An emergency situation is also an exception to the general rule requiring a patient’s prior consent. The delivery of medical services is rendered lawful in such circumstances either on the rationale that the doctor has implied consent from the patient to give emergency aid or, more accurately, on the rationale that the doctor is privileged by reason of necessity in giving the aid and is not to be held liable for so doing. On either basis, in an emergency, the law sets aside the requirement of consent on the assumption that the patient, as a reasonable person, would want emergency aid to be rendered if she were capable of giving instructions.

Medical Paternalism The legal climate favouring physicians in matters of informed consent reflects ‘medical paternalism’, also known as the ‘beneficence model’ of medical practice. This is synonymous to a ‘doctor knows best’ situation in which a ‘parental-like decision by a professional overrides an autonomous decision by a patient’, with the purpose of providing medical benefits to the patient. Goldman29 defines paternalism ‘as the overriding or restricting of rights or freedoms of individuals for their own good’. Justification for medical paternalism is based on the premise that the lay public is unable to comprehend the complexities of modern medicine, and that those with adequate education, that is, physicians, should make medical decisions for all patients. This belief pervades the tort system and government public health policy, for example, compulsory vaccination procedures.30 Contemporary reports of medication errors and medical malpractice illustrate the fallacy of medical paternalism, and emphasize the importance of patient autonomy as well as the right to refuse medical care. Medical paternalism assumes that current medical practices benefit everyone, but ignores how medical procedures have changed over the years. Each generation of physicians has believed that their medical practices were best, forgetting that physicians who lived before them held similar views about their own practices. History is replete with examples of drugs and medical procedures found to be ineffective or harmful, but which were thought of at the time to be helpful or even necessary.

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Right Not to Be Treated The right of self-determination, which underlies the doctrine of informed consent, also obviously encompasses the right to refuse medical treatment. A competent adult is generally entitled to reject a specific treatment or all treatment, or to select an alternate form of treatment, even if the decision may entail risks as serious as death and may appear mistaken in the eyes of the medical profession or of the community. Regardless of the doctor’s opinion, it is the patient who has the final say on whether to undergo the treatment.The doctrine of informed consent is plainly intended to ensure the freedom of individuals to make choices concerning their medical care. For this freedom to be meaningful, people must have the right to make choices that accord with their own values, regardless of how unwise or foolish those choices may appear to others. In Nancy B. v. Hotel-Dieu de Quebec,31 the plaintiff, aged 25, had suffered for two-and-a half years from Guillain-Barre syndrome, an incurable neurological disorder that left her incapable of movement. She could breathe only with the assistance of a respirator. With it she could live a long time; without it her life would be brief. Her intellectual capacity and mental competence were unaffected. To establish her right to refuse further treatment, including the continued use of the respirator, she commenced an action for an injunction against the hospital and her physician to require them to comply with her decision. The hospital entered an appearance but did not contest the claim. Her physician did not appear. The judge, of his own motion, made the attorney-general of Quebec a party. All parties were represented at the hearing. The attorney-general filed an appearance and intervention. The Supreme Court of Quebec held that the plaintiff was entitled to the injunction sought and permission should be given to her physician to cease treatment with the respirator at a time chosen by the plaintiff. In Malette v. Shulman32 Plaintiff, 57 years old, was rushed while unconscious by ambulance to hospital.The patient had a card that identified her as a Jehovah’s witness and on which she requested, on basis of her religious convictions, that she be given no blood transfusions under any circumstances. The doctor administered transfusions to her. She brought an action for assault and battery. At trial and on appeal,33 the plaintiff was declared entitled to $ 20,000 in damages. It was held that the doctor tortiously violated the patient’s rights over her

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own body by acting contrary to Jehovah’s witness card and administering blood transfusions that were not authorized. The doctor’s honest and even justifiable belief that treatment was medically essential did not serve to relieve him from liability for battery resulting from his intentional and unauthorized conduct. The judge said: if the objection has its basis in religion, it is more apt to crystallize in life threatening situations. The doctrine of informed consent does not extend to informed refusal.The written direction contained in the card was not properly disregarded on the basis that circumstances prohibited verification of that decision as an informed choice. The card constituted a valid restriction of Dr Shulman’s right to treat the patient and the administration of blood by Dr Shulman did constitute battery.

If a treatment is refused while a patient is competent, this stands even in cases when the patient later becomes mentally ill and becomes incapable of giving consent to a particular treatment. It was held by Court of Appeal for Ontario in Fleming v. Reid34 that neither the Welfare Board nor a court exercising jurisdiction under patria parens jurisdiction will have right to overrule the decision taken by a patient when competent. This decision was rendered in the case of appellants who were involuntary psychiatric patients suffering from schizophrenia.The respondent, their attending physician, determined that they were not competent to consent to psychiatric treatment, and proposed to treat them with neuroleptic drugs (which control or minimize psychotic episodes or symptoms associated with schizophrenia for many, but not all, patients and which have significant and unpredictable harmful side effects). While competent, the appellants had expressed the desire not to take the drugs. The official guardian was appointed pursuant to Section 1a(1) of the Mental Health Act as the appellants’ substitute decision-maker. An incompetent patient’s substitute decision-maker is obliged by Section 1a(6) of the act to give or refuse consent to psychiatric treatment in accordance with the wishes of the patient that have been expressed while competent. The official guardian, pursuant to Section 1a(6), refused to consent to the proposed treatment. The respondent applied under Section 35a(1) of the act to the review board for an order authorizing the treatment.35 The review board granted orders authorizing the administration of the drugs to the appellants on the basis that such treatment was in the appellants’ best interests. The decision was reversed by the Court of Appeal on the reasoning

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that in common law, every competent adult has the right to be free from unwanted medical treatment. A patient may specify in advance his refusal to consent to treatment in anticipation of circumstances wherein he may be unconscious or otherwise incapacitated, and thus be unable to contemporaneously express his wishes about a particular form of medical treatment. A doctor is not free to disregard such advance instructions, even in an emergency.These traditional common law principles extend to mentally competent patients in psychiatric facilities.The common law right to determine what shall be done with one’s own body and the constitutional right to security of the person can be treated as co-extensive. PERSONS UNDER DISABILITY

Evidence of Minority and Mental Ill-health Minority by virtue of age and mental ill-health (specifically, the inability to understand and reason) rob the subjects’ capacity for consent to medical examination or treatment. In a way, these two categories constitute the exceptions for normative requirement of consent from the patients. In both civil and criminal jurisdictions, including matrimonial cases, evidence may have to be collected about whether a person falls within the excepted category, and if they do, whether there is a competent person to signify consent. If the principal enquiry is whether a person is a minor or mentally afflicted, the relevant finding may have to be given by medical personnel by subjecting the individual to some medical tests. Objections may be raised on the ground that no one could be compelled to undergo the test due to constitutional guarantees of the right of privacy and the principle of autonomy that we have already seen. The dilemma is best resolved by balancing of interests between the rights of the patient, who may be a minor or a mentally ill person, and what has to be elicited in the public interest, even in the face of express refusal to consent. In criminal cases, proof of the age of a victim is essential in cases like rape, where even consensual sexual intercourse with a girl less than the age of 18 constitutes an offence. Special provisions are made under the Juvenile Justice Act and the Borstal Schools Act for setting up different adjudicatory bodies and different confinement rules for housing a person found guilty of the offence.

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Minors

effect of parent’s refusal for treatment Minority of the patient takes away the legal competence to contract; for the same reason minors cannot bind themselves by consent to treatment. The father, who is the natural guardian of the child till the latter reaches the age of eighteen, is the competent person to give consent. In the absence of the father, the mother is the lawful guardian. Absence of consent of the guardian will have the same consequences as the absence of consent of the patient. If the doctor undertakes treatment in such a situation he will be liable in damages for trespass to the person and may be guilty of a criminal assault.36 There is always this important assumption that the guardian will unfailingly ensure that the child receives proper treatment. Because the parents have rights and powers to perform their duties and responsibilities to the child in its best interests, ‘the common law has never treated such rights as sovereign or beyond review and control.’37

parental consent of contraceptive advice or abortion The Medical Termination of Pregnancy Act gives the right to the guardian to take a decision on abortion under the circumstances permitted by law.38 There are no specific provisions of law that give guidelines to the medical professionals to counsel a minor girl about contraceptives. With the increasing possibility of premarital sex in a more permissive society, as a measure of health policy for safe sex, and as a part of awareness campaign for AIDS prevention, the Indian legislative bodies will probably be impelled to specifically empower the medical personnel to give advice on contraception and immunize them against actions for failure to secure consent from parents. In the Indian social context, the parent’s role will be equally decisive in such instances. In the UK, by Section 5(1)(b) of the National Health Service Act, 1977 (replacing earlier provisions), the secretary of state was under a duty to arrange, to such extent as he considered necessary, for the giving of advice on contraception, the medical examination of those seeking such advice, their treatment, and the supply of contraceptive substances and appliances. No limit on the age of the persons to whom such advice or treatment might be given was prescribed. In 1974, the DHSS issued a

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memorandum of guidance on the family planning service. Section G of the memorandum related to children under sixteen and, as amended in 1980, stated that special care was needed not to undermine parental authority, and it was hoped that a doctor or other professional worker would always seek to persuade the child to involve the parent, and would proceed from the assumption that it would be most unusual to provide advice about contraception without parental consent. In Gillick v. West Norfolk and Wisbech Area Health Authority and Another,39 the plaintiff, who was the mother of five daughters, wrote to her local health authority seeking an assurance that they would not give contraceptive or abortion treatment to her daughters without her knowledge and consent. The authority replied that it would be most unusual for advice about contraception to be given without parental consent and that, while the authority expected their doctors to work within the DHSS guidelines, the final decision must be that the doctor. As a result of that reply the mother wrote a letter dated 3 March 1981 in which she forbade the medical staff employed by the area health authority to give any contraception or abortion treatment to her daughters while under sixteen without her consent. This did not produce a change of attitude by the authority and on 5 August 1982 the mother commenced proceedings by a specially endorsed writ claiming two declarations: (1) as against the area health authority and the DHSS, that on its true consideration the memorandum of guidance had no authority in law and gave advice that was unlawful and wrong and which adversely affected her rights and duties as a parent; and (2) as against the area health authority alone, that no doctor or other professional person employed by them might give any contraception or abortion advice or treatment to any of her children below the age of sixteen without her prior knowledge and consent. The mother’s purpose in bringing the action was to establish the extent of parental rights and duties in respect of girls under 16. There was no suggestion that any of her daughters needed such advice. Her contention was that the provision of contraceptive advice and treatment to a girl under sixteen constituted criminal conduct or was so analogous to it as to be contrary to public policy. The House of Lords held that statute and case law recognized the existence of parental rights but also provided that those rights were subject to the guiding principle that where the court had before it a question as to the care and upbringing of

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a child it must treat the welfare of the child as paramount. Parental rights to control a child derived from parental duty and existed for the protection of the child. A parent did not have the right completely to control the child until the child attained the age of 18. Parental control yielded to the child’s right to make their own decisions when they reached a sufficient level of understanding and intelligence to be capable of making up their own mind. Parental authority was, therefore, a dwindling right.The duration of parental rights could not be found by reference to the child attaining any particular age, but upon a judgment of what was best for the welfare of the particular child. Consequently, the parental right to determine whether or not a child under 16 would have medical treatment terminated if and when the child achieved a sufficient understanding and intelligence to enable them to understand fully what was proposed. But in the overwhelming majority of cases the best judges of a child’s welfare were the parents, and normally any important medical treatment would only be carried out with the parents’ approval, and that was why it would and should be ‘most unusual’ for a doctor to give contraceptive advice and treatment to a child without the knowledge and consent of the parents.There might be exceptional circumstances in which a doctor was a better judge than the parent of the medical advice and treatment that would conduce to a girl’s welfare, and where it might be desirable to entrust the doctor with discretion to give contraceptive advice and treatment without the consent or knowledge of the parents. An emergency, parental neglect or abandonment, and the inability to find the parent were examples of exceptional situations justifying a doctor treating a child without parental knowledge and consent. Further, Section 5(1)(b) of the National Health Service Act, 1977 (and other provisions), showed that the Parliament regarded advice and treatment on contraception as essentially medical matters. Those statutory provisions placed no limit on the age of the persons to whom such advice or treatment might be given. Accordingly, the memorandum of guidance issued by the department was not unlawful. Further, the guidance could be followed without involving the doctor in any infringement of parental rights. As a child under 16 had the capacity to consent to medical treatment provided they were capable of understanding what was proposed and capable of expressing their own wishes, a girl under 16 of sufficient maturity and intelligence could give valid consent to contraceptive advice and treatment.

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In India, a person aged less than 18 is a ‘child’ under Protection of Children from Sexual Offences Act, 2012. Pregnancy after sex with a person other than the spouse of a child will be taken as arising out of the offence of ‘rape’, even if there was consent, as per the amended provision of the IPC by Act 13 of 2013. Pregnancy by rape itself is a justification for medical termination of pregnancy under the MTP Act.

neo-natal circumcision The medical community views with favour the practice of circumcision for what they perceive as benefits of preventing conditions like phimosis, penile cancer, urinary tract infections, and promoting genital hygiene for male children.40 It is, however, doubtful if informed consent is obtained from the parents before the surgical procedure is undertaken at the time of delivery of the child. It seems more like a regular formality of taking signatures in several forms at the time of admission of the pregnant woman for delivery. Encouraging a patient to undergo a procedure that has no medical benefit is presumptively inconsistent with medical ethics. Prophylactic surgery on an informant through surrogate consent for possible medical benefits is highly suspect. Surrogates are under a legal obligation to decide not on the basis of how they want the patient to be treated, but rather on the basis of how the patient would choose to be treated if they were capable of choosing.41 As a general rule, the more a surrogate seems influenced in her decision-making by her personal values and preferences, the less willing a physician should be to accept the surrogate’s authorization for a procedure.42 Cases that involve female circumcisionn are rare.43 It is genital infibulation, often called pharaonic circumcision in Africa, and includes a clitoridectomy as well as the excision of the labia minora and as much as possible of the labia majora. The second type of damage resulting from female circumcision is that both clitoridectomy and pharaonic circumcision procedures greatly reduce and often remove totally the woman’s ability to enjoy sex. But there are other religious-cultural purposes attributed to female circumcision. Medical organizations in the developed world have tended to follow the lead of UNICEF in 1980 and WHO in 1984 by advocating the abolition of female circumcision

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as unnecessary mutilation that violates the bioethical principle to do no harm.44

reporting child abuse It is possible that a child suffers foetal abnormality that may result in mental retardation after birth due to drug abuse by the motherwhile pregnant.There is no law in India that requires reporting of such abuse for effective treatment of the mother. In the US, even laws that protect confidentiality make exceptions for child abuse cases.The Child Abuse Prevention and Treatment Act45 requires confidentiality of child abuse records to protect the rights of the parents and the child in civil but not in criminal proceedings. Federal funding statutes require states to make unauthorized disclosure of these records a criminal offence. However, states are permitted to except disclosures when requested by the following: (1) agencies or organizations, including a designated multidisciplinary case consultation team, that are legally mandated to receive and investigate reports of known and suspected child abuse and neglect; (2) courts (which may subpoena records in some restricted cases); (3) grand juries; (4) a properly constituted authority investigating a report of known or suspected child abuse or neglect or providing services to a child or family which is the subject of a report; (5) a physician who has before them a child that they suspect is the victim of abuse or neglect; (6) anyone legally authorized to place a child in protective custody and who needs the information to determine whether to do so; (7) agencies with authority to diagnose or treat a reported child; (8) anyone who is the subject of a report (the identity of the reported cannot be revealed if it would endanger the life or safety of the reported; most states protect this confidential disclosure); (9) the child, attorney, or guardian ad litem for the child; (10) State or local officials responsible for administration of the CPS caseworker or for oversight of the enabling or appropriating legislation; (11) individuals, agencies, or organizations conducting bona fide research, with no identifying information made available;

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(12) the original reporter, who may be provided with feedback or a summary of the outcome of the report; (13) agencies or persons conducting background screening for child-related employment; and (14) the DHHS and the Comptroller of the US or any of their representatives (45 CFR 1340.14). Confidentiality normally protects the patient or client from any unauthorized disclosure of information. However, all states in the US now have mandatory child abuse reporting laws that abrogate the professional–patient or client privilege. Mandated reporters are protected from civil or criminal liability for any report made in good faith. In many states, this immunity extends to participation in judicial proceedings arising from the reports. It is also important to note that individuals providing treatment services under programmes funded through the Federal Alcohol and Drug Rehabilitation Act are required to report suspicions of child abuse pursuant to state child abuse reporting laws.46

In Case of Mentally-ill Patient

determination of ill health When the state of mental health is the cause for action, such as when it affords the spouse a ground for dissolution of marriage, although the law does not itself contain specific provisions, the person against whom the allegation is made may be compelled to undergo medical examination. For example, the Hindu Marriage Act does not contain any express provision empowering the court to issue a direction upon a party to a matrimonial proceedings to compel them to be submitted to a medical examination but a three-member bench (V.N. Khare CJ, S.B. Sinha, and A.R. Lakshmanan, JJ ) of the Supreme Court held in Sharda v. Dharmpal,47 that it did not preclude a court from passing such an order. The Court found the power as available under the proceedings of Order 32, Rule 15 of the CPC for determination of the mental illness of a person and the provisions under Section 41 of the Indian Lunacy Act (now repealed) to examine a ‘lunatic’ for the purpose of determination of their competence as a witness. Further, the court said it had the power to issue appropriate direction for protection of

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the human rights of mentally ill persons and to see to it that a person suffering from mental illness gets adequate protection in terms of the Mental Health Act. After all, the primary duty of a court is to see that the truth is arrived at. It is axiomatic that a party to a civil litigation is not entitled to constitutional protection under Article 20 of the Constitution of India. Thus, although the civil court may not have any specific provisions in the CPC and the Evidence Act, it has an inherent power in terms of Section 151 of the CPC to pass all orders for doing complete justice to the parties to the suit. In all such matrimonial cases where divorce is sought, say on the ground of impotency, schizophrenia, etc., normally without involving a medical examination, it would be difficult to arrive at a conclusion as to whether the allegation made by a spouse against the other spouses seeking divorce on such a ground is correct. In order to substantiate such an allegation, the petitioner would always insist on medical examination. If respondent avoids such medical examination on the ground that it violates their right to privacy or right to personal liberty as enshrined under Article 21 of the Constitution of India, then it may in most of such cases become impossible to arrive at a conclusion. It may render the very grounds on which divorce is permissible nugatory. Therefore, when there is no right to privacy specifically conferred by Article 21 of the Constitution of India and with the extensive interpretation of the phrase ‘personal liberty’ as inclusive of this right, it cannot be treated as absolute. What is emphasized is that some limitations on this right have to be imposed, particularly where two competing interests clash.Where the legislature has conferred a right upon his spouse to seek divorce on such grounds, it would be the right of that spouse that comes into conflict with the so-called right to privacy of the respondent to compel a person to medical examination. Thus the court has to reconcile these competing interests by balancing them to secure justice. The Supreme Court concluded: (1) A matrimonial court has the power to order a person to undergo medical test. (2) Passing of such an order by the court would not be in violation of the right to personal liberty under Article 20(3) of the Indian Constitution. (3) However, the court should exercise such a power if the applicant has a strong prima facie case and there is sufficient material

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before it. If, despite the order of the court, the respondent refuses to submit to a medical examination, the court will be entitled to draw an adverse inference against them.

mental health act, 1987 Objects and Reasons The Mental Health Act, 1987, replaced the Indian Lunacy Act, 1912, as the latter had become outmoded. The very expression ‘lunacy’ is regarded as offensive, and the newer act took stock of the changed attitudes towards people afflicted with mental illness, recognizing that no stigma should be attached to such illness, as it is curable, especially when it is diagnosed at an early stage. The act states in its preamble that the mentally ill are to be treated like any other sick individuals in accordance with the new approach. The definition of mentally ill excludes from the definition a person of mental disorder other than mental retardation.48 The act seeks (1) to regulate admission to psychiatric hospitals or psychiatric nursing homes of mentally ill-persons who do not have sufficient understanding to seek treatment on a voluntary basis, and to protect the rights of such persons while being detained; (2) to protect society from the presence of mentally ill persons who have become or might become a danger or nuisance to others; (3) to protect citizens from being detained in psychiatric hospitals or psychiatric nursing homes without sufficient cause; (4) to regulate responsibility for maintenance charges of mentally ill persons who are admitted to psychiatric hospitals or psychiatric nursing homes; (5) to provide facilities for establishing guardianship or custody of mentally ill persons who are incapable of managing their own affairs; (6) to provide for the establishment of a Central Authority and State Authorities for Mental Health Services; (7) to regulate the powers of the Government for establishing, licensing and controlling psychiatric hospitals and psychiatric nursing homes for mentally ill persons; and

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(8) to provide for legal aid to mentally ill persons at state expense in certain cases. The act enables an inspecting officer to enter any psychiatric hospital and interview in private any patient receiving treatment and care for the purpose of enquiring into any complaint made by or on that patient’s treatment and care. The hospital may be de-licenced if it is reported that the proper medical care is not given.49 Voluntary Admission and Discharge of the Patient Any individuals (not including a minor) who considers himself mentally ill and wants to be admitted to any psychiatric nursing home for treatment may request the medical officer in charge for being to be admitted as a voluntary patient.50 Where the guardian of a minor believes that it is mentally ill and wants to admit it in any psychiatric hospital or psychiatric nursing home for treatment, he may request the medical officer-in-charge to admit it as a voluntary patient.51 The medical officer-in-charge shall make such inquiry as he may deem fit within a period not exceeding 24, and if satisfied that the applicant or, as the case may be, the minor requires treatment in the psychiatric hospital or psychiatric nursing home, that person may be admitted as a voluntary patient.52 The patient shall be discharged if a request is made either by the adult patient or by the guardian if the patient is a minor.53 A minor patient who attains majority shall be informed of this and that unless a request for their continuance as an in-patient is made by them within a period of one month of such intimation, they shall be discharged, and if, before the expiry of that period, no request is made to the medical officer-in-charge for continuance as an in-patient, they shall be discharged when that period expires. If the medical officerin-charge of a psychiatric hospital or psychiatric nursing home is satisfied that the discharge of a voluntary patient will not be in the patient’s interest, they shall, within 72 hours of the receipt of a request, or, if no request has been made by the voluntary patient before the expiry of the period within 72 hours of such expiry, constitute a board consisting of two medical officers and seek its opinion on whether the patient needs further treatment. If the board is of the opinion that the patient needs further treatment in the psychiatric hospital or psychiatric nursing home, the medical officer shall not discharge the

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voluntary patient but continue treatment for a period not exceeding 90 days at a time.54 Admission in Other Cases Any mentally-ill person who does not, or is unable to, express willingness for admission as a voluntary patient may be admitted and kept as an in-patient in a psychiatric nursing hospital or psychiatric nursing home on an application made by a relative or a friend of the mentally ill persons if the medical officers-in-charge are satisfied that in the interest of the mentally ill persons it is necessary so to do.55 In R.Malarvizhi v. Inspector of Police and Others,56 in a custodial fight between the wife and the brother of a person who was mentally ill, the court directed the admission of the patient to a mental hospital for treatment without any move for admission by the wife or relative, and further directed that the patient, if he became well, would be competent to decide with whom he should stay. An application for admission called a reception order may also be made by a medical officer in charge of a psychiatric hospital or psychiatric nursing home or by the husband, wife, or any other relative of the mentally-ill person.57 Where a medical officer-in-charge of a psychiatric hospital or psychiatric nursing home,in which a mentally-ill person is undergoing treatment under a temporary treatment order is satisfied that the mentally-ill person is suffering from mental disorder of such a nature and degree that his treatment in the psychiatric hospital or psychiatric nursing home is required to be continued for more than six months, or it is necessary in the interests of the health and personal safety of the mentally-ill person or for the protection of others, he shall make an application to the magistrate within whose jurisdiction the hospital is situated, and who will authorize the detention on then application that may be made by the medical officer, or the spouse of the mentally-ill person, or if there is no spouse, or if they are out of the country, by any relative, after being satisfied on the medical condition requiring detention on the basis of a medical certificate from the medical practitioner.58 Powers of a Guardian Any suitable person may be appointed as guardian for mentallyill individuals who are incapable of taking care of themselves. The order of appointment will be made either by the district court or the

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collector of the district for the benefit of the mentally-ill person.59 In Regina v. Bournewood Community and Mental health NHS Trust, Ex Parte L,60 the applicant, who was 48, was autistic and severely mentally retarded. He frequently became agitated and had a history of self-injurious behaviour. Since he was unable to speak and his level of understanding was severely limited, he was incapable of consenting to medical treatment. He was a resident for over 30 years in a mental hospital, but in 1994 went to live with paid carers whilst remaining under the care of the hospital. In 1997, he became particularly agitated at a day centre and, since his carers could not be contacted, he was taken to the accident and emergency department and then to the behavioural unit of the hospital where he had previously been an in-patient. His consultant decided that his best interests required his readmission to the unit with a view to stabilizing his condition. She deliberated over whether it was necessary to apply for an order under Section 3 of the Mental Health Act, 1983, for compulsory detention, but since he was compliant and had shown no desire to leave, she decided to admit him as an informal patient pursuant to Section 131(1) of the act. He was kept in an unlocked ward, but the consultant would have detained him compulsorily had he sought to leave. The carers took the view that the applicant was being wrongfully detained and an application was made in the high court on his behalf for judicial review, an order of habeas corpus ad subjiciendum, and damages for false imprisonment and assault. The judge held that although the act of 1983 provided a comprehensive statutory regime for those formally admitted, Section 131(1) preserved the common law jurisdiction in respect of informal patients and, since the applicant had been informally admitted and the requirements of the common law principle of necessity had been satisfied, he had not been unlawfully detained. The Court of Appeal set aside the judgment. On further appeal to the House of Lords, they observed: Parliament, in enacting the Mental Health Act 1983, had recognised that persons suffering from mental disorder who were treated for their condition as in-patients in hospital fell into two categories, those who were compulsorily and formally admitted regardless of their will under sections 2 to 5 of the Act, and those who were informally admitted under Section 131(1) of the Act; that Section 131(1) was in identical terms to, and was to be construed in the same way as, Section 5(1) of the Mental

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Health Act 1959, which had allowed the informal admission of both consenting patients and those who, without capacity to consent, had not manifested any objection, and the basis upon which a hospital was entitled to care for and treat such compliant incapacitated patients was the common law doctrine of necessity; that although the taking of the applicant to hospital could be said to have been a detention in the sense that, in the absence of justification, the tort of false imprisonment would have been committed, the decision that he should remain in hospital after his readmission under Section 131(1) did not (Lord Nolan and Lord Steyn dissenting) amount to an actual detention, since he had been placed in an unlocked ward and the possibility of lawful restraint had he sought to leave had not given rise to his detention in fact at any earlier date; that since all steps taken had been done in accordance with the trust’s duty of care to the applicant and in his best interests, to the extent that the applicant had been detained such detention had been justified by the common law doctrine of necessity; and that, accordingly, the tort of false imprisonment had not been committed against the applicant.

Abortion or Sterilization in Cases of Mental Retardation The provisions of the Medical Termination of Pregnancy Act that give the guardian the power to consent for a mentally-ill person61 cannot include a mentally retarded person, as Section 2(l) of the Mental Health Act excludes ‘mentally retarded person’ from the definition of mentally-ill person. The provisions of the National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999, makes express provisions to cover such cases.

national trust for welfare of persons with autism, cerebral palsy, mental retardation and multiple disabilities act, 1999 Section 3 describes the constitution of the National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities: With effect from such date as the Central Government may, by notification, appoint, there shall be constituted, for the purposes of this Act, a body by the name of the National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities, which shall be a body corporate by the name of aforesaid, having

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perpetual succession and a common seal, with power, subject to the provisions of this Act, to acquire, hold and dispose of property, both movable and immovable, and to contract, and shall, by the said name, sue or be sued. (2) The general superintendence, direction and management of the affairs and business of the Trust shall vest in a Board which may exercise all powers and do all acts and things which may be exercised or done by the Trust. (3) The head office of the Trust shall be at New Delhi and the Board may, with the previous approval of the Central Government, establish offices at other places in India. (4) The Board shall consist of— (a) a Chairperson to be appointed by the Central Government from amongst the persons having expertise and experience in the field of autism, cerebral palsy, mental retardation and multiple disability; (b) nine persons to be appointed in accordance with such procedure as may be prescribed from amongst the registered organisations out of which three members each shall be from voluntary organisations, associations of parents of persons with autism, cerebral palsy, mental retardation and multiple disability and from association of persons with disability: Provided that initial appointment under this clause shall be made by the Central Government by nomination; (c) eight persons not below the rank of Joint Secretary to the Government of India nominated by that Government to represent the Ministries of Departments of Social Justice and Empowerment, Women and Child Development, Health and Family Welfare, Finance, Labour, Education, Urban Affairs and Employment and Rural Employment and Poverty Alleviation, Members, ex officio; (d) three persons to be nominated by the Board representing the associations of trade, commerce and industry engaged in philanthropic activities; (e) the Chief Executive Officer, who, shall be of the rank of Joint Secretary to the Government of India, Member-Secretary, ex officio. (5) The Board may associate with itself, in such manner and for such purposes as may be determined by regulations, any person whose assistance or advice it may desire for carrying out the objects of the Trust: Provided that such person shall have a right to take part in the discussions relevant to that purpose but shall not have a right to vote at a meeting of the Board and shall not be a member for any other purpose: Provided further that the maximum number of persons so associated shall not exceed eight and so far as possible the person so associated shall belong to the registered organisation or from the professionals.

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Section 10 of the act sets out the objects of the Trust: (a) to enable and empower persons with disability to live as independently and as fully as possible within and close to the community to which they belong; (b) to strengthen facilities to provide support to persons with disability to live within their own families; (c) to extend support to registered organisations to provide need based services during the period of crisis in the family of persons with disability; (d) to deal with problems of persons with disability who do not have family support; (e) to promote measures for the care and protection of persons with disability in the event of death of their parent or guardian; (f) to evolve procedure of the appointment of guardians and trustees for persons with disability requiring such protections; (g) to facilitate the realisation of equal opportunities, protection of rights and full participation of persons with disability; and (h) to do any other act which is incidental to the aforesaid objects.

Section 13 provides for the constitution of local-level committees: (1) The Board shall constitute a local level committee for such area as may be specified by it from time to time. (2) A local level committee shall consist of— (a) an officer of the civil service of the Union or of the State, not below the rank of a District Magistrate or a District Commissioner of a district; (b) a representative of a registered organisation; and (c) a person with disability as defined in clause (t) of Section 2 of the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995 (1 of 1996). (3) A local level committee shall continue to work for a period of three years from the date of its constitution or till such time it is reconstituted by the Board. (4) A local level committee shall meet at least once in every three months or at such interval as may be necessary.

Appointment of Guardian Section 14 details the procedure for appointment of a guardian. This section requires even a parent who invokes the provisions of the act to seek for his or her own appointment as a guardian. It shall also become

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possible for an institution for such appointment. The person with disability will be assessed first to decide if they require a guardian and the purpose for which guardianship is sought. (1) A parent of a person with disability or his relative may make an application to the local level committee for appointment of any person of his choice to act as a guardian of the persons with disability. (2) Any registered organisation may make an application in the prescribed form to the local level committee for appointment of a guardian for a person with disability: Provided that no such application shall be entertained by the local level committee, unless the consent of the guardian of the disabled person is also obtained. (3) While considering the application for appointment of a guardian, the local level committee shall consider— (a) whether the person with disability needs a guardian; (b) the purposes for which the guardianship is required for person with disability. (4) The local level committee shall receive, process and decide applications received under sub-sections (1) and (2), in such manner as may be determined by regulations: Provided that while making recommendation for the appointment of a guardian, the local level committee shall provide for the obligations which are to be fulfilled by the guardian. (5) the local level committee shall send to the Board the particulars of the applications received by it and orders passed thereon at such interval as may be determined by regulations.

Section 15 sets out that every person appointed as a guardian of a person with disability under this chapter shall, wherever required, either have the care of such person of disability and his property or be responsible for the maintenance of the person with disability. When a Local Committee is Not Set Up The procedure under the act cannot avail in places where a local committee has not been set up. In cases of treatment to the classes of people governed under the act, the court will assume the role of patria parens to sanction the course of treatment. If approached for termination of pregnancy for a mentally retarded person, the court will in appropriate cases obtain the views of an expert body comprising of doctors, social workers, and psychologists before rendering a decision. In Chandigarh

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Administration v. Nemo,62 a mentally retarded person in a government-run care centre for the destitute had been raped by a staff and had become pregnant. The Chandigarh administration had approached the court for permission to terminate her pregnancy. The woman, who was admittedly a major but was assessed to have a mental maturity of only a 9-year-old girl, desired to carry the foetus to full term.The court had called for a report from the expert body, inter alia, on (1) her mental condition; (2) her physical condition and ability for self-sustenance; (3) her understanding about the distinction between the child born out of and outside wedlock as well as the social connotations attached thereto; (4) her mental and physical capacity to raise a child; (5) her perception about bringing up a child and the role of an ideal mother. Considering her mental condition, the bench ordered the termination of pregnancy, but in Suchita Srivastava v. Chandigarh Administration, the Supreme Court upturned the decision and refused permission.63 It held that people with borderline, mild, or moderate mental retardation are capable of living in normal social conditions even though they may need some supervision and assistance from time to time. A developmental delay in mental intelligence, the court cautioned, shall not be equated with mental incapacity, and the reproductive autonomy expressed by a mildly retarded person to retain the foetus and bear the child to full term shall not be trivialized. It should in fact be respected. The court directed the state-run institution where the mentally retarded person was living to provide all medical and emotional help to continue the pregnancy and bear the expenses of bringing up the child. The position in India is opposite to what exists in Australia, which recognizes parental authority as sufficient to decide on sterilization of a person of unsound mind or a minor, but would deem it desirable that sanction from court also be obtained.64 In Canada, following the decision of the Supreme Court in Re Eve65, the law appears to be that the court should never authorize a non-therapeutic sterilization of a mentally retarded person under its parens patriae jurisdiction.

Child Custody Disputes and the Mental Condition of the Parent Issues of the mental status of the competing parents in child custody battles have frequently cropped up in the US. Frequently, one party will

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seek to introduce evidence of the other party’s mental health though medical records. However, Federal common law, state common law, state statutes, and the federal rules of evidence recognize the importance of protecting confidential communication with mental health professionals by recognizing psychotherapist–patient privilege.66 Still, in such proceedings, it has been held by US courts that no privilege is absolute especially when it relates to determining the fitness of the parents to have the custody of the child. The privilege can have a serious impact on child custody and the dissolution of the marriage proceedings. In Re Matthew R.,67 it was held that such privilege if granted can seriously impact the child custody and dissolution of marriage proceedings. If the nature of the information relates directly to the well-being of the child or to the parent’s ability to adequately care for child, and the court believes the child is potentially in danger, courts are likely to admit the information despite the confidentiality. There are two competing interests involved when a court determines whether to compel discovery of a patient-litigant’s mental health records over their objection in a child custody dispute.The first involves the privacy, confidentiality and privilege expectation of both the patient and the treating mental health professional in those communications. The second involves the application of the ‘best interests of the child’ standard, which is the basis of child custody determination in virtually every jurisdiction in the US. In Zuniga v. Pierce,68 the court reconciled these competing interests by balancing them. The court stated: ‘This is necessarily so because the appropriate scope of the privilege like the privilege itself, is determined by balancing the interests protected by shielding the evidence sought with those advanced by disclosure.’ The tripartite test states that a ‘legitimate need’ must be present for the evidence to exist, the issue before the court must be relevant and material, and the moving party must demonstrate that the information to which they are seeking access ‘cannot be secured from any less intrusive source’. Allowing the court to order independent examination of a parent’s mental faculties without piercing the confidentiality of the patient–psychotherapist relationship avoids thwarting the psychotherapeutic process and allows the court to obtain all relevant evidence before it in order to make the best decision regarding the best interests of the children.

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Laznovsky v. Laznovsky69 similarly addresses the admissibility of mental health records of a parent in a child-custody proceeding. The court utilized the same balancing test used by most jurisdictions. It weighed the best interest of the child standard and the important interest in placing the child in the most safe, stable, and nurturing environment possible versus protecting confidential information revealed in the course of therapy, compromising the psychotherapist–patient privilege and a basic right to privacy. The court concluded that ‘the benefits to society of having confidential and privileged treatment available to troubled parents far outweighs the limitations placed upon the court by not having such information revealed against a parents’ wishes.’

Serious Illness That Impairs Capacity to Consent The principle of necessity to give a particular treatment even without consent may arise when the patient’s state of health would not admit of such disclosure. But this principle is restricted only to cases where the patient is temporarily incompetent (being unconscious) to permit a procedure that if delayed would result in imminent danger to the life or health of the patient. But if the patient’s illness is such that continuation of treatment is futile, whose consent should the doctor take to discontinue it? The answer seems to be that a doctor whose patient is incapable of deciding whether or not to consent to treatment is under no absolute obligation to prolong the patient’s life, regardless of the circumstances or the quality of the patient’s life. Airdale70 was a case of a 21 year-old patient, AB, in the care of the applicant health authority. He had been in a PVS state for three-and-a half years after suffering a severely crushed chest, which caused catastrophic and irreversible damage to the higher functions of his brain. He was being fed artificially and mechanically through a naso-gastric tube. The unanimous opinion of all the doctors who had examined him was that there was no hope whatsoever of recovery or improvement of any kind in his condition, and that there was no reasonable possibility of his ever emerging to a cognitive sapient state from his existing PVS state in which, although he continued to breathe unaided and his digestion continued to function, he could not see, hear, taste, smell, speak, or communicate in any way, was incapable of involuntary movement, could not feel pain and had no cognitive function. In those circumstances,

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the consultant geriatrician at the hospital where AB was being cared for reached the clear conclusion that it would be appropriate to cease further treatment, which would involve withdrawing the artificial feeding through the naso-gastric tube, and declining antibiotic treatment if and when infection appeared. If such a course were adopted, the lack of sustenance would bring to an end the physical functioning of AB’s body within one to two weeks, and he would die by starvation. The consultant’s view was supported by other distinguished medical experts. The health authority responsible for AB’s care applied to the court for declarations that it and the responsible physicians could lawfully discontinue all life-sustaining treatment and medical support measures designed to keep AB alive, including the termination of ventilation, nutrition, and hydration by artificial means, and that they could lawfully discontinue and thereafter refuse medical treatment to him except for the sole purpose of enabling him to end his life and die peacefully with the greatest dignity and the least pain, suffering, and distress. The plaintiffs’ action was supported by the parents and family of AB. The judge granted the declarations sought. The official solicitor appealed to the Court of Appeal, which affirmed the judge’s decision. The official solicitor then appealed to the House of Lords, contending that the withdrawal of life support was both a breach of the doctor’s duty to care for his patient, indefinitely if need be, and a criminal act. The House of Lords dismissed the appeal and held that medical treatment, including artificial feeding and the administration of antibiotic drugs, could lawfully be withheld from an insensate patient with no hope of recovery when it is known that the result would be that the patient would die shortly thereafter, provided responsible and competent medical opinion is of the view that it would be in the patient’s best interests not to prolong his life by continuing that form of medical treatment because it is futile and would not confer any benefit on him. Furthermore, discontinuance of life support by the withdrawal of artificial feeding or other means of support does not amount to a criminal act, because if the continuance of an intrusive life support system is not in the patient’s best interests, the doctor is no longer under a duty to maintain the patient’s life, but is simply allowing his patient to die of his pre-existing condition, and his death would be regarded in law as exclusively caused by the injury or disease to which his condition is attributable.

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In R v. Human Fertilisation and Embryology Authority, ex p Blood,71at the applicant’s request, samples of sperm were taken from her husband prior to his death while he was in coma. The subsequent storage of the sperm was technically unlawful under Human Fertilisation and Embryology Act, 1990, in that it was without the husband’s consent; for the same reason medical treatment of the applicant with the sperm was held to be unlawful.The law cannot be different in India, for there is no law that makes the body or part of the body to be the property of the person unless he had authorized the removal under the provisions of the Organ Transplantation Act72 before his death. In the absence of consent, a person who is authorized to take the custody of the body could give such consent for therapeutic purposes. It is unlikely that a spouse desiring pregnancy through stored semen could be interpreted as needing it for therapeutic or research purposes.

procedure to be adopted by a high court In Aruna Shanbaug v. Union of India,73 after setting out the US courts’ views authorizing the guardian’s consent for termination of life support, held in the light of the extant Indian law74 making illegal the attempt to commit suicide, preferred the UK view in Airedale NHS Trust Respondents and Bland Appellant75 as a more apposite view to follow for a patient in a PVS state. A journalist applied to the court in alleged patient interest that tubular feeding be stopped and the patient be allowed to die a dignified death. Taking into account the report of the doctor and the evidence relating to the care given by the hospital staff, the court held that the appropriate person who could represent the patient was the hospital itself, and proceeded to set down the procedure to be followed in such situations, which is to approach the jurisdictional high court for appropriate directions under Article 226 of the Constitution: (1) When such an application is filed the Chief Justice of the High Court should forthwith constitute a Bench of at least two Judges who should decide to grant approval or not. Before doing so the Bench should seek the opinion of a committee of three reputed doctors to be nominated by the Bench after consulting such medical authorities/medical practitioners as it may deem fit. Preferably one of the three doctors should be a neurologist, one should be a

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psychiatrist, and the third a physician. For this purpose a panel of doctors in every city may be prepared by the High Court in consultation with the State Government/Union Territory and their fees for this purpose may be fixed. The committee of three doctors nominated by the Bench should carefully examine the patient and also consult the record of the patient as well as taking the views of the hospital staff and submit its report to the High Court Bench. (2) Simultaneously with appointing the committee of doctors, the High Court Bench shall also issue notice to the State and close relatives e.g. parents, spouse, brothers/sisters etc. of the patient, and in their absence his/her next friend, and supply a copy of the report of the doctor’s committee to them as soon as it is available. After hearing them, the High Court bench should give its verdict. The above procedure should be followed all over India until Parliament makes legislation on this subject. (3) The High Court should give its decision speedily at the earliest, since delay in the matter may result in causing great mental agony to the relatives and persons close to the patient.

The high court should give its decision assigning specific reasons in accordance with the principle of the ‘best interest of the patient’ laid down by the House of Lords in Airedale’s case. The views of the near relatives and committee of doctors should be given due weight by the high court before pronouncing a final verdict, which shall not be summary in nature.

Patients under Anaesthesia Suppose that a person is not under disability when consent for a particular surgical procedure is obtained. In the course of that surgery, some complication develops requiring a further surgical procedure while the patient is still under anesthesia. In this situation, the doctor cannot undertake any other surgery for which consent has not been obtained. It would be a different thing altogether if the surgeon undertakes some measure to save the patient without consent. Emergency situations are always an exception for treatment without consent. If it is not an emergency, but the doctor adopts a procedure not originally contemplated, in regimes where ‘informed consent’ is the norm, the doctor will be liable for battery as well as for negligence. In regimes where the degree of care is a part of standard medical practice, the

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doctor may still be liable for action for damages for treatment without consent, although the subsequent surgical procedure could have been perceived as a possible risk but not communicated to the patient. In Samira Kohli v. Dr Prabha Manchanda and Anr,76 the appellant had filed a complaint before the state consumer disputes redressal commission seeking compensation for loss of reproductive organs, irreversible permanent damage, pain, emotional stress and trauma, decline in health, and increasing vulnerability to health hazards.The appellantpatient charged that the respondent falsely invented a case that appellant was suffering from endometriosis to explain the unauthorized and unwarranted removal of uterus and ovaries, and such radical surgery was either to cover-up negligence in conducting diagnostic laparoscopy or to claim a higher fee. The court found that unless the unauthorized additional or further procedure was necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay the further procedure until the patient regains consciousness, a doctor cannot perform such a procedure without the consent of the patient. There was evidently no emergency or life-threatening situation during the laparoscopy and when the consent form referred to diagnostic and operative laparoscopy and ‘laparotomy if needed’, it did not amount to consent for OH-BSO surgery removing the uterus, ovaries, and fallopian tubes. It was a clear case where no consent had been given by the appellant for conducting hysterectomy and bilateral salpingo-oopherectomy. It was no defence for the doctor to contend that consent had been given by mother, for her consent could not be treated as valid or real. The removal of ovaries and uterus was an unauthorized invasion and interference with the appellant’s body amounting to tortious act of assault and battery and thus constituted ‘deficiency in service’. In Murray v. McMurchy,77 the Supreme Court of British Columbia, Canada, held that a doctor carrying out a caesarean section under anaesthesia for delivery of a child was not authorized to perform sterilization if the previous consent for such a procedure had not been obtained. It acould provide a successful defence to an action by a patient for a claim for battery to plead that the doctor found fibroid tumour and it was desirable to remove it, especially when a surgeon could be protected by the principle of necessity but it could be supported only in cases of interventions in life threatening situations. The court held that a perceived danger for future pregnancies

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did not mean immediate threat or danger to the patient’s health or life, and it would not have been unreasonable to postpone the operation to secure the patient’s consent. Again, the fact that the doctor found it convenient to perform the sterilization without consent as the patient was already under general anesthesia was held to be not a an invalid defence. Again, the possibility that the patient might have consented if she had been conscious is no defence to an action for surgical procedure without express consent.78 STERILIZATION With regard to an operation to sterilize an adult woman who is unable to consent because of her mental incapacity where the purpose is to avoid the risk of her becoming pregnant rather than the treatment of diseased organs, the fundamental and irreversible nature of the operation is such that as a matter of good practice, a formal declaration for it should be sought by those caring for the woman or intending to carry out the operation.79 The law does recognize a special category of treatment based on its attitude towards the sterilization of children, as evidenced by Lord Templeman’s speech in In re B. (A Minor) (Wardship: Sterilization),80 where he said: Sterilisation of a girl under 18 should only be carried out with the leave of a High Court judge. A doctor performing a sterilisation operation with the consent of the parents might still be liable in criminal, civil or professional proceedings. A court exercising the wardship jurisdiction emanating from the Crown is the only authority which is empowered to authorise such a drastic step as sterilisation ... a decision should only be made by a High Court judge. In the Family Division a judge is selected for his or her satisfactory method of reaching a decision which vitally concerns an individual but also involves principles of law, ethics and medical practice.

The right to bodily inviolability and the right to procreate, or the right to choose whether to procreate or not is the fundamental premise on which the court will exercise its jurisdiction. The position in India is more apposite to what exists in Australia, which recognizes parental authority as sufficient to decide on sterilization of a person of unsound mind or a minor, but would deem it desirable that a sanction from a court is also obtained.81 In Canada, following the decision of the Supreme Court in Re Eve,82 the law appears to be that the court should

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never authorize a non-therapeutic sterilization of a mentally retarded person under its parens patriae jurisdiction. In cases where US courts have authorized sterilization, they have adopted two broad bases: one being the ‘best interests approach’ and the other being the ‘substituted judgment’ approach. ISSUE OF CONSENT IN RELATION TO VACCINATION The current large-scale immunization programmes against diseases like polio, small pox, and measles, or the requirement of certain types of vaccination while securing a visa for visiting foreign countries may involve no issue of consent of the individual. At the time of admission into schools, one might encounter a mandate of a complete vaccine receipt as a condition for entry into the classroom.83 Obviously, if one may not refuse vaccinations, a basic component of informed consent is absent, thus nullifying the consent. Whereas informed consent is, in theory, the rule with other medical procedures, state legislatures have negated informed consent for vaccines by enactment of compulsory vaccination laws. In Allison v. Merck,84 the informed consent dilemma for parents faced with vaccination decisions for their children was illustrated in the case of 17 monthold Thomas Allison, who, together with his mother, Jo Ann Allison, sued Merck and Co. for ‘encephalitis ... blindness, deafness, mental retardation and spastic contractures’ allegedly inflicted on Thomas by Merck’s MMR (measles, mumps, rubella) vaccine. The court stated: Obviously, the situation in mass immunization projects is quite different from the emergency, voluntary accepted treatment of rabies cases [rabies vaccine]. Ms Allison never had any real choice as to whether her son was to receive the vaccine in question. Not only was she, let us say, ‘strongly encouraged’ to make the decision to go ahead with her child’s vaccination, she was faced with the Hobson’s choice of either having the vaccine administered or not having the privilege of sending her son to private or public school ... Choosing not to have her son attend school, of course, would have subjected her to criminal penalties unless she had the means to have her son educated at home ... Even if the Allisons could be seen to have been properly warned of the risk inherent in this vaccine, it is hard to conclude that they freely accepted the risk of the horrible injuries resulting in this case.

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Mazur v. Merck85 was a Pennsylvanian case involving a 13 year-old girl who suffered irreversible brain damage associated with a measles vaccine received during a mass vaccination programme at school. The court, like all US courts, described vaccines as ‘unavoidably unsafe’ and said that vaccine manufacturer Merck & Co. adequately warned of risks in its package insert, although the parents, like most American parents, were not given one. Because the manufacturer sold the vaccine to the federal government (Centers for Disease Control and Prevention), who can rarely be sued, the vaccine manufacturer prevailed, leaving the parents solely responsible for the care of their now mentally-retarded daughter, even though they withheld permission for her to be vaccinated. When the patient is a child, a parent or guardian must give permission prior to treatment. When parents refuse recommended medical care for their children, a legal conflict can ensue. Although state statutes have been in flux within the past few years, many states still permit selected religious groups such as Christian scientists to withhold conventional medical care from their children with no criminal penalties. However, courts have imposed medical care on children against a parent’s wishes, sometimes overriding religious beliefs, if the court feels the treatment is important to the children’s health. Medical care has even been imposed in cases where the child’s welfare was not in immediate danger.86 In 1944, the US Supreme Court stressed ‘that the state has a wide range of power for limiting parental freedom and authority in things affecting the child’s welfare; and ... this includes, to some extent, matters of conscience and religious conviction.’87 The court specifically mentioned vaccination as an area in which the government may override parental consent: ‘thus, [the parent] cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds. The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.’ In the Matter of Christine M,88 three-year-old Christine M. of Brooklyn, New York, was hospitalized in August 1990 for accidentally ingesting rat poison, and while in the hospital, a physician recommended that she received a measles vaccine due to ‘an outbreak of a measles epidemic which placed Christine in danger

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of contracting the disease in the absence of an immunization.’ After the father refused to permit the vaccination, the physician reported the situation to the hospital social worker, who in turn filed a report of ‘suspected child abuse or maltreatment’ with the local Child Protection Service (CPS). Although Christine’s father ‘impressed the court as a diligent, loving and concerned parent’ and the family’s ‘home was clean and adequately furnished and the children appeared well cared for’, a petition alleging child neglect for failing to vaccinate Christine was filed in the family court of Kings County, New York, in January 1991. Nine fact-finding sessions were held during the next 14 months, and in late 1992 the court decided that, indeed, Christine was a ‘neglected child’, having been ‘placed ... in imminent danger of becoming impaired’ through lack of measles vaccination. If Christine’s father had expressed a ‘bona fide religious exemption’ from New York’s compulsory vaccination laws, instead of asserting that ‘vaccinations were both medically and scientifically unnecessary and unsafe’, Christine might not have been found ‘neglected’. The judge stated that courts determine ‘whether a belief is “truly” or “sincerely” held’ by ‘relying heavily upon its unique ability to observe the demeanor of witnesses and to weigh their credibility.’ The court found ‘that while [Christine’s father] ... articulated religious beliefs contrary to vaccination, he ... failed to demonstrate that his opposition to inoculation stemmed from a sincerely held religious conviction and had not merely been framed in terms of religious belief in order to gain the exemption required.’ In labelling Christine a ‘neglected child’ the court carefully noted that ‘the term “neglected” was limited to the legal definition of that term [in relation to lack of vaccinations] and in no way suggested that [Christine’s father] failed in his parental duty to his daughter in any other respect’, describing Christine’s parents as ‘capable and loving’ and mentioning that ‘Christine and her siblings [were] well cared for’. Since the measles epidemic had passed, thus minimizing Christine’s risk of contracting measles, the court ‘declined to utilize its discretionary power to order inoculation’. All sides appeared to have won something from the outcome. The local CPS proved that Christine M. was ‘neglected’ under local law, the parents were not forced to vaccinate the child, the child had never

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been removed from their care, and in today’s public concern against child abuse, the judge did not appear ‘soft’ on child neglect. ALCOHOL BREATH ANALYSIS AND BLOOD TEST The Motor Vehicles Act makes punishable the offence of driving or attempting to drive a motor vehicle by anyone who has alcohol in his blood exceeding 30 mg per 100 ml of blood detected in a test by a breath analyser.89 The Constitution of India guarantees the fundamental right against self-incrimination under Article 20(3) and protects against testimonial compulsion. This does not extend to deny medical personnel from secure blood and urine analysis, who by virtue of Section 53 of the CrPC, are empowered to examine and give a report.90 By the use of the expression ‘to be witness’ in Article 20(3) of the Constitution, the makers of the Constitution have not intended to put obstacles in the way of efficient and effective investigation into crime and of bring criminals to justice. Even mere examination of the person and taking of blood sample in itself is not an incriminating circumstance, and therefore such persons cannot be said to have been compelled to be witnesses against themselves.91 In Breithaupt v. Abram,Warden,92 the petitioner, while driving a truck on a state highway, was involved in a collision with a passenger car, resulting in three deaths. He was seriously injured too. A pint whisky bottle, almost empty, was found in the glove compartment of the truck. While the petitioner was lying unconscious, the attending physician used a hypodarmic needle to draw a blood sample at the request of a state patrolman. The laboratory analysis revealed 17 per cent alcohol. This was admitted as evidence at the trial over the petitioner’s objection, and he was convicted in the state court for involuntary manslaughter. It was held by the US Supreme Court that he was not deprived of due process of law in violation of the 14th amendment It was further observed that as against the right of an individual that his person be held inviolable must be set the interests of society; and the judgment was concluded with the following significant observation: Furthermore, since our criminal law is to no small extent justified by the assumption of deterrence, the individual’s right to immunity from such invasion of the body as is involved in a properly safeguarded blood test is far outweighed by the value of its deterrent effect; due to the

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public realization that the issue of driving while under the influence of alcohol can often by this method be taken out of confusion of conflicting contentions.93

Through Section 129 A, the Bombay Prohibition Act permits the collection of blood to test the alcohol content present in the body of the accused. Rule 4 of the Bombay Prohibition (Medical Examination and Blood Test) Rules sets out the procedure for carrying out the test. When it was contested in State v. Seshappa that these provisions were unconstitutional, a division bench of the Bombay High Court ruled,94 The Bombay Prohibition Act is brought on the statute book to effectuate the policy of Prohibition. The taking of blood is empowered to be done only by a registered medical practitioner. It is thus under the protective eye of the law. It is intended to help the scientific determination of intoxication and the results of the test may as well prove innocence as the guilt of the person. Since the procedure for such extraction of blood is established by law, any deprivation of liberty on account of a person being compelled, to go before a medical officer for that purpose cannot be said to be ultra vires Art. 21 of the Constitution.

The symptoms that the doctor observes on production of the accused such as the stench of arrack in the suspect’s breath, redness of the eyes, and dilation of pupil, dry tongue, incoherence of speech, and a staggering of gait was held by the Madras High Court in Re Palani Goundan95 as constituting valid evidence and did not conflict with the provisions of the Constitution. POSITION OF GUARDIAN AD LITEM In Re A (Conjoined Twins: Medical Treatment),96 the Court of Appeal authorized an operation to separate conjoined twins on the basis that, although the operation would lead directly to the death of the weaker of the two babies, it was the only way to prevent the imminent death of both babies. The Court of Appeal granted permission to appeal to the House of Lords, but, after taking time to consider the matter, the Official Solicitor decided not to proceed with the appeal. The Official Solicitor’s decision was taken in part on the basis that the parents had decided not to appeal, and in part on the basis that the appeal had little prospect of success. One month after the Official Solicitor’s decision

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had been made public, and less than two weeks before the operation was due to take place, the director of a pressure group campaigning for absolute respect for innocent human life sought to be appointed as guardian ad litem for the weaker twin in place of the official solicitor. The president of the family division rejected the director’s application, and the director appealed. The Court of Appeal held that the official solicitor’s decision not to proceed with an appeal against authorization of the operation to separate the conjoined twins did not justify his removal as guardian ad litem of the weaker of the twins. If a guardian or litigation friend acted manifestly contrary to the child’s best interests, the court would remove him even if neither his good faith nor his diligence was in issue. In reaching a responsible and considered decision that another mind might possibly have disagreed with, the official solicitor had not acted manifestly contrary to the child’s best interests.

OVERRIDING CONTROL OF THE COURT It is well established that overriding control is vested in the court. This proposition is well established and was invoked by a person in public interest to authorize a surgical intervention of conjoint twins to be separated under orders of the Supreme Court of India.97 The children were 15 years of age and the Supreme Court’s direction was to the Chief Secretary of State (of Bihar) to make arrangements to bring the children to AIIMS, New Delhi, by an air ambulance of clinical management. Arrangemens were also made to take parents along with them at the expense of the State. The parents who were indigent would have nothing of it, but only wanted financial assistance to look after the children.Without the consent of the parents, the team of doctors could not carry out any clinical investigation. Raising the question whether the Court could override the wishes of parents, while applying the best interest standard test for saving the life of at least one child, the court seemed to prevaricate. In the absence of medical report about the prospect of medical course that would determine the course of intervention to be undertaken, the court did not force the issue, beyond giving benign directions that the local medical centre to carry out medical examination and send reports to AIIMS; urged the State of Bihar to meet the complete medical expenses for the treatment of the children and pay a consolidated amount of Rs 5000 every month

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and report to the court the treatment regimen every six months. No law was established, except to secure doles to the children, which the court said was in recognition of right to life guaranteed under Article 21 of the Constitution. In England, long ago the sovereign’s prerogative to protect infants passed to the Lord Chancellor, and through him to the judges, and it forms a part of the inherent jurisdiction of the high court. The Children Act, 1989,98 contains a statutory scheme for the resolution of disputes affecting the upbringing of children. The court must decide any dispute brought by a person having a recognizable interest. Consideration of a child’s welfare is a decisional process whereby, when all the relevant facts, relationships, claims and wishes of parents, risks, choices, and other circumstances are taken into account and weighed, the course to be followed will be that which is most in the interests of the child’s welfare.99 In re B (A Minor) (Wardship: Medical Treatment),100 where a child who was born suffering from Down’s Syndrome and an intestinal blockage required an operation to relieve the obstruction if she was to live more than a few days. If the operations were performed, there was a chance the child might die within a few months, but it was probable that her life expectancy would be 20 to 30 years. Her parents, having decided that it would be kinder to allow her to die rather than live as a physically and mentally disabled person, refused consent to the operation. The local authority made the child a ward of the court and, when a surgeon decided that the wishes of the parents should be respected, they sought an order authorizing the operation to be performed by other named surgeons. Templeman LJ said: On behalf of the parents Mr Gray has submitted very movingly ... that this is a case where nature has made its own arrangements to terminate a life which would not be fruitful and nature should not be interfered with. He has also submitted that in this kind of decision the views of responsible and caring parents, as these are, should be respected, and that their decision that it is better for the child to be allowed to die should be respected. Fortunately or unfortunately, in this particular case the decision no longer lies with the parents or with the doctors, but lies with the court. It is a decision which of course must be made in the light of the evidence and views expressed by the parents and the doctors, but at the end of the day it devolves on this court in this particular instance to decide...

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Dunn LJ said: I have great sympathy for the parents in the agonising decision to which they came. As they put it themselves, ‘God or nature has given the child a way out.’ But the child now being a ward of court, although due weight must be given to the decision of the parents which everybody accepts was an entirely responsible one, doing what they considered was the best, the fact of the matter is that this court now has to make the decision. It cannot hide behind the decision of the parents or the decision of the doctors; and in making the decision this court’s first and paramount consideration is the welfare of this unhappy little baby.101

In Cruzan, By Her Parents and Co-Guardians, Cruzan Et Ux. v. Director, Missouri Department of Health, et al.,102 petitioners, parents suing on their behalf and on behalf of their daughter, requested a court order directing the withdrawal of their daughter’s artificial feeding and hydration equipment after she was rendered vegetative in an auto accident. The appellate court denied their petition, holding that petitioners lacked authority to effectuate the request because there was no clear and convincing evidence of the daughter’s desire to have life-sustaining treatment withdrawn as required under the Missouri Living Will statute, Mo. Rev. Stat. § 459.010 et seq. (1986). The US Supreme Court affirmed. It said that the Due Process Clause, US Constitution Amendment XIV, did not require the state to repose judgment on matters concerning the right to refuse treatment with anyone but the patient herself. The court held that a state could choose to defer only to the patient’s wishes rather than grant the decision to close family members. This proposition is stated with same vehemence in a case from Canada, where the Court of Appeal for Ontario held that it will not exercise parens patria jurisdiction even in a case of treatment to be administered to a mentally ill patient when there is evidence to suggest that the same patient during sound health had been averse to it. However, In Re R. (A Minor) (Wardship: Consent To Treatment),103 in a somewhat similar case of a minor girl of 15 years, who understood the nature of treatment, the Court of Appeal in the UK ruled that the effect of refusal of consent for treatment during a period of lucid interval would not make any difference, and said that the court in the exercise of the wardship jurisdiction was entitled to override a minor’s decision either consenting to or refusing treatment, irrespective of their ‘competence’, and in any event, having regard to the fluctuating nature of her illness, the

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patient was not ‘competent’ to give or withhold her consent.The court said that a ‘Gillick competent’ child can consent to treatment, but if he or she declines to do so or refuses, consent can be given by someone else who has parental rights or responsibilities. Where more than one body or person has a power to consent, only a failure to, or refusal of, consent by all having that power will create a veto. Even when the condition of the patient is not a vegetative state, if the issue is whether a particular treatment which was intrusive and had the effect of prolonging the agony, the Court of Wards would take the decision that a normal parent would in the best interest of the patient. In re J. (A Minor) (Wardship: Medical Treatment),104 J., who was born prematurely in May 1990, suffered perinatal brain damage and required immediate resuscitation by means of mechanical ventilation, an invasive procedure that, with the accompanying intensive care procedures, was distressing to the child. In September, following convulsions and episodes when he stopped breathing, he was again placed on a ventilator. The most optimistic prognosis suggested that he had a considerably shortened life expectancy, that he would become a serious spastic quadriplegic, probably without sight, speech, or hearing, but that his only likely normal reaction was of pain.There was a possibility that he might at any time suffer respiratory collapse and require further resuscitation. The Court of Appeal said that although there was a strong presumption in favour of the preservation of life, no principle of public policy regarding the sanctity of life displaced the paramountcy of the ward’s best interests, and that accordingly even if a ward was not terminally ill, the court might in appropriate circumstances withhold consent to life-saving treatment. In so doing, the court in this specific case took note of the severe lack of capacity of the child in all his faculties which even without any further complication would make his existence barely sentient. Second, if further mechanical ventilation were required, that very fact would involve the risk of deterioration in J.’s condition due to further brain damage flowing from the interruption of breathing. Third, all the doctors drew attention to the invasive nature of mechanical ventilation and the intensive care required to accompany it. They stressed the unpleasant and distressing nature of that treatment. To add such distress and the risk of further deterioration to an already appalling catalogue of disabilities was clearly capable of producing a quality of life which justified the stance of the doctors and the judge’s conclusion.

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It cannot be disputed that the Due Process Clause of the US Constitution as per 14th amendment protects an interest in life as well as an interest in refusing life-sustaining medical treatment. Not all incompetent patients will have loved ones available to serve as surrogate decision-makers. And even where family members are present, there will, of course, be some unfortunate situations in which family members will not act to protect a patient. A state is entitled to guard against potential abuses in such situations. Similarly, a state is entitled to consider that a judicial proceeding to make a determination regarding an incompetent’s wishes may very well not be an adversarial one, with the added guarantee of accurate fact-finding that the adversary process brings with it. In re S (Adult Patient: Sterilisation),105 the patient, a 29 year-old woman with severe learning difficulties, was distressed by her menstrual periods and had a phobia about hospitals. On the mother’s application for a declaration that it would be lawful to perform a hysterectomy, the judge considered the relative merits of both procedures and of the further alternative of inserting a contraceptive coil. He found that pregnancy would be highly detrimental to the patient’s welfare, but that while sterilization would protect her from pregnancy, it would not reduce her menstruation and was not, therefore, in her best interests. The insertion of a contraceptive coil would prevent pregnancy, and reduce the patient’s menstrual flow, but it would have to be replaced every five years, requiring surgery under general anaesthetic each time. A subtotal hysterectomy would achieve the same result without the need for further surgical intervention, although as a surgical procedure it would be more invasive. The weight of the medical evidence was in favour of the contraceptive coil, at least as a first step, but the mother’s preference was for the hysterectomy. The Court of Appeal, while allowing the appeal preferred on behalf of the patient and reversing the decision of the lower court allowing the hysterectomy, notwithstanding the availability of the patient consent and overruling the decision of her mother, said that while a number of different courses might be lawful in any particular case, there could only logically be one best option, and it was for the court to decide which that was.Once satisfied that the proposed treatment options were within the range of acceptable opinion among competent and responsible practitioners, the court should move on to the wider and paramount consideration of which of them was in the patient’s best interests. Since the weight

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of medical evidence supported the less invasive procedure as the preferred option and the mother’s concerns did not tilt the balance towards major irreversible surgery for therapeutic purposes, the judge’s declaration should be set aside and a declaration be made allowing the patient to be fitted with a contraceptive coil. Would the court be always guided by the medical opinion of what is in the best interests of the patient? The answer to this difficult decision was made in a case where the patient had slipped to a PVS state.The Court of Appeal in Frenchay Healthcare NHS Trust v. S106 said: Although the court had the ultimate power and duty to review the medical decision in the light of all the facts and should not necessarily accept medical opinion as to what was in the patient’s best interests as being in fact in the patient’s best interests, the court should be reluctant to place those treating the patient in a position of having to carry out treatment which they considered to be contrary to the patient’s best interests unless the court had real doubt about the reliability, bona fides or correctness of the medical opinion in question.

The wardship of the court would be exercised only on behalf of the mentally-ill person and not behalf of the child of the mentally ill,107 either born or when in utero.108 COULD THERE BE CONSENT TO BE TORTURED? The consent to a physician is only for the purpose of treatment. It is most unlikely that their professional expertise is ever employed to cause any harm to a patient, even if the patient invites such a masochist exercise. In a case that had no involvement of medical personnel, the question was whether a person could consent to be tortured. As a matter of public policy, there could be no such consent to any person and a fortiorari, it would apply also to a patient–doctor interface. In R v. Brown and other appeals,109 the appellants belonged to a group of sadomasochistic homosexuals who over a 10-year period from 1978 willingly participated in the commission of acts of violence against each other, including genital torture, for sexual pleasure. The passive partner or victim in each case consented to the acts being committed and suffered no permanent injury. The activities took place in private at a number of different locations, including rooms equipped as torture chambers at the homes of three of the appellants.Video cameras were

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used to record the activities and the resulting tapes were then copied and distributed amongst members of the group. The tapes were not sold or used other than for the personal entertainment of members of the group. The appellants were tried on charges of assault occasioning actual bodily harm, contrary to Section 47 (a) of the Offences against the Person Act, 1861, and unlawful wounding, contrary to Section 20(b) of that act. The Crown’s case was based very largely on the contents of the video tapes. Following a ruling by the trial judge that the consent of the victim afforded no defence to the charges, the appellants pleaded guilty and were sentenced to terms of imprisonment. The appellants appealed against their convictions, contending that a person could not be guilty of assault occasioning actual bodily harm or unlawful wounding in respect of acts carried out in private with the consent of the victim. The Court of Appeal dismissed their appeals. The appellants appealed to the House of Lords. The House of Lords held (Lord Mustill and Lord Slynn dissenting) that consensual sadomasochistic homosexual encounters occasioned actual bodily harm to the victim, contrary to Section 47 of the 1861 Act, and unlawful wounding, contrary to Section 20 of that act, notwithstanding the victim’s consent to the acts inflicted on him, because public policy required that society be protected by criminal sanctions against a cult of violence which contained the danger of the proselytization and corruption of young men and the potential for the infliction of serious injury. Accordingly, a person could be convicted of unlawful wounding and assault occasioning actual bodily harm, contrary to Subsection 20 and 47 of the 1861 Act, for committing sadomasochistic acts that inflicted injuries that were neither transient nor trifling, notwithstanding that the acts were committed in private, the person on whom the injuries were inflicted consented to the acts and no permanent injury was sustained by the victim. It followed that the appellants had been properly convicted and that their appeals would be dismissed. CONSENT FOR BEING A SUBJECT OF MEDICAL RESEARCH The Indian Medical Council Regulations, 2003, lays down guidelines for securing consent from patients for treating them as human subjects for medical research.110 As a human rights issue, medical

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research on vulnerable sections such as persons in captivity in war camps, prisoners, women, and children is a separate study in itself and dealt with in Chapter 2. In John Moore v. The Regents of the University of California et al.,111 a patient stated a cause of action against his physician for breach of fiduciary duty to disclose facts material to securing consent, or for performing medical procedures without having first obtained the patient’s informed consent, by allegations that the physician used certain cells extracted from the patient in potentially lucrative medical research without the patient’s permission, and that the physician failed to disclose pre-existing research and economic interests in the cells before obtaining consent to the medical procedures by which they were extracted. Allegations that the physician had an undisclosed research interest in the patient’s cells at the time he sought consent to a splenectomy stated a cause of action for breach of fiduciary duty or lack of informed consent, as did allegations that the physician concealed an economic interest in postoperative procedures for taking blood and other samples. It was not necessary for the patient to allege that the physician knew his cells had potential commercial value when blood tests were first performed, and it was unnecessary to allege that the operation lacked a therapeutic purpose or that the procedure was totally unrelated to therapeutic purposes. There have been recent reports of breach of statutory prescriptions for clinical trials. The Drug Controller General of India suspended the clinical trial of an anti-cancer drug in Hyderabad and has withdrawn its permission to Axis Clinicals to carry out such trials. It is reported that the studies were being carried out by Axis Clinicals at its bio-equivalence study centre in Serlingampally, Miyapur, in which poor women were administered the drug allegedly without taking their consent. The drug controller investigated the trial on 20 and 21 June 2011 and found that norms under Schedule Y of the Drugs and Cosmetics Rules were violated. The investigations were reported to have revealed various irregularities in the studies with respect to recruitment of participants, informed consent, independence of the ethics committee, and review and decision-making processes. The approval to the company to conduct all kinds of bio-availability and bioequivalence studies at its centres in Miyapur since suspended in the public interest. The controller was reported to have decided to

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investigate all such centres in Andhra Pradesh that are carrying out clinical trials of a similar nature. Axis Clinicals had carried out the bioequivalence studies on the anti-cancer tablet exemestane on poor women between 27 January and 15 February, allegedly without their informed consent. The incident came to light on 16 June 2011, when at least nine women from Piduguralla town in Guntur district complained of body pain, joint pain, chest pain, and extreme weakness. A few of them also had difficulty walking. A local doctor told them they could have been tested for breast cancer drugs. Apparently, the women had no idea as to what drug they had been administered. An independent investigation conducted by Sandhya Srinivasan and Sachin Nikarge112 followed the trial of lapatinib, a drug for breast cancer; one trial of risperidone, a psychiatric drug; and two trials of quetiapine, another psychiatric drug. They found that these trials exploited the fact that most Indians do not have access to good quality and affordable care and effective drugs, and therefore may accept offers that might provide free, better quality treatment.The patients were also vulnerable because they were seriously ill. In the case of psychiatric patients, they may not have been able to provide informed consent. NOTES 1 (2008) (2) ALD 69 (SC), (2008) (1) BLJR 790, (2008) 1 CompLJ 185(SC), I (2008) CPJ 56 (SC), 2008 (1) CTC 392, JT 2008(1) SC 399, (2008) 2 MLJ 662 (SC), (2008) 149 PLR 213, RLW 2008(1) SC 853, 2008 (1) SCALE 442, (2008) 2 SCC1. 2 (1972)[464] Federal Reporter 2d. 772. 3 (1914) 211 NY 125. 4 Andrew Grubb (ed.), Principles of Medical Law, 2nd edition (New york: Oxford University Press), p. 133. 5 1933 (3) DLR 260. 6 1949 (2) DLR 442. 7 1989(2) All ER 545. 8 [1985] 1 AC 871, [1985] 1 All ER 643, [1985] 2 WLR 480, 1 BMLR 132. 9 Beauchamp, ‘Informed Consent’, in Robert M.Veatch (ed.), Medical Ethics (Boston Portola Valley: Jones and Bartlett Publishers, 1989), p. 180. 10 [1944] 1 KB 476. 11 154 Cal. App. 2d.560 (1957). 12 See ‘real consent and informed consent’ earlier for the case reference.

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13 Canterbury v. Spence 1972 [464] Federal Reporter 2d. 772, quoted in Samira Kohli, see note 1 for case details. 14 Ibid. 15 [1981] QB 432. 16 14 ACWS (3d) 370;1989 ACWS LEXIS 35093. 17 (2004) 3 All ER 587. 18 68 O.R. (3d) 97;2003 Ont. Rep. LEXIS 302. 19 [1980] 2 SCR 880, 114 DLR (3d) 1. 20 P. 928, SCR. 21 [1957] 2 All ER 118. 22 1955 SC 200. 23 [1985] 1 All ER 643. 24 Samira Kohli v. Dr Prabha Manchanda and Anr 2008(2)ALD69(SC), 2008(1)BLJR790, (2008)1 CompLJ185(SC), I(2008)CPJ56(SC), 2008(1) CTC392, JT2008(1)SC399, (2008)2MLJ662(SC), (2008)149PLR213, RLW 2008(1)SC853, 2008(1)SCALE442, (2008)2SCC1. 25 MANU/SC/0600/1996, (1996) 2 SCC 634. 26 MANU/SC/0583/2001, (2001) 8 SCC 731. 27 MANU/SC/0836/1995. 28 The Ohio Revised Code specifically delineates the components of valid written informed consent for surgical or medical procedures. Despite past successes in patients suing physicians for battery based on the physicians’ failure to inform them of appropriate risks, Ohio legal precedent currently favours physicians. Ohio is not unique in this aspect. According to Katz, judges around the country have been reluctant to convict physicians of battery for failing to obtain valid informed consent, instead choosing to rely on standard medical practice as the criterion on which to base adequacy of informed consent. 29 Goldman, ‘The Refutation of Medical Paternalism’, in J. Arras and N. Rhoden (eds), Ethical Issues in Modern Medicine (1989), p. 57. 30 See ‘permanently vegetative state’ in Chapter 2 for the facts leading to the patient’s hospitalization and how the intervention through a petition had come about. 31 86 DLR (4th) 385;1992 DLR LEXIS 1762. 32 1990 ACWSJ LEXIS 51997;1990 ACWSJ 433556;20 ACWS (3d) 301; 67 DLR (4th) 321. 33 Ontario Court of Appeal. 34 4 OR (3d) 74;1991 Ont. Rep. LEXIS 127. 35 Only the decisions of substitutes of involuntary incompetent patients were subject to such review; voluntary incompetent patients could never be ordered to take drugs contrary to their previously expressed wishes. 36 In re R (A Minor) (Wardship: Consent to Treatment) [1992] Fam 11.

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37 Per Lord Scarman in Gillick’s case [1986] AC 112. 38 See Chapter 2 for a fuller discussion on the subject. See also ‘over-riding control of court’, for circumstances when the court could exercise the power of veto over parental decision. 39 [1986] 1 FLR 224. 40 This is stoutly contested in an article by J. Steven Svoboda, Robert S. Van Howe, and James G. Dwyer, titled ‘Informed Consent for Neonatal Circumcision: An Ethical and Legal Conundrum’, ( J. Contemp. Health L. & Pol’y17: 61). They argue that circumcision does not correct an existing injury, disease, or harmful malfunction. Thus, even if circumcision provides some medical benefit, there is no urgency to perform the procedure. General ethical and legal principles concerning surgery on children therefore dictate that the decision whether a male will be circumcised must be suspended until the male is capable of making the decision himself. This is even clearer if claimed medical benefits would not be realized until adulthood. 41 Deborah Schrag, Karen M. Kuntz, Judy E. Garber, and Jane C. Weeks, dealing with cases of preventive surgery for women suspecting the onset of cancer, observe that any surgical manipulation of sexual organs is also not appropriate. See ‘Decision Analysis—Effects of Prophylactic Mastectomy and Oophrectomy on Life Expectancy among Women with BRCA1 or BRCA2 Mutations’, New Eng. J. Med. 336 (1997): 1465. 42 J. Steven Svoboda, Robert S. Van Howe and James G. Dwyer, ‘Informed Consent for Neonatal Circumcision: An Ethical and Legal Conundrum’, J. Contemp. Health L. & Pol'y 17: 61. 43 Most African cultures practice female circumcision as a part of puberty rituals, though the Beja and the Beni Amir tribes of Sudan historically circumcised girls of seven to forty days old. But the age of circumcision for girls in Africa seems to be dropping. Descriptions of groups of newly circumcised girls often report ages ranging between four and nine years and in some groups the surgery is done on girls who are only 24 months old. See Christine E. Gudorf, ‘Bioethics and Law Symposium Deconstructing Traditional Paradigms in Bioethics: Race, Gender, Class, and Culture: Gender and Culture in the Globalization of Bioethics’, St Louis U. Pub. L. Rev. 15 (1996): 331. 44 Objections to surgeries for intersex are dealt with in Chapter 5. 45 42 USC 5101;The Child Abuse Prevention and Treatment Act (CAPTA) was originally enacted in PL 93–247. The law was completely rewritten in the Child Abuse Prevention, Adoption and Family Services Act of 1988 (PL100–294, 4/25/88). It was further amended by the Child Abuse Prevention Challenge Grants Reauthorization Act of 1989 (PL 101–126, 10/25/89) and the Drug Free School Amendments of 1989 (PL 101–226, 12/12/89).

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46 Child Welfare Information Gateway, www.childwelfare.gov (last visited 2 January 2011). 47 AIR (2003) SC 3450, (2003) (3) ALT41 (SC), (2003) (2) AWC 1534 (SC), (2003) (2) BLJR 1420, (2003) (2) CTC7 60, I (2003 )DMC 627 SC, [2004 (1) JCR 98 (SC)], JT (2003) (3) SC 399, (2003) (2) KLT 243 (SC), RLW (2003) (3) SC379, (2003) (3) SCALE 475, (2003) 4 SCC 493, [2003] 3SCR 106, (2003 )(2) UJ 870 (SC). 48 Section 2(o), Mental Health Act, 1987. The National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999, makes provisions for this category. Section 2 (g) of the Act states that ‘mental retardation’ means a condition of arrested or incomplete development of the mind of a person, which is specially characterized by sub-normality of intelligence. 49 Section 13, the Mental Health Act, 1987. 50 Section 15, ibid. 51 Section 16, ibid. 52 Section 17, ibid. 53 Section 18, ibid. 54 Section 18(2) and (3), ibid. 55 Section 19, ibid. 56 Judgment of Madras High Court dated 23.7.2003 in HCP 478 of 2003 reported in Manu/TN/1028/2003. 57 Section 20, ibid. 58 Sections 20, 22, 24, 25, ibid. 59 Sections 53, 57, ibid. 60 [1999] AC 458. 61 Section 3(4). 62 (2009) 3 RCR 767 (DB). 63 (2009) (4) RCR (crl) 233, 2009 (4) RCR (civ) 258. 64 Re Marion14 Fam LR 427(Family Court of Australia) (1990). 65 (1986) 25 SCR 388;31 DLR 4d 1. 66 See Chapter 2 for a longer examination of confidentiality in the doctor– patient relationship. The whole passage referring to US courts’ practice has been referred by the Supreme Court in Sharda v. Dharmpal cited above. 67 113 Md. App 701, 715, 688 A2d. 955, 961, cited in Sharda v. Dharmpal referred to above. 68 714 F.2d 632 (1983). 69 74.5 A.2d 1054 (Md. Ct. App. 2000). 70 Airedale NHS Trust v. Bland(1993) 1 All ER 821, (1993) AC 789, (1993) 2 WLR 316, (1994) 1 FCR 485, (1993) 1 FLR 1026, (1993) Fam Law 473, (1993) Crim LR 877, (1993) 4 Med LR 39, 12 BMLR 64, (1993) NLJR 199

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71 (1997) 2 All ER 687. 72 See Chapter 9 for a discussion on the procedure relating to consent for transplantation of organs of a dying person. 73 (2011) 4 SCC 454. See Chapter 2 for a discussion of the PVS state. 74 See Section 306 (abetment to suicide) and Section 309 (attempt to commit suicide) of the IPC; Gian Kaur v. State of Punjab 1996(2) SCC 648. 75 [1993] AC 789. 76 2008 (2) ALD 69 (SC), 2008 (1) BLJR 790, (2008) 1 CompLJ 185 (SC), I (2008) CPJ 56 (SC), 2008 (1) CTC 392, JT 2008 (1) SC 399, (2008) 2 MLJ 662 (SC), (2008) 149 PLR 213, RLW 2008 (1) SC 853, 2008 (1) SCALE 442, (2008) 2 SCC 1. The observations in this judgment were extensively relied in a subsequent judgment in Nizam Institute of Medical Sciences v. Prasant S. Dhananka (2009) 3 RAJ 634, where the court held that a consent for excision biopsy was not sufficient for inferring consent for the surgical removal of the tumour itself. 77 (1949) 2 DLR 442, (1949) 1 WWR 989. A similar view was also expressed in a judgement of the Court of Appeal in England in F., In re (1933) 3 DLR 260, 60 CCC 136, where the court held that the additional or further treatment which could be given (outside the consented procedure) should be confined to only such treatment as is necessary to meet an emergency, and as such needs to be carried out once and before the patient is likely to be in a position to make a decision for himself. 78 F., In re (1933) 3 DLR 260, 60 CCC 136. 79 In re F. (Mental Patient: Sterilisation), [1990] 2 AC 1. See also see Collins v. Wilcock [1984] 3 All ER 374 at 377–8 per Robert Goff LJ (as he then was); Wilson v. Pringle [1987] QB 237; T v T [1988] 1 All ER 613. 80 (1988) AC 199, 205–6. 81 Re Marion14 Fam LR 427 (Family Court of Australia)(1990). 82 (1986) 25 SCR 388;31 DLR 4d 1. 83 See Chapter 2. 84 P.2d 948,951 (Nev. 1994). 85 742 F. Supp. 239, 247 (E.D. Pa. 1990). 86 See, for example, Veilleux, ‘Medical Practitioner’s Liability for Treatment Given to Child Without Parent’s Consent’, A.L.R.4th 67 (1989): 511; Rampino, ‘Power of Court or Other Public Agency to Order Medical Treatment over Parental Religious Objections for Child Whose Life is Not Immediately Endangered’, A.L.R.3d 52 (1973): 1118; Williams, ‘Power of Court or Other Public Agency to Order Medical Treatment for Child Over Parental Objections not Based on Religious Grounds’, A.L.R.3d 97 (1980): 421. 87 Prince v. Massachusetts, 321US 158, 167 (1944). 88 In the Matter of Christine M., 595 NYS2d 606,607 (1992).

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89 Motor Vehicles Act, 1988, Section 185. If the content of alcohol as mentioned in the section is not proved, there is no offence, Jyothish S/o Unnikrishnan v. The State of Kerala, Manu/KE/0574/2009, High Court of Kerala, Crl MC No 3225 of 2009 decided on 16.10.2009; Rajavalse M v. State 1999 Crl LJ 58: The prosecution under this section invariably occurs while the driver under the influence of alcohol places passengers of the vehicle or any member of public in great danger by drunken driving that results in death or injuries. Rash or negligent acts causing death or injuries are punishable offences under the IPC, particularly Sections 279, 304A, and 337. See Kuldeep Singh v.State of Himachal Pradesh (2008) ACJ 2680, AIR (2008) SC3062, 2008 Cri LJ 3932, JT (2008) (8) SC 219, 2008 (10) SCALE 64; Ch. Ravindra Babu v. State of AP 2009 Cri LJ 4620. 90 Section 53 of the code only lays down a condition that medical examination will have to be done at the instance of a police officer not below the rank of sub-inspector. It does not debar other superiors officers or the court concerned from exercising the power if it is necessary for doing justice in a criminal case. 91 Anil A. Lokhande v. State of Maharashtra 1981 Cri LJ 125 (Bom). 92 (1957) 352 US 432. 93 Ibid. 94 1964 (2) Cri LJ 523. 95 1957 Cri LJ 976. 96 (2001) Fam Law 100, (2001) 1 FLR 267. 97 Aarushi Dhasmana v. Union of India Writ Petition (Civil) No 232 of 2012 decided on April 10, 2013. 98 Section 1(1) of the Children Act, 1989, provides: ‘When a court determines any question with respect to (a) the upbringing of a child ... the child’s welfare shall be the court’s paramount consideration.’ 99 Lord MacDermott, in his opinion in J v. C(1970) AC 668, 710–1 addressing the question of construction as to the scope and meaning of the words in the Guardianship of Infants Act 1925, ‘shall regard the welfare of the infant as the first and paramount consideration’. In re MB (Medical Treatment)(1997) 2 FLR 426, 439 Butler-Sloss LJ said: ‘Best interests are not limited to best medical interests.’ In In re A (Male Sterilisation)(2000) 1 FLR 549, 555 Dame Elizabeth Butler-Sloss P said: ‘In my judgment best interests encompasses medical, emotional and all other welfare issues.’ 100 (1981) 1 WLR 1421. 101 Ibid., p. 1424. 102 497 US 261,110 S. Ct. 2841,111 L. Ed. 2d 224, 1990 US LEXIS 3301, 58 USLW 4916. 103 (1992) Fam 11. 104 (1991) Fam 33.

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105 (2001) Fam 15. 106 (1994) 2 All ER 403, (1994) 1 WLR 601, (1994) 1 FLR 485, 17 BMLR 156, (1994) Fam Law 320. 107 In Robert Heijkamp and Another v. Bal Anand World Children Welfare Trust and Another, 2008(1) Bom CR 719, a petition for inter-country adoption of a child of a mentally ill person was filed with the Child Welfare Board acting as a guardian. Referring to the provisions of the Juvenile Justice Act (JJ Act) and the Mental Health Act, the Division Bench of the Bombay High Court said that the court will assume jurisdiction only after the Child Welfare Committee recommends intervention for rehabilitation of the child of a mentally ill person under Section 41(5)(a) of the JJ Act and a petition directly under the Guardians and Wards Act, 1890, is not maintainable. 108 In re F (In Utero)(1988) 2 WLR 1288, (1988) 2 FLR 307. 109 (1993) 2 All ER 75. 110 See also Chapters 2 and 8 for commentaries on clinical research on patients. 111 Supreme Court of California 51 Cal. 3d 120; 793 P.2d 479; 271 Cal. Rptr. 146; 1990 Cal. LEXIS 2858; 16 ALR5th 903; 15 USPQ2D (BNA) 1753. 112 For the full text of report, see ‘Ethical Concerns in Clinical Trials in India: An Investigation’, www.fairdrugs.org. (last visited 26 June 2011).

4

Doctor in Courts

EVIDENCE OF DOCTORS IN COURTS Doctors are a familiar sight in courts as expert witnesses generally and sometimes as a party to proceedings.1 In criminal proceedings, expert opinion is sought on the cause and time of death, and the doctors explain post-mortem reports that they have drawn. For trials of lesser offences, the doctor’s testimony will be vital in adjudication on the nature of injuries and whether they could have been caused in the manner and by the weapon presented during the trial. The actual commission of violence on a woman and the age of the victim are relevant in cases of rape, and a doctor’s account will be the most decisive in such a case. Doctors make disability assessments that have a bearing on issues relating to suitability or continuance in employment, or for termination of service; they also help courts in determination of compensation for injuries suffered in motor accidents and work-related injuries sustained in the course of employment. The doctor’s scientific expertise is put to optimum use in ascertaining paternity by DNA and blood sampling. Appraisal of the mental condition of patient, where the issue of consent or legal competence is relevant, and examining mental and physical conditions of a spouse in the matrimonial jurisdiction are other areas that mark doctors distinctively as active collaborators in the delivery of justice in civil cases. Before consumer fora the doctor is seen more as a party defending in medical malpractice cases or giving evidence to establish or rebut medical negligence as a witness to either one of the parties to the litigation. Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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A doctor’s evidence is primarily in the nature of opinion. It is necessary that these opinions rightly influence the decisions of the courts and stall unwarranted inference. As an opinion, medical evidence is merely a corroborative tool,2 and in criminal trials, for the defence, one to disprove the alleged facts. He is neither a prosecution witness not a defence witness, but an expert to assist the court. He is mostly cited as a witness for the prosecution. As per the Indian Medical Council Act, 1956, Section 15 (2)(c), only medical practitioners enrolled on a state medical register shall be permitted to provide any evidence in a proceeding under Section 45 of the Indian Evidence Act, 1872. The section accords to the doctor a status as an expert. The Supreme Court laid down directions for all courts to follow in the matter of summoning of doctors, and restricted it to cases where their evidence is absolutely essential; further, when they are summoned they should not be made to wait and waste time unnecessarily.3 In Raj Kumar v. Ajay Kumar,4 the Supreme Court empathized: Most of them are reluctant to appear before the Tribunals for obvious reasons either because their entire day is likely to be wasted in attending the Tribunal to give evidence in a single case or because they are not shown any priority in recording evidence or because the claim petition is filed at a place far away from the place where the treatment was given. Many a time, the claimants are reluctant to take coercive steps for summoning the doctors who treated them, out of respect and gratitude towards them or for fear that if forced to come against their wishes, they may give evidence which may not be very favourable. This forces the injured claimants to approach ‘professional’ certificate givers whose evidence most of the time is found to be not satisfactory.

Examination of a person by a doctor could be for a variety of reasons and for various purposes, such as assessing the medical condition before finalizing a proposal under an insurance scheme for life or illness; assessing disability or earning capacity under the Workmen’s Compensation Act, the Motor Vehicles Act, or Employees State Insurance Act; and ascertaining the extent of drunkenness and culpability for certain crimes. There are various other situations where the assessment of mental condition, physical ailment, etc., could be relevant in civil and criminal cases.

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Need for Medical Evidence in Criminal Cases Speaking to doctors on the topic of ‘What medicine can do for law’,5 Benjamin Nathan Cardozo said, ‘We look then to you, to the students of mind and body, for the nutriment of fact, solid if not liquid, that in many a trying hour will give vitality and vigor to the tissues of our law. Conspicuously is this true today in the administration of the law of crime. The field is one in which the physician is asserting himself year by year with steadily expanding power.’ Medical evidence covers a realm of scientific knowledge and thereby necessitates the courts’ understanding in a more comprehensive and holistic manner through medical evidence. The paramount concern for any court of law is to ascertain the truth. In corporal crimes like rape, murder, and assault, a certain understanding of anatomical features and pathological reactions may be necessary that no person could do better than a doctor, so that the court may make the correct decisions about relevant facts, such as when the injury could have been caused, whether the weapon seized could have cause the particular injury, and the seriousness of injury. A victim of a criminal assault is most likely to have been taken to a doctor for treatment, and the statement confided to a doctor, which might constitute the first version in court would also assume significance. In cases of diametrically opposite testimonies of the parties, the medical evidence resolves many a riddle and ensures the most credible and acceptable guide for a court of fact to come to just conclusions. If the direct evidence of the witnesses is satisfactory and reliable, the court may overlook the hypothetical medical evidence.6 In many cases the reliance on medical evidence has provided the necessary validation of the prosecution’s charges against the accused. Though corroborative in most cases, medical evidence can also be used to challenge the position adopted by the prosecution and to expose fallacies in its case. Where medical evidence on both sides is evenly matched, the benefit of doubt must be given to the accused.7

Is There Immunity for a Doctor against Flawed Evidence? If there is untruth in evidence on a point of fact, there could be action for perjury. However, if the opinion is shown to be flawed on preponderance of diverse or sometimes, inconsistent medical views on the

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subject, should a doctor be prosecuted for professional misconduct? Meadow v. General Medical Council 8 was a case before the Queen’s Bench that dealt with a doctor who had given evidence on the basis of some pathological reports that the death of two sibling children was not natural.The mother was convicted in a criminal trial on the basis of such evidence. It turned out that the results of important and relevant microbiological tests had not been disclosed by the pathologist. The GMC, to which the mother had complained of misconduct, ordered erasure of the name of the pathologist from the practitioner’s register. The bench held that a statement of a witness in court ought to have immunity from the civil process for two reasons: that a witness could provide evidence fearlessly, and to avoid multiplicity of actions, such as, independent tort claims, in which the value or the truth of their evidence would be tried over and over again. The court said that there is a public interest in play that goes beyond the rights of others to a legal remedy, and the decision of the GMC was reversed.The court, however, stated that this was not to suggest that there was blanket immunity, but it is restricted to what is stated in honest and in good faith. Doctors may not expect protection if they are dishonest or malicious or deliberately misleading. In a further appeal by the GMC under the same title,9 the common law precept of immunity from civil process could prevent action for damages in a court, but should not prevent a regulatory body to take appropriate action in the public interest. The court said, ‘It would be wrong in principle for the court to limit the powers of a fitness to practice panel by extending the immunity from civil court to fitness to practice proceedings; it would be inconstant with the duty of the fitness to practice panel to investigate and determine the fitness to practice of the expert.’10

Medical Certificate Appendix 4 in The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, lists the certificates, reports, and notifications that a doctor could issue: (1) Under the acts relating to birth, death, or disposal of the dead. (2) Under the acts relating to lunacy and mental deficiency and under the Mental Illness Act and the rules made thereunder.

