Bioethics and Biosafety 9789389795608

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Bioethics and Biosafety

Bioethics and Biosafety

M.K. Sateesh Scientific Officer Karnataka State Forensic Science Laboratories Bangalore

©Copyright 2020 I.K. International Pvt. Ltd., New Delhi-110002. This book may not be duplicated in any way without the express written consent of the publisher, except in the form of brief excerpts or quotations for the purposes of review. The information contained herein is for the personal use of the reader and may not be incorporated in any commercial programs, other books, databases, or any kind of software without written consent of the publisher. Making copies of this book or any portion for any purpose other than your own is a violation of copyright laws. Limits of Liability/disclaimer of Warranty: The author and publisher have used their best efforts in preparing this book. The author make no representation or warranties with respect to the accuracy or completeness of the contents of this book, and specifically disclaim any implied warranties of merchantability or fitness of any particular purpose. There are no warranties which extend beyond the descriptions contained in this paragraph. No warranty may be created or extended by sales representatives or written sales materials. The accuracy and completeness of the information provided herein and the opinions stated herein are not guaranteed or warranted to produce any particulars results, and the advice and strategies contained herein may not be suitable for every individual. Neither Dreamtech Press nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Trademarks: All brand names and product names used in this book are trademarks, registered trademarks, or trade names of their respective holders. Dreamtech Press is not associated with any product or vendor mentioned in this book. ISBN: 978-93-89795-60-8 EISBN: 978-93-89795-90-5

Dedicated to my beloved and benevolent parents B. Krishnaiah and Susheela Krishnaiah To my wife Sowmya Sateesh To my son Yajath S. Gowda

Foreword

The most striking feature of the Earth is the existence of life and the most striking feature of life is its diversity on the Earth. Today’s biodiversity is the result of 3.5 billion years of evolution. In the present fast moving biotechnological world, biodiversity and natural ecosystem play a major role in the enhancement of human needs. Human domination of the Earth’s ecosystem is reducing diversity of species within many habitats throughout the world. Biotechnology is also contributing for such instances from its varied type of activities. Hence the present need is developing wiser ethical and safety aspects of our ecosystem without compromising the development. Thus, education on bioethics and biosafety is essential at present. In 1971, the biologist Van Rensselaer Potter first coined the term “bioethics”. Potter used the term to refer to a new field devoted to human survival and an improved quality of life. Gradually, the term “bioethics” came to refer to “the broad terrain of the moral problems of the life sciences, ordinarily

taken to encompass medicine, biology, and some important aspects of the environmental, population and social sciences. A special field of bioethics is needed because, for better or for worse, the present century will probably be best described as the biological century or the biological age. Not only advances in medical science, but advances in many other fields will likely have biological components as well. We cannot hide our heads in the sand and pretend that difficult questions are not on their way, indeed, we already know about many of them, or at least their broad outlines. Many people have voiced concern about biotechnology and genetic engineering. Scientists have considered the issue of safety over recent years. Prevention of large-scale loss of biological integrity referring to human health as well as ecology is defined as “biosafety”. Biosafety issues, including human safety, environmental safety, food safety, socioeconomic impacts, ethical and moral issues to be clearly followed for any product of biotechnology, either living or non-living products,

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Foreword

before their widespread use or application. Thus, biosafety aspects are considered in large number of biotechnology syllabi throughout the world. This book is an attempt to give information in a single volume much needed by the students,

scholars and scientists of different disciplines in biotechnology. I congratulate Dr. M.K. Sateesh for his efforts in bringing out this book. I am confident that the students, teachers and research workers will receive this book. Dr. T. Prabhu B.Sc., M.B.B.S., M.D., FICP., Chairman, Medical Advisory Board, LN Lifecare Pvt. Ltd., Bangalore

