Jahrbuch für Recht und Ethik / Annual Review of Law and Ethics: Bd. 4 (1996). Themenschwerpunkt: Bioethik und Medizinrecht / Bioethics and the Law [1 ed.] 9783428486847, 9783428086849

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Jahrbuch für Recht und Ethik Annual Review of Law and Ethics Band 4 (1996) Herausgegeben von B. Sharon Byrd Joachim Hruschka Jan C. Joerden

Duncker & Humblot  · Berlin

Jahrbuch für Recht und Ethik Annual Review of Law and Ethics Band 4

Jahrbuch für Recht und Ethik Annual Review of Law and Ethics Herausgegeben von B. S h a r o n B y r d · J o a c h i m H r u s c h k a · Jan C . Joerden

Band 4

Duncker & Humblot · Berlin

Jahrbuch für Recht und Ethik Annual Review of Law and Ethics Band 4 (1996) Themenschwerpunkt:

Bioethik und Medizinrecht Bioethics and the Law Herausgegeben v o n B. Sharon Byrd Joachim Hruschka Jan C . Joerden

Duncker & Humblot · Berlin

Die Deutsche Bibliothek - CIP-Einheitsaufnahme Jahrbuch für Recht und Ethik = Annual review of law and ethics. — Berlin : Duncker und Humblot. Erscheint jährl. - Aufnahme nach Bd. 2 (1994) ISSN 0944-4610 NE: Annual review of law and ethics

Bd. 4. Themenschwerpunkt: Bioethik und Medizinrecht. - 1996

Themenschwerpunkt: Bioethik und Medizinrecht = Bioethics and the law / hrsg. von B. Sharon Byrd . . . - Berlin : Duncker und Humblot, 1996 (Jahrbuch für Recht und Ethik ; Bd. 4) ISBN 3-428-08684-8 N E : Byrd, B. Sharon [Hrsg.]; Bioethik und Medizinrecht; Bioethics and the law

Empfohlene Abkürzung: JRE Recommended Abbreviation: JRE Alle Rechte, auch die des auszugsweisen Nachdrucks, der fotomechanischen Wiedergabe und der Übersetzung, für sämtliche Beiträge vorbehalten © 1996 Duncker & Humblot GmbH, Berlin Fremddatenübernahme und Druck: Berliner Buchdruckerei Union GmbH, Berlin Printed in Germany ISSN 0944-4610 ISBN 978-3-428-08684-9

Vorwort Die meisten Beiträge zu diesem Band des Jahrbuchs für Recht und Ethik sind aus einem interdisziplinären und internationalen Symposion zum Thema ,3iotechnological Challenges for Law and Ethics" hervorgegangen, das die Herausgeber des Jahrbuchs in der Zeit vom 5. bis 11. August 1995 im Study and Conference Center der Rockefeller Foundation in Bellagio, Italien, veranstaltet haben. An diesem Symposion haben Mediziner, Philosophen, Juristen und Wirtschaftswissenschaftler teilgenommen, und zwar: Arno Baltes (Erlangen), B. Sharon Byrd (Jena), Ellen Wright Clayton (Nashville), Lloyd R. Cohen (Arlington), Raphael Cohen-Almagor (Haifa), Thomas Crofts (Frankfurt an der Oder), Angelika Drescher (Erlangen), Roger B. Dworkin (Bloomington), Gonzalo Herranz (Pamplona), David Heyd (Jerusalem), Joachim Hruschka (Erlangen), Lawrence Hunsicker (Iowa City), Jan C. Joerden (Frankfurt an der Oder), Frances Myrna Kamm (New York), Matthias Kaufmann (Halle), Matthias Kettner (Essen), Kamiar Khajavi (London), Rita Kielstein (Magdeburg), Hans-Martin Sass (Bochum), Albrecht E. Sippel (Freiburg), Deborah Spitz (Boston), Peter Stanglow (Frankfurt an der Oder). Für die Finanzierung dieses Symposions danken wir der Rockefeller Foundation, dem Land Brandenburg, dem Stifterverband für die Deutsche Wissenschaft und der Dr. Alfred Vinzl-Stiftung. Neben der Ergänzung der Symposions-Ergebnisse durch weitere Beiträge namhafter Wissenschaftler und Wissenschaftlerinnen sind im Abschnitt »Advance Directives in Multicultural Perspective" die Ergebnisse eines gleichnamigen Forschungsprojekts aufgenommen, das an der Georgetown University, Washington, unter der Leitung von Prof. Dr. Hans-Martin Sass durchgeführt und von der Volkswagen-Stiftung finanziert wurde. Für die Unterstützung bei der Drucklegung dieses Bandes des Jahrbuchs danken die Herausgeber insbesondere Frau Ayke Darìus am Institut für Strafrecht und Rechtsphilosophie in Erlangen, Frau Susen Pönitzsch am Lehrstuhl für Strafrecht und Rechtsphilosophie in Frankfurt an der Oder und Frau Heike Frank im Verlag Duncker & Humblot in Berlin. Der fünfte Band (1997) des Jahrbuchs für Recht und Ethik wird sich vorwiegend dem Thema „Kants Metaphysik der Sitten: 200 Jahre Tradition in der Unterscheidung von Recht und Moral" widmen. Die Herausgeber

Table of Contents Genetic Technology Ellen Wright Clayton : Problems Posed by Genetics for Law and Ethics: American Policies 3 Gonzalo Herranz: The Development and Dispersion of Technologies for Diagnosis of Genetic Diseases: A European Response 21 Albrecht É. Sippel : Gene Therapy - A New Medical Technique and Points to Consider

35

Roger B. Dworkin: Law and Ignorance: Genetic Therapy and the Legal Process

49

Hans-Martin Sass: Copernican Challenge of Genetic Prediction in Human Medicine ...

67

Rita Kielstein: Clinical and Clinical-Ethical Aspects of Genetic Prediction. The Case: Hereditary Kidney Disorders 81 Frances Myrna Kamm: Genetic Therapy, Disability and Enhancement

93

Hartmut Kliemt: Pränataldiagnostik und genetisches Screening im freiheitlich-demokratischen Rechtsstaat 99

Allocation of Scarce Resources Keith N. Hylton: The Law and Ethics of Organ Sales

115

Lloyd R. Cohen/Melisa Michelsen: The Efficiency/Equity Puzzle and the Race Issue in Kidney Allocation: A Reply to Ayres, et al. and UNOS 137

Patients' Rights David Heyd: Experimentation on Trial. Why Should One Take Part in Medical Research? 189 Jan C. Joerden: Should We Take Part in Medical Research? A Commentary on David Heyd's "Experimentation on Trial" 205 Raphael Cohen-Almagor: Patients* Right to Die in Dignity and the Role of Their Beloved People 213 Deborah Spitz: Collaboration Between Psychiatrist and Patient: How Avoidable is Paternalism? 233

Vm

Table of Contents

Matthias Kettner: Discourse Ethics and Health Care Ethics Committees Dieter Giesen: Patient-Physician Communication and the Law's Requirements

249 273

Gabriele Wolfslast: Aufklärungspflicht zwischen Informationsrecht und begrenzter Belastbarkeit des Patienten 301 Urban Wiesing: Die Integrität der Arztrolle in Zeiten des Wandels

315

Advance Directives in Multicultural Perspective Hans-Martin Sass: Regelungsbedarf bei Patienten Verfügungen und klinisch-ethischen Entscheidungskonflikten? 329 LS. Rothenberg/Jon F. Merz/Neil S. Wenger/Marjorie Kagawa-Singer/Darryl R. J. Macer/Noburu Tanabe/Shunichi Fukuhara/Kiyoshi Kurokawa/Hernan L·Fuenzalida-Puelma/ Patricio Figueroa/ Johannes G. Meran/Erwin Bernat/Takashi Hosaka/ Grant Ν. Marshall: The Relationship of Clinical and Legal Perspectives Regarding Medical Treatment Decision-Making in Four Cultures 335 Johannes Gobertus Meran : Advance Directives and Surrogate Decision Making. Ethical Questions, Legal Response and Clinical Summary. A Critical View 381 Erwin Bernât /Hans-Georg Koch /Alan Meisel: Das „Patiententestament" und der „Stellvertreter in Gesundheitsangelegenheiten". Ein Vergleich des deutschen, amerikanischen und japanischen Rechts 445 Hans-Martin Sass /Frederick O. Bonkovsky/Akira Akabayashi/Rita S. Olick: Advance Health Care Documents in Multicultural Perspectives

Kielstein/Robert 465

Madison Powers / Carmen Kaminsky/Motoko Hayashi: AIDS and Advance Directives: Clinical, Legal and Ethical Perspectives in Japan, Germany and the United States 509 Robert S. Olick/Rihito Kimura/Jan 7! Kielstein /Hideaki Hayashi/Marc Riedl/Mark Siegler: Advance Care Planning and the ALS Patient: A Cross-Cultural Perspective on Advance Directives 529 Robert S. Olick: A Disease-Specific Advance Directive for Amyotrophic Lateral Sclerosis Patients 553

Normative Ethics Margaret Gruter/Roger D. Masters: Balancing Altruism and Selfishness: Evolutionary Theory and the Foundation of Morality 561 Matthias Kaufmann: Ethikbegriindung und Ethikanwendung Gary Β. Herbert: John Locke: Natural Rights and Natural Duties

575 591

Table of Contents

IX

Werner Greve : Schiedsrichter der Schuld? Die Grenzen einer empirischen Psychologie der Be- und Entschuldigung 615

Recension Gerhard Werle / Thomas Wandres, Auschwitz vor Gericht. Volkermord und bundesdeutsche Straf justiz (Jan C. Joerden)

639

Contributors

643

Hinweise für Autoren

647

Information for Authors

649

Genetic Technology

1 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

Problems Posed by Genetics for Law and Ethics: American Policies Ellen Wright Clayton

We live in an age of intense interest in genetics. It is now possible to detect many diseases that for some time have been thought of as genetic, disorders such as chromosome anomalies and metabolic diseases that are inherited as simple Mendelian traits. The more dramatic development has been the recognition that many people have mutations that place them at much higher risk than the general population of developing relatively common diseases such as cancer and cardiovascular disease that previously had not generally been thought of as "genetic." The ability to treat these disorders and to avert the effects of predisposing alleles has also grown, although not nearly so quickly. The purpose of this paper is to explore the forces in the United States that govern the development and dispersion of these tests and to ask what role personal choice will have in how these tests are made available and used. The focus of this paper will be on the use of genetic tests to provide information about the present and particularly the future health of the individual who is being tested. These tests range from metabolic assays that have been used for years to diagnose genetic diseases such as phenylketonuria to newer techniques, such as linkage and direct mutation analysis, that can be used both to diagnose current illness as well as to detect mutations in genes that predispose the individual to develop diseases such as cancer. The use of genetic tests for reproductive decision making raises some different issues that will be discussed in a separate section of this paper.