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(3) (4) (5) (6) (7)

Under the Vaccination Acts and the regulations made there under. Under the Factory Acts and the regulations made there under. Under the Education Acts. Under the Public Health Acts and the orders made there under. Under the Workmen’s Compensation Act and Persons with Disability Act. (8) Under the Acts and orders relating to the notification of infectious diseases. (9) Under the Employee’s State Insurance Act. (10) In connection with sick benefit insurance and friendly societies. (11) Under the Merchant Shipping Act. (12) For procuring/issuing of passports. (13) For excusing attendance in courts of Justice, in public services, in public offices or in ordinary employment. (14) In connection with Civil and Military matters. (15) In connection with matters under the control of Department of Pensions. (16) In connection with quarantine rules. (17) For procuring driving licence. Appendix 2 gives a model form of certificate recommended for leave or extension or communication of leave and for fitness. It requires the nature and probable duration of the illness also to be specified.This certificate must be accompanied by a brief resume of the case giving the nature of the illness, its symptoms, causes, and duration. In court proceedings, it is an elementary rule of evidence that a certificate is itself not proof of what it contains, and the person who has given the certificate shall be required to support the certificate and stand the test of cross-examination by the person interested in denying its contents.

Proving Mental Illness The law affords complete immunity to an insane individual in criminal cases. ‘Insanity’ typically denotes the lack or impairment of the cognitive faculty that renders an individual incompetent with regard to the necessary intent for commission of a crime. In civil law litigation there are situations in which the mentally unsound are liberated from any encumbrances. However, two points should be kept in mind.With regard to the

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distinction between legal and medical insanity, the burden of proving insanity always lies with the party claiming it; that is, the defendant or respondent. The doctor’s evidence to prove insanity or a mental condition may be crucial, although there is no law compelling such a course.11 Numerous circumstances form the subject of civil law responsibility of the mentally unsound. For example, under Section 118 of the Indian Evidence Act, a court of law will disallow any witness who is unable to understand the nature of questions posed to him during an examination. Such an exception does not necessarily bar a lunatic from appearing in court. The marriage laws in India also seek to disqualify people of unsound mind from contracting a marriage.12 If this is proceeded with, the marriage is voidable at the instance of the mentally sound spouse.13 A person whose spouse is incurably of unsound mind, or has been suffering continuously or intermittently from mental disorder of such a kind and to such an extent that the person cannot reasonably be expected to live can cite the situation to obtain a divorce.14 The law of contracts also bar the mentally unsound from entering into contracts, and does not hold them responsible for any contractual obligations that may arise. Section 10 of the Indian Contract Act,1872, speaks about the necessary ‘capacity’ to contract, and Section 12 illustrates how a person, even if mentally unsound, would be competent to contract, if at the time when he makes it, he is capable of understanding it and of forming a rational judgment as to its effect upon his interests. The law of torts admits several views. The opinion of medieval writers and judges in England was that lunacy could not be a valid defence for an action for trespass. Modern authors take the diametrically opposite view, holding the estate liable for consequences for the wrongs done by the mentally ill.15

Determination of Age The determination of age can be a significant question in many a criminal and civil litigation. For criminal law, as a measure of general defence against being guilty and in rape cases, to effectuate the charge, the age of the victim will be relevant. It may also be a relevant consideration if the accused may need to be tried as a juvenile.16 In civil law it is again necessary to determine the age of any person so as to establish their liability under law. Age also assumes significance in service

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matters when an employee in an establishment seeks modification of the entry of age in the service register (which will have a bearing on the age of superannuation), but courts will always be careful not to modify the entry without unimpeachable proof.17 Election laws prescribe the minimum age for qualification as a voter as well as the candidate standing for election.18 Determining age is a task that is to be addressed with expertise; the court cannot make a whimsical, baseless assumption about the age of the parties. It is necessary, therefore, that medical evidence regarding age be precise and diligently given. In fact, the established practice from past precedents show that in cases of age disputes where the opinion stated by the expert is also uncertain, the same is dismissed as inconclusive evidence and has no value.19 The evidence of a medical officer with regard to age is of greater value than that of an ordinary witness, yet it is opinion rather than conclusive proof.20 The exercise is normally undertaken through examination of X-ray scans and by conducting an ossification test.The age determined through an ossification test may even be discarded when better evidence is available through the corporation birth register or the register of the hospital where the person is born.21 An error of two years more or less in determining the age was held to be possible when ascertained by radiological examination.22 Rule 22(5) of the Juvenile Justice (Care and Protection of Children) Act, 2000, sets out the certificate of birth issued by the school as having a higher order of priority than the opinion of the duly constituted medical board, and the decision of the high court to rely on the school certificate as against the medical board’s opinion was upheld by the Supreme Court.23 This is not to say that the school certificate is always correct. It is not infrequent that parents furnish an incorrect date of birth to school authorities in order to secure admission for their children.24 In borderline cases, where two views are possible, the court would lean in favour of regarding the accused as a juvenile.25 Age may also be determined by the number of teeth erupted, and the location and stage of eruption. IN CRIMINAL CASES AS AN EXPERT WITNESS

Dying Declaration The general rule is that all oral evidence must be direct; ‘if it refers to a fact which could be seen, it must be the evidence of the witness

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who says he saw it; if it refers to a fact which could be heard, it must be the evidence of the witness who says he heard it; if it refers to a fact which could be perceived by any other sense, it must be the evidence of the witness who says he perceived it by that sense.’ It is similar with regard to opinion. These aspects are elaborated in Section 60 of the Evidence Act. The eight clauses of Section 32 are exceptions to the general rule against hearsay just stated. Clause (1) of Section 32 makes relevant what is generally described as a dying declaration, though such an expression has not been used in any statute. It essentially means statements made by a person as to the cause of his death or as to the circumstances resulting in his death. The grounds of admission are, first, that the victim is generally the only principal eyewitness to the crime, the exclusion of whose statement might deflect the ends of justice; and second, the sense of impending death, which creates a sanction equal to the obligation of an oath. The general principle on which this species of evidence is admitted is that they are declarations made in extremity, when the party is at the point of death, when every motive to falsehood is silenced, and the mind is induced by the most powerful considerations to speak the truth; a situation so solemn and so lawful is considered by the law as creating an obligation equal to that which is imposed by a positive oath administered in a court of justice.26 There is a legal maxim, nemo moriturus praesumitur mentire, meaning that a man will not meet his maker with a lie in his mouth.27 It is essential that the declarant must be in a sound state of mind at the time of making the declaration.28 A conscious state may not be a fit state of mind to give a statement.29 A medical attendant is therefore required to certify that the patient is in a fit state of mind to make a statement before it is recorded.30 The Constitution Bench in Laxman v. State of Maharashtra31 resolved the difference of opinions between the decisions expressed by the two benches of three learned judges in Paparambaka Rosamma and Ors v. State of AP 32 and Koli Chunilal Savji and Another v. State of Gujarat.33 It held that there is no requirement of law that there should always be a medical certification that the injured was in a fit state of mind at the time of making a declaration and such certification by the doctor is essentially a rule of caution, and even in the absence of such a certification the voluntary and truthful nature of the declaration can otherwise be established. The injured could record the statement themselves in some cases. An endorsement

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by the doctor as regards mental fitness of the deceased is a rule of prudence and not the ultimate test as to whether or not the statement was truthful or voluntary. Even if there is no specific endorsement but a contemporaneous piece of evidence from the doctor that the patient was oriented to time and place and mentally clear at the time of recording the dying declaration, that itself would be sufficient.34

manner of recording dying declaration by a doctor Usually, after the doctor is satisfied about the competence and the ability of the injured person to give evidence, it is better that it is recorded in a question-and-answer form.35 This is more to evoke credibility than a necessary method. In a case where the deceased had 90 per cent burn injuries and the condition was precarious, elaborate questioning could not have been possible and the evidence of the doctor who had merely questioned the victim for the limited purpose of stating the history of the case was found as sufficient to support the truth of a dying declaration.36

recording of dying declaration by a person in the presence of a doctor The most common practice that the dying declaration is recorded by a person other than the doctor, after the doctor has certified that the patient is in a fit state of mind to give a statement. A magistrate recording a dying declaration has to be fully satisfied about the competence of the deceased to give a statement by such a certification.37 The Supreme Court in Chandra Narain Yadav v. Shibjee Yadav38 criticized a high court’s choice to discard a dying declaration obtained by a magistrate in the presence of a doctor who opined that the deceased was in a fit condition to make the statement. In State of Rajasthan v. Parthu,39 the dying declaration had been recorded in the presence of a doctor, who did not certify on the fitness of the deceased to make the statement, but attested to the thumb impression of the deceased on the statement. The Supreme Court held as unwarranted the decision of the high court in acquitting the accused convicted by the trial court on the basis inter alia of that statement, on the ground that the doctor had not certified that the deceased was in a fit state

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of mind to make a statement before the investigating officer and that he had not treated the deceased.Its reasoning was that although there could be no attestation of such a statement, what the doctor meant by this conduct was that the statement by the deceased was made before the investigating officer in his (doctor’s) presence and has been recorded correctly. Even the non-examination of a doctor in such a situation was found in Shanmugham v. State of TN40 as insufficient justification to discard the dying declaration. The presence of a doctor when the deceased had made a statement in Telugu and recorded by a magistrate, as translated by doctor in Tamil, was considered reliable in Ravikumar v. TN.41

value of doctor’s evidence relating to dying declaration When Conviction Could Be Made on the Basis of Such Evidence A dying declaration could form the sole basis for conviction if it is free from any form of doubt and is recorded in the manner provided under law.42 There is neither rule of law nor of prudence that a dying declaration cannot be acted upon without corroboration.43 If the court is satisfied that the dying declaration is true and voluntary, it can base conviction on it without corroboration.44 Merely because a dying declaration does not contain the details as to the occurrence does not mean that it is to be rejected.45 Similarly, it is not be discarded merely because it is a brief statement. On the contrary, the shortness of the statement guarantees truth.46 When It Is Not Safe to Rely on Such Evidence When there are two dying declarations and there is inconsistency between them, suggesting the possibility of tutoring and false implication due to strained relations, it will not be safe to rely on them for conviction.47 If a dying declaration is suspicious, it should not be acted upon without corroborative evidence.48 If the deceased was unconscious and could not have made a dying declaration, the evidence with regard to it is to be rejected.49 A dying declaration which suffers from infirmity by not following the procedure prescribed by law cannot form the basis of conviction.50 Normally in order to satisfy whether deceased was in a fit mental condition to make the dying declaration, the court looks to medical opinion. But where the eyewitness has said

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that the deceased was in a fit and conscious state to make this dying declaration, the medical opinion cannot prevail.51 Where the prosecution version differs from the version given in the dying declaration, the declaration cannot be acted upon.52

In Rape Cases There is no general rule that a rape case cannot be decided without evidence of a doctor. The police normally recommend that a woman be examined by a doctor, but the latter should not refuse to examine a person merely because the reference did not come through the police. A delay in the examination may result in loss of evidence, possibly even by the victim inadvertently.53 The offence demeans the dignity of the victim and it is assumed that in the Indian society, no girl makes allegation of rape against herself, conscious as she is about the repercussions in the form of social stigma flowing therefrom.54 There are any number of cases where convictions are recorded that discarded even the reports of the doctor that the hymen is intact or that the vagina admitted only tip of the little finger with difficulty, and no intercourse could have been done.55 It must be remembered that rape is a legal term and not a diagnosis to be made by the medical officer treating the victim. Consequently, the conclusion as to whether rape has occurred or not is a legal conclusion and not a medical one.56 To constitute the offence of rape, it is not necessary that there should be complete penetration by the penis with emission of semen and rupture of hymen. Partial penetration of the penis within the labia majora or the vulva or pudenda with or without emission of semen or even an attempt at penetration is sufficient for the purpose of law. In such a case, the medical officer should mention these facts in the report, but should not state that no rape has been committed. The only evidence that the doctor is to provide has to be whether there is evidence of recent sexual activity. Even the presence or absence of spermatozoa is ascertained only for the purpose of corroboration and is not always necessary.57 The corroborative evidence of the doctor shall consist of whether there are any injuries or scratch marks on any part of the body of the victim, particularly in the private parts; the presence of semen and the development of sexual organs; and age and capacity for sexual intercourse. Absence of evidence of one or

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the other of the above aspects may not disprove the criminal act, but positive evidence of any one of them will be very material for proof of guilt of the accused. Signs of physical violence are an indicator of the absence of consent, where consent is relevant.58 The law presumes absence of consent in certain situations59 and when the victim states in her evidence before the court that she did not consent.60 ‘Custodial rape’ makes irrelevant the issue of consent for the person who holds the position of authority or trust, such as when a public servant who induces or seduces a woman in his custody,61 or for the act of a superintendent or a manager of a jail62 or a member of the management or staff of a hospital.63

as regards assessment of age The definition of rape in the IPC makes determination of age relevant in cases where the victim is less than 16 years of age and when the issue of consent is irrelevant. A doctor’s evidence on the basis of X-ray scans of bones and ossification tests will be relevant, though not conclusive.64 In Vishan v. State of Maharashtra,65 the age determined as 19 after ossification test and the age as entered in the school were found to be not binding as against the evidence of the parent and the age as entered in the birth certificate maintained by the municipal corporation. Between school certificate showing the age to be 14 and the doctor’s evidence that the victim was more than 18, the latter’s assessment was discarded in S.Ramakrishna v. State.66

as regards the physical act and injuries On the Victim Injuries noted by the doctor would offer the best corroborative evidence to the offence of the commission of rape.67 The rupture of hymen in the 11 o’ clock position and the development of sexual character will be examined as corroborative evidence of the commission of rape.68 Bite marks on the cheeks or breasts may be present in sexual assault cases. But absence of injury does not disprove rape.69 In cases where the victim is examined a few days after the alleged incident, absence of injury is not uncommon.70 For lesser offences, when the act in question is outraging the modesty of a woman by acts such

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as fondling, there may not be injuries on the victim, but that might not be material to conviction.71 The doctor shall not make any hasty generalization by personal observations on the scope for consent of the victim in the sexual act by observing that there were no injuries on the victim. Sometimes the observation of the doctor about the size of the orifice of the sexual organ and the ease with which the fingers could be inserted may suggest that a woman is habituated to sex as if to suggest that the woman could be faking about being forced into sex. The victim should not be traumatized further by personal views in the doctor’s report, or claims that the absence of injuries means that the victim must have consented to sex, or that the victim was sexually active by reference to the finger test.72 The Evidence Act has been amended by insertion of Section 53A that provides that where the question of consent is in issue, the evidence on the character of victim or of such person’s previous sexual experience with any person shall not be relevant on the issue of such consent or the quality of consent. Section 146 has also been amended to provide that it shall not even be permissible to suggest to the victim in the cross examination as to the general immoral character or previous sexual experience of such victim with any person for proving such consent or the quality of consent. On the Accused It is most usual that the police present the accused for their examination. Noting the injuries on the accused, such as nail scratches on any part of the body or genitals and assessment of the ability of the accused for sex will provide important corroborative support to the prosecution. It is not always necessary that the accused shall have injuries on his person. Even if the act complained of is rape of a young child of about six years, the Supreme Court referred to the views of Modi in his book on Medical Jurisprudence (22nd edition, pp 502–6) held that it was not necessary that there should always be marks of injuries on the penis in such a case.73 In one case, even when the doctor gave evidence that two pin-head abrasions found on the genital of the accused could have been the result of forcible sexual intercourse, this was found to be not sufficient to establish the guilt in the facts of a case where the ‘theory of last seen’74 with the accused had not been established.75

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collection of blood and dna testing The amended provisions of the CrPC empower the compulsory examination of the accused in a criminal case in the course of investigation to be subjected to examination that shall include examination of blood, blood stains, semen, swabs in case of sexual offences, sputum and sweat, and finger nail clippings by the use of modern and scientific techniques including DNA profiling and such other tests as the medical practitioner considers relevant.76

Murder Cases

homicidal injuries When the doubt is whether the death was by suicide or homicide, the nature of injuries and doctor’s evidence as to whether such an injury could have been caused by the deceased or inflicted by some other person, the doctor’s evidence could be crucial. Wounds, even if small and insignificant, and inflicted on the vital organs or the main blood vessels, are likely to produce death much earlier than injuries, though extensive, inflicted on non-vital parts of the body.77 Post-mortem reports are important for assessing the cause of death and the identification of ante-mortem injuries in order to deduce whether the injuries could have been caused in the manner suggested by the prosecution, whether particular weapons could cause particular types of injuries, whether such were the injuries on the body, and whether such types of injuries are sufficient in the ordinary course to cause death. In State of HP v. Jeet Singh,78 the doctor’s evidence of poison and asphyxiation by smothering with a pillow were found to be the causes of death. If there is a conflict of opinion between the evidence from the doctor who conducted the post-mortem and the person who had given expert testimony that the death could have been natural, the evidence of the former would be preferred, as a doctor who performs the post mortem has had the occasion to look and examine the injuries on the body of the deceased.79

likelihood of weapons used Examination of the injury, including the edges, margins, ends, width, and shape, could all be vital pointers to the nature of weapon used for

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causing the injury. Doctors are not usually eyewitnesses, but use their expertise to assess whether a contusion or a lacerated wound could have been caused by a blunt weapon or a fall, or whether an incised wound could have been caused by a particular sharp weapon. The likelihood, probability or possibilities are all matters of opinion to be expressed by a doctor, and the quality of such evidence assessed by a court.

suicide or homicide In case of death occurring from wounds, the question often raised is whether they were the result of suicide, homicide, or accident. The following points are to be noted: (1) the situation and character of the wounds; (2) the number, direction, and extent of the wounds; and (3) the condition of the locality, the surroundings of the woundedperson, and the circumstances of the injury.80 Suicidal wounds are usually on the front or on the sides of the body, in easily accessible positions like the throat, chest, or wrist. They are usually incised or punctured wounds. A gunshot wound is usually a contact wound situated on either temple, in the centre of the forehead, the roof of the mouth, in the chest or epigastrium in front or the left side, and sometimes under the chin. Sometimes, the firing is done by pulling a string tied to the trigger by the big toe. In homicidal and accidental shooting, the wound may be on any part of the body and the path of the bullet may be in any direction. Lacerated wounds are either accidental or homicidal. Several injuries on the body, if they are deep and extensive, are, as a rule, homicidal. The presence of a large number of superficial wounds is presumptive evidence of self-infliction. ‘Modi presents a tabulation of the differences between suicidal and homicidal cuts with respect to direction of the wound, the depth of the wound, the presence of weapon used, the condition of the room, condition of clothes, etc.’81

Injuries The word ‘injury’ as defined under Section 44 of the IPC denotes any harm caused illegally to any person, in body, mind, reputation, or

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property. It will be possible to assess the injury, both physical and mental, by a doctor, but in the context of criminal cases, we normally refer to the physical harm that is caused by injures. Hurt is defined independently under the IPC under Section 319 as bodily pain, disease, or infirmity caused to any person. The definition of grievous hurt avoids the expression ‘grievous injury’ but it is understood that an injury that causes grievous hurt is in fact a grievous injury, and any other injury is simple in nature. Voluntarily causing hurt82 and voluntarily causing grievous hurt83 are distinct offences. The voluntary act of causing hurt or grievous hurt by dangerous weapons or means are aggravated offences.84 The classification of the injury and the weapons used will therefore have an immediate bearing on the nature of the offence and the types of punishment. Examination of injuries must record whether they were simple or grievous; their number; the character or their edges; the size as regards length, breadth, and depth; the line of direction; and their situation.While mentioning the exact situations, a reference to some bony prominences or anatomical landmarks should be made, for example, so many centimetres above or below the front or back of the left or right wrist, and elbow.85

Identification of the Individual The identity of the accused, the victim, and the witnesses are all of vital significance in a criminal trial. A case of baby swapping soon after birth may require the identification of the child as born to a particular mother. Identification of paternity is often important in matrimonial litigation, when non-access of the man with the mother who has given birth to a child may be taken up in defence to deny paternity. Subjecting a person to identification could itself be a point of objection on the constitutional touchstone of protection against self-incrimination.

through dental alignment and teeth Teeth are useful for identification in cases of bodies destroyed by fire or decomposition. Teeth are well protected and more resistant to destructive agents than any other structures. Dental peculiarities, like artificial, stained, carious, worn-out, filled, or missing teeth may provide vital clues for personal identification.86

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through hair Hair is an important means of establishing identity, as it resists putrefaction and the effects of dyeing, bleaching, cutting, and heat are apparent. The hair of Indians is generally dark and fine; that of the Chinese and Japanese is dark and coarse; and that of the people of African descent is curly and woolly.

ossification of bones The extent of ossification and the union of epiphysis in bones are important tools for determination of age. Epiphyseal union at the wrists may occur in girls at the age of 17 and 18 and in males at 19 and 20; at the knee in females at 16 and 17 and in males at 20 and 21. The four middle pieces of the sternum, which constitutes its body, fuse with one another from below upwards, between 14 and 25 years of age.The xiphoid unites with the body at about 40, while the manubrium rarely unites with the body except in old age.87 Determination of the accused’s age is a complex exercise where no fixed norms and abstract formula can be laid down. In a case where it had to be determined whether the accused was a juvenile, the Supreme Court said that the court should remember that an opinion based on the radiological examination is a useful guiding factor for determining the age of a person but it is not incontrovertible.88 The indication of age afforded by the appearance of wisdom teeth is notoriously untrustworthy. A medical officer may give an opinion as to the age of a prosecutrix on the basis of the general development of her body, like her secondary sex characters. Where opinion is based on particulars with regard to height, weight, etc., and the indications given by the doctor could be observed by a layman, the statement of the doctor is considered a mere opinion.89

physical features of the body The two prominent communities of Hindus and Muslims in India are sometimes recognized through absence or presence of circumcision, the sacred thread, marks on the forehead, tuft of hair, tan marks on the exposed part of the body due to peculiar types of clothes, piercing

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of ear lobes, etc. Ethnicity is determined by the types of skull, size of the forehead, the face, orbits, the upper extremity, and the lower extremities.

dna testing DNA consists of four nitrogenous bases—adenine, thymine, cytosine, and guanine—and phosphoric acid arranged in a regular structure. It is a polymer of nucleotides, which are the units strung together to form a DNA strand. The backbone of a strand is formed by a sugar base component and a phosphate group. The DNA molecule is composed of two DNA strands coiled in a double spiral (helix). DNA is like a book of instructions regarding the characters of the organism (from ant to elephant, bacteria to bulls, honey bee to humans).There are repeated specific sequences, which are individualistic in nature. In DNA typing, the DNA from samples like blood, semen, and hair is cut into fragments of sequence patterns using a specific enzyme.The fragments are separated into bands by gel electrophoresis, and then the DNA pattern is transferred to a nylon membrane to which a radioactive probe is added. An X-ray scan is then taken. From any sample in that particular fragment length, the bands from the same source are the same. This individualization is utilized for comparison. The developed X-ray film shows the DNA bands. They are then matched with the suspect. If they match, the person or the specimen is considered as identified and its individuality established. Thus, it is now possible to connect the blood, semen, teeth, or hair from the crime scene or from a body to a particular individual.90 However, a medical practitioner has to grapple with issues of consent and testimonial compulsion.91

Narco-analysis, Brain Mapping, and Lie-detectors The scientific credibility of narco-analysis is suspect but such tests are still carried out to gather details in hard cases where sufficient clues are not available to prove the guilt of an accused or when the prosecution cannot make any headway. The medical personnel that carried out the tests have to be examined in court to vouch for the correctness of the report to the extent to which the information collected could be relevant as a piece of evidence. As an incriminatory piece of evidence,

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they cannot be relied on because of the constitutional protection against self-incrimination under Article 20(3).92

Mental Condition of the Accused as General Defence

statutory provisions In criminal law, jurisprudence shows how even in the harshest of days, insanity was acknowledged as a possible defence for the defendant, as shown by the maxims furious nulla voluntes est (‘a mad man has no will’) and Furious absenti loco est (‘madness is like one who is absent’). Chapter 4 of the IPC deals with ‘General Exceptions’.The importance of the chapter was highlighted by Lord Macaulay before the House of Commons at the time of introduction of the bill: This Chapter has been framed in order to obviate the necessity of repeating in every penal clause a considerable number of limitations. Some limitations relate only to a single provision, or to a very small class of provisions. … Every such exception evidently ought to be appended to the rule which it is intended to modify. But there are other exceptions which are common to all the penal clauses of the Code, or to a greater variety of clauses dispersed over many chapters. It would obviously be inconvenient to repeat these exceptions several times in every page.We have, therefore, placed them in a separate chapter and, we have provided that every definition of an offence, every penal provision, and every illustration of a definition or penal provision, shall be construed subject to the provisions contained in that chapter.93

The principle embodied in the chapter is based upon the maxim actus non facit reum, nisi mens sit rea, that is, an act is not criminal unless there is criminal intent.94 Section 84 of the IPC lists insanity as one of the general exceptions to the commissioning of the crime.The section provides that ‘nothing is an offence which is done by a person who, at the time of doing it, by reason of unsoundness of mind, is incapable of knowing the nature of the act, or that he is doing what is either wrong or contrary to law.’ The burden of proving the existence of circumstances bringing the case within the purview of Section 84 lies upon the accused under Section 105 of the Indian Evidence Act. Under the section, the court shall presume the absence of such circumstances.The illustration (a) to Section 105 is as follows:

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(a) A, accused of murder, alleges that, by reason of unsoundness of mind, he did not know the nature of the act. The burden of proof is on A.

The question whether the appellant has proved the existence of circumstances bringing his case within the purview of Section 84 will have to be examined from the totality of circumstances. The unsoundness of mind that results in one being incapable of understanding the consequences can ordinarily be inferred from the circumstances. If, however, an act is committed out of extreme anger and not as a result of unsoundness of mind, the accused would not be entitled to the benefit of the exception in Section 84, IPC.95 To qualify, the accused must have been suffering from unsoundness of mind at the time of the commission of the act, and the burden of proving this lies on the accused. Prior or subsequent insanity is, therefore, no defence under Section 84.96

nature of burden of proof The McNaughten rules, as laid down in the M’Nughten’s case, have been recognized universally as the unsaid principles governing the determination of insanity.97 In Dahyabhai Chhaganbhai Thakkar v. State of Gujarat,98 the Supreme Court has held that even if the accused was not able to establish conclusively that he was insane at the time he committed the offence, the evidence placed before the court may raise reasonable doubt as regards one or more of the ingredients of the offence, including mens rea of the accused, and in that case the court would be entitled to acquit the accused on the ground that the general burden of proof resting on the prosecution was not discharged. The burden of proof on the accused to prove insanity is no higher than how it is cast on a party to establish in civil proceedings, which, in other words, means a preponderance of probabilities. The Court held that: The doctrine of burden of proof in the context of the plea of insanity may be stated in the following propositions: (1) The prosecution must prove beyond reasonable doubt that the accused had committed the offence with the requisite mens rea; and the burden of proving that always rests on the prosecution from the beginning to the end of the trial. (2) There is a rebuttable presumption that the accused was not insane, when he committed the crime, in the sense laid down by Section 84 of

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the Indian Penal Code: the accused may rebut it by placing before the court all the relevant evidence—oral, documentary or circumstantial, but the burden of proof upon him is no higher than that rests upon a party to civil proceedings. (3) Even if the accused was not able to establish conclusively that he was insane at the time he committed the offence, the evidence placed before the court by the accused or by the prosecution may raise a reasonable doubt in the mind of the court as regards one or more of the ingredients of the offence, including mens rea of the accused and in that case the court would be entitled to acquit the accused on the ground that the general burden of proof resting on the prosecution was not discharged.

As regards ascertaining the existence of circumstances bringing the case within the purview of Section 84 IPC as the time when the offence is committed, the court has ruled: When a plea of legal insanity is set up, the court has to consider whether at the time of commission of the offence the accused, by reason of unsoundness of mind, was incapable of knowing the nature of the act or that he was doing what was either wrong or contrary to law. The crucial point of time for ascertaining the state of mind of the accused is the time when the offence was committed. Whether the accused was in such a state of mind as to be entitled to the benefit of Section 84 of the Indian Penal Code can only be established from the circumstances which preceded, attended, and followed the crime.([1964] 7 SCR p. 363 at p.370)

shrikant anandrao bhosale v. state of maharashtra No two cases are the same; no two persons of unsound mind could be expected to behave the same way. It may be useful to refer to a case dealt with by the Supreme Court as illustrative of how the court would approach the defence of unsoundness of mind. In Shrikant Anandrao Bhosale v. State of Maharashtra,99 the Supreme Court relied on the existence of the following factors as allowing the general exception against culpability: 1. 2. 3.

The appellant had a family history—his father was suffering from psychiatric illness; The cause of ailment not known—heredity had played a part; The appellant was being treated for unsoundness of mind since 1992—he was diagnosed as suffering from paranoid schizophrenia;

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4. 5. 6. 7.

Within a short span, soon after the incident, he had to be taken for treatment of the ailment to the hospital twenty-five times; The appellant was under regular treatment for the mental ailment; The weak motive of killing of the wife—she was opposing the idea of the appellant resigning the job of a police constable; and Killing in daylight—the appellant made no attempt to hide or run away.100

As a Witness for Extra-judicial Confession Just as a doctor near a dying victim sometimes participates in recording a dying declaration, he can similarly earn the confidence of an assailant in a criminal case as the recipient of an extra-judicial confession. The concept of extra-judicial confession is primarily a judicial creation. It should be used with restraint in limited circumstances, and courts will invariably look for corroboration. An extra-judicial confession made to a doctor about the commission of an offence was found by the Supreme Court in a criminal case as a vital piece of evidence for finding the guilt of the accused.101

Ascertainment of Mental Illness in Criminal Proceedings Ascertainment of mental illness and care to the mentally unsound person who is an accused in a criminal case requires a doctor’s certification and attention in the following situations specified under the CrPC. Chapter 25 of the code deals with accused persons of unsound mind. Section 328 prescribes the procedure when the accused is a mentally ill person. When a magistrate has reason to believe that an accused against whom an enquiry is being held is of unsound mind, they shall inquire into the fact of such unsoundness of mind and shall have that person examined by the civil surgeon of the district or such other medical officer as the state government may direct.That surgeon or other officer will then be examined as a witness in writing. Pending such examination and inquiry, the magistrate may order the release of the mentally ill person on sufficient security being given in accordance with the provisions of Section 330. After the inquiry, if the magistrate is of the opinion that the accused is of unsound mind, he shall record a finding to that effect and shall postpone further proceedings in the case.

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Section 329 provides that if at the trial of any person it appears to the magistrate or court that the person tried is of unsound mind, the magistrate or court shall in the first instance try the fact of such unsoundness and incapacity, and if satisfied on such evidence that the accused is of unsound mind and consequently incapable of making his defence, the magistrate shall record a finding to that effect and shall postpone further proceedings in the case. Section 331 provides for resumption of inquiry or trial when the person concerned ceases to be of unsound mind. Section 337 of the code describes the procedure where a prisoner of unsound mind is reported as capable of making his defence. It provides that if the inspector general of prisons (if the prisoner is in jail) or two visitors of an asylum (if the prisoner is in a lunatic asylum) certify that the prisoner is capable of making his defence, this certificate shall be received as evidence, and the court or magistrate will deal with them as provided under Section 332 by proceeding with the inquiry or trial. Section 338 provides the procedure where a detained person of unsound mind is declared fit to be released.The section provides that if a person of unsound mind is detained under the provisions of subsection (2) of Section 330 and the inspector general or visitors certify that, in their judgment, that person may be released without danger of injury to themselves or any other person, the state government may order them to be released, or to be detained in custody, or to be transferred to a public lunatic asylum if they have not already been sent to one. If it orders them to be transferred to an asylum, it may appoint a commission consisting of a judicial and two medical officers. Subsection (2) of Section 338 provides that this commission shall make a formal inquiry into the state of mind of that person, take such evidence as is necessary, and shall report to the state government, which may order their release or detention, as it thinks fit.102 Section 339 of the code provides for delivery of the person of unsound mind to the care of relative or friend. IN CIVIL CASES AS A WITNESS

Assessing Mental Capacity or Illness The competence of an individual to enter into a contract depends on their mental condition and mental illness at the time of contract. This robs the element of consensus ad idem so essential to the validity

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of any contract. The benefit under a contract or enforcement of any legal obligation to a person who is mentally ill is therefore secured through a lawfully appointed guardian. The Mental Health Act makes provision for the appointment of a guardian for a mentally ill person, and a manager for administration of their property, and assigns to medical personnel the role of certifying illness, admit patients, and run hospitals. The prosecution or defence of actions in civil courts would require inquiries into the mental health of a litigant whose property or personal interest needs to be protected. Here again, doctors have important duties assigned through the CrPC to adjudge a person as being of unsound mind for appropriate action.103 Doctors may also be cited as witnesses to the mental capacity of a patient to execute a will at the relevant time.104 Insofar as the grounds for annulment of marriage have a bearing on the mental health of a patient, assessment and certification of a spouse fall within the province of a doctor’s assistance to the courts.105 Assessment of disability to secure the benefits of the provisions of the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995, and the certification of the mental condition for the applicability of the provisions of the National Trust for Welfare with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999, would require the medical personnel’s opinions or reports.

appointment of guardian A mentally unsound person could appear as a plaintiff or defendant through a guardian appointed by court under Order 32, Rule 15 of the CrPC. The court shall adjudge as mentally ill a person requiring appointment of a guardian, by seeking for medical opinion there for.106 It must be noted that a doctor examining a patient must know the proceedings for which the assessment and certification are necessary.The degree of mental illness is different for different type of situations. A person who may have to protect his person or property may yet fail to prosecute a litigation due to his mental capacity,107 and may still be appraised differently when facing a divorce suit brought on the ground that he is ‘incurably of unsound mind’, the requirement under the Hindu Marriage Act. A division bench of the Madras High Court held in G.V. Lakshminarayanan v. G.V. Nagammal108 that where there

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is a divergent opinion relating to the mental illness of a party, the court has the power to appoint a panel of doctors to determine the issue.

in matrimonial proceedings Issues of paternity, male virility, frigidity, mental disorder, and certain types of illness are contentious in matrimonial proceedings, and courts look to doctor’s evidence to render effective adjudication. Impotence as a cause for non-consummation of marriage, incapacity to consent to marriage due to mental unsoundness, and pregnancy by a person other than the petitioner are grounds for avoiding a marriage, subject to certain procedural conditions under Section 12 of the Hindu Marriage Act. Incurable unsoundness of mind or a disorder of such a kind and to such extent that the petitioner cannot reasonably be expected to live with the respondent, virulent and incurable form of leprosy, venereal disease in a communicable form, and voluntary sexual intercourse with persons other than his or her spouse are grounds for which medical evidence may be necessary for consideration in the dissolution of marriage by a decree of divorce under Section 13 of the Hindu Marriage Act. The Special Marriage Act and Divorce Act also contain similar provisions that lend primacy to securing medical opinions for rendering effective adjudication. It was held in Sharda v. Dharmpal109 that (1) a matrimonial court has the power to order a person to undergo medical tests; (2) passing of such an order by the court would not be in violation of the right to personal liberty under Article 21 of the Indian Constitution; (3) the court should exercise such a power if the applicant has a strong prima facie case and there is sufficient material before the court. If, despite the order of the court, the respondent refuses to be submitted to medical examination, the court will be entitled to draw an adverse inference against him. In determining whether the court should compel a person to undergo a medical test to ascertain the paternity of a child, the court should have due regard to statutory conclusive presumption of paternity under Section 112 of the Evidence Act, and shall not compel a party to submit to a test as a matter of routine.110 In a case requiring a blood grouping test to determine parentage, the Supreme Court held that it cannot normally be

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ordered by a court. A strong case of non-access of the husband of the woman who has conceived or delivered the child has to be made by the person questioning the legitimacy of the child, before the court passes an appropriate order. The court will also consider the effect of ordering a blood test on the status of the child and the character of the mother.111 The provision relating to blood grouping also applies to DNA tests.112

ascertaining mental capacity to contract Consensus is a vital component in fructifying a valid contract, and consensus requires a degree of competence of the individuals concerned to create binding rights and obligation; Sections 10–14 of the Contract Act lay down all the legal requirements; Section 10 sets out what agreements are contracts; Section 11 describes who are competent to contract; Section 12 defines what a sound mind is for the purpose of contracting; and Sections 13 and 14 define consent and free consent respectively. As the law requires the person contracting to be someone who is capable of understanding the contract and of forming a rational judgment as to its effect upon his interests, the courts may call for medical opinion to test the validity of a contract from the standpoint of an individual’s mental competence. A person who is usually mentally challenged but occasionally of sound mind may make a contract while the latter applies. A person who is usually of sound mind but occasionally not may not make a contract when he is of unsound mind.113

mental capacity to execute a will Unlike most other legal instruments, a will or testament speaks from the grave, as it were, and the fundamental requirement of the instrument’s validity is that it was executed in a sound state of mind. Section 2(h) of the Indian Succession Act defines a will to mean ‘the legal declaration of the intention of a testator with respect to his property which he desires to be carried into effect after his death’. Section 59 describes every person of sound mind who is not a minor as capable of disposing their property by will.The ‘free agency of the testator’ will be tested in all cases where there is an allegation of fraud, coercion, or importunity.114 There is no particular legal requirement to examine a

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doctor for testimony on the mental condition or disposing capacity that has a bearing on any illness preceding the execution of the will. In Smt. Radhamma v. H.N. Muddukrishna,115 the non-examination of a doctor treating the executant, who was allegedly incapacitated by paralytic attack, was taken by a division bench of the Karnataka High Court as a circumstance against a contention that the will could not have been executed by a person of sound mind. The doctor’s evidence lends greater credibility regarding the mental condition of a patient who has suffered from mental debility or continued ill health, and whose will is in question.

Doctor as Witness to a Will If doubts are raised in a court of law about the validity of a will executed in contemplation of death or in a hospital in the presence of a doctor, the doctor’s evidence may be crucial. It may also be possible that the doctor himself attests a will, in which case, his evidence becomes one of legal necessity to prove the will if the other attestor is not available. There are no recent cases reported from court with the doctor as a witness to a will and the value of his evidence. In a case before the Supreme Court of Wisconsin, Will of Poller: Goodell, Guardian ad litem, and Another v. Poller116 the attestation by three doctors for a will prepared in a solicitor’s office was taken as an unusual thing. An attempt was made to show that one of these doctors was paid to sign the will by the defendant, but the trial court excluded that evidence. This was found to be erroneous by the higher court, which said: The proof of undue influence generally rests in circumstantial evidence. ‘Fraud travels incognito.’ Here was an unusual situation. The will was not signed in the lawyer's office where it was drawn. In fact the evidence does not show who drew the will. An old gentleman eighty-five years of age presents himself in a physician’s office and wants to know what can be done to prevent ‘a crooked lawyer’ from breaking his will. Three physicians are assembled to witness the will. Sam Poller was the principal beneficiary under the will. If these doctors or some of them had been paid by Sam Poller for their services in the matter, it had a very material bearing upon the question of whether Sam Poller engineered the execution of the will.The pursuit of this inquiry might have opened up an illuminating field. It should have been permitted.

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The court set aside the probate and directed that a fresh enquiry be made.

Determination of Medical Negligence through Doctor’s Expert Evidence An expert witness in a given case normally discharges two functions. The first duty of the expert is to explain the technical issues as clearly as possible so that it can be understood by a layperson. The other function is to assist the judicial forum in deciding whether the acts or omissions of the medical practitioners or the hospital constitute negligence. In res ipsa loquitur situations, such as when the lab test shows negative for typhoid but the doctor persists in the treatment for the disease till the patient ultimately succumbs, it is not even necessary that a doctor should be examined to prove medical negligence.117 In most cases, whether a medical practitioner or the hospital is negligent is a mixed question of fact and law, and the court is not bound in every case to accept the opinion of the expert witness. A view held by the Supreme Court in Martin F.D’Souza v. Mohd. Ishfaq118 that a doctor’s opinion must always be taken by an investigating agency regarding a criminal complaint of medical negligence against a doctor was held in a subsequent decision,V. Kishan Rao v. Nikhil Super Speciality Hospital and Another,119 as not laying down the correct law. Reliance on a doctor’s affidavit assessing the quality of another doctor’s treatment when the issue was whether the latter was responsible for medical negligence was found as admissible under the Consumer Protections Act in Malay Kumar Ganguly v. Dr Sukumar Mukherjee.120

Assessing Disability

general Assessment of disability by a medical professional assumes relevance under various enactments in claims of special privileges in public appointments that make provision for reservations. In the context of employment, the extent of disability may have an important bearing on medical invalidation for continuation in appointment or termination of employment. In public transport systems, concessions are

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extended for fares to travel and reservation of seats. Injuries resulting ‘in the course of or out of employment’ (a requirement under the Workmen’s Compensation Act, 1923), enable the affected workman to claim compensation against the employer. The Income Tax Act also provides for a higher exemption from tax both for persons under disability121 and for parents or legal guardians of persons with disability.122 Deductions are also allowed to persons making donations to registered trusts and societies doing work for the handicapped.123 The act details the procedure for certification of disability through doctors124 and the types of disability that would qualify for these benefits.125 Guidelines for the evaluation and the procedure for certification of visual impairment, locomotor or orthopaedic disability, speech and hearing disability, mental retardation, and multiple disabilities were provided in The Gazette of India.126

motor accident claims tribunal cases The Motor Vehicles Act contains a distinct head of claim for determination of compensation for disability, which is continuing and permanent, that is, the disability which is not termporary, say, for a particular period, during the period of treatment or requiring temporary convalescence. Assessment of disability is not a lay exercise and there is a well-laid out protocol in medical texts that a medical professional is well acquainted with. The act does not set out any specific guideline except with regard to determining the loss of earning power under Schedule 2. Compensation is assessed by use of a structured formula specified under Section 163A of the act, and the schedule directs that the assessment shall be done in the same scale as specified under the Workmen’s Compensation Act. A tribunal that determines compensation for death or injuries examines the heads of claims, inter alia, for pain and suffering; treatment costs including consultation charges, hospital expense, medicines, etc.; doctors’ evidence for assessment of disability (whether permanent or temporary);127 the extent of loss of earning capacity; and estimation of future medical expenses.128 It is most desirable that the doctor who examines a patient and declares that permanent disability has resulted shall, while giving evidence, explain the disability certificate in non-technical terms, the nature of the disability, and to the extent necessary also state how the disability

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could impact the earning skills, whether the disability is for the whole body, and the extent to which it effects the day-to-day life as well as life expectancy. In Raj Kumar v. Ajay Kumar,129 the Supreme Court said that if a doctor giving evidence uses technical medical terms, the Tribunal should instruct him to state in addition, in simple non-medical terms, the nature and the effect of the injury. If a doctor gives evidence about the percentage of permanent disability, the Tribunal has to seek clarification as to whether such percentage of disability is the functional disability with reference to the whole body or whether it is only with reference to a limb. If the percentage of permanent disability is stated with reference to a limb, the Tribunal will have to seek the doctor’s opinion as to whether it is possible to deduce the corresponding functional permanent disability with reference to the whole body and, if so, the percentage.

The judgment also gives guidelines to courts about how to secure proof of the disability certificates. The Tribunals should realise that a busy surgeon may be able to save ten lives or perform twenty surgeries in the time he spends to attend the Tribunal to give evidence in one accident case. Many busy surgeons refuse to treat medico-legal cases out of apprehension that their practice and their current patients will suffer, if they have to spend their days in Tribunals giving evidence about past patients. The solution does not lie in coercing the doctors to attend the Tribunal to give evidence. The solution lies in recognising the valuable time of doctors and accommodating them. Firstly, efforts should be made to record the evidence of the treating doctors on commission, after ascertaining their convenient timings. Secondly, if the doctors attend the Tribunal for giving evidence, their evidence may be recorded without delay, ensuring that they are not required to wait. Thirdly, the doctors may be given specific time for attending the Tribunal for giving evidence instead of requiring them to come at 10.30 a.m. or 11.00 a.m. and wait in the court hall. Fourthly, in cases where the certificates are not contested by the respondents, they may be marked by consent, thereby dispensing with the oral evidence. These small measures as also any other suitable steps taken to ensure the availability of expert evidence, will ensure assessment of just compensation and will go a long way in demonstrating that courts/Tribunals show concern for litigants and witnesses.

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persons with disabilities (equal opportunities, protection of rights and full participation) act, 1995 This act defines through Section 2(i) ‘disability’ to mean, (i ) blindness; (ii ) low vision; (iii ) leprosy-cured; (iv ) hearing impairment; (v ) loco-motor disability; (vi ) mental retardation; (vii ) mental illness. The 1995 Act provides for placing mechanisms for prevention and early detection of persons with disabilities. Provisions for education and employment are the most potent tools for their empowerment, and the act addresses the agenda for establishment of special schools and reservation in public employment. The act declares that the government shall appoint in every establishment not less than 3 per cent of vacancies for persons or classes of persons with disabilities, of which 1 per cent each will be reserved for persons suffering from blindness or low vision, hearing impairment, loco-motor disability, or cerebral palsy, in the posts identified for each disability. Where in any recruitment year any vacancy cannot be filled up due to non-availability of a suitable person with disability or, for any other sufficient reason, it shall be carried forward in the next recruitment year and if a suitable person with disability is not available even then, it may first be filled by interchange among the three categories and only when there is no person with disability available for the post in that year, the employer shall fill the vacancy by appointment of a person other than someone with disability. All educational institutions of the government and other educational institutions receiving aid from the government shall reserve not less than 3 per cent seats for persons with disabilities.The appropriate governments and local authorities shall reserve not less than 3 per cent in all poverty alleviation schemes for the benefit of persons with disabilities. The rules framed under the act detail the mandate for issuing notifications to employment exchanges for vacancies and reservation for people with disability. Social security measures and affirmative action for preferential allotments of housing and shopping are also covered by the act. The non-discrimination directives underscore the agenda for adaptation of rail compartments, busses, toilets, and the installation of auditory signals at public roads and ramps in public buildings. Among the most significant provisions is the interdict against from dispensing with or reducing the rank of any employees who acquire a disability

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during his service, requiring the relocation of the employee within the same establishment to some other post with the same pay and service benefits. The Ministry of Welfare has drawn up guidelines for assessing mental retardation, locomotor or orthopaedic, visual and speech, hearing disabilities. As per the broad guidelines, the functional (permanent physical impairment [PPI]) disability due to congenital, post disease, or trauma have been evaluated. In case of locomotor conditions, broadly, the body has been divided into upper limb, lower limb, and trunk. In principle, the function of one part cannot be replaced by other, therefore each functional part in itself is 100 per cent, and thus loss of function/PPI of that part is taken as 100 per cent. On the other hand, the value for whole body cannot exceed 100 per cent. Thus, if the impairment is seen in more than one function or body part, the mathematical sum may exceed 100, but total of the individual cannot exceed 100 per cent. Thus, a total of one or all segments of body cannot exceed 100 per cent in any situation. Disability during and before Employment The doctor’s certification regarding disability may not result in termination of employment in defiance of the Act of 1995, except in exempted employments through a notification made under Section 47(2) of the act. The doctor shall elicit the nature of employment that the workman is engaged in and must correlate the disability to the particular type of work that he would be capable of doing. When a person presents himself for examination with reference to the fitness to employment, it may seem that he forsakes claims to confidentiality and allows for a disclosure of the illnesses that he suffers from. Medical profiling, or more particularly, genetic profiling for disease susceptibility for employment or at work places are serious confidentiality and privacy issues in foreign jurisdictions in relation to the control, transmission, and storage of personal health data, and are debated essentially on ethical considerations. Sukhsohit, a thalassemia major patient,130 had cleared All India Civil Services Examinations in 2008 but had been disqualified on medical grounds by the Department of Personnel and Training on account of his illness, but according to newspaper reports the Prime Minister intervened and asked the government to reconsider the issue.131 While the Act of 1995 paves the way for creating equal opportunities by

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requiring public authorities scouting for talent to reserve posts for persons with disability, the indications are that the public sentiment is pushing for equal opportunities even without regard to disability in the first place, so long as the particular illness allows a person to engage in the particular activity of employment. Testing HIV Positive It will not be possible to disqualify a person from employment on the ground that the prospective employee or the person in employment has tested HIV positive. The high courts have consistently taken the view that no discrimination could be practiced against such a person in admittance into public service.132 In Mr X, Indian Inhabitant v. Chairman, State Level Police Recruitment Board and Others, the High Court of Andhra Pradesh struck down as ultra vires Order 70(3) of the AP Revised Police Manual, which directed the candidates selected provisionally as stipendiary cadet trainees by direct recruitment to undergo a medical examination for HIV.133

workmen’s compensation act To assess compensation, the Workmen’s Compensation Act sets out in a schedule the percentages of loss of earning power depending on the privation of limbs or organs.When there are other types of injuries that are not set out in the schedule—commonly known as non-schedule injuries—that result in permanent or temporary disability, the doctor’s evidence will be necessary to assess the compensation payable in a claim for bodily injury. Again,with regard to provisions for compensation for occupational diseases under the act, a doctor’s certification will be crucial for identifying the nature of the illness as falling within the specifications in Schedule 3 of the act. The Workmen’s Compensation Act compensates for death or ‘bodily injury’, and there have not been any reports of cases in which compensation has been given for mental or psychiatric injuries due to the strain of work.

medical invalidation and disability pension Medical invalidation is one of the common incidents that give rise to termination of service in armed forces, where physical fitness to stand

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the rigours of service is a necessary part of the job. Rules invariably provide for medical examinations and reports before deciding on the fitness of the armed personnel to continue in service. Similarly, the rules that provide for a specific disability pension would require the disability to be attributable to or aggravated by military service.The medical certification shall elicit the nexus of the service to the illness or disability culminating in termination of service in order that the person becomes eligible for pension. The courts will give primacy to doctors’ evidence and the report of a medical board to assess not only the illness or disability but also to arrive at a decision on the likely effects of the disease or disability on service. In Ministry of Defence v. A.V. Damodaran,134 the Supreme Court stated that the medical board is an expert body and its opinion is entitled to due weight, value, and credence. It held as erroneous the view of the courts below in ignoring the opinion of the medical board, and rejected the claim to disability pension under Pension Regulations for the Army, 1961, and the Entitlement Rules for Casualty Pensionary Awards, 1982. PSYCHIATRIC INJURY Malingering, in a rudimentary manner, can be understood as the feigned prolonging of the ill effects of any disease or the exaggeration of an injury with the objective of illicitly deceiving the observer so as to accrue some benefit, most frequently of a pecuniary, compensatory nature. In cases of negligence that result in psychiatric injury to the plaintiff, malingering is a definite possibility. Therefore, the examination of such individuals by experts is crucial so as to filter out the false cases from genuine victms of the post-traumatic stress disorder. These kinds of examinations are more frequent in civil cases than criminal trials. The examining doctor has to employ circumspection; it is in the claimant’s interest to exhibit a greater suffering. However, many cases are genuine. Assessment of damages for psychiatric injuries is uncommon in the Indian scene, but it is important to know that such a claim is possible in the law of torts.135 Other than the primary victim who has suffered injury, a mere onlooker, a near relative, or a co-worker may also suffer mental trauma caused by an injury suffered by another. In Spring Meadows Hospital v. Harjat Ahluwalia through K.S. Ahluwalia,136 the Supreme Court admitted a claim by parents for compensation for the

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pain and suffering that they had to undergo on account of the suffering of their child, who had suffered a PVS state due to medical negligence, in addition to the compensation to the child. In Pravat Kumar Mukherjee v. Ruby General Hospital & Ors,137 the National Consumer Commission awarded Rs 10,00,000 as damages to the parents of the deceased, who was brought to the hospital in a critical condition due to injuries suffered in a motor accident, but was turned out without adequate care because the medical expenses were not paid in advance. In Puttathayamma(smt.) v. ESI Corporation,138 the Karnataka High Court saw fit to accommodate claims for ‘employment injury’ resulting in mental strain and trauma against the employer. The employer could not be said to be discharged of liability merely because psychiatric counselling was made available in the workplace.The employer should have ensured effective intervention that would stem the illness at the initial stage.139 PATERNITY TESTING The court could order parties to the dispute to undergo medical examination and submit blood samples for DNA testing to determine paternity. As Sinha J stated in the Sharda case, ‘Having regard to the complexity of the situation, the doctor’s opinion may be of utmost importance for rejecting or granting of petition.’ There is, however, no compulsion that the party undergo such a test even after specific direction. If the party refuses to submit blood samples, in spite of court direction, the best course would be to draw an adverse inference against such party. It is most unlikely that the court would resort to procedures for contempt of court by ordering arrest or attachment.140 The English courts at one point of time held that they had no power to order a blood test on the ground that it would constitute battery, which no court may authorize.141 However, in subsequent cases the court was empowered to issue such a direction in civil litigation. The provision was also effectuated for determining the paternity of a child with the purpose of securing his rights.142 It is also the opinion of eminent jurists143 that the aversion of courts to accepting medical evidence as part of regular proceedings is ill-founded and baseless. Advancements in science have provided vital assistance in the process of determining paternity and information regarding sex crimes. In India the legal disposition on the ambit of the court’s power was laid out in

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Goutam Kundu v. State of Bengal & Anr.144 Courts in India cannot order blood tests as a matter of course; petitions made to that effect in order to have a roving inquiry cannot be entertained unless reinforced through definitive prima facie evidence.145 Goutam Kundu, even when it denied a right to a husband to compell the wife to give a blood sample, is not an authority for the proposition that under no circumstances can the court direct that blood tests be conducted. The court did, of course, sound a note of caution against mechanical passing of such order, which could imperil the child’s legitimacy status. In some other jurisdictions, it has been held that such directions should ordinarily be made if it is in the interest of the child. NOTES 1 The MCI does not stipulate any particular dress code, but the practice has generally gained ground that doctors are clad in white overcoats. It is therefore only desirable that a doctor, while attending courts in his or her capacity as doctor, wears the white overcoat, as a measure of personal distinction and dignity. A challenge to the dress code prescribed for members of the Indian Military Nursing Service as in violation of Articles 14 and 21 was rejected by the Supreme Court in Jasbir Kaur v. Union of India,(2003) 8 SCC 720. 2 Solanki Chimanbhai Ukabhai v. State of Gujarat, AIR (1983) Cri LJ 822. 3 Pandit Parmanand Katara v. Union of India, AIR (1989) SC 2039. 4 (2011) 1 SCC 343. 5 Later published as a book, (New York: Harper & Brothers, 1930). 6 Maghar Singh v. State of Punjab (1984) Cri LJ921 (SC). 7 State (Delhi Administration) v. Gulzari Lal, AIR (1979) SC 1383. 8 (2006) 2 All ER 329. 9 Meadow v. General Medical Council (2007) 1 All ER 1 (CA). 10 See MCIR, Clause 7.7, referred to in Chapter 2 under the enumerated list of acts of misconduct. 11 Sona Bala Bora v. Jyotirindra Bhatachargjee,(2005) 4 SCC 501. 12 See Section 5(ii)(a), the Hindu Marriage Act, 1955. 13 See Section 12(1)(b), ibid. 14 See Section 13(1)(iii), ibid. See also Section 10(1) (iii) Divorce Act, 1869, which applies to Christians. It specifies incurable unsoundness of mind for a period of two years prior to the presentation of the petition as one of the grounds for divorce. 15 See Ramaswamy Iyer’s, The Law of Torts, 10th edition (LexisNexisButterworths, 2007), pp. 979–80.

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16 The Juvenile Justice (Care and Protection of Children) Act, 2000, adopts a child-friendly approach in the adjudication and disposition of matters in the best interest of children and for their ultimate rehabilitation through various institutions established under the enactment. A ‘juvenile’ or ‘child’ under the act means a person who has not completed eighteen years of age. 17 GM, Bharat Coking Coal Ltd v. Shib Kumar Sushad, (2000) 8 SCC 696. In case the date of birth is sought to be proved with reference to a school-leaving certificate or baptism certificate, the attempt of an employer to assess the age by a doctor for determining the date of superannuation was held by Calcutta High Court in Gyan Chandra Bhagat v. Damodar Valley Corporation,(1996) 5 SLR 125 as not proper. 18 The Constitution of India prescribes the age limit for the member of house of people as 25, for council of States at 30 (Article 84) and for membership for State Legislative Assembly at 25 and Legislative Council at 30 (Article 173). The minimum age for a voter is 18 (Article 326). 19 Harihar v. Emperor, AIR (1935) All 590; Emperor v. Jagganath, AIR (1937) All 553; Dilip v. Madhya Pradesh, 1987 Cr LJ 212. 20 Ram Suresh Singh v. Prabhat Singh @ Chottu Singh and Another (2009) (6) SCC 681. 21 Vishnu v. State of Maharashtra,(2006) 1 SCC 283. 22 Ram Suresh Singh v. Prabhat Singh, (2009) 6 SCC 681. In State of Maharashtra v. Mohd. Sajid Husain Mohd. S.Husain (2008) 1 SCC 213, (2008) 1 SCC (Crl) 176, AIR (2008) SC 155, the school-leaving certificate mentioning the date of birth was preferred to the date as mentioned in the FIR, in the first medical document, or in the affidavit filed by the person whose age was to be determined. 23 Ram Suresh Singh v. Prabhat Singh (2009) 6 SCC 681. 24 Vishnu v. State of Maharashtra (2006) 1 SCC 283. 25 Rajinder Chandra v. State of Chhatisgarh (2002) 2 SCC 287; Babloo Pasi v. State of Jharkhand (2008) 13 SCC 133. 26 Dashrath v. State of MP,(2007) 12 SCC 487. 27 Quoted in Nallapati Sivaiah v. Sub-Divisional Officer, Guntur, AP(2007) (4) RCR(Criminal) 439:(2007) (5) RAJ 291:(2007) (11) JT 313:(2008) AIR (SC) 19:(2007) (4) AICLR 605:(2007) (11) Scale 477:(2007) (10) SCR 347 28 See Section 32(1), Indian Evidence Act, 1885. 29 Paparambaka Rosamma v. State of Andhra Pradesh,(1999) 7 SCC 695. 30 In the absence of such certification, a statement by a magistrate recording his subjective satisfaction that the injured person was in a fit state of mind was found by the Supreme Court in Laxman v. State of Maharashtra (2002) 6 SCC 610 to be too risky to be acted upon.The same view was also held in Panchdeo Singh v. State of Bihar (2002) 1 SCC 577.

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31 (2002) (4) RCR(Criminal) 149:2002 CriLJ 4095:(2002) AIR (SC) 2973:(2002) (4) Crimes 42:(2002) (4) AICLR 309:(2002) (6) SCC 710:(2002) (6) Scale 135:(2002) (6) JT 313:(2002)SCC(Cri) 1491:(2002) (Sup1) SCR 697. 32 (1999) (4) RCR(Criminal) 104:(1999) AIR (SC) 3455:(1999) CriLJ 4321:(1999) (4) Crimes 150:(1999) (7) SCC 695,(1999) (5) Scale 451:(1999) (6) JT 585:(1999) (4) AICLR 279:(1999)SCC(Cri) 1361:(1999) (Sup2 ) SCR 328. 33 (1999) (4) RCR(Criminal) 594:(1999) AIR (SC) 3695:1999 CriLJ 4582:(1999) (4) Crimes 280:(1999) (9) SCC 562:(1999) (6) Scale 267:(1999) (7) JT 568:(2000) (1) AICLR 696:(1999) (Sup3) SCR 284:(2000) SCC(Cri) 432. 34 Sukanti Moharana v, State of Orissa (2009) 9 SCC 163. 35 Jose v. State of Kerala (1994) Supp (3) SCC 1, (1994) SCC (Crl) 1659; Kamalavva v. State of Karnataka (2009) 13 SCC 614, (2009) Crl LJ 4408. 36 Padmaben Shamalbhai Patel v. State of Gurjarat (1991) 1 SCC 744, (1991) SCC (Crl) 275. 37 A dying declaration recorded in hospital by an executive magistrate in the presence of the doctor who certified prior to the declaration that the deceased was in a fit state of mind to make the statement was held in Shambhu v. State of MP ([2002] 3 SCC 561) as entitled to credence. For a similar view, see also State of Karnataka v. Shariff (2003) 2 SCC 473, (2003) SCC (Crl) 561, AIR (2003) SC 1074; Ongole Ravikanth v. State of AP (2009) 13 SCC 647. 38 (1999) 6 SCC 63, (1999) SCC (Crl) 1060. 39 (2007) 12 SCC 754. 40 (2002) 10 SCC 4, (2003) SCC (Crl) 1501, AIR (2003) SC 209, 2003 Cri LJ 418. 41 (2006) 9 SCC 240. 42 Ramilaben Hasmukhbhai Krishti v. State of Gujarat (2002) 7 SCC 56. 43 Munnu Raja v. State of MP (1976) 3 SCC 104; (1976_ SCC (Cri)376; (1976) 2 SCR 764. 44 State of UP v. Ram Sagar Yadav (1985) 1 SCC 552:1985 SCC (Cri) 127:AIR (1985) SC 416; Ramavati Devi v. State of Bihar (1983) 1 SCC 211: (1983) SCC (Cri) 169:AIR (1983) SC 164. 45 State of Maharashtra v. Krishnamurti Laxmipati Naidu(1980) Supp. SCC 455,(1981) SCC (Cri) 364: AIR (1981) SC 617. 46 Surajdeo Oza v. State of Bihar(1980) Supp. SCC 769: (1979) SCC (Cri) 519: AIR (1979) SC 1505. 47 State of Gujarat v. Khumansingh Karsan Singh AIR (1994) SC 1641. 48 Rasheed Beg v. State of MP (1974) 4 SCC 264: (1974) SCC (Cri) 426.

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49 Kake Singh v. State of MP(1981) Supp. SCC 25: (1981) SCC (Cri.) 645: AIR (1982) SC 1021. 50 Ram Manorath v. State of UP(1981) 2 SCC 654: (1981) SCC (Cri) 581. 51 Nanahau Ram and Anr v. State of MP (1988) Supp. SCC 152: (1988) SCC (Cri) 342: AIR (1988) SC 912. 52 State of UP v. Madan Mohan (1989) 3 SCC 390: (1989) SCC (Cri) 585: AIR (1989) SC 1519. 53 State of Karnataka v. Manjanna (2000) 6 SCC 188. 54 The Supreme Court underscored the irrelevance of doctor’s evidence as a decisive factor in rape cases in Ranjit Hazarika v. State of Assam (1998) 8 SCC 635. In State of Punjab v. Gurmit Singh (1996) 2 SCC 384, it was held that no corroboration is necessary through doctor’s evidence when the victim had given clear evidence of the rape committed on her. 55 Wahid Khan v. State of Madhya Pradesh (2009[6]) RSJ 548. The fact that the hymen was intact was found in Madan Lal v. State of J & K (1997) 7 SCC 677 to be immaterial to affirm conviction of rape. 56 Madan Gopal Kakkad v. Naval Dubey (1992) 3 SCC 204, (1992) SCC (Crl) 598. 57 State of Himachal Pradesh v. Lekh Raj (2000) 1 SCC 247. 58 For a woman less than 18 years of age, consent is irrelevant for the offence of rape, as per the definition of rape under Section 375, IPC. 59 Proviso to explanation 2, Section 375, IPC, provides that a ‘Women who does not physically resist to the act of penetration shall not by the reason only of the fact, be regarded as consenting to the sexual activity’. Sections 53A and 146 of the Evidence Act make irrelevant any suggestion regarding the character of the victim for providing consent or quality of consent. 60 See Section 114A, IPC. 61 See Section 376C (b), IPC. 62 See Section 376C, (c), IPC. 63 See Section 376C (d), IPC. 64 State of Rajasthan v. NK (2000) 5 SCC 30, AIR (2000) SC 1812, 2000 Cri LJ 2205. 65 (2006)1 SCC 183. 66 (2009) 1 SCC 133. In State of MP v. Balu (2005) 1 SCC 108, against the age as determined by the doctor to be 13, variation to a range of three years was held to be possible, but still conviction was entered on the basis of evidence regarding age. 67 State of HP v. Lakhraj (2000) 1 SCC 247. 68 Siriya v. State of MP (2008) 8 SCC 72, AIR (2008) SC 2314. When evidence was presented by a doctor of the rupture of hymen and a physical examination revealing that a finger could go into the private parts of a

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five-year-old girl, it was held that rape could not be ruled out simply because the same injury could be caused by a glass piece, State of UP v. Babul Nath (1994) 6 SCC 29.The doctor’s evidence of a badly mutilated vaginal orifice in a four-year-old child, where the middle finger could be admitted, was found to be relevant for a decision regarding the offence of rape in State Govt. of NCT v. Sunil (2001) 1 SCC 652. 69 Sheikh Zakir v. State of Bihar (1983) 4 SCC 10; Tukaram v. State of Maharashtra (1979) 2 SCC 143; Viswanathan v. State (2008) 5 SCC 354, AIR (2008) SC 2222. 70 State of Punjab v. Ramdev Singh (2004) 1 SCC 421, AIR (2004) SC 1290. 71 Premiya v. State of Rajasthan (2008) 10 SCC 81. 72 See Pritiksha Baxi, ‘The Medicalisation of Consent and Falsity: The Figure of the Habitue in Indian Rape Law’,The Violence of Normal Times: Essays on Women’s Lived Realities (Delhi: Women Unlimited, 2005). 73 State of HP v. Gian Chand (2001) 6 SCC 71,AIR (2001) SC 2075.The court was examining the case of an accused being examined two days after the alleged incident and hence the court observed that even if there had been a mild injury, it could have healed. In State of Chhattisgarh v. Derha (2004) 9 SCC 699, the accused was examined after four days of the alleged rape of a girl of eight years, and the court held that the absence of injuries on the person was not relevant. 74 So called, when the prosecution projects a theory that the accused was last seen in the company of the victim, especially where there is no direct ocular evidence. 75 Jaharlal Das v. State of Orissa (1991) 3 SCC 27. 76 See Sections 53, explanation and 53 A, CrPC, 1973. 77 Chapter 7, Modi’s Medical Jurisprudence and Toxicology, 23rd edition (Delhi: LexisNexis Butterworths), p. 246. 78 (1999) 4 SCC 370. 79 Eswaraiah v. State of Karnataka (1994) 2 SCC 677, (1994) SCC (Crl) 601. 80 Chapter 25, Modi’s Medical Jurisprudence and Toxicology, 24th edition (Delhi: LexisNexis Butterworths), p. 763. 81 Ibid., pp. 768, 769. 82 IPC, Sections 321 and 323. 83 Ibid., Sections 322 and 325. 84 Ibid., Sections 324 and 326. 85 Chapter 26, Modi’s Medical Jurisprudence and Toxicology, 24th edition (LexisNexis Butterworths), p. 558. 86 Ibid., Chapter 10, p. 232. 87 Ibid. p. 238. 88 Babloo Pasi v. State of Jharkhand (2008) 13 SCC 133, (2009) 3 SCC (Cri) 266.

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89 Ramdeo Chauhan v. State of Assam (2001) 5 SCC 714. The Supreme Court said that it has to base its conclusions upon all the facts and circumstances disclosed on examining of the physical features of the person whose age is in question, in conjunction with such oral testimony as may be available. An X-ray ossification may provide a surer basis for determining the age of an individual than the opinion of a medical expert, but it can by no means be so infallible and accurate a test as to indicate the exact date of birth of the person concerned. The Supreme Court cautioned that too much reliance cannot be placed upon text books on medical jurisprudence and toxicology while determining the age of an accused. In this vast country with varied latitudes, heights, environment, vegetation, and nutrition, the height and weight cannot be expected to be uniform. 90 See Chapter 10, Modi’s Medical Jurisprudence and Toxicology, 24th edition (Delhi: LexisNexis Butterworths), p. 276. 91 See Chapter 3. 92 Selvi v. State of Karnataka (2010) 7 SCC 263. See Chapter 2 and Chapter 3 for further commentaries. 93 Macaulay, The Works of Macaulay,Volume II. 94 See T.N. Lakshmaiah v. State of Karnataka (2002) 1 SCC 219. 95 Shrikant Anandrao Bhosale v. State of Maharshtra(2002) 7 SCC 748. 96 State of MP v. Ahmadulla,AIR(1961) SC 998. 97 A relatively simplified version was the Durham Rule (originally said to be adopted in New Hampshire in 1871), embraced by the Circuit Court of Appeals for the District of Columbia in the 1954 case of Durham v. United States. The Durham Rule, sometimes referred to as the ‘product test’, provides that the defendant is not ‘criminally responsible if his unlawful act is the product of a mental disease or defect.’ The Durham Rule was originally seen as a way of simplifying the M'Naghten Rule and the Irresistible Impulse Test by making insanity and its relation to the crime a matter of objective diagnosis. Nevertheless, such a diagnosis proved to be more difficult to prove in practice than in theory. FindLaw, Thomson Reuters. 98 (1964) 7 SCR 361, AIR (1964) SC 1563, (1964) 2 Crl LJ 472. 99 (2002) 7 SCC 748. 100 On a stand-alone basis, the fact that the accused did not make any attempt to run away from the scene may not always be relevant. See Sheralli Wali Mohammed v. State of Maharashtra (1973) 4 SCC 79: (1973) SCC (Cri) 726. 101 M.A. Antony v. State of Kerala (2009) 6 SCC 220. 102 The relevant provisions to the manner of treatment of persons of unsound mind were dealt with extensively by the Supreme Court in response to a newspaper report about the status of several undertrials who languished in

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jails without any supervision by courts, News Item 38 Yrs in Jail Without Trial Published in the Hindustan Times, In Re v. (2007) 15 SCC 18. 103 Order 32, CPC provisions. 104 In Padmavati Anantrai Mehta @ Padmati A. Mehta v. Chandrakant Madavji Mehta and Another 2004(3) Bom CR 197, on finding that the doctor had given false evidence about the mental capacity of the testator, the court directed Indian Medical Association to take steps for debarring the doctor from practicing medicine. 105 Section 5(ii) requires the mental health for consent to marriage for a spouse to be an essential condition for the validity of marriage. Sections 12 and 13 enable parties to annul marriage with a person of unsound mind. The Supreme Court said in Sharda v. Dharmpal (2003) 4 SCC 493, in the context of the requirement of an incurable mental illness as a ground for divorce, ‘Having regard to the complexity of the situation, the doctor’s opinion may be of utmost importance for granting or rejecting a prayer for a decree of divorce. The question of whether a mental disorder is curable can be the subject of determination by a court of law having regard to the expert medical opinion and particularly the ongoing development in the scientific and medical research in this direction. 106 Kastrui Bai v. Anguri Chaudhary (2003)(3) SCC 225, AIR (2003) SC 1773. The Court set aside the order of the High appointing a guardian without an enquiry and directed the civil court to hold an enquiry regarding the alleged unsoundness of mind before appointing a guardian. 107 P.P. Ar. Rm. Sp. Ramanathan Chettiar v. A.R.R.M. Somasundaram Chettiar AIR (1941) Mad 505; Duyyuri Rami Reddi v. Duyyudu Papi Reddi and Others, AIR (1963) AP 160 108 AIR (2007) Mad 231. 109 (2003) 4 SCC 493. 110 Banarsi Dass v. Teeku Dutta (2005) 4 SCC 449. 111 Goutam Kundu v. State of WB (1993) 3 SCC 418.The court held that the request for a blood test had been made by the appellant-husband to avoid payment of maintenance under Section 125 CrPC and was therefore not allowed. In R. Balasubramanian v. Vijayalakshmi Balasubranian (1999) 7 SCC 311, a wife’s offer to undergo a paternity test when there is an allegation by the husband that she has had voluntary sexual intercourse with another was found to be proof of husband’s cruelty as the husband did not press the charge and did not want any medical test. 112 Ramkanya Bai v. Bharatram (2010) 1 SCC 85. 113 See Section 12 of the Contract Act and its illustrations. 114 See Section 61 of the Indian Succession Act. 115 AIR (2006) Kant 68, (2006)(2)HLR 193. 116 204 Wis. 127; 235 NW 542; 1931 Wisc.LEXIS 318.

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117 V. Kishan Rao v. Nikhil Super Speciality Hospital & Another 2010(2) RCR(Civil) 929: 2010(3) RAJ 240: 2010(2) RCR(Criminal) 878. 118 (2009) 3 SCC 1. 119 (2003) 4 SCC 493. 120 (2009) 9 SCC 221 (paras 45, 46) 121 Section 80 U of the Income Tax Act, 1961, allows an exemption of Rs 40,000 from the income of the assessee with disability. 122 Section 80 DD of the Income Tax Act, 1961: Parent or relative upon whom the person with disability is dependent is allowed deductions of rupees forty thousand for maintenance, which includes medical treatment of person with disability. 123 Under Section 80G, deduction from income is allowed at 50 per cent of the amount donated to the eligible institution. The amount on which deduction is claimed under the section, however, cannot exceed 10 per cent of the gross total income exemptions.This is only in respect of certain specific projects for research, development, etc. (Section 80GGA). 124 A disability certificate shall be issued by a physician, an oculist, or a psychiatrist as the case may be, working in a government hospital. 125 Rule 11D specifies categories to be considered as ‘physical disability’ for the above sections. Physical disability shall be regarded as a permanent physical disability if it falls in any of the categories specified below, namely: a. permanent physical disability of more than 50 per cent in one limb; or b. permanent physical disability of more than 60 per cent in two or more limbs; or c. permanent deafness with hearing impairment of 71 decibels and above; or d. permanent and total loss of voice. Blindness: Blindness shall be regarded as a permanent physical disability, if it is incurable and falls in any of the categories specified below, namely: ALL WITH CORRECTIONS

Better eye

Worse eye

6/60-4/60 or field of vision 110-20

3/60 to Nil

3/60 to 1/60 or field of vision 100

FC at 1 foot to Nil

FC at 1 foot to Nil or field of vision 100

FC at foot to Nil or field of vision 100

Mental retardation: Mental retardation shall be regarded as a mental retardation if Intelligence Quotient is less than 50 on a test with a mean of 100 and a standard deviation of 15 such as the Vechsle Scale.

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126 The Gazette of India, Extraordinary Part-II Section 1, Dated 13 June 2001. 127 See the author’s book Accident and Compensation Laws (Nagpur : Wadhwa, 2005), Part II, Chapter 4, ‘Assessment of Disability’. 128 Madan Lal Papneja v. State of Haryana in FAO 422 of 2003 dt 12.11.2010 reported in MANU/PH/2408/2010. 129 (2011) 1 SCC 343. 130 Thalassemias (thal-a-SE-me-ahs) are inherited blood disorders. ‘Inherited’ means that parents pass the genes for the disorder on to their children. Thalassemias cause the body to make fewer healthy red blood cells and less hemoglobin (HEE-muh-glow-bin) than normal. Hemoglobin is an iron-rich protein in red blood cells. It carries oxygen to all parts of the body. Hemoglobin also carries carbon dioxide (a waste gas) from the body to the lungs, where it's exhaled. People who have thalassemias can have mild or severe anemia. This condition is caused by a lower than normal number of red blood cells or not enough hemoglobin in the red blood cells. Courtesy: Department of Health & Human Services, US. 131 India Today, 27 September 2011. 132 The Bombay High Court said in MX of Bombay Indian Inhabitant v. M/s ZY and Another (AIR [1997] Bom406) that pre-employment HIV/AIDS screening as part of the assessment of fitness to work is unnecessary and should not be required. The Madras High Court examined the issue at great length in Y & X v. Secretary, Transport Department, Government of T.Nadu (WP [MD] NOs947) and 12474 of 2010 dated 4.1.2011 and also made reference to decisions from the US and South Africa to add support for holding that an HIV positive person could not be disqualified for selection (in that case as a driver in the transport corporation) to public employment. 133 2006 (2) ALD 513. 134 (2009) 9 SCC 140. The primacy of medical opinion of the board and the need for the courts to act upon it was also underscored in Union of India v. Surinder Singh Rathore (2008) 5 SCC 747; Controller of Defence Accounts (Pension) v. S. Balachandran Nair (2005) 13 SCC 128. In Union of India v. jujhar Singh (2011) 7 SCC 435, the Supreme Court relied on the medical opinion to reject a claim for disability suffered by a member of the armed forces in a motor accident during leave, holding that such disability could not be said to arise from or be attributable to military service. 135 See the author’s work Accidents and Compensation Laws (Nagpur: Wadhwa, 2005), and also Chapter 6 for commentaries on ‘nervous shock or psychiatric injury’. 136 (1998) 4 SCC 39. 137 2005-(002)-CPJ -0035 –NCDRC.

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138 (2000) II LLJ 97. 139 In Daw v. Intel Corporation UK Ltd (2007) 2 All ER 126, the court of appeal held that the management’s failure to take action at the appropriate time had resulted in the employees’ mental stress and found the liability could not be avoided by the mere provision for counselling services at the workplace. 140 After stiff resistance to giving blood samples, N.D. Tiwari was finally prevailed over by orders of the high court to submit to doctors for giving blood samples, in the presence of a high-level team of members of the judiciary, lawyers, and the plaintiff claming to be his son along with his mother, The Hindu, 30 May 2012. 141 S.V. S.W. v. Official Solicitor (1972) AC 24. 142 B.R.B. v. B., (1968) 2 All.E.R. 1023. 143 Phipson on Evidence, 14th edition; Wigmore on Evidence, Volume 8, 3rd edition. See also Halsbury’s Laws of England, Volume 17, 4th edition ( judge’s duty in a proceeding on ordering medical examination). 144 AIR (1993) SC 2295. 145 Ibid.

5

Medical Negligence

Negligence1 of a medical professional in the manner of treatment takes varying forms and definitions depending on the jurisdiction invoked. Their descriptions are not mutually exclusive, and there could be overlapping of the core element of ‘want of care’. The respective standards of proof vary; the consequences of proof obtain different end results. In civil law, it conforms to the uncodified law of torts and satisfies the element of negligence as understood by the common law practice, conditioned in various countries through judicial pronouncements and commentaries by jurists. In criminal law, the standard of proof as beyond reasonable doubt requires a certain rigid approach that civil courts do not apply. What could give rise to certain assumptions in a typical situation of res ipsa loquitur in a civil case, which transfers the onus of proof on the person accused of negligent conduct, will be quite different to a similar charge in a criminal case. Generally speaking, it is the amount of damages incurred that determines of the extent of liability in tort,2 but in criminal law it is not the amount of damages but the amount and degree of negligence that determines liability. To determine liability in criminal law, the degree of negligence has to be higher than that which determines liability for damages in civil law. The essential ingredient of mens rea cannot be excluded from consideration when the charge in a criminal court is of criminal negligence.3 A hybrid situation arises in actions before consumer fora where the requirement of proof under the Consumer Protection Act is ‘deficiency of service’. A whole body of case law has arisen through pronouncements of district fora, state commissions, and the national commission, the three hierarchical tiers of the mechanism of adjudication under the Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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act. The act does not override other laws, but will be supplement the relief provided under other jurisdictions.4 A comparison of the provisions of the IPC with the thresholds under tort law or the Consumer Protection Act reveals the foundational principle that the attributes of care and negligence are not similar under the civil and criminal branches of medical negligence. An act that may constitute negligence or even rashness under torts may not amount to the same under the IPC, as it happened in the decision of the Supreme Court in Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others,5 when the criminal case against the doctors was dismissed but the claim for damages against the doctor and the hospital before the Consumer Disputes Redressal Commission was allowed. AS CRIMINAL OFFENCE To fasten liability in criminal law, the degree of negligence has to be higher than that of negligence enough to fasten liability for damages in civil law.The essential ingredient of mens rea cannot be excluded from consideration when the charge in a criminal court consists of criminal negligence.6 The concept of recklessness also involves mens rea.7 Recklessness on the part of the doer of an act does presuppose that there is something in the circumstances that would have drawn the attention of an ordinary prudent individual to the possibility that his act was capable of causing the kind of serious harmful consequences that the section which creates the offence was intended to prevent, and that the risk of those harmful consequences occurring was not so slight that an ordinary prudent individual would feel justified in treating them as negligible. It is only when this is so that the doer of the act is acting ‘recklessly’ if, before doing the act, he either fails to give any thought to the possibility of there being any such risk or, having recognized that there was such risk, he nevertheless goes on to do it.8

The moral culpability of recklessness is not located in a desire to cause harm. It resides in the proximity of the reckless state of mind to the state of mind present when there is an intention to cause harm. There is, in other words, a disregard for the possible consequences. The consequences entailed in the risk may not be wanted, and indeed the actor may hope that they do not occur, but this hope nevertheless fails to inhibit the taking of the risk. Certain

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types of violation, called optimizing violations, may be motivated by thrill-seeking. These are clearly reckless.

Penal Law Provisions The IPC does not itself contain any definition for negligence, and lists it as an offence synonymous with the term ‘rashness’.9 In Dr Suresh Gupta v. Govt of NCT of Delhi and Anr,10 the patient, a young man with no history of any heart ailment, was subjected to an operation performed by Dr Suresh Gupta for nasal deformity.The operation was neither complicated nor serious but the patient died. On investigation, the cause of death was found to be ‘not introducing a cuffed end tracheal tube of proper size as to prevent aspiration of blood from the wound in the respiratory passage’. The bench formed an opinion that this act attributed to the doctor, even if accepted as true, could be described as an act of negligence as there was lack of due care and precaution. But, the court categorically held, ‘for this act of negligence he may be liable in tort, his carelessness or want of due attention and skill cannot be described to be so reckless or grossly negligent as to make him criminally liable’. The correctness of this decision was doubted by a subsequent two-member bench dealing with yet another case,11 when a complaint against a doctor was made for medical negligence. The referring bench had assigned two reasons for their disagreement with the view taken in the Dr Suresh Gupta case: (1) Negligence or recklessness being ‘gross’ is not a requirement of Section 304A of IPC and if the view taken in Dr Suresh Gupta’s case is to be followed then the word ‘gross’ shall have to be read into Section 304A IPC for fixing criminal liability on a doctor. Such an approach cannot be countenanced. (2) Different standards cannot be applied to doctors and others. In all cases it has to be seen whether the impugned act was rash or negligent. By treating doctors separately through introduction of degrees of rashness or negligence, the plain and unambiguous language of Section 304A would be compromised. If by adducing evidence it is proved that there was no rashness or negligence involved, the trial court dealing with the matter will decide appropriately. But a doctor cannot be placed on a different pedestal indeducing whether rashness or negligence was involved. In reformulating the issues in

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jurisprudential terms, the three-member bench in Jacob Mathew v. State of Punjab and Another12 posed two questions: (1) Is there a difference in civil and criminal law on the concept of negligence? (2) Is a different standard applicable in recording a judgment of negligence when a professional, in particular, a doctor is to be held guilty of negligence? The analysis that follows is how the Supreme Court dealt with the issue.

Illustrations about Medical Professionals under IPC The illustrations provided in the IPC itself will reveal that the proof of negligence for medical professional has a different yardstick. Section 88 in the chapter on general exceptions provides exemption for acts not intended to cause death and done by consent in good faith for a person’s benefit. Section 92 provides for exemptions for acts done in good faith for the benefit of a person without their consent even though the acts caused harm and that person had not consented to it. The section has four exceptions that are not of interest in the present context. Section 93 saves from criminality certain communications made in good faith. To these provisions are appended the following illustrations:

section 88 A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under a painful complaint, but not intending to cause Z’s death and intending in good faith, Z’s benefit, performs that operation on Z, with Z’s consent. A has committed no offence.

section 92 Z is thrown from his horse, and is insensible. A, a surgeon, finds that Z requires to be trepanned. A, not intending Z’s death, but in good faith, for Z’s benefit, performs the trepan before Z recovers his power of judging for himself. A has committed no offence. A, a surgeon, sees a child suffer an accident which is likely to prove fatal unless an operation be immediately performed.There is no time to apply to the child’s guardian. A performs the operation in spite of the entreaties of the child, intending, in good faith, the child’s benefit. A has committed no offence.

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section 93 A, a surgeon, in good faith, communicates to a patient his opinion that he cannot live. The patient dies in consequence of the shock. A has committed no offence, though he knew it to be likely that the communication might cause the patient's death.

The Supreme Court recounted Lord Macaulay’s own words about the IPC:13 Under the provisions of our Code, this case would be very differently dealt with according to circumstances. If A. kills Z. by administering abortive to her, with the knowledge that those abortive are likely to cause her death, he is guilty of voluntary culpable homicide, which will be voluntary culpable homicide by consent, if Z. agreed to run the risk, and murder if Z. did not so agree. If A. causes miscarriage to Z., not intending to cause Z.’s death, nor thinking it likely that he shall cause Z.’s death, but so rashly or negligently as to cause her death, A. is guilty of culpable homicide not voluntary, and will be liable to the punishment provided for the causing of miscarriage, increased by imprisonment for a term not exceeding two years. Lastly, if A. took such precautions that there was no reasonable probability that Z.’s death would be caused, and if the medicine were rendered deadly by some accident which no human sagacity could have foreseen, or by some peculiarity in Z.’s constitution such as there was no ground whatever to expect, A. will be liable to no punishment whatever on account of her death, but will of course be liable to the punishment provided for causing miscarriage. It will be admitted that when an act is in itself innocent, to punish the person who does it because bad consequences, which no human wisdom could have foreseen, have followed from it, would be in the highest degree barbarous and absurd. (p. 419) To punish as a murderer every man who, while committing a heinous offence, causes death by pure misadventure, is a course which evidently adds nothing to the security of human life. No man can so conduct himself as to make it absolutely certain that he shall not be so unfortunate as to cause the death of a fellow-creature. The utmost that he can do is to abstain from everything which is at all likely to cause death. No fear of punishment can make him do more than this; and therefore, to punish a man who has done this can add nothing to the security of human life. The only good effect which such punishment can produce will be to deter people from committing any of those offences which turn into murders what are in themselves mere accidents. It is in

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fact an addition to the punishment of those offences, and it is an addition made in the very worst way. (p. 421) When a person engaged in the commission of an offence causes death by rashness or negligence, but without either intending to cause death, or thinking it likely that he shall cause death, we propose that he shall be liable to the punishment of the offence which he was engaged in committing, superadded to the ordinary punishment of involuntary culpable homicide. The arguments and illustrations which we have employed for the purpose of showing that the involuntary causing of death, without either rashness or negligence, ought, under no circumstances, to be punished at all, will, with some modifications, which will readily suggest themselves, serve to show that the involuntary causing of death by rashness or negligence, though always punishable, ought, under no circumstances to be punished as murder. (p. 422)

The Supreme Court also pointed out to the following statement of law on criminal negligence by reference to surgeons, doctors etc. and unskillful treatment contained in Roscoe's Law of Evidence: Where a person, acting as a medical man, &c., whether licenced or unlicenced, is so negligent in his treatment of a patient that death results, it is manslaughter if the negligence was so great as to amount to a crime, and whether or not there was such a degree of negligence is a question in each case for the jury. ‘In explaining to juries the test which they should apply to determine whether the negligence in the particular case amounted or did not amount to a crime, judges have used many epithets, such as ‘culpable,’ ‘criminal’, ‘gross’, ‘wicked’, ‘clear’, ‘complete.’ But whatever epithet be used and whether an epithet be used or not, in order to establish criminal liability the facts must be such that, in the opinion of the jury, the negligence of the accused went beyond a mere matter of compensation between subjects and showed such disregard for the life and safety of others as to amount to a crime against the State and conduct deserving punishment. (p. 848–9) Whether he be licenced or unlicenced, if he display gross ignorance, or gross inattention, or gross rashness, in his treatment, he is criminally responsible.Where a person who, though not educated as an accoucheur, had been in the habit of acting as a man-midwife, and had unskillfully treated a woman who died in childbirth, was indicted for the murder, L. Ellenborough said that there was no evidence of murder, but the jury might convict of man-slaughter. ‘To substantiate that charge the prisoner

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must have been guilty of criminal misconduct, arising either from the grossest ignorance or the [most?] criminal inattention. One or other of these is necessary to make him guilty of that criminal negligence and misconduct which is essential to make out a case of manslaughter. (p.849)

Indian Decisions on Criminal Negligence

privy council’s view The Privy Council in John Oni Akerele v. The King14 dealt with the case of a duly qualified medical practitioner who gave his patient an injection of Sobita, which consisted of sodium bismuth tart rate as given in the British Pharmacopoea. However, the injection was an overdose, and the patient died. The doctor was accused and convicted of manslaughter, recklessness, and negligence. The matter reached the House of Lords, who quashed the conviction: (i) That a doctor is not criminally responsible for a patient's death unless his negligence or incompetence went beyond a mere matter of compensation between subjects and showed such disregard for life and safety of others as to amount to a crime against the State. (ii) That the degree of negligence required is that it should be gross and that neither a jury nor a court can transform negligence of a lesser degree into gross negligence merely by giving it that appellation.... There is a difference in kind between the negligence which gives a right to compensation and the negligence which is a crime. (iii) It is impossible to define culpable or criminal negligence, and it is not possible to make the distinction between actionable negligence and criminal negligence intelligible, except by means of illustrations drawn from actual judicial opinion....The most favourable view of the conduct of an accused medical man has to be taken, for it would be most fatal to the efficiency of the medical profession if no one could administer medicine without a halter round his neck.

The Privy Council refused to accept the view that criminal negligence was proved merely because a number of persons were made gravely ill after receiving an injection of sobita from the appellant, coupled with a finding that a high degree of care was not exercised. They also disagreed with the claim that a criminal degree of negligence was proved merely because a too-strong mixture was dispensed once and a number of persons were made gravely ill.

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practitioner of one system of medicine prescribing medicine of another system In Juggankhan v. The State of Madhya Pradesh,15 the accused, a registered homoeopath, administered 24 drops of stramonium and a leaf of daturato the patient suffering from guinea worm. The accused had not studied the effect of such substances on a human being. The poisonous contents of the leaf were not satisfactorily established by the prosecution.The Supreme Court exonerated the accused of the charge under Section 302, IPC. However, it was established that stramonium and dhatura leaves are poisonous and in no system of medicine except perhaps Ayurveda are these used. Homoeopathy, which the accused claimed to follow, did not permit use of the substance administered to the patient. The accused had no knowledge of the effect of such substance being administered and yet he did so. Thus, the accused was held to be guilty of a rash and negligent act.The principle that emerges is that a doctor who administers a medicine known to or used in a particular branch of a medical profession declares by implication that he has knowledge of that branch of science, and if he does not, in fact, possess that knowledge, he is prima facie acting with rashness or negligence. In Poonam Verma v. Ashwin Patel and Ors,16 a doctor registered as medical practitioner and entitled to practice in homoeopathy only prescribed an allopathic medicine to the patient. The patient died, and the doctor was held to be negligent and liable to compensate the wife of the deceased on the ground that the doctor who was entitled to practice in homoeopathy only was under a statutory duty not to enter the field of any other system of medicine, and as he trespassed into a prohibited field and prescribed the allopathic medicine to the patient causing the death, his conduct amounted to negligence actionable in civil law.

degree of negligence in criminal cases The question of degree has always been considered relevant to a distinction between negligence in civil law and negligence in criminal law. In Kurban Hussein Mohamedalli Rangawalla v. State of Maharashtra,17while dealing with Section 304A of the IPC, the following statement of law by Sir Lawrence Jenkins in Emperor v. Omkar Rampratap18 was cited with approval:

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To impose criminal liability under Section 304A, Indian Penal Code, it is necessary that the death should have been the direct result of a rash and negligent act of the accused, and that act must be the proximate and efficient cause without the intervention of another’s negligence. It must be the causa causans; it is not enough that it may have been the causa sine qua non.

K.N.Wanchoo J, speaking for the court, observed that this of the law has been generally followed by high courts in India and was the correct view with regard to the meaning of Section 304A. The same view has been reiterated in Kishan Chand and Anr. v. The State of Haryana.19 In order to hold the existence of criminal rashness or criminal negligence it must be established that the rashness was of such a degree as to amount to taking a chance while knowing that injury was most likely imminent. The element of criminality will be assessed in the conduct of the accused, if he has undertaken the risk of doing an act with recklessness and indifference to the consequences. Lord Atkin in in Andrews v. Director of Public Prosecutions20 stated, ‘Simple lack of care— such as will constitute civil liability is not enough; for purposes of the criminal law there are degrees of negligence; and a very high degree of negligence is required to be proved before the felony is established.’ Thus, a clear distinction exists between ‘simple lack of care’, incurring civil liability, and ‘very high degree of negligence’, which is required in criminal cases. Lord Porter said in his speech in the same case—‘A higher degree of negligence has always been demanded in order to establish a criminal offence than is sufficient to create civil liability’.21 The oft-quoted statement of law in Andrews was noted with approval by the Supreme Court in Syad Akbar v. State of Karnataka.22 It dealt with and explained the distinction between negligence in civil law and in criminal law in terms of the marked difference as to the effect of evidence, namely the proof, in civil and criminal proceedings. In civil proceedings, a mere preponderance of probability is sufficient, and the defendant is not necessarily entitled to the benefit of every reasonable doubt, but in criminal proceedings, the persuasion of guilt must amount to such a moral certainty as to convince the court beyond all reasonable doubt. Where negligence is an essential ingredient of the offence, it must be established by the prosecution as culpable or gross, and not merely based upon an error of judgment. Negligence is an omission to do something that a reasonable

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person guided by considerations that ordinarily regulate the conduct of human affairs would do, or doing something that a prudent and reasonable man would not do. Criminal negligence is the gross and culpable neglect or failure to exercise that reasonable and proper care and precaution to guard against injury either to the public generally or to an individual in particular, which, having regard to all the circumstances out of which the charge has arisen, it was the imperative duty of the accused person to have adopted.23 In criminal proceedings, the burden of proving negligence as an essential ingredient of the offence lies on the prosecution. It cannot be regarded as proved or established by resorting to the rule.24

plea of medical negligence in defence by accused charged with murder There have been instances when the accused have pleaded medical negligence as the cause for death, and that they were not responsible for the offence of murder. However, the provisions of the IPC make it possible for the charge to stick even in cases where such negligence could be proved, but that would not itself be a ground for discharging the accused from guilt. In Antrum v. State of Maharashtra25 it was held by reference to explanation 2 to Section 299, IPC that where death is caused by bodily injury, the person who causes such bodily injury shall be deemed to have caused the death, although by resorting to proper remedies and skilful treatment the death might have been prevented. In a situation like this, the court will examine whether the particular act alleged against the accused could have caused an injury that they knew might cause death.26

plea of interference for wrong line of treatment If defence of medical negligence cannot be available to another person accused of murder, a medical professional charged with criminal negligence cannot plead in their defence that another person had interfered with the line of treatment, forcing the accused to alter the course of treatment that resulted in the alleged mishap. Such interferences, even if proven, cannot diminish the primary responsibility of the part of a medical professional in charge of a patient.27

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criminal negligence in medical termination cases The rigour of law contained through Section 314 of the IPC has to some degree been mitigated by the provisions contained under the Medical Termination of Pregnancy (MTP) Act, which decriminalizes a medical termination of pregnancy in certain situations contained under Section 3 of the act. However, the MTP Act confines the practice to hospitals established or maintained by the government or a place temporarily approved for the purpose of the act by the government or a district level committee constituted by that government with the chief medical officer of district or district health officer as the chairperson of the committee.28 Even without reference to any negligence, the very act of medical practice of termination of pregnancy at a place that is not approved would become punishable with rigorous imprisonment for a term which shall not be less than two years, but may extend to seven years. The exception relating to the place and the opinion of not less than two medical practitioners shall not apply to emergency situations necessary to save the life of a pregnant woman.29 In Surendra Chauhan v. State of MP 30 the Supreme Court found that the fact that the doctor had not been competent to terminate the pregnancy under the MTP Act and the rules. The doctor who had been questioned under Section 313 CrPC about the death of a patient who was three months pregnant but died while performing the operation had no explanation consistent with his innocence. A positive evidence of innocence may not have been necessary but a failure to explain death in such a situation was sufficient to render him guilty and sentenced to 18 months RI31 and a fine of Rs 25,000.