Preface

Biotechnology is a much sought after subject these days. The reasons behind this scenario are many. Some being, tremendous growth of industries, high pay scales, simulating stories in the media about large-scale genomic sequencing such as human genome sequencing and new studies on genetic diseases. This makes it very challenging for a teacher to sustain the students’ enthusiasm while at the same time not to forget the basic moral principles of life and environment. Biotechnology has to be adapted to the wider arena of social and ethical contexts. The focus of the present-day biotechnologists is on goal-oriented approaches, without understanding the sustainable developments that form the environment. Biosafety and Bioethics introduces the readers to the basic concepts of ethics and safety that are essential for various branches of science, which use different components of the environment for technical procedures. The study of biosafety and bioethics has had a major impact on all the biological sciences and the quality of human life. Significant

achievements have been made using many prokaryotic and eukaryotic organisms to understand the principles that govern life. Many such achievements made by biotechnologists have helped in developing new branches of science such as molecular biology, genetic engineering, proteomics and genomics. Thus, the field of biotechnology is a major branch of science encompassing several smaller branches of it. Bioethics is a very complex and difficult subject as it concerns troubling questions like the nature of life and death, the kind of life to be considered worth living, what constitutes murder, how people in very painful circumstances should be treated, what are the responsibilities of one human being to others, and other such. Bioethics is not a wholly independent field. It has to draw a great deal from other ethical discussions. Today, the medical technology is pushing the limits of what humans can do as also our understanding of such discussions. Medicine, today, forces us to confront the nature of life and death in a manner that we are not accustomed to. This has

x Preface

necessitated the application of ethical principles and arguments to medical and biological issues. Although medical professionals are educated to handle triage that involves technical questions like who has the best chances of survival, neither they nor other members of the society are trained for situations involving ethical triage. In our pluralistic society, we are faced with a diversity of values and ethical ideals, but it is difficult to tell which values need to be employed when and which ethical dilemmas deserve our immediate attention. One of the results seems to be that we are forced to deal with one crisis after another. Our lack of sound reasoning and coherent values prevents us from engaging in careful and advance deliberations that would make it easier for us to handle new situations. Today, bioethics has become more a matter of crisis management and less of reasoned discourse. A special field of bioethics is needed because, for better or for worse, the coming century will probably be best described as the Biological Century or the Biological Age (in contrast to the Industrial Age that the West so recently experienced). Not only advances in medical science, but advancements in many other fields too will likely involve biological components. Throughout the world, many people are voicing increasing concern about biotechnology and genetic engineering. Scientists have also considered the issue of safety over the recent years. A special committee of the National Academy of Sciences specifically reviewed the issues on the introduction of genetically engineered organisms using recombinant DNA (rDNA) technology into the environment. It concluded that there is no

evidence of any specific hazards existing either in the use of rDNA technique or in the transfer of genes between unrelated organisms, and that the risks associated with the introduction of rDNA engineered organisms are the same kind as those associated with the introduction of unmodified organisms. Thus, at present more emphasis has to be given on using releasing, transporting and handling of potentially dangerous or new organisms in science. While taking any decision, a balanced integration of scientific and social knowledge should be considered. Biotechnology is one of the most exciting areas of natural sciences and its applications have to reach the common man. Biotechnology has attracted worldwide attention after the successful mapping of the entire human genome in February 2001 by the National Institute of Health and Celera Genomics. In December 2002, the birth of Baby Eve, claimed to be the first cloned human, has only reinforced the global attention on biotechnology. This branch of science is considered a field that can end the world’s hunger in a lesser duration. It is no longer a specialized segment of science confined to high-tech laboratories. The subject of biotechnology is now entering into the degree and even pre-university classes. The common man today talks of biotechnology in the same breath as he talks about information technology. Newspapers too are given information on all fields of biotechnology to educate the masses. The Government of India framed a draft of the biotechnology policy in 2005. This further attracted more and more categories of people from all walks of life to know about the role of biotechnology in society.