I. Characteristics of Scientific Research and Health Care in the United States that May Affect Development and Use of Genetic Tests In order to understand the specific issues posed by genetics, it is necessary first to examine the complex system of health care in which this information will be used. A number of forces exist, many of which work in opposition to each other.

1*

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Ellen Wright Clayton

1. Factors Favoring the Spread of New Technology There is tremendous interest in expanding knowledge and in bringing new tests and technology to market. The directions taken in research depend on a complex set of interactions between public and private funding entities and investigators. Turning first to the relationships between public funding agencies and researchers, for many years, billions of dollars of public funds have been devoted to basic and applied research. O f this money, the three billion dollars currently being spent over 15 years under the auspices of the National Center for Human Genome Research to sequence the genomes of humans as well as of other organisms represent only a fraction of the publicly funded research that seeks to determine the role that inheritance plays in the development of disease. Which projects are funded depends on initiatives taken by the agencies and on the evaluation of proposals by peer reviewers who bring their own sense of what constitute worthwhile questions to the table. Thus, the current emphasis placed on genetics is shaped by and shapes the questions pursued by investigators, whose own careers in turn depend on their ability to obtain funding and to demonstrate the relevance of their research. The public's primary interest in promoting research has always been the expectation that increased knowledge will improve health. To this end, the results of research undertaken with public funds have been used by the private sector to bring technologies to market. This public-private partnership has received increasing emphasis in recent years and is now an explicit part of many projects. 1 Private entities have also conducted or funded a great deal of research themselves. These private efforts are driven by the need to achieve profits and so must seek to serve the needs and demands of patients and health care providers. These demands in turn can be affected by numerous factors, including marketing by private companies, the general enthusiasm of the media for reporting new discoveries in genetics, and the desires of physicians to provide and patients to receive the latest technologies, many of which enter the market with relatively little regulation. The resulting demand appears to be virtually insatiable.

2. Factors that Tend to Limit Patients' Options Regarding These Technologies a) The Limited Role of Informed Consent A Vision of Patient Choice Largely Unfulfilled In the wonderland of this technology, the naive observer might look at the requirements of informed consent in medicine and non-directive counselling in genetics and conclude that patients are truly free to decide which technologies to use. 1 This sort of collaboration is exemplified by the National Action Plan for Breast Cancer, a public-private collaboration to promote the development of optimal approaches to cure breast cancer.

Problems Posed by Genetics for Law and Ethics

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The true impact of the doctrines of informed consent and non-directive counselling on medical practice, however, is much more limited than might appear on superficial inspection. Honest assessment reveals that thoroughgoing conversation and shared decision making between patients and physicians occurs infrequently. 2 The possibility, and even the desirability, of non-directive counselling is increasingly called into question.3 The commitment by physicians to patient choice was always fragile at best. Informed consent and non-directiveness are true newcomers in the field of medical ethics, arising only in the latter half of this century. Notions that patients should follow doctors' orders are far more deeply ingrained in medical practice. The language of medicine is full of terms such as "compliance" that convey this picture of unequal authority within the physician-patient relationship. In reality, physicians generally play an important and even dispositive role in determining what options patients consider and elect.

b) The Roles of Efficacy and Third Party Payment Factors external to the physician-patient relationship also limit patient choice. One of these forces is the process by which the impact of health care is assessed, which often ignores the role of patients' desires. Outcomes research, for example, measures such endpoints as death, morbidity, and health care costs. Psychosocial consequences of medical interventions typically are not included in the calculus. In such analyses, a patient's choice to pursue something other than the least costly or most life-prolonging intervention would be viewed as an adverse outcome even if the patient's choice of care were more concordant with his or her wishes and values. Another factor is the growing role that third party payment and, to a lesser extent, the government as provider plays in limiting patients' options. As noted previously, clinicians have a large role in deciding what interventions to pursue. For much of this half of the century, clinicians' decisions were relatively unrestrained and generally were rather insensitive to cost because payers reimbursed for what the doctor ordered, a factor that may have made patients happy but that many cite as contributing to the dramatic increase in health care costs in the United States. This has begun to change. Third party payers in the United States increasingly exclude some tests and treatments from coverage or limit the percentage of the charges covered. Similarly, national and state governments offer some interventions and not others. It is here that the emphasis on efficacy has its main effect 2 Jay Katz, The Silent World of Doctor and Patient, New York: Free Press, 1984. 3 Angus Clarke, "Is Non-Directive Genetic Counselling Possible?", 338 Lancet 998 (1991).

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Ellen Wright Clayton

The impact of the failure to consider patients' concerns in assessing efficacy becomes more substantial as payers increasingly pay only for the less expensive of two interventions of relatively equal efficacy. Payers are also less likely to cover tests that will not alter patient behavior in ways that affect measured health outcomes. Capitation and economic credentialing give providers financial incentives not to order tests and treatments of great cost or questionable efficacy. Even physicians in fee for service or managed care plans that permit patients to buy services out of plan may fail to discuss diagnostic or therapeutic interventions that they know will be poorly covered or excluded, perhaps judging that the patient will not want to pay. These forces that lead physicians to limit options for patients, although potent, are not unopposed.4 Patients generally can pursue claims, arguing that had they been informed of options not discussed by their providers, they would have appealed to their payer or even would have paid for the services out of their own pockets. In order to prevail, however, patients must demonstrate that the desired services would have led to improved outcomes. The difficulty of making such a showing contributes to the lack of success often seen in these claims.

c) The Problem of "Genetic Discrimination" Thus, a host of forces converge to limit the options made available to patients. There are also forces that particularly affect patients' choices regarding genetic tests. Again, third party payers play a substantial role, often providing individuals with reasons not to have genetic testing. The funding of health care in the United States primarily through employer-based and some private insurance means that obtaining genetic information may impair access to care.5 In the private insurance market, individuals who have a history of, or who have a predisposition to, serious disease may find themselves forced to pay higher premiums, subjected to long waiting periods for coverage, or simply denied coverage in whole or in part. In this regard, it is not yet clear whether genetic predispositions will be regarded as preexisting conditions so that surveillance for and treatment of the disorder that may later occur would be excludedfrom coverage. Efforts by the states to prevent what is seen by many as inappropriate "genetic discrimination" particularly by insurers have had limited impact for a number of 4 The ethical and legal problems posed by decisions not to discuss expensive or non-covered options with patients are complex and beyond the scope of this paper. Many of the issues are addressed in Frances H. Miller, "Denial of Health Care and Informed Consent in English and American Law", 18 American Journal of Law and Medicine 37 (1992). 5 NIH Working Group on Ethical, Legal and Social Implications of Human Genome Research, Genetic Information and Health Insurance: Report of the Task Force on Genetic Information and Insurance, Bethesda, Maryland: National Institutes of Health, National Center for Human Genome Research, 1993.

Problems Posed by Genetics for Law and Ethics

7

reasons. The few attempts at reform have struggled with the problems of partial reform - e.g., trying to distinguish genetic tests and conditions from others.6 But even well thought out, comprehensive efforts by the states would have limited impact because most individuals have health coverage provided by employers who are self-funded. These programs are governed only by federal law, which until recently has provided little substantive control or protection.7 The United States Equal Employment Opportunity Commission recently interpreted the Americans with Disabilities Act to provide most individuals with greater protection from employment and perhaps even insurance discrimination on the basis of genetic predisposition.8 But the expanded protection provided by the ADA is still incomplete, so there remains a realrisk of loss or limitation of insurance coverage if a person were to obtain genetic information.

3. Limits on Changing Patients

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Behavior

Even when measures that improve outcome are available, it is well known that patients frequently do not adhere to their physicians' advice. The whole subject of increasing compliance, or patients' willingness to do as their doctor suggests, is complex, raising a host of psychosocial as well as strictly medical issues. Patients are more likely to follow their clinicians' advice if they believe that the proposed change will not be too burdensome and that it is really needed.9 Patients are more likely to take medicines, for example, if they believe that the medicine will take care of a problem that they see as pressing and if the drugs taste good, have no side effects, and need to be taken only once or twice a day for a limited period of time. The ethical and legal dilemma is to define limits on efforts to induce or even coerce compliance. The provider may threaten or cajole. She may schedule more frequent visits if permitted by the patient's schedule and insurer and the provider's other obligations. But in the end, tfre physician's power is usually limited to that of persuasion.10 6 Karen M. Rothenberg, "Genetic Information and Health Insurance: State Legislative Approaches", Workshop on "Genetic Discrimination and Health Insurance: A Case Study on Breast Cancer", Bethesda, Maryland, July 11,1995. 7 Employee Retirement Income Security Act of 1974, 29 U.S.C.A. §§ 1001-1461 (1995). β Equal Employment Opportunity Commission. Compliance manual section 902: definition of the term "disability", Washington, DC 5/15/95. 9 Joy Melnikow / Catarina Kiefe, "Patient Compliance and Medical Research: Issues in Methodology", 9 Journal of General Internal Medicine 96 (1994); Lisa S. Morris / Richard M. Schulz, "Medication Compliance: The Patient's Perspective", 15 Clinical Therapeutics 593 (1993); David A. Sciar/Teresa A. Tartaglione /Michael J. Fine, "Overview of Issues Related to Medical Compliance with Implications for the Outpatient Management of Infectious Diseases", 3 Infectious Agents and Disease 266 (1994).

10 Thomas L Beauchamp/James F Childress, New York: Oxford, 1989.

Principles of Biomedical Ethics, 3rd ed.,

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Ellen Wright Clayton

One might also expect third party payers to provide patients with incentives to follow advice that will be expected to improve outcome in the long term, particularly if the improvement leads to decreased health care costs. Insurers, for example, already offer individuals who do not smoke and who engage in health promoting activities lower rates on some types of insurance. This trend can be expected to increase, particularly with regard to behaviors that are seen as modifiable, but only up to a point. Even though a universal policy of covering effective preventive care should work to the benefit of all payers, patients in the United States routinely change payers so that individual insurers have less incentive to encourage specific patients to incur costs in the present for preventive and therapeutic measures designed to avert problems and costs in the future. The institution that could be more likely to seek to alter individual behavior is the government, both because it pays for the health care services of a substantial number of citizens and because the need to control the costs of health care in all sectors of society has become a major political issue. There is a long history in the United States of attempting to regulate or eliminate risky behaviors and even, in some instances, directly restraining particular individuals. But while there may be strong incentives for the government to act, several factors may limit its response. While the debate about global health care costs has been occurring primarily on the national level, tradition and the recent emphasis on deregulation mean that thè states have most of the authority to make decisions about medical care. States have significant incentives to limit the amount of money spent on the recipients of Medicaid, who are generally the poorest and least politically powerful individuals in the population, but they have less reason to focus on reducing costs in the rest of the population. Nonetheless, under the United States Constitution, states have far reaching authority under both the police power and the doctrine of parens patriae to intervene in the activities of their citizens, first to prevent individuals from harming others and second to protect individuals from harming themselves. This authority in recent years has been exercised only in relatively limited circumstances. Adults generally are subjected to mandated medical care or restraint only when their disease poses a serious risk of harm to others. Thus, observed administration of drugs or even quarantine are increasingly required for patients infected with tuberculosis.11 By contrast, treatment typically has been imposed on adults whose diseases present arisk of serious harm only to themselves only when the adults are no longer competent.12 The culture and the laws of the United States generally permit competent adults to refuse even life-saving medical treatment. u Ronald Bayer /David Wilkinson, "Directly Observed Therapy for Tuberculosis: History of an Idea", 345 Lancet 1545 (1995); Michael D. Iseman/David L Cohn/ John A. Sbarbaro , "Directly Observed Treatment of Tuberculosis. We Can't Afford not to Try it", 328 New England Journal of Medicine 576 (1993). 12 Ellen W Clayton, "From Rogers to Rivers. The Rights of the Mentally 111 to Refuse Medication", 13 American Journal of Law and Medicine 9 (1987) (psychotropic medication).