Guidelines Laid Down by Supreme Court While Prosecuting Medical Professionals There is an increasing tendency to criminal actions against doctors through filing by private complaints and sometimes by the police after an FIR is lodged. The investigating officer and the private complainant cannot always be expected to have knowledge of medical science so as to determine whether the act of the accused medical professional was rash or negligent within the domain of criminal law under Section 304A of the IPC. Once initiated, the criminal process subjects the medical professional to serious embarrassment and sometimes

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harassment. He has to seek bail to escape arrest, which may or may not be granted to him. At the end, he may be exonerated by acquittal or discharge, but the loss to his reputation cannot be compensated. In Martin F.D’Souza v. Mohd Ishfaq,32 falling under the Consumer Protection Act, the Supreme Court said: whenever a complaint is received against a doctor or hospital by the Consumer Fora (whether District, State or National) or by the Criminal Court, then before issuing notice to the doctor or hospital against whom the complaint was made, the Consumer Forum or Criminal Court should first refer the matter to a competent doctor or committee of doctors, specialized in the field relating to which the medical negligence is attributed, and only after that doctor or committee reports that there is a prima ficie case of medical negligence should notice be then issued to the concerned doctor/hospital. This is necessary to avoid harassment to doctors who may not be ultimately found to be negligent. We further warn the police officials not to arrest or harass doctors unless the facts clearly come with the parameters laid down in Jacob Mathew’s case (supra); otherwise the policemen will themselves have to face legal action.

However, in V. Kishan Rao v. Nikhil Super Specialty Hospital and Another,33 it was held that the directions are contrary to the law laid down in Indian Medical Association v. Shantha Devi34 and Dr J.J. Merchant v. Shrinath Chaturvedi,35 and what is statutorily permitted under the Consumer Protection Act itself to follow the procedure without delaying the proceedings.What the Supreme Court said in D’Souza must be taken as a direction of healthy practice and not an inviolable mandate. In Kishan Rao, the Supreme Court was dealing with an instance of res ipsa loquitur situation, where the doctor misdiagnosed malaria for typhoid even when the lab tests proved negative for typhoid and gave treatment for typhoid that ultimately resulted in death.The fact that an expert’s evidence was not made available to substantiate a complainant’s case before the consumer forum was taken by the high court and the National Commission to hold that the complainant had not established ‘deficiency of service’. While setting aside the judgments the Supreme Court laid down that it may not be necessary to examine experts in all medical negligence cases, and those cases should be decided by the consumer Fora on the basis of the procedure prescribed under the act.

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exhortation for statutory rules or executive instructions Statutory rules or executive instructions incorporating certain guidelines need to be framed and issued by the Government of India or the state governments in consultation with the MCI. So long as it is not done, the Supreme Court36 was laying down certain guidelines for the future that should govern the prosecution of doctors for offences involving criminal rashness or criminal negligence. (1) A private complaint may not be entertained unless the complainant has produced prima facie evidence before the court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor. (2) The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam’s test to the facts collected in the investigation. (3) A doctor accused of rashness or negligence, may not be arrested in a routine manner (simply because a charge has been levelled against him). Unless his arrest is necessary for furthering the investigation or for collecting evidence or unless the investigation officer feels satisfied that the doctor proceeded against would not make himself available to face the prosecution unless arrested, the arrest may be withheld.

AS AN ACTION IN TORT

Negligence by Professionals In the law of negligence, professionals such as lawyers, doctors, architects, and others are included in the category of persons professing some special skill or skilled persons generally. Any task that has to be performed with a special skill would generally be admitted or undertaken only if the person possesses the requisite skill for performing that

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task. Any reasonable person entering into a profession that requires a particular level of learning to qualify as a professional of that branch, by implication assures the person dealing with him that the skill he claims to possess will be exercised, and exercised with a reasonable degree of care and caution. He does not assure the client of the result. Lawyers do not tell their client that they will win the case in all circumstances.37 Physicians would not assure their patient of full recovery in every case. Surgeons cannot and do not guarantee that the result of surgery will invariably be beneficial to any extent for the person operated on.The only assurance that such professionals can give or can be understood to have given by implication is that they are possessed of the requisite skill in the branch of the profession they are practicing, and while undertaking the performance of the task entrusted to them, they would be exercising their skill with reasonable competence. This is all that the person approaching the professional can expect. Judged by this standard, professionals may be held liable for negligence on one of two findings: either they were not possessed of the requisite skill that they professed to have possessed, or they did not exercise, with reasonable competence in the given case, the skill which they did possess.38 The standard to be applied for judging whether the person charged has been negligent or not would be that of an ordinary competent person exercising ordinary skill in that profession. It is not necessary for all professionals to possess the highest level of expertise in the branch they practice but it may be possible that the standard of duty to care may also be inferred after factoring in the position and stature of the doctors concerned as well as the hospital; the premium stature of service available to the patient certainly raises a legitimate expectation.39 In Michael Hyde and Associates v. J.D.Williams & Co. Ltd,40 CA, Sedley LJ said that where a profession embraces a range of views as to what is an acceptable standard of conduct, the competence of the defendant is to be judged by the lowest standard that would be regarded as acceptable. In Chester v. Afshar,41 the House of Lords ruled that the surgeon who had failed to properly explain the degree of risk to a patient about the nature of a surgery cannot defend the action for negligence by contending that the patient should not only prove that she would not have consented to surgery if the risk had been explained then and there, but also that she would never have consented to surgery all her life.42

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The Bolam Principle Repeated An oft-quoted passage defining negligence by professionals, generally and not necessarily confined to doctors, is to be found in the opinion of McNair J. in Bolam v. Friern Hospital Management Committee,43 in the following words: Where you get a situation which involves the use of some special skill or competence, then the test as to whether there has been negligence or not is not the test of the man on the top of a Clapham omnibus, because he has not got this special skill. The test is the standard of the ordinary skilled man exercising and professing to have that special skill ... A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.

After a review of various authorities Bingham LJ in in Eckersley v. Binnie44 summarized the Bolam test in the following words: From these general statements it follows that a professional man should command the corpus of knowledge which forms part of the professional equipment of the ordinary member of his profession. He should not lag behind other ordinary assiduous and intelligent members of his profession in knowledge of new advances, discoveries and developments in his field. He should have such awareness as an ordinarily competent practitioner would have of the deficiencies in his knowledge and the limitations on his skill. He should be alert to the hazards and risks in any professional task he undertakes to the extent that other ordinarily competent members of the profession would be alert. He must bring to any professional task he undertakes no less expertise, skill and care than other ordinarily competent members of his profession would bring, but need bring no more. The standard is that of the reasonable average. The law does not require of a professional man that he be a paragon combining the qualities of polymath and prophet.

The degree of skill and care required by a medical practitioner is so stated in Halsbury's Laws of England (4th edition,Volume 30, Para 35): The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case, is what the law requires, and a person is not liable in negligence because someone else of

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greater skill and knowledge would have prescribed different treatment or operated in a different way; nor is he guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even though a body of adverse opinion also existed among medical men. Deviation from normal practice is not necessarily evidence of negligence. To establish liability on that basis it must be shown (1) that there is a usual and normal practice; (2) that the defendant has not adopted it; and (3) that the course in fact adopted is one no professional man of ordinary skill would have taken had he been acting with ordinary care.

In the opinion of Lord Denning, as expressed in Hucks v. Cole,45 a medical practitioner was not to be held liable simply because things went wrong from mischance or through an error of judgment in choosing one reasonable course of treatment in preference to another. A medical practitioner would be liable only if his conduct fell below that of the standards of a reasonably competent practitioner in his field. The decision of the House of Lords in Maynard v. West Midlands Regional Health Authority46 by a bench consisting of five law-lords has been accepted as having settled the law on the point by holding that it is not enough to show that there is a body of competent professional opinion that considers the decision of the defendant professional was wrong if there also exists a body of equally competent professional opinion that supports the decision as reasonable in the circumstances. It is not enough to show that subsequent events show that the operation need never have been performed if at the time the decision to operate was taken it was reasonable, in the sense that a responsible body of medical opinion would have accepted it as proper. Lord Scarman, who recorded the leading speech—with which other four Lords agreed—quoted the following words of Lord President (Clyde) in Hunter v. Hanley,47 saying that the words cannot be bettered: In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion, and one man clearly is not negligent merely because his conclusion differs from that of other professional men ... The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care... ...

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... a doctor who professes to exercise a special skill must exercise the ordinary skill of his specialty. Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence ... ... that a judge’s ‘preference’ for one body of distinguished professional opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions, truthfully expressed, honestly held, were not preferred.

The classical statement of law in Bolam’s case has been widely accepted as establishing the standard of care required both of professional men generally and medical practitioners in particular. It has been invariably cited with approval before courts in India and applied to as a touchstone to test the pleas of medical negligence. In tort, it is enough for the defendant to show that the standard of care and the skill attained was that of the ordinary competent medical practitioner exercising an ordinary degree of professional skill. The fact that a defendant charged with negligence acted in accord with the general and approved practice is enough to clear him of the charge. Two things should be noted. First, the standard of care, when assessing the practice as adopted, is judged in the light of knowledge available at the time (of the incident), and not at the date of trial. Second, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at the time it should have been used. A mere deviation from normal professional practice is not necessarily evidence of negligence. It should also be noted that a mere accident is not evidence of negligence. An error of judgment on the part of a professional is not negligence per se.The greater the emergency and the complication, the greater the chances of errors of judgment. At times, the professional is confronted with a choice between the devil and the deep sea, and he has to choose the lesser evil. The medical professional is often called upon to adopt a procedure that involves a higher element of risk, but which he honestly believes will provide greater chances of

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success for the patient rather than a procedure involving lesser risk but higher chances of failure. Which course is more appropriate would depend on the facts and circumstances of a case. The usual practice nowadays is, before adopting a given procedure, to obtain the consent of the patient or of the person in charge of the patient if the patient is not be in a position to give consent. So long as it can be found that the procedure that was in fact adopted was acceptable to medical science at that time, the medical practitioner cannot be held negligent merely because he chose to follow one procedure and not another, and the result was a failure. No sensible professional would intentionally commit an act or omission that would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dearly in his career. Even in a civil jurisdiction, the rule of res ipsa loquitur is not of universal application, but has to be applied with extreme care and caution to cases of professional negligence and in particular to that of doctors. It would otherwise be counter-productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur. Res ipsa loquitur is a rule of evidence that actually belongs to the law of torts. An inference as to negligence may be drawn from proved circumstances by applying the rule if the cause of the accident is unknown and no reasonable explanation is provided by the defendant. The purpose of holding a professional liable for his act or omission, if negligent, is to make life safer and to eliminate the possibility that the negligence will recover in the future.The human body and medical science are too complex to be easily understood. To hold in favour of an instance of negligence associated with the action or inaction of a medical professional requires an in-depth understanding of the working of that professional as well as the nature of the job and of errors committed by chance, which do not necessarily involve the element of culpability. Dealing with a case of medical negligence needs a deeper understanding of the practical side of medicine. The three constituents of negligence are: (1) A legal duty to exercise due care on the part of the party complained of towards the party complaining about the former’s conduct within the scope of the duty; (2) breach of that duty; and (3) consequential damage. Cause of action

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for negligence arises only when damage occurs, for damage is a necessary ingredient of this tort.48 An accident during the course of medical or surgical treatment has a wider meaning. Ordinarily, an accident means an unintended and unforeseen injurious occurrence; something that does not occur in the usual course of events or that could not be reasonably anticipated.49 Care has to be taken to see that the result of an accident that is exculpatory will not be confused with the consequence of negligence.

Cases of Medical Negligence Dr Laxman Balkrishna Joshi v. Dr Trimbak Bapu Godbole and Anr50 was a case under the Fatal Accidents Act, 1855, in which the duties that doctors owe to their patients came up for consideration. It does not make a reference to any other decided case. The court held that the doctor who holds himself out as competent to give medical advice and treatment, impliedly undertakes that he is possessed of skill and knowledge for that purpose.When consulted by a patient, such a person owes him certain duties, namely, a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to be given, or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires.The doctor no doubt has discretion in choosing the treatment for the patient, and such discretion is relatively larger in cases of emergency. In this case, the death of patient was caused by shock resulting from reduction of the fracture attempted by the doctor without taking the elementary caution of giving anaesthesia to the patient.The doctor was held as guilty of negligence and liability for damages in civil law. Criminal negligence or liability under criminal law was not an issue before the court; it did not arise and hence was not considered. In Achutrao Haribhau Khodwa and Ors v. State of Maharashtra and Ors51 the court noticed that in the very nature of the medical profession, skills differ from doctor to doctor and more than one alternative course of treatment are available, all of which are admissible. Negligence cannot be attributed to a doctor so long as he is performing his duties to

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the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession. In this case, a mop was left inside the patient’s abdomen during an operation. Peritonitis developed, which led to a second surgery being performed on her, but she did not survive. Liability for negligence was fastened on the surgeon because no valid explanation was forthcoming for the mop. The doctrine of res ipsa loquitur was held applicable in a case like this. Spring Meadows Hospital and Anr v. Harjol Ahluwalia through K.S. Ahluwalia and Anr52 is again a case of liability for negligence by a medical professional in civil law. A child that had been admitted for typhoid had ultimately been rendered incurably comatose due to drug overdose. However, it cautioned that an error of judgment is not necessarily negligence.The court referred to the decision in Whitehouse & Jorden,53 and cited with approval the following statement of law contained in the opinion of Lord Fraser, determining when an error of judgment can be termed as negligence: The true position is that an error of judgment may, or may not, be negligent, it depends on the nature of the error. If it is one that would not have been made by a reasonably competent professional man professing to have the standard and type of skill that the defendant holds himself out as having, and acting with ordinary care, then it is negligence. If, on the other hand, it is an error that such a man, acting with ordinary care, might have made, then it is not negligence.

sterilization cases The cases in India and the UK have generally been defencive of medical professionals in actions complaining of the failure of ‘family planning’ procedures, and this predilection could be seen as due to the fact that success in these cases is never 100 per cent, and negligence cannot be presumed. Even apart from failures of sterilization procedures resulting in patients who become pregnant, there have been cases of sterilization performed on unconscious patients without consent.54 The cause of the failure of the sterilization may be obtained from laproscopic inspection of the uterine tubes, or by X-ray examination, or by pathological examination of the materials removed at a subsequent operation of re-sterilization. The discrepancy between

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operation notes and the result of X-ray films with respect to the number of rings or clips or nylon sutures used for occlusion of the tubes will lead to logical inference on the part of the gynaecologist in case of failure of sterilization.55 In State of Haryana and Ors v. Smt. Santra56 too the Bolam test was approved. This case involved liability for compensation under civil law, claiming damages of Rs 3,00,000 against the state for failure of a tubectomy performed by a surgeon working in a government hospital. The plaint alleged inter alia that the plaintiffs, the husband and wife, considered abortion to be a sin, and that is why after learning of the conception they did not opt for it. The defendants filed a joint written statement. It was submitted that there was no negligence or carelessness in the performance of the surgery. It was stated in authoritative text books of medical science that pregnancy occurring after sterilization may be attributable to natural failure. Medical evidence was adduced to the effect that there was a 0.3 per cent to 3 per cent chance of failure in the operation. It was also submitted that the plaintiffs, having learnt of the unwanted pregnancy, should have sought medical opinion and opted for medical termination of it within 20 weeks, which is permissible and legal.57 The Supreme Court examined the various techniques of sterilization,58 the relative reliability of each of the tests, and the possible causes for failure.59 The Court has upheld the decree awarding damages for medical negligence as the lady had chosen to undergo complete sterilization and not a partial operation and, therefore, both her fallopian tubes should have been operated upon. It was found that only the right fallopian tube was operated upon and the left fallopian tube was left untouched. She was issued a certificate that her operation was successful, and was thus assured that she would not conceive a child in the future. It was in these circumstances that a case of medical negligence was found and a decree for compensation in tort was held as justified. In Eyre v. Measday from the UK,60 the facts of the case were that in 1978, the plaintiff and her husband decided that they did not wish to have any more children. The plaintiff consulted the defendant, a gynaecologist, to undergo sterilization.The defendant explained to the couple the nature of the particular operation he intended to perform, emphasising that it was irreversible. He stated that the operation ‘must be regarded as a permanent procedure’ but he did not inform the plaintiff that there was a small risk (less than 1 per cent) of pregnancy

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occurring following the operation. Consequently, both the plaintiff and her husband believed that the result of the operation would be to render her absolutely sterile and incapable of bearing more children. In 1979, the plaintiff became pregnant and gave birth to a child. The plaintiff brought an action against the defendant for damages, inter alia, for breach of contract, contending that his representation that the operation was irreversible and his failure to warn her of the minute risk of the procedure being unsuccessful amounted to breach of a contractual term, or express or implied collateral warranty, to render her irreversibly sterile. The judge dismissed her claim and the plaintiff appealed to the Court of Appeal. The court held: (1) The contract undertaken by the defendant was to carry out a particular type of operation rather than to render the plaintiff absolutely sterile. Furthermore, the defendant’s representations to the plaintiff that the operation was ‘irreversible’ did not amount to an express guarantee that the operation was bound to achieve its acknowledged object of sterilizing the plaintiff. On the facts, it was clear that the representations meant no more than that the operative procedure in question was incapable of being reversed. (2) Where a doctor contracted to carry out a particular operation on a patient and a particular result was expected, the court would imply into the contract between the doctor and the patient a term that the operation would be carried out with reasonable care and skill, but would be slow to imply a term or unqualified collateral warranty that the expected result would actually be achieved, since it was probable that no responsible medical man would intend to give such a warranty. On the facts, no intelligent lay bystander could have reasonably inferred that the defendant was intending to give the plaintiff a guarantee that after the operation she would be absolutely sterile and the fact that she believed that this would be the result was irrelevant.

The appeal was dismissed. The Court of Appeal upheld the finding of the trial judge that the risk of pregnancy following such a procedure to which the plaintiff was subjected is described as very small. It is of the order of two to six in every thousand. There is no sterilization procedure that is entirely without such a risk. Slade LJ stated that in the absence of any express warranty, the court should be slow to imply against a medical man an unqualified warranty as to the results of an intended operation, for the very simple reason that, objectively speaking, it is most unlikely that a responsible medical man would intend

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to give a warranty of this nature. Of course, objectively speaking, it is likely that he would give a guarantee that he would do what he had undertaken to do with reasonable care and skill; but it is quite another matter to say that he has committed himself to the extent suggested in the present case.

Purchas LJ stated that it is true that as a matter of deliberate election the defendant did not, in the course of describing the operation which he was recommending, disclose that there was a very small risk, one might almost say an insignificant risk, that the plaintiff might become pregnant. In withholding this information it must be borne in mind, first that the defendant must have believed that the plaintiff would be sterile, second that the chances were extremely remote that the operation would be unsuccessful, third that in withholding this information the defendant was following a practice acceptable to current professional standards and was acting in the best interest of the plaintiff, and fourth that no allegation of negligence in failing to give this information to the plaintiff is pursued any longer in this case.There are, therefore, in my judgment, no grounds for asserting that the result would necessarily be 100% successful.

In Thake v. Morris,61 the claim for damages was founded on contract and not in torts. The Court of Appeal firmly rejected the possibility of an enforceable warranty. Neill LJ said, ‘A reasonable man would have expected the defendant to exercise all the proper skill and care of a surgeon in that speciality: he would not have expected the defendant to give a guarantee of 100% success.’ Nourse LJ observed that ‘of all sciences medicine is one of the least exact. In my view, a doctor cannot be objectively regarded as guaranteeing the success of any operation or treatment unless he says as much in clear and unequivocal terms.’ Merely because a woman who had undergone sterilization became pregnant and delivered a child, the operating surgeon or his employer cannot be held liable for compensation on account of unwanted pregnancy or unwanted child. The claim in tort can be sustained only if there was negligence on the part of the surgeon in performing the surgery. The proof of negligence must satisfy Bolam test. Neither can the surgeon be held liable in contract unless the plaintiff alleges and proves that the surgeon had assured 100 per cent exclusion of pregnancy after the surgery and was only on the basis of such assurance that the plaintiff was persuaded to undergo surgery. Ordinarily a surgeon

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does not offer such guarantee. There must always be proof of the cause of failure of the procedure and this failure must indicate negligence on the part of the medical practitioner.The Supreme Court noted in State of Punjab v. Shiv Ram that while educated persons belonging to the middle class and the upper class do voluntarily opt for family planning and are careful enough to take precautions or remedial steps to guard against the consequences of failure of sterilization, the illiterate and the ignorant and those belonging to the lower economic strata of society may face real problems if there is failure in such cases. The House of Lords held in Rees v. Darlington Memorial Hospital NHS Trust62 that the costs of bringing up the child born through such pregnancy cannot be claimed. While examining the evidence of negligence against a doctor, courts have also seen it in the context of, want of consent for undertaking the particular kind of treatment. For instance, removal of uterus when the patient is under the influence of anesthesia for a procedure involving sterilization has given rise to actions for damages, although the doctor may have taken an impromptu assessment at the operation table that circumstances existed for the removal of uterus as well. From a narrow definition of negligence, the doctor’s action may not have been legally suspected, but the want of consent renders the failure of the doctor to warn the patient of the off chance of a more serious procedure to be actionable on the ground of battery. In Murray v. McMurchy63 the Supreme Court of British Columbia, Canada, was considering a claim for battery by a patient who underwent a caesarean section, during which the doctor found fibroid tumours in the patient’s uterus. Being of the view that such tumours would be a danger in case of future pregnancy, he performed a sterilization operation. The Court upheld the claim for damages for battery. It held that sterilization could not be justified under the principle of necessity, as there was no immediate threat or danger to the patient’s health or life and it would not have been unreasonable to postpone the operation to secure the patient’s consent. The fact that the doctor found it convenient to perform the sterilization operation without consent as the patient was already under general anaesthesia, was held to be not a valid defence. A somewhat similar view was expressed by the Court of Appeal in England in F. (Mental Patient: Sterilisation), In re.64

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medical camps Programmes of healthcare on a large scale may become necessary as a measure of national health policy. Here, it is not merely a patient–doctor interface on a one-to-one basis. A large number of people may show up for diagnostic investigation and treatment in medical camps organized by the government or NGOs. Immunization programmes for pulse polio, measles, chicken pox, and cholera are undertaken in a big way not in hospital environment but in public places. Mass diagnosis of anaemia, cataracts, diabetes, etc. may be preliminary to clinical treatment as well as surgical procedures. Treatment in less-than-ideal operation venues may themselves pose problems relating to cures. Failed sterilizations and loss of vision after eye surgery have often resulted in litigations that have found not only the doctors in the dock but also the organizations and the governments responsible for having the camps organized to be answerable for damages. In A.S.Mittal and Anr v. State of UP and Ors,65 the Supreme Court was intervening in public interest litigation where the complaint was that several persons who had undergone cataract operations in an eye camp conducted by Lions Club resulted in loss of sight. Patients developed post-operative infection of intra-ocular cavities, causing complete damage to the operated eyes. It was found that it was due to contamination in the saline bought and used by the surgeons to irrigate the eyes during surgery. Apart from the issue of product liability, in cases of mass use, a pre-test for safety and purity of the article was necessary, and the failure to do so would be actionable. Underscoring the necessity for maintenance of the highest standards of aseptic and sterile conditions at places where surgery is conducted, the court said that it was not merely on the formulation of the theoretical standards but really on the professional commitment with which the prescriptions are implemented that the ultimate result rested. The court said: The law recognizes the dangers which are inherent in surgical operations. Mistakes will occur on occasions despite the exercise of reasonable skill and care. Where the operation is a race against time, the court will make greater allowance for mistakes on the part of the surgeon or his assistants, taking into account the ‘Risk-benefit’ test. However, a mistake by a medical practitioner which no reasonably competent and a careful practitioner would have committed is a negligent one.

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Noticing that the persons who had organized the eye camp were acting pursuant to and under the authority of government, the court held that state would also be held to vicariously liable. (However, in the circumstances of the case with limited factual foundations laid before the court and limited scope of the proceedings under Article 32 and Article 131, no appeal could be made to the doctrine of state action. On behalf of the state, it was submitted that the state would approach the matter not with the spirit of a litigant in any adversary action but would look upon the proceedings as a participatory exploration for relief to the victims. State also submitted that it was willing to render help to the victims within the constraints of its resources).

immunization programmes Vaccines are among the greatest success stories in public health.66 Vaccines have exterminated smallpox, nearly ended polio, and reduced outbreaks of measles, pertussis, and other illnesses to an all-time low. Vaccines are believed to be the best defence against infectious diseases, but no vaccine is 100 per cent safe or effective. Scientists are trying to develop safer, more effective vaccines. People react differently to vaccines, so some people may have side effects or do not gain resistance to the disease. The risks of side effects are never disclosed in largescale drives of immunization programmes. However, a decision not to immunize a child also involves risk. It is a decision to put the child and others who come into contact with him or her at risk of getting a potentially deadly disease.67 India carries out massive immunization programmes against several viral and bacterial diseases: Polio, cholera, small pox, chicken pox, whooping cough, diphtheria, mumps, malaria, flu, and other diseases that have pandemic propensities. There are sporadic reports of drug contamination and questions have arisen about who is responsible for the deadly effects of their administration. Large-scale dissemination takes place through government agencies and NGOs, and liability will no doubt have to be placed only at their doors for any harmful effects that it might cause. Cases in courts have been few and far between. Whenever deaths or serious injuries have resulted from the defective quality of vaccines, governments have announced ex gratia payments to silence any large-scale public outcry. Actions against vaccine

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manufacturers themselves have not been reported from any courts in India.68 The Delhi High Court69 has directed the Union Government to take four factors—cost, efficacy, side effects, and incidence of the disease in India—into consideration before including any new vaccine in its Universal Immunization Programme. The direction by a division bench came after a public interest litigation filed by a former union health secretary and other experts in the field complaining that the vaccines on trial had been included in the universal immunization programme without the requisite studies by an independent body. They alleged that the vaccines, which were of questionable utility, expensive, and also carried possible side-effects, were introduced at the cost of the public exchequer at the behest of the WHO and vaccine manufacturers. The petitioners wanted that the government’s policy should prescribe mandatory analysis and epidemiological studies to be carried out before introduction of a vaccine in the public health system.The government submitted that it was testing the efficacy of the pentavalent vaccines—DPT, HIV, and Hepatitis-B—in two states before implementing it in the whole country. It was further submitted that an expert committee had been set up to examine the recommendation of the Health Ministry’s National Technical Advisory Group on Immunization to introduce vaccines in the immunization programme.

medical termination of pregnancy Issues of medical negligence may manifest through death of the patient while performing the operation or procedure to terminate pregnancy, or the foetus may survive to full term and result in birth of the child. The latter situation would arise if the procedure to terminate is resorted to before conception by sterilization or the failure of drugs administered for termination of pregnancy. Dilation and curettage (D&C) may sometimes be a hit-and-try method compared to surgical termination.70 The Delhi Consumer Commission in R. Madhu v. Dr Indu Khurana71 made a distinction between negligence of a high degree to a milder ‘deficiency of service’ for not performing a ‘complete abortion even through (surgical) method of medical termination’ that resulted inconception to grant the relief of damages of Rs 25,000. In Mrs Poonguzhali v. Ruwsec Health Centre and Another,72 the failure of the patient to follow up with medical consultation as advised after

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a surgery, which may make possible appropriate corrective action for ensuring abortion, was found as a circumstance not establishing a case of deficiency in service. In Shakila Sathanandam v. Dr S.S. Kodmani & Others,73 administration of a drug after detection of pregnancy for termination and the surgical intervention following its failure resulted in lot of pain and suffering. The complaint was that the complainant and her husband approached the first opposite party and requested the first opposite for the MTP. The first opposite party prescribed ‘Cyclenov-P’ and ‘Cyclenov-E’ and requested the complainant to wait for a few days, but in spite of the treatment, the complainant did not have any menstruation. Therefore, she again approached the first opposite party, who prescribed ‘Dependal-M’.The complainant was also advised to be admitted in the hospital of the second opposite party. Accordingly she was admitted and the MTP was performed. The complainant was prescribed ‘Doxy I’ and ‘Proxvon’. She was further advised to go for a review after a few days.The complainant, in the meanwhile, was bleeding from uterus per vagina and informed the first opposite party about it. She consulted the first opposite party, but the bleeding did not stop even after taking medicine prescribed by the first opposite party. The complainant appeared for a re-checkup before the first opposite party when she diagnosed it as dysfunctional uterus bleeding ( DUB) and prescribed her ‘Kerutin-C’. She also asked the complainant to take 40 tablets of ‘Regstrone’. This tablet resulted in clotting of blood in the uterus. The first opposite party came and saw the complainant only after ten hours of her admission in the nursing home, again diagnosed her condition as DUB, and advised her to get discharged on the next day. There was bleeding again. The complainant developed chest pain, stomach pain, and a reeling sensation. Her pulse rate dropped. She tried to talk to the first opposite party, but she could not. As her condition was bad, she was taken to another private clinic and nursing home, where a scan was taken. The scan report showed that it was an incomplete abortion, and the doctor there performed surgery to remove the remnants. She was discharged the next day. Thus, according to the complainant, the first opposite party was negligent in prescribing cyclenov-P and cyclenovE for more than thirty-nine days.These tablets, it was stated, would not be effective for bringing about an abortion after 39 days of conception. There was carelessness and negligence in not removing the contents of

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the uterus and of the remnants while conducting the MTP. The first opposite party negligently diagnosed the cause as DUB. She failed to exercise due care and caution and failed to visit the hospital. She failed to conduct proper physical examination. The state commission found that the documents produced clearly established that the surgery performed or the procedure carried out by the first opposite party for MTP was done carelessly. It said: In other words, she [the doctor] performed an incomplete abortion leaving remnants in the uterus as a result of which the complainant suffered bleeding from uterus and underwent pain, suffering and hardship and that she had to again undergo a procedure for evacuation of the contents. Therefore, in such circumstances, the principle of res ipsa loquitur would apply. The 1st opposite party has failed to exercise the necessary care and caution. She had failed to exercise the standard of care and has not exhibited the necessary skill. There has been negligence and carelessness in the performance of the abortion. As a result of which the abortion was not done completely and the remnants were left which led to the bleeding and other consequential physical and mental suffering. Therefore, this is a clear case where we find that there has been an abandonment of duty, lack of care and caution on the part of the 1st opposite party. She had performed the MTP procedure or surgery, as the case may be, in an half baked manner and that she failed to exercise the necessary expertise and skill as a result of which the incomplete abortion had come about. Therefore, it follows, there is deficiency in service.

The commission awarded the complainant Rs 2,50,000 as damages. In so far the MTP Act prescribes the persons who are competent to perform the procedure and the places where they could be done, what would be the effect if a complainant before a civil forum, say in a suit or a consumer complaint, shows that the medical practitioner had not followed the procedure prescribed under the act? The act obviously cannot advert to medical procedures, and therefore a person claiming damages for a failed operation or procedure has to independently establish negligence. In such a case, the violation of provisions of the MTP Act may be aggravating factors for quantification of damages. However, if the complaint is that the person who carried out the procedure was not competent or that the requisite sanction of a committee as enjoined under the statute was not obtained, the consumer forum or

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civil court will not take note of violations in the act. The Gujarat state commission said in Ghanshyam Rathod v. Dr(Mrs) Ushaben H.Shah & Others74 that violation of the provisions of the MTP Act will not per se constitute a ‘consumer dispute’.

Removal of Uterus In determining the issue of negligence, the standard medical practice will be the touchstone on which it will be decided whether there is an actionable wrong. In Smt. Vinitha Ashok v. Lakshmi Hospital and Ors,75 when there was condition suggestive for dilating cervix for suspected cervical pregnancy, the use of a laminaria tent76 instead of a dilapan77 was found, upon medical evidence, that in Kerala the commonly used method was dilation and evacuation or curettage and the procedure adopted by the doctor conformed to the standard medical practice. Accepting the view of the National Commission, the Supreme Court concluded that there was no negligence. Removal of the uterus without prior consent while performing sterilization on a spot decision by the surgeon for defects or problems noticed in it may not qualify for negligent act stricto sensu, but will still be actionable for damages for battery. In Samira Kohli v. Dr Prabha Manchanda and Another,78 the choice of surgical removal of uterus for endometriosis instead of conservative management was not found to be a negligent act. But on the issue of want of consent, the court found that even the consent of mother of the patient could not justify the act of removal of uterus when the consent of the patient was only for laparotomy, and particularly when the woman had not reached the age of menopause.

removal of brain after death Under the definition of Transplantation of Organs Act, the brain is a human organ and can be a donation for therapeutic or research purposes for removal after death.79 If the brain is removed by a pathologist for examination of the cause for death, but not delivered after examination to the next of kin, will an action for negligence lie at the instance of the next of kin? The answer depends on whether the retention was authorized or not. It also depends on the question in some

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jurisdictions on an epistemological enquiry of whether an organ in a corpse is property or not; if it is not, whether a lawful exercise of work or skill on an organ of a dead person would give such a right.The predominant legal view is that there is no property in a corpse or organ80 except when some value had been added by human intervention.81

improperly preserved semen Since the law of negligence is a kind of tort law that derives its legitimacy in India on the basis of common law, the failure to preserve semen collected from a corpse on instructions or semen delivered during life time for preservation for use in reproduction techniques82 will give rise to an action for breach of contract of bailment.83 In Year worth v. North Bristol NHS,84 men undergoing chemotherapy treatment at NHS Trust hospital for cancer had been advised to provide samples of semen before the therapy began as the treatment might damage fertility. The samples that were given thawed on account of the negligence of the Trust in allowing the amount of liquid nitrogen in the storage tanks to fall below the requisite level. After an enquiry on whether semen could be said to the property of the individual, the court of appeal held that the ejaculated sperm was intended solely for their benefit. Even if the ultimate use would not have been possible without the interposition of professional licence holders, who alone could have made the storage relevant for use and not the donors themselves, the fact that the owners of the sperm had a right to use it in a particular way indirectly recognized their ‘ownership’ of the semen. Even the Human Fertilization and Embryology Act, 1990, recognized their ownership. The law of bailment would also cast a responsibility for the negligence of the hospital in its due preservation.85

major and minor operations A surgery is a medical procedure involving an incision with instruments performed to repair damage or arrest disease in a living body. Surgical procedures are categorized as as major and minor. A minor surgery is any surgical procedure that does not involve anaesthesia or respiratory assistance, whereas a major surgery is any surgical procedure that does.86

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Since administration of anaesthesia involves some amount of risk,87 the final outcome in a surgical procedure must factor in this element. Consequently, the understanding of whether medical negligence exists or not in a given case must take note of the gravity of the problem that the patient has the complexity and the seriousness of the operation. Every surgical operation is attended by risks. We cannot take the benefits without taking the risks. Every advance in technique is also attended by risks. Doctors, like the rest of us, have to learn by experience; and experience often teaches in a hard way.88

diagnostic errors In the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion and a doctor is not negligent merely because his conclusion differs from that of other professional men.89 The true test for establishing negligence in diagnosis or treatment is whether a doctor has been proven guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care.90 Again, skills differ from doctor to doctor and more than one alternative course of treatments may be available.91 An error of judgment is not necessarily proof of negligence.92 In Whitehouse v. Jordan,93 quoted in Kusum Sharma, the House of Lords held: The true position is that an error of judgment may, or may not, be negligent. It depends on the nature of the error. If it is one that would not have been made by a reasonably competent professional man professing to have the standard and type of skill that the defendant holds himself out as having, and acting with ordinary care, then it is negligence. If on the other hand, it is an error that such a man, acting with ordinary care, might have made, then it is not negligence.

In a complicated case, court would be slow in inferring negligence if the doctors performed their duty to the best of their negligence.94 A criminal case registered for medical negligence was refused to be quashed, in a case of initial mis-diagnosis by a child specialist that the child which was found to have an abnormal increase in white blood cells was diagnosed and treated as a case of tuberculosis, when it turned out to be leukaemia, on the ground that the issue required full-fledged evidence.95A wrong diagnosis and treatment of a woman as suffering from diabetes when she had some other ailments was found actionable,

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and Employees State Insurance Corporation (ESIC) was found liable vicariously for ‘deficiency of service’ of the doctor working at the hospital.96

doctor as intermediary for defective products A doctor that prescribes a medicine manufactured by a particular pharmaceutical company does not always become liable for a defective medicine unless the risk in consumption of the drug or the defect was known to him or could have been known to him. In Walls v. Armour97 the US District Court for the Middle District of Florida found that the jury could reasonably conclude from the greater weight of the evidence that Armour failed to warn of its product’s risk in a timely fashion and that Armour’s negligence in doing so was the direct proximate cause of the decedent’s fatal HIV infection. Factor concentrate is the prevailing product in the treatment of haemophilia, a blood clotting disorder, for without such treatment the patient would eventually bleed to death. Specifically, factor concentrate is a ‘batch (product) made from pools of plasma of thousands of donors.’98 Thus, for example, anywhere from 53 to 95 per cent of factor VIII concentrate users have become HIV-infected as a direct result of the prescribed blood product.99 Factor concentrate, however, is not the only plasma product available for treatment. Moderate, like mild hemophiliacs may benefit from the use of cryoprecipitate, a substantially safer product.100 Cryoprecipitate is a clotting agent in which each individual dose is prepared from the plasma of one single volunteer donor, thereby drastically reducing the risk for HIV infection to 0–17 per cent. The importance and impact of these statistics is the equivalent of life and death to those moderate haemophiliacs that could have benefitted from cryoprecipitate treatment. The defendant to this action, Armour Pharmaceutical Company, was a Delaware Corporation that manufactured and sold factor VIII concentrate from 1982 to 1985.101 Jason, the patient, was treated with Armour’s product between 30 January 1983, and 24 May 1985, as a result of the decedent’s hereditary infliction of Type A hemophilia.102 Factor VIII was Armour’s plasma product, which on 10 November 1983 infected Jason with AIDS. Armour alleged that Dr Barbosa was a learned intermediary and he should have been aware of such AIDS-related risks, thus relieving

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Armour of their imposed duty to warn. The facts presented clearly demonstrated that Dr Barbosa did not possess first-hand knowledge of the AIDS risk in connection with Factor VIII, hence, he did not break the chain of proximate causation. In fact, when asked how it would have affected his treatment of Jason if he had received a warning in July 1983 from a concentrate manufacturer that there was a possible risk of AIDS transmission via Factor VIII concentrate, Dr Barbosa testified that he would have switched Jason to cryoprecipitate, a safer treatment and one from which Jason, as a moderate haemophiliac, could have benefitted.

blood banks The operation of the blood banks is done through a system of licensing under the Drugs and Cosmetics Rules, 1945.103 Rule 122G, which prescribes a kind of licence, enjoins that the operation of a blood bank or processing of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is a full-time employee and is a medical officer possessing (1) a postgraduate degree in medicine, MD (Pathology/Transfusion Medicines); or (2) degree in medicine (MBBS) with a diploma in pathology or transfusion medicines with adequate knowledge of blood group serology, blood group methodology, and the medical principles involved in the procurement of blood or preparation of its components; or (3) a degree in medicine (MBBS) with experience working in a blood bank for one year during regular service and adequate knowledge and experience in blood group serology, blood group methodology, and medical principles involved in the procurement of blood or preparation of its components, the degree or diploma being from a university recognized by the Central Government. To the extent to which the rules require a medical graduate to be in charge of a blood bank, any mishap in the manner of blood storage or transfusion shall most likely make the person responsible for the adverse consequences to a donor or a recipient. Transfusion of Mismatched Blood Acute transfusion reactions manifest as adverse signs or symptoms during or within 24 hours of a blood transfusion. The most frequent

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reactions are fever, chills, pruritus, and urticaria, which typically are resolved promptly without specific treatment or complications. Other signs occurring in temporal relationship with a blood transfusion, such as severe shortness of breath, red urine, high fever, or loss of consciousness may be the first indication of a more severe potentially fatal reaction. Transfusion reactions require immediate recognition, laboratory investigation, and clinical management. If a transfusion reaction is suspected during blood administration, the safest practice is to stop the transfusion and keep the intravenous line open with 0.9 per cent sodium chloride (normal saline). A clerical check of the information on the blood unit label and the patient’s identification should be performed to ensure that the ‘right’ blood unit was administered to the ‘right’ patient. In most cases, the residual contents of the blood component container should be returned to the blood bank together with a freshly collected blood sample from the patient, and a transfusion reaction investigation should be initiated.104 In Common Cause v. Union of India,105 the Supreme Court dealt with a public interest litigation case highlighting the serious deficiencies and shortcomings in the matter of collection, storage, and supply of blood through the various blood centres operating in the country, particularly in the context of an enormous increase of HIV-infected cases. The court, inter alia directed the government to establish a National Council of Blood Transfusion as a society registered under the Societies Registration Act. A direction was also issued to all the state governments to establish State Councils of Blood Transfusion and also undertake to adopt strict licencing procedures for establishment of blood banks under the Drugs Control Act. Wrong blood transfusion is an error that no hospital or doctor exercising ordinary care would have made. Such an error is not an error of professional judgment but in the very nature of things a sure instance of medical negligence. In Postgraduate Institute of Medical Education & Research v. Jaspal Singh106 it was held that the hospital’s breach of duty in mismatched blood transfusion contributed to the patient’s death, if not wholly, but surely materially. Mismatched blood transfusion to a patient having sustained 50 per cent burns by itself bespoke of negligence.

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Transfusion of HIV Infected Blood AIDS is not a single disease but is a syndrome caused by various diseases, and resulting from the destruction of the body’s defences by the HIV virus. In healthy individuals, infections and cancers are kept at bay by an array of defenders in the body, which constitute its immune system. These defenders—the white blood cells (WBC)—are at work every day, recognizing foreign invaders in the body and fighting them both by recruiting an army of cells that attack infection directly and by producing specific chemicals called antibodies, which neutralize the invaders. The detection of these antibodies in blood samples is used to determine past or present infection. In trying to explain the cause for the malady, the full bench in the Andhra Pradesh High Court in Smt. M. Vijaya v. v. The Chairman and Managing Director, Singareni Collieries Company Ltd and Others107 observed: How exactly HIV knocks down the immune system is still a matter of active research. According to the most widely accepted theory, HIV lymphocytes (WBC) play a vital role in orchestrating the defences of the immune system. The strange thing about HIV is the long time it takes to do its damage. After entering the human body, HIV may be ‘hidden’ several years before triggering its rapid multiplication and destruction of the cells. This way it escapes being attacked by antibodies, which are circulating in the blood to seek out and destroy it. Ultimately, HIV destroys WBCs and the body falls prey to opportunistic infections and cancers described as the hallmark of AIDS.

Transfusion of HIV-infected blood without proper checking was found by the full bench to entitle the infected woman to obtain compensation on the ground of negligence. The court granted compensation of Rs 1,00,000 in a writ petition and gave liberty to the petitioner to also approach the civil court for proper quantification of damages. Whether the infection was contracted only through blood transfusion is a question of fact. M. Chinnaiyan v. Sri Gokulam Hospital & Another108 was a case for damages for negligence by a husband for the death of his wife after an episode of blood transfusion, when HIV was detected after a lapse of about one-and-a half years after the blood transfusion.The State Consumer Disputes Redressal Commission held that it could not be definitely said that HIV had been transmitted only from the blood transfused and not through any other vector.

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The commission reasoned that the complainant has not stated that his blood had been tested before the transfusion of blood to his wife, whose blood had been infected and later resulted in her death, and said that this would also show that the possibility of sexual transmission of HIV from the complainant himself could not be denied. In State of Maharashtra v. Devahari Devasingh Pawar,109 the supply of HIV-contaminated blood from a blood bank by a government medical college and hospital resulted in transmission to some patients who were given blood transfusions. The negligence of the doctors and of the hospital staff was such as not to be taken as arising out of discharge of official duty, and hence held not to require sanction for prosecution under Section 197 of the CrPC.

delay in ambulance service As an ancillary service to a doctor’s treatment or a hospital, any delay or negligent act of an ambulance service in arriving at the patient’s door, despite being contacted on the advertized classified number, could give rise to a lawful claim for damages. In Kent v. Griffiths and Others,110 the doctor treating an asthmatic patient had telephoned the defendant ambulance service on the emergency 999 line, but the ambulance did not arrive until forty minutes later, during which time the patient had suffered a respiratory arrest. Rejecting the contention that the ambulance service did not owe a duty of care, the English Court of Appeal held that ambulance emergency service was part of health service and its care function included transporting patients to and from hospital when it was desirable to use an ambulance for that purpose.

incorrect lab reports that have a bearing on treatment If the regimen of treatment adopted turns out to be dangerous to a patient on account of the errors in the lab reports over which the doctor himself had no control, it shall be dealt with on the principle of vicarious liability familiar to tort law. If the lab is part of the doctor’s establishment, the liability of the doctor treating the patient is unexceptional. If, on the other hand, the lab is suggested by the

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doctor himself, he will make himself liable for the action brought at the instance of the patient and may obtain an indemnity from the lab owner or technician for the error in the report. If the lab was chosen by the patient himself, the liability will be tested on the question of fact that the treatment was not irreversible and the doctor could not have set right the mistake by administration of the right drugs after the mistake was found out. AS A COMPLAINT FOR ‘DEFICIENCY IN SERVICE’

General The passing of the Consumer Protection Act opened a floodgate of litigations against medical professionals complaining of negligence. The access to consumer fora is in keeping with the definition of the act that includes the concept of negligence in ‘deficiency of service’. The definition is loaded: It shall be invoked against a provider of service under a contract for consideration. It is but a species of the law of torts. The decisions examined above under ‘medical negligence’ apply also to cases examined under the Consumer Protection Act, except when the consumer fora may direct parties to resort to a regular civil court remedy, if the complexity of facts of the case are such as a summary procedure provided under the Consumer Protection Act will not be appropriate to undertake an adjudication. The complainant need not necessarily be a patient, but a secondary victim who may have suffered pain and suffering for the deficient service meted out to a near relative. In Spring Meadows Hospital and Another v. Harjol Ahluwalia and Another,111 the Supreme Court upheld the compensation awarded to the parents for the pain and suffering that they had to undergo for the deficient service rendered to a child through wrong administration of drugs that had caused brain damage, rendering her vegetative. In Pravat Kumar Mukherjee v. Ruby General Hospital & Ors,112 the National Consumer Commission awarded Rs 10,00,000 as damages for the parents of the deceased for unethically turning out a patient brought in a critical condition due to injuries suffered in a motor accident without giving adequate care for not depositing medical expenses in advance that cost a young man his life.

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Definition of ‘Deficiency of Service’ In Indian Medical Association v. V.P. Shantha and Ors,113 a three-judge bench decision of the Supreme Court, the principal issue was whether a medical practitioner renders ‘service’ and can be proceeded against for ‘deficiency in service’ before a forum under the Consumer Protection Act, 1986. The Court dealt with how a ‘profession’ differs from an ‘occupation’, especially in the context of the performance of duties and hence the occurrence of negligence. The Court noted that medical professionals do not enjoy any immunity from being sued in contract or tort (that is, in civil jurisdiction) on the ground of negligence. However, in the observation made in the context of determining professional liability as distinguished from occupational liability, the court has referred to authorities, in particular, Jackson and Powell, and have so stated the principles, partly quoted from them: In the matter of professional liability professions differ from occupations for the reason that professions operate in spheres where success cannot be achieved in every case and very often success or failure depends upon factors beyond the professional man’s control. In devising a rational approach to professional liability which must provide proper protection to the consumer while allowing for the factors mentioned above, the approach of the courts is to require that professional men should possess a certain minimum degree of competence and that they should exercise reasonable care in the discharge of their duties. In general, a professional man owes to his client a duty in tort as well as in contract to exercise reasonable care in giving advice or performing services.114

The test is always whether there has been any professional negligence. The proof that is necessary in an action in tort shall again be the guiding principle.115 The standard medical procedure shall be the watchword in deciding whether the doctor has caused a deficient service. If there are divergent views on a medical procedure to be adopted, the court will see if there has been a proper appraisal of the situation to the patient and whether consent was obtained before applying the procedure on the patient. If the parameters are present, there will be no ground for action for negligence.116 In Kusum Sharma v. Batra Hospital,117 the Supreme Court laid down the following principles as emanating from the examination of English and Indian law:

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(1) Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do. (2) Negligence is an essential ingredient of the offence.The negligence to be established by the prosecution must be culpable or gross and not the negligence merely based upon an error of judgment. (3) The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires. (4) A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field. (5) In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of other professional doctor. (6) The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Just because a professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence. (7) Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession. (8) It would not be conducive to the efficiency of the medical profession if no doctor could administer medicine without a halter round his neck. (9) It is our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessarily harassed or humiliated so that they can perform their professional duties without fear and apprehension. (10) The medical practitioners at times also have to be saved from such a class of complainants who use criminal process as a tool for

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pressurising the medical professionals/hospitals, particularly private hospitals or clinics for extracting uncalled for compensation. Such malicious proceedings deserve to be discarded against the medical practitioners. (11) The medical professionals are entitled to get protection so long as they perform their duties with reasonable skill and competence and in the interest of the patients. The interest and welfare of the patients have to be paramount for the medical professionals.

Failure to Observe Duty to Give Details of Treatment as Proof of Deficiency of Service The proof of deficiency of service is essentially a question of fact. The attending physician or surgeon is bound to file the written version in time to explain the treatment regiment adopted on the patient, the entries in the medical records as regards the condition of the patient and the medicines administered, etc., to prove that there existed no negligence on their part. In Marghesh K. Parikh v. Dr Mayur H. Mehta,118 the Supreme Court was considering the combination of serval factors: the doctor’s failure to produce case papers for six years and explain why the record pertaining to the treatment given to the patient was held from the state commission till the complainant’s evidence was virtually over; the non-filing of the case papers/bed-ticket maintained by the hospital, which would have disclosed the line of treatment adopted by him; along with the reply and withholding those papers till the completion of the evidence of a doctor examined by the complainant. They conjointly were treated as serious attempts to mislead the court and the Supreme Court directed a fresh examination on the issue of negligence, when it found that the National Commission had earlier erred in finding that negligence had not been established.

Action against Physician for ‘Free’ Medical Treatment An action for medical negligence on the basis of tort applies the principle of doctors owing a duty of care to a patient which they fail to employ. Here, it is irrelevant that the service offered by a doctor is gratuitous or for consideration. A right of action for an aggrieved patient definitely lies in both cases. A contract for service supposes

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consideration as its bedrock, and an action based on a contract will therefore enable a doctor to plead want of consideration as valid defence to deny liability. Since the Consumer Protection Act attaches ‘deficiency of service’ to a ‘contract for service’, it is expected that the service rendered by a doctor, in order that it is actionable in a consumer forum and its hierarchical tiers, is non-gratuitous.119

Treatment under Terms of Employment Where ‘free’ or subsidized treatment is given to employees as one of the terms of service, it cannot be treated as a gratuitous service. A right of action under the Consumer Protection Act is protected. V.P. Shantha120 has made a distinction between a non-governmental hospital or nursing home where no charge whatsoever was made to any person availing of the service and all patients are given free service (vide para 55(6) at p.681), and services rendered at a government hospital, health centre, or dispensary where no charge whatsoever is made to any person availing of the services and all patients are given free service (vide para 55[9]) on the one hand and service rendered to an employee and his family members by a medical practitioner or a hospital or nursing home which are given as part of the conditions of service to the employee and where the employer bears expenses of the medical treatment of the employee and his family members (para 55[12]) on the other. In the first two circumstances, it would not (sic) be free service within the definition of Section 2(1)(o) of the act. In the third circumstance it would (sic not) be. Treatment at a railway hospital on nominal charges will therefore amount to service for consideration and an action for ‘deficiency of service’ will lie.121

The ESI scheme is an insurance scheme, and service given in the ESI hospitals or dispensaries to a member of the scheme or his family cannot be treated as gratuitous. Consequently, medical service rendered in the ESI hospital or dispensary by the ESI Corporation falls within the ambit of Section 2(1)(o) of the Consumer Protection Act.122

Action against Hospital and Non-impleadment of Attending Doctor The principle of vicarious liability recognized in the field of torts makes the hospital liable for the negligent conduct of a doctor. The

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joint liability in India always means joint and several liability that will make possible either a joint action against both of them or sever the liability against only one of them. The procedural law enables a court to deliver a judgment for or against one or more of joint parties.123 In Smt. Savita Garg v. The Director, National Heart Institute,124 the appellant had filed an original petition impleading the medical institute where her husband was admitted as a party but she had not impleaded the attending physician. The Court said that it was inconsequential and awarded the claim against the hospital. In Malay Kumar Ganguly v. Dr Sukumar Mukherjee,125 the Supreme Court held that even if the persons against whom the case is filed take up the defence that some other doctors involved in the treatment have not been added, the court shall proceed against the parties who are before the court and apportion the damages to the extent of their respective culpability.

Complicated Questions of Law and Facts The Consumer Forum adjudicates matters in a summary fashion126 and normally matters that involve complicated questions of law and facts are best left to be decided by civil courts. However, there has not been consistent authority to this aspect also, as when in Dr J.J. Merchant and Ors v. Shrinath Chaturvedi,127 the Supreme Court said that the object of the act was to provide speedy and simple redressal, but a delay in disposal of the complaint itself would not be a ground for rejecting it and directing the complainant to approach the civil court. It further cautioned that it would be improper to hold that in cases where negligence of experts is alleged, consumers should be directed to approach the civil court. It would be left to the discretion of the commission to examine the experts, if required, in appropriate matter.The Consumer Protection Act, 1986, specifically empowers the consumer fora to follow the procedure that will not require more time or delay the proceedings. Referring to the pendency of the cases in the National and state commissions, the court emphasized the powers of the president of the National Commission or the state commissions to form benches for the disposal of the pending cases depending upon the workload and the time frame contemplated under the Consumer Protection Act. It also urged the legislature to take appropriate steps in providing proper infrastructure so that the act is properly implemented

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and the legislative purpose of providing alternative, efficacious, speedy, inexpensive remedy to the consumers is not defeated or frustrated.

Limitation for Filing Complaint The complaint for damages for ‘deficiency of service’ has to be filed within two years from the time when the cause of action arises.128 It is a question of fact as to what constitutes a cause of action. In the US the courts go by a ‘discovery principle’ of when the effect of the negligent act is discovered by the patient to sue for damages.129 The decisions cited before the Supreme Court were recalled in V.N. Shrikhande (Dr) v. Anita Sena Fernandes130 for the case of a patient who was herself a nurse, and had sued her doctor for what was definitely a case of negligence, leaving a swab inside her abdomen after a surgery.The Supreme Court, however, found, on an issue of fact, that the patient had been complaining of pain for nearly nine years after surgery and had not reported to the doctor all the while and only after a surgical removal 10 years after the first operation had she issued a notice and filed the complaint under the act. The Supreme Court declined to draw lessons from the American examples and found that the complaint was barred by limitation. NOTES 1 Negligence is strictly nonfeasance and not malfeasance. It is the omission to do what the law requires, or the failure to do anything in a manner prescribed by law. It is the act that can be treated as negligence without any proof as to the surrounding circumstances, because it is in violation of statue or ordnance, or is contrary to the dictates of ordinary prudence, Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others (2009) 9 SCC 221, (2009) (4) RCR (civil) 14, (2009) (4) RCR (crl) 2, 2009(5) RAJ 405. 2 It must be remembered that a humanitarian approach or non-charging of professional fees can in no way be considered factors in denying the compensation for mental agony suffered by the victim or their relatives, Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others (2009) 9 SCC 221, (2009) (4) RCR (civil) 14, (2009) (4) RCR (crl) 2, (2009) (5) RAJ 405. 3 Jacob Mathew v. State of Punjab and Another (2005) ACJ 1840, AIR (2005) SC 3180, (2005) (2)ALD(Cri) 334, (2005) (5) ALD52(SC), (2005) (3) AWC 2756 (SC), III (2005) CPJ 9 (SC), 2005 Cri LJ 3710, 2005(4) CTC 540, 122 (2005) DLT 83 (SC), (2005) (85) DRJ330, (2005) 3 GLR 2126, (2006[2]

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JCR184[SC]), 2005 (3) JKJ5[SC], JT 2005 (6) SC 584, 2005 (3) KLT 965 (SC), RLW 2005 (4) SC 2790, (2005) 6 SCC 1. 4 Section 3 of the act reads: ‘Act not in derogation of any other law: The provisions of this act shall be in addition to and not in derogation of the provisions of any other law for the time being in force.’ 5 (2009) 9 SCC 221, 2009(4) RCR (civil) 14, 2009(4) RCR (crl) 2, 2009(5) RAJ 405. 6 R. v. Lawrence, 1981 1 All ER 974 (HL), per Diplock. 7 R. v. Caldwell 1981(1) All ER 961 (HL). 8 Ibid. 9 Lord Diplock in R. v. Caldwell 1981(1) All ER 961 (HL) dealt with the concept of recklessness as constituting mens rea in criminal law. His Lordship warded against adopting the simplistic approach of treating all problems of criminal liability as soluble by classifying the test of liability as being ‘subjective’ or ‘objective’, and said, ‘Recklessness on the part of the doer of an act does presuppose that there is something in the circumstances that would have drawn the attention of an ordinary prudent individual to the possibility that his act was capable of causing the kind of serious harmful consequences that the section which creates the offence was intended to prevent, and that the risk of those harmful consequences occurring was not so slight that an ordinary prudent individual would feel justified in treating them as negligible. It is only when this is so that the doer of the act is acting “recklessly” if, before doing the act, he either fails to give any thought to the possibility of there being any such risk or, having recognized that there was such risk, he nevertheless goes on to do it.’ 10 (2004) ACJ 1441, AIR (2004) SC 4091, (2004) (2) ALD(Cri) 739mm (2004) 3 CompLJ 271 (SC), 2004 CriLJ 3870, (2004) (4) CTC 309,112 (2004) DLT 866 (SC). 11 Jacob Mathew v. State of Punjab and Another, see note 3 above. 12 (2005) ACJ 1840, AIR (2005) SC 3180, (2005) (2) ALD (Cri) 334, (2005) (5) ALD 52 (SC), 2005 (3) AWC 2756 (SC), III (2005) CPJ9 (SC), 2005 Cri LJ 3710, (2005) (4) CTC 540, 122 (2005) DLT 83 (SC), 2005 (85) DRJ 330, (2005) 3 GLR 2126, (2006[2]JCR184[SC]), (2005) (3) JKJ5 (SC), JT (2005) (6) SC 584, (2005) (3) KLT 965 (SC), RLW (2005) (4) SC 2790, (2005) 6 SCC 1. 13 Lord Macaulay, Speeches and Poems with the Report and Notes on the Indian Penal Code (Houghton: Mifflin and Company, 1874). 14 AIR (1943) PC 72. 15 MANU/SC/0078/1964. 16 MANU/SC/0530/1996. 17 MANU/SC/0093/1964.

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18 4 Bom LR 679. 19 (1970) 3 SCC 904(1970) 3 SCC 904(1970) 3 SCC 904. 20 (1937) AC 576. 21 Ibid., Para 1.13. 22 (1980) 1 SCC 30, 1980 SCC (Crl) 59. 23 The law as laid down by Straight J in the case Reg v. Idu Beg (1881) 3 All. 776, was held good and noticed in Bhalchandra Waman Pathe v. State of Maharashtra 1968 Mh.L.J. 423,MPLJ 371 (SC) a three-Judge Bench decision of Supreme Court. 24 In Krishnan and Anr v. State of Kerala (1996) 10 SCC 408, the Supreme Court observed that the proved facts would themselves speak of sharing of common intention and while making such observation one of the learned judges constituting the bench had in his concurring opinion merely stated ‘res ipsa loquitur’. But in Syed Akbar, the Supreme Court noted, ‘Nowhere it has been stated that the rule has applicability in a criminal case and an inference as to an essential ingredient of an offence can be found proved by resorting to the said rule. In our opinion, a case under Section 304A IPC cannot be decided solely by applying the rule of res ipsa loquitur.’ 25 AIR (2008) SC 409, JT (2007) (12) SC 526, (2007) (13) SCALE 15. 26 See definition of ‘culpable homicide’ occurring under Section 299 and the punishment under Section 304 of the IPC. A person causing death by negligence could be prosecuted independently for offence under Section 304A of the IPC. 27 Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others (2009)(4) RCR (civil) 14, (2009) (4) RCR (crl) 2, (2009) (5) RAJ 405, following Smt. Savita Garg v. The Director, National Heart Institute (2004) 8 SCC 56. 28 Section 4, MTP Act, 1971. 29 Section 5, ibid. 30 (2000) 4 SCC 110, 2000 SCC (Crl) 772, AIR (2000) SC 1436, (2000) Cri LJ 1789. 31 The minimum period of punishment for a person who was not competent to terminate pregnancy under the MTP Act under Section 5 is two years. 32 (2009) 3 SCC 1. 33 (2010) 5 SCC 510, 2010 (3) RAJ 240. 34 (1995) 6 SCC 651. 35 (2002) 6 SCC 635. 36 Jacob Mathew v. State of Punjab and Another (2005) ACJ 1840, AIR (2005) SC 3180, (2005) (2) ALD (Cri) 334, (2005) (5) ALD 52 (SC), (2005) (3) AWC 2756 (SC), III (2005) CPJ 9 (SC), (2005) Cri LJ 3710, (2005) (4) CTC 540, 122 (2005) DLT 83 (SC), 2005 (85) DRJ 330, (2005) 3 GLR 2126, (2006 [2] JCR 184 [SC]), 2005 (3) JKJ5 (SC), JT 2005 (6) SC 584, 2005 (3) KLT

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965 (SC), RLW 2005 (4) SC 2790, (2005) 6 SCC 1. See also Nizam Institute of Medical Sciences v. Prasanth S. Dhananka, (2009) 6 SCC 1 for an extensive treatment of the subject of medical negligence. 37 This comparison was made by the Supreme Court in Martin F. D’Souza v. Mohd Ishfaq (2009) 3 SCC 1. 38 In C.P. Sreekumar, M.S. (Ortho) v. S.Ramanujam 2009(6) SCALE 613, the Supreme Court held in a case of a 42-year-old person suffering a hairline fracture of the neck of the right femur that the choice of hemiarthroplasty for a garden type I fracture that had developed to a more serious garden III type facture after treatment by plaster of paris bandage was found to be no evidence of medical negligence.The Supreme Court said, ‘No firm conclusion as to the preference of one or the other procedure can be drawn but for a Garden type III fracture on a young person, internal fixation is ordinarily the favoured but not the only option as some of the texts also proceed on a school of thought which prescribe that in order to avoid long drawn out recovery and other complications, it is advisable to go in for a hemiarthroscopy, notwithstanding the age factor. ... In the light of the fact that there is some divergence of opinion as to the proper procedure to be adopted, it cannot be said with certainty; that the appellant Dr Sreekumar was grossly remiss in going in for hemiarthroplasty.’ 39 Malay Kumar Ganguly v. Dr.Sukumar Mukherjee and Others, Crl App 1191–4 of 2005 decided with Civ App 1727 of 2007, decided by the Supreme Court on 7 August 2009, (2009) (4) RCR (civil) 14, (2009) (4) RCR (crl) 2, (2009) (5) RAJ 405. 40 (2001) PNLR 233. 41 (2004) 3 All ER 587. 42 The HL was dealing with a failed case of spinal surgery that left the patient with partial paralysis, and the medical opinion was that there was 1–2 per cent risk of failure, which was found to not have been communicated to the patient. 43 (1957) 1 WLR 582, 586. This principle is already stated in Chapter 2 dealing with medical ethics and the unethical act itself is specie of negligence and hence re-stated here. 44 (1988) 18 Con.L.R. 1, 79. 45 (1968) 118 New LJ 469. 46 (1985) 1 All ER 635 (HL). 47 1955 SLT 213. 48 Justice G.P. Singh(ed.), Law of Torts, 24th edition (New Delhi: Ratanlal and Dhirajial, 2002), pp. 441–2. This follows the classic definition as found in Charlesworth and Percy on Negligence, 10th edition (2001),which states that in current forensic speech, negligence has three meanings. They are: (1) a state

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of mind, in which it is opposed to intention; (2) careless conduct; and (3) the breach of duty to take care that is imposed by either common or statute law. All three meanings are applicable in different circumstances, but any one of them does not necessarily exclude the other meanings. (Para 1.01) The essential components of negligence, as recognized, are three: ‘duty’, ‘breach’, and ‘resulting damage’, that is to say: 1. the existence of a duty to take care, which is owed by the defendant to the complainant; 2. the failure to attain that standard of care, prescribed by the law, thereby committing a breach of such duty; and 3. damage, which is both causally connected with such breach and recognized by the law, has been suffered by the complainant. (Para 1.23) If the claimant satisfies the court on the evidence that these three ingredients are made out, the defendant should be held liable in negligence. (Para 1.24) 49 Black’s Law Dictionary, 7th edition, sub verso. 50 AIR (1969) 168, MANU/SC/0362/1968. 51 (1996) 2 SCC 634, MANU/SC/0600/1996. 52 (1998) 4 SCC 439, MANU/SC/1014/1998. 53 (1981) 1 ALL ER 267. 54 See Chapter 3. 55 State of Punjab v. Shiv Ram (2005) 7 SCC 1, AIR (2005) SC 3280. The court found held the negligence had not been established, as the operation had been performed by a competent surgeon and a mere failure of the operation could not lead to an inference of negligence. 56 MANU/SC/0295/2000. 57 Section 3(2), explanation II of the MTP Act affords a justification for abortion that would not go against the penal provision contained in the IPC thus: ‘Where any pregnancy occurs as a result of failure of any device or method used by any married woman or her husband for the purpose of limiting the number of children, the anguish caused by such unwanted pregnancy may be presumed to constitute a grave injury to the mental health of the pregnant woman.’ 58 (i) Radiotherapy: A menopausal dose of external beam irradiation to the ovaries is only attractive in so far that they sterilize without involving the woman in an operation. Their disadvantages are such that they are rarely used except in older women who are seriously ill. (ii) Removal of ovaries: This sterilizes (provided an accessory ovary is not overlooked) but is very rarely indicated as it often results in severe climacteric symptoms. (iii) This is effective but involves an unnecessarily major operation and destroys menstrual as well as reproductive function. Its chief place is in those cases where the need for sterilization is associated with disease in the uterus or cervix. But, to preclude

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further childbearing, it is commonly carried out as part of another operation. Examples are vaginal hysterectomy as part of the cure of prolapse and caesarean hysterectomy. The latter is sometimes advocated in preference to caesarean section and tuba legation on the grounds that it prevents future uterine disease as well as conception. Those women who have ethical objections to tuba legation may well prefer to have a ‘scarred uterus’ removed. Except in special circumstances, however, caesarean hysterectomy is not justified as a sterilization procedure. As an elective sterilization procedure for non-pregnant women, some gynaecologists advocate hysterectomy (preferably vaginal) in preference to tubal resection.This is because it removes the possibility of the future development of uterine disease such as carcinoma of the cervix and eliminates the chance of the woman suffering menstrual and other upsets that sometimes follow less radical procedures. Hysterectomy, however, carries a much higher immediate morbidity rate than surgical tubal resection and can be followed by other disturbances and regrets at loss of menstrual function—an outward sign of femininity. (iv) Resection of fallopian tubes: If the pelvic organs are healthy, one of the best methods is to remove 1–2 cm of the middle of each tube and to bury the legated ends separately under the peritoneum. Sometimes the cornea of the uterus are excised, together with the adjacent portions of the tubes. Excision of the whole of both tubes is not so safe because it leaves the ovum free to wander into a possible uterine fistula, and fimbriectomy should never be performed. Retention of the abdominal osier is an advantage for it tends to ensure that ova become trapped in the occluded tubes. Of the more simple operations on the fallopian tubes the best is the Pomeroy procedure, in which a loop of tube is excised and the cut ends secured with a ligature. This method has the advantage of avoiding troublesome haemorrhage which can attend the techniques described above, requires only limited access, is speedy, and fails in not more than 0.3 per cent of cases.The technique of crushing and legation of the tubes without excising any part of them (Madlener operation) is very unreliable, the failure rate being 3 per cent; it is rarely practised now. Whatever technique be used for dividing the tubes, it is important to ligature their cut ends with plain catgut.This is much more likely to result in firm closure than is the use of unabsorbable material, or even chromic gut. Most failures are due to neglect of this medico-legally very important point. Resection of the tubes is usually carried out abdominally and is particularly easy to perform two to four days after delivery when the uterus is an abdominal organ and the tubes readily accessible. It can then, if necessary, be carried out under local analgesia. Tuba resection (preferably using the Pomeroy technique) can also be performed vaginally either during the course of another operation or as the route of choice. As a method of choice it is not new as is sometimes suggested; it was regularly carried out in the 1920s.

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59 The most common reason is that the woman was already pregnant at the time of sterilization. Pregnancy can also occur if the provider confused another structure in the body with the fallopian tubes and blocked or cut the wrong place. In other case pregnancy results because clips on the tubes come open, because the ends of the tubes grow back together, or because abnormal openings develop in the tube, allowing sperm and egg to meet. 60 (1986) 1 ALL ER 488. 61 (1986) 1 All ER 497 (CA). 62 (2003) 4 All ER 987. 63 (1949) 2 DLR 442: (1949) 1 WWR 989. 64 (1990) 2 AC 1: (1989) 2 WLR 1025: (1989) 2 All ER 545 (HL). 65 AIR (1989) SC 1570, JT (1989) (2) SC 419, 1989 (1) SCALE 1535, (1989) 3 SCC 223, (1989) 3 SCR 241, (1989) (2) UJ 276 (SC). 66 The Drugs and Cosmetics Rules, 1945, establishes a Central Drugs Laboratory that lays down inter alia the function of the Director of the Central Research Institute, Kasauli, in respect of the safety and efficacy of vaccines . 67 See http://www.cdc.gov/Features/VaccineSafety. 68 See also Chapter 2. 69 The Hindu, 10 September 2010. 70 See the decision of Delhi State Consumer Commission for data relating to success or failure rates of abortion by D&C method as against surgical termination, R. Madhu v. Dr Indu Khurana Complaint Case No C-383/98 dt 17 January 2008 reported in 2008 (CT1) GTX 404. 71 Ibid. 72 (2005) (2) CPJ 347. 73 (2005) (3) CPJ 121. 74 Appeal No. 18 of 1999 decided on 6 July 2004, reported in 2004 (CT2) GTX 1595-SCGUJ. 75 AIR (2001) SC 3914, JT (2001) (8) SC 142, (2001) (6) SCALE 476, (2001) 8 SCC 731, (2001) (2) UJ 1566 (SC). 76 ‘A cone of dried seaweed that swells as it absorbs water, used to dilate the cervix nontraumatically in preparation for induced abortion or induced labor’, Mosby’s Medical Dictionary, 8th edition (Elsevier, 2009). 77 It is a hygroscopic cervical dilator, consisting of a firm rod equipped with a plastic handle and a thread loop to facilitate insertion and removal, 2011–12 Medicem. 78 (2008) 2 SCC 1. 79 See Chapter 9 for more on the Transplantation of Organs Act, 1994. 80 Sir Edward Coke wrote in his Institutes of England, mostly published in 1641, that the ‘burial of the Cadaver is nullius in bonis (in the goods of no one) and belongs to Ecclesiastical cognizance.’ In his Commentaries on the Laws of

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England, published in 1765, Sir William Blackstone wrote that heirs do not have a right in the bodies or ashes of the deceased. See Year worth v. North Bristol NHS (2009) 2 All ER 986 for passages taken from Blackstone. See also Chapter 2 for further discussion on the above topic. 81 In Dobson v. North Tyneside Health Authority (1996) 4 All ER 474, a claim for wrongful detention of brain removed by a pathologist for examination by next of kin of deceased was dismissed on the ground that there was no property in an organ in a dead body. The situation would be different if an organ had obtained different attributes by virtue of skill, such as dissection or preservation techniques, for exhibition or teaching purposes (see Doodeward v. Spence (1908) 6 CLR 406. In R V. Kelly (1998) 3 All ER 741), the Court of Appeal also outlined other uses that could impress the organs with other attributes, such as when they are intended for organ transplant operation or extraction of DNA or as an exhibit in a trial. 82 See also Chapter 6. 83 Section 148 of the Indian Contract Act defines that ‘a “bailment” is the delivery of goods by one person to another for some purpose, upon a contract that they shall, when the purpose is accomplished, be returned or otherwise disposed of according to the directions of the person delivering them. The person delivering the goods is called the “bailor”. The person to whom they are delivered is called the “bailee”.’ 84 (2009) 2 All ER 986. 85 Section 151 of the Contract Act enjoins: ‘In all cases of bailment the bailee is bound to take as much care of the goods bailed to him as a man of ordinary prudence would, under similar circumstances take, of his own goods of the same bulk, quality and value as the goods bailed.’ 86 Based on WordNet 3.0, Farlex Clipart Collection (Princeton University: Fartex Inc, 2003–08). 87 All types of anaesthesia carry some risk, although major side effects and complications are uncommon. Local anaesthesia is the safest. General anaesthesia affects the entire body, so side effects are more common. However, the American Society of Anesthesiologists says that complications due to anaesthesia have dropped dramatically over the last twenty-five years. This is due to better anaesthetic drugs and better monitoring techniques. Risks from any type of anaesthesia include: (1) allergic reaction to the medicines used; (2) breathing problems. Risks from local and regional anaesthesia include: (1) bleeding and infection (rare); (2) long-term nerve damage (very rare) and (3) temporary weakness or paralysis in the area that received the anaesthesia. Risks from general anaesthesia may include: (a) irregular heartbeat; (b) heart attack (rare); (c) nausea and vomiting; (d) stroke (rare) and (e) temporary mental confusion (delirium).

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See http://www.righthealth.com/topic/Anesthesia_Risk/overview/adam20?f did=Adamv2007280#ixzz0rwQo5VnS (last visited 26 June 2010). 88 Denning LJ in Roe v. Minister of Health in (1954) 2 QB 66, quoted in Kusum Sharma v. Batra Hospital (2010) 3 SCC 480. 89 Kusum Sharma v. Batra Hospital(2010) 3 SCC 480. 90 Boam v. Friern Hospital Management Committee(1957) 2 All ER 118, quoted with approval in Kishan Rao, referred to in note 33 above. 91 Achutrao Haribhau Khodwa v. State of Maharashtra(1996) 2 SCC 634. 92 Spring Meadows Hospital v. Harjol Ahluwalia (1998) 4 SCC 39. 93 (1981) I All ER 267, (1981) 1 WLR 246. 94 Malay Kumar Ganguly v. Dr Sukumar Mukherjee (2009) 9 SCC 221, (2009) 3 CPJ 17. 95 B. Jagdish v. State of AP (2009) 1 SCC 681, (2009) 1 SCC (Crl) 597, (2009) 1 KLJ 579, (2009) 1 CPJ 18, (2009) Cri LJ 828, (2009) 76 AIC 56. 96 Kishore Lal v. KChairman, ESIC,(2007) 4 SCC 579. 97 832 F. Supp. 1467 (M.D. Fla. 1993). 98 Ross D. Eckert, ‘The Aids Blood-Transfusion Cases: A Legal and Economic Analysis of Liability’, San Diego L. Rev. 29(1992): 203, 231. 99 Walls, F. Supp. 832, p. 1501. 100 Ibid. 101 Ibid., p. 1469. 102 Ibid. 103 See Part XB of the Rules for the Requirements for the collection, storage, processing and distribution of whole human blood, human blood components by blood banks and the manufacture of blood products. 104 For comprehensive studies on reactions of mismatched blood transfusion and the clinical management, see www. medscape.com, and www.emedicine.com. 105 (1996) (3) RCR(Civil) 3 (SC), (1996) 1 SCC 753, AIR (1996) SC 929. 106 (2009) 7 SCC 330. 107 (2002) (3) RCR(Civil) 135:(2001) AIR (AP) 502:(2002)(1) FJCC 256. 108 1999-(001)-CPJ -0587. 109 (2008) 2 SCC 540. 110 (2000) 2 All ER 474. 111 III (1998) SLT 684, 1 (1998) CPJ 1 (SC), (1998) 4 SCC 39. 112 2005-(002)-CPJ -0035 -NCDRC. 113 MANU/SC/0836/1995. 114 See Jackson and Powell on Professional Negligence, 3rd edition, paras 1-4, 1-5, and 1-56. 115 The failure to obtain consent for a particular course of treatment would also be a component of negligence. See also Chapter 3.

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116 See C.P. Sreekumar, M.S. (Ortho) v. S.Ramanujam 2009(6) SCALE 613. 117 (2010) 3 SCC 480 at p. 507 (para 89). 118 (2011) 1 SCC 31. 119 Indian Medical Association v. V.P. Shantha (1995) 6 SCC 651. 120 (1995) 6 SCC 651. 121 Laxman Thamappa Kotgiri v. G.M., Central Rly (2007) 4 SCC 596. 122 Kishore Lal, v. Chairman, Employees State Insurance Corporation,AIR (2007) SC 1819, (2007) (4) ALD 36 (SC), (2007) (3) AWC 3082 (SC), (2007) (2) BLJR 1653, (2007) BusLRSN-2 (SC), (2007) 2 CompLJ 385 (SC), I (2008) CPJ 13 (SC), 2007 (3) CTC 561, (2007 [3] JCR 189 [SC]), (2008) (3) JKJ 1 (SC), JT (2007) (6) SC 541, (2007) (2) KLT 979 (SC), (2007) IIILLJ 181 SC, (2007) 4 MLJ 540 (SC), RLW 2007 (3) SC 2437, 2007 (6) SCALE 660, (2007) 4 SCC 579. 123 See Order 1 Rule 4(b) of the CPC. 124 AIR (2004) SC 5088, (2004) (4) AWC 3699 (SC), (2004) (3) BLJR 2145, (2005) (3) Bom CR4 30, (2004) 4 CompLJ 255 (SC), IV (2004) CPJ 40 (SC), (2005 [1]JCR 22 [SC]), JT 2004 (8) SC 607, 2004 (3) KLT 919 (SC), (2005)139PLR74, RLW2005(1)SC67, 2004 (8) SCALE694, (2004)8SCC56 125 (2009) 9 SCC 221,2009(4) RCR (civil) 14, 2009(4) RCR (crl) 2, 2009(5) RAJ 405. After remand to the National Commission, it disposed of the appeal on 21 October 2011, apportioning the compensation and making the surgeons pay Rs 40,40,000, Rs 26,93,000, and Rs 26,93,000 respectively on the basis of assessment of the respective culpability of the attending doctors and the hospital to pay Rs 40,40,000, apart from costs. 126 See Section 13 of the Consumer Protection Act, 1986. Consumer fora themselves are not civil courts within the meaning of the provisions of the CPC, though they may have all the trappings of Civil Courts, Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others,(2009)_(4) RCR (civil) 14, (2009) (4) RCR (crl) 2, (2009) (5) RAJ 405. 127 AIR (2002) SC 2931, (2002) (5) ALD 43 (SC), (2002) (4) AWC 2865 (SC), (2002) (3) BLJR 1899, (SCSuppl) 2002 (4) CHN6, (2002) 4 CompLJ 145 (SC), III (2002) CPJ 8 (SC), (2002[3]JCR137[SC]), JT (2002) (6) SC1, (2002) (4) MhLj 494, (2002) 3 MLJ 133 (SC), (2002) (5) SCALE 545, (2002) 6 SCC 635, (2002) SUPP 1 SCR 469, (2002) (2) UJ 1220 (SC), (2002) (5) WLN 751. The observation in this judgment about the undesirability of relegating parties to civil suit was cited with approval in a subsequent judgment of the Supreme Court in Nizam Institute of Medical Sciences v. Prasanth S. Dhananka (2009) (7) SCALE 407, which dealt with an adjudication sought under the Consumer Protection Act relating to complicated issues of patient consent and the degree of culpability of a medical practitioner in the choice of surgical procedure and diagnostic details of a patient suspected to have neurofibroma, with mass in left hemithorax and posterior mediastinal erosion of the left second, third, and fourth ribs.

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128 See Section 24A of the Consumer Protection Act. 129 Ayers v. Morgan 149 W Va 783: 144 SE 2d 156 (1965); Morgan v. Grace Hospital Inc 86 Idaho 485: 389 P 2d 224 (1964); Josephine Flanagan v. Mount Eden General Hospital LEXSEE 24 NY 2d 427; John D. Adams and Jeanette S. Adams v. New Rochelle Hospital Medical Center 11 919 F Supp 711 are cases of swabs left inside the body after operation but the cause of action was not taken as arising before the time when by a subsequent surgery, the swab was noticed inside. Quinton v. United States 304 F 2d 234 (5th Cir 1962) was the case of a stillborn child delivery caused by a wrong transfusion of blood group. 130 (2011) 1 SCC 53.

6

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IVF

The Medical Procedure IVF is a procedure where the eggs from a female are removed from the ovary and fertilized in a petri dish with sperm from the male partner to form an embryo, which is then implanted into the woman’s uterus. Traditionally, prior to proceeding with IVF, other kinds of medical examination should be considered for conditions that can be easily treated. Even today, IVF accounts for only 20 to 40 per cent of pregnancies in most clinics, and it involves a considerable expense. The other examinations include sperm analysis of the male partner, hysterosalpingograms to examine the fallopian tubes, ovulation detection kits, ultrasound to evaluate ovulation, progesterone level, surgical procedures such as hysteroscopy and laparoscopy to diagnose endometriosis, fibroids, etc., which can be easily corrected through the laparoscope. In many infertility clinics especially in private settings the physicians go directly to IVF bypassing the basic investigations (may be due to financial incentives). IVF involves stimulating the women’s ovaries with hormonal injections and producing super ovulation (30 to 40 eggs instead of the usual 10 to 12 per cycle).The eggs are removed via ultrasound-guided aspiration with a needle and then mixed with the sperms from the male partner and fertilized in a petri dish. The fertilized eggs or embryos (one to four) are then transferred to the woman’s uterus. Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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The Test-tube Baby Phenomenon The first test tube baby was conceived via IVF and embryo transfer in a procedure by Dr Patrick Steptoe and Dr Robert Edwards, who implanted the embryo into the genetic mother’s uterus. The child had been born on 2 July 1978. The world’s second baby born through IVF and embryo transfer perhaps took place on 3 October 1978 in India, thanks to the efforts of Dr Subhas Mukherjee and his colleagues.1

Indications for Adoption of Technique Normally an infertile couple who are not able to conceive due to low sperm count, presence of pus cells that hamper motility of spermatozoa, male impotence, a block in the fallopian tubes, endometriosis, and other conditions that obstruct ovulation or fertilization of eggs. IVF may involve a foreign donor outside the bonds of marriage, an egg from the ovaries of another woman, and implantation of the embryo in the spouse or a surrogate. The development of IVF also means that it is possible to remove a single cell from a newly fertilized IVF embryo and carry out pre-implantation genetic diagnosis (PGD) before implanting it. The same single cell biopsy technique could test tissue compatibility by human leukocyte antigen (HLA) typing. A transplantation of stem cells from a person whose tissue is compatible and who has no defects to another person who, say, has some congenital blood disorder like thalassaemia major, offers great scope for treatment.2

New Possibilities for Procreation In countries where same-sex marriages are legal, the availability of IVF procedures makes it possible for gay and lesbian couples to become parents in their own right. A person that opts to change sex from female to male may still retain ovaries.3 A dead man could still be responsible for impregnation of a woman, if the sperm from the deceased person is extracted and used.4 Women in a lesbian relationship could each bear a child after impregnation through unknown sperm donors and raise children born to them, and be a parent for the child born to their partner.The problem of custody could, however, be a major issue when

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the couple decides to separate.5 The high demand for ‘donor sexuals’6 by lesbian couples is a common story doing the rounds in magazines.7 A gay couple could make a contract with a surrogate mother for the use of sperm from one of them, and become fathers simultaneously to the same child.8

Ethical Justification In cultures that recognize the institution of marriage itself as necessary for procreation and perpetuation of the clan, infertility could be a ground for the breakdown of marriages. It is common place that the slur of an infertile spouse has a gender bias, so that a woman that does not become pregnant becomes the target of harassment, even apart from the incessant dowry demands that might mar the harmony of wedlock. During times when the small family norm was not yet a national population policy, it was possible to adopt children from within the immediate family circle when the couple was infertile.With small families now becoming a reality in populations living in small towns and villages too, the adoption is not practiced among family members. With the advancement in medical techniques for assisting infertile couples for increasing chances of pregnancy, the advantages are too obvious to be missed. The right to have a child is not merely a matter of personal preference but an issue of social good, for the society benefits from fulfilled families.There are authors like Robertson,9 who sees the moral right to reproduce as central to personal identity and dignity, and Dworkin,10 who sees the right of procreative autonomy as firmly embedded in every genuine democratic culture. John Harris11 says that the freedom to pass on one’s genes is also widely perceived to be an important value and it is but natural to see this freedom as a plausible dimension of reproductive liberty.To what extent would we allow this liberty to flourish? Should this include a right to pre-implantation genetic diagnosis (PIGD)? Determining the sex of the child is an offence in India; however, what if the mother wants to obtain information about the status of her embryo to make a decision to continue her pregnancy or donate it to another woman or for research? Answers may be found by understanding the concepts of autonomy and the personal preferences of women involved in the choices.

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Is There an Appropriate Age for a Woman to Be a Recipient of Oocytes? There have been reports of woman even above the age of 60 delivering babies through the use of Assisted Rreproductive Technology (ART) techniques.12 Some argue13 that it raises a serious ethical issue whether a doctor shall encourage such techniques to women above the age of 45 to prevent deep psychological problems to a child born to an old mother, where the latter may not be emotionally and physical fit to rear the child. The Human Fertility and Embryology Authority in the UK does not allow women above 45 years of age to be recipients of donor oocytes. The American Society of Reproductive Medicine recommends a thorough medical examination and a high-risk obstetric consultation for all women above 45 years of age receiving donor oocytes. And, in order to undergo ART, they need to get cleared by a peer review committee. The Assisted Reproduction Technologies Bill, 2008, does not fix any upper age for donor recipients of oocytes. Dr Poongothai Aladi Aruna writes: At present the number of donor oocyte recipients may be only a few thousands in India. But an increase in female literacy could encourage women to focus on their careers, use methods of contraception on a wider scale, and marry late. These factors could alter the reproductive epidemiology in India as in the western world. The optimum childbearing period is between 20 and 35 years, and nearly 85 per cent of the women in this group will conceive naturally. Difficulty to conceive and the risk of miscarriage increase after 35 years of age. The success rate of live births following IVF treatment even for women below 35 years of age is 31 per cent, and this rate drops to less than five per cent in women over 42 years of age. Therefore, it is important to create awareness among the public on the issues surrounding late motherhood.14

SURROGACY

General

biblical and other stories In the Old Testament there is an episode where Abraham’s infertile wife Sarah commissions her maid Hagar to bear her child by persuading

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Abraham to sleep with her.15 Rachel, the barren wife of Jacob, commissioned her maid Bilhah to have a child by Jacob.16 In India, Srimad Bhagvata reveals that, unable to cope with the tyrannical ways of their demon King Kamsa, the Yadavas beseeched Lord Mahavishnu to put an end to their sufferings. The Lord assured that he would be born in the house of Vasudeva and would vanquish the demon king.Vasudeva married Kamsa’s sister Devaki. Coming to know of the divine plan, Kamsa started killing every child born to Devaki. The Lord therefore transplanted the seventh child from Devaki’s womb to Rohini’s womb, the second wife of Vasudeva.17 That was Balrama. The eighth child born to Devaki was Krishna, a manifestation of the Lord himself, who was left with Yashoda by Vasudeva and brought back a stillborn child to Devaki to deceive Kamsa.

the concept Surrogacy is usually resorted to by a married couple who have had multiple miscarriages or who have failed repeated IVF attempts for unexplained reasons and seek the help of a willing woman to bear the child. It is never an issue of convenience of the woman unwilling to bear the burden of pregnancy and looking for a proxy. There are no laws in India that explicitly regulate this practice. The childless couple may have to enter into a surrogacy agreement containing all the terms requiring consent of the surrogate mother to bear the child, the medical procedures of artificial insemination, the right to be reimbursed in the reasonable expenses for carrying the child to full term, and willingness to hand over in adoption the child that is born to the contracting couple.

the medical procedure The essence of partial surrogacy is that eggs are recovered from the ovaries of the ‘commissioning mother’ after IVF stimulation. They are inseminated and fertilized in a laboratory, and then a number of embryos are placed in the uterus of a surrogate mother who has agreed to carry the child until birth and then surrender it to those with whom she had entered into an agreement. Traditionally, a surrogate mother was inseminated with the male client’s sperm so that the child would share some genetic relationship with the couple. This is called

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traditional surrogacy or complete surrogacy. Now it is possible to use both donated egg and sperm or an embryo from individuals outside the bond of marriage for the couple seeking a child. This is called gestational surrogacy. Egg transfer is a far more complicated procedure than sperm transfer. For several weeks, an egg donor must inject herself with Lupron, which shuts down the ovaries so that eggs cannot develop. The donor then injects herself for approximately one week with hormones to hyper-stimulate the ovaries and cause an excessive number of eggs to be produced. The donor then receives an injection of human chorionic gonadotropin (hCG).The eggs are then harvested by laparoscopy or ultrasound. The recipient of a transferred egg must also undergo hormonal treatment in order to synchronize her menstrual cycle with that of the woman transferring the egg. The recipient of the egg often needs additional hormone injections after the egg is transferred to facilitate implantation of the egg in the uterine wall.18

the global scene Surrogacy remains an ethically controversial area, and different societies and different nations take radically different stances in their approach to it.19 Italy, Germany, Turkey, and Japan prohibit surrogacy arrangements. Commercial surrogacy arrangements are permitted in California and the Ukraine. Italy, Germany, France, Switzerland, Greece, Spain, Norway, New Zealand, and several Australian states prohibit commercial surrogacy contracts. The enforcement of surrogacy contracts is sharply limited in Canada, Israel, and the UK. In the US, the Federal Government has not regulated surrogacy. Instead, surrogacy is regulated inconsistently among the states through a combination of legislative action and court decisions.20 However, the Supreme Court of New Jersey in In the matter of Baby M, a pseudonym for an actual person21 invalidated the surrogacy contract post-child birth and restored the surrogate as the mother of the child and holding that the contract of surrogacy and the payment made to the surrogate mother conflicted with law and public policy. It said at the same time that it found ‘no offense to our present laws where a woman voluntarily and without payment agrees to act as a surrogate mother, provided that she is not subject to a binding agreement to surrender her child.’ In India, there is no law that regulates this practice, nor does it punish. It therefore flourishes here. Some of the

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cases that have come to the courts expose the inadequacies of law and how they make one realize that the road to parenthood is no bed of roses but a trek through a thorn forest, an imagery expressed in the high court decision by Justice Hedley.22 With conflicting provisions across the world legal regimes, potentially difficult conflict-of-law issues arise. Where there is a commercial element to the surrogacy, which may be permitted in a foreign country where the surrogate mother bears the child, there are bound to be problems if legitimacy to the transaction is sought by the parent in their own country where commercial surrogacy is prohibited. In a case brought before the high court of justice in the UK, the court highlighted the obvious difficulties of nationality, control of the commercial element, the rules of consent and the question of legal parentage as important matters for a court to cope with before a parental order could be issued in the case of English parents, bringing a happy ending to the child that was born through a surrogate arrangement with a Ukrainian married woman.23

issue of adoption The child born through a surrogate mother is normally expected to be handed over to the couples on whose behalf the child is conceived. In the German couple24 case the Union expressed difficulty to acceding to a suggestion to the Child Adoption Regulation Agency (CARA) to offer the child born through a surrogacy arrangement to be offered for intercountry adoption. A characteristic which distinguishes surrogate parentage from situations in which conventional adoption takes place, and bears directly on what is to be perceived as the welfare and interests of the child, is that the child’s existence is the result of an intended chain of events in which adoption is a contemplated step even at the stage of its conception. In Re A and B,25 a case before the Supreme Court of New South Wales, an arrangement had been made with the sister of the sperm donor’s wife for surrogacy. After the child was born and an application had been moved by the couple for taking the child in adoption from the birth mother through an application in court, it was opposed by the NSW Department of Community Services.The department raised a number of arguments: the public policy of discouraging surrogacy arrangements, the potentially adverse emotional impacts of the child’s conception and birth, the inability of the child to be consulted at this

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stage, the possibility of H and W later deciding to observe secrecy about the child’s origins, and the disturbance of ordinary family relationships if the birth mother became the child’s aunt. The department suggested various alternative regimes of guardianship and parenting orders, which would still leave open the possibility of an adoption order at a later stage. The Supreme Court of New South Wales took notice of the following circumstances: The applicants took part in prenatal appointments and prenatal classes. They took a parental role towards the child from the time of her birth onwards. They were both present throughout the birth mother’s labour, shared the same room at the hospital and participated in all decisions by paediatric staff. All remained at the hospital for five days and were discharged together. The child then went home with the proposed adopting parents and had been in their continuous care since then. The applicants did not plan to extend their family further. The birth mother’s conduct has been appropriate for an aunt, well-known to the child, while having a relationship and a family of her own, and living in a distant place.There was also happy communication between the child and her half-sister. Overall relationships were happy and appropriate for two families where the wives are sisters and their daughters were cousins, and the sisters lived independent lives. Accordingly, it rejected the objection and while granting the adoption order, ruled, inter alia: (1) Although H and W26 may have committed a technical breach of s 50 of the Adoption of Children Act, in that their payment of the birth mother’s legal and medical expenses was made without official approval, it was unlikely that there could be a prosecution or that, if there were, any penalty would be imposed. In any event, the issue of an offence was peripheral to the question of the welfare and interests of the child. (2) Section 14 of the Status of Children Act 1996 (NSW), which came into force on 1 September 1998, is procedural in character, and applies whenever the question of parentage comes before the court, irrespective of the time when the underlying facts occurred. Although H’s name appeared on the birth certificate as the father, the effect of s 14 was that H as the semen donor was irrebuttably presumed not to be the father of the child. (3) Surrogacy arrangements, even where there is no commercial aspect, are not an institution which should be encouraged by the law.27 Nevertheless, consideration for the welfare and interests of the particular child must override any broader public policy considerations.