Preface xi

Biotechnology is an interdisciplinary field encompassing not only biological sciences but also material sciences. Owing to this interdisciplinary nature, biotechnology finds appeal in both science as well as engineering students. The present book is intended to be an introduction to the subject for the students of both streams. An integrated approach to biosafety and bioethics has been adopted in the book. The content has been systematically presented, built up with simple and clear illustrations, and contains both a historical account and the latest information on the subject. Biosafety and Bioethics has been written to meet the requirements of the students of biotechnology of various universities and engineering institutes. It provides an insight into the basics of bioethics and biosafety in the field of biotechnology. Under ‘biosafety’, topics such as socio-economic impact of biotechnology, biosafety regulations, biosafety protocol and its implementation, guidelines for research and release of transgenic organisms, public education of transgenic organisms production, handling and disposal of hazardous material, good manufacturing practices and good laboratory practices are dealt with. It also includes topics such a IPR and their impact on biodiversity, Indian Biodiversity Act, international organizations dealing with IPR and

their related issues, traditional knowledge and their exploitation, ethical and safety issues in consumption of GM foods. Under ‘bioethics’, topics such as the study of Human Genome Project (HGP), along with the ethical, legal and social issues involved in it, molecular detection of presymptomatic genetic diseases, prenatal diagnosis, fetal sex determination, genetic diversity research and related ethical issues, stem cell research, use of animals and humans in research and testing, organ transplantations, xenotransplantation, human and animal cloning along with related ethical and social issues, have been dealt with. It also covers other topics like the intellectual property rights (IPR), patents, biodiversity, genetically modified foods and crops and labeling of GM products with related ethical issues. This part of the book explains both basic and applied aspect of bioethics. Though I have tried to make the book comprehensive and correct in all respects, it is possible that some errors might still have been left due to oversight. Any suggestions or constructive criticism from the readers will be deeply appreciated and carefully considered in the preparation of the next edition. M.K. Sateesh [email protected]

Acknowledgements

I express my heartfelt gratitude to Dr. T. Prabhu, Former Principal, Bangalore Medical College and Former Chief of Laboratories, Medinova Diagnostic Center and Sagar Apollo Hospital, Bangalore for being a true source of inspiration to me and extending his constant encouragement and support. I am also grateful to Prof. H.A. Ranganath, Vice-Chancellor, Bangalore University, Prof. V.S. Ranganathan, Prof. S. Shankara Bhat, Prof. K.A. Raveesha, Dr. R. Ramachandra, Prof. Rangappa, Mysore University, Prof. Geetha Bali, Bangalore University, Dr. S. Shishupala, Kuvempu University. Dr. A.B. Vedamuthy, HOD, Oxford College, Dr. D.V.S.S.R. Prakash, AMC College, Mr. Bhaskar Reddy, Director, CMR Institutions, Mrs. Rashmi Bhaskar Reddy, Dr. Krishne Gowda, Principal, Government Science College, Bangalore, Dr. Ramakrishnaiah, Government Science College, Bangalore, Dr. H. Nagabhushana, Dr. H.N. Ramesh Babu, Dr. Rajeshwari Ramesh Babu, Dr. Y.L. Krishnamurthy, Kuvempu University, Dr. Sumithra K. Urs. U.S.A., Dr. K.P. Guruprasad, Manipal Institute of Biotechnology, Dr. Gangadhar, V.V.

Puram College, Mr. Chandrashekara Joshi, Dr. G.R. Jhanardhana, Dr. S. Umesh, Dr. S. Satish, Mysore University, Dr. S. Puttaraju, Karnataka Pollution Control Board, Dr. S. Manjunath, Bangalore University, Dr. L. Rajanna, Bangalore University, Mr. M.K. Girish, President, Rotaract International, Mysore, Mr. S. Satish Kumar, Ku. Samrudhi, Ku. Samskruthi, Mrs. Gayathri Girish, Mr. Sangameshar, Mr. B. Umamahesh, SigmaAldrich, Mr. C.R. Naveen Kumar, Biocon India, Late Mr. Krishne Urs, Dr. S.T. Girish, Mrs. Indira Marigowda, Mrs. Shylaja Suresh, Mrs. Pankaja Ramanna, Ms. K.S. Sneha, Mr. K.S. Sandeep, Mr. Sripadhraj, Mr. Prashanth, GCI Solutions, Mr. Santhosh, Oxford College, Mr. Raghunath, Research Scholar, NIMHANS, Mr. Nagendra Prasad, SJCE, Mysore, Late Mr. B. Basavaiah and Late Mr. Chickathayamma, my teachers, my colleagues, my students, friends and all my well wishers for their direct and indirect support. I also thank the Forensic Science Laboratories for providing an environment that made this book possible.