Problems Posed by Genetics for Law and Ethics

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Π . How Do these Conflicting Forces Affect the Dispersion of Genetic Technology? Let us consider two examples of genetic testing to demonstrate how these forces might interact. 7. The Case of Limited Efficacy in Treating Adult Diseases and Predispositions As is often true in medicine, the ability of medicine and science to detect genetic disease or predispositions frequently exceeds the ability to intervene to improve outcome. Mutation or linkage analysis for changes in BRCA1 is illustrative.13 Such mutations, which are autosomal dominant traits, are thought to account for approximately 5% of cases of breast cancer as well as a substantial number of cases of ovarian cancer. Even though individuals at risk of having these mutations generally have family histories remarkable for early onset of breast and/or ovarian cancer in women from different generations, widespread concern about this cancer means that many other women might also be interested in being tested were it available. Thus, interest by private industry in developing these tests is high. Once the technical challenges of developing the test are met, the rate of its use may depend largely on how well women are informed about the lack of certainty regarding how best to care for women who are found to have mutations in this gene. As is true in much of genetics, having a mutation is not a sentence of doom. Women who are known carriers of mutations in BRCA1 are not necessarily destined to develop breast cancer during young adulthood, and they have only an 85% risk of developing the disease over their lifetimes. The most effective program of preventive surveillance is not known, and even bilateral mastectomy does not completely eliminate the risk of developing breast cancer. The difficulties of screening for ovarian cancer are even more complex, as are the side effects of prophylactic oophorectomy. As a result, early detection of carriers could easily lead to increased health care costs as these women pursue more intensive surveillance or surgery, but these interventions may not lead to more prolonged disease-free survival. It is imperative that women be informed of these limitations before they decide about testing. To this end, many major professional organizations are making efforts to ensure that physicians are aware of these limitations. Another question is how such tests would be paid for. Providing third party payment for tests to detect mutations in BRCA1 is not attractive in a health care sys-

Douglas F. Easton/Deborah Ford/D. Timothy Bishop/Breast Cancer Linkage Consortium, "Breast and Ovarian Cancer Incidence in BRCA1-Mutation Carriers", 56 American Journal of Human Genetics 265 (1995); Kent F. Hoskins/Jill E, Stopfer/Kathleen A. Calzone/Sofia D. Merajver/Timothy R. Rebbeck/Judy E . Garber /Barbara L Weber, "Assessment and Counselling for Women with a Family History of Breast Cancer: A Guide for Clinicians", 273 Journal of the American Medical Association 577 (1995).

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tem that focuses on improving outcomes, particularly if allaying anxiety is not part of the calculus of efficacy. Moreover, testing may be seen as undesirable from the payer's perspective because women found to have these mutations typically receive medical interventions that are extremely costly. But to the extent that insurers and payers can increase rates or exclude individuals at increased risk from coverage, third parties may wish to encourage testing although there is little evidence that they have chosen to do so so far. Concerns about insurability have led some women to pay for tests out of their own pockets and either decline to share the results with their physicians or ask their physicians to withhold the information from the insurer, courses of action that raise a whole host of difficulties. 14 The problems of lack of proven interventions andrisk of compromising insurability are so substantial that a consensus group recommended that testing for BRCA1 occur only in the context of research protocols where there have been virtually unparalleled efforts to ensure that women are adequately informed about the possible ramifications of being tested.15

2. The Case of Proven Intervention for Adult Diseases and Predispositions In general, the gap between diagnosis and intervention closes over time. Yet even when effective treatment is possible, genetic diseases and predispositions typically are not amenable to easy, inexpensive, one-time interventions, but rather often require significant surgery or long term lifestyle changes or medical treatments. Individuals who are known to have mutations in the gene for familial polyposis, for example, can avert their risk of developing colon cancer if they begin routine colonoscopy at an early age and have a total colectomy within ten years of developing polyps.16 People with hemochromatosis can prevent liver and cardiac failure if they undergo routine phlebotomy.17 14 If a person applies for insurance and does not disclose information about his or her health status, the insurer may later refuse to pay, saying that the person committed fraud. A person who realizes that insurers have access to medical records may choose a couple of different paths, each of which may have adverse consequences. She may simply fail to share test results with her physician, a course of action that could compromise care. She may also disclose to her physician, asking the physician not to enter the information into her medical record. This course also presents the risk of compromising care if the patient is cared for by other physicians, as well as an ethical dilemma for the physician who runs the risk of committing fraud. 15 National Advisory Council for Human Genome Research, "Statement on Use of DNA Testing for Presymptomatic Identification of Cancer Risk", 271 Journal of the American Medical Association 785 (1994). M Rhodes /D.M. Bradburn, "Overview of Screening and Management of Familial Adenomatous Polyposis", 33 Gut 125 (1992). 17 C. Niederau/ G. Strohmeyer /W. Stremmel, "Epidemiology, Clinical Spectrum and Prognosis of Hemochromatosis", 356 Advances in Experimental Medicine and Biology 293 (1994).

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Long experience has shown that individuals at risk often fail to follow through with effective interventions, particularly when the risk of becoming symptomatic seems to be remote either in time or in their own personal experience. What are the implications of the observation that people do not always follow medical advice? The first is the recognition that estimates of the efficacy of diagnosis and treatment are likely to be flawed if they are based on assumptions of complete compliance. More realistic expectations regarding behavior may lead to lower estimates of the impact of diagnostic and therapeutic measures on health. One response to these more accurate estimates of the effects of diagnosis might be to deny or limit funding for tests that are unlikely to lead to health-promoting changes in behavior. The rationale underlying such a choice is that if people will not change what they do in response to the test, there is little reason to make the test widely available or to provide third party coverage. It seems unlikely that the government will take steps to promote or require testing and compliance with medical recommendations. The narrow approach that states have taken in recent years to exercising their police powers and powers of parens patriae suggests that, because genetic diseases rarely present immediate threats of harm to others, adults generally will not be subjected to genetic tests or required to undergo medical or lifestyle changes against their wishes. State governments may have the legal authority to enact such programs, but the emphasis on personal liberties within the United States would make such state action politically impossible. A course short of direct personal invasion that the state could consider to decrease the impact of genetic predispositions would be ensuring that information about a person's genetic risk be shared with his or her relatives. After all, biological relatives of individuals who are found to carry specific mutations generally are more likely than the general population to be carriers as well and so might profit from knowing about their genetic risk. One possibility would be to require patients to share this data with their family members. But how would such a duty be enforced? Relatives cannot force each other to share information because the law in the United States generally provides that people cannot sue their family members about such matters. Moreover, the conditions under which a physician could breach a patient's confidentiality and share information with relatives against the patient's wishes are quite few. At present, the law generally prohibits physicians from making such disclosures. Several bodies of commentators have concluded that ethical principles permit physicians to discuss a patient's genetic makeup with relatives over the patient's objection, if ever, only when efforts have been made to convince the patient to share the information and where the risk is great and could be averted by prompt intervention that would be undertaken only in the case of disclosure.18 The fact that the ability to diagnose genetic diseases and predisposi-

18 President's Commission for the Study of Ethical Problems in Medicine and Biomed and Behavioral Research, Screening and Counseling for Genetic Conditions, Washington,

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tions often far exceeds the ability to intervene effectively means that the conditions that justify unwanted disclosure would rarely, if ever, be met. States do have the power to alter these rules, both to require individuals to share information with their relatives and to provide legal protection for physicians who disclose such information. 19 But here as well, the states are very unlikely to make these changes, particularly in light of the tremendous concerns about genetic privacy in the United States fueled by worries about access to health care. 20 In summary, even when genetic tests can diagnose diseases or predispositions for which there are clearly effective treatments, physicians will still retain primary responsibility for determining which tests to include in the medical armamentarium and for inducing patients to act upon the information they receive. For the most part, the role of third party payers will be limited to deciding not to cover tests when the intervention that could avert or treat disease is not likely to be undertaken or where the benefits of treatment would be apparent only in the relatively distant future. Although governments appear to have the legal authority to force people to engage in some health-promoting behaviors, it seems likely that states will avoid direct coercion and will pursue other approaches such as education. 3. The Special Case of Children In contrast with the hands off approach generally taken toward decisions by adults regarding their own care, the state is far more likely to invoke its power as parens patriae to provide diagnosis and treatment for children who become seriously ill during childhood. All states currently screen newborns for the presence of metabolic diseases that are often inherited as simple Mendelian traits. In almost all cases, these programs are mandatory. If parents do not provide children who have genetic diseases with treatment that can avert serious harm, the state has the power to ensure that treatment is given even if that means removing the child from the parents' custody. The scope of these powers to require diagnosis and treatment DC: U.S. Government Printing Office, 1983; Committee on Assessing Genetic Risks , Division of Health Sciences Policy ; Institute of Medicine, Assessing Genetic Risks: Implications for Health and Social Policy, Washington, DC: National Academy Press, 1994. Interestingly, there has been no reported litigation in which a patient sued the physician for disclosing genetic risk or any in which a relative sued, arguing that the physician should have breached the patient's confidentiality regarding genetic risk. 19 States, for example, already require health care providers to report a large number of infectious diseases. In most cases, the state notifies individuals who may have been put at risk by exposure to the infected patient rather than requiring the physician to perform tracking and notification. 20

Karen M. Rothenberg (op. cit. fn. 6); George J. Annas/Leonard H. Glantz/Patricia Roche, The Genetic Privacy Act, Boston, Massachusetts: Health Law Department, Boston University School of Public Health, 1995.

A.