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(4) H and W were persons of good reputation, in good health, with appropriate resources to fulfil the responsibilities of parents. An order for adoption was the most advantageous course to follow in this case in order to secure the welfare and interests of the child.

Surrogacy in the UK The first legislation dealing with surrogacy was Surrogacy Arrangements Act, 1985, in the UK, which declared it to be an act to regulate certain activities in connection with arrangements made with a view to women carrying children as surrogate mothers.The act prohibits negotiating surrogacy arrangements on a commercial basis.28 Even an advertisement issued by a person willing to be a surrogate mother or looking for a surrogate mother is deemed to be an offence.29 The Human Fertilisation and Embryology Act, 1990, was later enacted to amend the provisions of Surrogacy Agreements Act and to make provisions to prohibit certain practices in connection with embryos and gametes, and more importantly, about the persons who in certain circumstances are to be treated in law as the parents of a child.30 The act defines a mother as a woman who is carrying or has carried a child as a result of the implantation of an embryo or of sperm and eggs and no other woman, is to be treated as the mother. This will not apply to a situation when the child is treated by virtue of adoption as not being the child of any person other than the adopters, such as when there is a surrogacy agreement where surrogate mothers agree to carry the children to full term for others who are the adopters.31 The act protects the secrecy of information as to the identity of a person whose gametes have been used or from whom an embryo has been taken.32 An exceptional situation for treating congenital disability for the child shall allow for disclosure of information by orders of the court.33 A surrogacy arrangement is not amenable to specific enforcement by or against parties making it.34

lawful expenses In the UK, under Section 30(7) of the Human Fertilisation and Embryology Act, 1990 (hereafter the 1990 Act), no money or other benefit other than for expenses reasonably incurred could be given or received in relation to surrogacy unless such payment had been authorized by the court. The amount paid towards loss of earnings (when

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the surrogate mother was on state income support, which fact was not disclosed) to be apart from expenses for carrying the child, would be against law.35 In Briody v. St Helen’s and Knowsley Health Authority,36 an English woman complained of negligent obstretic treatment meted to her by her doctor that render her incapable of bearing a child and hence forced to opt for a surrogate arrangement with a Californian woman. In a suit for damages against her doctor, she included the commercial costs of surrogacy, being the expenses alleged to have been paid to the surrogate mother.The Queen’s Bench Division refused the costs of surrogacy to be not legitimate and held it to be opposed to public policy. The costs of surrogacy pursuant to a surrogacy agreement that an English woman had entered into with a Californian who was to bear the child were held to be not legitimate and opposed to public policy by the Queen’s Bench, where the former complained that her ability to bear children had been negated by a medical practitioner treating her negligently and hence the compensation against the defendant for medical malpractice should include ‘commercial surrogacy costs’.37

position of the ‘birth mother’ In a pre-1990 enactment case, Re: P (minors) (wardship: surrogacy),38 H and W entered into a surrogacy agreement with S. The child was to be conceived by artificial insemination using H’s sperm and S’s eggs. S conceived identical twins. S decided that she would not surrender the children and retained their custody. H sought custody as the genetic father. He claimed that he could offer them a superior intellectual and material upbringing. The court held that custody could be retained by S; she had bonded with them (she had been with them for five months by the time of trial); the content of surrogacy agreement did not bind the court. On the touchstone of welfare considerations for the child, there was a reversal of fortune for yet another mother in MW (adoption: surrogacy),39 in which the surrogate mother claimed custody of the child two-and-a half years after birth and delivery to the commissioning parents, and refused her consent to an adoption order from the genetic mother.The court not merely refused her plea but an injunction order was also issued preventing her from contacting the child until adulthood.The 1990 Act affords better protection when the commissioning

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parents are married or when either one or both of them contribute gametes to the creation of the child. It permits the court to issue an order making the commissioning parents the legal parents of the child, provided, inter alia, that the application is made within six months of the birth, the child’s home is with the commissioning couple, the birth mother and her husband or the father have also agreed, no payments relating to the process (other than expenses) have been made or received by the commissioning couple and at least one of the parents is domiciled in the UK.40 In Re: Q (parental orders),41 H and W entered a surrogacy arrangement with S, who was unmarried herself. A child was conceived with the egg taken from W and fertilized with donor sperm (that is, not of H). The law contemplates a licenced treatment, and that was given, as the surrogate mother was unmarried. Since S was unmarried, there is no question of consent of the father.42 As the donor father’s identity was not disclosed,43 H and W were entitled to a parental order under Section 30 of the act.

Surrogacy in Japan In response to the request by the Ministry of Justice and the Minister of Health, Labour and Welfare to the President of the Science Council of Japan, the council constituted the Assisted Reproductive Technologies Review Committee. It conducted a minute examination of the rights and wrongs of regulating surrogate pregnancy from medical, ethical, social and legal aspects. In principle, surrogate pregnancy, it proposed, should be prohibited. Commercial surrogate arrangements shall be punished and the doctor offering such services shall also be liable for punishment. Trials of surrogate pregnancies could, however, be done under strict vigil, under the aegis of a public administrative organization. Notwithstanding the legal prohibition, recognizing the potential for children born through surrogacy, it said that the surrogate mother shall be the mother and with respect to a married couple commissioning surrogate pregnancy, parenthood shall be established by way of adoption procedures. The Supreme Court of Japan through a decision dated 23 March 2007 in Minshu44 negated in principle even the judgment of a foreign court making the commissioning married couple the legal parents. A Japanese couple had through a surrogacy agreement with

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a woman in Nevada (where a surrogacy agreement is valid) when the Japanese woman had a hysterectomy to treat cervical cancer. She had the ovaries moved outside the pelvis and preserved them so as to prevent them from being damaged by radiation therapy. At a centre in the US, her eggs taken from her ovaries were artificially inseminated with her husband’s sperm, and two of the fertilized eggs were transplanted into the surrogate mother’s uterus.The latter carried the fertilized egg of the Japanese couple to full term and delivered twins. The court at Nevada ordered the state and county registrars to accept birth certificates treating the Japanese couple as the parents. On their return to Japan, they applied to the state authorities to accept the birth notification, but it was rejected by the state. The court of first instance upheld the state decision but the first appellate court quashed the first court order. The Supreme Court restored the first court’s order, finding that the foreign court’s order was against domestic law and hence against public policy. The Court said, ‘The existing legal system of the Civil Code concerning a natural parent-child relationship by blood… [contemplated] that a woman should conceive and deliver a child using her own egg. ... No provision of the Civil Code seems to be intended to acknowledge the maternity of the child for a woman who has not received or delver the child (sic).’ The Court ultimately ruled, somewhat harshly that there is no choice by (which it is possible) to construe the existing Civil Code to require that a woman who has conceived and delivered a child shall be the mother of the child, and that a mother–child relationship cannot be deemed to be established between the child and the woman who has not conceived or delivered the child, even where the child is born using the egg donated by that woman (sic).

Surrogacy in New Zealand The legal status of a child born as a result of a surrogacy arrangement is determined by the Status of Children Act, 1969, relating to whether the child is born in New Zealand or outside New Zealand. Under its law, as the egg and sperm donor will usually have no legal parental relationship with the child as a result of the surrogacy arrangement, the child born outside the country through such arrangement is not entitled to be issued with New Zealand citizenship by descent. A child born to a surrogate mother does not meet the ‘born to’ requirement.

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This means that the child will not be able to enter and live in New Zealand unless the child has been adopted, and the adoption meets the necessary requirements to be recognized in New Zealand. An intercountry adoption is the only way that one can create a legal parental relationship with a child born as a result of a surrogacy arrangement in a country that is a signatory to the Hague Convention on Protection and Co-operation in Respect of Inter-country Adoption.

Surrogacy in India Media reports frequently cover cases of foreigners arriving in India looking for surrogate mothers, suggesting the relatively lower costs as the cause for India being the preferred destination.45 For the usually uneducated Indian women who are involved in the surrogacy business, it is a respectable way to earn a living and support themselves and their family. But a lot of surrogate mothers in India prefer to live incognito during this phase because of non-acceptance by the society in general. Also, most surrogate mothers in India are reported to belong from the rural background where the lure of money is stronger than the wealthy metros.46 In the US, surrogate mothers are typically paid $ 15,000, and agencies claim another $ 30,000. In India, the entire cost ranges from $ 2,500 to $ 6,500. The industry is estimated to be valued at $ 449 million, and the number of cases of surrogacy is believed to have doubled in the recent years based on newspaper classifieds and inquiries at clinics.47 There are also no official figures on the number of surrogate births in India but it estimated that about 100 to 150 occur annually in India, with the number of failed surrogacy attempts estimated to be much higher.48 The hard numbers remain elusive, partly because the practice is defused among small towns like Anand, Gujarat.49 What constitutes lawful expenses for bearing the child and what amounts to financial allurement or financial recompense for bearing the child are difficult to gauge.

The ‘German Couple’ Case Lawful adoption is possible in India only when the surrogate mother (if she is married and her husband is alive) agrees with her husband to grant the adoption to the couple seeking the child. If the couples

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seeking a surrogate mother are foreigners, there is a further problem of inter-country adoption procedures, which are not grounded on statutory provisions but driven by judgments of the Supreme Court50 and high courts. There is no law or guideline to suggest what the lawful expenses that could be paid to a surrogate mother shall be. If a child is born to a surrogate mother by artificial insemination using the semen of a person not her husband, the issue of paternity raises the issue of whose name shall be entered in the birth certificates that may be compulsorily registered in some states. We may require a birth and death registration law, like, for example, what exists in Australia.51 It is the lack of a provision like this that created a problem in the case of Jan Blaz v. Anand Municipality,52 where the birth certificate had been issued giving the commissioning parents’ names, who were a German couple, as the mother and father of the twins that had been born to the surrogate mother. This was subsequently changed to the surrogate mother’s name by the municipality while still retaining the name of the commissioning male parent as the father. This led to the problem of citizenship and the identity of the children. Although passports had been issued in the names of the children as Indian citizens, showing the German male parent and the Indian surrogate mother as father and mother respectively, the passport office sought the surrender of the passports when it heard that the German couple had approached the high court for rectification of entries in the birth certificates.The passports had been surrendered, and when the German parents filed a writ petition before the high court again for the return of the passports to enable them to apply to German authorities for change of citizenship, the passport office filed an objection in court that the children are not Indian citizens under Section 3(1)(b) of Citizenship Act, but it would issue an identity certificate showing name of surrogate mother, which did not entail citizenship to the children but would enable the German parents to take their children out of India. Children out of surrogacy, the passport officer said, could not be treated as Indian citizens. The high court in its judgment said that it was more concerned with the rights of the children than with the rights of biological parents, surrogate mother, or the donor of ova. Making reference to the fact that there was no law in India that prohibited artificial insemination, egg donation, lending a womb, or surrogacy agreements and the fact that egg donor was an Indian national, the court said that the children

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are Indian nationals, and the gestational surrogate who has given birth to the child was the natural mother, a view prevailing in Japan. It said that the statutory presumption53 that may arise making conclusive the paternity of a child born to a woman and a man whose marriage has not been legally dissolved will have to undergo a change to register the actual paternity. It also held, ‘no presumption can be drawn that child born out of a surrogate mother, is the illegitimate child of the commissioning parents, so as to have a legal right to parental support, inheritance and other privileges of a child born to a couple through sexual intercourse. The only remedy is a proper legislation drawing such a presumption including adoption.’ The case is moving towards a curious end, hopefully to the benefit of the children. When the matter arrived at the Supreme Court on a special leave petition brought at the instance of the Union against the direction to release the passports, the couple requested that the children be offered for inter-adoption to them, as surrogacy was not recognized in Germany. With regard to a direction to the Central Adoption Resource Agency to grant adoption as a one-time measure, the Union had reservations on the ground that inter-country adoption could be given only if a child had been abandoned by biological parents.54 The Union is reported to have decided to grant an exit permit to the children to enable the German couple to take them to Germany and apply for citizenship at Germany. The Supreme Court has not resolved the legal issue yet.

the case of japanese child Baby Manji Yamada v. Union of India and Another55 dealt with the dilemma of a child abandoned by a surrogate mother when the biological parents (the requisitioning couple) from a foreign country (Japan) were separated. The woman did not want the child and the male could not get a visa to claim lawful custody. The municipality at Anand, where the child had been born, had entered the name of the genetic father in the birth certificate. The child had been moved to a hospital when a habeas corpus petition had been filed by an NGO, M/s Satya bringing to light the inadequacies of existing law and imploring the Union to enforce stringent laws relating to surrogacy and the money-spinning racket that was being perpetuated. The Supreme Court, while disposing of a petition filed under Article 32 of the Constitution by a person claiming to be the grandmother

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of the child, did not feel impelled to take a pro-active role where the legislature had failed but gave permission to the petitioner to take the child to Japan after a passport was issued, with liberty given to any person to approach the commission constituted under the Commission for Protection of Child Rights Act, 2005, if any foul play was suspected.56

medical tourism and international surrogacy The high incidence of foreigners arriving to India searching for surrogate mothers is due to India being advertised as a healthcare destination and promotion of medical tourism and cheaper costs for securing the birth of a child through surrogacy arrangements that are not prohibited.It is believed that the reproductive segment of the Indian medical tourism market is valued at more than $ 500 million a year,57 and couples in search of fertility treatment travel not only from Western countries but also from Asian countries like Sri Lanka, Pakistan, Nepal, Bangladesh, Thailand, and Singapore.58 The recent cases referred to above highlight the irresponsible way by which the commissioning parents and the doctors have gone through this practice without a proper legal basis that exposed the children vulnerable to statelessness59 and left the courts gasping for finding a solution in the absence of suitable legislation.

icmr guidelines The ICMR set guidelines on ethical and legal aspects of ART. They ensure, in the absence of legislation decriminalization of such practices and secured immunity to the medical practitioners, against removal or suspension of registration for practice for professional misconduct or unethical practice if they conform to the regulations. Of the various provisions, the following seem significant: Desirable Practices/Prohibited Scenarios There would be no bar to the use of ART by a single woman who wishes to have a child, and no ART clinic may refuse to offer its services. The ART clinic must not be a party to any commercial element. A surrogate mother carrying a child biologically unrelated to her must register as a patient in her own name. A third-party donor and a surrogate mother must relinquish in writing all parental rights concerning the

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offspring and vice versa. No ART procedure shall be done without the spouse’s consent. The provision or otherwise of AIH or ART to an HIV-positive woman would be governed by the implications of the decision of the Supreme Court in the case of X – vs – Hospital 2 (1998) 8 Sec. 269 or any other relevant judgment of the Supreme Court, or law of the country, whichever is the latest. The accepted age for a sperm donor shall be between 21–45 yrs and for the donor woman between 18–35 yrs. Sex selection at any stage after fertilization, or abortion of foetus of any particular sex should not be permitted, except to avoid the risk. Collection of gametes from a dying person will only be permitted if widow wishes to have a child. No more than three eggs or embryos should be placed in a woman during any one treatment cycle, regardless of the procedure used, excepting under exceptional circumstances (such as elderly women [above 37 years], poor implantation [more than three previous failures, advanced endometriosis, or poor embryo quality] which should be recorded. Use of sperm donated by a relative or a known friend of either the wife or the husband shall not be permitted. It will be the responsibility of the ART clinic to obtain sperm from appropriate banks; neither the clinic nor the couple shall have the right to know the donor identity and address, but both the clinic and the couple, however, shall have the right to have the fullest possible information from the semen bank on the donor such as height, weight, skin colour, educational qualification, profession, family background, freedom from any known diseases or carrier status (such as hepatitis B or AIDS), ethnic origin, and the DNA fingerprint (if possible), before accepting the donor semen. It will be the responsibility of the semen bank and the clinic to ensure that the couple does not come to know the identity of the donor. The ART clinic will be authorized to appropriately charge the couple for the semen provided and the tests done on the donor semen. Same will be applicable for oocytes donation. The data of every accredited ART clinic must be accessible to an appropriate authority of the ICMR at the national level. The true informed consent should be made on the consent form, witnessed by a person who is in no way associated with the clinic. Sourcing of Sperm and Oocyte Donors and Surrogate Mothers Semen banks: Either an ART clinic or a law firm or any other suitable independent organization may set up a semen bank. The bank will ensure that all criteria mentioned above are met and a suitable record of all donors is kept for 10 years after which, or if the bank is wound

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up during this period, the records shall be transferred to an ICMR. On request for semen by an ART clinic, the bank will provide the clinic with a list of donors (without the name or the address but with a code number) giving all relevant details. The bank shall keep a record of all semen received, stored and supplied, and details of the use of the semen of each donor. This record will be liable to be reviewed by the accreditation authority. The bank must be run professionally and must have facilities for cryopreservation of semen, following internationally accepted protocols. Semen samples cryopreserved for at least six months before first use must be tested for HIV and hepatitis B and C. The bank must ensure confidentiality in the identity of the semen donor. An appropriate charge may be levied by the bank for the storage. All semen banks will require accreditation.

ICMR Guidelines on Surrogacy: General Considerations (1) A child born through surrogacy must be adopted by the genetic (biological) parents unless they can establish through DNA fingerprinting (of which the records will be maintained in the clinic) that the child is theirs. (2) Surrogacy by assisted conception should normally be considered only for patients whom it would be physically or medically impossible to carry a baby to term. (3) Payments to surrogate mothers should cover all genuine expenses associated with the pregnancy. Documentary evidence of the financial arrangement for surrogacy must be available. The ART centre should not be involved in this monetary aspect. (4) Advertisements regarding surrogacy should not be made by the ART clinic. (5) A surrogate mother should not be over 45 years of age. (6) A relative, a known person, as well as a person unknown to the couple may act as a surrogate mother for the couple. (7) A prospective surrogate mother must be tested for HIV and shown to be sero-negative for this virus just before embryo transfer. She must also provide a written certificate that (a) she has not had a drug intravenously administered into her through a shared syringe, (b) she has not undergone blood transfusion; and (c) she and her husband (to the best of her/his knowledge) has had no extramarital relationship in the last six months. The prospective surrogate mother must also declare that she will not use drugs intravenously, and not undergo blood transfusion of blood, not obtained from a certified blood bank. (8) No woman may act as a surrogate more than thrice in her lifetime.

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General Considerations (1) Minimum age for ART in a woman shall be 20 years. Between 20 and 30 years, two years of cohabitation/marriage without the use of a contraceptive, excepting in cases where the man is infertile or the woman cannot physiologically conceive. For a woman over 30 years, one year of cohabitation/marriage without use of contraceptives. (2) Advertisements through hoardings and paper advertisements shall be banned. An honest display at appropriate places or publicity of statistics, fee structure, quality of services provided, should be encouraged. (3) No new ART clinic may start operating unless it has obtained a temporary registration to do so. This registration would be confirmed only if the clinic obtains accreditation (permanent registration) from the Center or State’s appropriate accreditation authority within two years of obtaining the temporary registration. The registration must be renewed every seven years. Existing ART clinics must obtain a temporary registration within six months of the notification of the accreditation authority, and permanent registration within two years of the notification. … (4) In the case of a divorce during the gestation period, if the offspring is of a donor programme, be it sperm or ova, the law of the land as pertaining to a normal conception would apply.

Stung by unsavoury examples, the Union Home Ministry has issued new Indian visa regulations effective from 15 November 2012 that all foreigners visiting India for surrogacy will have to apply for medical visas that shall accompany a letter from the embassy of the foreign country recognizing surrogacy, and that the children born through Indian surrogate mothers will be permitted entry into their country as a biological child of the commissioning couple. After the surrogate baby is born, exit permission will have to be secured from Foreigners Regional Registration Office to vouch that all local obligations to the surrogate mother have been complied with. The further precondition is that the commissioning parents shall be man and woman and must have been married at least for two years before application.

the delhi artificial insemination (human) act,1995 This act is applicable in the National Capital Territory of Delhi. It regulates the donation, sale, and supply of human semen and ova for

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the purpose of artificial insemination. It requires registration and yearly renewal by any person intending to running a semen bank. Before accepting semen for artificial insemination, the semen bank shall test the donor for the presence of HIV 1 and 2 antibodies through the Enzyme Linked Immuno Sorbent Assay (ELISA) Kit and screen for HIV-surface antigen, and only if the results are negative will the donor be allowed to donate. The donated semen shall be stored either by cryo-preservation through liquid nitrogen freezing or any other safe method for a minimum period of three months in order to exclude a window period of HIV 1 and 2 infection in the donor. The second ELISA test is performed on the donor after three months, and if negative, the semen shall then be used. It is also required by the practitioner, under this act to (1) seek the written consent of the husband and the wife seeking artificial insemination (AI); (2) test the recipient for HIV 1 and 2 and other sexually transmitted diseases before performing AI; (3) not segregate the XX/XY chromosomes for AI; and (4) seek the written consent of the recipient for using the semen on the basis of only one ELISA test being negative, where facilities for cryo-preservation and liquid nitrogen for semen are not available.60

the assisted reproductive technologies (regulation) bill, 2008 The Ministry of Health and Family Welfare, Union of India, presented National Guidelines for Accreditions, Supervision and Regulation of ART clinics in India, prepared by a committee of experts under the joint aegis of the Indian Council of Medical Research and National Academy of Medical Sciences.This has led to the Assisted Reproductive Technology (Regulation) Bill, 2008, aimed to provide for a national framework for the regulation and supervision of assisted reproductive technology. The Law Commission has also submitted Report No 228 (dated 5 August 2009), underscoring the need for legislation to regulate ART clinics as well as the rights and obligations of parties to surrogacy arrangements. The draft bill has been drafted by a twelve-member committee consisting of medical experts from the ICMR and the Ministry of Health. Among other provisions, the bill suggests the rights

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and duties of the patients, donors, surrogates, and children. The draft bill contains the following major provisions with respect to surrogacy: (1) The commissioning parties and the surrogate mother must enter into a surrogacy agreement which will be legally enforceable. (2) Surrogates must have all expenses, including insurance expenses, incurred during pregnancy and through delivery of the child paid for by the commissioning parties. (3) The surrogate mother may also receive monetary compensation for agreeing to act as a surrogate. (4) The surrogate must relinquish parental rights over the child. (5) A woman serving as a surrogate must be between the ages of 21 and 45 and may not serve as a surrogate for more than three live births. (6) Commissioning parties must approach registered semen banks or advertise to arrange surrogate mothers; clinics are prohibited from arranging surrogates. (7) The birth certificate for the child will bear the names of the child’s ‘parents’. (8) The commissioning parties are legally bound to accept the child regardless of any abnormality the child may have. (9) Foreign and non-resident Indian commissioning parties must appoint a local guardian who will assume legal responsibility in caring for the surrogate. (10) Foreign and non-resident Indian commissioning parties must provide the ART clinic with documentation that they would be able to take the child born through surrogacy outside the country. (11) The child born of surrogacy is considered the legitimate child of the commissioning parties, even in the event of divorce. (12) A child born of surrogacy would have the right to obtain nonidentifying information about the surrogate upon attaining age of 18. NOTES 1 The technique used by Indian doctors is said to be different from the British counterparts’ methods. The Indian doctors used gonadotropins for ovarian stimulation before egg harvesting in an IVF cycle.They harvested eggs

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through a transvaginal route by colpotomy and froze and thawed a human embryo before transferring it into the uterus, leading to the successful birth of a girl baby named Durga. See T.C. Anand Kumar in ‘In-Vitro Fertilization nod Embryo Transfer in India’, ICMR Bull.,17 (1986): 41. 2 See Chapter 8. 3 Thomas Beatie, formerly known as Tracy, a beauty queen from Hawaii, had kept his female reproductive organs in hopes that he would someday have children. His sexual reassignment surgery was in 2002. He married, but his wife was infertile. The couple used a sperm donor to conceive. Their first child, a girl named Susan, was born by natural childbirth on 28 June 2008 (TheTimes of India, 10 June 2009). According to Life & Style Magazine (4 November 2010), Thomas and his wife had a third child through Thomas in July 2010, and he wanted to be a surrogate mother to anyone who has problems conceiving. 4 The dead man, soldier Keivin Cohen, was killed in the Gaza Strip in 2002. A court in Israel ruled in favour of his parents, who had the sperm extracted after his death, although he had not left a will. Although Mr Cohen, 20, was single and had left no written expression of his desire to become a father, his family claimed that had long been his wish. The Cohens appealed for volunteers who were willing to be impregnated with the sperm and raise the child. In an interview on Israel’s Channel 10 news, Mr Cohen’s mother, Rachel, said that more than two hundred women offered to help, AFP news agency reported. During the four-year legal case, Ms Rosenblum presented testimony from Mr Cohen’s family and friends that he had stated his wish to have children. The court in Tel Aviv was reported to have said that the family could use the sperm to impregnate a 25-year-old woman who had agreed to be the mother (BBC News, 19 June 2007). 5 In re G (children) (FC) [2006] UKHL 43, the House of Lords decided upon a custody case involving a lesbian couple, G and W.The facts were as follows. G and W had a relationship from 1995 until 2002.They had two female children together, in that G was artificially inseminated abroad on two occasions. W already had a son, conceived by the same method during a previous relationship. The son considered the girls his siblings, and vice versa. The girls had a close relationship with both G and W. After the breakup they lived with G but maintained contact with W. Court orders were made making G’s the primary home, but providing for some weekend and holiday contact with W. Both G and W formed new relationships. G evidently wished for the girls not to maintain contact with W. She moved with her new partner and the girls to Cornwall, without warning even her own solicitor, let alone W, and in clear breach of the court orders regarding shared arrangements. W located her with the help of the authorities. G agreed, no doubt grudgingly, to continue with

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the previous court order concerning shared custody. Concerned about G’s failure to comply with the court order about not moving to Cornwall, the court reversed the arrangement so that W’s would be the primary home and G, despite being the biological mother, was left with some weekends and some holidays. G appealed all the way to the House of Lords. One issue before the court was the weight to be given to the fact that G was the biological parent, and indeed the only biological parent in the equation. Baroness Hale said that if the case had been the more common scenario (that is, had W been a man), the courts would never have reversed the original arrangement of G being the primary carer, not because she was the biological parent, but because the courts would not have wanted to disrupt the children’s schooling in Cornwall, and also because G had resumed compliance with the shared custody arrangement. On the other hand, if G had continued to be evasive, they might well have done. Baroness Hale’s point was that in each case the biology of the parents would not be the decisive factor, or even one with any particular weight. 6 This is not a medical term nor does it denote any sexual deviance, but a popular connotation employed in print and electronic media to refer to persons who advertise as ‘sperm donors’. 7 ‘The Coffee Shop Baby’, Newsweek, 10 October 2011 .The impregnation attempt through artificial insemination as opposed to natural insemination (actual sex) is made through injecting fresh sperm into the vagina, or loading it into a latex cup that fits on the cervix.The article suggests that many women also believe their donor-conceived children have a right to know their fathers, something most sperm banks have resisted, fearing such openness would scare off potential donors. It is further reported that Canada’s public-health department issued an ‘information update’ noting the rise of free-sperm websites and warning that the distribution of fresh semen (for assisted conception) is prohibited. 8 The Times of India (18 November 2008) reports that an Israeli gay couple, Yonatan and Omer Gher, had a child named Evyatar (meaning ‘more fathers’ in Hebrew) through a surrogate mother at a fertility clinic at Bandra, Mumbai. It is now reported in Israeli news (16 December 2010) that the Jerusalem Family Court had granted permission to the partner of the biological father of the child to adopt the child. 9 J.A. Robertson, Children of Choice (Princeton, NJ: Princeton University Press, 1994). 10 R. Dworkin, Life’s Dimension (London: Harper Collins, 1993). 11 John Harris, Reproductive Choice, in Living with the Genome (Pargrave Macmillan, 2006). 12 The world’s oldest mother, Rajo Devi Lohan, delivered of a child at seventy thanks to the ART technique, but she was reported as dying just

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18 months after giving birth due to frail health and due to complications arising out of IVF pregnancy, See http://www.dailymail.co.uk/news/ article-1286412/Worlds-oldest-mother-Rajo-Devi-Lohan-reveals-dying. html#ixzz1WLY84L2L. 13 Dr Poongothai Aladi Aruna, ‘Issues of Parenthood at Older Age’, The Hindu, 24 August 2011. She pleads for a public debate to create awareness of the ethical issues involved in fertility treatment procedures. 14 Ibid. 15 Genesis16. 16 Genesis 30: 1–8. 17 Srimad Bhagavata, Sk: X; Ch 2; Sl:1–15. 18 Mary Lyndon Shanley, ‘Making Babies, Making Families: What Matters Most in an Age of Reproductive Technologies’, Surrogacy, Adoption, and Same Sect and Unwed Parents 103 (2002). 19 Re: X v. Y (Foreign Surrogacy)[2008] EWHC 3030 (Fam). 20 Usha Rengachary Smerdon, ‘Crossing Bodies, Crossing Borders: International Surrogacy between the United States and India’, www. childtrafficking.com/Docs/smerdon_08_cross_borders_1009.pdf. 21 109 NJ 396, 537 A.2d 1227, 1988 NJ Lexis, 77 ALR 4th I dt 3 February 1988. 22 Re: X v. Y (Foreign Surrogacy) [2008] EWHC 3030 (Fam). 23 Ibid. 24 Union of India v. Jan Blaz pending before the Supreme Court of India as SLP 31639 of 2009 registered as Civil Appeal 8714/2010, last listed on 14.7.2011. 25 26(Australian) Fam LR 317, 2000 NSW LEXIS 172; BC200003799. 26 The full names of parties withheld in the judgment. 27 ‘The Case for Discouragement of Surrogacy Arrangements’ was strongly made by Ms Penne Watson Janu in her article so titled in Journal of Law and Medicine 4(1996): 72, her principal perspective being the exploitation of women and fragmentation of motherhood, and the subordination of the welfare and interests of the child. 28 The Surrogacy Arrangements Act, 1985, Section 2. 29 Ibid., Section 3. Section 4 deals with various penalties and the procedure for prosecution. 30 Preamble to the Human Fertilisation and Embryology Act, 1990.The act constitutes an authority to keep under review information about embryos and any subsequent development of embryos, and about the provision of treatment services and activities governed by the act; publicize the services provided to the public in pursuance of licences and to provide information for a person to whom licences apply and to those who are receiving treatment services.

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31 The Human Fertilisation and Embryology Act, 1990, Section 27. See Section 28 for the definition of ‘father’, which includes, inter alia, that if the woman is artificially inseminated, the person who is married to her. If impregnation is not done with the sperm of the other party of the marriage, the other party shall be treated as the father of the child, unless it is shown that he did not consent to the implantation of the embryo or the sperm and eggs or to her insemination. 32 See Section 31 of the Act, 1990. 33 See Section 34, ibid. 34 See Section 36, ibid. 35 Re C; Application by Mr and Mrs X Under S 30 of The Human Fertilisation and Embryology Act 1990, Family Division, [2002] EWHC 157 (Fam), [2002] 1 FLR 909. 36 [2000] 2 FCR 13, [2000] Lloyd’s Rep Med 127. 37 Briody v. St Helen’s and Knowsley Health Authority, Queen’s Bench Division (Crown Office List), [2000] 2 FCR 13, [2000] Lloyd’s Rep Med 127. 38 [1987] 2 FLR 421 QB. 39 [1995] 2 FLR 759. 40 Re: G (surrogacy: foreign domicile) [2007] EWHC 2814. 41 [1996] 1 FLR 369. 42 If S had been married, the consent of her husband would have been required under Section 28(2) of HFEA. 43 Section 30(5) of HFEA requires that the father of the child must give unconditional consent. 44 Supreme Court Reporter (Civil Cases) Vol. 61, No. 2, p. 619. 45 See ‘Foreign Couples Turn to India for Mothers’, International Herald Tribune, 3 March 2008. 46 Lifestyle Lounge, http:/iloveindia.com (last visited 8 May 2008). 47 The Christian Science Monitor, 3 April 2006 (last visited 8 May 2008). 48 New-Medical.Net, published 7 February 2007. The report estimates the cost in India to be $ 10,000 to $ 12,000. 49 The Christian Science Monitor, 3 April 2006, reports that Dr Nayna Patel, director of Anand’s Kaival Hospital, cautions against seeing the trend in financially exploitative terms. ‘This is not the same thing as donating a kidney (for money).... A nine-month pregnancy can never be forced’, she says. ‘Beyond the commercial angle, having a child is a deeply emotional issue.’Anand’s Kaival Hospital has up to 20 surrogate mothers. In the last two years since surrogacy began here, six babies have been delivered and two more are on the way. Some 75 per cent of the clients are non-resident Indians from the UK, the US, Japan, and Southeast Asia. How Anand became a hotbed of a virtual ‘cradle of the world’ is interestingly reported in Marie Claire (Hearst Digital Media) thus: ‘In 2003, Dr Patel orchestrated the surrogacy of a local woman who wanted to ‘‘lend’’ her womb to her UK-based daughter. The woman gave birth to

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test-tube twins—her own genetic grandchildren—and the event made headlines worldwide. Afterward, Patel was inundated with requests for surrogacy. She now has 45 surrogate mothers on her books, mostly impoverished women from nearby villages. Twenty-seven of them are currently pregnant, and each will be paid between $ 5000 and $ 7000—the equivalent to upwards of 10 years’ salary for rural Indians. More than 50 babies have been born at the clinic in the past three years, half to Westerners or Indians living overseas.’ 50 Lakshmikant Pandey v. Union(1984) 2 SCC 244; further clarified in Laxmi Kant Pandey v. Union of India (2001) 9 SCC 379; Indian Council Social Welfare v. State of AP (1999) 6 SCC 365; Anokha v. State of Rajasthan (2004) 1 SCC 382; John Clements v. State of AP (2004) 13 SCC 400; St Theresa’s Tender Loving Care Home v. State of AP (2005) 8 SCC 525; Craig Allen Coates v. State (2010) 8 SCC 794. 51 In Australia, Section 6 of the Artificial Conception Act, 1984, provided in these terms: (1) Where a woman becomes pregnant by means of (a) artificial insemination; or (b) the procedure of implanting in her womb an ovum (whether or not produced by her) fertilized outside her body, any man (not being, in the case of a married woman, her husband) who produced semen used for the artificial insemination or the procedure shall, for all purposes, be presumed not to have caused the pregnancy and not to be the father of any child born as a result of the pregnancy. (2) The presumption of law that arises by virtue of subs(1) is irrebuttable.

52 Gujarat High Court in LPA 2151 of 2009 dt 11.11.2009. 53 See Section 112 of the Indian Evidence Act. 54 Guidelines have been issued by Department of Child and Social Welfare in terms of the judgment in L.K.Pandey v. Union of India between the years 1984 and 1991 for adopting Indian children to foreign parents. But the Supreme Court itself said in Anokha v. State of Rajasthan (2004) 1 SCC 382 that these directions would not apply if children are not orphans but had biological parents living and they were willingly offering their children in adoption. 55 (2008) 13 SCALE 76. 56 The Times of India, dated 6 November 2008 reported that passport had been given and the child had been taken to Japan. 57 ABC News, 27 April 2010. 58 Usha Rengachary Smerdon, ‘Crossing Bodies, Crossing Borders: International Surrogacy between the United States and India’, www. childtrafficking.com/Docs/smerdon_08_cross_borders_1009.pdf. 59 A condition where a person is left without any nationality. 60 Http://www.indiandoctors.com/medical/artificialinseminationact.htm (last visited 11 October 2010).

7

Sex Selection and Medical Termination of Pregnancy

PROHIBITION AGAINST SEX SELECTION

The Sex Ratio The predominantly patriarchal, social, cultural, and religious set-up founded on the principle that the family line runs through a male has contributed extensively to the secondary status of women in India. This has led to a strong desire to avoid the birth of a female child in the family, resulting in an imbalance in the child sex ratio that is increasing at an alarming rate in some of the states and union territories. Misuse of the techniques like amniocentesis to determine the sex of the foetus and subsequent abortions if the foetus was found to be female were highlighted by social activists in the 1980s.Thereafter, due to the relentless efforts of activists and after intensive public debate all over India, the Parliament enacted the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act on 20 September 1994, and it was brought into operation from 1 January 1996. The act has since been amended with effect from 14 February 2003 to make it more comprehensive and renamed as ‘Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994’.1 The techniques of pre-conception sex selection have been brought within the ambit of the act so as to pre-empt the use of such technologies, which significantly contribute to the imbalanced sex ratio.2 In India, as per the 2011 census, there are 944 females per 1000 males. While the overall sex ratio encompassing twenty-nine states shows an Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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encouraging trend, the same is not true of the girl child in the age group of 0–6 years. A defining indicator of the grim scenario is the sharp increase in the imbalance in the child sex ratio (in the age group 0–6 years) over the last decade. The overall child sex ratio has shifted from 945 females to a thousand males in 1991, to 927 in 2001, and still further to 914 in 2011. Alarmingly, the urban areas, more literate and therefore perceived as being more modern, have shown a huge 29-point shift from 935 in 1991 to 906 in 2001. Regional variations in the sex ratio reflect the diverse levels of social obstacles that girls and women face in different parts of the country. The situation is worse in the north-western states of India, with Punjab recording the maximum decline of 77 points, from 875 in 1991 to 798 in 2001, followed by Haryana, Himachal Pradesh, Chandigarh, Delhi, and Gujarat. The top three states in terms of the child sex ratio in 2001 were in South India—Pondicherry, Kerala, and Lakshadweep.3

Socio-cultural Factors and Practices An examination of the causes for the aversion to the girl child indicates that they are rooted in rituals and perceptions that go back centuries: the fear of having to pay for a girl’s dowry, the belief that for true salvation a son should perform the last rites, the conviction that lineage and inheritance run through the male line, and that a son will look after his parents in their old age, whereas the daughters will belong to another family.Tied up to all this is the old perception of seeing only men as the bread earners. The subjugated position of women makes them vulnerable to various forms of violence, both within and outside the family— domestic violence, rape, sexual abuse, dowry harassment, and trafficking. Perhaps the most horrifying form of this gender-specific violence is female infanticide. Ironically, progress in science and technology and the easy availability of new machines that are able to identify the sex of the foetus, has spawned another form of violence—female foeticide, or killing the girl child in the womb. For several parents, there is little or no moral guilt attached to elimination of a foetus, as compared to killing the girl child after she is born.These sex-selective abortions are preceded by sex identification, which is done by amniocentesis, chorionic villus sampling and, the most popular technique: ultrasonography. Interestingly, none of these techniques and machines are new. Some of them have

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been in use in India since 1975 but primarily for the determination of genetic abnormalities, which is what they were created for. However, over the past few decades they have been misused to determine the sex of the foetus. If it is a female, an abortion inevitably follows.

The Physician’s Role Unlike female infanticide, female foeticide requires a medical practitioner to determine the sex of the foetus. This could have been a great deterrent in effectively countering female foeticide if, from the very beginning, doctors had refused to allow this technology to be used for sex-identification and sex-selection. Unfortunately, several medical practitioners have become willing or unwitting facilitators of foeticide, colluding with parents and other relatives of the unborn child to do sex determination tests. Easy, quick money was a motivation for some of them, and a few others simply saw it as another medical service or even a way of helping parents and stopping female infanticide.

Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 Female infanticide was prohibited through legislation in pre-Independence India. However, the law was toothless and there were few, if any, convictions. The IPC, 1860, also had provisions of punishment for causing miscarriage and similar offences, but these too were rarely enforced. Three decades after Independence, as pre-natal diagnostic techniques spawned female foeticide and an imbalanced sex ratio, the government issued a directive in 1978 banning the misuse of amniocentesis in government hospitals or laboratories. The relentless efforts of activists led Maharashtra to enact a law to prevent sex determination tests—the Maharashtra Regulation of Pre-natal Diagnostic Techniques Act, 1988. In 1994, after intensive public debate all over India, the Parliament enacted the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act on 20 September 1994. The act, which came into operation from 1 January 1996, provided for the regulation of the use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders, chromosomal abnormalities, and certain congenital malformations or sex-linked disorders; and the

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prevention of the misuse of such techniques for the purpose of prenatal sex determination leading to female foeticide. It has provisions for institutions that are responsible for policy-making and those which are responsible for the implementation of the act. It elaborates on the penalties for various offences and lays down who is to take cognizance of complaints and how this is to be done.

The Amending Act of 2003 The act has been amended with effect from 14 February 2003 with a view to make it more comprehensive, and renamed the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (PNDT Act).4 It brought within its ambit the techniques of preconception sex selection to pre-empt the misuse of such technologies. It has explicit provisions for the use, regulation, and monitoring of ultrasound machines to curb their misuse for detection of the sex of the foetus. The act prohibits determination and disclosure of the sex of foetus, as well as any form of advertising about facilities for prenatal determination of sex. It prescribes punishments for contravention of its provisions imprisonment up to five years and a fine of up to Rs 1,00,000. The act provides for prohibition of sex selection, before and after conception,5 and regulation of prenatal diagnostic techniques (for example, amniocentesis and ultrasonography) for detection of genetic abnormalities by restricting their use to registered institutions. It allows the use of these techniques only at a registered place for a specified purpose and by a qualified person registered for this purpose;6 prevention of misuse of such techniques for sex selection before or after conception;7 prohibition of advertisement of any technique for sex selection as well as sex determination;8 prohibition on sale of ultrasound machines to persons not registered under this act;9 registration of genetic counselling centres, genetic labs, and genetic clinics;10 and punishment for violation of provisions of the act.11

Persons Entitled to Registration The pre-natal diagnostic technique itself could be carried out only if a person who is qualified undertakes such an examination and records in writing existence of any one or more of the conditions spelt out

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under Clause (3) of Section 4. Section 5 prohibits the communication of the sex of the foetus, which is again intended to prevent the misuse of such information. Section 6 prohibits the determination of sex by any genetic counselling centre or genetic laboratory or genetic clinic. The provisions of the act are carried throughby the application of the rules of the year 1996 and Rule 3 specifies the qualification of employees for three categories of investigations: (1) genetic counselling centre, (2) genetic laboratory, and (3) genetic clinic, ultrasound clinic, or imaging centre. For each of these categories, the rules specify the respective qualifications of persons who shall be employed. A genetic counselling centre could not be established without a gynaecologist or a paediatrician or a medical geneticist. A genetic laboratory shall have a person who is either a medical geneticist or a lab technician with certain degrees. A genetic clinic, ultrasound clinic, or imaging centre shall have a gynaecologist with experience of performing at least 20 procedures and a sonologist, imaging specialist, radiologist, or registered medical practitioner with a postgraduate degree, diploma, six months training, or a year’s experience in sonography or image scanning, or there shall be a medical geneticist. The expressions ‘medical geneticist’, ‘gynaecologist’, ‘sonologist’, and ‘medical practitioner’ have all been defined. A ‘medical geneticist’ is defined under Section 2(g) as a ‘person who possesses a degree or diploma in genetic science in the fields of sex selection and pre-natal diagnostic techniques or has experience of not less than two years in any of these fields after obtaining (i) any one of the medical qualifications recognized under the Indian Medical Council Act, 1956 (102 of 1956); or (ii) a postgraduate degree in biological sciences.’ A ‘sonologist’ or a ‘imaging specialist’ is defined under Section 2(p), which reads as follows: ‘A “sonologist or imaging specialist” means a person who possesses any one of the medical qualifications recognized under the Indian Medical Council Act, 1956 (102 of 1956), or who possesses a post-graduate qualification in ultrasonography or imaging techniques or radiology.’ The appendix to the rules sets out the forms under which the certificate of registration shall be issued. Form A, which is a form of application for registration of an ultrasound clinic or imaging centre, requires a declaration that the organization that installs the equipment has understood the provisions of the act and all the employees have also been explained under the act and the Rules. Form B is the certificate of registration

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issued for a particular period of time, and Form C is for rejection of application for grant or renewal of registration; Form D specifies the form of maintenance of records by genetic counselling centre; Form E by the genetic laboratory and Form F for genetic clinic, ultrasound clinic or imaging centre.

Penalties In Varsha Gautam (Dr) v. State of UP12 a sting operation caught a doctor prepared to reveal details of the sex of the child to a woman who wanted to abort it if it was a female. A criminal case was registered against the doctor for offence under the act. A petition to quash the investigation was sought on the grounds inter alia that the Appropriate Authority (AA) had not sanctioned the lodging of a complaint, and that there had been no case made out. The Allahabad High Court refused to interfere, stating that there was definite material for investigation, and the sanction was necessary only when the concerned court sought to take cognizance, and there could be no bar of investigation under Section 28 of the act. Under the provisions of the act, a Central Supervisory Board (CSB) constituted under the chairmanship of the Union Minister for Health and Family Welfare is empowered to monitor the implementation of the act. State-level supervisory boards fulfil this responsibility in the states or union territories (UTs), where the act is implemented by the AAs constituted at state, district, or sub-district levels. The state-or UT-level AA has been made a multi-member body to facilitate implementation and monitoring. The AAs are empowered with the powers of a civil court for search, seizure, and sealing of the machines, equipment, and records of the violators. Their power extends to sealing premises and commissioning witnesses. It is now mandatory to maintain proper records of the use of ultrasound machines and other equipment capable of detecting the sex of foetus, and tests and procedures leading to preconception selection of sex. The sale of ultrasound machines too has been regulated by allowing such a sale only to the institutions registered under the act. The power to cancel registration, which the AA could exercise under Section 20, could be initiated after a show-cause notice suo motu, or on a complaint and pending enquiry could also suspend registration. The show-cause notice may not be necessary

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under circumstances where the genetic centre has itself admitted sex selection and even justifies its action as necessary to ‘family balancing’ in prior proceedings in court.13 The act also empowers the AA to report to the State Medical Council recommending action for suspension of registration of a medical practitioner if charges are framed by the court and till the case is disposed of; and on conviction, to remove his name from the register of the council for a period of five years for the first offence and permanently for the subsequent offence.14 In Dr Preetinder Kaur v. State of Punjab,15 the Punjab and Haryana High Court held that the power to lodge a complaint by the AA exercised through the Project Officer, Enforcement Cell but subsequently ratified by AA would amount to an irregular exercise of power, but would not be illegal, vitiating the cognizance taken by the court. With regard to irregular exercise, the court protected the medical practitioner by causing a restraint against the AA from making any recommendation for suspension of licence to the state medical council till the conclusion of the criminal case.

Pre-conception Techniques Aiding Sex Preference The above act regulates only the practice of sex determination during the stage of pregnancy. It should be remembered that advances in assisted reproductive technologies have provided parents with an accurate method of selecting the sex of their children before conception. At this time, two methods that provide the best prospects for sex selection are pre-implantation genetic diagnosis (PGD) of embryos and sperm-sorting through flow cytometry. There is no law to regulate this practice. The ethical and legal dilemmas presented by preconception methods of sex selection vary in many ways from those presented by post-conception techniques. PGD may be resorted to in order to avoid having a baby with a certain genetic disposition to the particular sex that a parent wants to avoid. But sex preferences are mostly non-therapeutic reasons and driven by cultural preferences of a particular sex. A prospective parent is likely to experience less guilt choosing the sex of the child at the pre-conception stage than terminating pregnancy to avoid having a child belonging to a particular sex. The use of PGD also has relevance to how we value embryos. Are we prepared to assign a high value principally by the

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fact that the embryo has a potential for life or are we prepared to compromise our ethical stand by the fact that we have laws that even enable termination of pregnancies? Perhaps the right of a woman to choose what to do with the foetus has to be balanced with the right of the foetus to survive. It is only that a foetus does not have the ability to exercise an option while the person that carries it does. The fundamental question is whether it is ethically appropriate to act as a loving parent only to a child of particular sex. This argument is based on notions that prospective parents who are overly concerned with characteristics of their potential children are not prepared for the unconditional love and acceptance that being a good parent entails. These characteristics of the parent–child relationship can be harmed by the attitude that children can be selected and designed based on the parents’ notions of the ideal child or family.16 Additionally, there is some concern that if parents begin to have a ‘designer’ attitude toward their children, and select traits such as gender, they may feel guilt and remorse if the child for which they selected certain characteristics is born with other genetic abnormalities or fails to live up to their notions of stereotypical gender roles.17 This can affect their relationship with the child, as the child is a constant reminder of its parents’ dashed hopes. The designer attitude is also seen as a potential stepping stone for eugenics, which raises yet another reason for regulating pre-conception sex selection.18 Renee C. Esfandiary observes, ‘The consideration of genetic makeup when making reproductive decisions suggests that the value of an individual is not based on their intrinsic worth, but instead is dependent on their genetic makeup. Human dignity is compromised when individuals know that they are the product of genetic manipulation.’19 Certainly, the state has some interest in protecting future children from these kinds of harm, despite the fact that they are quite abstract. Here the state’s concern about female infanticide and the logic for legislation to prevent pre-natal diagnostic techniques from aiding sex preference will also apply to pre-conception choice. A counter-argument could be that in a country like India, where the population policy dictates limiting the size of the family to not more than two, it would serve the policy better if the parents are able to decide on the sex of the children rather than continuously having children till the child of their preferred sex arrives.

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ABORTION

General In India, the transition from a regime of proscription against abortion by treating it as a criminal offence liable for punishment under the IPC to legitimizing the practice as health and family planning measures through the enactment of the MTP Act, 1971, has been fairly easy, unlike in the West, where the movement towards legalizing abortion has been tumultuous involving major heated public debates. According to the IPC the offence falls under ‘Offences Affecting the Human Body’, and provides that causing a miscarriage with or without consent for a purpose other than saving the life of the woman is punishable.The MTP Act makes for a quantum difference in approach, as if by a legislative sleight through a non-obstante clause, it decriminalizes abortion without bringing an amendment to the IPC or abrogating the penal provisions. The MTP Act sets some limitations regarding the circumstances when abortion is permissible, the persons who are competent to perform the procedure, and the place where it could be performed. Outside the ring of protection that the act draws, the IPC still operates.

The Penal Provisions in the IPC 312. Causing miscarriage: Whoever voluntarily causes a woman with child to miscarry shall, if such miscarriage be not caused in good faith for the purpose of saving the life of the woman, be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both; and, if the woman be quick with child, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine. Explanation: A woman who causes herself to miscarry, is within the meaning of this section. 313. Causing miscarriage without woman’s consent: Whoever commits the offence defined in the last preceding section without the consent of the woman, whether the woman is quick with child or not, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine. 314. Death caused by act done with intent to cause miscarriage: Whoever, with intent to cause the miscarriage of a woman with child, does

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any act which causes the death of such woman, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine; ... and if the act is done without the consent of the woman, shall be punished either with imprisonment for life, or with the punishment above mentioned. Explanation: It is not essential to this offence that the offender should know that the act is likely to cause death. 315. Act done with intent to prevent child being born alive or to cause it to die after birth: Whoever before the birth of any child does any act with the intention of thereby preventing the child from being born alive or causing it to die after its birth, and does by such act prevent that child from being born alive, or causes it to die after its birth, shall, if such act be not caused in good faith for the purpose of saving the life of the mother, be punished with imprisonment of either description for a term which may extend to ten years, or with fine, or with both. 316. Causing death of quick unborn child by act amounting to culpable homicide: Whoever does any act under such circumstances, that if he thereby caused death he would be guilty of culpable homicide, and does by such act cause the death of a quick unborn child, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine. Illustration: A, knowing that he is likely to cause the death of a pregnant woman, does an act which, if it caused the death of a woman, would amount to culpable homicide. The woman is injured, but does not die; but the death of an unborn quick child with which she is pregnant is thereby caused. A is guilty of the offence defined in this section.

MTP Act, 1971

when termination of pregnancy is permissible The Act 34 of 1971 was passed on 10 August 1971 with the avowed object to liberalize and to permit termination of pregnancy.20 This act contains no provision inconsistent with the object of the Preconception and Prenatal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994,21 prohibiting prenatal sex determination.22 The act sets out at least three circumstances when medical termination is permissible: (1) to protect the mother’s health, strength, or life; (2) on humanitarian grounds such as when the pregnancy arises from a sex crime like, rape; and (3) when there is a substantial risk, that is, the child, if

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born, would suffer from deformities and diseases. The Supreme Court made a substantial dent in the last situation, when it warned in Suchita Srivastava v. Chandigarh Administration23 in the context of approving the continuation of pregnancy of a mentally retarded person: Empirical studies have conclusively disproved the eugenics theory that mental defects are likely to be passed on to the next generation. The ‘Eugenics theory’ has been used in the past to perform forcible sterilizations and abortions on mentally retarded persons. (See generally: Elizabeth C. Scott, ‘Sterilization of Mentally Retarded Persons: Reproductive Rights and Family Privacy’, Duke Law Journal 806–65 [November 1986]) We firmly believe that such measures are anti-democratic and violative of the guarantee of ‘equal protection before the law’ as laid down in Article 14 of our Constitution. It is also pertinent to note that a condition of ‘mental retardation’ or developmental delay is gauged on the basis of parameters such as Intelligence Quotient (IQ) and Mental Age (MA) which mostly relate to academic abilities. It is quite possible that a person with a low IQ or MA may possess the social and emotional capacities that will enable him or her to be a good parent. Hence, it is important to evaluate each case in a thorough manner with due weightage being given to medical opinion for deciding whether a mentally retarded person is capable of performing parental responsibilities.

Termination of certain pregnancies by registered medical practitioners24 shall be possible where the length of the pregnancy does not exceed twelve weeks if such medical practitioner is of the opinion, formed in good faith that (1) the continuance of the pregnancy would involve a risk to the life of the pregnant woman or of grave injury to her physical or mental health25 or (2) there is a substantial risk that if the child were born, it would suffer from such physical or mental abnormalities to be seriously handicapped. Where the length of the pregnancy exceeds twelve weeks but does not exceed twenty weeks, the opinion to permit abortion or otherwise shall be taken by not less than two registered medical practitioners.26 The limitation of the period of gestation does not apply in a case where the termination of pregnancy is, in the opinion of a medical practitioner, who may not even have experience or training in gynaecology and obstetrics,27 immediately necessary to save the life of the pregnant woman.28 The act specifies two circumstances where the anguish caused by such unwanted pregnancy may result in grave injury to the mental health of the pregnant woman:

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(1) where any pregnancy is alleged by the pregnant woman to have been caused by rape;29 (2) where any pregnancy occurs as a result of failure of any device or method used by any married woman or her husband for the purpose of limiting the number of children.30 Even in situations justifying termination of pregnancy, the primordial requisite of securing the consent of the woman cannot be dispensed with. However, if the termination of pregnancy is carried out without consent, the doctor shall become liable for criminal offence.31 In determining whether the continuance of a pregnancy would involve risk of injury to the health, account may be taken of the pregnant women’s actual or reasonable foreseeable environment.32 In a case where pregnancy has resulted from rape, it shall not be necessary for the woman to seek for permission from the magistrate before whom the criminal case is pending before committal. When such a petition was presented to preserve the foetus to carry out the DNA test to identify the rapist, the Delhi High Court in Mahima v. State,33 while reversing the order of dismissal of the petition by the victim, gave directions to preserve the foetus, conduct a DNA test, and produce the report before the trial court. If it was not possible to terminate the pregnancy for any reason whatsoever, then the medical board was directed to conduct the DNA test by the prescribed medical modes as a proof of conception by the accused.

extent of immunity to a medical practitioner The medical practitioner who terminates a pregnancy in the manner and under the circumstances mentioned under the act shall not be liable to prosecute for any offence under the IPC in the light of the express provision contained under Section 3(1). Section 8 also provides immunity to a doctor for any damage caused or likely to be caused for any act done in good faith under the act. The effect of the non-obstante clause is clear and unambiguous. It becomes an overriding provision and is to prevail over anything contained in any relevant existing law that is inconsistent with the new enactment. A non-obstante clause is a legislative device that is usually employed to give overriding effect to certain provisions over some contrary provisions that may be found either in the same enactment or another. The purpose is to avoid the operation of all contrary provisions. It is equivalent to saying that in spite of the provision or act mentioned in the non-obstante clause, the

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enactment following it, will have its full operation or that the provisions indicated in the non-obstante clause will not be an impediment for the operation of the enactment.34 The immunity available to a medical practitioner under this act shall not be given to any other person who may have prevailed on the woman to terminate her pregnancy when proceeded against for offence under the IPC.35 If the medical practitioner is not trained in gynaecology as required under the act or if he has carried out the surgery negligently or without consent, he shall become liable for conviction under Section 314, IPC36. A homeopath who had no proper training in gynaecology and whose surgical intervention resulted in death of the woman was found guilty and a fine of Rs 1,00,000 was directed to be paid by the Supreme Court in Dr Jacob George v. State of Kerala,37 in consideration of the fact that the woman was survived by a young child.

in the event of a minor or ‘mentally ill’ The pregnancy of a minor or ‘a mentally ill person’ under circumstances when termination is permissible shall be done only with the consent in writing of her guardian.38 The guardian is defined as a person who is having care of the person who is a minor or mentally ill,39 and may give consent only for the circumstances set down under the act. Suppose that the circumstances do not exist, the girl is a minor, the parent gives consent, and the minor wants to retain the foetus—the termination of pregrancy shall not be undertaken. This was held so in V. Krishnan v. G. Rajan alias Madipu Rajan and The Inspector of Police (Law and Order),40 when a Division Bench of the Madras High Court said: The prayer in the petition (by the parent of a minor who had married a person without the consent of her parents and through whom she had become pregnant) cannot be granted on the averments made in the affidavit. The pregnant girl is capable of understanding the world as well as the consequences of the pregnancy. Her opinion is of great importance and the court should take that into account before considering the prayer of the petitioner. If termination of pregnancy is ordered against the will of the girl, it will harm her mental health and may also affect her physical health. It is her fundamental right to have child having become pregnant.

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The bench examined the religious views on teenage pregnancies and the right of a guardian to determine pregnancy in global regimes, and stated in the context of the Indian law: The provisions of the Act do not confer or recognise any right on any person to cause an abortion or termination of pregnancy. Even the pregnant woman cannot terminate the pregnancy except under the circumstance set out in the Act. Even during the first trimester, the woman cannot abort at her will and pleasure. There is no question of abortion ‘on demand’. Section 3 is only an enabling provision to save the registered medical practitioner from the purview of the Indian Penal Code. Termination of pregnancy under the provisions of the Act is not the rule and it is only an exception. The normal rule that the pregnancy should continue to its term shall prevail unless a registered medical practitioner in the case of a pregnancy not exceeding twelve weeks or two registered medical practitioners in the case of a pregnancy exceeding 12 weeks but less than twenty weeks, opine in good faith that the continuance of the pregnancy would involve (i) a risk to the life of the pregnant woman, or (ii) grave injury to her physical or mental health, or (iii) there is a substantial risk that if the child were born, it would suffer from such physical or mental abnormalities as to be seriously handicapped. Under Section 3(2), there can be no termination of pregnancy if the length of the pregnancy had exceeded twenty weeks. The only exception thereto is found in Section 5, under which the pregnancy can be terminated immediately to save the life of the pregnant woman at any stage of the pregnancy, if the opinion of the medical practitioner is formed in good faith. Under explanation I to (2), if the pregnancy is alleged to have been caused by rape, the mental anguish resulting there from shall be presumed to constitute a grave injury to the mental health of the pregnant woman.The Explanation only provides for a presumption which can be rebutted in the facts and circumstances of the case. It is not necessary for us to refer to Explanation II in the present case. Sub-section (4)(a) of Section 3 provides that if the pregnant woman has not attained the age of 18, or if she is a lunatic, the pregnancy shall not be terminated except with the consent of her guardian in writing. Sub-section (4)(b) provides that no pregnancy shall be terminated except with the consent of the pregnant woman save as otherwise provided in Clause (a).

The Criminal Law Amendment made in 2013 alters the definition of ‘rape’ under Section 376 IPC and raises the age of consent to sex to 18. Consequently, it makes sexual intercourse with a woman less than

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18 years of age who is not the spouse as constituting the offence, even if she has consented to sex. Any pregnancy that results under such a situation will legitimize termination of pregnancy by a doctor. Even the information to the police given by the doctor about the identity of the male who has caused the pregnancy cannot result in breach of confidentiality, since the provision in the Evidence Act that gives professional privilege against guideline issued by IMC Cabot overrides the duty to report sexual offence against any ‘child’ by virtue of Section 9 of Protection of Children of Sexual Offences Act, 2012. A mentally-ill person means a person who is in need of treatment by reason of any mental disorder other than mental retardation.41 The provision for consent by a guardian under the Medical Termination of Pregnancy act does not apply to a mentally retarded person. In Suchita Srivastava & Another v. Chandigarh Administration42 the Supreme Court dealt with a case of ‘mildly mentally retarded person’, a victim of rape in a government-run home, where it refused permission sought from the state administration for termination of pregnancy.The Court found the ‘best interest principle’ to be applied in a given case would be to examine what was in the best interests of the pregnant woman, and if she wanted to retain the foetus, medical termination of pregnancy would be impermissible. The substituted judgment principle would not be justified for the court to overrule the decision of the mother in a case where (1) the medical report suggested that there would be no danger to the mother to carry the pregnancy to full term; (2) the woman was already nineteen weeks advanced in pregnancy and (3) when she wanted to retain the foetus.The woman was 19 years old but had mental growth of an eight-to nine-year-old girl, yet, acting on the medical report that she was capable of rote-memorization and imitation, had learnt to perform basic bodily functions, and was capable of simple communications, the Court held that the ‘best interests’ test alone should govern the inquiry and not the ‘substituted judgment’ test, and consequently rejected the permission sought for termination of pregnancy. In so doing, the Supreme Court also cited the principles laid down in United Nations Declaration on the Rights of Mentally Retarded Persons 1971 (G.A.Res. 2856 (XXVI) of 20 December, 1971, and in particular to Principle 7,which prescribed that a fair procedure should be used for the restriction or denial of the rights guaranteed to mentally retarded persons, should ordinarily be the same as those given to other human beings. The Court observed:

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In respecting the personal autonomy of mentally retarded persons with regard to the reproductive choice of continuing or terminating a pregnancy the MTP Act lays down such a procedure. We must also bear in mind that India has ratified the Convention on the Rights of Persons with Disabilities (CRPD) on October 1, 2007 and the contents of the same are binding on our legal system.

Referring to the peculiarities of the case, the Supreme Court commented: persons who are found to be in borderline, mild and moderate forms of mental retardation are capable of living in normal social conditions and do not need the intensive supervision of an institutionalised environment. As in the case before us, institutional upbringing tends to be associated with even more social stigma and the mentally retarded person is denied the opportunity to be exposed to the elements of routine living. For instance, if the victim in the present case had received the care of a family environment, her guardians would have probably made the efforts to train her to avoid unwelcome sexual acts. However, the victim in the present case is an orphan who has lived in an institutional setting all her life and she was in no position to understand or avoid the sexual activity that resulted in her pregnancy. The responsibility of course lies with the State and fact-situations such as those in the present case should alert all of us to the alarming need for improving the administration of the government-run welfare institutions.

place where pregnancy may be terminated No termination of pregnancy shall be made in accordance with the act at any place other than a hospital established or maintained by the government, or a place for the time being approved for the purpose of this act by the government.43 A doctor carrying out the termination of pregnancy in a hospital that is not approved under the act and the relevant rules shall become liable for conviction under Section 314 of the IPC.44

offences and penalties The termination of a pregnancy by a person who is not a registered medical practitioner shall be an offence punishable under the IPC.45 The IPC makes the voluntary act of causing miscarriage not done in good faith for the purpose of saving the life of the woman an offence

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punishable for a term which may extend to three years or with fine or with both, and if the woman is in an advanced stage of pregnancy shall be punished with imprisonment of either description, which may extend to seven years and shall also be liable to a fine.46 The explanation to this provision makes the woman who causes herself to miscarry as falling within it. By virtue of Section 313, IPC, a person who causes a miscarriage without the consent of the woman, whether the woman is is in an advanced stage of pregnancy or not shall be imprisoned with life, or with imprisonment which may extend to 10 years and also be liable to a fine. Even an act done with the intent to prevent a child being born alive or to cause it to die after death is punishable under Section 315, IPC, with imprisonment that may extend to 10 years or a fine, or both. An act done to terminate pregnancy that results in death would be culpable homicide.47 If the woman is injured but does not die, but the death of her advanced, unborn child is thereby caused, the person will be guilty of the offence, which may extend to punishment with imprisonment upto 10 years, and shall also be liable to a fine.48 To the extent to which the provisions of the MTP Act allow for termination of pregnancy on certain stated grounds, the IPC provisions shall be read down to cover only cases which are not excepted under the act.49

Ethics of Medical Termination of Pregnancy The MTP Act does not address any ethical issues, but in legal regimes that proscribe abortions, they stem from a moral standpoint that medical termination of pregnancy results in the death of a living being. The fundamental question is what makes killing a human being wrong. We may then consider whether these characteristics, whatever they might be, apply to the earliest stages of human life in the womb.50 Explanations that have roots in religion include the traditional Christian doctrines such as that all humans are made in the image of God or that all humans have an immortal soul.51 In Roe v. Wade52 the US Supreme Court decided, by a 7–2 majority, that an implied constitutional right to privacy, whether based on the 14th amendment concept of personal liberty or in the ninth amendment’s reservation of rights to the people, was sufficiently broad to encompass a woman’s right to terminate her pregnancy.53 The Court summarized its decision as follows:

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(a) For the stage prior to approximately the end of the first trimester, the abortion decision and its effectuation must be left to the medical judgment of the pregnant woman’s attending physician. (b) For the stage subsequent to approximately the end of the first trimester, the State, in promoting its interest in the health of the mother, may, if it chooses, regulate the abortion procedure in ways that are reasonably related to maternal health. (c) For the stage subsequent to viability, the State in promoting its interest in the potentiality of human life may, if it chooses, regulate, and even proscribe, abortion except where it is necessary, in appropriate medical judgment, for the preservation of the life or health of the mother.

It delved into the history of abortion in Anglo-American criminal law, and Justice Blackmun concluded that a right to abortion was consistent with that history.54 As early as the mid-thirteenth century the common law punished abortion after foetal formation as homicide. Foetal formation, or the point at which the foetus assumed a recognizably human shape and was believed to be ensouled, was thought to occur some forty days after conception. By the mid-seventeenth century, abortion was prohibited as a ‘great misprision’ or serious misdemeanour. By the early nineteenth century at the latest, the common law appears to have prohibited abortion only after ‘quickening’. Quickening, which occurs between the twelfth and the twentieth week of pregnancy, is the point at which the mother first perceives foetal movement. The later common law may have chosen this point because it was the point at which unborn life was believed to begin or because it was the point at which it could be legally proved to have begun. In the 1992 case of Planned Parenthood of South Eastern Pennsylvania v. Casey,55 the majority of the Supreme Court, led by Justices Souter, Kennedy, and O’Connor, retained and reaffirmed the central holding in Roe, but said that the Pennsylvania law that required notification of abortion to the husband was invalid.

Legitimacy of Abortion: The Global Scene The problem is not confined to the US and extends to other AngloAmerican jurisdictions where there is a legal right to an abortion. Canada is a prime example. In 1988, the Supreme Court of Canada affirmed a woman’s right to abortion and struck down provisions in the Criminal Code that regulated abortion as unconstitutional.56 The court

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also found it was unconstitutional to make an order restricting the liberty of a pregnant mother who was addicted to a chemical substance that was harming her foetus.57 Current German laws permit abortion after mandatory counselling and a three-day waiting period. This scheme was a political compromise necessitated by the re-unification of Germany. Rather than criminalizing abortion, German law focuses on counselling, employment security, social welfare, and financial support to persuade pregnant women to give birth to their children. In this way, German law successfully achieves some degree of protection for the unborn by obtaining voluntary recognition of personal responsibility and respect for the personhood of the unborn.58 In Ireland, the 146-year-old abortion law that banned the practice underwent a change allowing for termination of pregnancy to alleviate life threatening conditions, including a woman’s own threat to commit suicide if refused a termination.59

Medical Termination of Pregnancy of Children in Womb with Defects The most critical decisions are the ones when the child in the womb is diagnosed to have some mental or physical deformities when the mother decides to terminate the pregnancy.60 Not only can we then ask ourselves: Do we want a child? But with genetic information we can ask ourselves: Do we want this particular child? This reframes the nature of the parenting relationship, making our parenting conditional upon the child meeting certain criteria.61 The issue now swings from health concerns to avoiding disability. Within this understanding of disability, genetic technology then becomes a tool not for promoting community health but a mechanism of social control for avoiding the appearance of difference.62 Even apart from the point of view of health and avoidance of disability, with modern notions of individual liberty, many pregnant woman believe that apart from them, no one else will have a right to decide about what she wishes to do with the foetus. In today’s society, some pregnant women deny the biological fact that they are mothers until their baby is born. Late-term abortion is justified as a form of selfdefence to get rid of involuntary servitude and a form of slavery caused by pregnancy.63 Instances of partial-birth abortion performed on foetuses with chromosomal abnormalities, performed under the guise of

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reducing suffering, threaten the best interests of the mother and infant. It is suggested that an alternative for parents faced with the decision to terminate their pregnancy is a perinatal hospice. A perinatal hospice recognizes the value of bringing these infants to term by treating them as beings conceived with a tangible future. This alternative is preferred because of post-termination psychological distress and because biblical teachings64 emphasize the dignity and worth of each foetus.65

No Right of Objection for Any Person Other than the Patient or Guardian Janaway v. Salford Area Health Authority66 was a case of a conscientious objector to abortion who was neither the patient nor any near relation or even a doctor. A medical secretary refused to type a letter referring patient for abortion by a doctor as conscientiously objecting to the treatment proposed. The question was whether the request to the secretary to type the letter meant any requirement to ‘participate in any treatment’ in the context of the UK law of Abortion, Act, 1967, which under Section 4(1) empowered a person participating in the treatment to conscientiously object to the treatment. In consequence of her continued refusal to type any such letters, the authority dismissed her. On an application for judicial review, she sought a declaration that by reason of her conscientious objection she was not under a duty to carry out work of such a nature.The House of Lords held that the expression ‘participate’ in Section 4(1) of the Abortion Act, 1967, should be given its ordinary and natural meaning for it was not being used in a criminal context and it had not been the intention of the Parliament to import into Section 4(1) the criminal law concept of principal and accessory. To ‘participate in any treatment authorised by this Act’ meant actually to take part in treatment administered in a hospital or other approved place in accordance with Section 1(3) for the purpose of terminating a pregnancy. The applicant in typing a letter that referred a patient to a consultant with a view to a possible termination of a pregnancy under Section 1 would not have been participating in treatment authorised by the act. In Doe, et al. v. Bolton, Attorney General of Georgia, et al.,67 the US Supreme Court similarly held that Supreme Court will not pronounce upon the propriety of a challenge by nurses, clergymen, social workers,

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and nonprofit corporations favouring abortion reform to a state’s criminal abortion statutes where the issues they seek to litigate are sufficiently and adequately presented by challenges to the statutes filed by a married, pregnant woman who desires an abortion, and by a group of statelicenced physicians against whom the statutes operate more directly. NOTES 1 The challenge to the constitutional vires of the act was repulsed by a division bench of the Bombay High Court in Vijay Sharma and Mrs Kirti Sharma v. Union of India (UOI) through the Ministry of Law and Justice and Ministry of Health and Family Welfare AIR (2008) Bom 29, 2007(6) All MR336, 2007(5) Bom CR 710. 2 Annual Report (2005) on the implementation of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, PNDT Division, Ministry of Health and Family Welfare, Government of India. 3 Census 1991 and 2001, Office of the Registrar General and Census Commissioner, Ministry of Home Affairs Note. 4 The act obtained enforcement thanks to Supreme Court’s directions in Central Enquiry into Health & Allied Themes (CEHAT ) v. Union of India (2003) 8 SCC 398 to the central and state governments and securing from them affidavits giving details ofthe fact of constitution and notification of AAs under the act to make the provisions functional by appointing individuals to man the offices created for that purpose. A challenge to the constitutionality of the act as offending Article 21 of the Constitution was rejected by a division bench of the Bombay High Court in Vinod Soni v. Union of India 2005 Crl LJ 3408, 2005(4) RCR (Crl) 590, 2006(1) CrlCC 970. A subsequent selective challenge to the some of the sections was also rejected by the Bombay High Court in Vijay Sharma v. Union of India AIR (2008) Bom 29. In many states, even AAs had not been notified who could initiate action in a criminal court. The states have fallen in line one by one after the directions from Supreme Court and the high courts. See also Hemaanta Rath v. Union of India AIR (2008) Ori 71 for directions issued to the state for notification of AAs under the act within a time frame. 5 Section 3A of the act. 6 Section 4, ibid. 7 Section 6, ibid. 8 Section 22, ibid. 9 Rule 3A, inserted vide GSR, 109 (e) dt 14-2-2003. 10 Sections. 18 and 19.

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11 Section 23. 12 2006(2) FJCC 377. 13 M.I. Clinic Pvt Ltd v. Appropriate Authority, PNDT Act,AIR (2005) Bom 26. 14 Section 23, PNDT Act. 15 2010(2) RCR (Civil) 211. 16 See Vicki G. Norton, ‘Unnatural Selection: Non-therapeutic Preimplantation Genetic Screening and Proposed Regulation’, UCLA L. Rev. 41(1994): 1581, 1600, 1604–6. She notes the concern that parents will use reproductive technology to produce children who will satisfy the parents’ financial and emotional desires, not the child’s best interests. 17 Eric T. Jeungst quotes the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research as stating, ‘taken to an extreme, this attitude treats a child as an artifact and the reproductive process as a chance to design and produce human beings according to parental standards of excellence’. See ‘Prenatal Diagnosis and the Ethics of Uncertainty’, in Monagle and Thomasma (eds), Health Care Ethics, Critical Issues for the 21st Century (Rockville, Maryland: Aspen Publishers Inc., 1988), pp. 15, 23. Gail Vines asserts that sex selection may give parents a feeling of control over reproduction, but leaves them less able to cope when things go wrong. See ‘The Hidden Cost of Sex Selection’, New Scientist (1 May 1993): 13. 18 Rachel E. Remaley, ‘The Original Sexist Sin: Regulating Preconception Sex Selection Technology’, Health Matrix 10: 249. 19 Esfandiary, argues in favour of the interests of children in preserving individuality; see ‘The Changing World of Genetics and Abortion:Why the Women’s Movement should Advocate for Limitations on the Right to Choose in the Area of Genetic Technology’, Wm. & Mary J.Women & L.4 (1998): 499, 500. 20 The challenge to the constitutional validity of the act before the Calcutta High Court in Murari Mohan Koley v. The State and Anr (2004) 3Cal LT609 on the ground that the act violated Article 21 of the Constitution was dismissed. A similar challenge before the Rajasthan High Court in Nand Kishore Sharma and Ors. v. Union of India (UOI ) and Anr, AIR (2006) Raj166 (2006) WLC(Raj)UC411 also failed. 21 See further commentaries on the act in Chapter 2. The MCIR regards sex determination as constituting unethical medical practice. 22 Bharatbhai Dhanjibhai Modi v. Collector and Ors, AIR (2008) Guj106, (2008) GLH(1)772, (2008)2GLR1128. 23 (2009) (5) RAJ 306, (2009) (4) RCR (civil) 259, (2009) (4) RCR (crl) 233. 24 Section 2(d): ‘Registered medical practitioner’ means a medical practitioner who possesses any recognized medical qualification as defined in Clause

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(h) of Section 2 of the Indian Medical Council Act, 1956 (102 of 1956), whose name has been entered in a state medical register and who has such experience or training in gynaecology and obstetrics as may be prescribed by rules made under this act. In Doe et al. v. Bolton, Attorney General of Georgia, et al. 410 US 179; 93 S. Ct. 739; 35 L. Ed. 2d 201; 1973 US LEXIS 112, the Supreme Court ruled that only hospitals accredited by the Joint Committee on Accreditation of Hospitals could perform abortions to be unconstitutional as being not reasonably related to the purposes of the statute. It also ruled that a state criminal abortion statute’s requirement that two licenced physicians concur that the judgment of a pregnant female’s doctor that an abortion should be performed is unconstitutional has no rational connection with the patient’s needs, and unduly infringes on the physician’s right to practice. 25 Section 3(2)(i). 26 Section 3(2)(ii). 27 Explanation to Section 5. 28 Section 5. 29 Explanation 1 to Section 3(2). 30 Explanation 2 to Section 3(2). 31 In Dr Nisha Malviya and Another v. State of MP2000Cri LJ671, the complainant victim of rape denied having consented to the termination of a pregnancy. It was held to have caused the disappearance of important evidence of rape punishable under Section 201, IPC read with 314, IPC. 32 Section 3(3). 33 2003VIAD (Delhi)510, 106(2003)DLT143. 34 Dr Usha Sharma v. State, Delhi High Court in Crl MC No. 2773/2004 and Crl M No. 8782/2004 Decided On: 17.11.2006. 35 Shri Bhagwan Katariya and Others v. State of MP 2001(4)MPHT20 (CG). 36 State represented by P.P., of High Court v. Dr Joaquim Antonio D’Silva 2000(5) Bom CR 609. 37 1994(2)ALT(Cri)134,1994(43)BLJR410,1994CriLJ3851,1994(2)Crimes 100(SC), JT1994(3)SC225, 1994(1) KLT 872 (SC), 1994(2)SCALE563, (1994) 3SCC430, [1994]3SCR486, 1995(1)UJ620(SC). 38 Section 3(4). 39 Section 2(a). In the US, the state laws that originally required consent for abortion for a minor from her parent slowly became less rigorous when the states enacted laws that prohibited the physicians from performing an abortion on a pregnant minor until 48 hours after a written notice of the pending abortion is delivered to her parent or guardian.The passage of Mass. Gen. Laws Ann. ch. 112, § 12S, which required minors to get parental consent for an abortion, prompted a constitutional challenge to the provision by a physician and some others joining him that the consequences of denying a minor the right to

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make a decision regarding her pregnancy were grave, the district court held the law to be bad. The Supreme Court vacated the judgment and directed the decision from the State Supreme Court in the decision cited as (Bellotti, Attorney General of Massachusetts, et al. v. Baird et al. 443 US 622; 99 S. Ct. 3035; 61 L. Ed. 2d 797; 1979 US LEXIS 17).Utah Code Ann. § 76-7-304(2), which required parent’s consent of abortions under certain circumstances, was held to be constitutional and an action that sought to prohibit the governor and the attorney general from enforcing it was dismissed by the US Supreme Court in HL v. Matheson, Governor of Utah, et al. 450 US 398, 101 S.Ct.1164. In Kelly A. Ayotte, Attorney General of New Hampshire, Petitioner v. Planned Parenthood of Northern New England, et al., 546 US 320; 126 S.Ct. 961; 163 L. Ed. 2d 812; 2006 US LEXIS 912; 74 USLW 4091; 19 Fla. L. Weekly Fed. S 67, the US Supreme Court upheld the constitutional validity of Prenatal Notification Prior to Abortion Act except for the failure to provide an emergency health decision permitting a physician to perform an abortion in a medical emergency without parental notification.The court held: First, states have the right to require parental involvement when a minor considers terminating her pregnancy. Second, a state may not restrict access to abortions that are ‘necessary, in appropriate medical judgment for preservation of the life or health of the mother’. Planned Parenthood of Southeastern Pa. v. Casey, 505 US 833, 879, 112 S.Ct. 2791, 120 L. Ed. 2d 674 (plurality opinion). Third, New Hampshire has not taken issue with the case’s factual basis: In a very small percentage of cases, pregnant minors need immediate abortions to avert serious and often irreversible damage to their health. New Hampshire has conceded that, under this Court’s cases, it would be unconstitutional to apply the act in a manner that subjects minors to significant health risks. In an earlier decision rendered in 1997 in Martin D. Lambert, Gallatin County Attorney v. Susan Wicklund et al., 520 US 292; 117 S.Ct. 1169; 137 L.Ed. 2d 464; 1997 US LEXIS 2077; 65 USLW 3662; 97 Cal. Daily Op. Service 2232; 97 Daily Journal DAR 4159, the Supreme Court had upheld the validity of Montana code requiring parental notice, so long as the law provided adequate exceptions in cases (i) where the minor had a court appointed guardian, the minor is sufficiently mature to decide whether to have an abortion; (ii) there is evidence of a pattern of physical, sexual, or emotional abuse of the minor by one of her parents, a guardian, or a custodian; or (iii) the notification of a parent or guardian is not in the best interests of the minor. Similar reasoning was adopted while holding parental notification required under Ohio law to be constitutionally valid, Ohio v. Akron Center for Reproductive Health et al. 497 US 502; 110 S. Ct. 2972; 111 L. Ed. 2d 405; 1990 US LEXIS 3302; 58 USLW 4979. The Supreme Court, however, ruled as unconstitutional the Minnesota law that required both the parents to be notified as constituting

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an unreasonable intrusion on choices concerning the arrangements of the household in Hodgson et al. v. Minnesota et al. 497 US 417; 110 S. Ct. 2926; 111 L. Ed. 2d 344; 1990 US LEXIS 3303; 58 USLW 4957. 40 HCMP No. 264 of 1993/HCP No. 1450 of 1993 decided on 2.12.1993. 41 Section 2(b) of the MTP Act. 42 (2009) 9 SCC 1, 2009(5) RAJ 306. 43 Section 4. 44 Surendra Chauhan v. State of MP AIR (2000) SC 1436, (2000) (1) ALD(Cri)869, 2000CriLJ1789, JT (2000) (3)SC507, (2000) (2)MPHT421, RLW2000(2)SC340, (2000) (2)SCALE513, (2000)4SCC110, (2000) 2SCR515, (2000) (2)UJ898(SC). 45 Section 5(2). 46 IPC, Section 312. 47 See Section 316, IPC. This includes a doctor is not authorized to terminate pregnancy, although the woman had consented to medical termination, Surendra Chauhan v. State of MP(2000) 4 SCC 110, 2000 SCC (Crl) 772. 48 Explanation to Section 316, IPC. 49 See Section 3(1): ‘Not withstanding anything contained in the Indian Penal Code (45 of 1860), a registered medical practitioner shall not be guilty of any offence under that Code or under any other law for the time being in force, if any pregnancy is terminated by him in accordance with the provisions of this Act.’ 50 The following information was available to the Supreme Court of USA when it was deciding Roe v. Wade 410 U.S. 113, 35 L. Ed. 2d 147;93 S. Ct. 705 (1973), which it secured as opinions of experts: When does the heart begin to beat? At 18 days [when the mother is only four days late for her first menstrual period], and by 21 days it is pumping, through a closed circulatory system, blood whose type is different from that of the mother. J.M. Tanner, G. R. Taylor, and the editors of Time-life Books, Growth (New York: Life Science Library, 1965) When is the brain functioning? Brain waves have been recorded at 40 days on the Electroencephalogram (EEG). H. Hamlin, ‘Life or Death by EEG’, JAMA (12 October 1964): 120. Brain function, as measured on the Electroencephalogram, ‘appears to be reliably present in the fetus at about eight weeks gestation’, or six weeks after conception. J. Goldenring, ‘Development of the Fetal Brain’, New England Jour. of Med., (26 August 1982): 564. When does the developing baby first move? ‘In the sixth to seventh weeks. . . . If the area of the lips is gently stroked, the child responds by bending the upper body to one side and making a quick backward motion with his arms.This is called a ‘total pattern response’ because

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it involves most of the body, rather than a local part.’ L. B. Arey, Developmental Anatomy, 6th edition (Philadelphia: W. B. Sanders Co., 1954). At eight weeks, ‘if we tickle the baby’s nose, he will flex his head backwards away from the stimulus.’ A. Hellgers, M.D., ‘Fetal Development, 31’, Theological Studies, 3(7) (1970): 26. Another example is from a surgical technician whose letter said, ‘When we opened her abdomen (for a tubal pregnancy), the tube had expelled an inchlong fetus, about 4-6 weeks old. It was still alive in the sack. “That tiny baby was waving its little arms and kicking its little legs and even turned its whole body over.” ’ J. Dobson, Focus on the Family Mag., (August 91): 16. When are all his body systems present? By eight weeks (two months). Hooker and Davenport, The Prenatal Origin of Behavior (University of Kansas Press, 1952). When does he start to breathe? ‘By 11 to 12 weeks (three months), he is breathing fluid steadily and continues so until birth. At birth, he will breathe air. He does not drown by breathing fluid within his mother, because he obtains his oxygen from his umbilical cord. This breathing develops the organs of respiration.’ ‘Life Before Birth’, Life Magazine, (30 April 1965): 13. ‘Maternal cigarette smoking during pregnancy decreases the frequency of fetal breathing by 20%. The “well documented” higher incidence of prematurity, stillbirth, and slower development of reading skill may be related to this decrease.’ 80 F. Manning, ‘Meeting of Royal College of Physicians & Surgeons’, Family Practice News (15 March 1976). ‘In the 11th week of gestation fetal breathing is irregular and episodic. As gestation continues, the breathing movements become more vigorous and rapid.’ C. Dawes, ‘Fetal Breathing: Indication of Well Being’, Family Practice News (16 March 1976): 6. Episodic spontaneous breathing movement have been observed in the healthy human fetus as early as ten weeks gestational age. Conners et al.,‘Control of Fetal Breathing in the Human Fetus’, Am J. OB-GYN (April 89): 932. And 11 weeks (nine weeks post-fertilization). Cunningham,Wm. Obstetrics (1993): 193. See J.C. Willke, ‘Why Can’t We Love Them Both’, Chapter 12, ‘Fetal Development’, at http://www.abortionfacts.com/online_books/love_them_ both/why_cant_we_love_them_both_12.asp#How%20e arly%20do%20some %20organs%20form? 51 ‘Ethics’, Encyclopedia Britannica Online, sub verso, http://www.britannica.com/eb/article-252583 (last visited 8 August 2010). 52 410 US 113, 35 L. Ed. 2d 147;93 S. Ct. 705 (1973).

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53 Charles I. Lugosi powerfully argues against the judgment on the premise that the 14th amendment was intended to protect people from discrimination and harm from other people. Racism is not the only thing people need protection from. As a constitutional principle, the Fourteenth Amendment is not confined to its historical origin and purpose, but is available now to protect all human beings, including all unborn human beings. The Supreme Court can define ‘person’ to include all human beings, born and unborn. It simply chooses not to do so. Science, history, and tradition establish that unborn humans are, from the time of conception, both persons and human beings, thus strongly supporting an interpretation that the unborn meet the definition of ‘person’ under the 14th amendment. The legal test used to extend constitutional personhood to corporations, which are artificial ‘persons’ under the law, is more than met by the unborn, demonstrating that the unborn deserve the status of constitutional personhood. There can be no ‘rule of law’ if the Constitution continues to be interpreted to perpetuate a discriminatory legal system of separate and unequal for unborn human beings.‘Conforming to the Rule of Law: When Person and Human Being Finally Mean the Same Thing in Fourteenth Amendment Jurisprudence’, Issues L. & Med. 119: 22. 54 This view has been stoutly contested in the article, John Keown, ‘Back to the Future of Abortion Law: Roe’s Rejection of America’s History and Traditions’, Issues in Law & Medicine (Nat’l Legal Center for Medically Dependent & Disabled, 2006). He concludes with resounding historic material for his conclusion, ‘the primary purpose of the prohibition on abortion, both at common law and by statute, has been the protection of the unborn. There is, moreover, cogent evidence that the law’s disapproval of abortion has reflected social mores. Professor Dellapenna’s recent exhaustive study concludes: ‘all groups in society (viewed collectively, even though some individuals dissented within any given group), including women, people of color, lawyers, doctors, clergy, journalists, and others, supported the prohibition of abortion until very recent times.’ 55 505 US 833, 846 (1992). 56 R. v. Morgentaler (No. 2), [1988] 1 SCR 30 (Can.). 57 Winnipeg Child and Family Servs. v. G., [1997] 3 SCR 925 (Can.). 58 Judgment of the First Senate of 25 February 1975, 39 Bverf GE 1, aff’d, Judgment of the Second Senate of the 28 May 1993, 88 Bverf GE 203, trans. in Robert E. Jonas and John D. Gorby, ‘West German Abortion Decision: A Contrast to Roe v. Wade’, Marshall J. Pract. & Proc.9 (1976): 605. 59 The change in law was triggered by an angry global response to the tragic death on 28th October 2012 of Savita Halappanavar, a woman of Indian origin, who had a miscarriage but denied abortion inspite of the fact that her

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17 weeks foetus was not viable because the law did not permit abortion when the foetus had a beating heart.. 60 In this climate, where the lives of people with disability are not valued, the tradition of neutrality in genetic counselling actually operates to support eugenic practices. See Dorothy Wertz and John Fletcher, ‘Sex Selection Through Prenatal Diagnosis: A Feminist Critique’, in Helen Bequaert Holmes and Larau Purdy (eds), Feminist Perspectives in Medical Ethics (Indiana: Indiana University Press, 1992), p. 241. 61 Jennifer Fitzgerald, LL.B. ‘Geneticizing Disability: The Human Genome Project and the Commodification of Self ’, Issues L. & Med.14 (1998):147. She also argues that if we understand disability, along with gender, race, and class, as part of the other created by the dominant paradigm, practices such as selective abortion then become something other than mere health issues.Working from an understanding of these frameworks of disability, these practices become qualitatively different from practices such as simply providing rubella immunizations to young women. They are embedded in the desire to root out difference, to take life simply because it differs from the norm, because it belongs to the other. The motivation goes beyond community health for the desire to eliminate the difference exists even where the difference is something as unthreatening to one’s health as a cleft palate. 62 Christopher Newell,‘Some Ethical Issues Associated with Genetic Engineering for People with Disabilities’, Australian Disability Rev. (February 1992): 79. 63 Nancy J. Hirschmann, ‘Subversive Legacies: Learning From History/ Constructing the Future: Abortion, Self-defense and Involuntary Servitude’, Tex. J.Women & L. 13(2003): 41. 64 ‘Who gives man his mouth? Who makes him deaf or mute? Who gives him sight or makes him blind? Is it not I, the Lord?’ Exodus 4:11. See also John 9:3 (Specific biblical instances of such divine prerogative include the case of the man born blind ‘so that the work of God might be displayed in his life’). 65 Byron C. Calhoun, James S. Reitman, and Nathan J. Hoeldtke, ‘Perinatal Hospice: A Response to Partial Birth Abortion for Infants with Congenital Defects’, Issues L. & Med.13(1997), p. 125. According to them, perinatal death presents an occasion to acknowledge and mourn our collective mortality and to contemplate the potential value and purpose of all life. A perinatal hospice supports parents through their grief when their infant dies and maximizes the opportunity for authentic mourning. Despair over the prospect of suffering and death often leads to the discovery of new meaning in life, even when it is deformed and all too brief: ‘It is better to go to a house of mourning/than to go to a house of feasting,/for death is the destiny of every man;/the living should take this to heart.’ Such authentic mourning can transform one’s initial response to overwhelming suffering into the conviction that ‘Anyone who

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is among the living has hope—even a live dog is better off than a dead lion!’ The example of a loving and supportive delivery of a newborn with trisomy 18 with multiple anomalies who succumbs moments after birth illustrates this opportunity to ‘take to heart’ the implications of mortality and transform the dread and grief of this experience into new meaning. 66 (1989) AC 537. 67 410US 179; 93 S.Ct. 739; 35 LEd 2d 201; 1973 US LEXIS 112.

8

Medical Research and Patents

Medical research and patents are two distinct areas of study.With regard to the term ‘medical research’, for the purpose of this book, we will concern ourselves with the recent developments in the field of genetics and how the ethical issues concerning the subject are addressed. Much of the research is on the anatomy and physiology of humans for identifying the causes of the various diseases. Micro-biology is another subject of serious study. The extent to which it posses legal issues for resolution will be of particular interest for us. Clinical trials on patients by pharmaceuticals and medical personnel, even when consent have been given, will be suspect if undertaken on certain classes of people, like prisoners and persons under disability due to minority in age, illiteracy, etc. Pharmacological research attracts a whole branch of industry through both state and private enterprises for massive investments. Recent discoveries and patent-related issues will be examined to introduce to the reader the concepts that make this branch of intellectual property rights the most lucrative area of practice for legal professionals. MEDICAL RESEARCH

Biotechnology and Its Application in Medical Research Biotechnology has been defined as the use of biological organisms for commercial ends.1 The field embraces a cluster of innovations at different stages of development, including, for example, recombinant DNA technology, antisense technology, DNA amplification, genomics, bioinformatics, proteomics, and transcriptomics.2 ‘Recombinant’ Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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means ‘new combination’. ‘Recombinant DNA technology’ (rDNA), also known as ‘genetic engineering’, refers to a method of inserting genetic material from one organism into another of either the same or different species, or the process of changing the genetic complement of a cell or an organism. None of these biotechnologies has advanced in isolation. For example, advances with DNA amplification procedures, including Polymerase Chain Reaction (PCR) and ligase chain reaction (LCR), made rDNA viable; progress with bioinformatics (information technology) required to record, catalogue, search, and analyze human DNA facilitated early sequencing of the human genome by June 2000; and this stunning achievement five years in advance of the predicted deadline accelerated identification of disease-causing genes.3

Gene Patents

meaning Genetic research is inherently expensive, and without the possible reward of the limited monopoly, it would be close to impossible to solicit funding. Many of the companies may borrow money in order to carry out the research and cannot survive without the revenue generated from licensing their patent. It is also unlikely that there would be such a rush to find the possible cures to genetically created health problems without the prospect of rewards. Gene patents must satisfy all of the statutory requirements that all other patent applications must fulfill, including patentable subject matter, novelty, utility, enablement and disclosure, and non-obviousness. A common assumption is that genes are not patentable because they are naturally occurring. But the US Supreme Court has held in Diamond v. Chakrabarty4 that purified forms of naturally occurring substances are in fact patentable. The US Supreme Court reasoned that the purified forms do not naturally exist and that human ingenuity is required to actually purify and identify the sequence. In a 5-4 decision, the Court held that living organisms can be patented. The issue before the Court was whether or not a micro-bacteria that was not present in nature, was capable of being patented. The Court determined that a patent could be granted because the organisms at issue did not naturally occur in nature, a decision that paved the way for gene patents.