xiv

Acknowledgements

Thanks are also due to Mr. V.N. Narasimha Murthy and my wife, Mrs. Sowmya Sateesh, a software engineer with GCI Solutions Pvt. Ltd., for their help in the form of suggestions after a thorough and critical reading of the manuscript. I pay may humble regards to my parents, Mr. B. Krishnaiah and Mrs. Susheela Krishnaiah. I thank my wife and my son Yajath S. Gowda for all their patience and co-operation while preparing this

book. I also express my thanks to my brother Mr. M.K. Girish, my sister Mrs. M.K. Sandhya Sateesh Kumar, my in-laws and other family members for showing great forbearance and encouraging me during the writing of this book. Without the help of all these people, timely completion of this book would not have been possible. M.K. Sateesh

Contents

Foreword ............................................................................................................................................ vii Preface ................................................................................................................................................ ix Acknowledgements ......................................................................................................................... xiii 1. Introduction to Bioethics and Biosafety ................................................................................ 1 1.1. Introduction to Bioethics ................................................................................................. 2 1.2. Need of Bioethics ............................................................................................................. 3 1.3. Definition of Bioethics ..................................................................................................... 3 1.4. Other Definitions of Bioethics ......................................................................................... 3 1.5. Bioethics and its Relations with Othe Branches .............................................................. 3 1.6. Applications to Bioethics .................................................................................................. 4 1.7. Introduction to Biosafety ................................................................................................. 6 1.8. Need for Biosafety ........................................................................................................... 9 1.9. Issues in use of Genetically Modified Organisms ......................................................... 10 1.10. Definition of Biosafety ................................................................................................... 10 1.11. Applications of Biosafety ............................................................................................... 11 1.12. Levels of Biosafety ........................................................................................................ 11 1.13. Criteria used for Biosafety Level ................................................................................... 11 Summary ........................................................................................................................ 11 Exercise .......................................................................................................................... 13 2. Human Genome Project and its Ethical Issues .................................................................. 2.1. Introduction ................................................................................................................... 2.2. Facts of Genome ........................................................................................................... 2.3. Genome Arrangement .................................................................................................... 2.4. Genome Sequencing ...................................................................................................... 2.5. Physical Maps ................................................................................................................

15 15 16 18 19 22

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Contents

2.6. 2.7. 2.8. 2.9. 2.10.

Fusion of Genetic Linkage Maps and Physical Maps .................................................... Comparison of Human with other Organisms ............................................................... Functional Genomics is the Future of HGP .................................................................. Future of HGP in the Medicine and Genetics ................................................................ Ethical, Legal and Social Implications (ELSI) of HGP .................................................. Summary ........................................................................................................................ Exercise ..........................................................................................................................

25 25 34 35 36 37 39

3. Molecular Detection of Pre-Symptomatic Genetic Diseases and its Importance in Healthcare ................................................................................................ 41 3.1. Introduction ................................................................................................................... 41 3.2. DNA and Disease ........................................................................................................... 44 3.3. Diseases and their Genetic Basis ................................................................................... 44 3.4. Genetic Screening and its History ................................................................................. 49 3.5. Human Genetic Disorders and their Chromosome Locations ....................................... 50 3.6. Gene Testing .................................................................................................................. 51 3.7. Merits and Demerits of Gene Testing ............................................................................ 76 3.8. Testing for Genetic Diseases and their Importance in the Healthcare System .............. 78 3.9. Some of the Major Genetic Diseases and their Characteristics ..................................... 82 3.10. Diagnosis of Genetic Diseases ...................................................................................... 84 3.11. Points to be Considered in Genetic Testing ................................................................... 98 Summary ........................................................................................................................ 99 Exercise ........................................................................................................................ 101 4. Prenatal Diagnosis, Genetic Manipulations and their Ethical Issues ............................ 4.1. Introduction ................................................................................................................. 4.2. Types of Prenatal Technologies ................................................................................... 4.3. New Developments in Prenatal Diagnosis ................................................................... 4.4. Genetic Manipulation ................................................................................................... 4.5. Indian Scenario in Prenatal Diagnosis and their Applications ...................................... 4.6. Genetic Manipulations and Ethical Considerations ...................................................... 4.7. Future Aspects of Genetic Manipulation and Germline Therapy ................................. Summary ...................................................................................................................... Exercise ........................................................................................................................