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of children has been the subject of much discussion, exploration of which is beyond the scope of this paper.21 Attention more recently has been focused on the appropriateness of testing children for mutations that can predict late onset disease. Parents often seek such testing when they discover the presence of such mutations in themselves or their adult relatives. Many commentators have urged that testing should not be done during childhood if there is no effective intervention that must be undertaken prior to adulthood, reasoning that the child should be allowed to make this important decision for him- or herself on reaching decision making capacity.22 Similarly, some have argued that parents have no protectible reason to determine whether their children carry recessive disorders since such information is of relevance only to the children's later reproductive decision making. Others, however, believe that parents ought to be able to decide whether or not to have their children tested, arguing that these choices are well within the scope of usual parental authority and even entitlement.23 4. The Special Case of Reproductive

Genetic Testing

Genetic testing can also be used to help families make reproductive decisions. If people who are contemplating pregnancy are known to be carriers of mutations, they can decide whether to avoid having children altogether, whether to use the new reproductive technologies to obtain gametes from others, or in some instances, whether to use prenatal diagnosis. Once pregnancy has occurred, prenatal diagnosis may be possible to determine whether the child is affected or a carrier. The options available to prospective parents who find that their unborn child has a genetic disorder are limited. Most diseases that can be diagnosed prenatally are not amenable to treatment in utero, 24 and even treatment provided after delivery may not

21 Lori Β. Andrews , Medical Genetics: A Legal Frontier, Chicago: American Bar Foundation, 1987; Ellen W. Clayton, "Screening and Treatment of Newborns", 29 Houston Law Review 85 (1992). 22 American Society of Human Genetics Board of Directors, American College of Medic Genetics Board of Directors, "Points to Consider: Ethical, Legal, and Psychological Implications of Genetic Testing in Children and Adolescents", 51 American Journal of Human Genetics 1233 (1995); Dorothy C. Wertz/Joanna H. Fanos/Philip R. Reilly, "Genetic Testing for Children and Adolescents: Who Decides?", 272 Journal of the American Medical Association 875 (1994). 23 Mary Ζ Pelias, "Genetic Testing in Children and Adolescents: Unresolved Issues", American Society of Human Genetics Annual Meeting, Montreal, Canada, October, 21, 1994. But see Ellen W. Clayton, "Removing the Shadow of the Law from the Debate about Genetic Testing of Children", 57 American Journal of Medical Genetics 630 (1995). 24 Congenital adrenal hyperplasia may be one of the few genetic disorders whose course can be altered by treatment in utero. See LS. Levine/ S. Pang, "Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia", 7 Journal of Pediatric Endocrinology 193 (1994); P.W. Speiser /M.I. New, "Prenatal Diagnosis and Treatment of Congenital Adrenal Hyperplasia", 7 Journal of Pediatric Endocrinology 183 (1994).

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ameliorate all the child's problems. Down syndrome, one of the most common disorders detected prenatally, is illustrative - associated anatomical abnormalities can often be repaired but retardation and other medical problems remain. As a result, prospective parents who learn about a defect in their unborn child generally have only a choice between continuing or aborting the pregnancy. The wider array of potential options prior to pregnancy would seem to make preconception testing preferable. Yet most people have tests that could be performed prior to conception only after pregnancy has occurred so that the overwhelming majority of reproductive genetic testing is, in practice, a step in the process of prenatal diagnosis.25 Given the political volatility of abortion in the United States, one might expect that the inextricable link between prenatal diagnosis and abortion would strongly discourage the dispersion of reproductive genetic testing. But the weight of policy in the United States favors the use of this type of testing.26 Virtually all states provide funding for genetic services, and a few require private insurers to cover these tests. California has gone one step further and requires that all pregnant women be offered maternal serum alpha feto protein testing to screen for neural tube defects and, to a lesser extent, aneuploidies such as Trisomy 21. 2 7 Although much play is given to the individual's and couple's right to procreational autonomy, one of the justifications for offering testing is that prenatal diagnosis and abortion are less expensive than caring for affected children after birth. This sort of logic has precedent in the United States in the eugenics laws enacted in the first half of this century 28 Some public officials even today state that decreasing the number of affected children born is a goal, or at least a benefit, of providing genetic ser29

vices.

25 Michael Kaback/Joyce Um-Steele/Deepti Dabholkar/Davod Brown /Nancy Levy/ Karen Zeiger, "Tay-Sachs Disease - Carrier Screening, Prenatal Diagnosis, and the Molecular Era", 270 Journal of the American Medical Association 2307 (1993); Ellen W. Clayton/ Vickie L Hannig /Jean P. Pfotenhauer /Robert A. Parker/Preston W. Campbell III /John A Phillips III, "Lack of Interest by Nonpregnant Couples in Population Based Cystic Fibrosis Carrier Screening", 58 American Journal of Human Genetics 617 (1996). 26 Troy Duster, Backdoor to Eugenics, New York: Routledge, 1990; Ellen W. Clayton, "What the Law Says About Reproductive Genetic Testing and What it Doesn't", in: Karen M. Rothenberg/Elizabeth Thomson, eds: Women and Prenatal Testing: Facing the Challenges of Genetic Technology, Columbus, Ohio: Ohio State University Press, 1994, pp. 131178. 27 The regulations in California contemplate that women will be free to choose whether or not to have the blood test. 17 Cal. Code Regs. § 6527 (1995). A recent study, however, revealed that physicians feel great pressure to get women to agree to have the test because they perceive with some reason that it is difficult to defend a case in which a woman refused the test and then had a child with a neural tube defect. Nancy A. Press/Carol H. Browner, "Collective Silences, Collective Fictions: How Prenatal Diagnostic Testing Became Part of Routine Prenatal Care", in: Karen M. Rothenberg/Elizabeth Thomson, eds: (op. cit fn. 26), pp. 201-218. 28 Daniel 7. Kevles, In the Name of Eugenics: Genetics and the Use of Human Heredity, New York: Knopf, 1985; Philip R. Reilly, The Surgical Solution - A History of Involuntary Sterilization in the United States, Baltimore: Johns Hopkins University Press, 1991.

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Of greater importance than official policy for the dispersion of reproductive genetic testing is the widespread availability of actions for wrongful birth. 30 In these cases, parents who have a child with a genetic disorder allege that had they been aware of their risk of having an affected child, they would have taken steps prior to conception or prenatally to avert the birth of the child. Most states allow parents with valid claims to recover at least the extra medical costs required for the child's care, so the potential damages can be quite large. Yet as in most cases of alleged medical malpractice, physicians can be found to be negligent only if they failed to provide information or tests that would have been provided by other reasonable practitioners. For the most part, decisions about which reproductive genetic tests to include in the care of patients have not been made systematically, but rather represent the aggregate of decisions by individual practitioners who feel pressure to add interventions that they see or believe that their peers are using. As a result, the number of tests offered has expanded dramatically, sometimes in the absence of good data about the demand for testing. Some factors do tend to slow the use of reproductive genetic testing. A few states have decreased or eliminated public funding for prenatal diagnosis and have tried to limit or ban some abortions of fetuses found to have genetic disorders. Since the late 1970s, the federal government has made clear that virtually none of its funds can be used to pay for abortions, including those that a woman may desire after she finds that her unborn child is affected by a serious disorder. Thus, most poor women effectively do not have access to many tests that are readily available to other women because poor women cannot act on the information they might receive. In recent years, the medical profession has also made some efforts to promote a more thoughtful approach to the adoption of new tests. When the gene for cystic fibrosis was identified in the late 1980s, carrier screening was rapidly made available to people with a family history óf CF. It was widely expected at that time that tests for carrier screening would be developed by commercial entities and offered to the general population. Many prominent organizations, such as the American Society of Human Genetics, and individual commentators were concerned that population based screening might cause more harm than good and so called for pilot studies prior to incorporation of these tests into medical practice.31 These 29 George C. Cunningham, "Balancing the Individual's Rights to Privacy against the Need for Information to Protect and Advance Public Health", in: Bartha M. Knoppers/Charles M. LaBerge, eds: Genetic Screening: From Newborns to DNA Typing, New York, New York: Excerpta Medica, 1990, pp. 205-215. 30 Claims brought on behalf of the child for "wrongful life", by contrast, have been far less successful, offering only a limited measure of damages in four states. Jeffrey R. Botkin/ Maxwell J. Mehlman, "Wrongful Birth: Medical, Legal, and Philosophical Issues", 22 Journal of Law, Medicine, and Ethics 21 (1994). 31 C. Thomas Caskey/Michael M. Kaback/Arthur L Beaudet , "The American Society of Human Genetics Statement on Cystic Fibrosis", 46 Am J Hum Genet 393 (1990); "Statement of the American Society of Human Genetics on Cystic Fibrosis Carrier Screening", 51 Am

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pilot studies were undertaken and are now nearing completion. Fortunately, for the most part, people who received testing in these protocols understood what is involved, and those who were found to be carriers appeared to do well with the information. The most remarkable finding of these studies, however, is that relatively few people were interested in having this test prior to conception and that the demand even among pregnant women appeared to be quite sensitive to physician input. 32 Thesefindings have cooled the enthusiasm for population based screening. Finally, despite the hostility currently being expressed in the United States about childbearing by the poor, there is likely to be little official enthusiasm for inducing or coercing people to have reproductive genetic testing. Some argue that such pressure would impermissibly intrude on the individual's constitutional right to make procreative decisions.33 While others question whether such assertedrightswould actually receive this level of protection, the link with abortion and sterilization is too close to make forced reproductive genetic testing politically acceptable.

5. Reflections on Personal Responsibility for Health Some assert that people should be encouraged or forced to promote their own health, an argument that should seem attractive in a political culture that seeks to emphasize self-reliance. For many genetic disorders, it is difficult to base such contentions on the need to control the costs of medical care because treatment and surveillance are often so expensive even when compared with the medical costs of allowing the disease to run its course.34 Another argument is that it is morally reJ Hum Genet 1443 (1992); Benjamin S. Wilfond/Norman C. Fost, "The Cystic Fibrosis Gene: Medical and Social Implications for Heterozygote Detection", 263 Journal of the American Medical Association 2777 (1990); Benjamin S. Wilfond/Norman C. Fost, "The Introduction of Cystic Fibrosis Carrier Screening into Clinical Practice: Policy Considerations", 70 Milbank Q 629 (1992). 32 Hilary Bekker/Michael Modell /Gill Denniss/Anne Silver/Christopher Matthew/Martin Bobrow/Theresa Marteau, "Uptake of Cystic Fibrosis Carrier Testing in Primary Care: Supply Push or Demand Pull?", 306 BMJ 1584 (1993); Ellen W. Clayton/Vickie L Hannig/ Jean P. Pfotenhauer / Robert A. Parker/Preston W Campbell III /John A. Phillips III (op. cit fn. 25); Ellen S. Tambor/Barbara A. Bernhardt / Gary A. Chase/Ruth R. Faden/Gail Geller/Karen J. Hofman/Neil A. Holtzman, "Offering Cystic Fibrosis Carrier Screening to an HMO Population: Factors Associated with Utilization", 55 Am J Hum Genet 626 (1994); but see E.K. Watson/E. May all/J. Chapple/M. Dalziel/K. Harrington/C Williams/R. Williamsony "Screening for Carriers of Cystic Fibrosis through Primary Health Care Services", 303 BMJ 504(1991). 33 John A. Robertson, Children of Choice: Freedom and the New Reproductive Technologies, Princeton, New Jersey: Princeton University Press, 1994; John A. Robertson, "Procreative Liberty and Human Genetics", 39 Emoiy LJ 697 (1990). 34 But see Office of Technology Assessment, U.S. Congress, Healthy Children: Investing in the Future, Washington, DC: U.S. Government Printing Office, 1988, demonstrating that early detection and treatment of children with PKU and congenital hypothyroidism is less costly than long term care of affected children who are untreated.