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Chakrabarty was not without exception as was examined in a still later judgment of the US Supreme Court in Assoication for Molecular Pathology, et al. v. Myraiad Genetics Inc., et al,5 where the challenge was brought to a claim for patent for the discovery of the precise location and sequence of two human genes, mutations of which could substantially increase the risks of breast and ovarian cancer. The issue for consideration was whether a naturally occurring segment of DNA is patent eligible under domestic law by virtue of its isolation from the rest of the human genome, as well as the patent eligibility of synthetically created DNA known as complementary DNA (cDNA) which contained the same protein-coding information found in a segment of natural DNA but omitted portions within the DNA segment that did not code for proteins. The Court held that a naturally occurring DNA segment was a product of nature and not patent eligible merely because it had been isolated but cDNA was patent eligible because it was not naturally occurring.6 The first biotechnological inventions date from the 1970s, when the first gene was cloned (1973), the first rDNA experiment was performed on an animal (1974), the first cell fused (fybridoma) (1975), and Sanger and Gilbert independently developed DNA sequencing methods (1977). It was not until 1974 that the public awakened to biotechnology when researchers proposed to insert in bacteria a sequence of DNA from a virus known to cause cancer in monkeys. In response to the public outcry that followed, the scientific community volunteered a 16-month moratorium on rDNA experiments on animals (except humans) and the Department of Health, Education, and Welfare (DHEW) established the first biotechnological regulatory body, the Recombinant DNA Advisory Committee (RAC) in the UK. Section 3 (j) of the Patents Act lays down that patents shall not be granted for ‘plants and animals in whole or any part thereof other than micro-organisms but including seeds varieties and species and essentially biological processes for production or propagation of plants and animals’. As an exception to an exception, micro organisms and micro-biological processes (that is, processes in which micro-organisms or their parts are used to make or to modify products) are patentable. In Dimminaco AG v. Controller of Patents and Designs,7 the issue was the patentability of an invention relating to a process for the preparation of an infectious Bursitis vaccine for poultry before the 2002 amendment

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allowing patents for micro-organisms.The Calcutta High Court, while setting aside the order of rejection of patent on the ground that, unlike an inanimate object, a living organism cannot be considered for conversion physically or clinically into any other product, held that the practice of the patent office in granting patents for end products containing living virus must be noted, and directed reconsideration of the patent application. However, biological materials such as organs, tissues, and cells, and process of preparing shall therefore not be patentable as they are ‘parts’ of plants and animals. While the patent office may grant patents for biological material such as rDNA, plasmids, and processes of manufacturing provided they are produced by substantive human intervention, it is unlikely to grant patents for gene sequences, DNA sequences which do not disclose their functions, if they lack inventive step or industrial application.8 The patent office is also unlikely to grant patents for processes that involve cloning human beings or animals, processes for modifying the germ line, the genetic identity of human beings or animals, and uses of human or animal embryos for any purpose that might be considered as against public order and morality.9 A biotechnological invention that is traditional knowledge or is an aggregation or duplication of known properties of traditionally known components cannot be patented.10

Benefits of Medical Research in Human Embryos In 1978, Louise Brown, the first baby conceived outside a woman’s body was born in Oldham, England. Since that time, reproductive technology has provided, among other things, for cryo-preserving gametes and embryos for years, possibly even for decades; testing embryos for genetic flaws prior to implantation; and transferring ova, produced in the body of one woman and fertilized in vitro, to the body of a second woman for gestation and birth. Moreover, treatment for infertility has produced so-called spare embryos: that is, embryos produced in vitro and cryo-preserved for future reproductive use but not in fact needed for that purpose. IVF treatment can help women to bear children when they are unable to do so by the normal process of fertilization. The screening of embryos before implantation enables a choice as to the characteristics of the child to be born.Whether such a choice should be permitted and why are difficult ethical questions. Potential benefits of

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research involving human embryos lie in the prevention of congenital disorders. Studies of eggs, sperm, and early embryos may lead to ways of preventing some chromosomal abnormalities from developing. Also, in the future, those who support research envisage the development of techniques, including embryo biopsy, which might allow the very early detection of embryos with single-gene disorder or chromosome defects that would result in seriously abnormal babies.Where there is a prospect of a child being born with an obvious inherited single-gene disorder, pre-implantation diagnosis could ultimately result in reduced likelihood of that happening. The technique of embryo biopsy could extend the use of IVF from treating infertile couples to those at risk of passing on a hereditary handicap. It would involve the removal and culture of one or two cells from an embryo still in vitro, and need not affect the subsequent development of the embryo. It is also possible that it could give rise to the possibility, in some instances, of rejecting defective embryos in favour of healthy ones and reducing the number of requests for abortion on the grounds of foetal abnormality. Future attempts would include developing non-invasive techniques for detecting defective embryos.

Stem Cell Research

embryonic stem cell research and cloning About two decades after the birth of the first child conceived in vitro, scientists announced the development of another, significantly different method for creating human embryos outside the human body: somatic cell nuclear transfer (SCNT) or cloning.11 On 5 July 1996, scientists in Ireland successfully cloned a lamb, which they named as Dolly.12 The technique used to create Dolly, developed by Ian Wilmut at the Roslin Institute in Scotland, involves removing the nucleus from an ovum and then merging the denucleated ovum with the nucleus of a somatic13 cell from the animal to be cloned. Wilmut’s laboratory used an adult sheep’s mammary cell, though in theory any somatic cell could have been used because each somatic cell contains the full complement of the nuclear DNA of the animal.14 After the fertilized egg cell began to divide it was implanted into the uterus of a sheep. That sheep gestated and gave birth to the lamb, Dolly. It carried the DNA of the sheep from which the mammary cell had come, not the DNA of the sheep that gestated and gave birth to Dolly.

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Responses to cloning were immediate and widespread.15 Within a day of Wilmut’s announcement, then US President Clinton asked the National Bioethics Advisory Commission to study the ethical implications of cloning and make recommendations for appropriate federal responses.16 That group issued a report that recommended congressional action prohibiting somatic cloning of a human for at least three to five years.17 In November 1998, a team of researchers at the University of Wisconsin and a team at Johns Hopkins University published reports of the first successful isolation and culturing of human embryonic stem (ES) cells.18 In 2001, George W. Bush made an announcement that federal funds for research on umbilical cord, placenta, adult, and animal stem cells which would not involve the same moral dilemma as embryonic stem cell research would. His speech recognized the great potential for human good to improve the quality of life, to save lives and to conquer disease, but cautioned against committing to research beyond existing stem cell lines, which were created from embryos that have already been destroyed. Objections to therapeutic cloning and embryonic stem cell research come from diverse groups for different reasons. Here pro-life advocates have been joined by an unexpected combination of feminists, concerned with a view of women as ‘egg bearers’,19 and intellectual neo-conservatives, in whose view cloning is a risky, untoward defiance of nature.20 As the social and legal debate about embryos extends into the context of therapeutic cloning and stem cell research, lines of ideological affiliation shift.21

european court of justice bans embryonic stem cell patent The Court of Justice of the European Union has held in Oliver Brustle v. Greenpeace eV 22 that the use of human embryos for therapeutic or diagnostic purposes that are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not. The case before the court was brought on a reference from the German Federal Court of Justice in a case seeking the annulment of a patent held by Brustle, which related to neutral precursor cells23 and the processes for their production from embryonic stem cells and their use for therapeutic purposes. The patentee claimed that there were already clinical applications, particularly for patients suffering from Parkinson’s disease.

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The European Court prefaced its order with a statement that it did not broach questions of a medical or ethical nature, but was restricting itself to a legal interpretation of the European Parliament’s directive24 on the extent of legal protection of biological inventions. The Court held that the directive showed that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected. It followed that the concept of ‘human embryo’ must be understood in a wide sense. Accordingly, any human ovum must, as soon as fertilized, be regarded as a ‘human embryo’ if that fertilization is such as to commence the process of development of a human being. A non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted and a nonfertilized human ovum whose division and further development have been stimulated by parthenogenesis must also be classified as a ‘human embryo’. Although those organisms have not, strictly speaking, been the object of fertilization, due to the effect of the technique used to obtain them, they are capable of commencing the process of development of a human being just as an embryo created by fertilization of an ovum could. Dealing with the question on the patentability of an invention involving the production of neural precursor cells, the court held, first, that this presupposed that stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell entails the destruction of that embryo. Not to exclude from patentability such an invention would allow a patent applicant to avoid the non-patentability through skilful drafting of the claim. The court held that an invention shall be excluded from patentability where the implementation of the process required either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in the present case, does not refer to the use of human embryos. The industry has received the judgment with scepticism that it could pave way for benefit of basic research that could still take place in Europe but the research application will take flight for commercial exploitation in the US and other countries.25

human stem cell research and the potential for clinical application The ES and EG26 cells present in the earliest stages of embryo and foetal development can generate all the human cell types, and are capable, at

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least for some time, of self-renewal. Many diseases such as Parkinson’s and juvenile-onset diabetes mellitus result from the death or dysfunction of just one or a few cell types and the replacement of those cells could offer effective treatment and even cures. Problems of immunerejection following organ transplant can be tackled by the application of human ES cells and embryonic germ EG cells. ES cells derived through somatic cell nuclear transfer (SCNT) offer the possibility that therapies could be developed from a patient’s own cells. Research using ES and EG cells offer great insights into the possibilities of birth defects, infertility, and pregnancy loss. ES and EG cells provide large quantities of homogeneous material that can be used for biochemical analysis of the patterns of gene expression and the molecular mechanisms of embryonic differentiation. It is also possible that injections of ES and EG cells would revive the complete immune response to patients undergoing bone marrow transplantation following high dose chemotherapy.27 A programme titled 60 Minutes II, A Holy Grail, broadcast on the CBS Television Network on 5 June 2002, presented a case that exemplified the idea that stem cells shall be thought of as the Holy Grail of medicine. A young patient by name of Keone Penn in Atlanta, who suffered from a case of sickle cell anaemia, a painful and often fatal genetic blood disease, was injected with stem cells extracted from four to six ounces of umbilical cord blood taken from an infant, Kyle, just fifteen minutes after he was born at Chicago. The cord blood had been sealed, packed in dry ice, and given to a courier who transported the package for Keone. The stem cells injected into Keone’s vein migrated to the bone marrow and created what his doctor called as a blood factory, replacing the deceased blood with healthy blood. It was the umbilical cord stem cells that cured the patient and not stem cells from human embryos.28

tissue typing Apart from assisted reproduction, could there be permission for tissue typing such as the case where the object of the treatment was to allow a woman to bear a child with a tissue type that would enable stem cells to be provided to a sick sibling? This was the question posed in R (on the application of Quintavalle) v. Human Fertilisation and Embryology Authority.29 Z was a child who was born with beta thalassaemia major. His condition might be cured by a transplant of stem cells from

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someone with matching tissue. Those cells could be supplied from blood taken from the umbilical cord of a newborn child, or from bone marrow. Z’s parents wished to undergo a procedure that involved the IVF; the removal from each developing embryo of a single cell by a biopsy; the examination of that cell using molecular genetics to see whether the embryo carried beta thalassaemia (PGD); simultaneous use of the same process to identify whether the embryo had the same tissue type as Z (tissue typing); the jettison of embryos found by that analysis to be either bearing beta thalassaemia disease or of a different tissue type to Z; and implantation in the mother’s womb of an embryo shown to be free of beta thalassaemia and of the same tissue type as Z. An application was made to the defendant authority for a ruling as to whether an IVF clinic could properly apply for a licence to administer treatment including tissue typing. The authority’s decision was that it would be prepared in principle to grant a licence for treatment that included tissue typing, but only where PGD was already necessary to avoid the passing on of a serious genetic disorder, and subject to certain conditions. In accordance with that decision, the authority granted a licence to a clinic to carry out the treatment on the parents. The claimant, who acted on behalf of a campaigning group that wanted to facilitate debate on ethical issues arising from human reproduction, and, in particular, assisted reproduction, sought judicial review of the authority’s decision on the ground that the authority had no power under the Human Fertilisation and Embryology Act, 1990,30 to issue a licence that permitted the use of tissue typing to select between healthy embryos. Her application was allowed, and the authority appealed. It contended that the treatment that the parents sought was for the purpose of assisting a woman to carry a child, and was, therefore, treatment within the terms of Schedule 2(1) of the act, and that a biopsy with the object of tissue typing was a practice ‘designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose’ within Paragraph 1(1) (d) of Schedule 2 to the act, since in determining suitability, regard could be had to the desired characteristics of the child that would be produced by the embryo. The court of appeal held that ‘when concern as to the characteristics of any child that she might bear might inhibit a woman from bearing a child, IVF treatment coupled with PGD that would eliminate

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that concern could properly be said to be ‘for the purpose of assisting women to carry children’. The activities that the authority had licenced in the instant case were the same as those it regularly licenced for the purpose of assisting women to bear children free of hereditary diseases. The difference was as to the desired characteristics identified by the biopsy. That difference might be critical in determining whether or not the authority would decide to licence the activities in question. That difference could not, however, be critical in determining whether or not the treatment, including the PGD, was ‘for the purpose of enabling women to carry children’. On a further appeal to the House of Lords, it was held that both PGD and HLA typing could lawfully be authorized by the authority as activities to determine the suitability of the embryo for implantation ...The concept of suitability was broad enough to include suitability for the purposes of the particular mother ...The limits of permissible embryo selection were for the authority to decide.The fact that decisions left by the [Human Fertilisation and Embryology] Act 1990 to the authority might raise difficult ethical questions was no objection; it had been specifically created to make ethical distinctions and, if Parliament should consider it to be failing in that task, it had regulatory powers in reserve.

ethical issues The key distinction in the debate surrounding embryo research appears to be between the use of an embryo with the intention of achieving a successful pregnancy leading to a healthy baby, and its use for other reasons (such as improvement of knowledge about disease).Those who are opposed to all research involving human embryos argue that procedures which lead to the destruction of the embryo or which make it unsuitable for transfer to a woman should not be permitted in any circumstances. According to them, that research cheapens the act of procreation and turns embryos into commodities.31 Genetic manipulation may be done to correct the prospect of a child that may be born with some abnormalities. At the other extreme, procedures that do not damage the embryo, or that are actively beneficial to it, do not give the same cause for concern even though such procedures may form part of what some would regard as a programme of research (for example the

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observation of embryos developing in different nutrient fluids prior to transfer to a woman). John A. Robertson concludes: A more fruitful approach to research issues at the beginning of life is to recognize that for most persons the ethical or normative questions that arise are less about the duties intrinsically owed to embryos or fetuses than they are about symbolizing or expressing the high respect that most persons have for human life generally. This respect is shown, not by banning all research with embryos or aborted fetuses, but by allowing such research only when good reasons exist for engaging in it and an institutional, or even national, review process to assess those reasons has been implemented.32

Several legal cases have involved disputes between divorcing couples about the disposition of embryos frozen during treatment for infertility. One case, Davis v. Davis,33 decided in Tennessee in 1992, starkly suggests the law’s confusion about embryos. The case developed out of a dispute between a divorcing couple about the disposition of seven frozen embryos produced from the husband’s sperm and the wife’s ova. Each of the three state courts that rendered decisions in the case characterized the ontological status of the disputed embryos differently from the other two. The trial court portrayed the embryos as children and vested temporary custody of the frozen embryos with the divorcing wife. The intermediate appellate court understood the status of the embryos as resting somewhere between property and body organs. And the state’s highest court concluded that the embryos, while neither persons nor property, enjoyed a special status because of their potential for human life. There have been also cases making women responsible for conduct that might have contributed to the health of the foetus. For example, in the US, in some states, women have been prosecuted for allegedly harming the foetus through the use of drugs.34

Cadaver Storage and Medical Research

disposal of dead body The fundamental right to life and personal liberty guaranteed under Article 21 of the Constitution has been given an expanded meaning by judicial pronouncements. The right to life has been held to include the right to live with human dignity. By Indian tradition and culture, the same human dignity with which a living human being is expected

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to be treated should also be extended to a person who is dead (if not more).35 Duties to protect the dignity of the human body after its death are deeply rooted in our nation’s history. The Supreme Court of Rhode Island observed:36 By the civil law of ancient Rome, the charge of burial was first upon the person to whom it was delegated by the deceased; second, upon the scriptihaeredes (to whom the property was given), and if none, then upon the haeredes legitimi or cognati in order. The heirs might be compelled to comply with the provisions of the will in regard to burial. And the Pontifical College had the power of providing for the burial of those who had no place of burial in their own right.

The provisions for disposal of dead bodies are invariably considered as matters of hygiene and health issues.37 The statutory prescriptions about the mode of storage of dead bodies are themselves set out under the Anatomy Acts that are passed under various states.

the anatomy act, 1949 A model legislation that was passed by the Indian Parliament was adopted with minor modifications in all states.The objects of the legislation have been to provide for supply of unclaimed bodies38 of deceased persons to teaching medical institutions and hospitals for the purpose of anatomical examination and dissection or medical relief or treatment. When there is any doubt regarding the cause of death the Acts also provide that the unclaimed body to be referred to the police officer under Section 174 of the CrPC, 1898 (also of the 1973 Code). Pending receipt of any claim, the dead body shall be removed to the hospital or the teaching medical institution for preservation from decay. Dead bodies which are received shall be kept temporarily in the cold storage of the mortuary until they are removed to the Anatomy Department. In the Anatomy Department they shall be washed and preserved by means of formalin or glycerin solution. Those which are not required for immediate use shall be kept in a tank containing a preservation solution.39

post-mortem without consent In re Organ Retention Group Litigation,40 the claimants in a group action were all parents of deceased children on whom post-mortems had been

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conducted by doctors to establish the causes of death. The claimants brought claims against the defendants seeking damages for psychiatric injury caused, in each case, by unlawful interference with a body and negligence. The claimants alleged that, although they had consented to the post-mortems, the organs of the children had been removed, retained, and subsequently disposed of without their knowledge and consent as required by Sections 1 and 2 of the Human Tissue Act, 1961. On the claims, the QB held (1) that Sections 1 and 2 of the 1961 Act provided for two different regimes for different situations; that Section 2(2) required no more than a consent to a post-mortem being obtained without further explanation; that once the requirement under Section 2(2) was complied with, a post-mortem could be conducted; that if the post mortem was for ‘the purpose of establishing or confirming the causes of death or of investigating the existence or nature of abnormal conditions’ pursuant to Section 2(1), no further consent was required for the removal and retention of organs necessarily involved in the post mortem; that, in the circumstances, the removal and retention of the organs were lawful and the claimants’ right of possession to the organs based on a duty of burial did not arise; and that, accordingly, there could be no action for wrongful interference with a body. However, the claimants’ case on negligence was held to be sustainable. It only arose in the context of hospital post-mortems. The evidence of doctors and the experts showed that doctors could owe a duty of care to a mother after a death of her baby on a doctor–patient basis. Once the doctor–patient relationship was established, the doctor owed a duty of care when seeking consent for a post mortem examination. Although the duty was to ensure non-objection, some explanation of what the parents were being asked not to object to must have been involved. The duty of care extended to giving the parents an explanation of the purpose of the post-mortem and what it involved, including alerting them to the fact that organs might be retained. The practice of not warning parents that a post-mortem might involve the removal and subsequent retention of an organ could not be justified as a practice to be adopted in all cases. In the circumstances, only one of the claims in negligence succeeded and the other two claims failed. In the Canadian case Edmonds v. Armstrong Funeral Home Ltd,41 a claim was by a widower for damages for the alleged unlawful autopsy on the body of his deceased wife. The Court of Appeal of the Alberta

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Supreme Court said in its judgment referring to two Scottish cases (Pollok v. Workman42 and Hughes v. Robertson43) ‘If then, as seems clearly established, the plaintiff had the right to the custody and control of the remains of his deceased wife any unauthorised interference with that right, such as is alleged, was an invasion of his right and would give a cause of action.’ In yet another case in the US,44 a claim for damages for wrongful autopsy without consent was upheld by the Massachusetts Court of Appeal, which reasoned: Because many persons regard an autopsy with aversion, it may not legally be performed without consent of the person having the duty to bury the body unless authorized by statute. The need for a remedy for injuries caused by unauthorized autopsies sets such a claim apart from other negligent, intentional, or reckless injuries to dead bodies. The right asserted against those who perform a wrongful autopsy is the right to what remains when the breath leaves the body, and not merely to such a hacked, hewed, and mutilated corpse as some stranger, an offender against the criminal law, may choose to turn over to an afflicted relative.

is there property in a corpse? There is no property in a corpse.45 A dead body is not property, and it does not belong to surviving relatives in the order of inheritance like other property of the estate. It is hard to envision a ‘property’ right in another person’s remains.46 However, personal representatives or other persons charged with the duty of burying a body have a right to its custody and possession in the interim, infringements of which are actionable. By statute, those representatives also have certain powers in relation to the use of a body for medical purposes. On the other hand, once a body has undergone a process or other application of human skill, such as stuffing or embalming, it can be the subject of property in the ordinary way, and the same goes for body parts. Thus in the grisly case of R v. Kelly,47 robbers who abstracted and sold preserved specimens from the Royal College of Surgeons’ collection were rightly held as convicted of theft. It is an open question whether there can be property in bodies and body parts that have not been subject to any such process but are legitimately wanted for some other purpose, such as accident investigation or use as an exhibit in court.48 In so far as there can be property in corpses or parts thereof, presumably it will vest initially in

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the person carrying out the stuffing or embalming process, or taking steps for their preservation, on the basis that he is the first possessor. Re Organ Retention Group Litigation,49 is also an authority for the proposition that if an autopsy is conducted with consent, the removal of organs for the purpose of lab tests is implicit, and no action will lie for damages for removal of organs. The US courts have always recognized the rights of the next of kin of a deceased person to possession of the body for decent burial or cremation but not a right to the body as if it were property.50 To provide California non-profit eye banks with an adequate supply of corneal tissue, Cal. Gov’t Code § 27491.47(a) authorized the coroner to remove and release or authorize the removal and release of corneal eye tissue from a body within the coroner’s custody without any effort to notify and obtain the consent of next of kin if the coroner has no knowledge of objection to the removal. The law also provided that the coroner or any person acting upon his or her request shall not incur civil liability for such removal in an action brought by any person who did not object prior to the removal nor be subject to criminal prosecution.51 In Robert Newman, as father and next of kin of Richard A. Newman and Others v. L. Sathyavagiswaran, MD, in his official capacity as Chief Medical Examiner-Coroner of the County of Los Angeles,52 the parents whose deceased children’s corneas were removed by the Los Angeles County Coroner’s office without notice or consent brought a suit challenging the removal. The court of appeals concluded that the longstanding recognition in the law of California, paralleled by national common law, that next of kin have the exclusive right to possess the bodies of their deceased family members created a property interest, the deprivation of which must be accorded due process of law under US Const. amend. XIV. The court ruled that parents have property interests in the corneas of their deceased children protected by the Due Process Clause of US. Constitution that guarantees the process, established by law, to be followed before the right to property is denied.

ownership of biological materials stored in its biorepository Samples collected from patients for research by universities or other research facilities shall belong only to the recipient universities and facilities, not to doctors or researchers who perform research.

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Researchers who leave the university cannot ask for transfer of the samples to their new place of research. However, it might be possible for the university to accommodate requests from researchers from other facilities for transfer of samples for the purpose of research.53 In Moore v. Regents of the University of California,54 the Supreme Court of California declined to grant relief to a plaintiff who, as a tissue donor, sued his doctor for conversion on the ground that his cell had been used by the defendant without his permission to produce a new cell line, and had subsequently been patented. Similarly, in Cornellio v. Stamford Hospital,55 a suit for the recovery of pap smear specimen slides that contained the plaintiff ’s genetic material was dismissed on the ground that the plaintiff could not show ‘an actual interference with the ownership or right of possession.’ These two decisions do not necessarily establish that an individual retains no ownership over excised cells or tissues and it might be possible for a person to maintain ownership upon removal. This will have an important bearing for those who have tissues removed for the purpose of cloning an organ. In Hecht v. Superior Court,56 prior to his suicide, the deceased ejaculated sperm which he arranged to be stored with the apparent intention that after his death, it would enable his cohabitant to give birth to his child. In claiming the right to call for the use of sperm, she relied on the fact that by his will, he purported to bequeath the sperm to her. His adult children through a previous relationship denied the will and challenged her right to use the sperm. The Court of Appeal of Californian Authority held that sperm was something that could be disposed through a will. In a still later case, in Yearworth v. North Bristol NHS,57 The Court of Appeal found that an action negligence lay against a hospital for allowing sperm that had been collected from cancer patients before chemotherapy to thaw due to improper storage. In doing so, the Court of Appeal was answering a preliminary objection before a trial court, which was sustained in the lower jurisdiction with the contention that there was no property in semen.

Clinical Trials Rule 122 DAA of the Drugs and Cosmetics Rules, 1945, defines clinical trial as a systematic study of new drug(s) in human subject(s) to generate date of discovering and/or verifying the clinical pharmacological (including pharmacodynamic58 and pharmacokinetic59)

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and/or adverse effects with the objective of determining safety and/ or efficacy of the new drug. Rule 122 DA requires an application for permission to be made to the licencing authority prescribed under the rules for clinical investigation or any clinical experiment by an institution. Schedule Y details the procedure for conducting clinical trials and for securing permission. In all trials, a freely given, informed, written consent is required from each study subject. Where a subject is not able to give informed consent (for example, an unconscious person, a minor, or those suffering from severe mental illness or disability), it may be obtained from a legally acceptable representative.60 It is the responsibility of the ethics committees that review and accord approval to a trial protocol to safeguard the rights, safety, and wellbeing of all trial subjects. India has been for long a haven for copying medical formulations of drugs by reverse engineering invented and marketed in foreign countries. In the post-WTO scenario that recognizes product patents, there is a compulsion for India to invent new drug formulations. The pharmaceutical companies can stay competitive and increase profits only by new inventions and secure protection for their new products through product patents. The fact that the patent life is only 20 years is itself a raison d’être for new inventions and exploit the market within the patent period to the maximum. Clinical trials are the only means by which the efficacy of medicines could be validated and they have become increasingly relevant in India since 2005. There have been reports of abuse of ethical practices and physical harm to human subjects as admitted by the Union Government itself.61 The Parliamentary Standing Committee on Health and Family Welfare, in its report presented to the Rajya Sabha on 8 May 2012 on the functioning of Central Drugs Standard Control Organisation (CDSCO), makes a damning revelation of the unholy nexus that exists in the country between the drug industry, the medical profession, and the body that oversees the licencing and trial of drugs. Many of the expert opinions recommending new drugs were reported to be written by the drug manufacturers themselves.62 According to the report, between January 2008 and October 2010, a total of 33 drugs were approved without clinical trials by resorting to Schedule Y in the Drugs and Cosmetics Act that allows for waiving the requirement in ‘public interest’. A provision introduced in the Rules to expedite the introduction of new drugs in emergency situations of such as the outbreak of new diseases like SARS (severe acute respiratory syndrome),

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bird flu, or swine flu is, the committee has noted, misutilized for nonemergency situations.

the four phases There are four phases of clinical trials.63 In the first phase, the human pharmacology phase, the objective is the estimation of safety and tolerability with the initial administration of an investigational new drug into humans. Studies in this phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteer subjects or certain types of patients. Drugs with significant potential toxicity such as cytotoxic drugs are usually studied in patients. The second phase is the therapeutic exploratory trial, which is to evaluate the effectiveness of a drug for a particular indication or indications in patients with the condition under study, and to determine the common short-term side-effects and risks associated with the drug. Studies in the second phase should be conducted in a group of patients who are selected by relatively narrow criteria leading to a relatively homogeneous population. These studies should be closely monitored. An important goal for this phase is to determine the doses and regimen for trials in the third phase. Doses used in the second phase are usually (but not always) less than the highest doses used in Phase 1. Additional objectives of Phase 2 studies can include evaluation of potential study endpoints, therapeutic regimens (including concomitant medications) and target populations (such as mild versus severe disease) for further studies in Phase 2 or 3. Therapeutic confirmatory trials mark the third stage. Studies in Phase 3 are designed to confirm the preliminary evidence accumulated in Phase 2 that a drug is safe and effective for use in the intended indication and recipient population. These studies should be intended to provide an adequate basis for marketing approval. Studies in Phase 3 may also further explore the dose-response relationships (relationships between dose, drug concentration in blood, and clinical response), use of the drug in wider populations in different stages of disease, or the safety and efficacy of the drug in combination with other drugs. For drugs intended to be administered for long periods, trials involving extended exposure to the drug are ordinarily conducted in Phase 3, although they may be initiated in Phase 2. These studies carried out in Phase 3 complete

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the information needed to support adequate instructions for use of the drug (prescribing information). For new drugs approved outside India, Phase 3 studies needs to be carried out primarily to generate evidence of efficacy and safety of the drug in Indian patients when used as recommended in the prescribing information. Prior to the performance of Phase 3 studies in Indian subjects, the licensing authority may require pharmacokinetic studies to be undertaken to verify that the data generated in the Indian population is in conformity with the data already generated abroad. Post-marketing trials are studies (other than routine surveillance) performed after drug approval and related to the approved indications. These trials go beyond the prior demonstration of the drug’s safety, efficacy, and dose definition. These trials may not be considered necessary at the time of new drug approval but may be required by the licensing authority for optimizing the drug’s use. They may be of any type but should have valid scientific objectives. Phase 4 trials include additional drug–drug interaction, dose-response or safety studies and trials designed to support use under the approved indications, for example, mortality–morbidity studies, epidemiological studies, etc.

trials on vulnerable sections Clinical trials without consent constitute professional misconduct.64 Vulnerable sections include women in general65 and pregnant womenparticularly,66 children, soldiers in captivity,67 and the mentally afflicted who are treated as human subjects for research. Further, the concept of informed consent applicable in Western communities has little relevance in communities such as Africa and Asia, where important decisions are commonly made by heads of households or group leaders rather than by individuals. International codes of ethics similarly fail to address cross-cultural research, because they are based primarily on Western ethical standards. Among the most well-known are the Nuremberg Code,68 the Declaration of Helsinki,69 and the guidelines developed jointly by the Council for International Organizations of Medical Sciences with the WHO (CIOMS guidelines).70 Each of these codes of ethics delineates principles of conduct that essentially reflect values of respect for persons, beneficence, and justice. The CIOMS guidelines are the most comprehensive, giving significant attention to

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cross-cultural conflicts in research and making a number of recommendations.71 Even consent is sometimes no justification for research on human subjects and there is a need to protect individual liberty as the US Supreme Court observed via Justice Brandis’s dissent in Olmstead v. United States:72 ‘Experience should teach us to be most on our guard to protect liberty when the government’s purposes are beneficent. Men born to freedom are naturally alert to repel invasion of their liberty by evil-minded rulers. The greatest dangers to liberty lurk in insidious encroachment by men of zeal, well-meaning but without understanding.’ In non-therapeutic administration of drugs for research, even consent may not be a sufficient safeguard and the right to action will be tested on normal understanding of tort law against harm and contractual obligations.73 At another level, children are often exposed to ‘off-label’ distribution of drugs to test the efficacy of drugs on children. AIDs-related therapies and drugs, which have resorted to this practice and the general improvement in identifying the measures for cures have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.74

MCIR Clinical drug trials or other research involving patients or volunteers as per the guidelines of the ICMR can be undertaken, provided ethical considerations are borne in mind. Elaborate guidelines were issued in 2006 for biomedical research on human participants by the ICMR called the ICMR Code.75 The guidelines fall into eight chapters that cover general principles on ethical considerations involving human participation; ethical review procedures; general ethical issues that include compensation for participation in clinical trials;76 specific principles for clinical evaluation of drugs including vaccines; and principles for epidemiological studies, human genetics, genomics research, research in transplantation, and assisted reproductive technology. The violation of existing ICMR guidelines in this regard shall constitute misconduct.77 The requirement of consent is best illustrated through a Californian case, Moore v. Regents of the University of California78 The case involved the removal of the spleen from the appellant on the premise of an

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imminent medical procedure.The spleen was later used to manufacture an immortal spleen line that was subsequently patented. The Supreme Court of California, admonishing the defrauding action of the respondents, stated that the necessary information was not disclosed to the appellant, thereby making his consent redundant. The case is not very clear about the validity of the patent itself, but applying to the Indian context, it would have meant misconduct, liable for action in the manner contemplated by the MCIR if the patentee was a person governed by their ambit. There are certain prohibited areas of research under MCIR. They are: (1) Any research related to germ line genetic engineering or reproductive cloning; (2) Any in-vitro culture of intact an human embryo, regardless of the method of its derivation, beyond 14 days or formation of primitive streak, whichever is earlier; (3) transfer of human blastocysts79 generated by SCNT,80 parthenogenetic,81 or androgenetic82 techniques into a human or non-human uterus; (4) any research involving implantation of human embryo into uterus after in vitro manipulation, at any stage of development, in humans or primates. Animals in which any of human stem cells have been introduced at any stage of development should not be allowed to breed. Research involving directed non-autologous donation of any stem cells to a particular individual is also prohibited.

Duty to Compensate for Damges for Injury or Death The injury or death resulting out of clinical trial is not infrequent going by the recent media reports. Taking note of several complaints of the unethical practice of drafting as subjects several persons of the vulnerable categories, like rural and tribal population in places in Andhra Pradesh, Madhya Pradesh, and Gujarat, the government has circulated a draft amendment to the Drugs and Cosmetics Rules, 2011, by notification dated 18 November 2011. The amendment recommends (1) incorporation of effective provisions for providing financial compensation to the trial subjects in case of trial related injury or death; (2) enhancement of responsibilities of Ethics Committee, Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial-related injury or deaths. Such information has to be provided to Drug Controller

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General (India) (DCG[I]); and (3) Amendment of the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects. It is anybody’s guess how the law shapes itself when it becomes law.83 MEDICAL INVENTIONS AND PATENTING

Patents and Objects The Patents Act, 1970, requires that the patentability satisfies three prerequisites—the invention must be new, should involve an inventive step, and must be capable of industrial application.84 Additionally, the invention should not be an invention excluded under Sections 385 and 486 of the Patents Act.87 A new invention refers to an invention or technology that has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the patent application with the complete specification. The term ‘invention’ includes both products and process. In the US there exists a 200-year-old patent system established by Thomas Jefferson for the express purpose of making sure that ‘both individuals and society reap the benefits of human industry and creativity.’ Surely, Thomas Jefferson could never have predicted what a quandary his highly successful patent system would face over Mother Nature’s secrets.88 The object of patent laws is to encourage scientific research, new technology, and industrial progress by rewarding innovation with a temporary monopoly.89 Grant of exclusive privilege to own, use, or sell the method or the product patented for a limited period stimulates new inventions of commercial utility.90 The price of the grant of the monopoly is the disclosure of the invention at the patent office, which after expiry of the period fixed on the monopoly passes into the public domain. The patent laws ‘promote the Progress of Science and useful Arts’ by rewarding innovation with a temporary monopoly. (U. S. Const., Art. I, §8, cl. 8).The monopoly is a property right; and like any property right, its boundaries should be clear. This clarity is essential to promote progress, because it enables efficient investment in innovation. A patent holder should know what he owns, and the public should know what he does not. For this reason, the patent laws require inventors to describe their work in ‘full, clear, concise, and exact terms’, (35 U. S. C. §112)

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as part of the delicate balance the law attempts to maintain between inventors, who rely on the promise of the law to bring the invention forth, and the public, which should be encouraged to pursue innovations, creations, and new ideas beyond the inventor’s exclusive rights.91 The invention for which a patent is claimed may be a product or an article or process, and in the case of an article, the patent is in the end product or the article, and in the case of a process, the patent does not lie in the end product but only in the process by which it is arrived.92

Claims

general The claim to patent is done by setting out a complete specification of a single invention, or a group of inventions linked so as to form a single inventive concept. The claims must be clear and succinct and must be fairly based on the matter disclosed in the specification.93 A claim is a portion of the specification which fulfils a separate and distinct function. It defines the monopoly, and the patentee is under a statutory obligation to state in the claims, clearly and distinctly, what is the invention which he desires to protect.94 The function of the claim is to define the scope of the invention claimed.The applicant must describe the advantage sought to be achieved by his invention in the claim. It is the duty of the patentee to tell the public of his claim so that others may not do without infringing the patent. In other words, he must mark out, with adequate distinctiveness the boundary of the territory that he claims to be exclusively of his own.95

specifications Every specification, whether provisional or complete, shall describe the invention and shall begin with a title sufficiently indicating the subject-matter to which the invention relates. Every complete specification shall (1) fully and particularly describe the invention and its operation or use and the method by which it is to be performed; (2) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; (3) end with a claim or claims defining the scope of the invention for which protection is claimed; and (4 ) be accompanied by an abstract to

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provide technical information on the invention.The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification. It is on a proper construction of the specifications and the claims that the true nature of the invention claimed is to be determined and the patent granted must be construed.96

outline of procedure for grant of patent Applications for patents shall ordinarily not be open to public for a prescribed period.97 The applicants may request the controller to publish their application at any time before the expiry of the prescribed period and the controller shall do so, except when a secrecy direction is imposed, has been abandoned, or has been withdrawn. Upon publication of an application, the depository institution may make the biological material mentioned in the specification available to the public. The publication will have the same privileges and rights as if a patent has been granted, but will not entitle the patentee to institute any proceeding for infringement until the patent has been granted. In respect of patent applications relating to pharmaceuticals and agro-chemicals, a patentee shall not be entitled to complain of infringement against enterprises that have made significant investments and were producing and marketing the product covered by the patent. The patentee will only be entitled to receive reasonable royalty from such enterprises. Examination of the application, undertaken on request, shall be to see whether it and the specification meet the requirements of the act and whether there is any lawful objection to the grant. The examiner will investigate whether the invention claimed in any claim has been anticipated.That is, an antecedent statement must, in order to invalidate the subsequent patent, be such that a person of ordinary knowledge of the subject would at once perceive and understand and be able to apply the discovery practically, without the necessity of making further experiments. A communication of the invention to the government for investigation shall not amount to anticipation. A patent may not be used to an inventor if the result would be to stop a prior use from continuing.The prior use must be substantial and not minimal, and it must have been an intentional use of the same product. A sale or an agreement to

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sell a substance to the public amounts to prior use such as to invalidate a patent, even though no known method of analysis would reveal the composition of the substance.98 Apart from prior use, anticipation by prior publication will also deprive an invention of patentability, but collaboration agreements cannot be relied on as prior publication. The examiner shall make a report on patentability to the controller, who has the power to refuse the application or require an amendment. He also has the power to direct that a reference be made to any other patent in the specification if he is of the view that an invention in respect of which an application is made cannot be performed without substantial risk of infringement to the other patent. A patent may be granted to one invention only. The patent shall carry the seal of the patent office and the date on which the patent is granted shall be open to public inspection. The term of patent is 20 years.99 Every patent will have the effect throughout India.100 Claims for patent of addition may also be made to improvements and modifications of the main invention which is not part of the specification. If such addition discloses a novel and ingenious device, it may be made an independent patent, even while revoking the parent patent on the ground of anticipation by prior knowledge.

opposition proceedings to grant of patents The act provides for two stages at which opposition proceedings may be instituted: pre-grant and post-grant. The grant of a patent is virtually a grant of monopoly right against the whole world, and that is why such a wide-ranging right of objection has been deliberately given at a pre-grant stage. Mere registration of the patent does not guarantee its resistance to subsequent challenges. Patent Act does contemplate multiple challenges to the validity of a patent. Section 25(1) is a summary procedure. The requirement as per Section 25(1) read with Rule 55 is that on filing of representation by way of opposition, the applicant has to file his reply statement. The objective of Rule 55 is to decide the pre-grant opposition expeditiously, whereas the post-grant opposition stage contemplates more elaborate procedure as is evidenced from Rules 55A to 62. A patent which survives the pre-grant and post-grant challenges can still be made vulnerable on grounds different from the ones raised at those stages. Challenge can be in the form

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of a counter claim in a suit on the grounds set out in Section 64.101 Sections 92 and 92A contemplate that the Central Government can step in any time by invoking the provision for compulsory licencing by way of notification. Therefore, the fact that there is a mechanism to control the monopoly of a patent holder (Section 84 and Section 92) and to control prices (by means of the drug price control order) will not protect an invalid grant of patent.102 In the pre-grant opposition, the onus is on the patent applicant to show that the alleged invention would result in enhancement of the known efficacy of the stated substance; whereas in the post-grant opposition, the onus will be on the objector to show that the alleged invention does not result in such enhancement. It may also become possible to file a counter claim for revocation or invalidation of patent in a suit that may be filed by the patentee complaining of infringement.103

Patenting Drugs

product patents In the case of a product patent, the article or apparatus that is the end product qualifies for patent protection. The dichotomy between the product patent and process patent was specifically recognized through Section 5 of the Patent Act, which said that no patent shall be granted in respect of claims for substances intended for use as food, medicine, or drug, but claims for the methods or processes of manufacture of these substances shall be patentable. Section 5 is now deleted, but the definition of ‘invention’ incorporates elements of both product and process patents.

process patents A process of manufacture could qualify for patent if it satisfies the patentability criterion. The manner of manufacture must satisfy the ‘vendibility test’, that is, (1) it should result in the production of a saleable product, (2) it should restore or improve the former condition of a vendible product, and (3) it should have the effect of preserving from deterioration some vendible product to which it is applied.104 In contrast to a product patent where the end product itself will amount to a manufacture, the process patent would amount to a manufacture

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only if it results in the production of some tangible product.This vendibility excludes the method or process of treating human diseases.105 However, there exists a difference in the method of treatment that will produce a cosmetic result in the human body for which a person may be ready to pay a price, and is hence patentable.106 However, a process of creating a permanent wave (a hairstyle) was held to be not patentable on the ground that the result achieved was not a manner of new manufacture.107

medical practice procedure Method of Treatment Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatment of human beings, or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products is not patentable.108 In Australia, during the time when surgical and medical procedures were excepted from patentability, the high court maintained a distinction between a process for the cosmetic treatment of hair and nails that was held patentable though medical treatment of disease, malfunction, or incapacity were not.109 But a process designed to improve the health of the body or cure a defect is not patentable.110 A method of treatment of a human ailment with a known substance does not even qualify as an invention.111 US Law It is sometimes argued that there is a theoretical basis for patenting innovative medical procedures, particularly in the field of medical surgery. One of the overarching goals of the patent system is to drive discovery. The reward theory incentivizes researchers to determine the sequences for genes in order to secure a patent, disclosure of which may lead to the development of new medical treatments. The combination of the incentive to invent and the sharing of information promote necessary medical progress. In the US in 1996, Congress adapted the Patent Act to allow for the infringement of medical process patents. This adaptation fosters medical treatments despite infringement, and continues to encourage innovation. This medical treatment infringement exception is a one-of-a-kind and the patented process cannot be used in any

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other manner. The policy behind this 1996 congressional adaptation is to continue the encouragement of invention, but at the same time it ensures that the public is not deprived of the newest medical treatments, the same way as the Indian Patent Act does through Section 3(i) and achieves the necessary balance between protecting both public and private interests. The American Society of Cataract and Refractive Surgery views medical procedure patents as having a chilling effect on the dissemination of new ideas.The Society claims that if medical procedure patents are enforced, ‘doctors would operate in secrecy, behind closed doors so that their “methods” would not be stolen by an observer.’ In Pallin v. Singer,112 eye surgeon Dr Samuel Pallin sued several of his peers, including fellow eye surgeon, Dr Jack Singer, for the infringement of a medical procedure patent covering a new cataract surgery technique. It is a rare instance of one physician suing another over an invention such as a medical procedure patent. The invention at stake was patent number 5, 080, 111, a technique for making a chevron shaped incision into the white wall of the eye in such a fashion to be ‘substantially self sealing’ and suture less. The Pallin patent reportedly resulted in a ‘savings of $17 per operation.’ Despite these savings, the defendants objected to paying either the patent royalty fee of $5 per operation or a flat fee for a clinic of $2,500 to $10,000 per year. In the district court proceeding, Singer and the other defendants moved for summary judgment, alleging invalidity of the patent. The district court denied this motion on the grounds that the defendants failed to demonstrate the lack of a genuine issue of material fact regarding the obviousness of the innovation, one of the key factors of patent validity. Ultimately, the court entered a consent order declaring the four patent claims of the Pallin patent in controversy to be invalid, and Dr Pallin agreed not to enforce the remaining patent claims. During this litigation, the American Medical Association House of Delegates voted to condemn the patenting of medical and surgical procedures. They further agreed to ‘work with Congress to outlaw this practice.’ In response, a restriction on medical procedure patent infringement remedies was introduced in Congress and signed into a law called the Medical Procedures Innovation and Affordability Act113 by the President. The outcome of this legislative activity reveals much about the perceptions of the medical and patent

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law professions, as well as the fundamental underpinnings of the US patent system.114

pharmacological inventions It appears that the nature of drug research and development has changed in recent years. Advances in molecular biology and genetic engineering are generally switching research from a chemical basis to a biological basis. The latter is based more on understanding of the human body and pathologies than on the more traditional largescale systematic assays of many molecules. Competition among research-based pharmaceutical firms is largely over new products of superior quality. A ‘pharmaceutical substance’ means a new entity involving one or more inventive steps.115 The introduction of innovative products demonstrating high efficacy, few side-effects in optimal doses, and other important product attributes generally ensures premium prices. A striking example is Pfizer’s impotence pill,Viagra, which was introduced in March 1998 and sold $ 78 million worth of prescriptions in its first 48 hours on the market at $ 7 a pill in the US.116 Key Exception to Patentability Section 3(d)117 excepts from patentability a mere discovery of new form of a known substance that does not enhance the known efficacy of the substance; to this extent, it is a conditional exception. If it is possible to invent an enhancement of a known efficacy, it could still be patentable. The discovery of a new property or new use for a known substance contained in the latter part of the section is indeed an absolute exception.118 A discovery of a new property for Aspirin— as a blood thinner useful for treating clots and prevention of stroke— when the drug was always known to be a pain killer is an example of the reach of Section 3(d) as an exception to patentability.119 The mere use of a known process, machine, or apparatus will not also be an invention, but if it results in a new product or employs at least one new reactant, it will amount to an invention. It still requires an inventive step and will have to satisfy all the three tests of patentability referred to above to qualify for a product patent. Until the TRIPS agreement, there was no product patent for pharmaceuticals in India,

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which encouraged the growth of the generic pharmaceutical industry. The TRIPS mandate contains transitional provisions for developing countries to continue with exclusive marketing rights (EMRs) through Article 31, which allows for use without authorization of the right holder. After the Amendment Act of 2005, a committee headed by Dr R.A. Mashelkar has observed in its report that granting patents only to new chemical entities (NCEs) or new medical entities (NMEs) and excluding other categories of pharmaceutical inventions is likely to contravene the mandate under Article 27 to grant patents to all inventions. The committee observed that excluding new forms of crystals, polymorphs, etc. if they satisfy the criteria of patentability is not TRIPS compliant. Enhanced Efficacy as the Test of Invention and Patentability All derivatives of a known substance would be deemed to be the same substance unless they differ significantly in properties with regard to efficacy. In the field of pharmacology, if a discovery is made from a known substance, the patent applicant must show that the discovery has resulted in the enhancement of the known therapeutic efficacy of that substance.120 The derivatives should contain properties that are significantly different with regard to efficacy of the substance from which the derivative is made. Therefore, if an objection to the grant of patent is made on the ground that the discovery did not enhance therapeutic efficacy, the onus is on the person who applies for the patent to establish the enhancement of therapeutic efficacy, and the controller shall consider the objections before granting it.121 Bioavailability of Drugs The drugs that are marketed are not necessarily the same as how they are originally invented. Lead compounds122 are the first step in drug development. The key characteristic of an efficacious drug is its bioavailability, which determines the extent and rate of a drug’s appearance in the bloodstream after administration in dosage form. In determining whether there is an enhancement in efficacy or bioavailability of a drug, the court will normally have to consider the ‘common general knowledge’ with regard to bioavailability.123

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Privileges Attached to Patent

conditions that may be imposed to the grant The grant of a patent under this Act shall be subject to the condition, inter alia, in the case of a patent in respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own use or for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the government or any other dispensary, hospital or other medical institution which the Central Government may, having regard to the public service that such dispensary, hospital or medical institution renders, specify in this behalf by notification in the Official Gazette.124 A patent granted under this Act shall confer upon the patentee, (a) where the subject-matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India; (b) where the subject-matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India.125

patent linkage Patent linkage is a system in which the drug controller refuses to grant or delays a marketing approval to a generic drug manufacturer to manufacture and sell a drug if it is already patented.The opposition to patent linkage is that it is supposedly against public health interests and will delay the entry of cheap, generic medicines into the market and keep medicines out of reach of those who need them. In the Indian context the perception is that, if introduced, the patent linkage system would seriously impact the early entry of generic drugs into the market. Such early entry of generic drugs is possible either through mechanisms such as compulsory licencing within the Patents Act itself, or where there is a bona fide belief that a patent has been wrongly granted. The issue has arisen in a recent case. Bayer Corporation filed a writ petition against the Union of India, the DCGI, and Cipla Ltd,

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seeking an order that the DCGI should consider the patent status of its drug, sorefenib tosylate, before granting a marketing approval to any generic versions of the drug, and refuse marketing approval to any generic version. Sorefenib tosylate is used to treat renal cancer and is sold by Bayer at Rs 2,85,000 for 120 tablets (a month’s dosage). The court of first instance rejected Bayer’s attempt to introduce the patent linkage system in India through a court direction.126 A division bench of the Delhi High Court127 also dismissed the appeal. The court held that there was no scope for the DCGI to go beyond the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules in order to ensure protection of a patent by refusing marketing approval to a generic manufacturer only because the drug in question is patented.The court ruled that Section 156 only states that the Government cannot also infringe a patent. It is a negative obligation on the Government to not infringe. It creates no duty or positive obligation on the Central Government, or any department thereof, to protect a patent from infringement. In granting marketing approval to a patented drug, the DCGI is by no means itself infringing any patent or abetting the infringement of any patent by the Applicant in whose favour the marking approval is being granted.

Raising the question of whether a genetic version of a patented drug is a spurious drug, it held that under Section 17B of Drugs and Cosmetics Act a drug shall be deemed to be spurious: if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug. In the instant case, Respondent will use its own brand name and label and therefore there is no question of manufacturing a drug under a name which belongs to another drug.

The Supreme Court affirmed the decision.

remedies against patent infringement The holder of a patent, his assignee, and licencee, or in case of death, their legal representatives shall be entitled to enforce the benefits of patent for appropriate action against any person who makes an

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infringement of the patent. The remedies shall, subject to the objections that may be taken which are outlined for a post-grant situation (as described above), be diverse depending on the relief that would satisfy the plaintiff complaining of breach. The infringement may be in a number of ways: a colourable imitation in the manufacture of the patented article or a replication of the process in full or in part that is material to the new. Even a threatened release of a product that the plaintiff could show prima facie that might be construed as an infringement can be injuncted as a qua timet action. It must be borne in mind that the fact that the controller had issued a patent cannot estop a defendant to contend that there has been a prior user or that the product lacks novelty.128 The grant of a patent does not make the patent impregnable.129 In an action for infringement, the question of a patent’s lack of knowledge existing in favour of the plaintiff is irrelevant. An innocent infringement is equally actionable.While an injunction might issue against such infringement, damages or an account of profits will not be granted against the defendant who is able to prove that at the date of infringement he was not aware and had no reasonable grounds for believing that the patent existed.130

EMRs EMRs were transitional provisions that were added to the Patents Act, 1970, by the Patents (Amendment) Act, 1999. They were applied in case of a product ‘waiting for a patent in the ‘mail box’131 obtained marketing approval before the ‘mail box’ is opened and a decision is made on whether or not to grant the patent. In such a case, the manufacturer could request EMRs for up to five years or until a decision is rendered on the patentability of the product, whichever is shorter. However, EMRs were subject to two preconditions: a patent should have been granted for the same product in another WTOmember country after 1995 (the date of entry into force of TRIPs), and marketing approval should have been obtained for this product in the other member country. EMRs were supposed to prevent others entering the market until the patent would be granted or rejected. Chapter 4A, which dealt with EMRs, has been omitted by the Patents (Amendment) Ordinance, 2004, and the Patents (Amendment) Act, 2005, as the act provides for the grant of product patents for medicines, drugs, or agro-chemicals.132

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novartis case The First Stage:The Subject of Patentability The Novartis case133 had its origin in India in 1997 when a patent application was filed by Novartis AG for the crystalline form of imatinib mesylate (brand name Glivec) which was a slightly different version of their 1993 patent,134 a vital anti-leukaemia drug, in the Chennai Patent Office. The petitioner claimed that the petitioners had invented the substance in two forms—Alpha and Beta—of which the Beta form can be stored easier, is less hygroscopic, easier to process, and guarantees a constant quality of the final drug product. The Beta crystalline form of imatinib mesylate also results in higher bioavailability over the 1993 compound and, hence, differs significantly in properties with respect to efficacy. In 2003, Glivec was granted EMR in the Indian market. Novartis obtained orders preventing some of the generic manufacturers from producing the generic equivalents of Glivec in India. Soon, Novartis was selling Gleevec at $ 2,666 per patient per year. Generic companies had been selling their generic versions at $ 177–266 per patient per month. Pre-grant oppositions were filed by Natco Pharma Ltd, M/s Cipla Ltd, M/s Hetro Drugs Ltd, M/s Cancer Patient Aid Association, and M/s Ranbaxy Laboratories Ltd, and in an order dated 25 January 2006, the Assistant Controller of Patents and Designs, Chennai Patent Office, rejected the Novartis application. Novartis AG and its Indian subsidiary, Novartis India Ltd, filed writ petitions in the Madras High Court challenging the decision of the controller. The petitioner alleged that Section 3(d) of the Patents Act, 1970, as amended by the Patents (Amendment) Act, 2005, is invalid, illegal, and unconstitutional. The petitioner argued for a similar declaration in this case, emphasizing that Section 3(d) was not in consonance with the TRIPs Agreement. The betacrystalline form of imatinib mesylate was being produced and sold on a commercial scale in India from 2003 after getting the EMR. The generic manufacturers and civil society organizations alleged that Novartis’s invention lacked novelty, was obvious to a person skilled in the art, and was merely a new form of a known substance that did not enhance the efficacy of the substance and therefore was not patentable under Section 3(d) of the Patents Act. Different crystalline forms of imatinib mesylate did not differ in properties with respect

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to efficacy, and thus, the various forms of imatinib mesylate must be considered the same substance under Section 3(d). These arguments were based on the fact that Novartis had already been granted a patent in 1993 for the active molecule imatinib, and the present application only concerned a specific crystalline form of the salt form of that compound. The Second Stage:The Constitutionality of Provision and Issue of Jurisdiction In the case brought before the Madras High Court, the court mainly considered the jurisdictional issue. The high court refused to look into the question of whether a private party has a right to enforce an international agreement or whether the Patents (Amendment) Act, 2005, is compatible with the TRIPs agreement. The court also rejected the argument of the petitioner that the discretion vested in the patent examiners could be misused and the decision to reject the petitioner’s patent application was due to the excess discretionary power entrusted with the statutory authority, thus violating Article 14 of the Constitution of India. It was held that the amended provision could not be invalidated solely on the ground that there is a possibility of misusing the power. Before dismissing the petitions, the court observed that the ‘object which the Amending Act wanted to achieve was to prevent ever-greening; to provide easy access to the citizens of this country to life saving drugs and to discharge their constitutional obligation of providing good healthcare to its citizens.’The importance of the high court judgment was that it paved the decks for retention of the amended provision of Section 3(d) of the Patents Act. The Wrapping Up Act:The Judgment of the Supreme Court Before the Supreme Court, the posers were: whether the product for which the appellant claimed patent qualified as a ‘new product’ through an invention involving a technical advance over the existing knowledge that made the invention ‘not obvious’ to a person skilled in the art; in case the appellant’s product satisfied the tests and thus qualified as ‘invention’ within the meaning of clauses ( j) and ( ja) of Section 2(1), could its patentability still be questioned and denied on the ground that Section 3(d) put it out of the category of ‘invention’? The court brought out the history of patent law in India and examined the technical details relating to the product before launching on inherent

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fallibilities of the patent application itself. The Court observed that there was no clarity in the application about what was the substance before the beta crystalline form of Imatinib Mesylate. Dealing with the component of invention as having greater therapeutic efficacy, it said: In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of Section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy.

As if to allay fears of foreign investors that the amended provision under Section 3(d) itself was a disincentive to innovation and research, the Court clarified: . We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Patent Act.That is not said in this judgment.

The Court said nothing of national interest; it did not defend its judgment on emotive issues on poor patients or affordability. It simply found the product was no invention to merit a patent.

Compulsory Licences In as much as a patent guarantees a monopoly of use, its abuse is prevented through a mechanism of compulsory licence. At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds: (1) the reasonable requirements of the public with respect to the patented invention have not been satisfied, (2) the patented invention is not available to the public at a reasonably affordable price, (3) the patented invention is not worked in the territory of India.135 The powers of the controller upon an application made as above shall be exercised with

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a view to ensuring that patented inventions are worked on a commercial scale in the territory of India without undue delay and to the fullest extent that is reasonably practicable, and that the interests of any person for working on or developing an invention in the territory of India under the protection of a patent are not unfairly prejudiced.136 In the first-ever case of compulsory licencing approval, the Indian Patent Office cleared on 12 March 2012, the application of Hyderabad’s Natco Pharma to sell generic drug Nexavar, used for renal and liver cancer, at Rs 8, 880 (around $175) for a 120-capsule pack for a month’s therapy. Bayer offers it for over Rs 2,80,000 (roughly $5, 500) per 120 capsules. The order provides hope for patients who cannot afford these drugs.137 It is possible that many local pharmaceutical companies utilize similar opportunities to seek for compulsory licence to manufacture patented products of immense value if the patentee has not been able to market their products effectively on account of price constraints.138 This could in turn trigger a process of foreign companies tying up with Indian counterparts to manufacture or/and market life-saving costly drugs at relatively cheaper prices.139 MEDICAL RESEARCH AND HEALTHCARE INITIATIVES OF THE STATE

Correlation between Tobacco Smoking and Cancer For centuries the leaves of the tobacco plant have been used for making smoking tobacco and chewing tobacco. Tobacco contains small amounts of nicotine, a stimulant that acts on the heart and other organs and the nervous system when tobacco is inhaled, ingested, or absorbed. Nicotine’s effect on the nervous system causes people to become addicted to it, and the stimulating effects make smoking and chewing tobacco pleasurable. It took a fairly large volume of research and considerable time before a sure nexus was established between tobacco consumption and cancer.140 The initial attempt by cigarette manufacturers was to sound ‘cool’ by suggesting that there were no health hazards with advertisement like, ‘More doctors smoke Camels’.141 Post Second World War, around 1948, the initial research undertaken by Wynder142 and Graham143 was directed at attempting to prove that there existed no connection between smoking and cancer but the result showed

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patients with lung cancer had a history of smoking.144 About the same time in the UK, a doctor duo, Doll and Hills, carried out a study which also showed a positive correlation between incidence of lung cancer and smoking habits.145 Filter cigarettes or low tar or light cigarettes contain no less risk than un-filtered cigarettes. Smoking, which is as dangerous to health as addictive it was, fell to be targeted by all fiscal planners to levy indirect taxes without fear of public resistance. Due to compulsion of war finance, the British Government had to mobilize additional resources and took a bold decision of introducing excise levy on un-manufactured tobacco. Survey on feasibility of imposing excise duty on tobacco was made in 1942. The advent of excise on tobacco led to mass recruitment of personnel to cover every nook and corner of the country.146 Since then, every finance minister found the excise levy as a convenient source of public revenue on tobacco products.147

Regulation on Sale, Distribution, and Advertisement on Tobacco Products

tobacco litigation worldwide Tobacco-related litigation across the globe has moved in slow stages. Initially, for over four decades after the conclusion of the Second World War, the tobacco industry was able to fend off actions brought against them by individual clients by making it difficult to produce proof of what they were required to prove in tort actions, namely, that there was any deception or negligence on the part of the manufacturer to persons complaining of illness arising out of smoking. The industry persistently refused to admit that smoking caused any disease and it was remarkably successful at convincing judges and juries that the smoker was entirely at fault for ‘choosing’ to smoke in the face of known risks as well as the government mandated health warnings included on cigarette packs since 1966. Three types of litigations raged in the US: individual actions, class actions, and state actions. In Australia, in the year 1991, the Federal Court ruled that advertisements run in 1986 by the Tobacco Institute of Australia denying adverse health effects from environmental tobacco smoke violated the Trade Practices Act, 1974, which prohibits misleading or deceptive conduct in trade or commerce.148 The tobacco industry’s solid phalanx cracked in 1996 in the

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US when Brooke Group Ltd, parent of the once major player Liggett & Myers Tobacco Company, settled with several suing states. It agreed to pay monetary damages, add meaningful warnings on cigarette packages, and provide testimony about industry misconduct in pending cases against its competitors.149 Building on the American experience, lawyers in Argentina, Ireland, Israel, Finland, France, Japan, Norway, Sri Lanka,Thailand, and Turkey have filed cases in their respective country courts against tobacco companies.150 In 2000, in Japan, the Emperor Arkihito ended the tradition (begun by Hirohito in 1964) of giving out cigarettes to his staff on his birthday. Victim of Passive Smoking Entitled to Right of Action What the primary victim—the smokers—could not yet prove successfully, a class action suit at Florida by non-smoking flight attendants exposed to environmental tobacco smoke did, which resulted in a settlement in exchange for a $300 million fund to research the diagnosis and treatment of diseases caused by environmental tobacco smoke, as well as an agreement on procedures to simplify and facilitate future trials.151 The US Supreme Court recognized the prisoner’s claim that being housed with a smoking cellmate constituted cruel and unusual punishment, in violation of the eighth amendment to the US Constitution.152 A court even allowed tenants to withhold rent when their landlord failed to protect them from environmental tobacco seeping into their apartment from a nightclub on their premises.153 In Australia, a claim brought before Human Rights and Equal Opportunity Commission under the Disability Discrimination Act, 1992, proved successful when it was held that the failure to provide access to a smoke-free environment in a nightclub constituted unlawful discrimination in respect of a person with a disability due to asthmatic lungs.154 Indemnity Claims Third-party reimbursement claims have been pursued in two ways. Some of the states in the US have filed cases against tobacco companies for the costs incurred through social security commitments for persons suffering illnesses from tobacco use through Medicaid reimbursements. The States of Guatemala, Venezuela, Bolivia, and Nicaragua have all cases pending in the federal district courts in Washington DC, seeking the recovery of national healthcare expenses related to tobacco. Courts

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in the Marshal Islands and the Canadian Province of British Columbia have suits filed in their countries. The insurance companies have also filed cases for the costs incurred by them for meeting the health insurance claims of tobacco consumers. The government health insurance body in the department of St Nizaire, France, and two private health insurers in Israel covering majority of Israeli citizens have filed similar actions.155

court directives in india In India, as in England, there is no case law of successful claims for damages against tobacco companies either on the grounds of fraudulent advertisements or the healthcare expenses incurred by state or insurance companies. As in England, so in India, the attempt has been to discourage smoking and consumption of tobacco products, by imposing steep excise levies banning advertisements, and proscribing smoking in public places.The first major restriction on a tobacco product came in the year 1975 when it was mandated through a statute that every package of cigarettes should contain a warning that smoking was injurious to health.156 The 1975 Act also required that every advertisement shall carry a similar warning.157 The implementation of the act was still not effective.The Kerala High Court was the first in India that banned smoking in public places.158 A writ petition was independently filed in the Supreme Court seeking for a ban on smoking in public places.159 When the case came for orders on 31 August 2001, the Court passed an order for implementing the 1975 Act. At a later hearing, the learned attorney-general as well as counsel for the parties submitted that in consideration of the harmful effect of smoking, smoking in public places was required to be prohibited. On this submission, the Court sought response of the Central Government. There was no response for two consecutive hearings but the attorney-general, with all emphasis at his command160 submitted that appropriate order banning smoking in public places be passed. The counsel for the petitioner was also reported to have made a similar submission. Counsel appearing for other respondents also supported the same. The raison d’être was that smoking in public places indirectly deprived non-smoking persons of their lives without any process of law as guaranteed under Article 21 of the Constitution, and hence non-smokers could not be compelled

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to become helpless victims of pollution caused by cigarette-smokers. It was therefore held that smoking must be prohibited in public places. That was, incidentally, the history of public ban on smoking in public places that came through court judgments even before the central statute banned it.161 Subsequently, when a law was passed in 2003, the Madhya Pradesh High Court162 directed the Central Government to notify the applicability of the provision for determining the nicotine and tar levels in the cigarette. There is no law completely banning the sale and manufacture of cigarettes and an attempt to secure such an all-India ban through court order was rejected by the Andhra Pradesh High Court,163 when it held that such a law could be passed only by the Parliament.

the legislative restrictions in india A comprehensive law to prohibit the advertisement of; to provide for the regulation of trade and commerce in; and production, supply and distribution of, cigarettes and other tobacco products was brought through Cigarettes and Other Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003.164 The expression ‘cigarette’ excludes beedis, cheroots, and cigars by definition contained under Section 3. The preamble says that the act was to give effect to the resolutions passed by the 39th and 43rd WHO meetings held respectively on 15 May 1986 and 17 May 1990, urging its member states to implement the measures to ensure that effective protection is provided to non-smokers from involuntary exposure to tobacco smoke, and to protect children and young people from being addicted to the use of tobacco; and to consider in their tobacco control strategies plans for legislation and other effective measures for protecting their citizens with special attention to risk groups such as pregnant women and children from involuntary exposure to tobacco smoke, discourage the use of tobacco and impose progressive restrictions, and take concerted action to eventually eliminate all direct and indirect advertising, promotion, and sponsorship concerning tobacco. The 2003 Act states that it was aimed at achieving improvement of public health in general as enjoined by Article 47 of the Constitution. The stringent provisions include visual representation warning that tobacco is injurious to health, details of nicotine and tar

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content in every packet, prohibition to smoke in public places,165 and prohibition of sale or distribution of tobacco products to any person below the age of 18 years and in any area within a radius of a100 yards of any educational institution.

gutka, paan, and other tobacco products Attempts to ban tobacco products like gutka and pan masala through government notifications have brought mixed results. A Central Government notification166 issued by the Ministry of Health and Family Welfare (Department of Health) under Section 33 DDE of the Drugs and Cosmetics Act, 1940, banning the tobacco ingredient in toothpaste was upheld by the Supreme Court in Laxmikant v. Union of India (UOI ) and Ors.167 However, a state government notification under the Presentation of Food Adulteration Act168 was unexpectedly struck down on a finding that there exists no policy at an all-India level to ban tobacco products.The issue was brought before the Supreme Court in Godawat Pan Masala Products I.P. Ltd and Anr v. Union of India (UOI ) and Ors,169 and the Court held that there were several legislations that only regulated tobacco trade, but none existed to ban it.170 It could not be also treated that tobacco products are res extra commercium, and the ban could be imposed through statute and not through subordinate legislation by a government notification. The Supreme Court went on to say that the (Maharashtra) State Food (Health) Authority has no power to prohibit the manufacture for sale, storage, sale or distribution of any article, whether used as an article or adjunct thereto or not used as food. Such a power can only arise as a result of wider policy decision and emanate from Parliamentary legislation or, at least, by exercise of the powers by the Central Government by framing rules under Section of the Prevention of Food Adulteration Act.

Just not executive incompetence, it went on to uphold the manufacturer’s fundamental rights by declaring that the impugned notifications were unconstitutional and void as abridging the fundamental rights of the appellants/manufacturers guaranteed under Articles 14 and 19 of the Constitution. In Laxmikant’s case, the Supreme Court relied on the communication sent by the DGHS to the Director of Medical Education and Training to discourage the use of gutka in the Orissa Government as a justification for the ban, and had held a

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diametrically opposite view that a person engaged in trade that added a tobacco ingredient in his product has no right to complain of the infringement of Article 19. As if to placate the anti-tobacco movement for what it did in Godawat Pan Masala, the Supreme Court held that the sale of gutka in plastic sachets was to be banned in Ankur Gutkha v. Indian Asthama Care Society and Ors.171 It further directed the central government to carry out a survey by the National Institute of Public Health to ascertain the harmful consequences of gutka, pan masala, and other tobacco products. Was any such proof necessary? Was the Supreme Court saying that the use of a plastic sachet was more harmful than what it contained? IODIZED SALT Iodine is a micro nutrient that is naturally present in the food supply in many regions. Many things are natural sources of iodine. Salt water fish and sea vegetables, for example, contain abundant amounts of iodine.The material can also be found in plants grown on soil that is rich in oceanic materials, and in animals grazed on such soils. In some regions of the world, however, access to iodine is limited, and conditions like goitre are epidemic.172 However, where natural levels of iodine in the soil are low and the iodine is not absorbed by vegetables, iodine added to salt provides the small but essential amount needed by humans. Iodine deficiency affects two billion people worldwide and is the leading preventable cause of mental retardation. According to public health experts, iodization of salt may be the world’s simplest and most cost-effective measure available to improve health. The Central Government brought an amendment to the rules framed under the Prevention of Food Adulteration Act banning sale of common salt for direct human consumption without iodizing the product. The source of executive power of rule making was Section 23(1A)(f) of the Prevention of Food Adulteration Act. On a challenge to the Supreme Court on the vires of the rule,173 the court said that the section allowed making a rule to prohibit sale only if the substance is injurious to health when used as food. If use of common salt is not injurious to health, the question of making a rule prohibiting the sale of such a substance would not arise. It further reasoned that making available medicines or medicinal preparations to improve public health was not the object of the Prevention of Food Adulteration Act. If the

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objective was to get people to use iodized salt, recourse could not be by making a rule banning the sale of common salt for human consumption under the act. The court said that the act could not be used to make a rule intended to achieve an object wholly unrelated to the act. The court allowed for the continuation of the ban contained in Rule 44I for a period of six months. It directed that the Central Government might within that period review the compulsory iodization programme, and if it decided to continue, might introduce appropriate measures, legislative or otherwise. It added that that if it failed to take any action within the expiry of six months from the date of judgment (4 July 2011), Rule 44I shall cease to operate.The South African Government instructed that all salt for sale was to be iodized after 1 December 1995. Kazakhstan appears to be the only other country where use of iodized salt is mandatory.174 ENSURING STANDARDS The Drugs and Cosmetics Act contains provisions to ensure that standards of quality are maintained by prescribing standards of drugs for manufacture, import, and supply. They allow for ban, confiscation, and penal action for misbranding, adulteration, and spurious drugs from entering the market. Although the offences are cognizable and nonbailable there is complete lack of alacrity of state inspecting agencies to check the prevalent practice of dumping in India banned or substandard drugs elsewhere in the world. Recent cases have demonstrated that foreign companies operating in India manufacture import and distribute drugs that are not merely substandard but significantly deleterious to safety and public health. In one case before a district court of Maryland in the US, Ranbaxy, India’s largest generic drug manufacturer agreed to pay $500 million to the US and 32 of its states to resolve criminal and civil allegations by the US and Dinesh Thakur (a former director of Ranbaxy)175 that Ranbaxy had ‘falsified drugs data and systematically violated manufacturing/laboratory practices resulting in substandard and unapproved drugs’. Ranbaxy entered into a settlement agreement with the US Department of Justice to avoid litigation over the charges that Ranbaxy had ‘knowingly manufactured, distributed and sold in interstate commerce and made false statements about certain batches, lots or portions of lots of the Covered Drugs during the period in violation of Food, Drugs and Cosmetics Act (FDCA)’ impinging on the ‘strength, purity, and quality of the drugs’ thus amounting to ‘unapproved new drugs’.

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The inefficiency of the judicial system to mete out quick justice is just as well a disincentive for an affected party from resorting to punitive or compensatory actions in criminal or civil jurisdictions, the way it was done in the US court by the State agency and a public spirited person. In yet another significant case, the European Commission on the pharmaceutical sector unearthed a new practice of brand-name firms entering into ‘pay-for-delay’ deals with generic companies not to deliver versions of their drugs, which usually cost a fraction of the original medicine, to market, although the issue is also complicated by patent ownership. The Eurpoean Commission is reported to have imposed exemplary penalties against several pharmaceutical companies including India’s Ranbaxy for entering into such deals.176 The Competition Act, 2002, voids anti-competition agreements but the penalty provided there under is no more than 10 per cent of the annual turnover and there are no significant instances where any meaningful investigation has been carried out to check malpractices indulged in by pharmaceutical companies and bring them to book.

APPENDIX 8.1 Section 3 of the Patents Act Section 3. What are not inventions The following are not inventions within the meaning of this Act— (a) an invention which is frivolous or which claims anything obviously contrary to well-established natural laws; (b) an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment; (c) the mere discovery of a scientific principle or the formulation of an abstract theory 2 [or discovery of any living thing or nonliving substance occurring in nature]; (d ) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

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(e)

(f)

( g) (h) (i)

( j)

(k) (l )

(m) (n) (o) (p)

Explanation—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; the mere arrangement or rearrangement or duplication of known devices each functioning independently of one another in a known way; [deleted] a method of agriculture or horticulture; any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products; plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; a mathematical or business method or a computer program per se or algorithms; a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions; a mere scheme or rule or method of performing mental act or method of playing game; a presentation of information; topography of integrated circuits; an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.

NOTES 1 Martin Fransman, ‘Biotechnology: Generation, Diffusion and Policy’, in Charles Cooper (ed.), Technology and Innovation in the International Economy (UNU Press: 1994), pp. 41, 42. 2 ‘Bioinformatics is the term coined for the new field that merges biology, computer science, and information technology to manage and analyze

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[biotechnological] data, with the ultimate goal of understanding and modeling living systems.’ US Dept of Energy Human Genome Program, Genomics and Its Impact on Medicine and Society: A 2001 Primer 3 (2001), available at http://www. ornl.gov/hgmis. Proteomics is ‘the study of protein expression and function.’ Transcriptomics involves large-scale analysis of messenger RNAs (molecules that are transcribed from active genes) to determine when, where, and under what conditions genes are expressed. The genome is an organism’s complete set of the DNA. The study of the genome or genomics may be structural or comparative.The former involves three-dimensional modeling of proteins to uncover clues to their functions and provide biological targets for drug design. Comparative genomics compares DNA sequence patterns of humans with well-studied model organisms to identify and interpret gene functions. 3 Nathan A. Adams, ‘Creating Clones, Kids & Chimera: Liberal Democratic Compromise at the Crossroads’, Nat'l Legal Center for Medically Dependent & Disabled, Inc. Issues in Law & Medicine, 2004. 4 447 US 303, 309–10 (1980). 5 569 U.S. (2013) decided on 13 June 2013. The media interest in this case incidentally was that a popular Hollywood actress underwent a total mastectomy after genetic counselling on the future prospect of her contacting breast cancer, arising out of a lab test that had a direct bearing to the patent claims of Myriad (a pharmaceutical company). The latter discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer. The average American woman has a 12 to 13 per cent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 per cent for breast cancer and between 20 and 50 per cent for ovarian cancer. Before Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in establishing a woman’s risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers. Myriad identified the exact location of the BRCA1 and BRCA2 genes on chromosomes 17 and 13. Chromosome 17 has approximately 80 million nucleotides, and chromosome 13 has approximately 114 million. Within those chromosomes, the BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. If just exons are counted, the BRCA1 is only about 5,500 nucleotides long; for the BRCA2 gene that was about 10,200. Knowledge of the location of the BRCA1 and BRCA2 genes allowed Myriad to determine their typical nucleotide sequence. That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer. Myriad’s patents would, if valid, have given it the exclusive right to isolate an individual’s

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BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome. The patents would have also given Myriad the exclusive right to synthetically create BRCA cDNA. In Myriad’s view, manipulating BRCA DNA in either of these fashions triggered its ‘right to exclude others from making’ its patented composition of matter under the Patent Act. 6 The court had to grapple with the fact that isolation was necessary to conduct genetic testing and Myriad was not the only entity to offer BRCA testing after it discovered the genes. The University of Pennsylvania’s Genetic Diagnostic Laboratory (GDL) and others provided genetic testing services to women. Petitioner Harry Ostrer, then a researcher at New York University School of Medicine, routinely sent his patients’ DNA samples to GDL for testing. After learning of GDL’s testing and Ostrer’s activities, Myriad sent letters to them asserting that the genetic testing infringed Myriad’s patents. In response, originally GDL had agreed to stop testing and informed Ostrer that it would no longer accept patient samples. Myriad also filed patent infringement suits against other entities that performed BRCA testing, resulting in settlements in which the defendants agreed to cease all allegedly infringing activity. Myriad, thus, solidified its position as the only entity providing BRCA testing. Explaining Chakrabarty, where scientists had added four plasmids to a bacterium, which enabled it to break down various components of crude oil, the Court found justification that the modified bacterium was patentable. It explained that the patent claim was ‘not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter—a product of human ingenuity having a distinctive name, character [and] use. The Chakrabarty bacterium was new “with markedly different characteristics from any found in nature”, due to the additional plasmids and resultant “capacity for degrading oil”. In this case, however, the Supreme Court held, ‘by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.’ 7 (2002) IPLR 255. 8 See Manual for Patent Practice and Procedure, Patent Office. 9 The Patents Act, Section 3(b). 10 Ibid., Section 3(p). 11 Wilmut et al.,‘Viable Offspring Derived from Fetal and Adult Mammalian Cells’, Nature 385 (1997): 810. 12 In February 2003, the Roslin Institute, where Dolly was cloned, announced the sheep’s death; Dolly suffered from progressive lung disease. 13 Somatic means, ‘affecting body as distinct from mind’, Encarta dictionary. A somatic cell is a body cell, as distinguished from a germ cell, (1) Cells of the

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body which in mammals and flowering plants normally are made up of two sets of chromosomes, one derived from each parent, (2) all cells of an organism with the exception of germ cells. 14 Human somatic cells normally contain 46 chromosomes: 22 pairs plus an additional pair composed of two X chromosomes (in the case of a female) or an X chromosome and a Y chromosome (in the case of a male). See ‘The President’s Council on Bioethics, Human Cloning and Human Dignity:An Ethical Inquiry’, (July 2002), p. 35, available at http://www.bioethics.gov/reports/cloningreport/ fullreport.html. Usually, fertilization in humans occurs when the egg cell fuses with a sperm cell, resulting in a zygote containing a nucleus with 46 chromosomes (half from the female progenitor and half from the male progenitor). 15 It is even argued that the quality of medical professionals is not sufficiently high to place on their shoulders the responsibility of this mammoth task to pilot people to the appropriate decision. See Albert E. Gunn,‘The Healing Profession Needs Healers:The Crisis in Medical Education’, Issues L. & Med. 15: 25, where he says, in the context of Dr Richard Seed’s attempt to garner support for cloning a human being, after the Dolly success story, ‘It was quite a leap from Dolly, the first cloned sheep. The reaction was immediate, and the news anchors analyzed the controversy with utmost seriousness. National Public Radio (NPR), with its trademark strained news-speak, was right on the case.The consensus seemed to be that it was a bad idea.The President was against it.The only question was, why? The arguments against cloning a human being seemed to boil down to: we’re not ready for this. And where were the physicians? Did any physician or medical professional society articulate a clear argument against the cloning of human beings? Dr Seed could not get any physicians to help him, but instead of a reasoned evaluation of what cloning involves and why it is incompatible with man’s nature, the medical profession’s reaction was the oft-used aphorism: ‘Be not the first to accept the new nor the last to reject the old.’ Since IVF has already created life in the test tube, the line between this and cloning was dim. No physician, nor, for that matter, any pundit or newscaster, could provide a cogent argument one way or the other.Technology was seen as moving too fast, but the medical profession was in the high grass on the specifics. 16 Andrea L. Bonnicksen, ‘Creating a Clone in Ninety Days: In Search of a Cloning Policy’, Jurimetrics J. 38 (1997): 23, 24. 17 ‘Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Commission: Executive Summary’, Jurimetrics J. 38 (1997): 3, 6. 18 An ES is a formative cell capable of giving rise to all other kinds of cells and ES cells are derived from the inner cell mass of a blastocyst embryo. James A. Thomson, et al., ‘Embryonic Stem Cell Lines Derived from Human Blastocysts’, Science 282 (1998): 1145–7; Proceedings of the National Academy of Sciences USA 95 (1998): 13726–31.

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19 R. Alta Charo and Laurie Zoloth, ‘Commentary; Stem Cell Research: Issue for Women’, L.A.Times, 12 August 2002, p. B11. 20 Charles Krauthammer, who served on President George W. Bush’s Council on Bioethics, opposed reproductive cloning on the ground that cloning threatens ‘dehumanization of human life.’ 21 Nathan A. Adams, IV, ‘Creating Clones, Kids & Chimera: Liberal Democratic Compromise at the Crossroads’, Issues in Law & Medicine (2004). 22 Case C-34/10 dt 18.10.2011, available at www.curia.europa.eu (last accessed on 20.11.2011). 23 Precursor cells are immature corporeal cells that are still capable of multiplying. They develop and change into particular mature corporeal cells. Neutral precursor cells are defined as immature cells which can form that cells in the nervous system, as for example, neurons. 24 Article 6(2)(c) of Directive 98/44/EC. 25 International Business Times, 18 October 2011. 26 EG cells are cells that are derived from precursors of germ cells from a foetus. 27 (US) National Bioethics Advisory Commission’s report. 28 The story is narrated by Carol Marin in ‘60 Minutes II, Holy Grail’ in the book, The Stem Cell Controversy, Debating the Issues, 2nd edition (Prometheus Books, 2006). 29 (2005) 2 All ER 555, on appeal against the decision in R (on the application of Quintavalle) v. Human Fertilization and Embryology Authority [2003] EWCA Civ 667, [2004] QB 168, [2003] 3 All ER 257, [2003] 3 WLR 878, [2003] 2 FLR 335, [2003] 2 FCR 193, 73 BMLR 116. 30 The Human Fertilisation and Embryology Act, 1990 (UK), regulated the creation and use of human embryos outside the body, prohibited absolutely certain practices in connection with embryos and established the Human Fertilisation and Embryology Authority, which was empowered to grant licences to authorize certain otherwise prohibited activities. 31 George Annas, Arthur Caplan, and Sherman Elias,‘The Politics of Human Embryo Research—Avoiding Ethical Gridlock’, New England Journal of Medicine 334 (1996): 1331. 32 ‘Ethics and Policy in Embryonic Stem Cell Research’, The Stem Cell Controversy. 33 No. E-14496, 1989 WL 140495 (Tenn. Cir. Ct. Sept. 21, 1989), rev’d, No. 180, 1990 WL 130807 (Tenn. Ct. App. Sept. 13, 1990), aff ’d,842 S.W.2d 588 (Tenn. 1992), reh’g in part No. 34, 1992 WL 341632 (Tenn. Nov. 23, 1992) (mem.). 34 In the US, an increasing number of states have dealt with the issue of prenatal alcohol and other drug abuse by mandating that substance-affected infants be reported at the time of birth. Some states specifically mention

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prenatal drug exposure in their statutes defining child abuse and neglect. However, these states often limit the definition of ‘drug exposure’ to illegal substances. Although prenatal exposure to alcohol is a leading cause of mental retardation, only four states currently require that foetal alcohol syndrome (FAS) be reported.The condition of the infant that triggers mandatory reporting laws varies from state to state. Some states require only a positive toxicology screen at birth. Others require physical signs of addiction or dependence. Still others require reporting of drug- and alcohol-affected infants based on a more general assessment of the newborn’s imminent risk of harm or need for protection. Child Welfare Information Gateway, www.childwelfare.gov (last visited 2 January 2011). 35 The Madurai Bench of the Madras High Court said in S.Sethu Raja v. Chief Secretary, Government of Tamil Nadu (2007) 5 MLJ 404, (2007)2 MLJ 739(Crl) in the context of a claim by the father of a deceased boy whose body had been kept in a mortuary for nearly seven months in Malaysia. It took note of the fact that the petitioner did not even see the body of his son and that if the petitioner was financially sound, he could have gone to Malaysia and brought it to India for the funeral rites. But he was an agricultural coolie, with four sons and a daughter, including the dead son. Therefore, as a welfare state, the government was held to owe a duty to arrange for the body to be brought to India. 36 Pierce v. Proprietors of Swan Point Cemetery, 10 R.I. 227, 235–6 (1872). 37 For instance, the Madras City Municipal Corporation Act, 1919, makes provisions through Sections 318 to 326 for disposal of the dead. There are, however, no provisions for retention or storage of dead bodies or organs in dead bodies. In the absence of a statutory provision, there may not be even a claim for damages for costs incurred in removing the bodies. This could be seen as an issue of public policy, as laid down in a county case in the state of Georgia, where the county sought to recover the expenses it incurred in recovering, identifying, and properly disposing of bodies found at the crematorium. The court held that the tort claims were barred by the free public services doctrine, under which a county, absent specific statutory authorization or damage to government-owned property, could not recover the costs of carrying out public services from a tortfeasor whose conduct caused the need for the services. See Walker County v. Tri-State Crematory et al., 284 Ga. App. 34; 643 S.E.2d 324; 2007 Ga. App. LEXIS 249; 2007 Fulton County D. Rep. 733. 38 ‘Unclaimed body’ means the body of a person who dies in a hospital, prison, or public place that has not been claimed by any near relatives within such time as may be prescribed. The rules framed under the act of the various states provide for the period as falling between 24 and 72 hours.

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39 Rules framed under the various state enactments invariably provide for mode of preservation. It is a matter of cultural practice across the globe to treat even a dead body in a state of dignity. In a case where a Research Institute did not take adequate care of the body and did not put it to research or therapeutic use, it was held in Court of Appeal of Louisiana, Fourth Circuit 2006-1515 (La.App. 4 Cir. 09/05/07); 966 So. 2d 1069; 2007 La. App. LEXIS 17715 September 2007, that a class action for unjust enrichment, negligent misrepresentation, fraud, breach of contract, and unauthorized mutilation of dead bodies was maintainable. 40 [2004] EWHC 644 (QB), [2005] QB 506. 41 [1931] 1 DLR 676. 42 (1900) 2 F 354. 43 1913 SC 394. 44 Frances Kelly v. Brigham & Women’s Hospital & Others 51 Mass. App. Ct. 297; 745 NE2d 969; 2001 Mass. App. LEXIS 24. 45 See Chapter 9 for issues relating to commercial transaction of human organs of a live individual as well as an enquiry whether semen extracted from a dead body could be a ‘human organ’. 46 In Madhu Vijayan and Another v. S.G. Ravishankar Manu/DE/0945/2006, the dispute was for custody of the ashes between the wife and son of the deceased O.V. Vijayan (a renowned author and storyteller) on the one hand and his nephew, who had performed the obsequies, on the other. The court said there was no property in the ashes but resolved the controversy between parties by allowing the legal heirs to offer prayers with the ashes kept in the custody of the nephew, and that the ashes could be jointly immersed at Haridwar by both the litigating parties, a ceremony that was completed nearly a year after the death. 47 (1998) 3 All ER 741. 48 This case threw an interesting sidelight in Attorney-General v. Guardian Newspapers Ltd (QB) [1999] EMLR 904, CO/4505/98, Independent (23 July 1999),when the Observer was proceeded against for contempt for interfering with course of justice by reporting on the case with a view that the accused Kelly was an artist and was making moulds with organs from dead bodies for exhibition. The bench ruled against the motion for prosecution, upholding the right of freedom of speech and holding that the jury that was called upon to find whether Kelly had been dishonest could not have been influenced by the article in the newspaper. It reasoned (per Sedley LJ, one of the opinions), ‘it is simply not possible to be sure that the risk created by the publication was a substantial risk that a jury, properly directed to disregard its own sentiments and any media comment, would nevertheless have its own thoughts or value judgments reinforced by the article to a point where they influenced the verdict. As a first cross-check, I doubt whether an appeal would have been

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allowed had the jury which convicted Mr Kelly read the article. As a second cross-check, it seems to me that the threat from this article, published when it was, to the course of justice in Mr Kelly’s trial was not sufficient to make either prior restraint or subsequent punishment a proportionate response in a society which, as a democracy, values and protects the freedom of the press.’ 49 [2004] EWHC 644 (QB), [2005] QB 506. 50 O’Donnell v. Slack 55 P.906 (Cal. 1899); Brotherton v. Cleveland 923 F.3d.477 (6th Cir 1991); Florida v. Powell 497 So.2d.1188 (Fla.1986); Whaley v. Tuscola 58 F.3d.1111 (6th Cir 1995). 51 Cal. Gov’t Code § 27491.47(b). 52 287 F3d 786; 2002 US App. LEXIS 6881; 2002 Cal. Daily Op. Service 3221; 2002. 53 The Washington University v. William J. Catalona at the United States District Court for the Eastern District of Missouri, Eastern Division, 437 F. Supp. 2d 985; 2006 US Dist. LEXIS 22969. 54 793 P.2d 479 (Cal.1990). 55 1997 WL 430619 (Conn. Super 21.7.1997). 56 20 Cal. Rptr 2d 275 (Ct App 1993). 57 (2009) 2 All ER 986. 58 Depending on the drug and the endpoints studied, pharmacodynamic studies and studies relating to drug blood levels. 59 i.e., characterization of a drug’s absorption, distribution, metabolism and excretion. Although these studies continue throughout the development plan, they should be performed to support formulation development and determine pharmacokinetic parameters in different age groups to support dosing recommendations. 60 A legally acceptable representative is a person who is able to give consent for or authorize an intervention in the patient as provided by the laws of India. 61 To an unstarred question no. 3028 which was to be answered on 20 December 2011, the Union Minister of Health admitted to several instances of mishaps in the experiments conducted without adequate licence in the States of Andhra Pradesh, Gujarat, and MP. 62 See Frontline, 13 July 2012 issue under the cover story, ‘The Toxic Nexus’. The article details several formulations like Nimesulide, phenformin, analgin, etc which have been banned in many foreign countries are marketed in India, by two factors: (i) Ban is enforced in India belatedly and (ii) that too, as a result of media outcry or court orders than at the initiatve of CDSO. 63 See Drugs and Cosmetics Rules, 1945, Schedule Y, Para 2. 64 See Chapter 2. 65 When Cleopatra’s handmaids were sentenced to death under government order, she was believed to have subjected them to insemination and subsequent operations. Upon opening their wombs, Cleopatra was said to have

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discovered that the male embryos were fully fashioned on the forty-first day after conception, and the female embryos were fully fashioned on the eightyfirst day. See http://www.judentum.org/talmud/traktate/niddah/niddah_30. html (last visited 3 January 2011). 66 Pregnant or nursing women should be included in clinical trials only when the drug is intended for use by pregnant and nursing women or foetuses and nursing infants, and the data generated from women who are not pregnant or nursing is not suitable. For new drugs intended for use during pregnancy, follow-up data (pertaining to a period appropriate for that drug) on the pregnancy, foetus, and child will be required. Where applicable, excretion of the drug or its metabolites into human milk should be examined and the infant should be monitored for predicted pharmacological effects of the drug. See Drugs and Cosmetics Rules, Schedule Y. 67 The bone grafting and nerve experiments were possibly the most savage, sadistic, and inhumane experiments during the Second World War. The experiments involved the regeneration of bones, muscles, and nerves, and the transplantation of bone. In order to carry out these goals, sections of bone were removed from the subjects, legs were removed at the hips, shoulders and arms were removed, and muscles and nerves were removed from healthy patients. These parts were then transferred to other victims in order to see if they could regenerate or transplant successfully. Most of these experiments resulted in death or permanent mutilations. These experiments took place at Ravensbrueck (a Nazi concentration camp) and were carried out by Herta Oberhauser. See ‘Evolution of Medical Ethics‘, https://owlspace-ccm.rice. edu/access/content/user/ecy1/Nazi%20Human%20Experimentation/ Pages/Bone%20Grafting.html (last visited 3 January 2011). 68 See ‘The Nuremberg Code’, in G.J. Annas and M.A. Grodin (eds), The Nazi Doctor and the Nuremberg Code: Human Rights in Human Experimentation (New York: Oxford University Press, 1992), p. 2. There have, however, been very few court decisions involving human experimentation. It is therefore very difficult for a common law human experimentation to develop. This absence of judicial precedent makes codes, especially judicially-crafted ones like the Nuremberg Code, all the more important. See Ericka Grimes v. Kennedy Krieger Institute, Inc. Myron Higgins, a Minor, etc., et al. v. Kennedy Krieger Institute, Inc 366 Md. 29; 782 A.2d 807; 2001 Md. LEXIS 496. 69 See World Medical Assembly, ‘World Medical Association Declaration of Helsinki,’ in Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993), pp. 47–50 (citing the 1989 Declaration of Helsinki). 70 See Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993) (hereinafter CIOMS Guidelines).