103 103 103 108 108 115 117 118 119 120

5. Ethical, Legal and Social Implications of Human Genome Project................................ 5.1. Introduction ................................................................................................................. 5.2. Ethical, Legal and Social Implications (ELSI) and its Origin ...................................... 5.3. ELSI Establishment ..................................................................................................... 5.4. ELSI Research Goals ................................................................................................... 5.5. Details of ELSI Program ............................................................................................. Summary ...................................................................................................................... Exercise ........................................................................................................................

123 123 124 125 127 132 137 138

Contents xvii

6. Genetics Studies on Ethnic Races ...................................................................................... 6.1. Introduction ................................................................................................................. 6.2. Ethnicity ....................................................................................................................... 6.3. Main Advantage of the Genetics Studies ..................................................................... 6.4. Categories and Definitions ........................................................................................... 6.5. Role of Race and Ethnicity in Heart Disease ............................................................... 6.6. Research and Advancement in Human Races .............................................................. 6.7. Examples of Studies on Ethnic Races ......................................................................... 6.8. Human Genome Project and Human Rights ................................................................ 6.9. Ethical Concerns Involved with Genetic Research ..................................................... Summary ...................................................................................................................... Exercise ........................................................................................................................

139 139 141 142 143 144 145 152 155 155 156 156

7. Biosafety Guidelines and Regulations ............................................................................... 7.1. Introduction ................................................................................................................. 7.2. Definition of Biosafety ................................................................................................. 7.3. Aims of the National Institute of Health (NIH) Guidelines .......................................... 7.4. Regulations Specific to Biotechnology Companies and Research Institutions ............ 7.5. Biosafety Guidelines in India ........................................................................................ 7.6. Guidelines for Research in Transgenic Organisms ..................................................... 7.7. Introduction of Genetically Modified Organisms into the Environment ...................... 7.8. Environmental Benefits ................................................................................................ 7.9. Field Trials with Genetically-Modified Plants .............................................................. 7.10. Containment Levels ..................................................................................................... 7.11. Experiments with Microorganisms .............................................................................. 7.12. Research Involving Plants ........................................................................................... 7.13. Research Involving Animals ........................................................................................ 7.14. Biosafety Protocol [UN Cartagena Biosafety Protocol (CBP)].................................... 7.15. Mechanism of Implementation of Biosafety Guidelines .............................................. 7.16. Biosafety and Politics ................................................................................................... Summary ...................................................................................................................... Exercise ........................................................................................................................

159 159 160 161 165 168 170 173 174 175 175 183 185 187 190 198 205 207 209

8. Legal 8.1. 8.2. 8.3. 8.4. 8.5. 8.6. 8.7. 8.8. 8.9.

211 211 212 212 212 212 212 213 214 214

and Socio-economic Impacts of Biotechnology ...................................................... Introduction ................................................................................................................. Agriculture and Food Sector Issues ............................................................................ Institutional Issues ....................................................................................................... Social Issues ................................................................................................................ Cultural Issues ............................................................................................................. Business and Consumer Issues ................................................................................... Legal Impacts of Biotechnology .................................................................................. Social Impacts of Biotechnology ................................................................................. Economic Impacts of Biotechnology ..........................................................................

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Contents

Summary ...................................................................................................................... 214 Exercise ........................................................................................................................ 215 9. Use of Genetically Modified Organisms and their Release in the Environment ............................................................................................... 9.1. Introduction ................................................................................................................. 9.2. Present Scenario of GMOs .......................................................................................... 9.3. Future of GMOs .......................................................................................................... 9.4. Developing Agreed National and International Instruments of Governance ................ 9.5. GMOs and Scientific Responsibility ............................................................................ 9.6. Food Crops .................................................................................................................. 9.7. GM Products: Benefits and Controversies .................................................................. 9.8. Present Problems of GM Technology ......................................................................... 9.9. Transgenic Animals and their Escape .......................................................................... 9.10. Future Governance of New Technologies ................................................................... 9.11. Environmental Effects ................................................................................................. Summary ...................................................................................................................... Exercise ........................................................................................................................