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prehensible to harm oneself or to allow oneself to come to harm. This assertion is difficult to support in a political system and ethos based on autonomy, but would be more consistent in a society that recognizes that individuals live not in isolation but rather in relationships that create both rights and obligations.35 Even if one espouses this more communitarian approach of the individual's obligation to others to ensure one's own health, it becomes necessary to decide which behaviors it is appropriate to try to change. Drawing such lines, however, is a project fraught with dilemmas because U.S. policy has generally found it more acceptable to erect barriers to "freely willed bad behavior" and to require those who nonetheless indulge to bear the consequences of their choices than for problems for which the person is thought not to be at fault. What constitutes such "bad behavior" changes over time, but in recent years, disapproved acts have included using illegal drugs, drinking alcohol in excess, smoking, and becoming overweight. Calls for looking at more than the individual's actions have come from many sides, based in part on notions that these behaviors are not entirely "freely willed" but rather are also the products of other influences beyond the control of the individual.36 Genetics has become a potent addition to the cultural and environmental arguments that have been used to counter the focus on personal responsibility. The evolution of society's views regarding obesity demonstrates this tension well. "Fattism" is perhaps the last acceptable form of discrimination. There is, however, growing awareness that becoming and remaining overweight often is not simply the result of lack of self-control. An "obesity gene" has been described,37 and scientists recently reported the existence of a hormone that appears to be involved in avoidance of obesity.38 These developments make it less seemly to take coercive or punitive actions against those who weigh too much. Alcoholism has undergone a similar transformation, moving from evidence of moral weakness to disease and even in some instances genetic disease as efforts are made to find an "alcoholism gene."39 Thus, cries for greater self-reliance are called into question by the new genetics.

35 See generally Daniel Callahan, "Bioethics: Private Choice and Public Good", 24(3) Hastings Center Report 28 (1994). 36 See, e.g., DM. Gorman, "Alcohol Misuse and the Predisposing Environment", 50 British Medical Bulletin 36 (1994); Larry H. Patton, "Adolescent Substance Abuse. Risk Factors and Protective Factors", 42 Pediatric Clinics of North America 283 (1995). 37 Klaus Lindpaintner, "Finding an Obesity Gene - A Tale of Mice and Man", 332 New England Journal of Medicine 679 (1995); Jean Marx, "Obesity Gene Discovery May Help Solve Weighty Problem", 266 Science 1477 (1994). 38 Gina Kolata, "Researchers Find Hormone Causes a Loss of Weight", New York Times (7/27/95) Al. 39 American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Washington, DC: American Psychiatric Association, 1994, pp. 195-196; D.M. Ball/R.M. Murray, "Genetics of Alcohol Misuse", 50 British Medical Bulletin 18 (1994). 2 Jahrbuch fui Recht und Ethik, Bd. 4 (1996)

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Conclusion The actual dispersion of genetic tests in the United States is not the product of thorough going analysis and public discourse but rather the result of a number of public and private forces that often work at cross purposes. At present, the main conflict is between public and professional enthusiasm for new technologies and the recognition that, under the current method of health care funding in the United States, genetic testing may be harmful, particularly when no efficacious interventions exist for those who are found to have mutations. Whether genetic tests will benefit patients will depend largely on the ability to educate physicians about these concerns and on their willingness, in turn, to share this information with their patients. Different issues arise when effective measures are available. One can anticipate that physicians will become more directive in recommending testing to their patients. The questions will arise when patients refuse testing and decline to act upon the test results they do receive. The answers must recognize that in the United States, refusing intrusive medical intervention for one's own health is not morally reprehensible but rather is protected out of respect for autonomy. Recent history also suggests that neither the government nor third party payers will do much to create incentives and to exert pressure to alter these individuals' choices regarding using predictive genetic testing and acting on the results. In any event, justice demands that if individuals are to be held responsible for their decisions regarding the avoidance of genetic disease, they must have ready access to medical care without fear of loss of insurance, which is unlikely to occur in the United States. New developments in genetics have the potential to provide powerful tools for the promotion of health. The extent to which these tools will achieve these benefits will depend on which technologies are brought to market and how well patients and their physicians work together in the ofttimes hazardous health care system.

Zusammenfassung Der Beitrag diskutiert die komplexen rechtlichen und politischen Bedingungen, unter denen in den USA genetische Tests benutzt werden, um Vorhersagen über den künftigen Gesundheitszustand einer Person machen zu können und um eine Grundlage für Reproduktionsentscheidungen zu haben. Ärzte und Patienten zeigen für diese Tests oft einen großen Enthusiasmus, der teilweise durch die Medien und durch kommerzielle Werbung erzeugt wird. Doch treffen viele Einflüsse zusammen, von der Praxis ärztlichen Verhaltens .bis zum Verhalten der Versicherungen und des Staates, die die Wahlfreiheit der Patienten, sich einer genetischen Untersuchung zu unterziehen, stark begrenzen. Da im bestehenden Krankenversicherungssystem nach einem genetischen Test Versicherungsschutz möglicherweise nicht mehr zu erlangen ist und eine Untersuchung die Gesundheit des Patienten infolge-

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dessen damit beeinträchtigen kann, sollten derartige Tests in die klinische Praxis nur vorsichtig aufgenommen werden. Der Beitrag veranschaulicht diese Zusammenhänge am Beispiel von genetischen Tests zur Feststellung von Dispositionen zu Brust- oder Darmkrebs und erörtert die speziellen Probleme diagnostischer und prädiktiver genetischer Tests an Kindern. Anschließend behandelt er die rechtlichen und politischen Faktoren, die in den letzten Jahren die möglicherweise zu aggressive Verbreitung genetischer Tests als Grundlage von Reproduktionsentscheidungen gefördert haben. Er weist auf die Anstrengungen einiger Fachorganisationen hin, die auf eine besser überlegte Nutzung solcher Tests hinarbeiten. Schließlich erörtert er die Wirkung genetischer Tests auf die öffentliche Debatte über die Verantwortung eines jeden für seine eigene Gesundheit.

The Development and Dispersion of Technologies for Diagnosis of Genetic Diseases: A European Response Gonzalo Herranz

This paper is a European response to Professor Ellen Wright Clayton's article entitled "Problems Posed by Genetics for Law and Ethics: American Policies". As she has done, I will offer first a general view of the forces that govern the development and dispersion of genetic diagnostic services in Europe, considering also the role that personal choice and social pressure should have in how these tests are made available and used. My response to the questions posed by Professor Clayton does not pretend to show any remaining lack of common understanding. It could also not include the great variety of valuable opinions subjected to debate in the European scene. I will seek to present some points that more or less contrast with those she discusses. To begin with, I would like to say a few words on two related and, in some way, paradoxical topics. I. In Search of Contrasts 1. Is there Really a Divide between America and Europe? A source of unending surprise, and also of insight, is the detection and characterization of the differences, and coincidences, between American and European bioethics, and especially between American and European medical ethics. The United States and the European Union are indeed close relatives: they share a common cultural heritage, are oriented around the same Western hemisphere and are subjected to a comparable process of radical changes. Yet, both exhibit internal and historical diversities which make them two worlds apart. Some years ago, at a Conference held in New York City,1 the metaphors of two branches from one stem, and of a tale of two cultures were used to express the uni The proceedings of the Conference appeared in: Daniel Callahan /G. R. Dunstan, eds: "Biomedical Ethics: An Anglo-American Dialogue", 530 Annals of the New York Academy of Sciences, 1-175 (1988). A comparison of the role of government, the medical profession and the public in the general architecture of medical practice on both sides of the Atlantic

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avoidable feeling of inextricable similarity/diversity regarding how medical ethics is thought about and applied at the two shores of that broad river called the Atlantic. Some authors were forced to use, as a necessary methodological resource, the exaggeration of the differences in approach and in action to make more visible their comparative analyses. The same is true of the topic we are now dealing with. To highlight some of my considerations, I will probably engage in some degree of over-emphasis. I am confident that the following dialogue will help to bring things back to their proper place and dimension. 2. The Apparent Unity of Europe 1 think that the real problem is not only that of the differences on both sides of the Atlantic, but also the great deal of diversity present in Europe itself. Behind the concept and name of European Unity there lies hidden a very complex reality. Now it amalgamates North and South. It will not be long before East and West are melted in its crucible. If, as it is said, diversity is the salt and pepper of life, then the analysis of the heterogeneous medical ethics and law of Western European countries is a highly seasoned dish. There is still a long way ahead before medical, legal and ethical regulation reaches a truly authentic unification in Europe. The European Union is associated more with images of political negotiations, free circulation of goods, services and individuals, economic treaties, and social charters, than with the debate on ethics. The European Union is a universe in itself, with cultural diversity, ideological differences, and a project toward unity. We are installed in an ambivalent plot: though we may think that old and new differences are a treasure we cannot destroy, we must, at the same time, search for the harmonization of norms and the development of a common cultural environment. No country is forced to inhibit its own internal growth and the affirmation of its most deeply felt values, but at the same time no country will be bold enough to legislate unilaterally on controversial matters without causing a serious rift or resentment within the European community. Questions of medical ethics, to the extent to which they do not collide with consumer protection or other market-related issues, fall outside the scope of the Treaty of Rome.2 As a result, bioethics has been neglected for many years as an element alien to the scope and purposes of the European Union. However, things seem to be changing now, although the present poorly coordinated situation will probably last some time.3 The Maastricht Treaty includes public health activities in its Artican be found in: John Lister, "Shattuck Lecture - The Politics of Medicine in Britain and the United States", 315 The New England Journal of Medicine, 168-174 (1986). 2 See European Communities, 1992: The Social Dimension, Luxembourg: Office for Official Publications of the European Communities, 1990.