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71 Mary Terrell White on ‘Guidelines for IRB Review of International Collaborative Medical Research: A Proposal’ in J.L. Med. & Ethics 27: 87. 72 277 US 438, 479, 72 LEd 944, 48 S. Ct. 564 (1928). 73 Ericka Grimes v. Kennedy Krieger Institute, Inc. Myron Higgins, a Minor, etc., et al. v. Kennedy Krieger Institute, Inc 366 Md. 29; 782 A.2d 807; 2001 Md. LEXIS 496. These two cases concerned negligence actions involving children who allegedly developed elevated levels of lead dust in their blood while participating in a research study with Kennedy Krieger Institute. In both cases, the petitioners appealed from a ruling of the Circuit Court for Baltimore City granting Kennedy Krieger Institute’s motions for summary judgment. The Court of Appeals held that in Maryland a parent, appropriate relative, or other applicable surrogate could not consent to the participation of a child or other person under legal disability in non-therapeutic research or other studies in which there is any risk of injury or damage to the health of the subject. The court further held that informed consent agreements in non-therapeutic research projects under certain circumstances could constitute contracts, and that, under certain circumstances, such research relationships could, as a matter of law, constitute ‘special relationships’ giving rise to duties, out of the breach of which negligence actions might arise. The court also held that, normally, such special relationships were created between researchers and the human subjects used by the researchers, and that governmental regulations could create duties on the part of researchers towards human subjects out of which ‘special relationships’ could arise. 74 See Jennifer Rosato’s symposium article, ‘The Ethics of Clinical Trials: A Child’s View’, J.L. Med & Ethics 28: 362. 75 Full text available at www.icmr.nic.in. 76 However, payments should not be so large or the medical services so extensive as to make prospective participants consent readily to enrol in research against their better judgment, which would then be treated as undue inducement. On the other hand, research participants who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. In case of death, their dependents are entitled to material compensation. See ‘duty to compensate for damages for injury or death’ for further commentaries. 77 See Chapter 2. 78 271 Cal. Rptr. 146 (Cal 1990). 79 A hollow ball of 50-100 cells reached after about five days of embryonic development. It consists of a sphere made up of an outer layer of cells (the trophoectoderm), a fluid-filled cavity (the blastocoel), and a cluster of cells in the interior (the inner cell mass). 80 Somatic cell nuclear transfer: the transfer of a cell nucleus to an egg (or another cell) from which the nucleus has been removed.

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81 A form of reproduction in which an unfertilized egg develops into a new individual, occurring commonly among insects and certain other arthropods. 82 The development of an embryo that contains only paternal chromosomes because the egg has been activated by sperm without fusion of the egg and sperm nuclei. 83 A Madhya Pradesh-based ‘Swasthya Adhikar Manch’ has filed a PIL in the Supreme Court pointing out to several unethical practices indulged in by several pharmaceutical companies and seeking for a restraint against continuation of clinical trials. The case stands at the stage of notice to the Union Government and others, The Hindu, 6 February 2012. 84 The Patents Act, 1970, Section 2(1)(j), as amended by the Act of 2002. See also M/s Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries station AIR (1982) SC 1444. 85 See Appendix 8.1. 86 Inventions relating to atomic energy are not patentable. 87 Article 27 of the Trips Agreement itself allows for member countries to exclude patentability of inventions to protect their applications for healthcare of human, animal, and plant life. Section 3(d) of the Patent Act may be viewed as an exception contemplated under this article. 88 Robin Herman, ‘The Great Gene Gold Rush: US Rankles Other Countries with Preemptive Strike in the Race to Patent Human Genes’, Wash. Post (16 June 1992), (Health): 11, 16 (quoting Bernadine Healy, MD, former Director, National Institutes of Health, Public Health Service, Dept of Health and Human Services). 89 Halsbury’s Laws of India,Volume 20(2),‘Intellectual Property’, paras 185, 1428. 90 Bishwanth Prasad Radhey Shyam, v. Hindustan Metal Industries AIR (1982) SC 1444, (1983) IPLR 1, PTC Supp (1) 731 (SC). 91 Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co Ltd (2002) 535 U.S (2002) P1. 92 Thomas Brandt v. Controller of Patents, AIR (1989) Del 249, (1990) IPLR 37, PTC Supp (2) 192. 93 The Patents Act, Section 10. 94 Imperial Chemical Industries Ltd v. Controller of Patents and Designs, AIR (1978) Cal 77, cf Halsbury’s Laws of India,Vol 20(2) Patents para 185.1511. 95 Ram Narain v. Abassador Industries, AIR (1976) Del 87. 96 Thomas Brandt v. Controller of Patents AIR (1989) Del 249. 97 The provisions of the Patents Act are subject to several exceptions and address several situations, all of which are not reproduced here. 98 Bristol-Myers Co v. Beecham Group Ltd [1974] AC 646, [1974] 1 All ER 333. 99 The Patents Act, 1970, Section 53. 100 Ibid., Section 46(1).

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101 See the Patents Act, 1970, Section 64 on revocation of patents. 102 F. Hoffmann-LA Roche Ltd and Another v. Cipla Ltd,159 (2009) DLT 243, MIPR (2009) (2) 1, (2009) (40) PTC 125 (Del). 103 Patents Act 1970, Section 104. 104 Re GEC Application (1943) 60 RPC 1. 105 See Section 3(i), Patent Act. 106 Welcome Foundations Ltd (Hutching’s) Application (1980) RPC (NZ SC). 107 Maeder v. Ronda Ladies Hairdressing Salon (1943) NZLR 123. 108 Patents Act, 1970, Section 3(i). 109 Joos v. Commissioner of Patents ((1972) 126 CLR 611. 110 Welcome Foundations Ltd (Hutching’s) Application (1980) RPC (NZ SC). 111 Upjohn Co (Robert’s) Application (1977) RPC 94, (1976) FSR 87(CA). 112 1995 US Dist LEXIS 20824, at **8, 36 U.S.P.Q.2d 1050 (D.Vt. 1995). 113 This statute is more commonly known as the Physicians’ Immunity Statute. 114 For arguments in favour of medical procedure patenting see Joel J. Garris,‘The Case for Patenting Medical Procedures’, Am. JL & Med. 22: 85, 86. 115 Patents (Amendment) Act, 2005, Section 2(1)(ta). The former definitions made for a medicine or drug have been omitted as not exhaustive. The definition of ‘drug’ under the Drugs and Cosmetics Act, 1940, still subsists. 116 See Judy Foreman, ‘Treating Impotence Getting Easier’, Boston Globe (20 April 1998): C1. 117 The challenge to constitutional validity of this provision made in Novartis AG v. Union of India 2004(3) CTC95 was rejected by the Division Bench of the Madras High Court. 118 Also called as selection patents, they represent a problematic area of patent law which claim particular compounds to be individually new, but as falling within an earlier disclosure of broader group of compounds for which protection is already claimed. See Feroz Ali Khader, The Law of Patents: With a Special Focus on Pharmaceuticals in India (Delhi: LexisNexis, 2007) for a fuller treatment of the subject. 119 This type of discovery is called a Swiss Claim. 120 Novartis AG v. Union of India and Ors MANU/TN/1263/2007: (2007) 4 MLJ 1153. 121 Glochem Industries Ltd. represented by its Power of Attorney Holder v. Cadila Healthcare Ltd and Others,AIR (2010) Bom 76, (2010) (2) Bom CR 143, (2010) (112) Bom LR 269, MIPR (2010) (1)13. 122 That is, leading compound and not metal lead. 123 Feroz Ali Khader, The Law of Patents—With a Special Focus on Pharmaceuticals in India, Lexis Nexis (2007): 81. See Ivax Pharmaceuticals UK Limited v. Akzo Nobel NV [2006] EWHC 1089 for the enumeration of the factors that influence the bioavailability of a drug.

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124 Patents Act, 1970, Section 47(d). 125 Patents Act, 1970, Section 48. 126 Bayer Corporation and Ors v. Cipla, Union of India (UOI ) and Ors162 (2009) DLT 371, (2009) (41) PTC 634 (Del). 127 MIPR 2010 (1) 242, 2010 (43) PTC 12 (Del). 128 Cadila Pharamaceuticals Ltd v. Instacare Lab Pvt Ltd, (2001) PTC 472 (Guj). 129 Gandhimathi Appliances Ltd, Kelambakkam, Kancheepuram District v. LG Varadaraju,(2000) 3 MLJ 85. 130 See Patents Act 1970, Section 111. 131 The ‘mail box’ system is a TRIPs-imposed obligation on developing countries that wished to benefit from the TRIPs transitional period by delaying granting of patents for pharmaceutical products until 2005. In exchange for not granting patents, these countries had to establish a ‘mail box’ system for receiving and filing patent applications from the beginning of the transitional period in 1995. 132 India granted only a few EMRs for pharmaceuticals and agrochemicals during the transition period. Under this scheme, the following companies got marketing approval: Novartis AG for anti-blood cancer medicine, Glivec/ Gleevec (beta crystalline form of imatinib mesylate); Eli Lilly & Company, USA, for erectile dysfunction medicine, Cialis (Tadalafil); Wockhardt for Nadifloxacin under the brand name NADOXIN; United Phosphorus for fungicide saaf, a combination of carbendazim and mancozeb. 133 The case was fought in courts at two levels: first, at the Madras High Court, the court titled Novartis AG represented by its Power of Attorney Ranjna Mehta Dutt v. Union of India (UOI ) through the Secretary, Department of Industry, Ministry of Industry and Commerce and Ors., (2007) 4 MLJ 1153 that dealt with the constitutionality of section 3(d) of the Patents Act and second, at the Supreme Court that entertained a challenge to the rejection of patent by the Patent Office to the product Gleevec as affirmed by the Appellate Board, in Novartis AG v.Union of India in Civil Appeal No 2706-2716 of 2013 decided on 1 April 2013. 134 Called the Zimmermann patent, Jürg Zimmermann invented a number of derivatives of N-phenyl-2-pyrimidine-amine, one of which is CGP 57148[1] in free base form (later given the International Nonproprietary Name ‘Imatinib’ by the WHO).These derivatives, including Imatinib are capable of inhibiting certain protein kinases, especially protein kinase C and PDGF (platelet-derived growth factor)-receptor tyrosine kinase and thus have valuable anti-tumour properties and can be used in the preparation of pharmaceutical compositions for the treatment of warm-blooded animals, for example, as anti-tumoral drugs and as drugs against atherosclerosis. The N-phenyl-2pyrimidine-amine derivatives, including Imatinib, were submitted for patent in the US.The application was made on April 28, 1994 and patent was granted

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on May 28, 1996 under US Patent No. 5, 521, 184 (hereinafter referred to as ‘the Zimmermann Patent’).The Zimmermann compounds (i.e., derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under Patent No. EP-A-0 564 409. Since this patent had been granted before the product patent regime, it was not protected in India. 135 Patents Act, 1970, Section 84 (1). 136 Patents Act, 1970, Section 89. 137 The Times of India, 13 March 2012. 138 Natco has also applied for CL for Pfizer’s product Maraviroc, patented in India on 28 March 2007 under Indian Patent no. 204132 (885/MUM/1999; Cipla has applied for CL for Merck’s product Raltegravir patented in India on 15 February 2008 under Indian Patent no. 21`2400. See patentdaily.wordpress. com (last visited 11 April 2012). 139 Roche, the world’s biggest maker of cancer drugs, said it would offer ‘significantly’ cheaper, locally branded versions of its two cancer drugs, Herceptin and MabThera, by early next year (2013), under an alliance with India’s Emcure Pharmaceuticals Ltd, Livemint.com & Wall Street Jounal, 23 March 2012, (last visited 24 March 2012). 140 The regulation relating to tobacco trade and particularly the restrictive use of tobacco products find their justification only as an issue of public health, with positive proof coming through medical research that smoking is injurious to health. 141 Siddhartha Mukherjee, Emperor of All Maladies (Harper Collins Publication: London, 2011). Camels is a cigarette brand name. 142 A medical student at New York. 143 A US surgeon at St. Louis. 144 Their study was published in the Journal of the American Medical Association 143, 329 (1950). See also, Mukherjee, Emperor of All Maladies(2011), p. 246. 145 ‘Smoking and Carcinoma of the Lung: A Preliminary Report,’ British Medical Journal, Emperor of All Maladies by Siddhartha Mukherjee, Harper Collins Publication: London, 2011, p. 246. 146 ‘History of Central Excise Chennai’, http://centralexcisechennai.gov. in/historynew.htm (visited on 23 November 2011). 147 Excise duty on tobacco is contained in entry 84 in Union List under the Indian Constitution. 148 Nixon v. Philip Morris (Australia) Limited [1999] FGA 1107. 149 Tobacco Products Litigation Reporter, 1996, 1.1.3.160-3.174. Cf ‘Tobacco Litigation Worldwide’, BMJ 320 (8 January 2000), www.bmj.com (last visited 23 November 2011). 150 See ‘Tobacco Litigation Worldwide’. 151 Broin v. Philip Morris Companies Inc, aff’d Ramos v. Philip Morries Companies Inc. 1999 Fla App LEXIS 3422.

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152 Helling v. McKinney 509 US 25 (1993). 153 50–58Gainsborough Realty Trust v. Haile (Massachusetts Housing Court, Boston Division 1998), Tobacco Products Litigation Reporter 1998; 13:2.302– 2.312. 154 Meeuwissen v. Hilton Hotels of Australia Ltd, Human Rights and Equal Opportunity Commission, H97/51, 25 September 1997. 155 See ‘Tobacco Litigation Worldwide’. 156 Section 3, The Cigarettes (Regulation of Production, Supply and Distribution) Act, 1975 (49 of 1975). 157 Section 4, ibid. 158 K.Ramakrishnan and Another v. Sate of Kerala and Others AIR (1999) Ker 385, ILR (1999) 3 Ker 383. 159 Murli S. Deora v. Union of India (2001) 8 SCC 765. 160 The expressions as used by the Supreme Court in the judgment. 161 Rajasthan was perhaps the first state to ban smoking in public places through The Rajasthan Prohibition of Smoking and Non-Smokers’ Health Protection Act, 1999. The Gujarat High Court in a suo motu action against the Ahmedabad Municipal Administration (see (2006) 2 GLR 1129) warned the Civic authorities of contempt action if strict enforcement of the act regarding the ban of smoking in public places was not made. 162 Aviansh v. Union of India (2008) (4) MPHT 482, (2008) (4) MPLJ 49. 163 Society for Cancer in Oral-Cavity Prevention through Education, Hyderabad v. Union of India (UOI ) and Ors, AIR (2003) AP 168, (2002) (3) ALD 525, (2002) (3) ALT 579. 164 The constitutional vires was challenged in the Delhi High Court in Mahesh Bhat and Kasturi and Sons v. Union of India, (2008) BLR 366, 147(2008) DLT 561 on the ground that health was a state subject and the centre could not legislate. It was also contended that the provisions in the act that prohibited indirect advertisement of tobacco products amounted to unreasonable restriction of freedom of speech. But the court rejected both contentions. The power to legislate was traced to Entry 52 of the Union list dealing with regulation of industry, which included the tobacco industry as well. Dealing with the second objection, it held, inter alia, that a commercial advertisement has an element of trade and commerce, and did not fall strictly within the concept of freedom of speech, for it is not for propagation of ideas’ social, political, economic or furtherance of literature or human thought. It reasoned that protection under Article 19(1)(a) is limited and subject to the public interest test. 165 ‘Public place’ as defined in 2003 Act means any place to which the public have access, whether as of right or not, and includes auditorium, hospital buildings, railway waiting room, amusement centres, restaurants, public offices,

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court buildings, educational institutions, libraries, and public conveyances, which are visited by general public, but does not include any open space. 166 GSR-443(E) dt. 30 April 1992. 167 (1997) (2)JLJ83(SC), JT1997(5)SC39, (1997) (3)SCALE681, (1997)4SCC 739, [1997]3SCR861. 168 Notification dated 23 July 2002 issued by the Commissioner, Food and Drug Administration and Food (Health) Authority for the State of Maharashtra. 169 (2005) (1)ACR525(SC), AIR (2004) SC4057, (2004) (5)ALLMR(SC) 970, (2005) (1)BomCR194, JT (2004)(6)SC179, (2004)4MLJ67(SC), (2004) (6)SCALE388, (2004)7SCC68, [2004] Supp. (3) SCR 239, (2004) (2)UC1148, (2004) (2)UJ1449(SC). 170 The Supreme Court noted the following enactments that merely regulated usage of tobacco but did not ban it: The Industries (Development and Regulations) Act, 1951, merely imposed licensing regulation on tobacco products under item 38(1) of the First Schedule. The Central Sales Tax Act, 1956 in Section 14(ix) prescribes the rates for Central Sales Tax. Additional Duties of Excise (Goods of Special Importance) Act, 1957, prescribes the additional duty leviable on tobacco products. The Tobacco Board Act, 1975, established a Tobacco Board for development of tobacco industries in the country. Even the Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003, does not ban the sale of tobacco products listed in the Schedule except to minors. The tariff schedule of the Central Sales Tax Act has several entries that deal with tobacco and pan masala. 171 (2010) (10)UJ5316(SC). 172 From ‘Clear Answers from Common Questions’, Wisegeek, Copyright © 2003 - 2011 Conjecture Corporation (last visited 5 May 2012). 173 Academy of Nutrition Improvement and Ors v. Union of India JT (2011) (8) SC16, (2011) (3) KLTSN 45 , (2011)8SCC274. 174 Donald G. Jr McNeil, ‘In Raising the World’s I.Q., the Secret’s in the Salt’, New York Times, 4.12.2008, en.wikipedia.org/wiki/Iodised_salt. 175 The criminal case is U.S. v. Ranbaxy USA, 13-cr-00238, U.S. District Court, Maryland (Baltimore). The civil case is Thakur v. Ranbaxy U.S.A. Inc., 07-cv-00962, US district court, Maryland (Baltimore), report sourced to Bloomberg Business week, http://www.businessweek.com, dated 13.5.2013 (last visited 22 June 2013). 176 The Times of India, 20 June 2013, accessed from http://toi.in/6e6b5b.

9

Organ Transplant

Organ transplantation is a significant signpost that registers the advancement of medical care and reflects the constant endeavour in medical research to prolong life and improve its quality. It refers to the use of the organs of a living or dead person for the benefit of a person whose life has to be saved, or to remove a serious disability, such as corneal replacement. When a person could be treated as dead, when he or she could be a donor, who shall give consent for such donation, how to prevent trafficking in organs—these are the questions that arise within this area. In cases where the organ could be removed only after the lifetime of the donor, it is customary to ask the permission of the relatives, but, because organ removal must take place immediately after death, it may be impossible to reach the relatives in time. It has been suggested that there should be a widespread campaign to encourage persons to provide in their wills that their organs be used for transplantation. An alternative is to provide by law that permission is assumed unless removal has been forbidden by the individual in his lifetime. Such laws have been passed in Denmark, France, Sweden, Austria, and Israel. Compulsory post-mortem examination, a far more extensive procedure than organ removal for grafting, is required in most countries after unexpected death.There would seem to be no reason why organ removal for transplantation purposes should not also be acceptable to public opinion, provided there is a mechanism by which individuals in their lifetime can refuse this permission. This, of course, requires an efficient register of those who indicate their refusal; the register would be consulted before any organs would be removed. It is important that the public is adequately reassured that normal resuscitative efforts will Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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not be compromised only in order to secure the chances of harvesting an organ for transplant from the potential donor.1 The first successful transplantation of a kidney in 1954 led to an expansion of the rights of next of kin to the bodies of the dead. In 1968, the National Conference of Commissioners on Uniform State Laws approved the Uniform Anatomical Gift Act (UAGA), adopted by California the same year,2 which grants next of kin the right to transfer the body parts in their possession to others for medical or research purposes. The right to transfer is limited. The California UAGA prohibits any person from ‘knowingly, for valuable consideration, purchasing or selling a part for transplantation, therapy, or reconditioning, if removal of the part is intended to occur after the death of the decedent’,3 as does federal law (prohibiting the ‘transfer [of] any human organ for valuable consideration’).4 In the 1970s and 1980s, advancements in medical science and the related demand for transplant organs prompted governments across the world to search for new ways to increase the supply of organs for donation. Many perceived this as a hindrance to the supply of needed organs, the rule implicit in the UAGA being that donations could be effected only if consent was received from the descendent or next of kin. The majority of states in the USA adhere to the original version of the UAGA, which requires consent from the donee or next of kin for any transfer of organs. In India, eye donations are by and large voluntary. Kidney transplants kick up a lot of controversies as it is widely believed that the donors who are not relatives of the recipients are invariably indigent and illiterate, and much of the trafficking in organs is by exploiting the gullible. The enactment of a special legislation, with special committees to sanction approval of transplants and licensing of hospitals that could perform transplants, has done little to improve this murky side of medical practice. TRANSPLANTATION OF HUMAN ORGANS ACT,

1994

Some Important Definitions The Transplantation of Human Organs Act 42 of 1994 was passed by the Indian Parliament5 on 8 July 1994 to provide for the regulation of the removal, storage, and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in

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human organs. ‘Human organ’ means any part of a human body consisting of a structured arrangement of tissues that, if wholly removed, cannot be replicated by the body.6 The act contains important provisions determining who could be a competent donor, restricting the definition of one to a person who is not less than 18 years of age and who voluntarily authorizes the removal of any of their human organs for therapeutic purposes.7 ‘Therapeutic purpose’ is defined as the systematic treatment of any disease or the measures to improve health according to any particular method or modality.8 A deceased person means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardiopulmonary sense, at any time after live birth has taken place.9 The act also contains important definitions, such as what constitutes brain-stem death,10 a hospital11 and a human organ12 and a near relative13 who shall be involved in the decision of organ removal after the death of the donor.

is semen a human organ fit for ‘transplant’ after death? In so far the definition under Section 2(h) restricts the definition of human organ as a part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body, semen cannot be regarded as an organ. It is more a product of an organ than a human organ itself. In the UK the Human Tissue Act, which makes provisions for transplants of organs and other uses of organs as well as tissues taken from bodies both living and dead, excludes from the legislative framework gamates because they fall within Human Fertilization and Embryology Act, 1990. The latter act provides for licensing of hospitals and research institutes that can freeze and store them for possible future uses, including reproduction techniques. In India, there is no provision for donation of semen after death or to treat it as the property of a person to make a bequest.

brain-stem death Section 2(c) defines brain stem death as the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under Subsection (6) of Section 3. The loss of cardiopulmonary function as a determination of death is a concept

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inherently simpler to understand and accepted by the relatives as against brain-stem death or brain death.14 This definition is critical for making an informed decision about organ transplantation.15 The determinant of brain-stem death essentially follows the UK criteria for death as against the US criteria, where as per the Uniform Determination of Death Act irreversible cessation of the entire brain and brainstem function need to be documented that is brain death and not brain-stem death. A panel of four doctors who shall certify brain-stem death shall each perform the four tests: namely pupillary reflex, doll’s head eye movement, corneal reflex (both sides), gag reflex, cough (tracheal), eye movements on caloric testing bilaterally, absence of motor response in any cranial nerve distribution and apnoea test. Reversible causes of coma should be excluded by all possible means, namely the absence of any intoxication, depressant drugs, and neuromuscular blocking agents. Primary hypothermia, hypovolaemic shock and metabolic and endocrine disorders should also be sought for and excluded. An EEG is not mandatory, nor are other confirmatory tests like cerebral angiography, transcranial Doppler and radionuclide scan. So it is theoretically possible that a patient may be certified ‘dead’, even though the EEG may be documenting some cortical activity, because in India we are documenting brain-stem death and not whole brain death.16

declaration of time of death The declaration of death through the determinant brain-stem death raises two interesting questions, according to N.K. Sethi and P.K. Sethi.17 First, if the relatives refuse the donation of organs in a brainstem-dead certified patient, can the life support systems be disconnected and switched off ?18 Second, if the relatives request more time to decide about organ donation during which the cardiopulmonary function of the deceased patient ceases, what time does one record as the time of death? Can one die more than once (when one’s brain dies, and again later when one’s heart stops). Unfortunately, the Transplantation of Human Organs Act, 1994, does not clearly give any answers to the above two questions. However, the UK criterion (on which the Transplantation of Human Organs Act of 1994 is based) provides an answer to the above difficult question: ‘the medical officer

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will usually speak to the relatives and announce the death. The time of death is recorded as the time when the final test to fulfill the criteria for brain-stem death was satisfied’.19

Mode of Signifying Consent for Donation Donation of any organ of a person shall be only for therapeutic purposes.20 It should have been either expressly authorized by a person during his life or by a person authorized to give such consent after his death. Neither the grant of any facility or authority for the removal of any human organ from the body of a deceased person in accordance with the provisions of this act, nor the removal of any human organ from the body of a deceased person in pursuance of such authority shall be deemed to be an offence punishable under Section 297 of the IPC (45 of 1860).21 No registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained, in such manner as may be prescribed, all possible effects, complications, and hazards connected with the removal and transplantation to the donor and the recipient respectively.22

by a living person under express authority Any donor may authorize the removal, before his death, of any human organ of his body for therapeutic purposes. It shall be done in writing and in the presence of two or more witnesses, of whom at least one shall be a near relative of such person. The unequivocal authorization shall be carried out after his death by the person lawfully in possession of the dead body of the donor, unless he has any reason to believe that the donor had subsequently revoked the authority aforesaid, he shall grant to a registered medical practitioner all reasonable facilities for the removal of that human organ from the dead body of the donor.23 These provisions shall be understood as removal of organs from a donor who is not killed in the process by the removal of an organ for transplantation. By no stretch of imagination can the act be taken as allowing someone else’s life to be taken to save one’s own.24 However, in C.A. Thomas Master v. Union of India (UOI ) and Ors25 the petitioner claimed that he had approached some of the medical institutions under the control of the state government, including the District Hospital, Thirssur, seeking help to facilitate his voluntary death and for donation

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of his organs, including the heart, kidneys, and eyes. His request was not taken seriously and he was told that none of the hospitals under the state government had such facilities to enable the petitioner to voluntarily cause his death, which would not be suicide.The petitioner therefore approached the high court for the issuance of a writ of mandamus commanding the respondents to start ‘Mahaprasthana Kendra’ or voluntary death clinics in each district hospital so as to facilitate voluntary death and donation of bodily organs as well as their transplantation.There was a further prayer for a direction to the respondents to appoint a commission to study the practice of voluntary death in ancient India and to suggest methods for its practice in the context of environmental changes and technological advancement.The petitioner also prayed for a direction to the respondents to set apart funds and set up infrastructure for assisting voluntary organizations that are willing to facilitate voluntary deaths and the donation of bodily organs.The court said that in the absence of any legislation, and in view of the decision of the Supreme Court in Gian Kaur’s case 26 upholding the provision in the IPC making the attempt to suicide as an offence, no distinction could be made between suicide as ordinarily understood and the right to voluntarily end one’s life as distinguished by the petitioner.

mcir guidelines for live donor transplants The MCIR contains the following guidelines: 1. Donation from a live donor should be restricted to renewable tissues like bone marrow, or to a paired organ, which on removal will not greatly alter, physiological functions, as in the case of the kidney. Since the removal of an eye will compromise binocular vision and produce disfigurement, it should not be permitted in a live donor. 2. Surgery on the donor inflicts bodily harm on him or her, the extenuating circumstances being the saving of another human life. It is imperative that no risk be imposed on the donor beyond that inherent in surgery and the loss of a vital organ. Any manner of experimentation, though it may be intended to improve the survival of the graft, should be prohibited if there is the slightest extra risk to the donor. Examples are pre-treatment of the donor with immunosuppressives or anticoagulants.

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3. Every such research project should be preceded by careful assessment of predictable risks and compared to foreseeable benefits and improvement in the success rate of transplantation. 4. The interests of the donor should always take priority over those of the recipient of the transplant. 5. In view of the risk involved, the voluntary consent of the donor is absolutely essential. Further, the donor should be informed of all possible risks in a manner easily understood by the participant before the consent is taken. 6. It follows that the donor should have the legal capacity to give consent and be in a position to exercise free power of choice without the slightest element of force, duress, or coercion, and should have sufficient knowledge and comprehension as the participant to be able to make a decision with full understanding of the consequences. Children and mentally incompetent adults as also individuals with restricted autonomy should not be used as organ donors or as participants for such experiments. 7. Since the experiment would have consequences for the recipient too, the donor must be fully informed of the nature of the procedures and the possible effects on the recipient before consent is taken. 8. The responsibility of providing the above information to the donor, and of making sure that s/he understands fully the implications of what is to be done and what he or she consents to, rests entirely on the individual who directs the research project. 9. The experiment should be such as to yield fruitful results for the overall good of the donee without any risk to the life of the donor. The experiment should be undertaken only if there is no other method available of finding the answer to the question raised. 10. The experiment should be so planned and conducted as to avoid all unnecessary risks to the donor, to the organ to be transplanted, and to the recipient of the organ. Proper precautions should be taken and adequate facilities should be available to protect the donor from the most remote possibility of harm. 11. The donor should be at liberty to withdraw from the experiment and to abrogate the consent given earlier, with no requirement to offer any explanation of the reasons for his or her doing so. 12. If at any time during the course of the experiment the investigator comes to know that there is risk to the donor or to the recipient

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as a result of the procedure, it is her/his responsibility to terminate the experiment forthwith. 13. This does not preclude any treatment or procedure done on the organ or tissue after removal from the donor’s body, aimed at reducing its antigenicity and improving graft survival.

where no express authority is given Where no authority had been made by any person before their death but no objection was expressed by such person to any of their human organs being used after their death for therapeutic purposes, the person lawfully in possession of the dead body may authorize the removal of any human organ of the deceased person, unless he has reason to believe that any near relative of the deceased person has objection to any of their organs being used for therapeutic purposes.27 The act refers to the human organ of a deceased person and to not the whole body itself. The Anatomy Act of 1949 and the state enactments refer to use of an unclaimed body for therapeutic purposes and not the body which is not ‘unclaimed’. The inadequacy in the legislation was the subject of an unresolved debate in K. Uma Mahesh v. The State of Tamil Nadu, Rep. by its Secretary to Government, Health and Family Welfare Dept Fort St George, Ms 9 and 2 Others.28

authority in cases of bodies sent for post-mortem examination Where the body of a person has been sent for post-mortem examination for medico-legal purposes because the death was caused by accident or any other unnatural cause, or for pathological purposes, the person competent to give authority for the removal of any human organ from such dead body may, if he has reason to believe that it will not be required for the purpose for which such body has been sent for post-mortem examination, authorize the removal, for therapeutic purposes, of that human organ of the deceased person, provided that he is satisfied that the deceased person had not expressed, before death, any objection to any of their human organs being used for therapeutic purposes after death or, if they had granted authority for the use of any of their human organs for therapeutic purposes after death, this authority had not been revoked by them before their death.29

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when no authority for removal could be given No authority shall be given for the removal of any human organ from the body of a deceased person if there is reason to believe that an inquest may be required in relation to the body in pursuance of the provisions of any law for the time being in force.30 Permission for removal cannot be given when the body has been entrusted for the purpose of internment, cremation, or other disposal.31

in case of unclaimed bodies in hospital or prison In the case of a dead body lying in a hospital or prison and not claimed by any of the near relatives of the deceased person within forty-eight hours from the time of the death of the concerned person, the authority for the removal of any human organ from the dead body which so remains unclaimed may be given by the person in charge, for the time being, of the management or control of the hospital or prison, or by an employee of such hospital or prison authorised in this behalf by the person in charge of the management or control thereof.32 No authority shall be given if the person empowered to give such authority has reason to believe that any near relative of the deceased person is likely to claim the dead body even though such near relative has not come forward to claim the body.33 Can a person insist that the hospital shall take his body after his death? In K. Uma Mahesh v. The State of Tamil Nadu, Rep. by its Secretary to the Government, Health and Family Welfare Dept Fort St George, Ms 9 and 2 others,34 there was a challenge to the provisions of the Anatomy Act itself on the ground that there was no provision for acceptance of anybody except for those that were unclaimed.Without testing the vires of the act itself, the court said that the desire of the petitioner was commendable and directed the director of the Institute of Anatomy to accept the body if this was intimated and the body had been brought not long after death.

mcir guidelines on cadaver donor transplants 1. Every one should give a thought to the need for organ donation after death. In such an event one should make a decision and inform the next of kin, and register oneself with an appropriately constituted authority. Where one is opposed to donating her/his organs, this too, should be made known to the next of kin, so that

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this wish of the deceased may be respected after death. Such a ‘Living Will’ is in vogue in a number of countries in the world. If consent for organ donation is given prior to death in the presence of two or more witnesses, consent for transplantation of organs should be presumed and permissible without seeking further consent from relatives. In the absence of such prior directions from the deceased, the person in lawful possession of the body will make the decision to use the organs or not, as he may think fit, after consultation with the family. It is important that the medical team uses the body only for the purpose for which consent has been given. Remaining tissue and organs should be treated with the respect due to a human body, and will not be used for any purpose to which explicit consent had not been given unless anonymised. Under no circumstances should financial gain be made from any such procedure. There shall be no coercion and no monetary inducements offered to the family of the prospective cadaver donor. Confidentiality of the donation must be maintained on both sides: the recipient and her/his family will not be informed of the identity of the donor, and the family of the donor will equally be kept unaware of who receives the donated organ. This is essential to avoid any form of exploitation by the donor’s family.

mcir guidelines for recipients of transplants 1. The patient with failure of a vital organ is at a particular disadvantage in developing countries due to the enormous cost involved for the available interventions. If the organs involved are the kidneys, most Indians cannot afford to maintain themselves on dialysis. Similarly ventilators are available at very few centres. There are no artificial supports for other organs like the heart, the lungs and the liver, so death is imminent and no means is available to keep the individual alive short of replacing the organ concerned. Thus a measure of urgency is introduced into the search for a donor organ. 2. A desperate patient may consent to procedures, which put him or her at risk. It is all the more important that every research protocol for transplantation should be carefully reviewed by an appropriate committee of suitably qualified scientists, jurists and

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other eminent members of society, so that its scientific and ethical basis may be impartially evaluated. The transplant research team should have high technical expertise. Adequate data management, tissue storage facilities, and surveillance procedures should be available in a centre before it is authorised to conduct research into transplantation. If, at any time, a patient should refuse to take part as a participant for a research project, it should in no way interfere with his or her right to receive treatment of the best quality, which the team is capable of providing. Under no circumstances should there be a conflict between scientific content of a study and the best interests of the patient. Should there be need to choose, the experiment should be abandoned and the patient should receive the best treatment possible.

person competent to remove the human organ The removal shall be done only by a medical practitioner35 who shall satisfy first himself, by a personal examination of the body from which any human organ is to be removed, that life is extinct in that body.36 In the event of brain-stem death, no such removal shall be undertaken unless such death is certified, in such form and in such manner and on satisfaction of such conditions and requirements as may be prescribed by a board of medical experts consisting of the following: (1) the registered medical practitioner in charge of the hospital in which brain-stem death has occurred; (2) an independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner specified in Clause (i), from the panel of names approved by the Appropriate Authority; (3) a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in Clause (i), from the panel of names approved by the Appropriate Authority; and (4) the registered medical practitioner treating the person whose brain-stem death has occurred.37

authority for removal of human organs from bodies sent for post-mortem examination Where the body of a person has been sent for postmortem examination—(1) for medico-legal purposes by reason of the death of such person having been caused by accident or any other unnatural cause;

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or (2) for pathological purposes, the person competent under this act to give authority for the removal of any human organ from such dead body may, if he has reason to believe that such human organ will not be required for the purpose for which such body has been sent for postmortem examination, authorise the removal, for therapeutic purposes, of that human organ of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs being used, for therapeutic purposes after his death or, where he had granted an authority for the use of any of his human organs for therapeutic purposes, after his death, such authority had not been revoked by him before his death.

Restrictions on Removal and Transplantation of Human Organs

donation after death No human organ removed from the body of a donor before his death shall be transplanted into a recipient unless the donor is a ‘near relative’ of the recipient.38 Where any donor authorises the removal of any of his human organs after his death or any person competent or empowered to give authority for the removal of any human organ from the body of any deceased person authorises such removal, the human organ may be removed and transplanted into the body of any recipient who may be in need of such human organ.39

donation before death If any donor authorizes the removal of any of the organs before a person’s death for transplantation into the body of a recipient who is not a near relative, as is specified by the donor by reason of affection or attachment towards the recipient or for any other special reasons, the human organ shall not be removed and transplanted without the prior approval of the authorization committee.40 A near relative is a person who is a spouse, son, daughter, father, mother, brother, or sister. In Smt. Sumakiran Mallena v. The Secretary, Medical and Health and Others,41 the wife of the donor filed a writ petition challenging the decision of her husband to donate a portion of the liver to his father, who was reportedly suffering from decompensated cirrhosis of liver, anincurable HCV-related liver

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function. The court rejected the petition as not maintainable, holding that no legal right existed for the wife to prevent her husband’s decision. The court pointed out that the case had been filed on two wrong assumptions: that her husband’s affection towards his parents should be subservient to the marital relationship between him and the petitioner, and that he cannot donate his organs without her consent.

committee authorized to sanction donation in case of non-relative The Central Government shall constitute, by notification, one or more authorization committees consisting of such members as may be nominated by the Central Government on such terms and conditions as may be specified in the notification for each of the Union territories for the purposes of this section.42 The state government shall constitute, by notification, one or more authorization committees consisting of members nominated by the state government on such terms and conditions as may be specified in the notification for the purposes of this section.43 The committee has no power to direct the party to approach any near relative before sanction is sought for donation by a non-relative.44

enquiry by the authorization committee On an application jointly made, in such form and in such manner as may be prescribed, by the donor and the recipient, the authorization committee shall, after holding an inquiry and after satisfying itself that the applicants have complied with all the requirements of this act and the rules made there under, grant to the applicants approval for the removal and transplantation of the human organ.45 If, after the inquiry and after giving an opportunity to the applicants of being heard, the authorization committee is satisfied that the applicants have not complied with the requirements of this act and the rules made there under, it shall, for reasons to be recorded in writing, reject the application for approval.46 It was held by the High Court of Gujarat in Mehul Kishorsingh Jadeja v. Amarjit Singh (IAS ), Appellate Authority and Commissioner of Health and Others47 that the decision of authorization committee could be taken only after giving an opportunity of hearing

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to the applicants before the decision to reject the request is made. The committee shall have due regard to the provision in the act that in the case of non-relatives, it shall take into account the fact that donor has by reason of affection or attachment towards the recipient or for any other special reasons decided to donate their organ. The Supreme Court however cautioned in Kuldeep Singh and Another v. State of Tamil Nadu and Others48 that as the object of the statute was to rule out commercial dealings, it would be desirable to require the donor and recipient to give details of their respective financial positions and vocations. Finding that the existing legislative requirements were inadequate, the court suggested that it would be appropriate for the legislature to amend the rules and Form 1 so that the requirement for disclosing incomes and vocations for a number of previous financial years (say three years) should be statutorily incorporated. This, the court said, would help the authorization committees assess whether any commercial dealing was involved or not. Till then, the Supreme Court said, all the authorization committees should, in terms of the judgment, require the applicants to furnish their income particulars for the previous three financial years and their vocations.

high courts’ approaches The high courts have by and large been liberal in according sanctions even when the authorization committees have found the grounds insufficient. It is difficult to find a consistent rationale to these approaches modifying the decisions of the authorities in writ jurisdictions where courts have limited reach to gathering facts by evidence but make decisions only on the basis of incontrovertible facts brought through admitted documents and affidavits. Judges have generally been carried away by sympathetic considerations for the patient and prepared to trash any suggestion of financial allurements to non-relative poor donors. The income particulars were taken in one case49 of a donor alleged to be a servant of the recipient patient. Having regard to the income disparity between the donor and the recipient parties, the authorization committee as well as the appellate authority had held that payment of consideration that was prohibited under the act could not be ruled out. The high court, however, took a different view. It said that the authorities’

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conclusion based on great economic disparity between the donor and the recipient was a totally extraneous ground. It said that human conduct and reactions could not be measured in any mathematical terms. Instances were not unknown, said the judge, where people due to sheer love and affection or humanitarian consideration act for the welfare of the needy. A wall of suspicion in every case of kidney donation, the judged said, should not be allowed to jeopardize the health considerations of a seriously ill patient. In R. Shailaja and Another v. State of Karnataka, by the Secretary, Department of Health and Another,50 the Karnataka High Court found that the fact that donor (represented to be a servant of the recipient) was not residing with the recipient in the same house could not be taken as a ground for the assumption that the transaction was bona fide, as held by the authorization committee. The fact that the donor and the recipient belong to different castes and are from different places shall also not be an adequate reason to reject the application.51 In Arup Kumar Das and Anr v. State of Orissa and Ors,52 the refusal of sanction by the committee on the ground of lack of HLA matching was set aside by the Orissa High Court, which permitted kidney donation by an unrelated donor. The Court said that with the new immunosuppressant drugs, HLA matching was less important, and there was a need to give effect to the offer of a donor for kidney transplant. It said: In an unrelated donor and recipient combination, unless the donor pool of such unrelated donors is very large, it is unlikely that unrelated donor will match for HLA with the unrelated recipient. Further, if one has single unrelated donor being evaluated for a said recipient, then role of HLA matching is of not much importance as we are unlikely to get some, reasonable degree of matching. If other tests of matching like cross matching are negative, one should go for transplant even if there is no HLA match out of 6 HLA usually done.

when two jurisdictions of authorized committees are involved There is no prohibition under the act for removal of an organ from one recognized hospital situated in one state and its transplantation to a different recognized hospital in another state. In such a case, the Gujarat High Court53 said that the authorization committee will be required

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to impose a condition that after the organ is harvested, proper care is taken for its preservation through an accepted scientific method in order to see that the viability for the purpose of transplantation is not lost.While granting such permission, the authorization committee may also impose additional conditions. When the authorization committee within whose jurisdiction the donor and the recipient reside have examined the parties and given the sanction, and the transplantation is contemplated in another hospital in another state, Rules 6B and 6C under the act require the no-objection to be taken from the respective state authorization committees. However, in keeping with the general trend of the high courts, both the Andhra Pradesh High Court54 and the Madras High Court,55 following the decision of the former, read down the rules to mean that while the state where the donor and the recipient live in one state, the area of enquiry will be on the bona fides and the health issues of the respective parties, and when the operation is to be made in another state, the authorization committee of that state shall not again take up the issues considered by the former committee but will only consider whether the hospital is registered or not. It is submitted that the views expressed in the two decisions are open to doubt. Rule 6B provides that the state-level committees shall be formed for the purpose of providing approval or a no-objection certificate to the respective donor and recipient to establish the legal and residential status at the domicile state. If the donor, recipient, and place of transplantation are from different states, it is mandatory that the approval or ‘no-objection certificate’ from the respective domicile state government is obtained. It unduly restricts the sweep of the relevant rule to circumscribe the power of the authorization committee of the state where the operation is to be performed to merely satisfy itself about the registration of the hospital.

Regulation of Hospitals The hospital and the medical practitioner shall conduct, or associate with, or help in, the removal, storage or transplantation of any human organ shall be registered under the act.56 It can be carried out only in the place which is registered.57 The restriction as to place is not applicable to removal of the eyes or the ears. The term ‘ears’ includes ear drums and ear bones.58 The authority constituted under the act shall

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also have the power of renewal, suspension, or cancellation of registration.59 It shall enforce such standards as may be prescribed for hospitals engaged in the removal, storage, or transplantation of any human organ. It will also have the power to investigate any complaint of breach of any of the provisions of this act or any of the rules made there under and take appropriate action. It may also inspect hospitals periodically to examine the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed.60

Offences and Penalties

punishment of medical practitioners, hospitals, etc. Any person who renders his services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or helps in any manner in the removal of any human organ without authority shall be punishable with imprisonment for a term that may extend to five years and with a fine that may extend to Rs 10,000.61 It is only the removal for transplantation that causes offence under this provision. A surgeon causing the removal of a human organ during course of medical treatment or the operation without any kind of connection with transplantation of that organ will not come within ambit of Section 18.62 Where the person so convicted is a registered medical practitioner, their name shall be reported by the Appropriate Authority to the respective state medical council for necessary action, including the removal of his name from the register of the council for a period of two years for the first offence and permanently for the subsequent offence.63 The prosecution and conviction shall be done in the same manner as any other criminal case looking for strong proof beyond reasonable doubt that the persons charged are guilty of the offence. In Dr Shyam Sundar Prasad v. State of Bihar (now Jharkhand )64 a tailor from Ranchi alleged that while seeking funds to travel to any of the Gulf countries for employment in Mumbai, he was lured into a hospital for some medical check-ups, and he had been rendered unconscious and his kidney removed.The failure of the hospital to produce all the medical records was taken, inter alia, by the trial magistrate as proving guilt by drawing an adverse inference under Section 114(g) of the Evidence

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Act, but the high court reversed the ruling, saying that the burden on the prosecution to establish guilt had not been discharged. Curiously, the prosecution did not lay charge under any provision under the act, but had charged the accused for IPC offences under Sections 109, 326, 327, and 328. The case is more an illustration of lackadaisical approach of the prosecuting authority in failing to establish the case properly than justifiable grounds for letting the guilty go free.

punishment for commercial dealings in human organs Whoever—(a) makes or receives any payment for the supply of, or for an offer to supply, any human organ; (b) seeks to find a person willing to supply for payment any human organ; (c) offers to supply any human organ for payment; (d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human organ; (e) takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement referred to in clause (d); or (f ) publishes or distributes or causes to be published or distributed any advertisement,– (a) inviting persons to supply for payment of any human organ; (b) offering to supply any human organ for payment; or (c) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d), shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to seven years and shall be liable to fine which shall not be less than Rs 10,000 but may extend to Rs 20,000. The court may, for any adequate and special reason to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and a fine less than ten thousand rupees.65

Under a residual provision, there is scope for punishment for contravention any provision of the act for which no separate punishment is provided by a sentence with imprisonment for a term that may extend to three years or with a fine that may extend to Rs 5,000.66 Where any offence punishable under this act has been committed by a company, the company as well as every person who at the time the offence was committed was in charge of and was responsible to the company for the conduct of its business, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. However, it shall not render any such person liable to any punishment

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if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence.67

cognizance of offence No court shall take cognizance of an offence under this act except on a complaint made by (1) the Appropriate Authority concerned, or any officer authorized on this behalf by the Central Government or the government or, as the case may be, the Appropriate Authority; or (2) a person who has given notice of not less than 60 days, in such manner as may be prescribed, to the Appropriate Authority concerned, of the alleged offence and of his intention to make a complaint to the court. The metropolitan magistrate or a judicial magistrate of the first class shall be the court of competence to try any offence punishable under this act.68 The Human Rights Commission, it was held in Santhosh Hospitals Private Limited represented by its Administrative Officer, S. Chakravarthi v. State Human Rights Commission, represented by its Registrar and Others,69 did not have any jurisdiction to entertain any complaint against a doctor who was not a government servant, or the hospital for alleged violation of any offences under the act. The complaint that this provision contemplates excludes the need for a police report under Section 167(2) of the CrPC.70

A Case for Reward for Organ Donation In Common law, a living human body is incapable of being owned.71 The allied principle is that a person does not even ‘possess’ his body or any part of it.72 Without even the theological under pinnings, it could be a difficult position to take the medical community to assist any person wallowing in poverty to donate the organ for financial recompense. The scope for exploitation of the poor and the reports of commercialization in the trade of human organs were weighty reasons enough for enacting Transplantation of Human Organs Act, 1994. The act authorizes donation only from amongst specified classes of relatives and if the donor is a non-relative, the consent of such a donor shall be evaluated by an authorization committee that the donation is ‘for affection or attachments towards the recipient or other special reasons’.

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The act prohibits receipt of consideration for donation of any human organ. Pernicious, as the effect of commercialization of human organs could be, one cannot doubt that in its inception when the possibility of organ transplantation was made scientifically feasible, it could not have gone without notice that the procedure was capable of a grave mischief. The control mechanism to end commercialization and trafficking in human organs has operated between two extremes: the authorization committee invariably views every offer of donation of a non-relative with suspicion, while courts that have been called upon to examine the decisions of the committees have always seen the travails of the patient to be so overwhelming as to adopt a liberal approach with a view to saving their life. Perhaps the majority of these cases are related only to kidney transplant. Take a survey of all cases reported from various high courts. One will notice that the courts have often gone to the rescue of the patients and have rejected every instance of suspicion by authorization committees as not really relevant. The donor and recipient of non-relatives as servant and master, as poor and rich, as unrealistically charitably disposed and critically ill, respectively, have been found by courts as not sufficiently worthy reasons to doubt that the donor was consenting for donation only out of affection or attachment. It is conceded that despite the act, there is a large-scale illegal trade in donation of human organs for consideration. The concern seems to be more on the pitiable condition of a patient requiring donation, but if an equal measure of concern about possibility of exploitation of donor exists, they have seldom been voiced through judicial pronouncements. Amy L. Friedmen, an American academic transplant surgeon, pleads for legalization of payment for living organ donation,73 and asks, if we expect a non-relative donor to donate his organ without consideration, are we not expecting an unduly unjustified gratuitous altruism from a person who is prepared to suffer for it? A patient who receives donation of an organ has a chance of improving his quality of life. He will probably lead a normal life. He will also begin to earn. If the recipient can benefit, why shouldn’t the donor? There are many other categories of donation that exist outside the regulation of the act. Human hair is priced. Human blood is also taken for a price. All legal regimes accept legitimate costs of carrying a foetus by a surrogate mother as tenable. Perhaps at the farthest end of the

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tether lies an offer of the human body for pleasure by a sex worker for monetary compensation. The person other than a spouse who gifts semen in IVF procedures is usually rewarded, and so is a woman who gifts ‘productive eggs’. The Transplantation of Human Organ Act is significant in that it does not prohibit donation of an organ by a live individual, but regulates it. In that regard it has been admitted that the act has not been able to do away with commercial exploitation, the presence of middlemen, and the existence of a large black market. If all this must go, the first step should be to recognize that there is nothing illegal about fixing a price for an organ, and that a donor could be motivated by compensatory beneficence rather than gratuitous altruism. To expect a personal sacrifice only from a donor while at the same time having sympathy for an ailing patient does not put the donor and the patient on an even balance. A philosophical (or cynical?) resignation could only be, if kidney transplants are covertly done by violating the provisions of the act, is it time to bust the practice, not by prohibitions or incorporating more difficult parameters to assess the genuine willingness of a gratuitous donor, but as Ms Friedman says, by bringing these activities out of the closet and introducing governmental supervision and funding to provide equity for the poor, who will get equal access to such transplants? MINOR DONORS AND INCOMPETENT ADULTS Transplantation cases in relation to minor donors and persons who are mentally ill raise a lot of ethical issues. In a situation where the donor and donee are twins or members of the same family, and the parent of the minor donor takes the decision, it is imperative that the surgeon secures informed consent from the parent and all the four precepts of medical practice referred to already74 are observed.The Transplantation of Human Organs Act defines a competent donor as a person who is more than 18 years of age. Can a minor be a donor, if the guardian consents to it? What shall be the necessary parameters for the guardian to give the consent? We have no case laws on the subject, but the issues have rocked foreign courts, particularly in the US, and they are given here as possible source of possible guideline, if not binding precedents for courts to follow. The Mental Health Act, 1985, provides

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for the appointment of a guardian for the care of the person who is mentally challenged. There have been no reported cases of guardians applying for permission to donate the organ of an incompetent adult to a near relative. The cases in the US have applied the doctrine of the psychological benefit of the incompetent donor even when the state legislation did not expressly permit the guardian to give consent for donation.

Cases of Identical Twins

skin grafts In an Australian case reported as The Case of Jennifer and Sydney75, on 9 December 2002 Jennifer Cowan was injured when her father’s attempt to light the family fireplace resulted in an explosion. As a result, Jennifer suffered third-degree burns of over 80 per cent of her body surface area—only her head, hands, and intertriginous areas were spared. Doctors estimated that Jennifer had a 30-50 per cent chance of survival. Following a week of stabilizing treatment, including five days on a mechanical ventilator, Jennifer’s treatment focused on re-establishing a protective barrier over her burned areas. Her surgeon removed her dead skin and covered exposed areas with whatever unburned skin could be harvested from unburned parts of Jennifer’s body (i.e., autografts). Because Jennifer did not have enough unburned skin to cover all of her burned areas, additional human skin allografts were obtained using skin harvested from cadaveric skin donors. Doctors also used porcine xenografts (i.e., pigskin) to complete the job. Finally, a small piece of Jennifer’s normal skin was removed (i.e., biopsied) and shipped to a laboratory to grow sheets of new skin. Shortly after her injury, Jennifer’s surgeon learned that she was an identical twin. Upon learning this information, he entertained the notion that a skin graft from her identical twin, because of its identical genetic make-up, would give Jennifer her best chance of survival. Sensing that operating on Sydney for a skin graft donation would raise ethical and legal concerns, however, the surgeon requested review by the hospital ethics committee. The ethics committee interviewed Jennifer’s family, her surgeon, and a consulting psychologist who had examined both Sydney and the parents. After discussion and deliberation, the committee offered the following recommendations: (1) the proposed skin grafting from

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Sydney to Jennifer represented a valid ethical option because Sydney would benefit from a continuing close personal relationship with Jennifer as identified by preliminary psychological evaluations; (2) follow-up psychological support should be provided to Sydney during and following the donation period; (3) Sydney’s assent to the procedures was mandatory throughout the donation period; and (4) a court order to proceed with donation should be obtained before instituting isografting procedures. The girls’ parents unequivocally stated their preference for performance of the requested procedures. They were of the opinion that Sydney wanted to assist Jennifer if she could, and undergoing the proposed transplant procedures offered the best hope of keeping their family intact. Overall, the evidence for skin harvesting showed strong medical and parental support, Sydney’s concomitant assent, and equivocal prediction on psychological benefits for Sydney. The use of an incompetent minor as a skin transplant donor, even if an identical twin, would not be justified unless the transplant will save the recipient’s life. Major deficiencies include the high likelihood that Jennifer would have survived her burn injuries without skin transplantation and biased ethical and judicial procedures that led to the approval of skin harvesting from Sydney. The surgeon felt obliged to inform the family of all possible treatment alternatives in the informed consent discussion of Jennifer’s burn treatment, and he advised that the twin skin transplantation had the best risk/benefit ratio. Second, the court determined that the requisite emotional support was lacking, for the mother, as primary caretaker, was unable to provide the necessary support given her opposition to the harvesting procedure.76

kidney transplant The case of Hart v. Brown77 addresses kidney transplantation from a healthy seven-year-old to her twin sibling suffering from chronic renal failure following hemolytic-uremic syndrome. Because she experienced hypertensive complications, the ill twin underwent bilateral nephrectomies, leaving her no hope to recover kidney function. In an action for declaratory judgment, the parents asked the court to grant them authority to consent to kidney transplantation. The court held that ‘natural parents of a minor should have the right to give their consent to an isograft kidney transplantation procedure when their motivation

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and reasoning are favorably reviewed by community representation which includes a court of equity’. In reaching its holding, the court cited the following factors as of paramount importance: the procedure was necessary to save the life of the one twin; the risks of operation to both twins were negligible; transplant from a parent would be substantially more burdensome for the ill twin because life-long immunosuppressive treatment would be required; the prognosis for good health and long life was excellent if the operations were performed; and the parents’ motivation and reasoning were favorably reviewed by the children’s GALs and physicians, local clergy, and the court. The court also considered the psychological benefits to the donor—somewhat discounted by the court because of the child’s age and assent of the donor. CASES OF SIBLINGS To buttress its holding, the court cited several sources of authority. Regarding its authority to act in the case, the court cited Strunk v. Strunk,78 in which the court authorized parental consent under the theory of substituted judgment, and several unreported cases from Massachusetts involving kidney transplants between minor siblings, in which each court acted upon the inherent power of a court of equity. In addition, the court cited Bonner v. Moran79 as authority for the premise that non-therapeutic operations are legally permissible on a minor as long as the parents or other guardians consent to the procedure. The court acknowledged the need to balance the parents’ right to consent with the right of the incompetent donor child, and ultimately held that justice required granting the parents the right to consent to the kidney transplant. In the court’s opinion, parental interest with proper motivation and reasoning outweighed any contrary interest of the minor donor. Examination of the cases cited in Hart is instructive. In Strunk, a Kentucky appellate court considered the right of a natural mother, as guardian of her incompetent, mentally retarded adult son, to consent to transplant of one of his kidneys to his adult brother. The incompetent son resided at a state mental hospital and had an intelligence level of a six-year-old. Both his family and the mental health department approved of the kidney donation.The county and circuit courts

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agreed, reasoning that the transplant served the incompetent’s best interest, as psychological and emotional harms resulting from the loss of his brother outweighed the physical trauma of an operation. On appeal, the GAL questioned whether the court had the power to authorize the removal of an organ from an incompetent. The appellate court concluded that a court of equity had such power as part of its inherent powers, and stated that the previous equity doctrine of substituted judgment formed the basis of its power in this instance. In referring to the substituted judgment doctrine, the court stated, ‘The right to act for the incompetent in all cases has become recognized in this country as the doctrine of substituted judgment and is broad enough not only to cover property but also to cover all matters touching on the well-being of the ward.’ Here, the Strunk court did not use the term ‘substituted judgment’ as a standard for decision-making, but, rather, as a general term referring to the power of a court of equity to make a proxy decision for an incompetent. In addition to Strunk and Bonner, the Hart court relied heavily on three unreported cases decided by the Supreme Judicial Court of Massachusetts on emergency appeal.The three cases involved kidney transplants in identical twins aged 19, 14, and 14. Each donor consented to the transplant. In all three instances, the court authorized transplantation, concluding that the potential emotional detriment suffered by the healthy twin in response to the imminent death of the twin sibling, as detailed by expert psychiatric testimony, outweighed the potential physical detriment of kidney donation to the donor.These Massachusetts cases, by finding direct benefit to the donors, implicitly invoked parens patriae as the jurisdictional basis to authorize transplant procedures between identical twin minors. Following these three cases, genuine concern has been raised regarding the capacity of court proceedings to adequately safeguard the interests of the minor donor. Since Hart, several other courts have considered the topic of organ donation by a healthy incompetent sibling. In Little v. Little,80 a Texas appellate court affirmed a probate court order authorizing a kidney transplant from a 14-year-old female with Down’s syndrome to her brother. The brother, suffering from end-stage renal disease, and the mother, as guardian, petitioned the probate court for authorization to consent to kidney donation. After approval of the petition, the donor’s

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GAL appealed, arguing that the court lacked the power to authorize consent. The appellate court rejected the GAL’s argument and turned to the doctrine of substituted judgment. This doctrine, as construed by the Texas Supreme Court, requires a court to substitute itself as nearly as possible for the incompetent and act with the same motives and reasoning.Turning to the evidence, the court concluded that there was a close and caring relationship between the siblings and sufficient medical testimony to presume that the incompetent would receive substantial psychological benefit from serving as a transplant donor. Furthermore, the court determined that the incompetent seemed willing to go forward with the procedure without undue family pressure, that there was parental consent, that the brother would probably benefit substantially from transplant, and that the dangers of the operation were minimal. Finally, the court found that transplant was the only reasonable alternative without which the brother would suffer severe and progressive deterioration. While the court ultimately affirmed the probate court’s authorization of the kidney transplant, it complimented the vigorous adversarial role played by the GAL in defending the donor’s due process rights.

Non-therapeutic Operations In citing Bonner, the Hart court invoked the notion of negative implication to espouse the principle that non-therapeutic operations can be legally permitted on a minor as long as the parents or other guardians consent to the procedure. In Bonner, the surgeon was sued for assault and battery following a skin grafting procedure from a 15-year-old minor to his severely burned cousin. The operation was performed without the consent of the minor’s mother. The district court charged the jury that the surgeon would not be liable for battery if the boy was capable of appreciating, and did appreciate, the nature and consequence of the operation, and thereafter consented to the operation. The US Court of Appeals for the District of Columbia reversed, holding that the mother’s consent was necessary to avoid a claim of battery. Because the skin grafting procedure had already occurred, however, the court never addressed whether it had the power to authorize such an operation. As such, Bonner is generally regarded to hold only that a surgeon must obtain parental consent to operate on a

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minor to preserve an affirmative defence to a claim of battery brought by the minor’s parents. Bonner does not explicitly endorse a parent’s right to consent to non-therapeutic procedures in minors. THE STANDARD TESTS FOR CONSENT In contrast to the legal standard adopted in Hart, the courts in Strunk and the Massachusetts cases adopted a legal standard based on the best interest of the donor. Under this standard, the psychological benefits to the donor were weighed against the risk of physical harm from the transplant procedures using a ‘preponderance of the evidence’ evidentiary standard. This is in contrast to Hart, where the court deferred to parental decision-making provided that such a decision did not offend community mores or the court. Subsequent judicial opinions in this area, as discussed below, have expressly favoured the best interest standard; yet, the primacy of parental rights expressed in Hart appears to have important, albeit unstated, influence. INSTANCES WHEN COURTS HAVE REFUSED PERMISSION In contrast to Little, several courts have denied petitions for transplants between close family members, including siblings. In McFall v. Shrimp81, an adult dying of aplastic anemia sought a court order to mandate bone marrow donation by his adult first cousin, who had previously refused to undergo the procedure. The court rejected the petition, finding that the right to individual autonomy precluded the government from ordering an invasion of one’s body for the benefit of another without proper consent. In re Guardianship of Pescinski,82 the guardian of an incompetent adult with schizophrenia petitioned a Wisconsin county court for permission to consent to kidney donation by the incompetent to his sister, who was suffering from chronic renal failure. Other siblings either were incompatible donors or had refused donation for personal reasons. The incompetent’s GAL, however, objected to the proposed donation on the ground that the incompetent would receive no benefit from the procedure. Even in light of psychiatric testimony that described the incompetent as catatonic with little interaction with his environment

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or persons in general, the Wisconsin county court denied the petition. On appeal, the Wisconsin Supreme Court affirmed, expressly rejecting the substituted judgment doctrine adopted in Strunk. Specifically, the court found that in the absence of statutory authority granting it such power, the incompetent needed to consent to the procedure or receive an established benefit from the procedure for the court to have authority to grant the petition for the transplant operation. In dissent, one justice argued that the court did have jurisdiction based on its power in equity, and proposed a multi-factor test for determining whether a court should issue an approval of consent. These factors included the following: a strong showing that the recipient will suffer death without the transplant; all other reasonable steps to find another donor have been utilized; the proposed donor is closely related to the proposed donee; the incompetent would probably consent if he or she were competent; the proposed donor is in good health; and the operation presents minimal risk, such that the donor could function normally following it. In re Richardson,83 a Louisiana court rejected a proposed kidney donation from a 17-year-old mentally retarded boy to his adult sister, who was suffering from end-stage renal disease. Specifically, the court found that a transplant was not immediately necessary to save the sister’s life and that the proposed benefit to the boy, namely, that the sister, if transplanted, would be in position to care for him following the parents’ death, was too speculative. Moreover, because Louisiana law affords unqualified protection against intrusion into a minor’s property rights, the court found it inconceivable to afford less protection to a minor’s right to be free of bodily intrusion unless it was in the minor’s best interest. In the case of Curran v. Bosze ,84 the Illinois Supreme Court addressed whether minor twins should serve as bone marrow donors for their 12-year-old half-brother, who was dying of leukemia. As the twins were illegitimate progeny of the father, the mother brought a paternity action against the father after their birth. The mother was granted sole care, custody, control, and educational responsibility of the twins. Of particular importance was a provision in the paternity order that stated, ‘In matters of importance relating to the health, education, and welfare of the children, mother shall consult and confer with the father, with a view toward adopting and following a harmonious policy.’ The father requested the mother’s consent to screening and, if

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screening showed compatibility, to harvesting of a twin’s bone marrow for transplant to the 12-year-old. After gathering information on the procedure and subsequent deliberation, the mother refused. The father sought emergency relief in circuit court, but was denied after an initial hearing and again on remand from appeal. The father appealed to the Illinois Supreme Court. Upon review, the Illinois Supreme Court addressed its jurisdictional authority and announced a legal standard for deciding cases concerning bone marrow donation by minors. With regard to the former, the court was persuaded by the jurisdictional arguments presented in Strunk and Hart, and, thus, implicitly based its power to decide the case on the inherent powers of a court of equity. In regard to the latter, the court specifically rejected the application of the substituted judgment standard. While it had previously applied the standard to analyse decision-making by guardians of incompetents, the court held that the substituted judgment standard was not applicable when decisionmaking was required for a minor or a person who has never been competent. The substituted judgment standard demanded that the surrogate’s decision follow the expressed wishes of the incompetent or arise from the personal values of the incompetent during a period of competency. Because minors have not yet reached the age of competence, a surrogate decision has no basis in the minor’s mature intent and, thus, cannot represent a substituted judgment. As such, the court held that a parent or guardian may consent on behalf of a minor for bone marrow donation only when it would be in the minor’s best interest. The court went further and identified three critical factors that are necessary to meet the best interest determination. First, the parent or guardian must give informed consent to the bone marrow procedure. Second, the child’s caretaker(s) must be available to provide the child with emotional support. Third, there must be an existing, close relationship between a donor and the recipient, for as the court reasoned, there was no physical benefit to a child serving as a donor. Rather, the only benefit, if any, was psychological, which could be firmly grounded only if the proposed recipient and donor knew each other as family members at the time of the contemplated transplant. After having established the framework within which a best interest determination would be made, the court denied the petition for

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transplant for failing the three-factor test. First, the court found that the procedure lacked the necessary informed consent, as the twins’ mother understood the risks and benefits of the procedure and refused to consent based on the infrequent, but significant, complications from the procedure. Second, the court determined that the requisite emotional support was lacking, for the mother, as primary caretaker, was unable to provide the necessary support given her opposition to the harvesting procedure. Finally, the court found a close relationship lacking. Specifically, the court held that although the twins had met the proposed recipient on previous occasions, they did not know he was their brother. Because all three necessary factors were absent, the court denied the father’s petition. Further analysis reveals that the three critical factors discussed in Curran strongly favour parental decision-making authority for bone marrow donation in children. The first two factors require the parent or guardian to consent to the procedure and provide an emotionally supportive environment for the donor child. While not expressly dependent upon parental decision-making, the third factor necessitates indirect parental decision-making. In Curran, for instance, at their mother’s request, the twins were not previously told about their halfbrother. Of course, the mother had no direct relationship with the 12-year-old and, unlike the father, could make a detached decision for the twins. An interesting and difficult question would have arisen, however, had the mother objected to a transplant needed by the father instead of the half-brother. In this instance, while saving the life of the father would clearly serve the twins’ best interest, the twin donors’ primary caretakers would be unavailable to provide the required emotional support. As such, the court would be forced to rethink the necessity of the three-factor framework. INSTANCES WHEN PERMISSION MAY BE GRANTED To successfully petition for authorization of an organ donation by a minor to a sibling, the petitioner must satisfy two requirements, namely, the donation must be in the best interest of the child donor and the donor’s parents or guardian must give informed consent to the transplant. Regarding the former, one could show that the proposed donor may experience psychological benefit through donation,

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and the donor and potential recipient have a close family relationship. Where, however, the donor is so mentally defective such that he cannot experience psychological benefit, the best interest standard cannot be satisfied. Exceptions to this rule include when the donation is not necessary to save the potential recipient’s life or to prevent the recipient from suffering a severe disability, or where a comparable alternative treatment is available.This approach to the best interest of a child donor differs from the approach on bioethics. Courts are more deferential to parental authority and medical professionalism, whereas ethical analysis takes a more objective approach. As such, it should not be surprising if these different approaches lead to different results. DIVERGENCE OF VIEWS Legal commentaries express widely divergent viewpoints on what should be the proper legal approach toward organ donation from minors to siblings. One commentary proposes a statutory prohibition on all such procedures involving legal incompetents (i.e., minors and mentally disabled persons).85 Another commentary disavows statutory and judicial intervention, arguing that decisions regarding organ donations by minors are constitutionally protected and, thus, are reserved solely to parental discretion.86 Other proposals include adoption of a legislative standard for regulation of organ donation by minors,87 incorporation of a ‘clear and convincing’ evidentiary burden to establish the best interest standard,88 and modifications to the best interest or substituted judgment standards, or the criteria to measure them.89 Despite the refinements presented by the above legal commentaries, outside of legislative prohibition or outright approval of organ donations by minors, courts will continue to adjudicate these cases in much the same way they currently do. As such, court decisions lacking firm ethical grounding will continue to generate a great deal of debate. NOTES 1 ‘Transplant’, Encyclopædia Britannica Online, http://www.britannica .com / eb/article-14521. 2 Cal. Health & Safety Code § 7150 et seq. 3 Cal. Health & Safety Code § 7155. 4 42 USC § 274e.

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5 The act originally applied to the whole of the States of Goa, Himachal Pradesh, and Maharashtra and to all Union territories. It was subsequently adopted by many states by resolutions passed in that behalf under Clause (1) of Article 252 of the Constitution. 6 Section 2(h). 7 Section 2(f). 8 Section 2(o) 9 Section 2(e). 10 See commentary ahead. 11 (g) ‘Hospital’ includes a nursing home, clinic, medical centre, medical, or teaching institution for therapeutic purposes and other like institution. 12 See note 6. 13 (i) ‘Near relative’ means spouse, son, daughter, father, mother, brother or sister. In Balbir Singh v. The Authorisation Committee and Others, AIR (2004) Del 413, it was held that once it was shown that, for medical and scientific reasons, medical tests were not required for determining tissue and organ acceptability between near relatives like brother and sister, the same could be established and there is no requirement to carry out tests and obtain certificates therefore, to avoid delay, expense, and agony. It is only when other evidence is not available or is doubtful that resort to the tests prescribed may be had. 14 The problem with brain death is that many people, including members of the medical profession, compartmentalize it as a concept that is invoked only for the special situations of ventilated ‘beating heart’ corpses, and link the concept to the pragmatic needs of transplant medicine. In reality, brain death is the only scientifically tenable concept of death we have. Just as the publication by Vesalius in 1555 of the effects of artificial ventilation invalidated any concept of death based on spontaneous respiration, so developments in cardiopulmonary resuscitation and open-heart surgery in the 1960s led to the invalidation of concepts of death based on the continuation of heart beat.This together with the observations of coma dépassé and ventilator brain led to a neural based concept of death. See ‘Brain Death: One Concept Two Criteria’ by Peter K.K. Au-Yeung, Staff Specialist, Dept of Anaesthesia & Intensive Care,Yan Chai Hospital, Hong Kong, in BMJ (1 July 1999). 15 The issue of brain-stem death became controversial in Israel in the 1980’s with the beginnings of heart and liver transplants. Many people objected to organ donations in ‘beating hearts’ situations fearing conflict with the religious Halachic Law. In 1986, the Chief Rabbinate of Israel responded to an approach made to accept brain-stem death as religiously acceptable for pronouncing death and for obtaining permission for harvesting organs from donors. Dan Michaeli, Chairman, Board of Directors, Kupat Holim Clalit, Israel, on ‘Brain-Stem Death and Jewish Helachic Law’, BMJ (26 June 1999).

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16 N.K. Sethi and P.K. Sethi on ‘Brain-stem Death: Implications in India’, in JAPI 51 (September 2003). 17 Ibid. 18 In the UK also, none other than a doctor can decide about the provision or withholding of treatment from an adult who is unable to give consent, although good practice dictates that the family should be consulted and kept informed. Parents have more rights in regard to their children. In 1992, a 19-month-old child was declared brain dead after suspected non-accidental injury, but an emergency protection order was granted to require the consent of those who had parental responsibility before a life support machine could be switched off. A high court judge declared that the child was undoubtedly dead and that if the doctor considered it appropriate to withdraw ventilation this would not be contrary to the law, Re A (a minor) [1992] 3 Med LR 303–5. 19 All this is not to suggest that the public always accepts these criteria as sufficient.There are several occasions where in high-profile cases, doctors have resorted to applications to the court for permission to discontinue treatment. For instance, in the UK an application to the high court filed in 1992 to discontinue life-sustaining treatment for Tony Bland, who had been injured in the tragedy at Hills borough football ground, brought the ethical debate to the front pages of the national press. Occasional stories of ‘miraculous recoveries’ from comas are widely reported and may have led to an exaggeration of the small chances that patients have of recovering from a PVS state among a public that is increasingly well versed in this condition. See BMJ 318 (26 June 1999):1753–5 for a discussion on the subject. 20 Section 11. 21 Section 8. 22 Section 12. See Chapter 3 for further elaboration on the subject. 23 Section 3(1)(2). 24 Nagendra Mohan Patnaik and Ors v. The Government of AP rep. by Its Secretary, Health, Medical and Family Welfare Department and Ors (1997)(1) ALT 504. This decision contained a challenge to the vires of the act itself, but the high court rejected the challenge and held it to be constitutionally valid. 25 (2000) Cri LJ 3729. 26 (1996) Cri LJ 1660. 27 Section 3(3). 28 AIR (1998) Mad 283, (1998) (1) CTC 16, (1998) I MLJ 381. 29 Section 6. 30 The Anatomy Act, 1949, provides that when there is any doubt regarding the cause of death, the act also provides that the unclaimed body be referred to the police officer under Section 174 of the CrPC, 1898. Pending receipt of

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any claim, the body shall be removed to the hospital or the teaching medical institution for preservation from decay. 31 Section 4. 32 Section 5(1). 33 Section 5(2). 34 AIR (1998) Mad 283, (1998) (1) CTC 16, (1998) I MLJ 381. 35 Section 2(n): ‘A registered medical practitioner means a person who possesses any recognised medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956, and who is enrolled on a State Medical Register as defined in clause (k) of that section.’ 36 Section 3(5). 37 Section 3(6). 38 Section 9(1). See MCIR guidelines for cadaver donor transplants. 39 Section 9(2). 40 Section 9(3). See MCIR guidelines for live donor transplants. 41 (2008) 2 ALD 176. 42 Section 9(4)(a). 43 Section 9(4)(b). 44 B.L. Nagaraj and Others v. Dr Kantha and Others AIR (1996) Kant 82, ILR (1995) KAR 2050, (1995) (5) Kar LJ 519. 45 Section 9(5). 46 Section 9(6). 47 (2007) 2 GLR 1780. 48 AIR (2005) SC 2106, (2005) (2) AWC 1757, (2006) (2) CTC 700, JT (2005) (11) SC 80, (2005) (2) KLT 505 (SC), (2005) 3 MLJ 80 (SC), (2005) 11 SCC 122. 49 Rajinder Kumar v. State of Punjab and others AIR 2005 P & H 172, (2005) 140 PLR 642. A similar sympathetic view was taken by the Madras High Court in S. Samson v Authorization Committee for Implementation of Human Organ Transplantation AIR 2008 Mad 227, while setting aside the refusal of sanction by the authorization committee that had doubts about the altruistic offer by a non-relative and suspected financial bonding of the donor to the recipient, and permitting the transplant. 50 ILR (2005) Kar 953, (2005) (4) Kar LJ 133. 51 S. Malligamma @ Malligavva and Another v. State of Karnataka, Represented by the Secretary, Department of Health and Family Welfare and Another, ILR (2005) Kar 557. 52 111 (2011) CLT2, (2010) (II) ILR-CUT-690, (2010) (II) OLR 837. 53 Mukesh Gandhi v. Deputy Secretary (Health) Medical Education and Research AIR (2009) Guj 7.

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54 Smt. Kamala Devi v. The Director of Medical Education and Chairman, Authorization Committee for Organ Transplantation, Hyderabad and Anr, WP No. 5618 of 2009 decided on 30 March 2009. 55 Dr M. Anoop v.The State of Tamil Nadu by the Secretary to Government Department of Health and Authorization Committee Rep. by Its Chairman Directorate of Medical Education in WP No. 18657 of 2009 decided on 15 September 2009. 56 Section 14. 57 Section 10(1). 58 Section 10(2). 59 Section 15. Any decision regarding registration, suspension or cancellation is appealable under Section 17. 60 Section 13. 61 Section 18(1). 62 Hitesh Kishorechand Raithatha and Ors v.State of Maharashtra and Anr (2009) Cri LJ 439. 63 Section 18(2). 64 2007 (1) BLJR 382, (2007) Cri LJ 1989, (2007) I JCR 481 (Jhr). 65 Section 19. In R. Sailaja and Another v. State of Karnataka, by the Secretary, Department of Health and Another ILR (2005) Kar 953, 2005(4) Kar LJ 133, considering the plight of the patient, who was barely 32 years old, the judge considered what remedy would be available if he had no relative to offer a suitable kidney, and there was none to donate one in consideration of ‘love and affection’. He wondered if the section itself offended Article 21, which guaranteed the right to life, but did not answer the question. 66 Section 20. 67 Section 21. 68 Section 22, TOHO. 69 AIR (2005) Mad 348, (2005) 3 MLJ 406. In this case, the commission found that the so-called certificate of the authorization committee produced by the doctor was fake, and that the donor had been promised financial recompense. While finding that the Human Rights Commission had no right to entertain the complaint, the high court directed the competent authorities to take appropriate action to prosecute the guilty. 70 Jeewan Kumar Raut and Anr v. Central Bureau of Investigation AIR (2009) SC 2763, (2009) (57) BLJR 2885, (2009) Cri LJ 4109, (2010) 1 GLR 300 (SC), JT (2009) (9) SC 188, RLW (2009) (2) SC 2240, (2009) (9) SCALE 381, (2009) 7 SCC 526, [2009] 10 SCR 272, (2009) (7) UJ 3135 (SC). 71 Dominus membrarum suarum nemo didtur (no one is to be regarded as the owner of his own limbs) Ulpain Edict D9 2 13 pr, quoted in J.C.M.v. A.N.A. 2012 BCSC 584 (In the Supreme Court of British Columbia).

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72 R v. Bentham (2005) 2 All ER 65. Again, it is this recognition that makes an attempt to suicide an offence. So long as a person does not annihilate himself nobody could object to any organ from being donated. 73 BMJ 333 (7 October 2006). 74 See Chapter 2. 75 In re Sidney Cowan, No. 180564 (Probate Court of Jefferson County, Ala. 2003). 76 31 Am. J. L. and Med. 87, ARTICLE: Ethical and Legal Aspects of Using an Identical Twin as a Skin Transplant Donor for a Severely Burned Minor, by Samuel J. Tilden. 77 289 A.2d 386 (Conn. Super. Ct. 1972). 78 445 S.W.2d at 148. 79 126 F.2d 121 (1941). 80 576 S.W.2d 493 (Tex. Civ. App. 1979). 81 10 Pa. D. & C.3d 90 (1978). 82 226 N.W.2d 180 (Wis. 1975). 83 284 So.2d 185 (La. App. 1973). 84 566 N.E.2d 1319 (1990). 85 See Cara Cayette, ‘Organ Harvests from the Legally Incompetent: An Argument Against Compelled Altruism’ B.C. L. REV. 41(2000): 465, 514. (‘The only solution to this dilemma is legislation which requires that an individual be legally competent to give an informed valid consent before he or she may be a candidate for organ donation.’) 86 See Michael T. Morley, ‘Proxy Consent to Organ Donation by Incompetents’ YALE L.J. 111(2002): 1215, 1248. (‘The decision of parentguardians to tender proxy consent should not be second guessed by the courts. Whether or not one feels that parent-guardians are bound only to consider the best interests of the potential donor, final resolution of the issue is constitutionally committed to their sole discretion.’) 87 See Bryan Shartle, Proposed Legislation for Safely Regulating the Increasing Number of Living Organ and Tissue Donations by Minors, LA. L. REV. 61(2001): 433, 461. (‘The fact that only two of the seven reported cases (i.e. appealed cases) discussed above involved a living donation by a mentally competent minor gives rise to a fair assumption that such donations are usually approved —possibly rubber stamped by district courts—and, thus, the cases never appealed. A legislative standard ensures that every living organ or tissue donation by a minor, whether a questionable donation or not is reviewed on its own merits, rather than through case law analysis.’) Also, Alabama has a statutory exception for bone marrow donation by minors. ALA. CODE § 22-8-9 (West 2003) (‘Any minor who is 14 years old or older, or has graduated from high school, or is married, or having been married is divorced or is pregnant,

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may give effective consent to the donation of his or her bone marrow for the purposes of bone marrow transplantation. A parent or legal guardian may consent to such bone marrow donation on behalf of any other minor.’) 88 See Lynn E. Lebit, Compelled Medical Procedures Involving Minors and Incompetents and Misapplication of the Substituted Judgment Doctrine, J.L. & HEALTH 7(1992-3): 107,128. (‘Since this standard will be based on a presumption that no compelled procedure is in one’s best interests, one can only rebut this presumption by clear and convincing evidence....The proof required will be much more than an amorphous psychological benefit which may inure upon the minor....’) See also Robert W. Griner, Live Organ Donations Between Siblings and the Best Interest Standard:Time for Stricter Judicial Intervention, GA. ST. U. L. REV. 10(1994): 589, 610. (‘The benefit to be conferred on the donor, establishing the tissue donation as being in the donor’s best interest, should be shown by clear and convincing evidence.’) 89 See Jennifer K. Robbennolt et al., Advancing the Rights of Children and Adolescents To Be. Altruistic: Bone Marrow Donation By Minors, J.L. & HEALTH 9(1995): 213, 244. (‘Such factors might include: the minor’s capacity to appreciate the risks and benefits of a bone marrow harvest; the minor’s capacity to appreciate the nature of the potential recipient’s condition; the minor’s relationship to the potential recipient; the minor’s wishes regarding the harvest; the parent’s wishes regarding the harvest; the availability of a primary caregiver to provide emotional support to the minor donor; the risks and benefits of the procedure to the minor (including psychological risks and benefits) if they can be reasonably estimated.’). See also Patricia Huna, ‘Infants As Organ Transplant Donors: Should It Happen?’, SUM HTHLAW 6(1992): 24, 26. (‘Six factors emerge which could be used to guide future legislation in this subject area. They are the need for consent of the guardian; a substantial need by the donee and a strong probability of benefit to him or her; an absence of another medically preferable alternative; minimal present and future risks to the donor; strong evidence of psychological benefit to the donor; and an independent physician for the donor.’). See also Rachel M. Dufault, ‘Bone Marrow Donations By Children: Rethinking the Legal Framework in Light of Curran v. Bosze’ CONN. L. REV. 24(1991): 211, 245. (‘Modified as this comment suggests—eliminate the presumption in favour of parental decision-making, and embrace values of altruism as to children—the best interests test need no longer suffer from vagueness and manipulation.’)

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Sexuality: The Other Side

TRANSSEXUALS Transsexual individuals identify themselves as the sex opposite to that they were assigned at birth because the external genitalia they were born with and identified by at birth do not comport with their psychological or ‘brain’ sex.1 Transgender is an umbrella term, including cross-dressers, transvestites, drag queens, and transsexuals. Transsexual is more specific. It refers to those among persons whose biological gender does not match the internal self-image. Intersex is what used to be referred to as a hermaphrodite, or someone with both sets of sexual organs. They are rare, but they do exist. Ancient cultures (including Indian) and some religious texts recognize a third sex or gender status. Some argue that transsexualism is a purely psychological disorder because it does not have a known cause or origin like other biological conditions.2 Dr Harry Benjamin strongly supported the view that transsexualism was a form of intersex condition, saying: Intersexes exist, in body as well as in mind. I have seen too many transsexual patients to let their picture and their suffering be obscured by uninformed albeit honest opposition … Biologically minded authors are likely to consider … Trans-sexualism is one of the intersexual phenomena ... American authors reserve the term ‘intersexuality’ exclusively for visible signs of disorders of sexual development, that is to say, for hermaphroditic and pseudo-hermaphroditic abnormalities.The Europeans, especially the Germans, use the term in a much wider sense.3

But at the Brain Bank in the Netherlands, studies support the hypothesis that ‘there is a brain sex difference between men and Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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women, and transsexual people have the brain sex of that gender group to which they maintain they belong.’4 It appears that the brain may be more critical than the external genitalia to psychosexual development and adaptation.5 According to Milton Diamond, an expert on intersexed and sex-reassigned individuals, ‘brain sex’ is a ‘powerful and new approach that will get a good deal of attention legally since it trumps all the standard characteristics used to determine one’s sex.’6

Transsexual and Homosexual Often, transsexuals are erroneously confused with homosexuals or are regarded merely as transvestites. By definition, a transsexual cannot be a homosexual, even if he or she is attracted to members of his or her own physical sex.7 Unlike transsexuals, homosexuals know that they are attracted to members of their own sex, and feel sexually comfortable with their bodies as they are. Any person who dresses in the clothing of the opposite sex, however, is a transvestite. Transsexuals usually cross-dress because they believe that they belong to the opposite sex. Transsexuals may be transvestites, but not all transvestites are transsexuals.8

Property Rights in Hindu Law and Muslim Law for the Transgendered With the possible exception of the Cochin Makkathayam Thiyya Act,9 which treats a neuter as a female for the purpose of Hindu Succession Act, there is no codified law in India that makes specific reference to neuters as a class of persons to inherit property or figure as a propositus as constituting a fresh stock of descent. Ancient Hindu law treated them alongside idiots and impotent persons as disqualified from inheritance.10 The Hindu Inheritance (Removal of Disabilities) Act, 1928, however, removes such disqualifications except for lunatics or idiots from birth. Now the Hindu Succession Act states under Section 28 that no person may be disqualified from succeeding to any property on the ground of any disease, defect, or deformity. Duncan Derret would advocate that in the absence of a specific statutory provision, the rule of Islamic law may be drawn upon under the authority to apply justice, equity, and good conscience, and the property must be

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distributed according to the order applicable to the sex that the propositus most closely resembled.11

Transsexual Rights in Europe and the US In Europe, the recognition of transsexuals’ right to change their birthassigned sex is a recent development.12 Until 2002, Corbett v. Corbett governed English marriage law with respect to transsexuals, holding that an individual cannot change his birth-assigned sex.13 However, in I. v. United Kingdom (Case of I) in 2002, the European Court of Human Rights(ECHR) found that the UK violated Articles 814 and 1215 of the European Convention on Human Rights and Additional Protocols when it did not recognize the petitioner’s sex change.16 Seven states—California, Illinois, Maine, Massachusetts, Minnesota, New Mexico, and Rhode Island—have legislation that protects against discrimination based on gender identity. In 1966, a US court first considered the right of transsexuals to legally change their sex in Anonymous v. Weiner17 (Anonymous I). In Anonymous I, the petitioner sought to change the sex on her birth certificate from male to female in the New York Supreme Court. The Court sent the petitioner’s request to the administrative agency responsible for issuance of a new birth certificate, the Bureau of Records and Statistics of the Department of Health of the City of New York (Bureau).The Bureau, recognizing the possible consequences of any decision, called upon the New York Academy of Medicine (Academy) to study the problem and to submit its recommendations to the Board of Health. The Committee on Public Health of the Academy turned to a group of specialists to explore the issue of changing transsexuals’ birth certificates to reflect their identified sex. The Academy reported that it opposed a change of sex on a birth certificate for transsexuals, reasoning that the public interest in protection against fraud outweighed a transsexual’s right to privacy. After receiving the Academy’s opinion, the Bureau unanimously denied the petitioner’s application for amendment or issuance of a new birth certificate. On review of the petitioner’s request, the New York Supreme Court stated that it was unable to substitute its views for those of the administrative body in charge of maintaining the records of births and deaths because doing so would usurp a function of the executive branch of government.

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In Illinois, the Vital Records Act provides for the procedures necessary for the re-issuance of a birth certificate, which is particularly relevant to the recognition of transsexuals and to the outcome in Simmons. The act governs the reissuance of a birth certificate for the purposes of adoption, legitimacy, and sex-reassignment. The act provides, in part, that a person may obtain a new birth certificate subject to certain restrictions. Specifically, the act provides that a person shall have a new birth certificate issued after the State Registrar receives an affidavit from a physician stating that the physician has performed a surgery such that the applicant’s birth certificate should be changed.18 In Smith v. City of Salem,19 the Sixth Circuit became the first federal appellate court to extend Title VII protection to a transsexual employee. Jimmie Smith was a lieutenant in the Salem Fire Department and worked for seven years without incident. After being diagnosed with gender identification disorder, characterized by severe distress and discomfort caused by conflict between one’s gender identity and one’s sex at birth, Smith followed medical protocol and began ‘expressing a more feminine appearance on a full time basis’ including at work. Soon thereafter, his co-workers began to complain about his non-masculine appearance and that his mannerisms were not ‘masculine enough’. Smith’s condition became the subject of much concern among city officials, which resulted in a number of actions, including a three-day suspension. Based on this action, Smith sued.The district court, following fairly established body of law throughout the country, labelled Smith as a ‘transsexual’, found that transsexuality was not protected by Title VII and dismissed the case. On appeal, the Sixth Circuit distinguished the body of law relied on by the district court.Those cases made a distinction between sex (biological) and gender (biological and social) discrimination, and held that Title VII dealt only with biological discrimination. In the court’s view the earlier case law could be summed up in this manner: In this earlier jurisprudence, male-to-female transsexuals (who were the plaintiffs in Ulane, Sommers, and Holloway)—as biological males whose outward behaviour and emotional identity did not conform to socially-prescribed expectations of masculinity—were denied Title VII protection by courts because they were considered victims of ‘gender’ rather than ‘sex’ discrimination.This approach had been, in the words of the Sixth Circuit, ‘eviscerated’ by a still earlier decision in Hopkins v. Price Waterhouse. Applying Hopkins to Smith’s situation seemed simple, when the court reasoned,

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An employer who discriminates against women because, for instance, they do not wear dresses or makeup, is engaging in sex discrimination because the discrimination would not occur but for the victim’s sex. It follows that employers who discriminate against men because they do wear dresses and makeup, or otherwise act femininely, are also engaging in sex discrimination, because the discrimination would not occur but for the victim’s sex.

Barnes v. City of Cincinnati20 was a jury award based on sex discrimination in favour of a preoperative male-to-female transsexual probationary police sergeant who was denied permanent promotion. When he was promoted, Barnes was a male-to-female transsexual who was living as a male while on duty but often lived as a woman off duty. Evidence was offered that Barnes had a French manicure, had arched eyebrows, and came to work with makeup or lipstick on his face on some occasions. Much of the basis for his failure to receive a permanent promotion was attributed to his lack of ‘command presence’, a term that meant failure to have respect of his subordinates to some, and failure to project a certain kind of image to others. He also was criticized by one superior as not being masculine enough. All of this was sufficient for the court to uphold the jury’s finding of sex discrimination based on failure to conform to sexual stereotypes. At least one court outside the Sixth Circuit has directly addressed the rationale of the Salem and Barnes decisions, finding them wrongly decided. In Etsitty v. Utah Transit Authority,21 a male-to-female transsexual bus driver was terminated because of the employer’s concern about his use of female restrooms while out on route. He was, however, eligible to re-apply following his surgery, ‘when he no longer had male genitalia.’ The court, after first noting that all agreed that transsexuals as a class were not protected, specifically disagreed with the gender stereotyping argument adopted by the Sixth Circuit. In the court’s view, taken to the extreme, the theory in the Smith case would mean that if an employer cannot bar a transsexual male from dressing and appearing as a woman (because it would be sex stereotyping under Price Waterhouse), then a non-transsexual male must also be allowed to dress and appear as a woman. In fact, if something as drastic as a man’s attempt to dress and appear as a woman is simply a failure to conform to the male stereotype, and nothing more, then there is no social custom or practice associated with a particular sex that is not a

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stereotype. And if that is the case, then any male employee could dress as a woman, appear and act as a woman, and use the women’s restrooms, showers and locker rooms, and any attempt by the employer to prohibit such behaviour would constitute sex stereotyping in violation of Title VII. Price Waterhouse did not go that far. This complete rejection of sex-related conventions was never contemplated by the drafters of Title VII and is not required by the language of the statute or the Supreme Court opinion in Price Waterhouse. Even apart from the above reasoning, Americans with Disabilities Act22 does not specifically extend the coverage of the act to those whose behaviour is attributable to transsexuality.

Ambiguous or Traumatized Genitalia and Sexual Reconstruction Surgeries Cases of infants born with ambiguous genitalia23 are not common but nor are they rare. Of the 3–4 million children born annually in the US, approximately one in 2,000 are born with ambiguous external genitalia (thus approximately 1,500 to 2,000 such children yearly).Through a procedure called genitoplasty, an estimated 100–200 paediatric surgical sex-reassignments are performed in the US annually. The Hindustan Times reports in an article published on 26 June 2011 under the caption, ‘Docs turn baby girls into boys’ that girls are being ‘converted’ into boys in Indore by the hundreds every year at ages where they cannot give their consent. The report suggests that these surgeries are undertaken due to parental preference for boys over girls, and brings a new dimension to the already known proclivity towards female foeticide in some parts of north India, especially in Punjab, Haryana, Rajasthan, and Uttar Pradesh. In the early 1970s, John Money, a psychologist at the Johns Hopkins’ Hospital, reported the case of an identical twin, who lost his penis at the age of 8 months through a surgical mishap during phimosis repair. Along with psychologist Anka Ehrhardt, Money reported that, following counseling, the parents consented to sex-reassignment surgery (castration, removal of the scrotum, and initial fashioning of a vulva) and to raising their once-son, John, as their new-daughter, Joan. This case is now known in the psychological and medical literature as the John/Joan case.24 The parents were counseled to raise the child

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as a girl and to provide the child with only limited information. The parents were further instructed to keep J/J’s original sex a guarded secret. In fact, the parents later reported that, in order to foster secrecy, they were advised at the time to settle in a distant city. Joan was tomboyish as she grew and never felt completely female. She attempted to commit suicide and a stage came when her father narrated the childhood accident and the sex-change operation performed on her. After the surgical procedures [female-to-male sex re-reassignment surgery], John adjusted well. As a boy he was relatively well accepted and popular with boys and girls. At 16 years, to attract girls, John obtained a windowless van with a bed and bar. When occasions for sexual encounters arose, however, he was reluctant to move erotically. When he told his girlfriend why he was hesitant, that he was insecure about his penis, she gossiped at school and this hurt John very much. Nevertheless, his peers quickly rallied around him and he was accepted and the girl rejected. John later married a woman and adopted her three children. He has bonded with them as a father. ‘Coitus is occasional with his wife. They mostly pleasure each other with a great deal of physical affection and mutual masturbation. John can have coital orgasm with ejaculation.’ The case presents an ethical question in sex-assignment surgery on infants with ambiguous genitalia.The American Academy of Pediatrics published these guidelines: Research on children with ambiguous genitalia has shown that sexual identity is a function of social learning through differential responses of multiple individuals in the environment. For example, children whose genetic sexes are external genitalia (i.e., hermaphroditism) can be raised successfully as members of either sex if the process begins before the age of 21/2 years. Therefore, a person’s sexual body image is largely a function of socialization.