217 217 218 220 223 224 225 229 230 232 234 237 239 241

10. Hazardous Materials used in Biotechnology—their Handling and Disposal ................. 10.1. Introduction ................................................................................................................. 10.2. Duties of Employees .................................................................................................... 10.3. Disposal of Chemical Waste ........................................................................................ 10.4. Disposal of Hazardous Waste ...................................................................................... 10.5. Safety Statement .......................................................................................................... 10.6. Controlling the Exposure to Hazardous Substances .................................................... 10.7. Biological Agents (Biohazards) .................................................................................... 10.8. Immunization and Fist Aid ........................................................................................... Summary ...................................................................................................................... Exercise ........................................................................................................................

243 243 244 245 250 251 254 256 259 261 262

11. Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) ................. 11.1. Introduction ................................................................................................................. 11.2. Definition of Good Laboratory Practice (GLP) ........................................................... 11.3. Test Facility Organization and Personnel ..................................................................... 11.4. Quality Assurance Programme .................................................................................... 11.5. Facilities ....................................................................................................................... 11.6. Apparatus, Material and Reagents ............................................................................... 11.7. Test Systems ............................................................................................................... 11.8. Test and Reference Substances ................................................................................... 11.9. Standard Operating Procedures ................................................................................... 11.10. Performance of the Study ........................................................................................... 11.11. Reporting of Study Results .......................................................................................... 11.12. Storage and Retention of Records and Material ..........................................................

263 263 264 265 266 267 268 268 268 269 270 271 271

Contents

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11.13. Good Manufacturing Practices (GMP) ....................................................................... 11.14. Applicability of the GMP ............................................................................................. Summary ...................................................................................................................... Exercise ........................................................................................................................ 12. Public Education of Producing Transgenic Organisms..................................................... 12.1. Introduction ................................................................................................................. 12.2. Need of the Transgenic Organisms ............................................................................. 12.3. Public Education and their Involvement ...................................................................... 12.4. Different Examples of Pubic Education About Transganic Technology ..................... Summary ...................................................................................................................... Exercise ........................................................................................................................

272 274 278 280 281 281 283 284 287 289 290

13. Intellectual Property Rights (IPRs) ................................................................................... 13.1. Introduction ................................................................................................................. 13.2. Forms of Intellectual Property .................................................................................... 13.3. International and Regional Agreement/Treaties in Intellectual Property Rights ........... 13.4. Intellectual Property Rights Related Legislations in India ............................................ Summary ...................................................................................................................... Exercise ........................................................................................................................ 14. Intellectual Property Rights and Agricultural Technology, and their Implications for India and other Developing Countries ........................................ 14.1. Introduction ................................................................................................................. 14.2. Intellectual Property Right Problems and its Hindrance to Diffusion of Agricultural Biotechnology ...................................................................... 14.3. Biosafety Regulations ................................................................................................... 14.4. Ethical Implications ..................................................................................................... 14.5. Socioeconomic Impact ................................................................................................ 14.6. Environmental Impact.................................................................................................. Summary ...................................................................................................................... Exercise ........................................................................................................................ 15. International Organizations and Intellectual Property Rights ...................................... 15.1. Introduction ................................................................................................................. 15.2. World Trade Organization (WTO) ............................................................................... 15.3. WTO Treaties .............................................................................................................. 15.4. General Agreement on Tariffs and Trade (GATT) ...................................................... 15.5. Different Articles of the GAAT .................................................................................... 15.6. Trade-Related Aspects of Intellectual Property Rights (TRIPS) ................................. 15.7. Main Features of the Trips Agreement ........................................................................ 15.8. Role of the Trips Council ............................................................................................ 15.9. World Intellectual Property Organization (WIPO) ...................................................... 15.10. Practical Aspects of WIPO’s Legal and Technical Assistance to Developing Countries ............................................................................