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cle 129, and gives the European Union a legal basis for intervention in the area of health care.4 The European Parliament is developing means and measures to control scientific policy.5 In the past few years, it has begun to offer to the governments of the member states recommendations on human assisted reproduction, biotechnology and other such matters. It has even urged the national medical associations integrated in the Standing Committee of Doctors of the European Community to work hard towards harmonizing their codes of professional ethics and to include non-medical members on the boards disciplining medical doctors. But for the moment, it is easy for European doctors to turn a deaf ear to orders emanating from Brussels or Strasbourg, because European Community politicians and national medical organizations are still too reluctant to become involved in emotional discussions on issues in which national practices differ or where a more or less legitimate pluralism can be invoked as an efficient device to protect the status quo. But it seems unavoidable that, with the increasing powers conferred by the Maastricht Treaty, the European Parliament will see its influence on bioethical matters enhanced in the future. Until now, the Council of Europe has been the organization that has exerted the most pressure to set common standards on bioethical issues. Its Convention on Bioethics,6 drafted after many years of agonizing discussions, has gained a marked degree of acceptance, thanks to the flexible structure it adopted with independent additional protocols to offer advice on specific or polemical matters. Once signed by member states, it will play a leading role in the regulation of health-care ethics and law. The Council of Europe Bioethics Convention and its Explanatory Memorandum in its last (February 1995) revision by the Parliamentary Assembly is a good starting point for my analysis.7 3 Rory Watson, "Which 'Europe* Should Deal with Ethical Issues'*, 308 British Medical Journal, 362 (1994). 4 European Communities, Treaty on European Union, Luxembourg: Office for Official Publications of the European Communities, 1992. For a general view of the implications of the Maastricht Treaty for a coordinated policy on public health and medical ethics in Europe, see respectively: Editorial , "Health Issues for Europe", 343 The Lancet (245-246); and S0ren Holm, "A Common Ethics for a Common Market?", 304 British Medical Journal, 434-436 (1992). s Noëlle Lenoir, "La Bioética en la Comunidad Europea", in: Fundación BBV, eds: El Derecho ante el Proyecto Genoma Humano, vol. 1, Bilbao: Fundación BBV, 1994, 85-96. 6 Council of Europe, Draft Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Bioethics Convention and Explanatory Memorandum, Strasbourg: Directorate of Legal Affairs, 1994. A concise and up-dated history of the genesis and the troubled development of the Bioethics Convention can be found in: Gisela Bockenheimer-Lucius, "Die 'Bioethik-Konvention' Entwicklung und gegenwärtiger Stand der Kontroverse", (7) Ethik in der Medizin, 146-153 (1995). 7

Conseil de VEurope, Avis n° 184 de l'Assemblée Parlamentaire du Conseil de l'Europe sur le Projet de Convention de Bioéthique, Strasbourg: Comité Directeur pour la Bioéthique, 1995.

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Π . The Present State of Genetic Law and Ethics in Europe The main purpose of the Bioethics Convention is the protection of the dignity and identity of the human being. To this end, it guarantees for every person, without discrimination, the respect of his or her integrity and the other fundamental rights and freedoms in regard to the applications of biology and medicine. Genetics is considered in three articles: in article 16, which authorizes interventions on the human genome if done for preventive, therapeutic or diagnostic reasons, and if they do not affect the human germ-line; in article 17, which allows predictive tests of genetic diseases or predispositions only for reasons of health care or of scientific research connected with health care; and article 18, which regulates the confidentiality of genetic tests and data. The meaning and intentions of these three articles are expounded in the relatively lengthy sections of the explanatory Memorandum. These three articles are to be seen as a tight synthesis of the Council of Europe's 1992 Recommendation on Genetic Testing and Screening for Health Care Purposes.8 Its main ideas are the following: - The public must be informed about applications of genetics, in particular about their availability, purpose and medical, legal, social and ethical implications. A true genetic culture must be created: information must be offered in schools and in the media. - Genetic tests may only be carried out under the responsibility of a duly qualified physician, and the centers where they are performed are to be approved by the state and submitted to external quality assurance. - All the tests are, in principle, non-compulsory. No social benefit or employment should be made dependent on the undergoing of genetic tests or screening. The only exceptions to this principle must be justified by reasons of direct protection of the individual concerned or, if expressly allowed by law, of the public. - Genetic testing or screening procedures should always be accompanied by appropriate counselling, both before and after the procedure. - The sale to the public of tests for diagnosing genetic diseases, predispositions or carrier status, should only be allowed subject to strict licensing conditions regulated by national laws.

β See in this context: Conseil de VEurope, Recommendation R(92)3 du Comité des Ministres aux États Membres, sur les Tests et le Despistage Génétiques à des Fins Médicales, Strasbourg: Conseil de l'Europe, 1992. And also: Olivier de Dinechin/ Rodney Harris /Mathias Kettner /Lene Koch/Eduard Zwierlein, "Workshop of the Commission of the European Communities on Ethics of Human Genome Analysis: Survey of the European Discussion", 30 Journal of Medical Genetics, 257-269 (1993).

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- Insurers should not have the right to require genetic testing or to inquire about results of previously performed tests, as a pre-condition for the conclusion or modification of an insurance contract. - The Recommendation establishes rigid norms for data protection, professional secrecy, and research. These rules should be closely followed by national legislatures. There is a lot of legislative work to do. A recent comparative study on laws on genetic testing reveals that the countries of the European Union have shown a marked reticence to legislate in this area. Laws on genetic services are practically absent in many countries, and where they have been enacted, lawgivers have followed, according to Guillod,9 a "pointillist" approach, covering only specific aspects and leaving unattended many important issues. In contrast, there are abundant declarations, guidelines and professional codes proposed by international or national organizations (such as committees appointed by governments or parliaments, associations of doctors and lawyers, medical ethics agencies, national bioethics committees, private working parties, patients' help groups, and so on). They offer a polyphonic interpretation of a common theme, which Guillod has nicknamed "soft law". All of them show an undeniable spiritual kinship, stressing the principles of respect for patients as persons, theirrightto give informed consent to any form of genetic intervention, the strict prohibition of any type of discrimination based on genetic traits, and the rigid protection of confidential genetic data. ΙΠ. American-European Contrasts 1. Who Will Pay? The Different Role of Private Initiative and Public Control Probably one of the most marked disparities between the United States and the European Union resides in the role money plays in the doctor-patient relationship. American patients pay their doctors in a more or less direct way. In consequence, they are more aware of their autonomy, more prone to discuss with their doctors the outcome of medical interventions. They want to get a reasonable benefit in return for their money. For decades, their European counterparts have been experiencing the benefits of their national health services. In general, European patients are more dependent on the opinion of their general practitioners, who act as gatekeepers to secondary and tertiary care doctors. Rather than as consumers endowed with freedom to go shopping for medical interventions, they represent themselves 9 Olivier Guillod, "Réglementation de Γ analyse génétique humaine: quelques remarques de droit comparé", in: Institut Suisse de Droit Comparé, eds: Analyse génetique humaine et protection de la personalité. Colloque international, Laussanne, 14 avril 1994, Zürich: Schultess Verlag, 1994, 167-185.

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as usufructuaries of public health services for which they do not pay directly, but through taxation. Professor Clayton has given a clear description of the tension existing in America between the commercial incentives to increase genetic consumerism and to entice society into the wonderland of genetic technology, on the one hand, and, on the other, the untoward side-effects of willful or indiscriminate genetic testing. Although some predict unusual profits for groups capable of developing and patenting tests and procedures ahead of their rivals, others do not foresee great demand for testing. It is possible that in the future the situation in Europe could drift towards a more entrepreneurial medicine, but at least for the moment the commercial aspects of genetic services are here much less apparent than in America. In Europe there is practically no commercial advertising on genetic services. This is an important feature because it seems to me that the professional ethos of medical practice is strongly influenced by the quality and intensity of advertising. American medicine is at least partly organized as a competitive, free market activity motivated by financial gain, and not, as is common in Europe, solely as a professional service where the interests of the patient always come first because the doctor has no vested interest in profits. In this way, a difference is created between genetic services open to the dynamics of free supply and demand, and genetic services guided by the requirements of the ethics of diagnostic indication. To gain some insight on the attitude of European patients towards genetic interventions, it is worthwhile to consider a paragraph of the evidence CERES submitted to the Committee on the Ethics of Gene Therapy, set up by the Ministers of Health of England, Scotland and Wales10 (although the document refers to gene therapy, it is also appropriate for the point in discussion): "Changes in public moral values tend to bereflected in many practical ways, such as the allocation of resources. Many people with genetic defects live fulfilled lives as long as they have practical support. Yet physical impairment can turn into severe social handicap if the necessary support is not available. [...] Before assuming that 'defective' people want to be changed by gene therapy, we need to know far more, through systematic research, about how they would like society to change to suit them. Gene therapy may increase the tragic barriers of stigma and rejection for the many impaired people that it cannot benefit. The risk that society may become less tolerant and supportive of people with defects should be weighed seriously in cost-benefit calculations of gene therapy."

10 Consumers for Ethics in Research, "Consumer Views in Gene Therapy", 58 Bulletin of Medical Ethics, 14-20 (1990). Consumers for Ethics in Research (CERES) is a British influential forum for individuals and voluntary organizations that believe in the importance of involvement of consumers in decisions at all stages of medical research and health care. Very similar views on prenatal genetic diagnosis were expressed by German groups in the socalled Manifest of Cologne: Bundesverband fiir Körper- und Mehrfachbehinderte e.V., Bundesvereinigung Lebenshilfe für geistig Behinderte e.V., "Kölner Manifest: 4Vom Recht auf Anderssein'", 5 Ethik in der Medizin, 166-167 (1993).

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In a genuine European mood, the CERES Report concludes that the problem in the United Kingdom is not so much to make easy the consumer's free access to genetic services, as to decide the place that genetic services are to be assigned in the allocation of public resources. I am sure that such a conservative approach is dominant among a wide sector of people with genetic disorders and their guardians. Some mistrust towards private initiative is expressed in the CERES Report in relation to research funding. There are reasons to suspect that commercial sponsorship could result in the development of the more lucrative rather than the more beneficial projects, and that private trust funding of research tends to encourage projects that satisfy the whims of sponsors more than the needs of patients. It is easy to imagine that if genetic services become commercial, serious difficulties will arise if counselling remains a necessary and inseparable complement to testing. To inform the client in detail before or after the test could be financially ruinous from the company's perspective, since many potential users could decline to take the test, and laboratories would need to set up their own system of counselling or refer patients to public or private health services to receive the necessary support when the results are positive. In Europe the trust in public medicine remains strong. The idea that the social body, and not the private doctor, must play a prominent role in the supply and implementation of genetic health care is forcefully expressed in the Report of the Norwegian Parliament to the Government on "Biotechnology related to Human Beings", where, for instance, the advice is given that though the proposed legislation will serve to regulate developments, the treatment should only be permitted within the public health sector and should not be allowed to become part of a private, market-oriented health service.11 As genetic services are perhaps the branch of medical practice which could provoke most social concern, it is understandable that many responsible citizens and doctors opt for submitting them to strict public controls. Clarke has recently called attention to the danger that the need to recoup investment makes it likely that tests will be introduced into private health care systems before they have been properly evaluated and before they have been accepted into national health services or public insurance schemes. Perhaps such concerns carry an alarmist bias, but also contain some deep wisdom. They are a manifestation of that general attitude towards genetic issues identified by Mauron and Thévoz12 as 'pessimistic' (characterized by skepticism towards potential benefits, hypersensitivity to potential evils, strong advocacy of se" Parliamentary Report Ν 25 (1992-1993) to the Storting, "Biotechnology Related to Human Beings", Oslo: Ministry of Health and Social Affairs, 1993: 46. The Report was presented by the Norwegian Government to the Parliament (the Storting) on 12 May 1993. It was debated on 10 June 1993: the Government gained a majority for practically all its proposals. ι 2 For a detailed discussion, see Alex Mauron /Jean-Marie Thévoz, "Germ-line Engineering: A Few European Voices", 16 Journal of Medicine and Philosophy, 649-666 (1991).