This is strongly challenged by many academicians25 and even the consent obtained from parents for performing surgeries on children are contested on the grounds that practitioners obtain consent on (1) the false aura of urgency; (2) the failure to impart complete and accurate information; (3) the oppressive secrecy in which parents were advised to not discuss the situation with others and to particularly withhold all information from the child; (4) the failure of physicians to reveal the uncertainty of the outcome; and (5) the failure to account

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for the child’s ‘right to an open future’ in the decisional calculation. Waiting to see what the child desires is the most sensible approach because, as it has been often stated, the most important sex organ is between the ears rather than between the legs.26 Nancy Ehrenreich with Mark Barr vehemently argue27 that these surgeries are as objectionable as African cultural practices of female circumcision. They say that the parents of these children are often poorly informed about the need for and effects of the surgery and are sometimes pressured by doctors to consent to it.

sex-reconstruction surgery and indian law There is no specific law either permitting or proscribing genitoplasty in India.28 The MCI does not itself lay down any guidelines for its practice.29 However, emasculating or castrating is an offence under Section 320, of the IPC. If such a surgery is perceived as causing intentional harm, there is a right of defence under ‘general exceptions’ enumerated in Section 88 that any action taken in good faith—or when consent of the person is given to suffer that harm—cannot still constitute an offence. Birth and death registration laws in the state list under the Constitution of India and if a child is entered as belonging to a particular sex, any change in such entry must follow the procedure prescribed under such state law. There is no express provision in any state law that allows for change of entry regarding sex after surgery, and in the absence of specific statutory provisions, it shall become possible only on the directions of the court. Faizan Siddiqui v. Sashastra Seema Ba30 was a case before the Delhi High Court that dealt with the issue of disqualification of a person who was a hermaphrodite from a paramilitary force. The case presented unique facts relating to medical fitness of the candidate who was seeking recruitment to the Sashastra Seema Bal, which is involved in securing the border states of the country. She had passed the physical standards test, physical efficiency test, the written test, and the interview at the SHQ, SSB, Gorakhpur for selection to the post as female constable. She had, however, been declared medically unfit, possibly because of the hormonal treatment that she was continuing.The medical condition as elicited through the certificate from the doctor who had treated her was as follows:

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Faizan Siddiqui was seen by me in 2002, at age 15 years, for complaint of swellings in her labia (private parts). On examination, she had external gonads which appeared like testes, but no development of any male like sexual characteristics of her external genitalia. She had breast development and a feminine voice. The clinical suspicion of the disease Complete Androgen Insensitivity Syndrome was confirmed by the following tests: Karyotype 46 X Y, serum testosterone 1380 ng/dl, LH 15 IU/L. This is a condition where by birth, the action of male hormone on the body does not occur, so a baby who is born male has physical characteristics of a female, and throughout life develops like a girl, physically, mentally and psychologically. After appropriate counseling with patient and her parents, a surgical opinion was sought and Dr RK, professor of urology at this institution, performed a removal of testes followed by vaginoplasty, in 2002. Since then, she had been on female hormones by tablet. She had been advised to take female hormone lifelong. She was not expected to have any serious illness as long as she is compliant with her medication. She could certainly have a normal married life, and her condition was compatible with any career a woman normally can undertake. However, she had been counseled that she would not be able to bear children in the natural way.

The Court, while discarding a medical opinion rendered by the employer’s representative that she would not be suitable to the job, quoted the decision of US District Court judgment abhorring discrimination on account of sex-change surgery. It had also referred to the International Olympic Committee’s Stockholm Consensus Statement, which concluded that individuals who were diagnosed with androgen insensitivity disorder might compete as females at sporting events if they so wished, and that and rogen insensitivity does not accord competitive advantage over other women competitors.The court discarded as unreliable the medical opinion presented by the employer’s representative as to her unfitness and held that the rejection of her candidature was discriminatory on the ground of sex. The Court upheld the petitioner’s case to employment.

Disabilities Arising Out of Transgender Status

us cases Ulane v. Eastern Airlines31 involved discrimination against a post-operative transsexual. The plaintiff, Karen Ulane, had been a senior airline

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pilot prior to undergoing sex-change surgery. After the surgery, Ulane was dismissed on grounds which the court trial found that Eastern did not want transsexual in the cockpit. Ulane brought suit against the defendant airline for her reinstatement as a senior flying officer and for other relief. She based her claim on alleged contraventions of Title VII of the Civil Rights Act. Ulane succeeded; the trial court found that her employer had discriminated against her as a transsexual. When the plaintiff sought clarification of the finding, the court amended the judgment to include that ‘Ulane is also a female and has been discriminated against on this basis....’ With respect to the evidence of discrimination against Ulane as a female, the trial judge stated that ‘[it] is my intention that all of my findings and conclusions concerning sexual discrimination against the plaintiff by Eastern Airlines, Inc. apply with equal force whether plaintiff be regarded as a transsexual or a female.’32 The appeals court reversed, finding no evidence of discrimination against Ulane as a female.33 It deliberately avoided the sexual identity question, merely stating that Ulane ‘is a transsexual—a biological male who takes female hormones, cross-dresses and has surgically altered parts of her body to make it appear to be female.’ The appeals court confirmed earlier decisions which held that reference to the word ‘sex’ in the relevant section of Title VII of the Civil Rights Act means ordinary biological sex, male or female, and that Title VII is not so expansive in scope as to prohibit discrimination against transsexual. Accordingly, the appeals court found that it was unnecessary to decide whether or not plaintiff ’s employer had discriminated against Ulane as a transsexual. In Rush v. Johnson34, Carolyn Rush, a post-operative transsexual female, brought suit for review of a decision by the Director of the Georgia Department of Medical Assistance.The director refused Rush’s application for reimbursement of hospital and medical fees resulting from her sex-change procedures. Rush succeeded in the trial court, but the judgment was set aside on appeal and the case remanded to federal district court to determine two essential issues: (1) whether Georgia in fact, had a policy prohibiting payment for experimental medical or surgical services when it first rejected plaintiff ’s application, if so, (2) whether its determination that transsexual surgery is experimental is reasonable. It affirmed the finding on the first issue and said of the second question that there was no definite medical evidence that

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surgery was necessary and hence the surgery was merely experimental. Considering the factual situation existing when the trial court made its decision, the appellate court determined the first issue in the affirmative. The second, and perhaps the most important, issue focused on the testimony of five highly qualified medical and psychiatric specialists with expertise in the treatment of transsexualism.

UK Litigation Regina v. Tan35 concerned charges that Gloria Greaves, a post-operatic female, contravened section 30 of the Sexual Offences Act of 1956. Section 30 provided in part that it is an offence ‘for a man knowingly to live wholly or in part on the earnings of prostitution.’ (emphasis added). Clearly, a female cannot commit this offence. Gloria Greaves, formerly a biological male, underwent sex-change procedures in the usual form of plastic surgery and hormonal treatment. She considered herself a female in all respects and others regarded her as such. For the previous 20 years, according to her counsel, she had been recognized as a female for national insurance purposes. Moreover, she participated in a ceremony of marriage with a man, Brian Greaves, who at all times regarded her as a female. Her defence to the charge was that as a female, she was beyond the scope of the Act. Following the Corbett court and relying particularly on the Ormrod test, together with admissions regarding her biological features, the court found Gloria Greaves to be a male. In the interest of justice, her counsel urged the Court of Appeal to refrain from applying the Corbett decision to a criminal law issue. Counsel’s arguments did not persuade the court, which held that, ‘both common sense and the desirability of certainty and consistency demand that the decision in Corbett v. Corbett should apply for the purpose, not only of marriage, but also for the charge under Section 30 of the Sexual Offenses Act.’ The Corbett court had intended the Ormrod test to give a result consistent with the common law heterosexual definition of marriage.That court had emphasized that the test was established solely for marriage purposes.The appropriateness and the justice of the adoption of the Corbett decision in Regina v. Tan is doubtful.36 The decision in Regina v. Tan prejudices the aspirations of post-operative transsexuals who have endured extensive irreversible surgical procedures in order to overcome a serious psychological condition.

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European Commission of Human Rights Litigation The European Commission of Human Rights has given its opinion in two separate reports concerning cases where a Contracting State allegedly violated the European Convention of Human Rights by failing to issue a birth certificate indicating solely the transsexual’s post-operative sex. In the first of these cases, in Rees v. United Kingdom, the commission found that failure to correct an applicant’s birth register violated Article 8. With regard to Article 12, however, which guarantees the right to marry, the members of the commission found unanimously that the applicant’s rights had not been violated, but based their finding on two very different rationales. Five members reasoned that once the applicant’s birth register was amended, the obstacle to his marrying a biological female would be removed. The other five members of the commission found in part that ‘National laws may submit the exercise of the right to marry and found a family to limitations which are, neither unreasonable nor arbitrary according to the natural, fundamental institutions of marriage and the family which form part of the deeprooted tradition of the member states.’ The latter group of commissioners further found that contracting states were within the spirit of the convention if they established rules for the validity of marriage concerning the age of the parties, consanguinity and other relationships, mental state and physical incapacity to procreate, etc. Rees v. United Kingdom went up on appeal to the ECHR. By a majority of 12–3, the court held that Article 8, guaranteeing the right to respect for private and family life, had not been violated, mainly because the introduction of a system whereby the birth register of a post-operative transsexual may be amended would impose such onerous duties upon the British legislature, the State administration and the British population as a whole, as would upset any fair balance between the general interests of the community and the interests of any affected individual (the post-operative transsexual).The court rejected Mr Rees’ allegation that the UK violated his right to marry.The Court was of the opinion that the right to marry, as guaranteed by Article 12, refers to the traditional marriage between persons of opposite biological sex. The fact that the article concerned the protection of the institution of marriage ‘as the basis of the family’, the court stated, substantiated this view.

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The European court avoided the real issue, i.e., the determination of the sexual identity of the post-operative transsexual. Its failure to decide this essential question at the outset forced the court to regard Rees throughout as a biological female instead of as a post-operative transsexual male, and thereby prejudiced his case. The court, however, added a rider to its decision, expressing its concern for the legal problems facing post-operative transsexuals and the distress they suffer. The court added that for the time being, the determination of the sexual identity of post-operative transsexuals within the UK must be left to the law of that state, but that the need for appropriate legal measures should be kept under review. It also encouraged increased awareness of scientific and societal developments. This rider can be seen only as reluctance on the part of the European court to approve fully of the present formalistic approach adopted by the English courts.Thus, it would appear that the last word concerning the sexual identity of post-operative transsexuals in the UK has not been heard.

harassment of transgenders In Jayalakshmi v. The State of Tamil Nadu Rep. by Its Secretary, Public Department and Ors,37 sexual harassment had been alleged against police officials on an undertrial accused who was a transgendered person reporting to police station in compliance of bail conditions. On securing a report from the registrar (vigilance) of the high court that the person had immolated himself before the police station only on account of harassment caused to him, the Madras High Court awarded a compensation of Rs 5,00,000 against the state and directed appropriate departmental action against the erring police personnel, including the recovery of amount of compensation from them.

disqualification as to status in election The Madhya Pradesh High Court had even disqualified the election of a mayor of Katni, Kamala Jaan, who contested as a female. The decision has been challenged in the Supreme Court and is still pending.38 Kamala Jaan was reported to have said, ‘If we run as women,

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our political rivals say we are men, and if we contest as men, then they say we are women. This is very unfair.’39 The manner of determination of property rights under the Muslim law by assigning to the individual the sex that has the closest resemblance to the sex as female or female could be the best way out.

Government Initiatives for Transgenders The Unique Identification Authority of India (UIDAI) has now included T for transgender alongside the male and female categories.40 In 2006, the State of Tamil Nadu,41 recognizing that ‘aravanis (hijras) are discriminated by the society and remain isolated’, have issued the following directions: I. Counseling be given to children who may feel different from other individuals in terms of their gender identity. II. Family counseling by the teachers with the help of NGOs sensitized in that area should be made mandatory so that such children are not disowned by their families. The CEOs, DEOs, District Social Welfare Officers and Officers of Social Defence are requested to arrange compulsory counseling with the help of teachers and NGOs in the Districts wherever it is required. III. Admission in School and Colleges should not be denied based on their sex identity. If any report is received of denying admission of aravani’s suitable disciplinary action should be taken by the authorities concerned.

HOMOSEXUALITY

Sexual Relations between Persons of Same Sex The Hindu Succession Act, the Christian Marriage Act, and personal law for Muslims only account for marriage provisions between persons of the opposite sex, and indeed, it could not be otherwise, without amending the criminal law provision under Section 377,which considers any sexual relationship between persons of the same sex as an offence. The Delhi High Court (A.P. Shah CJ and Dr Muralidhar J) in Naz Foundation v. Government of NCT of Delhi42 declared this section to be unconstitutional, as offending Articles 14, 15, 19, and 21 in so far as it criminalized sexual relations between adults of the same sex over 18 years of age. Legitimization has an important bearing on succession

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and alimony from the partner in the event of death or abandonment. Gay and lesbian marriages, which have been taboo in all foreign legal regimes as well, have begun accepting this through legislation, though not without stiff opposition from religious groups and other conservative opinions. The US Congress too at first took a conservative stance. In 1996 it enacted the Defense of Marriage Act (DOMA) to empower the states to deny the legitimacy of same-sex marriages. But the constitutionality of measures denying recognition of same-sex marriage was suspect, especially in light of the US Supreme Court’s apparent shift in its consideration of gay and lesbian rights. The court had earlier found that a state sodomy statute enforced only against homosexuals violated no constitutionally protected rights in Bowers v. Hardwick.43 However, in 1996 in Romer v. Evans,44 the Court found that a state constitutional amendment that barred anti-discrimination measures that protected lesbians and gay men violated the US Constitution’s Equal Protection Clause by subjecting one group to a disadvantage that no other group had to suffer. In so doing, the Court took the remarkable step of invoking the landmark dissent in Plessy v. Ferguson45 (Harlan J, dissenting), in the opening paragraph of its decision: ‘The Constitution neither knows nor tolerates classes among its citizens’. Unheeded then, those words now are understood to state a commitment to the law’s neutrality where the rights of people are at stake. The court made it clear that it would not countenance a legal distinction that raised the ‘inevitable inference that the disadvantage imposed is born of animosity toward the class of persons affected.’

naz foundation v. nct of delhi and others This writ petition was founded on the plea that Section 377, IPC, covered sexual acts between consenting adults in private and therefore infringed the fundamental rights guaranteed under Articles 14, 15, 19, and 21 of the Constitution of India. In court, the challenge was limited to the plea that Section 377, IPC, should apply only to non-consensual penile non-vaginal sex and penile non-vaginal sex involving minors. The writ petition had been originally dismissed by the court in 2004 on the ground that there is no cause of action in favour of the petitioner, and that such a petition cannot be entertained to examine the academic challenge to the constitutionality of the legislation. The

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Supreme Court46 set aside this order, observing that the matter did require consideration and was not of a nature which could have been dismissed on the aforesaid ground. The matter was remitted to the High Court for a fresh decision. In Court, the Government of India spoke through two voices; the Ministry of Home Affairs sought to justify the retention of Section 377, whereas the Ministry of Health Welfare insisted that continuance of Section 377, IPC, has hampered HIV/AIDS prevention efforts. The court held in conclusion: We declare that Section 377 IPC, insofar it criminalises consensual sexual acts of adults in private, is violative of Articles 21, 14 and 15 of the Constitution. The provisions of Section 377 IPC will continue to govern non-consensual penile non-vaginal sex and penile non-vaginal sex involving minors. By ‘adult’ we mean everyone who is 18 years of age and above. A person below 18 would be presumed not to be able to consent to a sexual act. This clarification will hold till, of course, Parliament chooses to amend the law to effectuate the recommendation of the Law Commission of India in its 172nd Report which we believe removes a great deal of confusion. Secondly, we clarify that our judgment will not result in the re-opening of criminal cases involving Section 377 IPC that have already attained finality.

criminal law provision Section 377 of the IPC describes as unnatural offence, ‘Whoever voluntarily has carnal intercourse against the order of nature with any man, woman or animal, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.’ Explanation—Penetration is sufficient to constitute the carnal intercourse necessary to the offence described in this section.

law commission recommendations In Writ Petition (Crl.) No.33 of 1997, the petitioner Sakshi, an organization interested in issues concerning women, approached the Supreme Court of India for directions, inter alia, concerning the definition of the expression ‘sexual intercourse’ as contained in Section 375 of the IPC. The Supreme Court by its order dated 13 January 1998 directed the Law Commission to indicate its response with

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respect to the issues raised in the writ petition. The commission filed an affidavit dated 28 July 1998 setting out in extenso the portions of its 156th report on the IPC, dealing with the issues in question. In the report, the then Law Commission (14th) differed with the viewpoint of the writ petitioners except in certain minor respects. The Supreme Court, however, was inclined to agree with the submissions of the writ petitioners. The commission was asked by the Supreme Court by its order dated 9 August 1999 to examine the issues afresh. A copy of the draft of comments prepared by the commission was then forwarded to Sakshi inviting their views and for suggesting changes of a procedural nature, whether in the Criminal Procedure Code or the Evidence Act. Later on, three other organizations, namely, Interventions for Support, Healing and Awareness (IFSHA), All India Democratic Women’s Association (AIDWA), and the National Commission for Women (NCW) also presented their views on the proposed suggestions. After detailed discussions with these organizations, the commission recommended changes for widening the scope of the offence in Section 375 and making it gender-neutral. Various other changes have been recommended in Sections 376 and 376A–D; and a further recommendation by insertion of a new section, 376F, dealing with unlawful sexual contact; deletion of Section 377 of the IPC; and enhancement of punishment in Section 509 of the IPC. In order to plug the loopholes in procedural provisions, the commission has also recommended various changes in the CrPC, 1973, and in the Evidence Act, 1872. The final report focuses on the need to review the rape laws in the light of increased incidents of custodial rape and crime of sexual abuse against youngsters. Sexual assault on a child causes lasting psychic damage and, as such, it is essential to prevent sexual abuse of children through stringent provisions. The purport of these new sections is to substitute the offence of ‘rape’ under Section 375 with the offence of ‘sexual assault’ by including all kinds of penetration in the vagina, anus, or urethra of another, whether by a part of the human body or by an object. It was accordingly suggested that Section 376 be modified in the light of the change in Section 375, and that Sections 376A, 376B, 376C, and 376D be retained substantially except adapting them to the changes made in the offence under Section 375, and a few changes in the matter of

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punishment. It has also been proposed that ‘unlawful sexual contact’ be added as an offence under Section 376E, and Section 377 be deleted as unnecessary in the light of the preceding provisions. This section is intended to cover a wide variety of offences, including sexual harassment at the workplace and sexual perversions of the kind mentioned in the note submitted by Sakshi. Subsection (1) of this new section covers touching, directly or indirectly, with a part of the body or with an object, any part of the body of another person who is not their spouse with sexual intent and without their consent. If the other person is below 16 years of age, the commission recommended a greater punishment. If a person commits the offence of unlawful sexual contact on a young person who is in a relationship of dependency with them, the punishment is rigorous imprisonment that may extend to seven years, fine, or both, and if the offender happens to be the father, grandfather or brother, a still higher punishment is provided for. In the case of a ‘young person’, consent is treated as irrelevant. The commission itself pointed out that Sections 151, 152, and 153 of the Canadian Criminal Code also contain similar provisions. Section 509, IPC, is also sought to be amended to provide higher punishment where the offence set out in the section is committed with sexual intent.

cases in other countries examined in naz foundation The first successful international human rights cases concerning the privacy on same-sex relations were taken under the ECHR. In Dudgeon v. The United Kingdom, 45 Eur. Ct. H.R. (ser. A) (1981), and Norris v. Republic of Ireland, 142 Eur. Ct. H.R. (ser. A) (1988), the criminalization of such practices was deemed a violation of the privacy protection in Article 8 of the ECHR. In Dudgeon v. The United Kingdom, the ECHR held that ‘maintenance in force of the impugned legislation constitutes a continuing interference with the applicant’s right to respect for his private life (which includes his sexual life) within the meaning of Article 8 para 1 Article 8(1).’ In the personal circumstances of the applicant, the very existence of this legislation continuously and directly affects his private life. In Norris v. Republic of Ireland, the ECHR ruled that Ireland’s blanket prohibition on gay sex breached the ECHR. The Court quoted with approval the finding of an Irish Judge that ‘[o]ne of the effects of criminal sanctions against homosexual acts is to reinforce

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the misapprehension and general prejudice of the public and increase the anxiety and guilt feelings of homosexuals leading, on occasion, to depression and the serious consequences which can follow....[para 21]’ In Modinos v. Cyprus, 259 Eur. Ct. H.R. (ser. A) (1993), the ECHR again held that such a law violated the right to privacy, and maintained that even a ‘consistent policy’ of not bringing prosecutions under the law was no substitute for full repeal. In Toonen v. Australia, (No.488/1992 CCPR/C/ 50/D/488 /1992, March 31 1994), the Human Rights Committee held that the continuous existence of Tasmanian sodomy laws violates Article 17 of International Covenant of Civil and Political Rights. The committee observed: The Committee considers that sections 122(a) and (c) and 123 of the Tasmanian Criminal Code ‘interfere’ with the author’s privacy, even if these provisions have not been enforced for a decade. In this context, it notes that the policy of the Department of Public Prosecutions not to initiate criminal proceedings in respect of private homosexual conduct does not amount to a guarantee that no actions will be brought against homosexuals in the future, particularly in the light of undisputed statements of the Director of Public Prosecutions of Tasmania in 1988 and those of members of the Tasmanian Parliament. The continued existence of the challenged provisions therefore continuously and directly ‘interferes’ with the author’s privacy. [para 8.2]

In The National Coalition for Gay and Lesbian Equality v. The Minister of Justice, the Constitutional Court of South Africa struck down the sodomy laws on the ground of violation of rights to privacy, dignity and equality. Ackermann J. narrated the palpable invasion of their rights: The common-law prohibition on sodomy criminalises all sexual intercourse per anum between men: regardless of the relationship of the couple who engage therein, of the age of such couple, of the place where it occurs, or indeed of any other circumstances whatsoever. In so doing, it punishes a form of sexual conduct which is identified by our broader society with homosexuals. Its symbolic effect is to state that in the eyes of our legal system all gay men are criminals. The stigma thus attached to a significant proportion of our population is manifest. But the harm imposed by the criminal law is far more than symbolic. As a result of the criminal offence, gay men are at risk of arrest, prosecution and conviction of the offence of sodomy simply because they seek to engage in sexual conduct which is part of their experience of being

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human. Just as apartheid legislation rendered the lives of couples of different racial groups perpetually at risk, the sodomy offence builds insecurity and vulnerability into the daily lives of gay men. There can be no doubt that the existence of a law which punishes a form of sexual expression for gay men degrades and devalues gay men in our broader society. As such it is a palpable invasion of their dignity and a breach of section 10 of the Constitution. [para 28].

In Lawrence v. Texas 539 US 558 (2003), holding the Texas sodomy laws as unconstitutional, the US Supreme Court reversed its earlier decision in Bowers v. Hardwick. Kennedy, J., who delivered the opinion of the Court said: It suffices for us to acknowledge that adults may choose to enter upon this relationship in the confines of their homes and their own private lives and still retain their dignity as free persons. When sexuality finds overt expression in intimate conduct with another person, the conduct can be but one element in a personal bond that is more enduring. The liberty protected by the Constitution allows homosexual persons the right to make this choice. [page 567] The issue is whether the majority may use the power of the State to enforce these views on the whole society through operation of the criminal law. ‘Our obligation is to define the liberty of all, not to mandate our own moral code.’ [page 571] ....When homosexual conduct is made criminal by the law of the State, that declaration in and of itself is an invitation to subject homosexual persons to discrimination both in the public and in the private spheres.... [page 575]

Since 1967 the process of change has informed legal attitude towards sexual orientation. This process has culminated in the decriminalization of sodomy in private between consenting adults, in several jurisdictions. The superior courts in some of these jurisdictions have struck down anti-sodomy laws, where such laws remain on the statute book. In 1967, in England and Wales and in 1980, in Scotland sodomy between consenting adult males in private was decriminalized. However, in Northern Ireland the criminal law relating to sodomy remained unchanged. In 1982, in pursuance of the decision of the ECHR in Dudgeon v. United Kingdom, sodomy between adult consenting males in private was de-criminalized in Northern Ireland. The same conclusion was reached in 1988 in Norris v. Ireland and Ireland repealed sodomy laws in 1993.

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Laws prohibiting homosexual activity between consenting adults in private having been eradicated within 23 member-states that had joined the Council of Europe in 1989 and of the 10 European countries that had joined since (as on 10 February 1995), nine had de-criminalized sodomy laws either before or shortly after their membership applications were granted. In Australia, all the states with the exception of Tasmania, had by 1982 de-criminalized sexual acts in private between consenting adults and had also passed antidiscrimination laws which prohibited discrimination on the ground, amongst others, of sexual orientation. Tasmania repealed offending sections in its Criminal Code in 1997 in view of the decision of the United Nations Human Rights Committee in Toonen v. Australia. Consensual sexual relations between adult males have been de-criminalized in New Zealand. In Canada, consensual adult sodomy (‘Buggery’) and so-called ‘gross indecency’ were de-criminalized by statute in 1989 in respect of such acts committed in private between 21 years and older which was subsequently brought down to age of 18 years or more. In the US though the challenge to sodomy laws was turned down in Bowers v. Hardwick, but subsequently in Lawrence v.Texas, the sodomy laws in so far as between consenting adults in private were struck down. A number of open democratic societies have turned their backs to criminalization of sodomy laws in private between consenting adults despite the fact that sexual orientation is not expressly protected in the equality provisions of their constitutions. Homosexuality has been de-criminalized in several countries of Asia, Africa and South America. The High Court of Hongkong in its judgments in Leung T.C.William Roy v. Secy for Justice, dated 24 August 2005 and 20 September 2006 struck down similar sodomy laws.To the same effect is the judgment of the High Court of Fiji in Dhirendra Nandan & Another v.State, Criminal Appeal Case No. HAA 85 & 86 of 2005,decided on 26 August 2005. Nepalese Supreme Court has also struck down the laws criminalising homosexuality in 2008 [Supreme Court of Nepal, Division Bench, Initial Note of the Decision 21.12.2007].

Memorandum to the UN General Assembly On 18 December 2008 in New York, the UN General Assembly was presented with a statement endorsed by 66 States from around the world calling for an end to discrimination based on sexual orientation and gender identity.The statement, read out by the UN Representative

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for Argentina Jorge Arguella, condemns violence, harassment, discrimination, exclusion, stigmatization, and prejudice based on sexual orientation and gender identity. It also condemns killings and executions, torture, arbitrary arrest, and deprivation of economic, social, and cultural rights on those grounds. The statement read at the General Assembly reaffirms existing protections for human rights in international law. It builds on a previous joint statement supported by 54 countries, which Norway delivered at the UN Human Rights Council in 2006. UN High Commissioner for Human Rights, who addressed the General Assembly via a video taped message stated: ‘Ironically many of these laws, like Apartheid laws that criminalized sexual relations between consenting adults of different races, are relics of the colonial and are increasingly recognised as anachronistic and as inconsistent both with international law and with traditional values of dignity, inclusion and respect for all.’ Government of India is a party to the declared commitment to address the needs of those at greater risk of HIV including amongst High Risk Groups, such as MSM (See United Nations General Assembly Declaration of Commitment on HIV/AIDS, 2001, at para 64; NACO, MOHFW, National AIDS Control Programme Phase III [2007–2012] Strategy and Implementation Plan, November 2006, at pages 18-32). In the address of the Solicitor General of India before United Nations Human Rights Council47: Around the early 19th Century, you probably know that in England they frowned on homosexuality, and therefore there are historical reports that various people came to India to take advantage of its more liberal atmosphere with regard to different kinds of sexual conduct. ... As a result, in 1860 when we got the Indian Penal Code, which was drafted by Lord Macaulay, they inserted section. 377 in the Indian Penal Code, which brought in the concept of ‘sexual offences against the order of nature.’ Now in India we didn’t have this concept of something being ‘against the order of nature.’ It was essentially a Western concept which has remained over the years. Now homosexuality as such is not defined in the Indian Penal Code, and it will be a matter of great argument whether it’s ‘against the order of nature’.

Is Homosexuality a Disease? There is almost unanimous medical and psychiatric opinion that homosexuality is not a disease or a disorder and is just another

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expression of human sexuality. Homosexuality was removed from the Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1973 after reviewing evidence that homosexuality is not a mental disorder. In 1987, egodystonic homosexuality was not included in the revised third edition of the DSM after a similar review. In 1992, the WHO removed homosexuality from its list of mental illnesses in the International Classification of Diseases (ICD 10). Guidelines of the ICD 10 reads: ‘disorders of sexual preference are clearly differentiated from disorders of gender identity and homosexuality in itself is no longer included as a category.’ The Delhi High Court in Naz Foundation said: Homosexuality is not a disease or mental illness that needs to be, or can be, ‘cured’ or ‘altered’, it is just another expression of human sexuality. Thus popular morality or public disapproval of certain acts is not a valid justification for restriction of the fundamental rights under Article 21. Popular morality, as distinct from a constitutional morality derived from constitutional values, is based on shifting and subjecting notions of right and wrong. But moral conviction or instinctive feeling, however strong, is not a valid basis for overriding the individual’s privacy and for bringing within the ambit of the criminal law private sexual behaviour of this kind.48

The judgment observes that even if the penal provisions are not enforced,49 they reduce gay men and women to ‘unapprehended felons’. The judgment records the contention that laws that proscribe homosexuality is wrong in legal principle because: (1) They exceed the proper ambit and function of criminal law in a modern society, (2) They oppress a minority in the community and target them for an attribute that they do not choose and cannot change. In this respect they are like other laws of colonial times that disadvantage people on the ground of their race or sex. (3) They fly in the face of modern scientific knowledge about the incidence and variety of human sexuality. (4) They stigmatize and shame a section of citizens such that makes it hard to reach them with vital messages about safe sexual conduct, which is essential in the age of HIV/AIDS.

how it conflicts with constitutional morality The judgment in Naz Foundation states that the legislative object of protecting women and children has no bearing in regard to consensual sexual

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acts between adults in private. Section 377, IPC, is facially neutral and apparently does not target identities, but in its operation it does. Sexual orientation is analogous to sex, and discrimination on the basis of sexual orientation is not permitted by the fundamental rights protected under Articles 14 (equality), 15 (discrimination on the ground of sex), 19 (fundamental freedom guaranteeing right to privacy), and 21 ( right to personal life and liberty). The judgment examines the diverse legal regimes across the globe and considers opinions that may be suffused in Indian constitutional notions of equality, privacy, personal dignity, and morality.

objections that the judgment does not address Naz Foundation has been the subject of widespread debate in electronic and print media. Special leave petitions have been filed to the Supreme Court, and going by the newspaper reports, the objections have been on the following basis: (1) The judgment is against the Indian sense of morality, tradition, and cultural values. In other words, west is west; east is east. (2) It is against our religion: Hinduism, Islam, Christianity, Jainism, and Buddhism proscribe such sexual practices as sins. (3) Homosexuality is a disease. It can be cured. Legitimizing it is allowing an illness to permeate into our society and fester in a healthy environment. (4) Parental objections will see a new genre of runaway gay couples coming to police stations and courts seeking protection of their lives and liberty. The judgment, which runs into 105 pages, written with remarkable lucidity, verve, and logical persuasiveness, does not examine religious objections or what are perceived as against Indian culture. One may suspect that the omission is deliberate. The Court had delivered the judgment on the strength of legal reasoning that is distanced from religion and dogma.

disability arising out of sexual orientation Sexual orientation as a subject of disability or harassment has not come to court’s notice through any complaint. In the UK, following European Council’s Directive 2000/78 for establishing a general framework for equal treatment in employment and occupation, Employment Equality (Sexual Orientation) Regulations, 2003,50 has been brought into force. They regard unlawful subjection of an employee in a workplace as harassment on grounds of sexual orientation.51 Harassment may occur where

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the perpetrators believe that the victim is gay even if he is not. If the actual, perceived, or assumed sexual orientation of an employee by his fellow employees is not gay, then no complaint lies under this regulation.52 NOTES 1 See kdfletcherlaw.com: An Article, In re Marriage of Simmons: A Case for Transsexual Marriage Recognition, by Katie D. Fletcher, mentored by Judge Lola Maddox (last visited 5 May 2012). Jerold Taitz observes,‘Transsexualism, or gender dysphoria syndrome, is a rare psychological condition. It has been described as a “passionate, life-long conviction that one’s psychological gender—that indefinable feeling of maleness or femaleness—is opposite to one’s anatomic sex”. For a person suffering with the condition, it is no less real than the awareness and effect of any serious illness, incurable defect or physical malformation of the body. The syndrome may manifest itself as a state of depression leading to suicide in extreme cases. Usually, transsexuals are obsessively disgusted by their sexual organs and may seek to conceal them, as these genitalia identify them with their abhorrent anatomical sex.Transsexual males have been known to amputate their genitalia or to attempt to do so’. See ‘Judicial Determination of the Sexual Identity of Post-Operative Transsexuals: A New Form of Sex Discrimination’, American Journal of Law & Medicine (1987): 53. 2 Teresa A. Zakaria, ‘By Any Other Name: Defining Male and Female in Marriage Statutes’, Ave Maria L. Rev. 3(2005): 349, 356. The author uses the term transsexual to refer to a person who has a strong desire to become the opposite sex of his or her unambiguous birth sex and who suffers not from a biological condition but from a psychological disorder. The author supports this by stating that biological conditions have a known cause or origin, psychological disorders do not, and transsexualism does not have a known cause or origin. 3 Harry Benjamin, ‘Transvestism and Transsexualism’, Journal of Sex Research 5(2) (1953): 13. 4 See kdfletcherlaw.com: An article, ‘In re Marriage of Simmons: A Case for Transsexual Marriage Recognition’, by Katie D. Fletcher, mentored by Judge Lola Maddox (last visted 5 May 2012). 5 Julie A. Greenberg, ‘Defining Male and Female: Intersexuality and the Collision Between Law and Biology’, Ariz. L. Rev. 41 (1999): 265, 271 explaining with reference to case of the John/Joan story that provides stark evidence that a person’s brain, not anatomy or social environment, predetermines sexual identity. See text inside for reference to the story). 6 Quoted in ‘In re Marriage of Simmons: A Case for Transsexual Marriage Recognition’, by Katie D. Fletcher (last visted 5 May 2012).

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7 Quoted in In re Marriage of Simmons: A Case for Transsexual Marriage Recognition, by Katie D. Fletcher, last visted 5 May 2012. 8 Roth, ‘Transsexualism and the Sex-Change Operation: A Contemporary Medico-Legal and Social Problem’, Medico-Legal J. 49 (1981): 5, 14; Block and Tessler, ‘Transsexualism and Surgical Procedures’, Surgery, Gynecology and Obstetrics 132 (1971): 517, 522. 9 See Section 5. 10 See Yellavajhala Surayya v. Yellavajhalu Subbamma (1920) ILR 43 Mad 4. See also Mayne, Chapter 9, Hindu Law and Usage, 12th edition, (1986), p. 8328. 11 Derret’s Introduction to Modern Hindu Law (Oxford: 1962), pp. 375–6. 12 See I v. United Kingdom (Case of I), App. No. 25680/94, 36 Eur. Ct. H.R. Rep. 967 (2002), available at http://cmiskp.echr.coe.int/tkp197/search. asp?skin=hudoc-en (search Application Number 25680/94) (recognizing the right of a transsexual to change his or her birth-assigned sex); Goodwin v. United Kingdom, App. No. 28957/95, 35 Eur. Ct. H.R. 447 (2002), available at http:// cmiskp.echr.coe.int/tkp197/search.asp?skin=hudoc-en (search Application Number 28957/95) (finding the UK in violation of the European Convention on Human Rights by not recognizing a transsexual’s identified sex); Robert E. Rains, ‘Legal Recognition of Gender Change for Transsexual Persons in the United Kingdom: The Human Rights Act, 1998’ and “‘Compatibility’” with European Human Rights Law’, Ga. J. Int’l & Comp.L. 33(2005): 333(examining the legal treatment of transsexuals in the United Kingdom and by the European Convention on Human Rights). 13 Corbett v. Corbett, (1970)2 All E.R. 33, 49; see also Case of I, 36 Eur. Ct. H.R. Rep. 967 (explaining that Corbett held that sex for the purpose of marriage was to be determined by the chromosomal, gonadal, and genital tests where these are congruent and without regard to any surgical intervention). The Corbett case does not, however, address incongruence in the chromosomal, gonadal, and genital tests.The same view was reiterated in the decision in 2002 before the Court of Appeal in Bellinger v. Bellinger 2002(1) AllER 311, when it held that a marriage between male who had sexual re-construction surgery to become a female cannot marry lawfully a male and declaration sought for legitimizing such marriage under Matrimonial Causes Act, 1973, ought to fail. 14 Article 8—1. Right to respect for private and family life; 2. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interest of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others. [Council of Europe, Convention for the Protection of Human Rights and Fundamental Freedoms, Article 8, opened for signature Nov. 4, 1950, 213 U.N.T.S. 221, 230 (entered into force Sept. 3, 1953)].

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15 Right to marry: Men and women of marriageable age have the right to marry and to found a family, according to the national laws governing the exercise of this right. 16 Case of I, 36 Eur. Ct. H.R. Rep. 967, PP 42, 74, 85. ‘Under Article 8 of the convention in particular, where the notion of personal autonomy is an important principle underlying the interpretation of its guarantees, protection is given to the personal sphere of each individual, including the right to establish details of their identity as individual human beings.’ It had similarly held earlier held in Van Oosterwijck v. Belgium (3 Eur. Ct. H.R. 557 (1981) that by failing to amend the original birth register, the respondent State violated Article 8 of the convention, guaranteeing the right of respect for private and family life, and Article 12, guaranteeing the right to marry.The ECHR did not consider the merits of this case, finding that the applicant had failed to exhaust his domestic remedies in Belgium. 17 270 N.Y.S.2d 319 (N.Y. Sup. Ct. 1966). 18 410 Ill. Comp. Stat. 535/17(1)(d). 19 378 F3d 566 (6th Cir. 2004). 20 401 F.3d 729 (6th Cir.) cert. denied, 96 FEP Cases 1440 (2005). 21 95 FEP Cases 1836 (D. Utah). 22 42 U.S.C. § 12211(b)(1). 23 Ambiguous genitalia are physical anomalies in that the genitalia are not clearly identifiable as male or female.They are often detected at birth and are a sign of intersex. See Melvin M. Grumbach and Felix A. Conte,‘Disorder of Sex Differentiation’, in J.D. Wilson et al. (eds), Williams Text Book of Endocrinology, 9th edition (1998), pp. 1303, 1331. 24 For accounts of the John/Joan case, see Diamond & Sigmundson, ‘Sex Reassignment at Birth: Long Term Review and Clinical Implications’, Archives Pediatric Adolescent Med. 298 (1997):151. 25 The facts and analysis could be sourced in full to an article titled ‘An Emerging Ethical and Medical Dilemma: Should Physicians Perform Sex Assignment Surgery on Infants with Ambiguous Genitalia? By Hazel Glenn Beh Milton Diamondand published in Mich. J. Gender & L. 7 (2000): 1. 26 Milton Diamond, ‘Self-Testing: A Check on Sexual Identity and Other Levels of Sexuality’, in Gender Blending, B. Bullough,V. L. Bullough, and J. Elias (eds), (Amhearst, New York: Prometheus). 27 ‘Intersex Surgery, Female Genital Cutting,and the Selective Condemnation of “Cultural Practices”’, Harv. C.R.-C.L. L. Rev. 40 (Winter, 2005): 71. 28 The Hindustan Times reported (29 June 2011) under the caption,‘Minister, Rights Body Explore Law for Child Sex Surgeries’ that the Union Ministry of Women and Child Development is exploring the possibility of a law to deal with sex reassignment surgeries performed on children. Union Minister

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Krishnan Tirath is reported to have asked the National Commission for Protection of Child Rights (NCPCR) to look into the matter and consider whether it is possible to bring in a regulation and monitor these surgeries. A member of the NCPCR,Vinod Tikku, said that the commission was looking forward to exploring the possibility of such a legislation. The NCPCR has remarked that the practice ‘amounts to child rights violations in terms of perpetuation of the age-old preference for boys and biases against the girl child…’ 29 The report of the Hindustan Times on 27 June 2011 under the caption ‘Call for checks on sex surgeries’ is that the MCI has called for the formation of a medical board of experts to decide on the need for such a surgery in every case, and stringent checks in all cities. 30 MANU/DE/2299/2011, W.P (C) 7208/2008 dated 3.5.2011. 31 742 F.2d 1081 (7th Cir. 1984), cert. denied, 471 U.S. 1017 (1985). 32 581 F. Supp. 821, 839-40 (N.D. Ill. 1984). 33 Ibid., 1087. 34 565 F. Supp. 856 (N.D. Ga. 1983). 35 [1983] Q.B. 1053 (C.A.). 36 ‘Judicial Determination of the Sexual Identity of Post-Operative Transsexuals: A New Form of Sex Discrimination’ by Jerold Taitz, Boston University School of Law, American Journal of Law & Medicine, (1987): 53. 37 (2007)4MLJ849. 38 See The Times of India, 4 March 2003, under, ‘SC Notice to MP Govt on Eunuch’s Petition’. The same paper reports on 11 December 2011 under ‘Eunuch’s Election as Mayor Annulled,That the Sagar District Court on Friday Declared Kamala Kinnar’s Election as “Null and Void” because the Mayor’s Seat Was Reserved for a “Woman” Belonging to Scheduled Caste Category.’ 39 http://tinyurl.com/18po; http://www.voanews.com/mediastore/pasricha_india_eunuch_mayor_30aug02 (last visited 5 May 2012). 40 The Indian Express, Saturday (12 February 2011). 41 Vide G.O. (Ms) No.199 dated 21.12.2006. 42 CriLJ(2010):94, 160(2009)DLT277. An SLP has been admitted in the Supreme Court and pending. 43 478 US 186, 191 (1986). 44 517 US 620, 623 (1996). 45 163 US 537, 559 (1896). 46 Order dated 03.02.2006 in Civil Appeal No.952/2006. 47 rtsp://webcast.un.org/ondemand/conferences/unhrc/upr/1st/ hrc080410pm-ng.rm?start=02:18:32& end=02:37:42 at time index 16.30 as cited in the Naz Foundation judgment. 48 In the address of the Solicitor General of India before United Nations Human Rights Council: rtsp://webcast.un.Org/ondemand/conferences/

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unhrc/upr/1st/hrc080410pm-ng.rm?start=02:18:32&end=02:37:42 at time index 16.30. 49 The Times of India (10 July 2009): then CJI K.G. Balakrishnan is reported to have remarked that he had not come by any instance of a case filed against consenting adults for practices of homosexuality in his long judicial career. 50 This directive is to lay down a general framework for combating discrimination on the grounds of religion or belief, disability, age, or sexual orientation as regards employment and occupation, with a view to putting into effect in the member states in the European Union the principle of equal treatment. Before the applicability of the directive, in a conjoint hearing of two cases decided under the Sex Discrimination Act, 1975, in MacDonald v. Advocate General for Scotland and Pearce v. Governing Body of Mayfield School (2004) 1 All ER 339, the House of Lords adopted a restrictive interpretation to the expression ‘sex discrimination’, where the cases had been brought by an officer in Royal Air Force, who was removed from service for his admission during security clearance that he was a homosexual, and a teacher, who subjected to sustained campaign of verbal abuse from pupils that led to retirement on the basis of ill health. The House of Lords held that if in the first case, if he had been a woman and in the second case, if she had been a male, the treatment could not have been ‘less favourable’ and the treatment was not gender-specific, there was no cause of action for a complaint of discrimination. Curiously, the Law Lords did not question whether within the same sex, either as a male or a female, if the sexual orientation had been to the respective opposite sex to find an answer, that there would have been no discrimination resulting in loss of jobs and to that extent both the appellants had been discriminated on the ground of sex. 51 For the purpose of these regulations, Regulation 5(1) provides that a person (‘A’) subjects another person (‘B’) to harassment where, on grounds of sexual orientation, A engages in unwanted conduct that has the purpose or effect of (a) violating B’s dignity; or (b) creating an intimidating, hostile, degrading, humiliating, or offensive environment for B. Reg 5(2) Conduct shall be regarded as having the effect specified in paragraph (1) (a) or (b) only if, having regard to all the circumstances, including in particular the perception of B, it should reasonably be considered as having that effect. 52 English v. Thomas Sanderson Blinds (2008) EWCA Civ 1421, (2009) 2 All ER 468 (CA).

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COSMETIC SURGERY There has been an increasing number of surgeries to enhance personal appearance. The range of cosmetic surgery appears to have no imaginable limits. To illustrate, the Cleveland clinic has approved its doctors’ petition to be the first institution worldwide to perform a human face transplant.1 In 2005, the world’s first partial face transplant was performed in France.This operation has raised heated ethical concerns among professionals and lay persons alike.2 Cosmetic surgery appears to constitute a wholly separate market driven by an expanding consumer demand.3 A doctor treating a patient carries out what the patient wants or what the patient has been assured as surgically feasible. To moralists, cosmetic surgery is tampering with nature and hence ethically undesirable. There is a whole range of surgical procedures that qualify as plastic surgery but have nothing to do with cosmetic surgery.This chapter will outline only the surgical procedures that have no curative aspect but are performed to reconstruct the frame that the body is naturally endowed with. The five most popular surgical cosmetic procedures are liposuction,4 breast augmentation, eyelid surgery, rhinoplasty, and female breast reduction.5 Included in this category is the increasing rate of the number of corrective revision surgeries or ‘re-dos’. Sex-change operations are also dealt with in this chapter as a subject not merely related to patient preference, but also based on the assumption that natural defect is being ‘cured’. Sometimes there Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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might be no cosmetic surgery intended, but the surgical scar could be a cosmetic aberration if the result was on account of any defect in the manner of surgical incision or while closing the wound.6 They are also considered in the context of medical malpractice or negligence.

Non-therapeutic Intervention

enhancing beauty Enhancement of beauty is in the eyes of the beholder, and no objective standards are possible to assess if a particular cosmetic surgery guarantees the result that the patient believes that they will get. Part of why beauty is so important to humans is that our depth of perception allows us to see and recognize that other humans are watching us. Relatively few other species have the ability to perceive whether members of their species are looking at them, but we as humans are acutely conscious of whether or not we are the object of someone’s gaze.7 The courts have not looked beyond considerations of consent and the explanation of procedure in actions for negligence against doctors and complaints of unsatisfying results have run into rough weather. In Mok v. Wong8 the plaintiff sought cosmetic surgery to improve the appearance of her eyes, and signed consent forms for four-quadrant blepharoplasty on the upper and lower eyelids. After surgery, the plaintiff complained of a hooding effect, and the surgeon performed supplementary surgery, placing suspension sutures at the corners of the eyes. On healing, there was a slight inability to close the eyes, for which surgeon recommended minor corrective surgery. The plaintiff refused, and claimed in contract and negligence, alleging lack of consent to procedure, negligence in performance of surgery, failing to perform agreement that she would be made beautiful, and alleging that the effect of surgery had been disastrous to her marriage. Expert evidence indicated that it was uncommon to perform supplementary surgery so soon after original surgery, but that it was simpler as result. The court, however, held that the plaintiff was shown to have understood and signed consent,9 the surgeon did not guarantee beauty, and had explained the procedure.The surgery was properly performed, and supplementary surgery was appropriate.10 The action was accordingly dismissed.

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A typical case of a fastidious patient was presented in Lynn G v. Hugo,11 in which the plaintiff underwent a full abdominoplasty, or ‘tummy tuck’, and was dissatisfied with the result because of an unsightly scar on her abdomen. The facts presented a further complication by the fact that it was suggested at the trial that the plaintiff lacked the capacity to consent to the procedures because she suffered from body dysmorphic disorder (BDD), a preoccupation with slight or imaginary imperfections that causes considerable distress or functional impairment.12 On a question of fact, the court of appeal ruled in favour of the surgeon, holding that there was nothing to indicate that the patient did not possess the capacity to consent or that there was no informed consent.

breast implants The story begins in the 1940s and 1950s, when direct injections of silicone were used to enlarge women’s breasts. By the early 1960s, it was obvious that injections often produced painful and disfiguring complications. Plastic surgeons began working on an implantable device that could contain the silicone and presumably reduce the problems associated with direct injections. In subsequent decades, silicone gel implants were increasingly used to reconstruct breasts after mastectomy (in roughly 20 per cent of cases) and to augment the breasts of women dissatisfied with their natural appearance (in roughly 80 per cent of cases).13 A typical breast implant consists of a ‘thin, transparent silicone envelope (called the shell), filled with silicone gel, sterile saline (salt water), a combination of the two, or aqueous gel.14 Angell15 reports that implants were used for 30 years without sufficient study of their effects. She writes, ‘As it happened, medical researchers did not systematically begin to collect evidence on breast implants until around the time of the FDA ban.’ Notwithstanding their fiduciary duties, many surgeons were silent about the manufacturers’ failure to investigate systematically problems arising in the clinical setting. There was a strong financial interest for the plastic surgeons in maintaining that the implants were safe—even when they did not know whether that was true.16 Though it appears that any link between silicone gel implants and connective tissue disease is small, implants are indisputably linked with other health problems.17 Some women with implants

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have been diagnosed with recognized immune-related disorders such as scleroderma, rheumatoid arthritis, and lupus. Others complain of symptoms that do not fit recognized diagnoses; some physicians and scientists say these women have a general condition called connective tissue disease.18 There have been reports of ruptures that are believed to be caused by a procedure called ‘closed capsulotomy’, in which the physician attempts to relieve capsular contracture by squeezing the breast. Serious concerns are raised by a medical device that requires remedial surgery in an estimated one-quarter of cases. If better data on complications had been collected earlier, public and medical attitudes toward implants would probably have been more cautious. Women considering implants would have been better informed of the possible burdens accompanying a decision to undergo breast reconstruction or augmentation.

knowledge of known risks by previous surgery In Jean Ivy Hopps and Theodore J. Robinson and Frank v. Denhoed,19 plaintiff had undergone cosmetic surgery—a forehead lift—to remove wrinkles. She had already undergone other forms of cosmetic surgery involving the breasts and eyes, and had encountered problems with scarring. The plaintiff saw a video on surgical procedure for a facelift and signed consent. Plaintiff was left with visible scar just below hairline on forehead. The court held that the plaintiff was not unaware of procedures involved with cosmetic surgery, neither was she too sedated to understand consent. The defendant followed proper procedure and hence action for damages against the doctor was dismissed. BIOMEDICAL ENHANCEMENTS

Non-surgical Interventions By biomedical enhancements we mean the non-surgical tools adopted through administration of drugs whose principal objective goes beyond preventing disease, repairing disability, and restoring physiological wholeness. A defining characteristic of enhancements is that market demand for these products are not limited in the usual way by the demonstration of narrowly defined medical symptoms in a population.

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Enhancements transcend the normal, healthy workings of the human mind and body, promising to make people more than able-bodied, finer than good-looking, and better than well.20 If matrimonial ads are any indication, Indian men prefer fair-skinned women. If you have thought that the obsession for complexion is only for the fairer sex, you now have new advertisements of men with dark complexion being rejected by chic girls only to attract them when the same men have applied a fairness cream. Hair transplants, breast enhancement, treatment for leukoderma, memory improvement, dental braces—the areas of cosmetic enhancement are indeed varied. Doctors and advertisers are vying with each other to suggest that as exier you has a greater chance of survival than those with natural traits. Human growth hormones and prenatal sex selection also involve biomedical intervention and raises ethical issues, in that they go to tamper with the natural process of growth or natural conception. The injection of chemical proteins to increase the secretion of growth hormones alters the biological processes governing height in a way similar to how genetic technologies might someday enhance strength, intelligence, or personality for generations to come.21 Preconception sex-selection technology, originally created by the Department of Agriculture of the US (USDA) to sort livestock sperm, works by mixing sperm with a DNA-specific dye that helps separate X- from Y-bearing sperm by flow cytometry. The technique is called Micro-Sort. Selected specimens are used in conjunction with IVF techniques to achieve pregnancy. Available since 1995, Micro-Sort has a 76 per cent success rate in producing boys and a 91 per cent success rate in producing girls.22 The majority of couples using Micro-Sort sex selection technology have no difficulty conceiving on their own; they opt for non-sexual reproduction simply to choose for a boy or girl. Patients from around the world have used the technology to have more than 300 babies.23 Botox is another drug that became so popular that the drug marketed by a pharmaceutical company Allergan has entered the Oxford English dictionary and Merriam-Webster’s dictionaries. In a botox treatment, the doctor injects a diluted form of the drug into a patient’s facial muscles. Over the next few days, the toxin paralyses the tiny muscles that control facial wrinkling, not only halting the development of more wrinkles but eradicating existing ones. The drug has, however, run into rough weather with several class actions in the US against Allergan and doctors who prescribed the drug for its deleterious after-effects.24

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Objections to Enhancement Biotechnologies Dov Fox has gathered no fewer than nine broad objections to biomedical practices that aim to enhance human traits:25 (1) Equality One objection is that limited access to enhancement biotechnologies exacerbates inequalities of wealth and status between the haves and the have-nots. Enhancements promise economic, social, and psychological benefits for those who secure them, but many enhancements will be very costly, at least initially, such that availability will be restricted to those who can afford them. It is unlikely that it would be feasible for either the state or insurance companies to provide such products and procedures as a matter of general entitlement, making them difficult to acquire for those of modest economic means. (2) Fairness A second objection is that enhancements generate unfairness when individuals use them to gain relative advantage over others in zero-sum competitions such as athletic events and academic testing. It is for this reason that use of anabolic steroids are regarded as unacceptable for sportspersons as going to artificially enhancing their performance and disqualifying them from competition if proof is obtained for drug use. (3) Freedom of choice A third objection is that widespread use of enhancements which provide relative advantages compels usage by those who would choose against enhancements if not for pressure imposed by the decisions of others. Examples may be aplenty when examinees in college campuses may resort to using certain types of drugs that assure memory power or help to stay alert only because a few of the students have begun using the drugs. (4) Collective effectualness Negative externalities arise as when the choice of sex selection gives rise to the practice of a skewed preference to a particular sex for off springs. Problems of finding adequate females as partners for males may be a matter of such serious sociological concern that a nation may have difficulties to cope with for a balanced growth.

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(5) Attitudes of toleration A fifth objection is that enhancement biotechnologies reinforce and perpetuate harmful social prejudice. Certain types of plastic surgery, such as facial reconstruction, reshaping noses, re-coloration, etc exhibit tendencies when certain minority sections seek cosmetic changes to conceal their racial identity. When enhancement practices disguise a cultural affiliation occurring against a backdrop of exclusion and exploitation, it teaches the hurtful lesson that minorities are second-class citizens, less worthy of toleration or respect than of aversion and surgical repair.26 (6) Agency A sixth objection is that biotechnological enhancements threaten individual agency. This objection has to do with the shift away from achievements humans undertake through self-initiated striving, and toward those they experience by biochemical interventions, which act on us as passive subjects. New and more powerful means might weaken the spirit of human agency and cheapen the dignity of human activity. Faster and easier ways of enhancing our capacities might rob us of lessons learned and values gained only by actively engaging ourselves in the effort traditionally required for such enhancement. (7) Authenticity A seventh objection is that enhancements undermine the authenticity of users as selves endowed with a particular history and set of characteristics that are both individually unique and distinctly human. The use of mood elevators and antidepressants is a case in point when the drugs make us behave and think differently from how we are normally trained to behave. (8) Medicalization and normality The availability of new biotechnological cures--for memories of shameful behavior, a discontented personality, and the grief of mourning has expanded the definition of disease as patient expectations rise for healthcare professionals to alleviate a wider sphere of life’s adversities. Look at why we seek medical help or consume drugs these days. Take mood elevators for normal depressed feeling; dry cream for oily skin and oily cream for dry skin; get tanned if you are fair and get fairer if you are dark;

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get taller if you are short and vice versa. Everyone has to be Mrs Smart or Ms Just Beautiful. (9) Parental love and community solidarity Biotechnologies reflect an excessive aspiration to remake nature, carrying us further down the road by which people regard their talents and their children more as projects they design than as gifts they receive. In freeing ourselves from the contingency of nature we bear in common, we may find ourselves ill-equipped to understand why parents should love their children unconditionally and why the successful ought to adopt a charitable moral posture toward and share their fates with those who are less fortunate. As the chanced nature of our lot in life fades, so with it may fade the social basis for our moral commitment to the values of toleration and solidarity. LEGAL LIMITATIONS TO ADVERTISEMENTS TO REMEDIES’

‘MAGIC

The Law Applicable The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, was formed with the object to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities, and to provide for matters connected therewith.27 The Drugs and Cosmetics Rules, 1945,28 proscribe any form of claim of cure for certain types of illnesses.29 ‘Magic remedy’ includes a talisman, mantra, kavacha, and any other charm of any kind that is alleged to possess miraculous powers; is used for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals; or is intended to affect or influence in any way the structure or any organic function of the body of human beings or animals.30 ‘Drug’ is defined to include (1) a medicine for the internal or external use of human beings or animals; (2) any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals; (3) any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals; (4) any article intended for use as a component of any medicine, substance or article for any of the above.31 Advertisements about so-called machines

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of science or of electric treatment whose magically curative properties as capable of increasing the sexual virility of a patient will be treated as articles intended to influence the organic function of the human body, which is prohibited under the act. In Zaffar Mohammad alias Z.M. Sarkar v. The State of West Bengal,32 the Supreme Court held an advertiser liable for conviction on the basis of the following claim: New Life, New vigour, New Spirit, New Wave. If you want a cure, see to-day well known world-famous experienced registered Physician. Special diseases such as oldness in youth, all sorts of defects in nerves, or weakness, laziness are treated with full responsibility, with new methods, new machines of science and electric treatment and are cured permanently.

Under the act, no person shall take any part in the publication of an advertisement referring to any drug in terms that suggest or are calculated to lead to the use of that drug for (1) causing a miscarriage in women or prevention of conception in women; (2) the maintenance or improvements of the capacity of human beings for sexual pleasure; (3) the correction of menstrual disorder in women; or (4) the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, or condition specified in the Schedule,33 or any other disease, disorder, or condition (by whatsoever name called) that may be specified in the rules made under the act.34 The law also prohibits any misleading advertisement relating to a drug that gives a false impression regarding the true character of the drug, or is otherwise a false or misleading claim in relation to a drug or any material particulars.35 The prohibition also applies to any medical practitioner.36 There is a further prohibition for import or export of any document containing and advertisement of the nature referred above.37 A person guilty of the act prohibited shall be punishable after a trial by a magistrate of first class,38 (1) in the case of a first conviction, with imprisonment that may extend to six months, or a fine, or both; (2) in the case of a subsequent conviction, with imprisonment that may extend to one year, or with fine, or with both.39 If the person contravening any of the provisions of the act is a company, every person who, at the time the offence was committed, was in charge of and was responsible to the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly.40

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Inadequacy of Existing Law A division bench of the Punjab and Haryana High Court held that if the provisions of the act are to be effectively implemented against the menace of magical remedies and objectionable advertisements the offences prescribed under the act shall be made cognizable and recommended that the state governments shall authorize in all civil surgeons in their respective territories to file complaints under Section 32 of the Drugs and Cosmetics Act. It recommended that the state governments also authorize drug inspectors or any other gazetted officers, including civil surgeons, to file complaints for offences punishable under Section 15(3) of the Indian Medical Council Act. It further exhorted a strict vigil on the registration and qualification of medical practitioners, and to initiate action against those found to be violating the provisions. It suggested annual reports about verification of qualification and registration of medical practitioners, and any action taken against those found to be violating the provisions shall be sent to the state government.41

Internet Advertisements: Boon or Bane? The most popular advertisements for cosmetic surgery are posted in popular websites through the Internet. Internet auction sites abound with advertisements for sale of human organs and other objects that range from testicles to nude autopsy photos of murdered children.42 Shocking medical items that have been sold or at least offered for bidding on eBay include organs available for transplantion, drug-free urine, etc..43 Another website auctioned off the ova and sperm of fashion models for IVF, and promoted the auction as ‘Darwin’s Natural Selection at its very best’. Bids started at $15,000, and it received a 20 per cent service fee for the sale of the reproductive cells.44 Internet capabilities would be employed in all aspects of healthcare.45 It has been estimated that at least 20,000 websites offering health-care information exist on the ever-expanding Internet.46 Techniques of telemedicine have been developing for several years to enable patients in remote areas to get consultations from leading experts at academic medical centers. For example, with the expansion of bandwidth by fiber optic cable, radiologists can now read high resolution computed axial tomography (CAT) scans and magnetic resonance imaging (MRI) scans from hundreds of miles away,

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thereby cutting costs and improving access to high quality healthcare. As the technology has improved, interactive cyber medicine techniques have emerged so that patients and healthcare providers can communicate over the Internet to enhance their healthcare experience. Though much less widespread than medical information or medical advice websites, several websites have auctioned different types of surgeries. For example, the largest private hospital group in South Africa, Net care, has auctioned off surgeries such as breast reductions, skin resurfacing, and liposuctions, where the ‘winner’ received a recovery stay at a plush Johannesburg hotel.47 Another website offered a raffle for breast implants for those who bought a raffle ticket for $ 20 to $ 50.48 Wellesley College even auctioned off a vasectomy as part of a fundraiser.49 Among the several surgical auction sites in business on the Internet, a California site called MedicineOnline.com has gotten the most press by offering nearly forty procedures such as cosmetic surgery, cosmetic dentistry, LASIK vision correction surgery, and podiatry on its ‘Bid for Surgery’ website.50 The Supreme Court of the US has held that any governmental attempts to regulate or prohibit information posted on websites that is not defamatory may violate constitutional free speech protections,51 and the Communications Decency Act immunizes from liability websites that merely host or sponsor information provided by others. But in India, with the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, in place, it will be possible to proscribe and take penal action against objectionable advertisements that guarantee magic remedies.52 NOTES 1 ‘1st Human Face Transplant Planned’, Health24 News (2 November 2004). See also Chapter 9. 2 ‘Face Transplants: Medicine’s New Ethical Dilemma’, MSN Health & News (7 December 2005), http://articles. health.msn.com/id/100112040. 3 Theresa Marie Mantese, Christine Pfeiffer, and Jacquelyn McCl-inton, ‘Cosmetic Surgery and Informed Consent: Legal and Ethical Considerations’, MI Bar Jnl. 85: 26. 4 Liposuction is the only cosmetic surgery that has a mortality rate. See Daniel J. Penofsky, ‘Cosmetic Liposuction Malpractice Litigation’, Am. Jur. Trials 80 (2001): 32. There are no statistics available from India.

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5 The top five nonsurgical cosmetic procedures in the US were reported to be Botox injection (2,272,080), laser hair removal (923,200), micro dermabrasion (858,312), chemical peel (722,248), and collagen injection (620,476). Human-derived collagen products (CosmoDerm, CosmoPlast) were reported to have been used in 29 per cent of collagen-injection procedures. Hvaluronic acid (Hylaform, Restylane) was reported to have been used in 116,211 procedures and calcium hydroxyla patite (Radiance) in 31,913 procedures. 6 For instance, in H (A) v. Ho 136 ACWS (3d) 1140;2005 ACWS LEXIS 631, a surgical wound after hysterectomy disfigured the patient at her abdomen by creating ear bulges at each end of an unduly long incision.The British Columbia Supreme Court held that the plaintiff was entitled to damages reflecting the undesirable cosmetic results and associated pain and suffering flowing from the defendant’s negligence. 7 See Alex Kuczynski, ‘What Is Beautiful?’ Beauty Junkies (UK:Vermiliion, 2007). The author says that beauty indeed serves as the thrilling, exquisite counterpoint to old age and decay! 8 1996 ACWSJ LEXIS 137941;1996 ACWSJ 648124;63 ACWS (3d) 740. 9 The document signed by the patient read: ‘I hereby authorize Joseph K. Wong, MD’, to perform such plastic or reconstructive surgery upon me or upon (my) as we have heretofore agreed-upon and I understand that the doctor will give his best professional care toward the accomplishment of the desired results. I am advised that although good results are expected they cannot be and are not GUARANTEED; nor can there be any guarantee against untoward results.’ 10 The judge adopted the following reasoning: ‘It is probable that Madam Mok cannot completely close her right eye. This, I find on the evidence, is attributable to Dr Wong’s failure to correctly estimate the length of the suspending sutures. That is an error in judgment and a risk of the surgery which was disclosed to Madam Mok by Dr Wong prior to the surgery being undertaken. That error in judgment does not indicate a lack of care.The condition is something capable of adjustment and could easily have been adjusted by an office procedure in November 1989 as Dr Wong attempted to persuade Madam Mok to let him do. I find her failure to permit the adjustment was unreasonable and I find that it constitutes a failure to mitigate any damage she may have suffered.’ 11 752 NE 2d 250 (NY 2001). 12 The background facts further showed that over a six-year period, the plaintiff underwent a series of elective surgeries, including eyelid surgery, facial liposuctions, eyebrow tattooing, and wrinkle and skin growth removals. While the plaintiff ’s experts could only opine that the plaintiff ’s depression and obsession with her appearance was consistent with BDD, the defendant’s expert determined that the plaintiff did not suffer from BDD or any other ‘major psychiatric disorder’ that would impair her ability to consent.

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13 Marcia Angell, Science on Trial:The Clash of Medical Evidence and the Law in the Breast Implant Case (US: Norton,1996). The figures relate to the US. 14 Featured article under caption,‘Breast Implant Facts’, International Breast Implant Registry and Medic Alert Foundation (Turlock, CA). Breast implants can be categorized by the design and material used for the shell and by the material that is used to fill it. Implant shells are generally one of three types, smooth-surfaced silicone shells, textured-surfaced silicone shells, or polyurethane foam-coated shells. Similarly, the implants are filled with either silicone gel, saline, or double lumen. The silicone gel is a soft and flexible material whereas the saline is simply salt water. The double lumen implants contain two silicone envelopes, one filled with saline, the other with silicone gel, last visited 4 April 2008. 15 See Angell, Science on Trial (1996), pp. 97–108. 16 Julie M. Spanbauer argues that ‘Every woman contemplating breast augmentation surgery has a right to know that these calcifications, when viewed by a radiologist reading a mammogram, often look like cancerous tumors’ and that the silicone implant can ‘block or distort mammograms, causing a lump to go undetected at the early stage of cancer when it is still small.’ See ‘Breast Implants as Beauty Ritual: Woman’s Sceptre and Prison’, Yale J.L. & Feminism 9 (1997): 157. 17 In Hopkins v. Dow Corning Corporation, 33 F.3d 1116 (9th Cir. 1994),cert. denied, 115 S.Ct. 734 (1995),the Ninth Circuit Court of Appeals became the first federal appellate court to consider the admissibility and sufficiency of evidence that silicone gel breast implants (SGBI) cause connective tissue disease. Mariann Hopkins underwent a bilateral mastectomy for benign breast disease and reconstruction with silicone gel implants in 1976. In 1979, Hopkins was diagnosed with mixed connective tissue disease (MCTD), an illness characterized by fatigue, myalgia, arthralgia, and arthritis. Learning from a relative of a possible link between implants and MCTD, she filed a complaint in 1988 against the manufacturer, Dow Corning Corporation, alleging fraud, strict products liability, and breach of warranties. To show causation, Hopkins produced three expert witnesses. A toxicologist testified at trial that the implants had caused the MCTD. Although not a physician, he based his opinion on a review of Hopkins’s medical records as well as animal studies and biophysical data that he believed demonstrated silicone’s ability to cause immune disorders. Two physicians also testified for Hopkins. Neither had examined her, but they relied on her medical records, their clinical experience, symptoms consistent with exposure to silicone, self-authored scientific studies, the medical literature, and their own preliminary and unpublished epidemiologic study of over 200 women to conclude that Dow’s implants caused the MCTD. The jury accepted these opinions. It returned a verdict

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for Hopkins and awarded her $ 840,000 in compensatory damages and $ 6.5 million in punitive damages. Dow appealed, maintaining that the district court erred in not holding a hearing on the qualifications of Hopkins’ experts to testify as to causation and in admitting testimony that was not based on scientifically accepted principles. It sought to overturn the verdict on the ground that without this expert testimony there was insufficient evidence of causation. The Supreme Court had decided in Daubert v. Merrell Dow Pharmaceuticals, Inc. 506 US 738 (1993) that general acceptance was not essential to admissibility. Daubert prescribed a broader inquiry to verify that scientific testimony is founded on reliable scientific knowledge. Applying Daubert, the Ninth Circuit held that the admission of the expert testimony was not an abuse of discretion.The court concluded that Daubert was satisfied because Hopkins’ experts had based their opinions on the types of scientific data and techniques relied upon by medical experts in determinations of toxic causation when there is no solid body of epidemiologic data to review. Hopkins is but one of thousands of SGBI claims filed against Dow and other companies. Multi-district litigation produced a $ 4,225,070,000 class settlement, but many plaintiffs opted-out, Dow Corning declared bankruptcy. For a critical appraisal of this judgment, see Donald A. Lawson, ‘Hopkins v. Dow Corning Corporation: Silicone And Science’, Jurimetrics J. 37 (Fall 1996): 53. 18 Angell, Science on Trial (1996), pp. 97–108. 19 Scathing criticism has been mounted on the book of Angell in the article titled, ‘Breast Implants Revisited: Beyond Science On Trial’ by Rebecca S. Dresser, Wendy E. Wagner, Paul C. Giannelli in which they ‘agree with her on three fundamental points: (1) public health policy decisions should rest on good science; (2) there is a need to improve the evaluation of scientific evidence in the courtroom; and (3) existing scientific studies fail to establish a connection between silicone gel breast implants and immune system disorders.’ They say, ‘Angell virtually ignores the failure to conduct adequate’ research during the early stages of implant development and use. Her focus on later events in the breast implant controversy distorts her analysis of who is to blame for excluding good science from decisions on breast implants. Second, Angell’s analysis of the legal system is often superficial and ill-informed. Science on Trial inaccurately represents the history and current state of the rules on admissibility of scientific evidence in the courtroom. Third, Angell’s critique reflects professional myopia. Interdisciplinary inquiry challenges the scholar to see clearly the shortcomings of her own profession. Angell neglects the medical profession’s role in encouraging widespread use of implants without adequate data on risks. This omission, as well as the ferocity of her attacks on the legal system, reflects a lack of objectivity. Moreover, Angell presents an idealized picture of science, without acknowledging that other scholars

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portray a more complex and conflict-ridden process. She suggests that it is ludicrous to apply the adversarial model to matters of science, but fails to recognize the extent to which scientists can disagree among themselves about the quality and implications of their data’. 20 1984 ACWSJ LEXIS 28497;1984 ACWSJ 447148;29 ACWS (2d) 161. 21 Carl Elliot, ‘Better Than Well: American Medicine Meets the American Dream Xv’ (2003). Quoted in Dov Fox, ‘Safety, Efficacy, and Authenticity:The Gap Between Ethics and Law in FDA Decision-making’, Mich. St. L. Rev. 2005 (2005): 1135. 22 Curtis A. Kin, ‘Coming Soon to the Genetic Supermarket Near You’, Stan. L. Rev. 48 (1996): 1573, 1579. 23 MicroSort Gender Selection, http://www.microsort.com (follow ‘Current Results’ hyperlink) (last visited 5 May 2012). 24 John A. Robertson, ‘Preconception Gender Selection’, Am. J. Bioethics 1 (2001): 1, 2. 25 See Alex Kuczynski, ‘The Rise and Fall and the Rise and Fall of the Botox’, Beauty Junkies (UK: Vermilion, 2007). 26 Dov Fox, ‘Safety, Efficacy, and Authenticity: The Gap between Ethics and Law in FDA Decision-Making’, Mich. St. L. Rev. (2005): 1135. 27 See Michael J. Sandel, ‘The Case against Perfection: What’s Wrong with Designer Children, Bionic Athletes, and Genetic Engineering’, Atl. Monthly 293 (2004): 50, 60. 28 The legislative history and its constitutionality have been dealt with in the judgment of the Supreme Court in Hamdard Dawakhana v. Union of India (1960) 2 SCR 671, AIR (1960) SC 554, 1960 Cri LJ 735. 29 As amended through notification No F/16-/52-DS, dt 22 June 1954, Rule 106. 30 These are diseases and ailments (by whatever name described) which a drug may not purport to preventor cure or make claims to prevent or cure: 1. AIDS 2. angina pectoris;3. appendicitis; 4.arteriosclerosis; 5. baldness; 6. blindness; 7. bronchial asthma; 8. cancer and benign tumour; 9. cataract; 10. change in colour of the hair and growth of new hair; 11. change of foetal sex by drugs; 12. congenital malformations; 13. deafness; 14. diabetes; 15. diseases and disorders of uterus; 16. epileptic-fits and psychiatric disorders; 17. encephalitis; 18. fairness of the skin; 19. form, structure of breast; 20. gangrene; 21. genetic disorders; 22. glaucoma; 23. goitre; 24. hernia; 25. high/low blood pressure; 26. hydrocele; 27. insanity; 28. increase in brain capacity and improvement of memory; 29. improvement in height of children/adults; 30. improvement in size and shape of the sexual organ and in duration of sexual performance; 31. improvement in the strength of the natural teeth; 32. improvement in vision; 33. jaundice/hepatitis/liver disorders; 34 leukaemia; 35. leucoderma;

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36. maintenance or improvement of the capacity of the human being for sexual pleasure; 37 mental retardation, subnormalities and growth; 38. myocardial infarction; 39. obesity; 40. paralysis; 41. parkinsonism; 42. piles and fistulae; 43. power to rejuvenate; 44. premature ageing; 45. premature greying of hair; 46. rheumatic heart diseases; 47. sexual impotence, premature ejaculation and spermatorrhoea; 48. spondylitis; 49. stammering; 50. stones in gall-bladder, kidney, bladder; 51. vericose vein. 31 Section 2(c) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. An advertisement for selling nagmani by chanting mantras and tantras for money is prima facie an act is covered by the definition of ‘magic remedy’. See Dipankar and Ors v. State of Maharashtra (2003) (2) ALD (Cri) 70, (2003) Cri LJ 3271. 32 Section 2(b) of The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. 33 AIR (1976) SC 171, (1976) Cri LJ 190, (1976)1 SCC 428, [1976] 2 SCR 782, (1976) (8) UJ 21(SC). 34 1. appendicitis; 2. arteriosclerosis; 3. blindness; 4. blood poisoning; 5. Bright's disease; 6. cancer; 7. cataract; 8. deafness; 9. diabetes; 10. diseases and disorders of the brain; 11. diseases and disorders of the optical system; 12. diseases and disorders of the uterus; 13. disorders or menstrual flow; 14. disorders of the nervous system; 15. disorders of the prostatic gland; 16. dropsy; 17. epilepsy; 18. female diseases (in general); 19. fevers (in general); 20. fits; 21. forms and structure of the female bust; 22. gall stones, kidney stones and bladder stones; 23. gangrene; 24. galucoma; 25. goitre; 26. heart diseases; 27. high or low blood pressure; 28. hydrocele; 29. hysteria; 30. infantile paralysis; 31. insanity; 32. leprosy; 33. lecuoderma; 34. lockjaw; 35. locomotor atoxia; 36. lupus; 37. nervous debility; 38. obesity; 39. paralysis; 40. plague; 41. pleurisy; 42. pneumonia; 43. rheumatism; 44. ruptures; 45. sexual impotence; 46. small pox; 47. stature of persons; 48. sterility in women; 49. trachoma; 50. tuberculosis; 51. tumours; 52. typhoid fever; 53. ulcers of the gastro-intestinal tract; . 54. veneral diseases, including syphilis, gonorrhoea, soft chancre, veneral, granulima and lympho granuloma. (Of these, the italicized items relate to cosmetic cures, which the law seeks to regulate). 35 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, Section 3. 36 Ibid., Section 4. 37 Ibid., Section 5. 38 Ibid., Section 6. 39 Ibid., Section 10. 40 Ibid., Section 7. 41 Ibid., Section 9.

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42 Dr Barinder Singh, President, Ludhiana Medical Welfare Association v. State of Punjab (2009) 4 RCR (civil) 117, 2009(5) RCR (crl) 465. 43 See Marcia Stepanek, ‘Making a Killing Online: Ghoulish Auctions Run the Gamut from Bad Taste to the Truly Shocking’, Business Week, E.Biz (20 November 2000), EB 85. Items sold by or about serial murderers have become so common that they have been dubbed ‘murderabilia’. 44 In one instance, a seller offered a ‘fully functional kidney for sale’ on eBay. See Auction Watch Daily, Exclusive Features, ‘The Top Ten Bizarre Online Auctions’, http://www.auctionwatch.com/awdaily/features/bizarre/5.html (last visited 16 February 2001). Bidding on the kidney went as high as $ 5.7 million before officials at eBay shut down the auction. 45 ‘See Model’s Eggs to be Auctioned’, Telegraph Herald (Dubuque, IA) (24 October 1999), A2 (discussing the website www.ronsangels.com). 46 See Brian J. Caveney, ‘GOING, GOING, GONE: The Opportunities and Legal Pitfalls of Online Surgical Auctions’, W.Va L. Rev., 103 (2001): 591. 47 See Sherman Freidman, ‘Sixty-nine Million Use Net for Health Info— Survey’, Newsbytes News Network (2 May 2000). 48 See ‘Bid for Breast Reduction or a Tummy Tuck in Net Surgery Auction’, Birmingham Post (25 July 2000): 9. The auction was conducted on www.bidorbuy.co.za. 49 See Joyce Howard Price, ‘Cut-rate Plastic Surgery Website Hit on Several Fronts’; ‘Doctor: Patient May Pay More in Time for Novice’s Work’, The Washington Times (4 August 2000): A3. 50 See ‘A Snip for a Snip at Gala Auction’, The Evening Post, Wellington (29 October 1999): 2. 51 See MedicineOnline.com, ‘Bid for Surgery’, http://www. medicineonline.com/bidforsurgery, referred in Ronal E. Rice, James E. Katz (eds), The Internet and Health Communication: Experiences and Expectations (California: Sage Publications, 2001). 52 Reno v. ACLU, 117 S. Ct. 2329 (1997).

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Medical Insurance

INTRODUCTION Rising medical costs for treatment of illnesses and increasing awareness about the rights of action against doctors have contributed to the growth of schemes for health insurance or medical insurance. An insurance policy of this type is in common parlance called a mediclaim policy. For a patient, medical insurance covers risk against unexpected illness or accidental injuries and the treatment costs to be met. It provides for protection for a patient who at the time of commencement of policy (which is not a renewal of an existing policy), does not suffer from illness, but becomes ill or suffers an injury requiring medical treatment while the policy is in effect. Doctors also take insurance covers for actions by patients for damages claims against them, the premium depending on the nature of the risk. An insurance scheme can encourage people to be willing participants in a particular procedure or treatment, such as family planning and sterilization procedures, where the patient must be assured of compensation in the event of failure even without proof of medical negligence. It is not uncommon that persons travelling abroad are advised to secure medical insurance not only to cover high medical expenses in case of illness or medical emergency, but also to ensure in the first place that a doctor is prepared to commence treatment, assured as he will be, that the patient could have recourse to his own insurer in case of failure of treatment and not involve him singularly in litigation.

Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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Genesis of Mediclaim in India The Mediclaim Insurance Scheme, which was framed by the General Insurance Company (GIC), was a scheme approved by the Central Government. This is evident from Circular No. 464 dated 18 July 1986, issued by the Central Board of Direct Taxes under Section 119 of the Income Tax Act, 1961. It contains a reference to the budget speech of the finance minister in the year 1986–7, in which a proposal was announced to provide relief to self-employed people and salary earners other than those whose medical needs were taken care of by the employers (in respect of medical expenses incurred by them by allowing a deduction out of their total income), subject to limits, for any premium on medical insurance policies taken by them with the GIC. Pursuant to that, a new clause (ib) in Subsection (1) of Section 36 of the Income Tax Act, 1961, was inserted to allow for deduction to an employer in respect of the premium paid by them by cheque for insurance on the health of their employees in accordance with a scheme framed by the GIC and approved by the Central Government. Section 80-D was inserted in the act to provide a deduction upto Rs 3,000 a year to an assessee in respect of the insurance premium paid by them by cheque. Accordingly, the scheme was finalized as the ‘Hospitalisation and Domiciliary Hospitalisation Benefit Policy’ by the GIC and approved by the Central Government. This was popularly known as ‘Mediclaim’. Thereafter, Circular No. 537 dated 12 July 1989 was issued by the CBDT on deduction of tax at source during the financial year 1989–90 under Section 192 of the Income Tax Act, 1961. The survey of the Ninth Five Year Plan (Vol. 2), carried out by the National Sample Survey Organization (NSSO) indicated that the high cost of hospitalization is one of the factors leading to indebtedness, especially among the low and middle-income groups. Health insurance policies to meet the cost of hospitalization for major illnesses will ensure that healthcare costs do not become a major financial burden or cause of indebtedness among these patients or their families. Over the last two decades several health insurance schemes have been introduced. Some of the currently operationalised insurance schemes include Mediclaim. Group Medical Insurance Scheme, Group Health Insurance Scheme, Bhavishya Arogya (Insurance for senior citizens), Senior Citizen Unit Plan, Cancer Insurance, Asha Deep and Jan Arogya

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Bima Policy. It was observed that the premium of health insurance may have to be adjusted on the basis of health status, age and family of the person at the time of entry into health insurance. Yearly, ‘no claim bonus/adjustment of the premium’ could be made on the basis of previous year’s hospitalization cost reimbursed by the insurance scheme.

This would function as a mechanism through which heath education messages regarding the importance of optimum utilization of the preventive and promotive services as well as adopting a healthy lifestyle are reinforced by economic incentives.1

Mediclaim and Life Insurance There is a difference between mediclaim insurance and life insurance. A mediclaim policy is a non-life insurance policy meant to assure the policy-holder in respect of certain expenses pertaining to injury, accidents, or hospitalization expenses.2 However, they are not without similarities. The health insurance contract is related to the category of life contracts. A life contract would include the natural process of dying and a health insurance contract would obviously include what may be the natural onset of any type of illnesses. In a normal life assurance contract as distinct from contracts intended to be for a certain term, the assured must have, at least, the right of renewal, subject to reasonable conditions. A health insurance policy covers medical treatments. One is a policy for life, while the other for a healthy life. Even in a health policy, though under an annual contract on payment of annual premium, the assured must have a right of renewal subject to reasonable conditions, because the policy is not intended for a certain term, but meant to cover the risk of disease for life so long as the renewal premium is paid in time, as per the renewal clause. As in life insurance, the health insurance contract, made in consideration of an annual premium, is for a year with an irrevocable offer to renew upon payment of the agreed renewal premium.3

Object of Mediclaim The object of the insurance policy is to cater to medical expenses incurred by the assured. That is the ‘main purpose’ of the insurance contract. The object of the exclusion clause is to except the liability

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of the insurer. In a sense this is at variance with the object of the policy. Nevertheless, it is a part of the contract; the court should firstly seek to harmonise all the clauses, and attempt to give effect to it.4 Mediclaim would enable those belonging to the lower- and middleincome groups who are covered by such health insurance scheme to avail of a better quality of medical services that otherwise might be out of the reach of such persons. The mediclaim scheme is, therefore, not a subject of mere private concern of two contracting parties, but a result of a national concern reflected in the norms of the national health policy.5

Of Utmost Good Faith An important concept is that an insurance contract is a contract uberima feide (‘of utmost good faith’), so that concealment of a relevant fact regarding the history of health and illness issues will be a ground for the insurer to cancel the policy and disown liability.When information on a specific aspect is asked for in the proposal form, the prospective assured is under a solemn obligation to make a true and full disclosure of the information on the subject that is within his knowledge. Of course, the obligation to disclose extends only to facts that are known to the applicant and not to what he ought to have known.The opinion of the assured as to materiality of that knowledge is of no relevance.6 On the  subject of medical insurance, the most contested issues are whether there had been any concealment at the commencement of policy. Neither the medical nor the legal profession has distinguished itself in two decades of malpractice wars. Trial lawyers have fought to preserve a flawed status quo, while doctors have done too little to improve professional discipline or eliminate the underlying causes of medical malpractice. For doctors and lawyers, for the administration and legislature, the time has come to think about devising something better, not just for doctors, but for patients as well.7

Interpretation of Terms in Insurance Policy An insurance policy covers risk for illness and medical expenses for the policy holder. An insurer is always duty-bound to meet demands for

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financial claims.The optimum meeting point of demand and supply in a seemingly conflict situation is the success of insurance business. The right to secure a cover against medical expenses and the exclusion of liability to meet claims relating to certain types of illnesses, a right of renewal of a policy, and refusal to undertake risk for known illnesses are typical areas of conflict between an assured and the insurer. It is a settled legal position that if, after every effort to reconcile, more than two clauses of the insurance contract appear plainly in conflict, it is necessary to consider the comparative weight to be given to each of them. In such cases, one of the rules applicable to determine which clause shall prevail goes by the dictum contra proferentes (verba cartarum forties accipiuritur contra proferentem, i.e. words are to be interpreted most strongly against he who uses them),8 against those who offer it. The assured cannot put their own meaning upon a policy, but where it is ambiguous, it is to be construed in the sense in which he might have reasonably understood it. If the insurers wish to escape liability under given circumstances, they must use words admitting no possible doubt.9 MEDICAL INSURANCE PROCEDURES

Proposal Form A person who wants to insure himself against risk of illness and cover for medical expenses is first required to fill in a proposal form, which is a questionnaire that seeks to elicit the material facts in relation to the medical history of the proposer. In relation to a proposal form,the term ‘material’ is defined under Regulation 2(1)(d) of the Insurance Regulatory and Development Authority (Protection of Policy-holders’ Interests) Regulations, 2002, thus: ...‘proposal form’ means a form to be filled in by the proposer for insurance, for furnishing all material information required by the insurer in respect of a risk, in order to enable the insurer to decide whether to accept or decline, to undertake the risk, and in the event of acceptance of the risk, to determine the rates, terms and conditions of a cover to be granted; Explanation.—‘Material’ for the purpose of these Regulations shall mean and include all important, essential and relevant information in the context of underwriting the risk to be covered by the insurer.

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In a contract of insurance, any fact that would influence a prudent insurer in deciding whether to accept the risk is a ‘material fact’. If the proposer has knowledge of such a fact, they are obliged to disclose it, particularly while answering questions in the proposal form. Any inaccurate answer will entitle the insurer to repudiate his liability because there is clear presumption that any information sought for in the proposal form is material for the purpose of entering into the contract.

Oral Proposal Where a proposal form is not used, the insurer shall record the information obtained orally or in writing, and confirm it within a stipulated period with the proposer and incorporate the information in its cover note or policy. The onus of proof shall rest with the insurer in respect of any information not so recorded, where the insurer claims that the proposer suppressed any material information or provided misleading or false information on any matter material to the grant of a cover. TYPES OF POLICIES AND PERSONS COVERED After the opening up of the market for private players in the insurance business as well as its de-nationalizing, many insurance companies are vying with each other to promote various types of health insurance. Depending on the terms of policy, the person insured could recover the costs of medical treatment for hospitalization, doctor’s charges, medicines, and nursing costs. The policy could be taken individually, for the family members, or for groups of persons belonging to a homogeneous category either through an employer or an association of persons. There are also policies such as mediclaim policies for students to provide financial security in case of emergency situations, dealing with the students’ health, the death or disablement of the parents, or the guardians of the students. Educational institutions may also get mediclaim cover for the whole community of students studying in the institution. Policies for senior citizens over sixty cover the expenses for surgery, medical treatment and even health check-ups. Cashless mediclaim policies allow the assured to undergo treatment without having to pay the medical expenses upfront and then claim the same against the insurer. It will be possible under this scheme to take treatment

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from a network of hospitals that will not charge the patients but will process their claims through a third party administrator (TPA). The TPA either pays for the medical treatment on the spot and later asks for reimbursement from the insurer, or will get in touch with the insurer directly and get the payment from the insurer towards the cost of expenses for the insured. EXCEPTED CATEGORIES OF ILLNESSES All pre-existing diseases and injuries when the cover is initiated for the first term will usually be regarded as excepted categories of illness. Some normal medical illnesses are sometimes presumed as pre-existing and therefore excepted. During the first year of the operation of insurance cover, the expenses on treatment of diseases such as cataract, benign prostatic hypertrophy, hysterectomy for menorrhagia or fibromyoma hernia, hydrocele, congenital, internal diseases, fistula in the anus, piles, sinusitis and related disorders are not payable; if these diseases are pre-existing at the time of proposal they will not be covered during subsequent period of renewal either. If the assured is aware of the existence of a congenital disease since inception of policy, it will be treated as pre-existing.The bar against a claim for the excepted categories to operate if they occur within the first year must be understood to be applicable to fresh policies and for renewal of existing policies. In Jagmohan Bhatia v. Oriental Insurance Co. Ltd10 even a renewal after seven months was treated as not operating as a fresh policy on consideration of the fact in issue that no new proposal form was taken and no medical examination was insisted for that person while granting the renewal. REFUSAL TO RENEW MEDICAL INSURANCE

Illness at the Inception of Policy In New India Assurance Co Ltd v. Satpal Singh Muchal,11 the respondent’s mediclaim policy was renewed for one year. However, on receiving the information that he was suffering from kidney trouble, the appellant company terminated his policy and paid a pro rata premium, relying on a stipulation in the policy that the company could cancel it at any time while sending notice to the assured and refunding the pro rata premium. However, this should not be understood as a unilateral

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exercise and render an insurance cover meaningless. It should always be seen in the context of what was within the knowledge of the assured, what was disclosed at the time of taking the policy, and whether there had been any concealment. The validity of cancellation of the policy or the entitlement of the patient to obtain a valid coverage would be the issues for adjudication at the trial.

Unwillingness to Pay Additional Premium The Insurance Company is also required to maintain a solvency margin inter alia based on the concept of net incurred claims. Section 64VA(1A)(ii), Explanation (ii) of the Insurance Act specifies an average of the net incurred claims during the specified period not exceeding three preceding financial years. It is imperative for the insurer to see that it does not run the risk of not meeting the solvency margin prescribed under the act. In a situation where the insurer makes an upward revision of the premium to cope with increasing costs borne by it, an offer by the assured to pay a premium at the rate of previous year’s policy will not automatically result in renewal. An assured cannot insist on renewal at same rate.12 The concept of commercial insurance and a degree of commercial prudence are necessary in deciding the appropriate premium to be charged for renewal of a particular mediclaim account. The basic schedule of the premium to be charged from fresh entrants into the mediclaim scheme is drawn up by experts known as actuaries, and based on actuarial science. If a client’s account is found to be continuously resulting in a loss, it will be necessary to increase the premium.13

When the Insurer is an Instrumentality of the State

record of failed claim of an assured The insurance companies who are state functionaries may have more responsibilities than private companies.The state instrumentalities have to regulate their actions against arbitrariness and non-discrimination that could fall foul of Article 14 of the Constitution.14 Consequently, if a policy holder had a history of some dispute over a past claim, it would not be itself a justification for renewal of health insurance through a mediclaim policy.The Supreme Court said in Biman Krishna

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Bose v. United India Insurance Co Ltd15 said that if an assured lodges a claim with the company and the company does not honour it, the assured is left with no alternative but to knock on the doors of a court of law. Merely because the appellant had approached the consumer forum and the Supreme Court for redressal of his grievance, cannot disentitle the appellant to get his policy renewed.

disease contracted during currency of policy The Supreme Court said in United India Insurance Co Ltd v. Manubhai Dharmasinhbhai Gajera16 that if a renewal is based on mutual consent, there may be no automatic renewal. However, a mediclaim policy involving a senior citizen would stand on a somewhat different footing. It will depend upon the contract entered into between the parties and statutes operating in the field as well as the constitutional scheme. A functionary that is a part of the State under Article 12 cannot refuse to renew at its whims and caprice wherever renewal is subject to mutual consent of the parties. The Supreme Court was dealing with clauses in the mediclaim policies providing for renewal on mutual consent, when at the inception of the policy, there was no disease but contracted during the expiring policy period. In such situations, if the assured paid their premium, they were entitled to renewal, and the insurer could not deny renewal only because a disease was contracted during the term of the policy and the assured had availed of its medical benefits. Renewal of an insurance policy has to be done without excluding any disease already covered under existing policy that may have been contracted during period of policy.17 If a person had been coerced into consenting to exclusion of cover for cardiac ailments that subsequently occured, such consent given by petitioner would be taken as not voluntary and the person will not be bound by them.18

onerous liability If during the terms of the policy, the assured contracts an illness for the first time and the insurer had to stand cover for defraying the expenses, it cannot refuse renewal on the ground that the policy has become onerous or burdensome. Renewal of an insurance policy means a repetition of the original policy. A health insurance policy is

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meant to cover risk of disease. Any tendency to undertake risk selection to insure only low-risk individuals and exclude high-risk ones will be against constitutional ethos of equality. Liability of the insurer in respect of disease/injury occurring during continuance of cover without break will remain and it cannot be absolved from liability to perform a contract merely because performance has subsequently become more onerous.19 That a prudent insurer should not cover a risk that could turn out to be onerous is no excuse. Renewal could be refused only on grounds such as misrepresentation, fraud, or non-disclosure of material facts by the assured.The very nature of the insurance business involves instances where diseases may or may not occur, with varying degrees of liability for different people. The terms of the renewal as in the prospectus bind them and the assured shall be within their legal rights to insist on continuance of the cover of the mediclaim insurance on payment of the renewal premium in time. Frequency of claim when it arises under the cover issued under a mediclaim scheme, which the insurer is bound to honour under the contract, cannot constitute a ground for evading the liability, nor can it be said that such frequency amounts to a ‘high moral hazard’ entitling the insurer to cancel or refuse to renew the cover. Claims based on occurrence of diseases covered by the mediclaim insurance can never be considered as having any bearing on the moral integrity of the insurer when they are genuine, and their cover cannot be treated a ‘high moral hazard’ justifying refusal to renew, or cancellation of the cover.20 The Gujarat High Court21 laid down the following six principles in respect of mediclaim policy: (1) The insured has an option under the existing mediclaim insurance policy to continue the cover by payment of renewal premium in time in respect of the sum insured. (2) In case of renewal without break in the period, the mediclaim insurance policy will be renewed without excluding any disease already covered under the existing policy which may have been contracted during the period of the expiring policy. Renewal of mediclaim insurance policy cannot be refused on the ground that the insured had contracted disease during the period of the expiring policy so far as the basic sum insured under the existing policy is concerned. (3) In cases where the insured seeks an enhancement of the amount of sum insured at the time of renewal, the option to renew will not extend to the amount of such enhancement and renewal in respect

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thereof will depend upon the mutual consent of the contracting parties. (4) Renewal of a mediclaim insurance policy cannot be refused, despite timely payment of the renewal premium, on the ground that continuance of the cover would become more onerous or burdensome for the insurer due to the insured contracting a covered disease during the period of the existing policy. (5) The insurer may refuse renewal, even in cases where the insured has an option to renew the policy on payment of the renewal premium in time, on the grounds, such as, misrepresentation, fraud or non-disclosure of material facts that existed at the inception of the contract and would have vitiated the contract of insurance at its inception or non-fulfilment of obligations on the part of the insured or any other ground on which the performance of the promise under the contract is dispensed with or excused under the provisions of the Contract Act or any other law or when the insurer has stopped doing business. (6) The Government insurance companies continue to be ‘State’ within the meaning of Article 12 of the Constitution notwithstanding the entry of private companies in the field of general insurance, ending their monopoly by virtue of insertion of Section 24A in the Act of 1972 and they cannot arbitrarily cancel or refuse to renew an existing mediclaim policy.