293 293 294 296 297 298 299 301 301 303 306 314 320 322 323 324 325 325 325 330 330 334 336 337 338 347 349

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Contents

Summary ...................................................................................................................... 350 Exercise ........................................................................................................................ 351 16. Introduction to Patent and Process Involved in Patenting ............................................. 16.1. Introduction ................................................................................................................. 16.2. History of Indian Patent System and Law ................................................................... 16.3. Patenting Authorities .................................................................................................... 16.4. Essential Requirements for Patenting .......................................................................... 16.5. Types of Patent ............................................................................................................ 16.6. Requirements of Patent ................................................................................................ 16.7. Things that are Patentable ............................................................................................ 16.8. Things that are Non-Patentable ................................................................................... 16.9. The Procedure Involved in Patent Application and Granting of a Patent .................... 16.10. Patents in India ............................................................................................................ 16.11. Drug Patents in India ................................................................................................... 16.12. Various Types of Patent Applications in India .............................................................. 16.13. Patent Search ............................................................................................................... 16.14. Patent Cooperation Treaty (PCT) ................................................................................ 16.15. Patents and Compulsory Licensing ............................................................................. 16.16. Procedure for the Grant of Compulsory Licence ........................................................ 16.17. Impact of Intellectual Property Rights or Patenting on Biodiversity Rich Developing Countries .......................................................................................... 16.18. Farmers’ Rights ........................................................................................................... 16.19. Plant Breeder’s Rights ................................................................................................. 16.20. Applications for Plant Breeder’s Rights ....................................................................... 16.21. Impact of Plant Variety Protection............................................................................... 16.22. International Union for the Protection of New Varieties of Plants (UPOV) ................ 16.23. Trips Article 27.3(B) .................................................................................................... Summary ...................................................................................................................... Exercise ........................................................................................................................

353 353 355 356 357 357 358 360 360 361 363 364 366 368 369 373 377 378 381 384 385 388 390 395 403 404

17. Patenting Living Organisms ............................................................................................... 17.1. Introduction ................................................................................................................. 17.2. Beginning of Patenting Life .......................................................................................... 17.3. Patent and its Importance in Biology and Biotechnology ............................................ 17.4. Social Consequences of Recent Biotech Patents ......................................................... 17.5. Controversies Over the Patenting of Living Organisms .............................................. Summary ...................................................................................................................... Exercise ........................................................................................................................

405 405 405 410 414 419 422 423

18. Traditional Knowledge, Commercial Exploitation, and Protection ................................. 18.1. Introduction ................................................................................................................. 18.2. Definition of Traditional Knowledge ............................................................................ 18.3. Erosion of IK Systems ................................................................................................ 18.4. Outburst of Interest in IK ............................................................................................

425 425 426 428 429

Contents

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18.5. Need for the Protection of Traditional Knowledge ...................................................... 18.6. Types of Traditional Knowledge Protection ................................................................ Summary ...................................................................................................................... Exercise ........................................................................................................................

432 435 435 435

19. Bioethics in Biodiversity and Resource Management ..................................................... 19.1. Introduction ................................................................................................................. 19.2. Pressure on the Resources Available in the Natural Environment ............................... 19.3. Definition ..................................................................................................................... 19.4. Ethical Issues of Biodiversity ...................................................................................... 19.5. Acceleration in the Loss of Biological Diversity .......................................................... 19.6. Convention on Biological Diversity (CBD) .................................................................. Summary ...................................................................................................................... Exercise ........................................................................................................................

437 437 437 438 440 442 449 450 451

20. Ethical Issues in Genetically Modified Organisms: Foods and Crops ........................... 20.1. Introduction ................................................................................................................. 20.2. History of Genetic Modification .................................................................................. 20.3. Techniques of Genetic Modification ............................................................................ 20.4. Uses of Genetic Modification ...................................................................................... 20.5. Genetically Modified Food ........................................................................................... 20.6. Policy Around the World .............................................................................................. 20.7. Health Implications of Genetically Modified Foods ..................................................... 20.8. Steps for GM Food Technology Regulations .............................................................. 20.9. Possible Health Outcomes ........................................................................................... 20.10. World Health Organization and its Future Plans .......................................................... 20.11. Ethical Issues Associated with the Consumption of GM Food ................................... Summary ...................................................................................................................... Exercise ........................................................................................................................