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vere regulation, and systemic slippery-slope bias). That cautious stand is not to be put aside lightly: as the French-Swiss authors recognize, this standpoint, particularly prevalent among German-speaking bioethicists, has crystallized into a kind of conventional wisdom. In my view, such wisdom is a valuable ingredient of the European cultural heritage, the result of an admirablerightingof past wrongs. In the developed world, the conviction is becoming more and more widely spread that the age of the welfare state is drawing to a close and that a new period is beginning. The declining paternalism of the welfare state is giving way to a growing sense of individualistic autonomy, and at the same time is cutting off or reducing social welfare benefits. Such a situation, as in all periods of transition, creates opportunities andriskswhich should be carefully watched. Doubtless another factor that will affect the future dispersion of genetic testing and counselling will be their intrinsic value to solve real health problems. The consequences of the limited efficacy of current genetic information in treating adult diseases and predispositions to which the first of the two examples presented by Professor Clayton refers, are common to America and Europe. The forces, financial and professional, favoring the dispersion of genetic testing for cancer are weak on both sides of the Atlantic. The need and demand in Europe for genetic testing for cancer predisposition (BRCA1 for breast and ovarian cancer, and HNPCC for hereditary non-polyposis colon cancer) have been recently reviewed by Evans,13 and his conclusions are practically the same as those of Clayton's: familial clustering of common cancers presents perhaps one of the biggest dilemmas for health economists, because offering screening to those at high risk meets an extraordinarily small target population (there are in the United Kingdom perhaps only 20 families with breast and ovarian cancer with sufficient evidence of linkage to BRCA1). It is also obvious that the development and dispersion of genetic testing and counselling depend decisively on the number of specialists in clinical genetics. Here, Europe limps behind America. In 1993, the European Society of Human Genetics published the results of a survey on medical genetics manpower and training in the European Community and beyond on some important points: the recognition of clinical genetics as a formal specialty, the current number of appointed specialists, the rules guiding the training of future specialists, and the need for a common European diploma in clinical genetics. The results were disturbing: only in four member states was the specialty of clinical genetics recognized; the number of clinical geneticists was just above 200; only in five countries was there a formal training programme with a total of little more than one hundred trainees. The status and training of European clinical geneticists revealed troubling wide discrepancies. 13

D. Gareth Evans , "Genetic Testing for Cancer Predisposition: Need and Demand", 32 Journal of Medical Genetics, 161 (1995). On the limited use and applications of BCRAl-genetic testing, see: Kommission für Öffentlichkeitsarbeit und ethische Fragen der Gesellschaf fiir Humangenetik e.V., "Stellungnahme zur Entdeckung des Brustkrebsgens BRCA1", 7 Ethik in der Medizin, 156-159 (1995).

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Obviously the European Society of Clinical Genetics made some proposals to its members to improve the provision of services and the efficiency of training, but in a number of countries the situation will remain unsatisfactory for quite a lot of 14

years. 2. Who Will Decide? The Place of Individual

Autonomy

The explicit affirmation of individual autonomy constitutes in America a legal and ethical tradition, young but deeply rooted, and apparently stronger than in Europe. Over-simplifying things, it can be said that, although the founding ideas of modern individual autonomy originated in Europe, the contemporary autonomy of patients is a product made in the USA and imported from there. In comparison to their European fellows, American patients are often more aware of theirrights,have usually a very definite knowledge of their prerogatives as consumers of medical services, and express their desires with greater assurance. Yet Ellen Wright Clayton tells us that even in America free choice is not easy to exercise, that there are forces that limit the freedom of choice, that a deep and sincere doctor-patient communication is difficult to get, that in fact shared decision making between patients and physicians occurs infrequently.

3. Special Problems Posed by Prenatal Diagnosis Similar apprehensions have been manifested by Europeans and European geneticists on the reality of non-judgmental advice, especially in the case of prenatal genetic diagnosis. Clarke has radicalized the critique of non-directive genetic counselling, when he affirms that "ostensibly non-directive counselling in connection with prenatal diagnosis is inevitably a sham, not because of a personal failure on the part of the counsellor but as a direct result of the structure of the encounter between counsellor and client."15 Genetic testing and counselling is one of the situations where the doctor-patient relationship is more complex and time consuming, where the normal language of rights and duties is frequently insufficient. As the CERES Report pointed out, reducing ethical questions to questions of rightsdiscriminates with a false simplicity against the most vulnerable groups, such as very impaired babies.16 In our time of patient's rights, the physician's power remains strong. It is true that, today as well as yesterday, patients are prone to follow doctors' advice, espe14

Rodney Harris / Judith A. Rhind, "The Speciality of clinical genetics: European Society of Human Genetics Survey", 30 Journal of Medical Genetics, 147-152 (1993). is Angus Clarke , "Is Non-directive Genetic Counselling Possible?", 338 Lancet, 9981001 (1991). 16

Consumers for Ethics in Research (op. cit. fn. 10), p. 17-18.

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cially in those fields, such as genetic services where decisions are very hard to make. Doctors always know more. Often, the information time-pressed doctors offer about some issues is not scientific in content, clear in words, humane in tone, or respectful of parental freedom. It may be tinged with the personal prejudices of the doctor. Some physicians appear to believe that all that is at stake is a valueless life or that there are minimal requirements of humankind to become an acceptable member of the human family, or that it is socio-biologically unacceptable to increase the number of people with genetic defects. There are doctors with a strongly biased attitude towards human deficiency or suffering or with a notion of secondary prevention of genetic disorders, which automatically binds the diagnosis of abnormality with eugenic abortion. Some compare the cost of prenatal diagnosis and preventive termination with the cost of special health care and the education of people with genetic defects. The Report of the Royal College of Physicians of London offers a crude picture of monetary data in favour of abortion of fetuses with Down's Syndrome as a very effective cost/benefit intervention.17 Truly humane advice and decision making will not be possible if the rights of the handicapped fetus are not fully respected. The Spanish Medical Association's Code of Ethics and Deontology establishes in its article 25.2 that "The unborn child must be treated according to the same ethical guidelines, the informed consent of the parents included, which are applied to the diagnosis, prevention, treatment and research of the other patients."18 The Report of the Norwegian Parliament takes a step forward in this direction when it determines that the woman or the couple, after receiving thorough genetic counselling, and if the fetal conditions are found not to be fatal, should be put in touch with non-medical personnel who have experience in working with the disabled. The Report insists that the same principles should be applied whether the genetic prenatal test is carried out before or after the 12th week of pregnancy. It also reminds that all of us have genetic mutations, that the ideology of the welfare state, which secures equal opportunities, rights and duties, forms the basis of the philosophy of integration and grants a natural andrightful place for disabled people in society. The government's primary objective for work with disabled people is to ensure maximum participation and equality. The concept of equality, regardless of intellect or physique, colour, sex, creed and ethnic origin, is fundamental to the attainment of equal rights. All humans are equal regardless of personalities, heritage or lifestyle. Every individual is entitled to a full and meaningful life which is not dictated by others. Society, with its principle of solidarity, should allow room for everyone and give each of them the chance to be valuable members of society. 19 I think that all these elements are part of non-biased counselling. 17 Royal College of Physicians' Working Party , "Report on Prenatal Diagnosis and Genetic Screening: Community and Services Implications", London: Royal College of Physicians, 1989. 18 Organization Mèdica Colegial, "Código de Ètica y Deontologia Mèdica", Madrid: Organización Mèdica Colegial, 1990.

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As a manifestation of respect for the autonomy of people with defects, some attention must be paid to the way they would like to be treated. Before assuming that they want to be submitted to predictive tests, for example, we need to do research about the ways they would like society to change to suit them. The risk that society may become less tolerant and supportive of people with defects should be weighed seriously in cost-benefit calculations prior to the introduction of new genetic interventions. At the Joint Meeting of the European Parliament, the Parliamentary Assembly of the Council of Europe and members of the World Association of Childhood Friends, held at Strasbourg in April 1989,1 proposed including among the fundamental humanrightstherightto be respected despite genetic handicap. I think that this would be an interesting topic for discussion.20

4. The special Case of Children The norms about biochemical neonatal screening do not differ significantly on both sides of the Atlantic. The Working Party of the Clinical Genetics Society of the UK has recently published some recommendations on the genetic testing of children, stating, among other conclusions, that predictive genetic testing of children is clearly appropriate where onset of the condition regularly occurs in childhood or where there are useful medical interventions (diet, medication, surveillance for complications) that can be offered. In contrast, for well known reasons, the predictive testing for an adult onset disorder generally should not be undertaken if the child is healthy and there are no medically useful interventions that can be offered in the event of a positive test result.21 Although the recommendations have been objected to in some points,22 they can be held as representative of the European approach to paediatric genetics.

Parliamentary Report (op. cit. fn. 11), p. 7. 20 Gonzalo Herranz, "En qué consiste el respeto al patrimonio genètico", in: Association Mondiale des Amis de l'Enfance, eds: L'Enfant aurisquede la Science. Palais de l'Europe, Journée-Debate 10 avril 1989, Monaco: Association Mondiale des Amis de l'Enfance, 1989: 19-22. 21 Working Party of the Clinical Genetics Society (UK), "The Genetic Testing of Children", 31 Journal of Medical Genetics, 785-797 (1994). 22 Shirley Dolby, "GIG Response to the UK Clinical Genetics Society Report 4The Genetic Testing of Children'", 32 Journal of Medical Genetics, 490-494 (1995). GIG is the Genetic Interest Group, a national umbrella organization in the UK for the charities, voluntary organizations, and support groups which serve those affected by specific genetic disorders and their families.