In Shri Mukut Lal Duggal v. United India Insurance Co. Ltd, 22 in addition to directing the insurer to effect renewal of the policy, which they had declined earlier on the ground that it was onerous, the court had directed that a compensation be paid equivalent to what the insuredwould have secured towards medical expenses if the policy had been renewed, with interest for the delay involved in securing the reimbursement of the expenses, as well as litigation costs assessed at Rs 10,000. REPUDIATION OF LIABILITY

Non-disclosure of Material Fact As already noted, any non-disclosure of material fact relating to medical history of a person will allow the insurer to deny liability. In Satwant Kaur Sandhu v. New India Assurance Co. Ltd, 23 the fact that the person who availed of a mediclaim policy was suffering from diabetes as well as chronic renal failure, and was on regular haemodialysis were

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obvious instances of material facts, the non-disclosure of which was found to justify the insurer to repudiate the claim under the policy by the representative of the deceased assured. Even if an answer is merely inaccurate, the insurer will be entitled to repudiate his liability because there is clear presumption that any information sought for in the proposal form is material for the purpose of entering into a contract of insurance. In Bijoy Kumar Chaturvedi v.United India Insurance Co. Ltd,24 the fact that insurance company produced the expert opinion of two specialist doctors of its own panel was treated as not material, and the court reasoned that unless their opinion is rebutted by the opinion obtained from another set of experts, it would be unfair to ignore the evidence specially when they are corroborated by other factors. In this case, the CT Scan report showed that ‘the picture is suggestive of metastatic adenocarcinoma with papillary’(sic). Further it went on to state that ‘metastasis from ovarian malignant tumour may be considered’. After investigation, the ailment was diagnosed ‘as a case of metastatic CA front at area of brain, left chest and right ovary as per the discharge summary of the nursing home’ (sic). Metastatic refers to the transfer of a disease from its primary site to a distant part of the body.Therefore, if the cancer developed in the ovary, it would have spread to the other organs and subsequently to the lungs. This obviously would have taken some time and must have given some signs or symptoms beforehand.The National commission rejected the medical literature suggesting that 90 per cent of the screened patients who developed lung cancer are asymptomatic as not relevant, as, in the case in hand, the cancer had originated in the ovary and appeared to have spread to the lungs subsequently. The commission observed that it could not be said to be a sheer coincidence that the mother of the complainant fell ill within a month from the incorporation of her name in the mediclaim policy. It also said that good faith is an integral part of a contract of insurance and upheld the conclusion of the state commission that it was a case of suppression of a pre-existing disease.

knowledge of the assured about illness This is doubtless the most common defence to repudiate a policy. It has a direct bearing on suppression of a material fact and impinges on

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the doctrine of good faith. Normally, the proposal form itself gives a guide to the disclosures to be made by seeking responses to leading questions on history of past illnesses suffered. Further, it is essential for the insurer to prove that the pre-existing disease has a connection to the disease revealed during the term of the policy for which the claim is sought. In New India Assurance Co. Ltd v. Arunaben Jayantibhai Shah,25 the assured was diagnosed with cirrhosis of liver in December1998, after taking the insurance policy.The complainant had apparently suffered from diabetes and coronary artery disease in 1985, but he had stopped taking medicines for this two-and-a half years years prior to term of the policy, and was leading a normal and healthy life without the aid of medication. The National Commission held that the insurer had not proved that the cirrhosis and the treatment costs had any connection with the coronary artery disease and Diabetes. In New India Assurance Company Limited v. Usha Yadav and Ors,26 the insurer sought the repudiation of the claim on the ground that the deceased died due to consumption of alcohol. Before the Permanent Lok Adalat, in the action taken by the wife and children of the deceased, evidence was adduced with reference to a report by a panel of doctors that revealed increased total lung capacity (TLC) and deranged liver and renal functions. Despite treatment, the ascetic fluid cell count was not decreasing while urine progressively decreased. The deceased had also developed respiratory distress. He was shifted to the ICU, but suffered a massive upper GI bleeding and went into shock. He expired on 28 August 2006. It was noticed that alcohol consumption could not be the only cause for all those complicated diseases which led to the death of the deceased. The action of the insurance company in repudiating the claim by adopting some means or the other, as such, was held as rightly rejected, in the revision filed to the high court. The mere existence of certain symptoms of a disease is not relevant. It must be shown that the assured knew that such symptoms were caused by a disease, and this was deliberately suppressed. In Praveen Damani v. Oriental Insurance Co. Ltd,27 the National Commission observed that if an interpretation were to be made that even symptoms must be disclosed when even the assured did not know that it constituted any disease, the very purpose of taking a policy will become meaningless. In New India Assurance Co. Ltd v. Mary Jane Govias and Others,28 the assured suffered from a dry cough, which he did not suspect as

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anything serious. He was treated for allergy and when the condition persisted, he was seen by an ENT surgeon and underwent an indirect laryngoscopy examination,which showed nothing amiss. As the cough persisted, he was referred to another ENT surgeon,who recommended a biopsy, which was immediately done. The diagnosis established the disease of nasopharyngeal cancer only on 2 November 1994. On a repudiation of the policy by the insurer for a claim by the representatives of the assured, who had ultimately died, the National Commission upheld the decisions of the district forum and state commission when it posed the question, ‘when even the treating doctor was unaware that the assured was suffering from cancer or any serious disease, how could the assured know that he has a serious disease?’ The commission said that the assured did not know of cancer at the time of taking the policy or commencement of the policy, and also had no knowledge of the same till 2 November 1994. That the test was done on 1 November 1994, which was within thirty days from the commencement of the policy, could not be construed as indicating that it was within the knowledge of the assured. In Oriental Insurance Co. Ltd v. Asim J. Pandya29 a child was detected as having scoliosis that required surgical intervention. It was not a congenital ailment but the result of a gradual deterioration since a fall that the child had suffered when she was barely six months old and nearly seven years before the problem presented itself. The National Commission rejected the plea by the insurer that it was a pre-existing illness.

pre-existing illness disclosed but ignored by the insurer A disclosure of a medical procedure undergone for some illness, if made by the insured before undertaking a policy, will foreclose any scope for denying liability later at the instance of an insurer on the ground of non-disclosure. Consequently, it has been held that if there had been a disclosure of the fact of a bye-pass surgery that took place 10 years before the inception of the policy and the insurer did not insist on any medical examination at the time when the policy was first issued and continued extending it for four years, a repudiation when a heart ailment presented would not be justified.30

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reference to pre-existing disease, if wrongly recorded A mere clerical mistake in recording the medical history about the date of the first onset of the disease but subsequently corrected ought not to be a ground for the insurer to repudiate a policy that a preexisting disease existed.31

Operation of Exclusion Clauses

justness of exclusion That National Commission had occasion to deal with a clause in the mediclaim policy that it was not material whether the insured had knowledge of the disease or not, and that even existence of symptoms of the disease prior to effective date of insurance would enable the Insurance Company to disown the liability. The commission held the clause to be impermissible to deny liability, when it held in Praveen Damani v. Oriental Insurance Co. Ltd:32 If this interpretation is upheld, the Insurance Company is not liable to pay any claim, whatsoever, because every person suffers from symptoms of any disease without the knowledge of the same. This policy is not a policy at all as it is just a contract entered only for the purpose of accepting the premium without the bona fide intention of giving any benefit to the insured under the garb of pre-existing disease. Most of the people are totally unaware of the symptoms of the disease that they suffer and hence they cannot be made liable to suffer because the Insurance Company relies on their Clause 4.1 of the policy in a mala fide manner to repudiate all the claims. No claim is payable under the mediclaim policy as every human being is born to die and diseases are perhaps pre-existing in the system totally unknown to him which he is genuinely unaware of them. [In]hindsight everyone realises much later that he should have known [the onset of illness] from some symptom. If this is so every person should do medical studies and further not take any insurance policy.

Referring to the facts on record, the commission added: There is no material to show that the petitioner had any symptoms like chest pain, etc. prior to 11.8.2000. Since there were no symptoms, the question of linking up the symptoms with a disease does not arise. In any case, it is the contention of the complainant that he was thoroughly

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checked up by the doctors who were nominated by the Insurance Company and at that time he was found hale and hearty. In such set of circumstances, it would be difficult to arrive at the conclusion that the insured had suppressed the pre-existing disease.

burden of proof of pre-existing disease In Praveen Damani v. Oriental Insurance Co. Ltd,33 the assured claimed medical expenses incurred for a hysterectomy to treat fibroid in her uterus.The insurer repudiated the claim on the ground that the assured must have had the medical condition requiring treatment even at the time of the commencement of the policy. The National Commission placed the burden of establishing the knowledge and the presence of medical condition to justify a repudiation on the insurer: No record is produced by the Insurance Company to prove that the insured was aware of the Fibroids in her uterus. No record of her treatment in any hospital or clinic prior to the issuance of the insurance cover has been produced before us. Further no affidavit of any treating doctor that the insured was treated by the doctor for menorrhagia has been placed on record.

exclusion of illness dependent on pre-existing ailment There could be cases of certain types of ailment relating to relatively fragile parts of the body, such as the spinal cord and neck femur, that could fracture or require surgical intervention due to aggravation of other pre-existing illnesses. They may be included in exclusion clauses. To enable the insurer to successfully plead exclusion of liability, the connection of the pre-existing illness to the fracture of one or the other organs must be established. In Nirmalaben Jaysukhlal Sheth v. New India Assurance Company Ltd,34 the exclusion clause read thus: Notwithstanding anything what is stated in the policy, it is hereby declared and agreed that all cover is excluded from this policy in respect of claims occasioned by, happening through or in consequences of any disease which is existing on the date of commencement of risk, whether specifically declared of that in the proposal form completed by the insured. ...

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Subject to specific exclusion of all medical expenses incurred directly due to Lamimectomy—Any treatment related to spinal cord & neck femur (R), surgical implants, diabetes, hypertension, heart ailments and circulatory disorders, and any consequences attributable to, accelerated by or arising there from as per the medical history stated in the proposal form and medical reports attached thereto.

The assured suffered a fracture of the neck femur due to a fall, and the insurer invoked the exclusion clause to repudiate the claim for medical expenses. The National Commission found that the fracture had not occurred due to any pre-existing illness, and directed that the hospital bills be settled immediately.

Duty Not to Repudiate Liability Irresponsibly In New India Assurance Company Limited v. Usha Yadav and Ors,35 the court lamented the conduct of the insurance companies, such as relying on exclusion clauses irresponsibly and engaging parties in litigation even where there a strong case is made for giving effect to the terms of the policy. The court also observed that insurance companies that have huge cash reserves shall duly apprise the parties about all possible contingencies for exclusion of liability even at the time of accepting the proposal so that parties take informed decisions about taking mediclaim policies. PROFESSIONAL INDEMNITY INSURANCE Medical professionals who are sued for medical negligence may protect them selves through professional indemnity insurance that will cover the costs and compensation awarded against them in an action brought at the instance of a patient or his representative. The policy normally provides for a ceiling for satisfaction of the quantum of claim for anyone act (AOA) against the doctor by the insurer. A series of losses for bodily injuries or death attributable to the same cause, error, or omission relating to discharge of professional services, may by a term of policy, treated as AOA. While a civil liability could be insured, a criminal liability, by the very nature of punishment, could not be a subject of insurance. Exclusions are normally provided for personal claims like, defamation and libel, as well as claims arising from exposure to radiation and other nuclear or radio-active material.

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FORA FOR ACTION

Writ Jurisdiction Mediclaim policies and the disputes that arise can be argued via writ jurisdiction.36 In Pravat Kumar Mukherjee v. State of West Bengal,37 a writ petition purported to be in the public interest had been filed against the state for a direction to cancel the licence of a hospital under the Bengal Clinical Establishment Act. The ground was the hospital’s refusal to treat a patient brought in a serious condition for not depositing the medical expenses, although the attendant produced a mediclaim policy. The patient ultimately died when the patient was taken to another hospital. The Court refused to accede to the argument of non-availability of a provision under the act for any member of public to move for de-licensing a hospital, as well for the reason that compensation had been already recovered from the hospital for the alleged deficiency of service.

Consumer Forum Under the Consumer Protection Act, a policy holder may resort to action before the consumer fora and commissions at the state and national level to complain of deficiency of service of the insurer and to redress grievances relating to the repudiation, acceptance, renewal, or adequacy of settlements of mediclaim policies. The National Commission noted in Patel Kirtikumar Prehladbhai v. National Insurance Company Ltd38 that under Consumer Protection Act, 1986, the objective is to help consumers when they suffer from deficiency in service by service providers but cannot lend support to those who file false complaints with concocted records to make unlawful gains. There is a large body of case law on this subject from various state consumer commissions.

the complainant The assured person is most naturally the complainant. In group insurance schemes, although the proposal form may have been submitted by a leader, employer, or chief functionary of the group, the beneficiary in that group could just be the complainant.39 A secondary victim who may have suffered pain and suffering for the deficient service

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meted out to a near relative may sometimes also be a complainant. In Spring Meadows Hospital and Another v. Harjol Ahluwalia and Another,40 the Supreme Court upheld the compensation awarded to the parents for pain and suffering that they had to undergo for the deficient service rendered to their child by wrong administration of drugs that had caused brain damage to the child and rendered her vegetative. As mentioned above, in Pravat Kumar Mukherjee v. Ruby General Hospital & Ors,41 the National Consumer Commission awarded Rs 10,00,000 as damages to the parents of the deceased.

Permanent Lok Adalat Section 22 B of the Legal Services Authority Act empowers the Central Legal Services Authority or the State Authority to announce the establishment of Permanent Lok Adalats at such places and for exercising jurisdiction in such subjects as may be specified, which includes disputes arising out of insurance claims. As per the law now prevailing in notified places, cases can be instituted for claims less than Rs 10, 00,000.42 The procedure is less formal and encourages a conciliatory approach in resolving disputes. The decision by the Permanent Lok Adalat is final,43 subject, however, to the supervisory jurisdiction of the high court under Article 227 of the Constitution.

Civil Suit The CPC admits all cases that are civil in nature to be instituted through suits. Civil courts are ideal when complicated questions of law and facts arise and elaborate evidence may have to be given. Long pendency due to several other types of cases that may be instituted and pending before civil courts, the stiff, procedural rigmarole typical of civil actions in courts, and higher costs due to court fees payable are deterrents against approaching the civil courts.

Insurance Ombudsman The Insurance Act makes provision for the creation of a redressal mechanism for addressing grievances.44 Accordingly, the Redressal of Public Grievance Rules, 1998, have been put into operation through the government notification. There is a duty under the rules to pass

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an award within three months. Every insurer shall have proper procedures and effective mechanisms in place to address the complaints and grievances of policyholders efficiently and with speed, and the same along with the information in respect of the insurance ombudsman shall be communicated to the policyholder along with the policy document.45 The remedy before the ombudsman is efficacious and questions involving disputed questions of fact could be left for decision before the said forum.46

Insurance Regulatory Authority Any breaches of the obligations cast on an insurer, insurance agent, or insurance intermediary in terms of these regulations may enable the Insurance Regulatory Authority to initiate action against each or all of them, jointly or severally, under the Insurance Act or the Insurance Regulatory and Development Authority Act, 1999.47

Jurisdiction The insurance contract itself may provide for the place of jurisdiction. It shall normally be the place where the cause of action arose.48 A cause of action includes a bundle of causes, namely, the several justifications that make possible the claim, such as place of execution of the policy of insurance, the place of residence of the respondent or where the assured normally lives, where the assured suffers from illness, and where the treatment is given. A restriction in the policy of insurance among the several places to anyone place where the cause of action arose will be valid. EFFECT OF BENEFIT WITH REGARD TO MOTOR VEHICLES ACT An accident victim in a motor accident is entitled to claim compensation for injuries that include medical expenses. The right is statutory and not merely rooted in contract. The liability of the insurer under a mediclaim policy is, however, contractual, and the amount that a person obtains from the insurer as per contractual obligations under such a policy cannot be set off against the claim made under the Motor Vehicles Act before the Accidents Claims Tribunal.49

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TAXATION The Income Tax Act affords incentives to assessees of income tax by allowing the premiums paid towards medical insurance policies as qualifying for certain deductions from taxable incomes. It shall be a policy in accordance with the scheme framed by the GIC and approved by the Central Government. Presently, payments of premiums to cover the risk to members of the family (including spouse, children, and dependent parents) up to Rs 10,000 and up to Rs 15,000 for Hindu Undivided Families (HUFs) could be deducted from the taxable income respectively of the individual assessees or HUF assessees.50 Even medical expenses incurred admit of deductions, provided the amounts paid as premium shall also be computed in the expenses.51 NOTES 1 United India Insurance Company Ltd v. Mohanlal Aggarwal AIR (2004) Guj 191. 2 Satwant Kaur Sandhu v. New India Assurance Co. Ltd, (2009) 8 SCC 316. 3 United India Insurance Company Ltd and Another, Appellants v. Mohanlal Aggarwa AIR (2004) Guj 191. 4 Hari Om Agarwal v. Oriental Insurance Co Ltd, AIR (2008) Del 29. 5 United India Insurance Company Ltd and Another v. Mohanlal Aggarwal AIR (2004) Guj 191. 6 Joel v. Law Union & Crown Insurance Co (1908) 2 K 863 (CA), referred to in Satwant Kaur Sandhu v. New India Assurance Co. Ltd.(2009) 8 SCC 316. 7 Kenneth Jost, ‘Still Warring Over Medical Malpractice: Time for Something Better’, A.B.A.J. 79(1993): 68. 8 Verba cartarum fortius accipiuritur contra proferentem, that is, words are to be interpreted most strongly against he who uses them. 9 United India Insurance Company Ltd v. Mohanlal AggarwalAIR (2004) Guj 191; Purnima Prasad and Ors v. Oriental Insurance Co. Ltd and Ors. AIR (2006 Pat 158; Oriental Insurance Company v. Parkash Devi 2008-(002)-CPJ -0267 -NCDRC. 10 2003-(002)-CPJ -0191-NCDRC. 11 (2009) 12 SCC 673. 12 Ashok Kumar Dhingra and Others, Petitioners v. Oriental Insurance Company Limited and Others, AIR (2004) Del 161. 13 Regional Manager, United India Insurance Co. Ltd. v. K. O. John, AIR (2005) Ker 22.

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14 In United India Insurance Co Ltd v. Manubhai Dharmasinhbhai Gajera (2008) 10 SCC 404, the Supreme Court noted that the roles of private player and the state would be different. Whereas a private player in the field is only bound by the statutory regulations operating in the field, the public sector insurance companies are also bound by the directions issued by the GIC and the Central government. 15 (2001) 6 SCC 477. 16 (2008) 10 SCC 404. 17 T. Suresh v. Oriental Insurance Co. Ltd, AIR (2010) AP 86. 18 Akshoy Kumar Paul and Anr. v. New India Assurance Company, AIR (2007) Del 136. 19 Purnima Prasad v. Oriental Insurance Co. Ltd, AIR (2006) Pat 158. 20 United India Insurance Company Ltd and Another v. Mohanlal Aggarwal, AIR (2004) Guj 191. 21 Ibid. 22 (2006) ACJ 1576, 117 (2004) DLT 74, (2005) (82) DRJ 70, (2005) 141 PLR 10. 23 (2009) 8 SCC 316. 24 2009-(002)-CPJ -0306. 25 2009-(002)-CPJ -0121. 26 (2008) 151 PLR 313. 27 IV (2006) CPJ 189. 28 IV (2006) CPJ 228 (NC). 29 2006-(001)-CPJ -0115 -NCDRC. 30 New India Assurance Co. Ltd v. Vasant Rao 2006-(002)-CPJ -0113– NCDRC. 31 New India Assurance Co. Ltd. & Anr v. Vimal Singh Surana & Anr 2008(004)-CPJ -0219. 32 IV (2006) CPJ 189 (NC); 2007 (1) CPC 141. 33 Ibid. 34 2008-(002)-CPJ -0051 –NCDRC. 35 (2008) 151 PLR 313. To the same proposition, see also National Insurance Co. Ltd v. Bipul Kunda II (2005) CPJ 12 (NC) = 2005 CTJ 377 (CP); New India Assurance Co. Ltd v. Arun Krishan Puri 2009-(003)-CPJ -0006. 36 Hari Om Agarwal v Oriental Insurance Co Ltd, AIR (2008) Del 29. 37 AIR (2007) Cal 77. 38 2009-(003)-CPJ -0199. 39 New India Assurance Co. Ltd & Anrs v. Ritu Khemka & Anr 2009-(002)-CPJ -0301. 40 III (1998) SLT 684, 1 (1998) CPJ 1 (SC), (1998) 4 SCC 39. 41 2005-(002)-CPJ-0035-NCDRC.

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42 Legal Services Authority Act, 1987, Section 22C. 43 Ibid., Section 22E. 44 Insurance Act, Section 114(1). 45 Insurance Regulatory and Development Authority (Protection of Policy holders’ Interests) Regulations, 2002, Regulation 5. 46 Ashok Kumar Dhingra and Others, Petitioners v. Oriental Insurance Company Limited and Others, AIR (2004) Del 161. 47 Regulation 11(4). 48 Cause of action is a legal phrase used to indicate the most proximate cause that gives a right of action to a litigant to enforce his claim. 49 Shaheed Ahmed v. Shankaranarayana Bhat and Anr, (2009) ACJ1448, ILR (2008) KAR3277. 50 Income Tax Act, 1961, Section 80D. 51 Ibid., Section 80DB.

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MEDICAL EDUCATION AND PRECEPTS OF MEDICAL ETHICS: THE INDIAN EXPERIENCE A book that examines contemporary issues and challenges on the subject of law and medicine is not like alphabets that begin with ‘a’ and end with ‘z’. Several of the outlined subjects raise issues that confront just not the medical community but the average member of the public. The study commences from the status of medical education which produces the population of doctors. We have examined not the issues of curriculum and how to make the course materials better to churn out professionals of high caliber but examined only the laws that allow for admission of students and regulations that exist for establishing medical colleges. The major areas of concern are the commercialization of medical education and the high costs involved in securing medical degrees. An attempt through the Indian Medical Council’s regulation to homogenize admission criteria by a compulsory all India-level common entrance eligibility test for graduate and postgraduate courses was struck down by the Supreme Court in Christian Medical College,Vellore v. Union of India1 not merely as violative of minority rights guaranteed to establish educational institutions of their choice but also for breaching institutional autonomy that was to be assured to privately-managed unaided institutions and colleges established by deemed universities. It is strange logic that the MCI that could regulate professional examination cannot set uniform standards for admission into graduate and post graduate courses. It is all the more surprising that the judgment that allowed privately managed medical Medicine and the Law. K. Kannan. © Oxford University Press 2014. Published 2014 by Oxford University Press.

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colleges to have their own admission norms had a point of reasoning in the judgment that the common admission norm would work against poor students from rural areas to compete with city bred students, as though the privately managed colleges admitted poor students. Issues of reservation were the most predominant subjects debated when only limited seats were offered in government colleges, but the proliferation of privately managed colleges has brought fresh problems of quality of education, dilution of merit considerations, and high costs of education through capitation fees. There have been excessive controls through judicial interventions that have been counter-productive. Improved resource allocations by the state for establishing more government colleges that lay emphasis on merit and affordable costs of education are nowhere in sight. More scholarships through alumni support and establishing and subsidizing medical education have more to do with civil society’s propensities to charity and nobility of purpose than what legislation could help bring. For the same reason, courts’ rhetoric for noble gestures for setting up self-financing private colleges which shall shed capitation fees has helped no public cause. The minority institutions’ clamour for more autonomy has created a further sense of public alienation and resentment that constitutional guarantees for preservation of minority rights and culture have been misused. There is still a market for foreign medical degrees from Russia, China, Nepal, and East European countries, but the information that there is a poor pass percentage of students in the screening test conducted by the authority under the MCIR gives one an idea that Indian universities are better off in standards than many of the universities of these countries2. The subject of medical ethics gets predominant treatment for obvious reasons.The public perception that the medical professionals fleece the patients (the dissatisfaction quotient may be high against every other professional, as well!) and how they shall conduct themselves has been the subject of concern from the days of the Greek physician Hippocrates, that is, since the fourth century bce. The MCIR has set forth guidelines beyond what Hippocrates had to say, but it would seem that there needs to be constant reminders of even the age old ethical exhortations. If we recognize the fundamental precepts of medical practice to include autonomy, beneficence, non-malfeasance, and justice, they may not obtain importance in the same order in all countries.To a well-informed, educated class of people, autonomy may

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be an important issue. A typical Indian patient might be prepared to cede to the doctor a greater liberty to decide what is best for them and seldom question their decision regarding diagnosis or treatment regimen. Consequently, the serious dilemmas of whether the doctor could treat a patient without providing information on all the details of the treatment, or whether the treatment of a patient in an unconscious state could begin only after ascertaining any advance directives declared when conscious are rarely encountered by the medical community. Withdrawal of life support to a patient who cannot take such decision owing to their extreme ill-health or unconscious state is never an easy decision. For an affluent patient taking treatment in a private hospital, it may not yet be an issue, but a patient at a free government hospital or where there is a constant pressure on beds owing to over-crowding, the choice becomes more difficult to the hospital administration, as it has to make fair allocation of its scarce resources between patients, some of whom could afford the costs involved and many who cannot. There is always a lurking suspicion that the wealthy and influential have better manipulative power to draw the maximum advantage from state-run hospitals than the indigent rural folk. Confidentiality is also a serious casualty at the government-run hospitals that are overcrowded. Obtaining a patient’s history is never a private affair. The doctor is invariably surrounded in an out-patient ward with large number of patients and even personal gynaecological complaints are elicited in the presence of other patients. CLINICAL ESTABLISHMENTS It is not uncommon for a private practitioner to breach his duty by turning down a patient who may be in a critical condition. The public shows remarkable lenience in these cases and rarely complain much. It was unheard of that a doctor would turn out a patient who could not pay in advance till corporate hospitals have come on the scene.3 A hospital that operates on public money and declares dividends have to consider the paying capacity of a patient, but when there have been complaints of refusal to admit or administer treatment, the courts have tellingly punished the erring doctors and hospital administrations. Ethical rules of practice are directed against medical practitioners, but there has been no effective method of reining in corporate hospitals,

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which are juristic persons that cannot fall within the term ‘medical professional’. Consequently, they have fallen out of the existing ethical code. A doctor is not a master diagnostician anymore, and technology brought through expensive gizmos as part of hospital diagnostic tools is a new justification for costlier treatments. It may be rationalized that a hospital that advertises does not parade the skills of the doctor but benignly announces the efficacy of its ultra-modern facilities.With such a perception, there is no effective regulation of unethical advertisements of the medical care facilities of corporate hospitals. A doctor owning a nursing home is not prevented from running a pharmacy on the same premises, provided it is manned by a licenced pharmacist. Cases in foreign jurisdictions against doctors who prescribe medicines to benefit through pharmacies in which they have a proprietary do not apply in India under the existing regulations.4 These issues, however, have been revived with the passing of the Clinical Establishments (Registration and Regulation) Act, 2010. The act has restricted applicability, and more and more states must be willing to adopt the act by suitable legislation. The act itself has many serious limitations.5 The act makes emergency service mandatory for compulsory registration of every clinical establishment, subject to the availability of staff and facilities. Lofty as it may seem, it is bound to cast a heavy responsibility for small clinics that predominantly offer consulting services with minimum facilities for inpatient care.6 Quality medical care must start from state-run hospitals,which must set the benchmark for private performance. The unhygienic, poorly run state hospitals are forcing even poor patients to prefer private hospitals, and this only means a voluntary abdication of state duty by its default to enable the private enterprise to take control. One might even suspect that this act is the first step towards privatization of medical care, and what the government cannot efficiently do by running hospitals it is choosing to effect by regulating clinical establishments through bureaucratic controls.7 EUTHANASIA AND THE SANCTITY OF LIFE Doctors canno longer be unwitting collaborators in human rights violations. Thanks to the Supreme Court verdict in Selvi v. State of Karnataka,8 which describes narco-analysis, brain-mapping and lie-detectors as testimonial compulsions, doctors shall not be called to

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assist the investigation agencies in administering medicines or sticking needles to patients to ‘extract the truth’ or ‘detect lies’. Euthanasia exists in two forms, active and passive. The IPC criminalizes any attempt to suicide and, consequently, it equates assistance to termination of human life in both forms as abetment to suicide, rendering euthanasia unlawful. In Aruna Ramachandra Shanbaug v. Union of India,9 the permissible contours of mercy-killing a patient in a vegetative state were examined with remarkable sensitivity. Dignity in death is a seriously discussed topic in many countries.There are some countries in Europe and some states in the US that have permitted euthanasia in both forms. But the court approaches have generally been very cautious, and have not attempted to strike any new paths.They have held on to popular belief of the sanctity of life. Concepts of patient autonomy and primacy of advance directives are gaining ground as well, pointing ahead to different possibilities in future.10 STANDARD MEDICAL PRACTICE V. INFORMED CONSENT Interactions between the doctor and patient that deal with consent for treatment, the disclosure requirements of risks involved in the treatment, the effect of inability to secure consent in states of extreme illnesses, insanity, minority, etc., truly depict certain rigid protocols to be followed in their relations. In Indian medical practice, the doctor enjoys greater latitude of discretion in the treatment regimen undertaken, and the courts have adopted the British model of testing the validity of a medical negligence complaint by raising the question of whether a particular type of treatment conforms to standard medical practice rather than the American standard of informed consent.11 In certain situations like abortion and sex detection of child in womb, laws prescribe what a doctor could do. Here, the patient’s consent is not the only relevant criterion.Teenage pregnancies of unmarried girls is not a major issue in India yet, unlike in the US, where the doctor must notify the parents if the pregnant girl is less than 16 years old and chooses to have an abortion.12 Sutchita Shrivastava and Another v. Chandigarh Administration13 was unique in the sense that the court has distinguished between a mentally ill person who cannot exercise a choice and a mentally retarded person who may not, by such mental

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disability, forsake her volition to either retain or abort the foetus. The case also outlines the court’s jurisdiction not merely to determine that autonomy of the mother but going beyond it to rehabilitate the child after its birth.14 Reporting drug abuse in a pregnant woman that could harm the child in fetus is not yet a law in India, but US law15 regards it as an important exception to doctor–patient confidentiality issue in permitting disclosure to state agencies for effective intervention. Drug abuse is, mercifully, not a serious problem in India among women, but female foeticide is. Female infanticide is a post-birth malady and doctor could have no role to play, but foeticide could never be done without the aid of the doctor. The IPC has provisions for causing miscarriage, but they are never strictly enforced, considering the relatively low incidence of reported cases under the relevant provisions. The efficacy of the Pre-conception and Pre-natal Diagonastic Techniques (PNDTs) (prohibition of sex selection) Act as a deterrent to prevent foeticide in cases where sex determination has been done in violation of the provisions is seriously undermined by an inept investigation and a lack of adequate vigil.

Importance of Doctor’s Evidence in Courts The doctor’s role as an expert witness in court is crucial in both civil and criminal cases. The increasing reluctance of doctors to testify in court is also a fact. The Supreme Court laid down directions for all courts to follow in the matter of summoning of doctors and restricted the exercise to only those cases where their evidence is absolutely essential, and stated that when they are summoned they should not be made to wait and waste time unnecessarily.16 In a still later case,17 the Supreme Court took stock of the situation that the doctor who actually treated the patient does not attend court, busy as he is with his professional work and the patient who has to perforce bring support of medical evidence to prove his medical condition resorts to ‘regular court witnesses’ among doctors, whose quality of evidence is unsatisfactory. As the person who collects the first evidence of violence on the body, including private parts, the doctor’s evidence is vital in sexual assault cases. Rape itself is not a medical condition, and the doctor shall not make any hasty generalization by personal observations on the scope for consent in the sexual act by observing that there were no

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injuries on the victim. Sometimes inappropriate judgments about the victim’s sexual proclivity are made by the doctor from the size of the orifice of sexual organ with regard to the ease with which the fingers could be inserted. The victim should not be traumatized further by personal views in the doctor’s report or suggestions that the victim could have consented to sex based only on the absence of injuries or the finger test.18 Among civil cases, the doctor’s evidence is most sought after in motor accident claims where disability has to be assessed. The percentage of disability assessed can be anybody’s guess, and even in cases the assessment is made to conform to medically accepted norms, there is seldom any attempt to explain how the particular disability could impact earning skills and the degree of impairment in relation to activities that the victim could have been adept at before the onset of the disability. Psychiatric injury as a component of a head of claim for damages for a secondary victim, such as an onlooker or an industrial co-worker who is traumatized by an accident injury to another worker, is still in a nascent state in Indian courts, and if it gains acceptability, the doctor’s appraisal of mental injuries would be invaluable.19 The doctor has several cloaks to don. They are not merely witnesses but figure as defendants in large number of cases of claims to damages for medical negligence in many a consumer forum.20 MEDICAL NEGLIGENCE CASES The term ‘medical negligence’ carries several hues depending on the jurisdiction invoked. The standards of proof in a criminal prosecution could be greater than in a complaint of ‘deficiency of service’ under Consumer Protection Act, and still more different from how negligence could be proved in a properly constituted civil action through a full-fledged trial for damages in common law jurisdiction. The Supreme Court held that the police are required to take medical advice before launching a criminal prosecution against a medical practitioner,21 but in a subsequent judgment the court22 doubted the correctness of such a proposition and has sought reference for an authoritative pronouncement by a larger bench. The court has laid down certain guidelines for the future to govern the prosecution of doctors for offences in which criminal rashness or criminal negligence is an ingredient.23 The approaches of the courts and consumer forums

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have been, by and large, protective of the medical community, and the Bolam principle has helped them in a large way in looking for proof against ‘standard medical practice’ and reading down the requirement of want of ‘informed consent’ in Indian conditions, where an average patient from rural areas is illiterate and prepared to abide by their doctor’s diagnosis, advice, and treatment.24 It could have been just as well possible for the courts to look for stricter rules of professional rectitude and greater degree of responsibility to be shown by the doctor for their decision. After all, the fiduciary relationship ought to have ensured that the trust was not misplaced. Paradoxically, courts have taken the situation to be an extenuating circumstance and diluted the norms of liability by looking for bona fides of the line of treatment by the doctor to exculpate the doctor. There are perhaps more cases dismissed in actions against doctors than cases decided in favour of patients complaining of negligence. REPRODUCTIVE MEDICINE IVF procedures make it possible for infertile couples as well as gay and lesbian partners to ‘procreate’ and become parents in their own right. In countries where same-sex marriages are legal, the availability of IVF procedures offers a new possibility of parenthood. A person that opts to change sex from female to male may still retain ovaries to ‘bear’ a child physically. A dead man could be responsible for impregnation of a woman, if the sperm from the deceased person is extracted and used. Many of these possibilities have come about without adequate legal provisions to regulate them. There are no universally acceptable norms in surrogacy arrangements, and India is reported to have emerged as a favourite destination for infertile couples from foreign countries who seek to commission indigent surrogate mothers. The cases that have come to the Supreme Court25 have met with ad hoc approaches that have done no good either to commissioning parents, the children, or surrogate mothers. Even apart from a need for specific enactment legitimizing IVF procedures and regulating mechanisms, a whole host of legislative changes must come through changes in the Indian Evidence Act, Birth & Death Registration Acts of various states, the Citizenship Act, and the Passport Act. The unresolved issues are far too many. Given the vulnerabilities of Indian woman, it is debatable if

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any legislation could guarantee against exploitation of indigent persons and eliminate the commercial element in surrogacy agreements. RESEARCH AND CLINICAL TRIALS The science of genetic engineering that led to cloning was perhaps the most significant event in the 1970s. We may not go as far as to permit cloning human beings (on the ground of public order and morality) yet,26 but medical research in human embryos has yielded substantial benefits for many an infertile couple. The test-tube baby phenomenon has now become commonplace. Detection of chromosomal abnormalities or the prospect of birth with defects can be predicted with reasonable certainty. Unlike embryonic stem cell research with inherent dangers to human cloning attempts, research on umbilical cord, placenta, adult, and animal stem cells do not pose the same ethical dilemma and offer a vast scope for discoveries of life-saving measures and cures. Problems abound when decisions have to be taken for the transplant of stem cells from minor children even if the beneficiary is the child’s sibling. The relevance of these technological inventions and treatments is acutely felt, when, in the absence of statutory regulations, the courts may be forced to render adjudication on what is in the best interest of the child in its patria parens jurisdiction. Even beyond life the human frame holds interest for research. Dead bodies have enormous value. Is there property in a dead body? Should it be treated with dignity at the time of cremation or burial? Could there be justifiable claims for the ashes of a dead person? Does a doctor who harvests an organ after death for a charitable purpose and with good intentions, but without informing the next of kin, commit theft? Can a person grant a right through a will for sperm to be extracted for impregnation after his death? Unusual questions have unusual answers, and the courts have approached these issues with remarkable sensitivity, even while holding that there is no property as such in a dead body.27 Pharmaceutical research is the key to allopathic science, and herein lies the major areas of litigation in the branch of patent law. The amendment to the Patents Act re-defining the expressions invention, inventive step, and explanation of what are not inventions has effectively protected dangers of evergreen scuttled attempts of foreign

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companies to obtain patents and price their products high to reap higher profits and make even lifesaving drugs unavailable. The recent pronouncement of the Supreme Court in Novartis case28 restored the much needed balance of rewarding only genuine inventions and the production of generic drugs at affordable prices. Again, without clinical trials, there could be no medical invention or scope for testing the efficacy of medicines. Debates on issues of consent are central to medical ethics and are raised with alarming frequency. Media reports that expose stories of serious health hazards to the most vulnerable sections, such as tribals and illiterate rural folk, are surely a challenge to law enforcers when the Drugs and Cosmetics Rules and MCIR are found to be breached by researchers with impunity. Informed consent, although mandated by the protocol for clinical trials by way of two amendments to the Drugs and Cosmetics Rules, 2005, has not saved the continual breaches that are taking place in various clinical trials and admitted by the government through its reply in the Rajya Sabha debate on clinical trials to the un-starred question number 3028 on 20 December 2011. If the Supreme Court has discarded the informed consent as ineffective in Indian social conditions for medical treatment,29 would this work well for clinical trials? The amendment to the rules proposed by notification dated 18 November 2011 includes coverage of medical treatment costs and financial compensation due to (1) adverse affects of investigational products; (2) departure from approved protocol; (3) failure of an investigational product to provide the intended therapeutic effect; (4) administration of placebo providing no therapeutic benefits; (5) adverse effects due to concomitant medication administered as per approved protocol and (6 ) compensation for injury to a child in utero because of the participation of parent in clinical trial. It is most desirable that specific legislation is brought exclusively dealing with clinical trials, instead of allowing their entry through executive regulations through Drugs and Cosmetics Rules. It should provide for (1) exclusion of all vulnerable sections of people, including prisoners, illiterate, poverty stricken, and tribal community without any exception; (2) strict liability for any type of injury or death with liquidated sums of damages for death or injuries for persons participating in the clinical trials; and (3) require deposits of guarantee money upfront before a Licensing Authority at time of securing approval for clinical trial.

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HEALTHCARE AND STATE INITIATIVES What is now commonplace knowledge about the harmful effects of smoking tobacco required substantial research before laws were enacted to regulate the sale of tobacco products.30 Litigants in the US had to bring the issues to court before law-making agencies acted. The tobacco litigation did not merely stop with individual claims and class actions; but the federal government and the insurance companies also hopped on the bandwagon to sue the tobacco industry for reimbursement of the public expenses that they were forced to incur respectively. The tobacco litigation in the US and Canada, and fantastic compensations awarded by courts are not model cases in India. The state has done no more than regulate the sale by banning certain types of ads, warnings on cigarette packets and imposing steep taxes to de-incentivize consumption. It is doubtful that we will achieve a total ban on tobacco products any time within the next five decades. Banning liquor consumption and imposing total prohibition are still not a reality in the land of Mahatma Gandhi, although it is a declared Directive Principle of State Policy under Article 47.31 Nutrition correlates to sound health. The National Development Council (NDC) in its 53rd meeting, held on 29 May 2007, adopted a resolution to launch a Food Security Mission comprising rice, wheat, and pulses to increase the production of rice by ten million tons, wheat by eight million tons and pulses by two million tons by the end of the Eleventh Plan (2011–12). Accordingly, a centrally sponsored scheme, ‘National Food Security Mission’ was launched from 2007–8 to put the resolution into effect. If the National Food Security Bill becomes law, it promises that every family below the poverty line in rural as well as urban areas will be entitled by law, to 25 kilograms of rice or wheat per month at Rs 3 per kilogram. The Right to Food campaign demands a comprehensive ‘Food Entitlements Act’ that goes beyond the narrow promise of supplying food grains to the BPL population. Access to food has been improved by guaranteeing rural employment at least for a hundred days a year. The National Rural Employment Guarantee Act, 2005 (NREGA), is a step towards legal enforcement of the right to work, as an aspect of the fundamental right to live with dignity. There has been rampant corruption in the implementation  of the act, and the Supreme Court has directed a CBI investigation into allegations of malversation of public funds entrusted with state authorities in Orissa.32

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Poverty is still a serious malady in India.33 The Integrated Child Development Services (ICDS), launched in 1975, aims at the holistic development of children up to six years of age with a special focus on children upto two years, as well as expectant and nursing mothers.This is done through a package of six services: health check-ups, immunization, referral services, supplementary feeding,34 non-formal pre-school education, and advice on health and nutrition. In spite of its expansion in the last three decades, the impact on child nutrition and protecting the rights of the children is quite limited.35 Article 47 encompasses all these initiatives but between sloganeering and action, there is many a slip. The constitutional promise compels the state to act, but it is the public responsiveness and commitment that can guarantee success to these initiatives. HUMAN ORGANS Does organ transplantation from one body to another reduce human bodies to recyclable contrivances? The visually challenged would greatly benefit if just 1 per cent of the population in the world is prepared to donate eyes.36 Could we move towards a law that would provide for an implied authority for removal of eyes for donation in all cases where post-mortem is necessary by law, unless it is specifically objected to by the next of kin? Further, when we are discussing harvesting organs after death, the pivotal question is:When does death occur? The Transplantation of Human Organs Act resolved the issue by taking brain death occurring to a patient as certified by the authorization committee as the condition that could render eligible the person to be a lawful donor, provided consent had been elicited from that person during his life time in a prescribed form; or if after death, with the consent of the next of kin. Consent alone may not be sufficient at all times. Public policy would dictate an enquiry about why the person gave consent. Commercial exploitation of indigent persons through organized networks is rampant, but judges are prone to rejecting authorization committees’ views, and tend to be driven by emotive responses that their decisions mean the difference between life and death.37 If we are unable to curb the organ-trafficking racket, is it time to examine appropriate financial recompense that is made legally permissible in organ transplantation cases?38

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SEXUAL STEREOTYPES The sexual categories of male and female exclude a certain percentage of people who will not fall in either category. Their numbers may not be sizeable, but they bring a large number of serious issues to contend with, particularly in the attitudes that the society bears to them and the innuendos that are heaped on them. Today’s world recognizes rights of transsexuals and people with different sexual orientations. The problems of transsexuals and homosexuals are distinct. Sexchange surgeries to secure the identity proximate to the emotional and sexual orientation of the individual have resulted in termination from contracts of employment. Both traditional Hindu law and the Shariat assign to a transgender the sex that the person resembles for property rights,39 but in a recent case, election to the office of mayor in a constituency reserved for women was set aside on the ground that the returned candidate was a transgender.40 Challenges for transgenders have come about in a curious way; many of them in the lower strata of the society undergo sex reconstruction surgery and become sex workers. The problems of HIV/AIDS and related illnesses are a global scourge and there is a concerted attempt now to rehabilitate them to respectful employments that are otherwise being denied. It is time that the disabilities that they face are duly recognized to include them as eligible for reservation under the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995. Even the courts in the US and UK have come to their rescue, but in a halting way, unwilling to address the issue directly.41 Legislative interventions approving of same-sex marriages in many countries are responses to democratic expressions towards a just society that is inclusive of all diverse views and preferences. Even religious opposition could be blunted by the argument that God could not have erred and so the different sexual preference cannot be unnatural. A nonbeliever would argue for a theory of autonomy and liberty of the individual to express sexuality the way the person feels most comfortable with. But social prejudices die hard. It required a herculean forensic exercise to decriminalize homosexuality and promote LGBT rights in the judgment of the Delhi High Court in Naz Foundation v. NCT of Delhi.42 The changes in attitudes as well as in law have not come without stiff resistance in Western countries either. There have been gradual shifts from the DOMA that the US Congress introduced

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in 1996—empowering the states to deny the legitimacy of same-sex marriages—to the present status of legislation where six states, including New York, have legitimized homosexual marriages. In the UK also, gay marriages have been legitimized through the Marriages (Same-sex) Couples Act, passed in May 2013. The legal approbation is the first step to recognizing property and inheritance rights among the partners of the same sex. COSMETIC ENHANCEMENT AND MAGIC REMEDIES If the diagnostic skills of a doctor by physical, clinical examination are getting slowly suborned to judgments made based on computer-aided technology, at least for major types of ailments, cosmetic surgery is making the doctor truly an artist. The doctor here is not seen as curing an illness but engaged in the exercise of enhancing beauty.43 Assessment of medical negligence could be truly difficult, for there may not be a sure test of what the patient expects and how the doctor has stood up to the promised reconstruction of any part of the body to enhance beauty.44 Cosmetic enhancements through surgical procedures are still for the elite, given the cost factors and Indian resignation to accepting what are natural endowments, but many are prone to deception. Magical cures for many an ailment, proffered more often by quacks than fully qualified doctors, have come under the scanner of law enforcement agencies.The patient that succumbs to deceitful advertisement is seldom prepared to lodge a complaint. The patients’ taciturnity, weighed by unwillingness to admit to their folly in public, is the advertiser’s strength. MEDICAL INSURANCE As medical costs escalate and challenges to doctors’ treatment abound through litigations, insurance is the only mechanism that could hedge the risk for patient and doctor alike. Curiously, the mediclaim policies, as they are called, were introduced initially as tax-saving devices.45 There have been two major areas of litigation: first, alleged suppression of previous ailments as constituting lack of good faith by the insured, and second, failure of insurance companies to renew policies citing instances of ill health at the time of fresh commencement of the policies.The law has moved in favour of the patient, who can insist on right of renewal of policy despite contracting a new disease during the currency of the

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policy of the previous period, so long as it did not exist at the commencement of the previous policy period. The jurisdiction has been extended to the benefit of insured patient in writ proceedings as well, although purely contractual matters are normally spurned as out of bounds for litigants seeking redress through Article 226. The consumer forum, civil court, insurance ombudsman, Permanent Lok Adalat— almost every conceivable judicial forum is available for a litigant to secure redress against insurance company.This ease of access has perhaps become possible only because very few people resort to medical insurance.There appear to be cultural orientations that favour that treatment costs be borne ungrudgingly so that the cures are better assured! A HOPE FOR BETTER LIVING From the doctor as demigod to the professional scurrying for insurance cover—there is a lot that the law has done to regulate medical practice and assure patient welfare. There is still a long road ahead. Affordable medical care for the vast multitude of Indians living in remote villages is yet a distant dream. Tele-medicine, which could bring the expertise of the best clinician practicing in a city to a patient looking for advice in a village, is not fully realized. It has been suggested by a doctor and a former state health minister that initiatives for the creation of multi-purpose health workers, improving the role of specialist nurses, and accredited social health activists (ASHA) will provide a solution to needs in rural and underprivileged urban pockets.46 It is condescending to suggest that some less qualified persons shall attend to medical needs of rural folk. Technological advances and scientific discoveries have brought new scope for better living. Of what use is medicine if the quality of life is not improved? Of what improvement could we boast of, if the law cannot protect healthy practices and encourage discoveries for common good? Hope we must, that medicine and law achieve for humanity a life worth living. NOTES 1 T.C (c) No 98 of 2012 dated 18 july 2013. 2 See Chapter 1. 3 See Chapter 5, particularly the judgment in Pravat Kumar Mukherjee v. Ruby General Hospital & Ors 2005-(002)-CPJ -0035 -NCDRC.

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4 The American perspective is discussed in Chapter 2. 5 For a critical appraisal of the various provisions of the act, see Bismi Gopalakrishnan, ‘Clinical Establishments Act, 2010—Will It Cross the Quality Chasm?’ (2011) 6 SCC 36 (JS). 6 Section 12, dealing with conditions of registration, reads thus: ‘The clinical establishment shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilize the emergency medical condition of any individual who comes or is brought to such clinical establishment.’ 7 The huge official presence at the central, state councils with just one representative from the central or state medical association is illustrative of the point. 8 (2010) 7 SCC 263. See Chapter 2 for more commentary on human rights and Chapter 3 for consent. 9 (2011) 4 SCC 453. 10 See Chapter 2 for a discussion on euthanasia. 11 See Samira Kohli v. Dr Prabha Manchanda and Another (2008) 2 SCC 1, and Chapter 3. 12 See Chapter 7. 13 (2009) 9 SCC 1. 14 The Times of India, 24 September 2011, under ‘Find Play School for Victim’s Baby’, where the high court, which originally directed the termination of foetus gave directions to the state agency to find a suitable play school for the child born through the Supreme Court’s reversal of decision. 15 The Child Abuse Prevention and Treatment Act. See Chapter 3. 16 Pandit Parmanand Katara v. Union of India, AIR (1989) SC 2039. 17 Raj Kumar v. Ajay Kumar (2011) 1 SCC 343. 18 See Pritiksha Baxi, ‘The Medicalisation of Consent and Falsity: The Figure of the Habitue in Indian Rape Law’,The Violence of Normal Times, Essays on Women’s Lived Realities (Women Unlimited, 2005). See also Chapter 4. 19 See Chapter 4. 20 See Chapters 4 and 5. 21 Martin F. D’Souza v. Mohd. Ishfaq (2009) 3 SCC 1. 22 V. Kishan Rao v. Nikhil Super Specialty Hospital and Another (2010) 5 SCC 210. 23 Jacob Mathew v. State of Punjab and Another (2005) 6 SCC 1. See also Nizam Institute of Medical Sciences v. Prasanth S. Dhananka (2009) 6 SCC 1 for an extensive treatment of the subject of medical negligence. 24 Samira Kohli v. Dr Prabha Manchanda and Anr (2008) 2 SCC 1. 25 See Chapter 7 for the cases of German Twins and Babu Manji Yamada. 26 See Chapter 8.

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27 See Chapter 8. 28 Ibid. 29 Samira Kohli v. Dr. Prabha Manchanda and Anr (2008) 2 SCC 1. See Chapter 3. 30 See Chapter 8. 31 Gujarat has total prohibition. Notifications are issued banning sale of liquor on Gandhi Jayanti Day, during elections and religious festival days. Consumption of liquor can be regulated by announcing partial dry days (P.N. Kaushal and Ors v. Union of India (UOI ) and Ors, AIR (1978) SC1457, (1978) 3SCC558, [1979]1SCR122), restricting the hours of working of liquor shops, imposing restrictions on age limits (The Maharashtra law has raised the minimum age of person eligible to consume liquor to twentyfive), and ensuring that the location of liquor vends are not proximate to places of worship, educational institutions, etc. Trade in liquor has been held to be pernicious and hence there is no fundamental right to trade in a liquor business (State of MP v. Nandlal Jaiswal (1986) 4 SCC 566; Khoday Distillaries Ltd v. State of Karnataka (1995) 1 SCC 574; reasonable restrictions are therefore permissible (State of Punjab v. Devan Modern Breweries Ltd (2004) 11 SCC 26; P.N. Krishna Lal v. Government of Kerala 1995 Supp (2) SCC 187. 32 Centre Evironment & Food Securtiy v. Union of India, (2011) 5 SCC 668. 33 Some of the states have a very high poverty ratio for the total population. In the year 2004–5, this was more than 40 per cent in Orissa, Bihar, Chhattisgarh, and Jharkhand, and between 30 and 40 per cent in Madhya Pradesh, Chhttisgarh, Uttar Pradesh, and Uttarakhand. It may be noted that Orissa’s poverty level (47 per cent) is almost six times that of Punjab (8 per cent) in 2004–5, Copyright @ 2010 Oxfam India. 34 Rule 37B of the Packing and Labeling Rules under the Prevention of the Food Adulteration Act mandates that the baby food packaging must contain a statement to read, ‘Mother’s milk is best for your baby’ and that ‘infant food shall be introduced only after four months of age’. 35 ‘Food Security in India: Performance, Challenges and Policies’, (Oxfam India: 2010). 36 WHO estimates that 285 million people are visually impaired worldwide of whom 39 million are blind and 246 million have low vision. Factsheet N*282, issued in October 2011. 37 See Chapter 9. 38 Ibid. 39 See Chapter 10. 40 Ibid. 41 Ibid.

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42 2010 Cri LJ 94, 160 (2009) DLT 277. 43 See Chapter 11. 44 Ibid. 45 See Chapter 12. 46 See ‘Writing Out a Prescription for Healthcare Reforms’, The Hindu, 18 November 2011. Dr Poongothai argues that India requires professionals who are trained in institutions with standardized infrastructure, and accessible and equitable healthcare for both the rural and urban populace.

Index

A. Periyakarupan v. State of T.N., 26 abortion, 2, 196–9, 207 of children in womb with defects, 382–3 ethics and, 380–1 extent of immunity to a medical practitioner, 375–6 legitimacy of, 381–2 MTP Act, 1971, 372–80 objector to, 383–4 offences and penalties, 379–80 penal provisions in the IPC, 372–3 permissibility, 373–4 place where pregnancy may be terminated, 379 pregnancy of a minor or ‘a mentally ill person’, 376–9 Achutrao Haribhau Khodwa and Ors v. State of Maharashtra and Ors, 302–03 Achutrao Haribhau Khodwa v. State of Maharastra, 189 Adam, Sir Fredrick, 18 admission norms, 19–26. see also reservation Andhra Pradesh law, 42

merit and entrance test for postgraduate admission, 25 minority-run educational institutions, 23 process of selection, 21 adoption, 344–6 advance directives, 60–1, 64 reasons for not initiating, 61 in US, 63 Ahmedabad St.Xavier’s College Society case, 23 Airedale NHS Trust Respondents and Bland Appellant, 215–16 Ajay Kumar Singh v. State of Bihar, 31, 39 All India Council for Technical Education (AICTE), 46 All India Democratic Women’s Association (AIDWA), 507 Allison v. Merck, 219 alternative medicine, 12 American Medical Association (AMA), 179 American Society of Reproductive Medicine, 341 Amnesty International, 127 Anatomy Act, 1949, 404

Index Andrews v. Director of Public Prosecutions, 292 Anil Kumar Gupta v. State of UP, 33, 35 Anonymous v. Weiner, 493 Anti-fraud and Abuse Act since 1978, 107 Antrum v. State of Maharashtra, 293 Article 29(2), 28 Aruna Ramachandra Shanbaug v. Union of India, 76, 114, 215, 564 doctor’s testimony on medical condition, 146–50 Arup Kumar Das and Anr v. State of Orissa and Ors, 468 Ashok Kumar Thakur v. Union of India, 29, 36 A.S.Mittal and Anr v. State of UP and Ors, 308 Assisted Reproduction Technologies Bill, 2008, 341 Assisted Reproductive Technology (Regulation) Bill, 2008, 357–8 Assisted Rreproductive Technology (ART), 341 assisted suicide, 113–14 Assoication for Molecular Pathology, et al. v. Myraiad Genetics Inc., et al, 395 autonomy, right of, 172 advance directives, 60–1 under Article 21, 60 balance between individual’s autonomy and doctor’s ethical duty, 59 for a competent patient, 59–60 compulsory vaccination policy, 66–70 duty to care, 62 for a fully competent person in critical condition, 62–3 for an incompetent patient, 63–4 limits to patient, 59–60

579

Massachusetts law, 66–8 minor or incompetent patient, 64–6, 152n26 Ayurveda, 57 Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), 13, 86 Baby Manji Yamada v. Union of India and Another, 352 Bachelor of Medicine and Bachelor of Surgery (MBBS), 22 Bankers’ Books Evidence Act, 1891, 84 Barnes v. City of Cincinnati, 495 Beecher, Henry, 58 beneficence, 70, 192–3 Bentinck, Lord William, 18 Bhabhani Prasad Jena v. Convenor Secretary, 131 Biman Krishna Bose v. United India Insurance Co Ltd, 544–5 Biomedical Waste (Management and Handling) Rules, 1998, 87 Bolam v. Friern Hospital Management Committee, 5, 88, 186, 298 Bolitho v. City and Hackney Health Authority, 88 Bombay Prohibition Act, 223 Bonner v. Moran, 477 Bowater v. Rowley Regis Corporation, 180 Bowers v. Hardwick, 505, 510–11 breast implants, 522–3 Breithaupt v. Abram,Warden, 222 Briody v. St Helen’s and Knowsley Health Authority, 346 C.A.Thomas Master v. Union of India (UOI ) and Ors, 458 Calcutta Medical College, 18 Canterbury v. Spence, 87, 174 capitation fee, concept of, 40–1, 48

580 Carrie Jaffee, Special Administrator for Ricky Allen, Sr, Deceased, Petitioner v. Mary Lu Redmond et al., 92 Central Drugs Standard Control Organisation (CDSCO), 409 CESC Ltd v. Subash Chandra Bose, 143 Chandigarh Administration v. Nemo, 210–11 Chatterton v. Gerson and Another, 182 Chester v. Afshar, 184 Child Abuse Prevention and Treatment Act, 200 Child Adoption Regulation Agency (CARA), 344 Child Protection Service (CPS), 221 Children Act, 1989, 225 Chin Keow v. Govt of Malaysia, 10 Chitra Ghosh v. Union of India, 32 Christian Medical College,Vellore v. Union of India, 23, 25, 560 Civil courts, 555 Clinical Establishments Act, 2010, 144 Clinical Establishments (Registration and Regulation) Act, 2010, 78, 563 clitoridectomy, 199 Cochin Makkathayam Thiyya Act, 492 Code of Civil Procedure, 1908, 140 Code of Criminal Procedure(CrPC), 111, 140, 507–08 Commissioner of Health of New York v. Roe et al., 93 confidentiality, 2 consent to treatment, 65 alcohol breath analysis and blood test, 222–3 for being a subject of medical research, 230–2 in case of child custody disputes and mental condition of the parent, 211–13 case of mentally-ill patient, 201–03

Index case of serious illness that impairs capacity to, 213–16 components of informed, 179–95 control of courts, 224–9 effect of parent’s refusal for treatment, 196 evidence of minority and mental ill-health, 195 local committee and, 210–11 neo-natal circumcision, practice of, 199–200 parental consent of contraceptive advice or abortion, 196–9 patients under anaesthesia, 216–18 of persons under disability, 195–8 physician failure to secure, 191–2 position of guardian ad litem, 223–4 procedure for appointment of a guardian, 209–10 real and informed, 174–6 regarding sterilization, 218–19 relation to vaccination, 219–22 reporting child abuse, 200–01 and torture, 229–30 in various stages of treatment, 176–9 Consumer Disputes Redressal Commission, 285 Consumer Protection Act, 1986, 9–10, 191, 284–5, 321–2, 325, 327, 554 Convention for the Protection of Human Rights and Fundamental Freedoms, 62 Corbett v. Corbett, 493, 501 Cornellio v. Stamford Hospital, 408 cosmetic surgery, 520–1, 573 biomedical enhancements, 523–7 breast implants, 522–3 enhancement of beauty, 521–2

Index legal limitations to advertisements to ‘magic remedies’, 527–30 non-therapeutic intervention, 521–3 objections to enhancement biotechnologies, 525–7 use of botox, 524 Council of the Human Genome Organisation, 136 Cruzan, By Her Parents and Co-Guardians, Cruzan Et Ux. v. Director, Missouri Department of Health, et al., 226 Cruzan v. Director, Missouri Department of Health, 63, 70 Crystal M. Ferguson, et al. v. City of Charleston, et al., 93 Curran v. Bosze, 481–3 Dahyabhai Chhaganbhai Thakkar v. State of Gujarat, 258 Dangerous Drugs Act, 1930, 3 Declaration of Helsinki, 58 Declaration of Inuyama: Human Genome Mapping, Genetic Screening and Gene Therapy, 137 Declaration on Cloning, 137 Declaration on the Human Rights of individuals, 128–9 Defense of Marriage Act (DOMA), 505 ‘deficiency of service’, negligence in, 321–7 action against physician, 324–5 complicated questions of law and facts, 326–7 ESI scheme, 325 hospital liable for negligent conduct of a doctor, 325–6 limitation for filing complaint, 327 proof of, 324

581

Delhi Artificial Insemination (Human) Act,1995, 356–7 Delio v. Westchester Country Medical Center, 63 Dhirendra Nandan & Another v.State, 511 Diamond v. Chakrabarty, 394 Dimminaco AG v. Controller of Patents and Designs, 395 Director General of Health Services (DGHS), 83 disclosure of confidential information, 90–9 communicable disease of patient, 94–5 criminal proclivities of patient, 91–4 doctor as a witness against his patient, 95–7 extent of risk to be dislcosed, 181–4 HIV infection and AIDS, 94–5 legal basis for action for breach of confidentiality, 97–9 non-disclosure of a secondary risk, 183–4 reporting child abuse, 200–01 and Right to Information Act, 97 DNA evidence, 130, 170n175 DNA testing, 256 doctor-patient confidentiality. see disclosure of confidential information doctors in courts, 565–6 ascertaining mental capacity to contract, 264 for ascertaining mental capacity to execute a will, 264–5 ascertainment of mental illness in criminal proceedings, 260–1 assessment of disability, 266–72

582 burden of proving insanity, 243–4 in civil cases as witness, 261–5 collection of blood and DNA testing in rape cases, 252 determination of age, 244–5 determination of age relevant in rape cases, 250 determination of medical negligence, 266 dying declaration, evidence relating to, 245–9 evidence of, 239–40 as expert witness, 245–9 in homicide injuries, 252 identity of the accused, 254–6 immunity for a doctor against flawed evidence, 241–2 injures, 253–4 likelihood of weapons used, 252–3 in matrimonial proceedings, 263–4 medical certificate, 242–3 medical invalidation, 271–2 mental condition of the accused, 257–60 in murder cases, 252–3 narco-analysis, brain mapping, and lie-detectors, 256–7 need for medical evidence in criminal cases, 241 paternity testing, 273–4 psychiatric injury, 272–3 in rape cases, 249–51 as regards to physical act and injuries, 250–1 role in appointment of a guardian, 262–3 suicidal wounds, 253 as a witness for extra-judicial confession, 260 as witness to a will, 265–6 Doe, et al. v. Bolton, Attorney General of Georgia, et al., 384

Index Doe v. Roe, 97–8 D.P. Joshi v. State of M.B., 40 Dr. Preeti Srivastava v. State of M.P., 20, 31 Dr Jacob George v. State of Kerala, 376 Dr J.J. Merchant and Ors v. Shrinath Chaturvedi, 326 Dr J.J. Merchant v. Shrinath Chaturvedi, 295 Dr Laxman Balkrishna Joshi v. Dr Trimbak Bapu Godbole and Anr, 302 Dr Preetinder Kaur v. State of Punjab, 370 Dr Suresh Gupta v. Govt of NCT of Delhi and Anr, 286 Drugs and Cosmetic Act, 1940, 87 Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, 87, 110–12, 527 ‘dual loyalty’ conflict, 128 Dudgeon v. The United Kingdom, 508, 510 Due Process Clause, 226, 228 Dung Ngo v. Standard Tools & Equip., Co., 95 Dunn v. North York General Hospital, 183 durable power of attorney law, 63 Eckersley v. Binnie, 298 Edmonds v. Armstrong Funeral Home Ltd, 405 electronic commerce, 84 Eligibility Requirement Regulations and Screening Test Regulations, 50 Emperor v. Omkar Rampratap, 291 Employees State Insurance Act, 1948, 144 Employees State Insurance Corporation (ESIC), 316 Environmental Protection Act, 1986, 87 Etsitty v. Utah Transit Authority, 495

Index euthanasia, 2, 113–17, 563–4 active and passive, 114–16 Evidence Act, 246 Section 112 of, 131 Eyre v. Measday, 304 Factories Act, 1948, 144 fairness or justice, 77–8 Family Law Act, 184 Family Law Reform Act, 1969, 152n26 Federal Alcohol and Drug Rehabilitation Act, 201 Felde v. Vein and Laser Medical Centre et al., 184 female circumcision, 199, 234n43 Fleming v. Reid, 194 Food, Drugs and Cosmetics Act (FDCA), 436 Foreign Medical Graduates Examination (FMGE), 49 foreign universities general, 49 Medical Council regulations, 49–50 Frenchay Healthcare NHS Trust v. S, 229 Galen, 58 General Assembly of the United Nations by resolution A/ RES/51/162, 85 Ghanshyam Rathod v. Dr(Mrs) Ushaben H.Shah & Others, 313 Gian Kaur v. State of Punjab, 60 Gillick v. West Norfolk and Wisbech Area Health Authority and Another, 197 Gonzales v. Oregon, 115 Goutam Kundu v. State of Bengal & Anr, 274 Goutam Kundu v. State of West Bengal and Anr, 130 Guardian and Wards Act, 172

583

Guillain-Barre syndrome, 193 Guntur Medical College v. Mohan Rao, 29 Gupta, Madhusudhan, 18 G.V. Lakshminarayanan v. G.V. Nagammal, 262 habeas corpus ad subjiciendum, 206 Halsbury’s Laws of England, 298 Hamdard Dawakhana (Wakf) Lal Kuan, Delhi and Another v. Union of India and Others, 111 Hart v. Brown, 476 ‘health for all,’ national goal, 21 health insurance/medical insurance, 573–4 contract uberima feide (‘of utmost good faith’), 540 defence to repudiate a policy, 548–50 difference between mediclaim insurance and life insurance, 539 disease contracted during currency of policy, case of, 545 disputes via writ jurisdiction, 554–6 duty not to repudiate liability irresponsibly, 553 excepted categories of illnesses, 543 interpretation of terms in, 540–1 Mediclaim Insurance Scheme in India, 538–9 motor accident victims, 556 non-disclosure of material fact and denial of liability, 547–8 objects of, 539–40 onerous liability, 545–7 operation of exclusion clauses, 551–3 pre-existing illness disclosed but ignored by the insurer, 550

584 principles in respect of mediclaim policy, 546–7 procedure, 541–2 professional indemnity insurance, 553 reference to pre-existing disease, if wrongly recorded, 551 refusal to renew, 543–7 state instrumentalities, 544–5 tax benefits, 557 types of policies and persons covered, 542–3 unwillingness to pay additional premium, 544 Hecht v. Superior Court, 408 Hindu Inheritance (Removal of Disabilities) Act, 1928, 492 Hindu Marriage Act, 94, 201, 263 Hippocratic oath, 57–8, 94 homosexuality, 492, 504–11, 572–3 disability from, 514–15 Law Commission recommendations for, 506–08 UN General Assembly Memorandum, 511–12 Hopkins v. Price Waterhouse, 494 Hucks v. Cole, 299 Hughes v. Robertson, 406 HUGO Ethics Committee, 137 Human Fertilisation and Embryology Act, 1990, 215, 346 Human Fertility and Embryology Authority, 341 Human Fertilization and Embryology Act, 1990, 314, 456 human rights and conventions on clinical trials, 134–6 Declaration of Tokyo, 1975, 126 distinction between ‘volunteering’ and ‘being asked to volunteer’, 133

Index and experimentation, 128–9 historical perspective, 126 HIV/AIDS medicines and clinical trials, 136 and international conventions, 126–7 and medical ethics, 112–13. see also medical ethics narco-analysis, brain mapping, lie detectors, 129–34, 168n163–4 National Human Rights Commission and, 132–4 Nazi experimentation on human beings, 129, 167n161 right to be treated as a facet of, 143–4 testimonial compulsion, 129, 131–3, 169n174 violations under military regimes, 127–8 Human Rights Act, 1998, 151n20 human rights courts, 143 Human Rights Watch, 127 Hunter v. Hanley, 186–7, 299 imaging specialist, 368 Income Tax Act, 267 Indian Evidence Act, 91, 257 Indian Medical Association v. Shantha Devi, 295 Indian Medical Association v. V.P. Shantha, 190 Indian Medical Association v. V.P. Shantha and Ors, 322 Indian Medical Council Act, 1956, 4, 11, 19–21, 85, 120, 368 guarantee of quality, 20–1 section 33, 20 Indian Succession Act, 264 Indian Systems of Medicines and Homoeopathy (ISM&H), 86

Index Indira Sawhney v. Union, 29, 34, 36, 38 Information Technology Act, 2000, 84 informed consent Bolam test and, 186–90 choice regarding alternatives, 180–1 and extent of risk to be dislcosed, 181–4 Indian context, 190–1 medical paternalism, 192 physician failure to secure, 191–2 prime duty to inform, 179–80 right of self-determination, 193–5 standard medical practice v., 564–5 timing relevant to, 184–6 vs real consent, 174–6 institutional preference, 36–7 Insurance Regulatory and Development Authority Act, 1999, 556 Integrated Disease Surveillance Programme network, 83 International Committee of the Red Cross (ICRC), 127 International Council for Prison Medical Services, 139 International Covenant of Civil and Political Rights, 509 International Federation of Gynecology and Obstetrics (FIGO), 138 International Rehabilitation Council for Torture Victims, 139 Interventions for Support, Healing and Awareness (IFSHA), 507 IVF, 567 age for a woman to be a recipient of oocytes, 341 ethical justification, 340 for gay and lesbian couples, 339–40 involving foreign donor, 339 medical procedure, 338

585

right to pre-implantation genetic diagnosis (PIGD), 340 test tube baby phenomenon, 339 transplantation of stem cells from a person, 339 Islamic Academy case, 23 Islamic Academy of Education v. State of Karnataka, 43 Islamic Code of Medical Ethics, 138 Jacob Mathew v. State of Punjab, 8 Jacob Mathew v. State of Punjab and Another, 287 Jacobson v. Massachusetts, 66, 69 Jagdish Saran v. Union, 33, 36 Janaway v. Salford Area Health Authority, 383 Jan Blaz v. Anand Municipality, 351 Jean Ivy Hopps and Theodore J. Robinson and Frank v. Denhoed, 523 John Moore v. The Regents of the University of California et al., 231 John Oni Akerele v. The King, 290 Juggankhan v. The State of Madhya Pradesh, 291 Kasturba Medical College, 40, 44 Kerala v. R. Jacob, 32 Kishan Chand and Anr. v. The State of Haryana, 292 Koli Chunilal Savji and Another v. State of Gujarat, 246 Kuldeep Singh and Another v. State of Tamil Nadu and Others, 467 Kumari Jayashree v. State of Kerala, 36 Kurban Hussein Mohamedalli Rangawalla v. State of Maharashtra, 291 Kusum Sharma v. Batra Hospital, 322 LaFleur v. Cornelis, 6 Lawrence v. Texas, 510

586 Laznovsky v. Laznovsky, 213 Leung T.C.William Roy v. Secy for Justice, 511 lie detector test, guidelines on, 132–4 life-sustaining treatment, 61, 64, 70–3, 117–18 Little v. Little, 478 living wills. see advance directives Lt Col. Chopra Committee, 3 Lynn G v. Hugo, 522 M. Chinnaiyan v. Sri Gokulam Hospital & Another, 319 MacDonald v. Clinger, 98 Madrid Declaration on Ethical Standards for Psychiatric Practice, 137 Magan Medical Clinic v. California State Board of Medical Examiners, 106 Maimonides, Moses, 58 Malay Kumar Ganguly v. Dr Sukumar Mukherjee and Others, 266, 285, 326 Malette v. Shulman, 193 Marghesh K. Parikh v. Dr Mayur H. Mehta, 324 Marshell v. Curry, 175 Martin F. D’Souza v. Mohd. Ishfaq, 9, 266, 295 Massachusetts legislature on compulsory vaccination, 66–8 Maynard v. West Midlands Regional Health Authority, 299 Mazur v. Merck, 220 McKay v. Bergstedt, 114 medical certificate, 242–3 medical colleges colonial times, 18 concept of ‘capitation fee,’ 40 general, 40 private participation in establishing, 40 two-tier educational system, 42

Index Medical Council of India (MCI), 17–22, 24–6, 30, 37, 46, 49–50 Medical Council of India Screening Test, 49 medical council regulations, 85–100 character of physicians, 86–7 confidentiality, 90–9 duties of physicians to their patients, 87–90 duties of the physician in consultation, 99 physician-patient relationship, 90 physician’s obligations, 89–90 registered medical practitioners, 85–6 responsibilities of physicians to each other, 100 responsibilities of physicians towards paramedical profession, 100 telling the truth, 89 medical education admission norms, 19–26 apportionment of marks in examination and viva voce, 26 Bachelor of Medicine and Master of Surgery (MBCM), 18 caste vs class, 28–32 constitutional position regarding, 19 graduate courses, regulation of, 21–3 history of, 18–19 Indian experience, 560–2 Indian Medical Council Regulations, 21–6 licentiate qualification in medicine and surgery (LMS), 18 merit and entrance test for postgraduate admission, 25 mode of determining merit, 26

Index postgraduate courses, 24–5 privileges to minorities under Article 30, 19 process of selection for admission, 21 provisions relating to migration, 25 regulation of, 17 reservation, 26–8, 32–5 reservation quota, 22 standards of postgraduate, 21 suprerior marks vs commitment to serve humanity, 23 Medical Educational Institutions and Universities Bill, 2010, 48 medical ethics, 2, 562 autonomy, 59–70 beneficence, 70 clinical establishments and regulation through law, 79–80 code of conduct for doctors and professionals, 118–20 fairness or justice, 77–8 healthcare and state initiatives, 78 historical perspective, 57–9 in human genetics, 136–7 human rights and, 112–13 ideas of medical research with human subjects, 58 Islamic Code of Medical Ethics, 138 medical council regulations, 85–100 non-malfeasance, 70–7 organizations addressing ethical issues, 136–8 practicing euthanasia, 113–17 in psychiatric research, 137–8 in reproductive health, 138 telemedicine and, 80–5 medical geneticist, 368

587

Medical Procedures Innovation and Affordability Act, 420 medical research, 11–12, 568–9 biotechnology, 393–4 cadaver storage and, 403–08 clinical trials, 408–13 compulsory licences for, 428–9 duty to compensate for damges for injury or death, 413–14 EMRs, 425 genetic research, 394–6 and healthcare initiatives, 429–37, 570–1 in human embryos, 396–7 MCIR, 412–13 medical inventions and patenting, 414–18 medical practice procedure, 419–21 Novartis case, 426–8 patents, 418–19, 421–2 pharmacological inventions, 421–2 and prescribing standards of drugs, 436–7 privileges attached to patent, 423–5 stem cell research, 397–03 Medical Termination of Pregnancy Act, 1971, 87, 196, 294, 372–80 Medicare/Medicaid Anti-Fraud and Abuse Amendments, 106 Medicare Patient and Provider Protection Act of 1987, 107 Mehul Kishorsingh Jadeja v. Amarjit Singh (IAS ), Appellate Authority and Commissioner of Health and Others, 466 Mental Health Act, 1983, 92, 206 Mental Health Act, 1985, 474 Mental Health Act, 1987, 87 abortion or sterilization in cases of mental retardation, 207 objects and reasons, 203–04

588 powers of a guardian, 205–07 voluntary admission and discharge of the patient, 204–05 migrations, 25 caste status and, 35 minority-run educational institutions, 18 admission criteria, 23 Article 30 of the Constitution and, 23 fee structures, 43–4 institutional autonomy, 23 preference to students, 46–7 St Stephen’s College case, 44–5, 47 Missoula Clinic Pharmacy v. Zimmerman, 105 Missouri Living Will statute, 226 M’Nughten’s case, 258 Modinos v. Cyprus, 509 Mohini Jain v. State of Karnataka, 41 Mok v. Wong, 521 Moore v. Regents of the University of California, 408, 412 Mortimer, William, 18 Motor Vehicles Act, 222, 267 Motor Vehicles Act, 1988, 237n89 M.R.Balaji v. Mysore, 28 Mrs Poonguzhali v. Ruwsec Health Centre and Another, 310 Mr X, Indian Inhabitant v. Chairman, State Level Police Recruitment Board and Others, 271 Murray v. McMurchy, 176, 307 Nancy B. v. Hotel-Dieu de Quebec, 193 Narcotic Drugs and Psychotropic Substance Act, 1985, 87 National Board of Examinations (NBE), 49 National Childhood Vaccine Injury Act (NCVIA), 153n33

Index The National Coalition for Gay and Lesbian Equality v. The Minister of Justice, 509 National Commission for Women (NCW), 507 National Eligibility-cum-Entrance Test (NEET), 22–3 National Health Service Act, 1977, 196, 198 National Human Rights Commission, 139–40 people likely to be prejudicially affected, 141 powers relating to enquiries, 140–1 power to conduct investigation, 141 statement made to, 141 steps during and after inquiry, 142 National Medical Library’s Electronic Resources in Medicine (ERMED) consortium, 83 National OncoNET Project, 83 National Rural Health Mission (NRHM), 84 National Rural Telemedicine Network (NRTN) Project, 84 National Trust for Welfare of Persons with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999, 207–11 National Trust for Welfare with Autism, Cerebral Palsy, Mental Retardation and Multiple Disabilities Act, 1999, 262 Naz Foundation v. Government of NCT of Delhi, 504–06, 513–14 Naz Foundation v. NCT of Delhi, 572 negligence, 566–7 and Bolam Principle, 298–302 cases of, 302–03

Index Charlesworth and Percy on Negligence, 10th edition, 330n48 constituents of, 301–02 as criminal offence, 285–96 in ‘deficiency of service’, 321–7 delay in ambulance service, 320 diagnostic errors, 315–16 diagnostic investigation and treatment in medical camps, cases of, 308–09 doctor as intermediary for defective products, 316–17 errors in lab reports, 320–1 guidelines laid down by Supreme Court, 294–6 immunization programmes, cases of, 309–10 improperly preserved semen, 314 Indian decisions on, 290–4 major and minor operations, 314–315, 334n87 in medical termination of pregnancy, 294, 310–13 operation of blood banks, 317–20 penal law provisions, 286–7 plea of interference for wrong line of treatment, 293 by professionals, 296–7, 330n38 removal of brain after death, 313–14 removal of the uterus, 313 Section 88, IPC, 287 Section 92, IPC, 287 Section 93, IPC, 288 statutory rules or executive instructions, 296 sterilization, cases of, 303–07, 331n58, 333n59 transfusion of HIV-infected blood, 319–20

589

transfusion of mismatched blood, 317–18 neo-natal circumcision, practice of, 199–200 New India Assurance Co. Ltd v. Mary Jane Govias and Others, 549 New India Assurance Co Ltd v. Satpal Singh Muchal, 543 New India Assurance Company Limited v. Usha Yadav and Ors, 549 NHS Trust v. T (Adult Patient: Refusal of Medical Treatment), 65 Nish Maghu v. State of J & K, 30 non-malfeasance, 70–7 dilemma of saving one of conjoined twins, 71–3, 155n39 life-saving treatment, 70–3 persistent vegetative state (PVS) of a patient, 73–7 Norris v. Republic of Ireland, 508 North Dakota State Board of Pharmacy v. Snyder’s Drug Stores, 105 Nuremberg Code, 128, 144–6 Nuremberg Trials of 1947, 58 Oliver Brustle v. Greenpeace eV, 398 Olmstead v. United States, 412 Opium Act, 1878, 3 organ transplantation, 571 authority in cases of bodies sent for post-mortem examination, 461, 464–5 brain stem death as the stage for, 456–7 case for reward for organ donation, 472–4 case of minor donors and incompetent adults, 474–9 in case of unclaimed bodies in hospital or prison, 462

590 declaration of time of death, significance of, 457–8 divergent viewpoints, 484 donation of semen, 456 high courts’ approaches, 467–8 hospital regulations, 469–70 instances when courts have refused permission, 480–3 instances when permission may be granted, 483–4 by a living person under express authority, 458–9 MCIR guidelines on cadaver donor transplants, 462–4 Medical Council of India Regulations, 459–61 mode of signifying consent for donation, 458–65 non-therapeutic operations, 479–80 offences and penalties for transplantation without authority, 470–2 person competent to remove the human organ, 464 restrictions on removal and transplantation of human organs, 465–9 standard tests for consent, 480 Transplantation of Human Organs Act of 1994, 455–65 when no authority for removal could be given, 462 where no express authority is given, 461 Oriental Insurance Co. Ltd v. Asim J. Pandya, 550 P.A. Inamdar ‘s case, 23 P.A. Inamdar v. State of Maharashtra, 23, 43, 48

Index Pallin v. Singer, 420 Paparambaka Rosamma and Ors v. State of AP, 246 parens patriae jurisdiction, 219, 226 parental consent of contraceptive advice, 196–9 Patel Kirtikumar Prehladbhai v. National Insurance Company Ltd, 554 Patents Act, 437–8 Patents Act, 1970, 414 Patient’s Bill of Rights, 179 Patient Self-determination Act of 1990, 63 payment seats, 42 P.C. Kesavan Kuttynayar v. Harish Bhalla, 4 Pearce and Another v. United Bristol Healthcare NHS Trust, 88 Percival, Thomas, 58 Permanent Lok Adalats, 555 persistent vegetative state (PVS) of a patient, 73–7, 156n46, 213–14 Aruna Ramachandra Shanbaug v. Union of India, 76 Guardianship of Jane Doe, case of, 75 Nancy Ellen Jobes, case of, 75 Person Act, 1861, 230 Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995, 262, 269–71 Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995, 87 pharaonic circumcision, 199 Pharmacy Act, 1948, 87, 103 physician-patient relationship, 90 Planned Parenthood of South Eastern Pennsylvania v. Casey, 381 Poisons Act, 1919, 3

Index Pollok v. Workman, 406 Poonam Verma v. Ashwin Patel and Ors, 291 postgraduate courses, 24–5 merit and entrance test for postgraduate admission, 25 reservation, 25 Postgraduate Institute of Medical Education & Research v. Jaspal Singh, 318 Pravat Kumar Mukherjee v. Ruby General Hospital & Ors, 273, 321, 555 Pravat Kumar Mukherjee v. State of West Bengal, 554 Praveen Damani v. Oriental Insurance Co. Ltd, 549 Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, 364, 366–7, 565 Amending Act of 2003, 367 pre-conception techniques aiding sex preference, 370–1 Pre-natal Sex Determination Test Act, 1994, 87 Prevention of Food Adulteration Act, 435 Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Health Care (Resolution 46/119), 138 Principles of Medical Law, 175 professional misconduct rendering him/her liable for disciplinary action, 120–6 adultery or improper conduct, 120, 165n144 conviction by a court of law, 121 professional incompetence, 125–6 research on human subjects, 124

591

sex determination tests, 121 signing professional certificates, reports, and other documents, 121–4 violation of regulations, 120 Prohibition of Unfair Practices in Technical Educational Institutions, 48 Protection of Human Rights Act, 1993, 139–43 Puttathayamma(smt.) v. ESI Corporation, 273 quality-of-life judgments, 76 R. Madhu v. Dr Indu Khurana, 310 R. Shailaja and Another v. State of Karnataka, by the Secretary, Department of Health and Another, 468 Raj Kumar v. Ajay Kumar, 268 recklessness, concept of, 285, 328n9 Redressal of Public Grievance Rules, 1998, 555 Rees v. Darlington Memorial Hospital NHS Trust, 307 Rees v. United Kingdom, 502 Regina (Burke) v. General Medical Council (Official Solicitor and Others Intervening), 62 Regina (Pretty) v. Director of Public Prosecutions (Secretary of State for the Home Department Intervening), 64, 151n20 Regina v. Bournewood Community and Mental health NHS Trust, Ex Parte L, 206 Regina v. Tan, 501 regulations graduate courses, 21–3 postgraduate courses, 24–5

592 Reibl v. Hughes, 185 reservation, 22 basis for, 27–8 caste-based, 28–9 circumstances supporting, 39–40 compartmentalized and horizontal, 34–5 constitutional mandate, 26–7 creamy layer, 35–6 Delhi students for admission to postgraduate courses, case of, 34 domiciliary preference to state candidates, 31 effect of reconversion and, 29 ethics and, 38–9 institutional preference, 36–7 manner of applying, 32–8 percentage of, 33–4 postgraduate courses, 25 prohibition of discrimination, 28–9 relaxation of percentage for reserved category, 31–2 right to nominate admission of students, 32 rural and urban bias, 30–1 for the SCs/STs (Article 15(4)), 28–9, 34 vertical and horizontal, 34, 37–8 Reserve Bank of India Act, 1934, 84 res ipsa loquitur, 301 right of self-determination, 193–5 Right to Information Act, 97 right to refuse medical treatment, 61 R.Malarvizhi v. Inspector of Police and Others, 205 Rodriguez v. Attorney General of Canada, 64 Roe v. Wade, 380 Romer v. Evans, 505 Roscoe’s Law of Evidence, 289–90

Index Rush v. Johnson, 500 Russian Socialist Federated Soviet Republic (RSFSR), 128 R v. Human Fertilisation and Embryology Authority, ex p Blood, 215 Salgo v. Leland Stanford, 180 Salgo v. Stanford, 58 Sally McCormick v. Kent England, MD, and Michael Meyers, 96 Samira Kohli v. Dr Prabha Manchanda and Another, 174, 313 sanctity of life, principle of, 74–5 Sanjay Ahlawat v. Maharishi Dayanand University, 31 Satwant Kaur Sandhu v. New India Assurance Co. Ltd, 547 Saurabh Chaudri v. Union of India, 37 Schoendorff v. Society of New York Hospital, 175 Scribner, Belding H., 78 Selvi v. State of Karnataka, 131, 563 sex ratio, 364–5 sex selection, prohibition against penalties, 369–70 persons entitled to registration, 367–9 physician’s role, 366 pre-conception techniques aiding sex preference, 370–1 sex ratio and, 364–5 socio-cultural factors and practices, 365–6 Sexual Offences Act, 2012, 199 Shakila Sathanandam v. Dr S.S. Kodmani & Others, 311 Sharda v. Dharmpal, 263 Shrikant Anandrao Bhosale v. State of Maharashtra, 259–60 Shri Mukut Lal Duggal v. United India Insurance Co. Ltd, 547

Index Sidaway v. Bethlem Royal Hospital Governors and Ors, 187 Sidaway v. Bethlem Royal Hospital Governors and Others, 177 Skinner v. Railway Labor Executives’ Assn., 93 Smith v. City of Salem, 494 Smt. Aarti v. State of Punjab through Principal Secretary, 112 Smt. M.Vijaya v. The Chairman and Managing Director, Singareni Collieries Company Ltd and Others, 319 Smt. Radhamma v. H.N. Muddukrishna, 265 Smt. Savita Garg v. The Director, National Heart Institute, 326 Smt. Sumakiran Mallena v. The Secretary, Medical and Health and Others, 465 Smt.Vinitha Ashok v. Lakshmi Hospital and Ors, 313 sodomy laws, 509–11 somatic cell nuclear transfer (SCNT) or cloning, 397 sonologist, 368 Special Marriage Act and Divorce Act, 263 ‘special needs’ doctrine, 93 Spring Meadows Hospital and Another v. Harjol Ahluwalia and Another, 272, 303, 321, 555 St. Stephen’s College v. University of Delhi, 23, 33 state human rights commission, 142–3 State of Bihar v. M. Neethi Chandra, 38 State of Gujarat v. M.P. Shah Charitable Trust, 32 State of Haryana and Ors v. Smt. Santra, 304 State of HP v. Jeet Singh, 252 State of Maharashtra v. Devahari Devasingh Pawar, 320

593

State of M.P v. Nivedita Jain, 31 State of Punjab v. Mohinder Singh Chawla, 144 State of Punjab v. Shiv Ram, 307 state-of-the-art medicare, 17 State v. Seshappa, 223 Status of Children Act, 1969, 349 stem cell research, 397–403 ethical issues, 402–03 European Court Of Justice and, 398–9 potential for clinical application, 399–400 tissue typing, 400–02 sterilization, 218–19 Strachan v. John F. Kennedy Memorial Hospital, 61 Strunk v. Strunk, 477 Suchita Srivastava & Another v. Chandigarh Administration, 211, 374, 378 Surendra Chauhan v. State of MP, 294 surrogacy, 567–8 artificial insemination and, 356–7 Biblical and other stories, 341–2 commercial surrogacy arrangements, 343–4 concept, 342 ‘German Couple’ case, 350–2 ICMR guidelines, 353–6 in India, 350 in Japan, 348–9 Japanese child, case of, 352–3 lawful expenses, 346–7 medical procedure, 342–3 medical tourism and international, 353 in New Zealand, 349–50 position of the ‘birth mother’, 347–8 in UK, 346–8

594 Surrogacy Arrangements Act, 1985, 346 Surupsingh Hrya Naik v. State of Maharashtra through Additional Secretary, General Administration Deptt and Ors, 97 Sutchita Shrivastava and Another v. Chandigarh Administration, 564 Swati Gupta v. State of UP, 34 Syad Akbar v. State of Karnataka, 292 telemedicine, 157n54–5 confidentiality and data protection, 84–5 honouring medical prescriptions through the internet, 85 imaging and genetic testing, 84 meanings of, 81 objective, 81–2 as tool for better rural health service, 83–4 traditional methods and new possibilities, 82–3 Termination of Life for Request and Assisted Suicide (Review Procedures) Act, 2001, 118 Termination of Life on Request and Assisted Suicide (Review Procedures) Act, 2000, 115 testimonial compulsion, 129, 131–3, 169n174 Thake v. Morris, 306 therapeutic privilege, theory of, 87–9 Title VII of the Civil Rights Act, 500 T.M.A. Pai Foundation v. State of Karnataka, 23, 33, 43, 45 Toonen v. Australia, 509 Transplantation of Human Organ Act, 1994, 87, 113 Transplantation of Organs Act, 313 transplants, 2

Index transsexual individuals, 491–2, 572–3 disabilities arising out of transgender status, 499–504 disqualification as to status in election, 503–04 European Commission of Human Rights litigation against, 502–03 government initiatives for, 504 harassment issues, 503–04 property rights in Hindu law and Muslim law for the transgendered, 492–3 rights in Europe and the US, 493–6 and sexual reconstruction surgeries, 496–9 Tuskegee experiments, 129 two-tier educational system, 42 UK law of Abortion, Act, 1967, 383 Ulane v. Eastern Airlines, 499 unethical acts advertising, 100–02 dispensing by a physician of secret remedial agents, 110 overprescribing of drugs, 105 patents or copyrights, 102 physician as investor in pharmacies, 107–09 physician-pharmacy relationship, 102–09 professional misconduct rendering him/her liable for disciplinary action, 120–6 rebates and commission, 109–10 soliciting of patients directly or indirectly, 100 Uniform Anatomical Gift Act (UAGA), 455 Unique Identification Authority of India (UIDAI), 504 United Bristol Healthcare Trust, 88

Index United India Insurance Co Ltd v. Manubhai Dharmasinhbhai Gajera, 545 United Nations Commission on International Trade Law, 85 United Nations Declaration on the Rights of Mentally Retarded Persons 1971, 378 United States v. Greber, 107 Universal Declaration of Human Rights in 1948, 116 Unnikrishnan, J.P. v. State of A.P., 41 directions in, 42 T. M. A. Pai foundation on, 43–8 V. Kishan Rao v. Nikhil Super Speciality Hospital and Another, 9, 266, 295 vaccination laws, compulsory, 66–70, 153n33 challenges to state, 69–70 consent, 219–22 exemptions, 68–9 Massachusetts legislature, 66–8 Varsha Gautam (Dr) v. State of UP, 369 Veronia School District v. Wayne Action, 70 Vesalius, 58

595

Veterinary Council of India v. Indian Council of Agricultural Research, 21 Vinitha Ashok v. Lakshmi Hospital, 190 ‘Vision 2015’ document, 26 V.N. Shrikhande (Dr) v. Anita Sena Fernandes, 327 Voluntary Euthanasia Legalisation Society (Euthanasia Society), 115 Warrock Medical Center Hospital v. California State Board of Pharmacy, 105 Washington v. Harold Glucksberg, 116 Western system of medicine, 18 Will of Poller: Goodell, Guardian ad litem, and Another v. Poller, 265 Workmen’s Compensation Act, 1923, 267, 271 World Medical Education Conference, 1953, 18–19 Yearworth v. North Bristol NHS, 314, 408 Zaffar Mohammad alias Z.M. Sarkar v. The State of West Bengal, 528 Zuniga v. Pierce, 212