453 453 456 456 458 461 464 467 467 470 475 477 479 481

21. Labeling of Genetically Modified Food and Crops ............................................................ 21.1. Introduction ................................................................................................................. 21.2. Outburst of Genetically Modified Plants and Animals ................................................. 21.3. Public Health Principles Regarding the Regulation of GM Foods ............................... 21.4. Definition ..................................................................................................................... 21.5. Labeling of GM Food Products ................................................................................... 21.6. Benefits of Labeling ..................................................................................................... 21.7. Guidelines for Labeling of Genetically Modified Agricultural Products....................... Summary ...................................................................................................................... Exercise ........................................................................................................................

483 483 483 487 488 488 491 493 496 496

22. Stem Cell Research, Applications of Stems Cells and Ethical Issues Involved in Stem Cell Research and Use .......................................................................... 499 22.1. Introduction ................................................................................................................. 499 22.2. Definition of Stem Cells ............................................................................................... 500

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22.3. 22.4. 22.5. 22.6. 22.7. 22.8. 22.9. 22.10. 22.11. 22.12. 22.13. 22.14. 22.15. 22.16. 22.17.

Stem Cell Line .............................................................................................................. Adult Stem Cells .......................................................................................................... Identification of Stem Cells ......................................................................................... Stem Cell Research ...................................................................................................... Properties of all Stem Cells .......................................................................................... Hematopoietic Stem Cells ............................................................................................ Sources of Hematopoietic Stem Cells ......................................................................... Potential Uses of Human Embryonic Stem Cells ......................................................... Hematopoietic Stem Cells and their Clinical Applications ............................................ Other Applications of Hematopoietic Stem Cells ......................................................... Stem Cells in Gene Therapy—Principles and Promise ................................................ Autoimmune Diseases and Stem Cell-Based Therapies ............................................... Stem Cell Biosafety ...................................................................................................... Embryonic Stem Cell Research and Funding .............................................................. Ethical Issues of Stem Cell Research and Use ............................................................ Summary ...................................................................................................................... Exercise ........................................................................................................................

501 502 504 508 514 518 522 527 529 531 531 538 541 546 546 551 553

23. Use of Animals in Research and Testing, and Alternatives for Animals in Research ............................................................................................................ 23.1. Introduction ................................................................................................................. 23.2. Animal Research and Testing ...................................................................................... 23.3. Animal Models ............................................................................................................. 23.4. Genetically Modified Animals and their Use in Research and Testing ......................... 23.5. Ethical Issues in the Use of Animals in Research and Testing .................................... 23.6. Alternatives for Animal Models in Research and Testing ............................................ 23.7. Different Animal Models of Disease ............................................................................ Summary ...................................................................................................................... Exercise ........................................................................................................................

555 555 555 560 561 561 563 577 583 584

24. Animal Cloning, Human Cloning and their Ethical Aspects ........................................... 24.1. Introduction ................................................................................................................. 24.2. Definition ..................................................................................................................... 24.3. Birth of the Cloning Technology .................................................................................. 24.4. Types of Cloning ......................................................................................................... 24.5. DNA Cloning ............................................................................................................... 24.6. Reproductive Cloning .................................................................................................. 24.7. Therapeutic Cloning ..................................................................................................... 24.8. Animal Cloning ............................................................................................................. 24.9. History of Cloning ....................................................................................................... 24.10. Cloning and its Applications ......................................................................................... 24.11. Cloning and its Risks ................................................................................................... 24.12. Human Cloning ............................................................................................................ 24.13. Arguments Against and in Defence of Human Cloning ...............................................

585 585 586 586 588 589 590 593 596 597 599 600 601 602

Contents

xxiii

24.14. Ethics of Adult Human DNA Cloning .......................................................................... 24.15. Cloning Technology and its Problems ......................................................................... 24.16. Usefulness of Cloning Technology .............................................................................. Summary ...................................................................................................................... Exercise ........................................................................................................................

607 611 614 616 618

25. Testing of Drugs on Human Volunteers ............................................................................ 25.1. Introduction ......................