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5. Problems of Insurance and Employment In Europe, there is a common understanding among politicians, lawyers and doctors that genetic testing cannot be used to introduce discrimination in employment or insurance. Practically all declarations and laws made public until now echo the clauses of the 1989 Resolution of the European Parliament calling for a statutory ban on the selection of workers on the basis of genetic criteria and on the use of genetic analysis for mass examination of employees, establishing that the weeding out of individual workers with a predisposition to illness must never be an alternative to the improvement of the working environment, and declaring that insurance companies have noright to include genetic testing as a condition for any insurance contract.23 The Nuffield Council of Bioethics has offered more detailed advice on the uses of genetic screening for employment and insurance.24

IV. Conclusion The first of the rules for good practice of the Council of Europe 1992 Recommendation pleads for broad information to the European public about genetic services and their medical, legal, social and ethical implications. That means that dispersion of genetic diagnosis must be linked to the integration of genetics as a constituent of modern culture. Before such challenge can be accepted, some difficulties must be overcome: some related with manpower and financing; others with social and ethical issues. In Europe there is a shortage of clinical geneticists to attend to present needs and the much more demanding future expectations. Although the ideal setting for such services ought to be balanced between public and private medicine, the permanent financial scarcity with which the former is forced to survive, and the corresponding menace of rationing, promises to slow the expansion of public genetic services and to favour, at the same time, the migration of experts to private practice. That would be a very unfortunate loss. But, probably, the most decisive factor for the future development of genetic services will be the degree to which genetics is integrated into the structure of human culture. Greater awareness would afford countless opportunities for dialogue between experts and lay people, affected families and health services providers, bioethicists and lawyers, a dialogue in which many voices can be heard and none 23 European Parliament , "Resolution on the Ethical and Legal Problems of Genetic Engineering (16 March 1989)", 57 Bulletin of Medical Ethics, 8-10 (1990). Nuffield Council, 1993.

Council on Bioethics , Genetic Screening: Ethical Issues, London: Nuffield

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excluded. John Paul Π recently invited all people of good will to cooperate in the construction of a new culture of human life. 25 I think that the danger of a dominant genome ideology is very remote. It is almost certain that we will live through a time when the greater ability to diagnose than to treat will lead to a strong temptation toward eugenic selection. In such a situation it would be difficult to convince many people about the value of handicapped life. Respect for handicapped human life is not only a question of religious conviction but also of biological common sense. Speaking of the wonderful achievements of the DNA molecule, Lewis Thomas says: "To err is human, we say, but we don't like the idea much, and it is harder still to accept the fact that erring is biological as well." 26 An essential step in the education of the public about genetics would be an invitation to reflect repeatedly on the fact that what makes all of us marvelously different makes us also vulnerable to genetic blunder. Mistake and achievement are both integral parts of our nature. It is my feeling that America and Europe will experience very similar temptations and will overcome very like challenges.

Zusammenfassung Ein Vergleich der Bedingungen, unter denen genetische Methoden der Diagnose in den USA und in Europa eingesetzt werden, sieht sich angesichts der Unterschiede auf beiden Seiten des Atlantik und der Tatsache, daß Europa nicht ohne weiteres als homogene Einheit betrachtet werden kann, Schwierigkeiten gegenüber. Vor diesem Hintergrund stellt der Beitrag die Grundzüge der beginnenden rechtlichen Regulierung der genetischen Diagnose und die gereifte ethische Einstellung zu dieser Technik dar, wie sie sich in einigen Gesellschafts- und Berufsgruppen, im Rahmen der nationalen Gesetzgebung und in supranationalen Organisationen, dem Europäischen Parlament und dem Europarat, finden läßt. In der europäischen Gesellschaft gibt es unterschiedliche Einstellungen zu der Rolle, die die genetische Diagnose im Leben der Menschen spielen sollte. Im Gegensatz zu Amerika ist diese Einstellung aber vorherrschend „pessimistisch" geprägt. Es wird versucht, die Verbreitung genetischer Methoden der Diagnose durch eine strikte rechtliche und ethische Regulierung ihres Angebots einzuschränken. Auf diese Weise sollen die Risiken der Eugenik und der sozialen oder beruflichen Diskiminierung von Menschen mit genetischen Krankheiten vermindert werden. 25 John Paul II, Encyclical Letter Evangelium Vitae, Città del Vaticano: Libreria Editrice Vaticana, 1955, pp. 141-143. 26 Lewis Thomas, The Medusa and the Snail. More Notes of a Biology Watcher, New York: Bantam Books, 1979, p. 23. 3 Jahibuch für Recht und Ethik, Bd. 4 (1996)

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Wahrend Ärzte vor allem über den Einsatz genetischer Diagnosemethoden bestimmen, zeigen die Verbraucher kein Interesse an ihrer freien Kommerzialisierung auf dem privaten Sektor Auch innerhalb der nationalen Gesundheitsdienste ist keine intensive Nachfrage festzustellen. Darüber hinaus ist die Zahl der klinischen Genetiker, die neben der Diagnose die unerlässliche Beratung bieten können, verhältnismäßig klein. Schließlich scheint auch niemand bereit zu sein, die Mittel zur Verbesserung der Lebensqualität genetisch Behinderter zu verringern, um genetische Untersuchungen leichter und freier zugänglich zu machen.

Gene Therapy - A New Medical Technique and Points to Consider Albrecht E. Sippel I. The Moral Obligation to Disseminate Biological Knowledge Before I begin with my contribution, I want to say a few words on my background. I am not a person of the humanities or a professional on ethical debates. I am also not a practicing physician. I am an experimental molecular geneticist, a basic scientist with interest in bridging gaps between the actual biological sciences and the humanities. I see my contribution as largely informative, aimed at describing new developments in my field of science and pointing out border regions which I think are of legal and ethical relevance. As a geneticist I am confronted daily with the misconception of my students and the society at large on genetic issues. I feel strongly that most of our problems in finding commonly accepted guidelines comefrom a lack of dissemination of scientific knowledge. When Faraday was asked in 1831, what good is electricity, he gave his classical remark 1: "Sir, what good is a new-born baby?" This answer may have been appropriate for a time when it took a lengthy period before technology seized upon new knowledge, and it did so unnoticed by the larger part of the population. But what about our time, in which information reaches nearly everyone and in which it took only 20 years from the discovery of the structure of the DNA to conceiving a concept of gene therapy and only another 20 years for the first successful trials in patients? Recently I heard a talk on the "Relation between Physician and Patient" by the well respected German psychosomaticist Thure von Uexküll2. In his critical evaluation of modern medicine he said at the beginning: "One of the features of modern medicine is on the one hand its insecurity and at the same time its firm belief in progress, which doesn't even shy away from gene manipulation as a means to heal patients of their heritable diseases." I was shocked. What accounted for this statement about gene manipulation by a revered man of science? Was he the victim of a misconception, or did he take advantage of the misconception of larger parts ι Van Rensselaer Potter, "Bioethics, Bridge to the Future", Englewood Cliffs/New Jersey: Prentice-Hall inc., 1971,77. 2 Von Uexküll, "Psychosomatische Theorie. Das Arzt-Patient-Verhältnis", University of Freiburg/Germany, presentation 5. June 1991. *

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of the population to make room for alternative psychosomatic approaches in medicine? The kind of gene manipulation which is practiced in healing patients today, 4 somatic gene therapy* has little to do with heredity and reproduction. Since the word 'somatic* is widely unknown by the layman, and since genes are mostly connected with units of heredity, the term itself is not enough to separate this new therapyfrom matters of reproduction. It is now just about a hundred years ago that the eminent biologist of my present home town Freiburg, August Weismann (1834-1914), published his book "The Germ Plasm: A theory of Inheritance" in which he, for the first time, differentiated between germ cells or the germline and somatic cells, the soma of an organism3. He thought that the units of inheritance, "Idanten" as he called them - the word gene had still to be coined - were altogether equally distributed from generation to generation by the immortal cells of the germline, and that the differentiated character of the mortal soma cells is the result of an unequal loss of parts of the genetic material. We know today that this is not so, and that all cells of the soma, as equally the germ cells, contain in their nuclear DNA the full genome with all it's genetic information. Through the discovery of the DNA-structure by Watson and Crick in 1953, the dual nature of DNA as carrier of the genes became obvious, to be at the same time a molecule for self-reproduction and a molecule to function as carrier of information which can be used differentially as a blue print for the synthesis of the gene products RNA and proteins. Weismann demonstrated the non-heritability of somatic cell manipulations by a much copied experiment of his time. He could show that the successive cutting of tails of laboratory mice for 19 generations, did not have any influence on tail growth. Other biologists of those days continued this procedure in disbelief even for 64 generations. Somatic gene therapy deliberately affects only body cells. It has as little to do with heritable changes of the germline as organ transplantations. With this new medical technique not organs, not even living cells, but only genes will be transplanted - healthy genes which are the minimum of what is needed to repair a known gene defect. This procedure would be better called gene transplantation. Among scientists, doctors, lawyers and ethicists there is a broad consent, that somatic gene therapy does not pose any new juridical or ethical problems which have not already been dealt with through organ transplantation. I think we do have a moral obligation to relieve the population of its fears and resentments on gene therapy, since these stem, at least partly, from a misconception about its nature.

3 Klaus Sander, "August Weismann (1834-1919) und die theoretische Biologie des 19. Jahrhunderts", Freiburger Universitätsblätter, Heft 87/88,1985, 24. Jhig.

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Π . From Genome Knowledge to Disease Gene Therapy Our body is not an analogous image of our forefathers, not the result of an unique creational process, which becomes less perfectly molded with each copy. On the contrary, we are the product of a quasi digital reproduction. The center of this digital reproduction is what Walter Gilbert once called the holy grail of modern biology, our genome. The genome with its roughly 3 · 109 digits contains more information than we can imagine, and it contains it in a form which we do not yet satisfactorily understand. Firstly, it contains all our genes, an estimated number of a hundred thousand. Secondly, the gene information in our DNA does not resemble a telephone book. Sidney Brenner once remarked about the great difference between a telephone directory and a Shakespeare play, "While both have a grand cast of characters, only the play has a plot4". Our genome codes for a complex plot, which directs us through development and guides all our gene activities through the changing situations of life. And thirdly, our genome and those of our related animal species tell the story of how we came into being during evolution. The goal of the "Human Genome Project" (HGP) is to sequence the human genome5. Probably before the year 2000 we will be able to read the entire text on a CD in our personal computer. We will be able to read the text, but it will take hundreds of years before we will fully understand the information. Today the HGP is a gigantic endeavour to map all human genes to specific positions on the chromosomes. Unlike the Manhattan-Program to build the atomic bomb or the ApolloProgram to put a man on the moon, the HGP, as the first big scientific project of biology, does not focus only on its final goal. It delivers highly valuable information continuously on its way. There are about four thousand registered heritable diseases. Their afflicted genes are the first to be identified and characterized. Many of the biotechnological challenges for law and ethics have to be seen within this background. The information brought about by the genome project will affect us all, most likely much earlier than expected. Knowing about a disease gene allows early screening and diagnosis and is the most promising base to learn about the pathophysiology of an inheritable disease and to develop therapeutic protocols. Problems arise with the time lap between the competence for diagnosis and therapy. It is the effort of biologists and doctors to close these scissors of time as quickly as possible. In former years, when we were less able to suppress infectious diseases, heritable diseases played less of a role. Today they are as cause of death for young people in the developed countries in the same category as accidents and addictions. Beside more conventional therapies, human gene therapy is considered the spear head in jnedicine for the treatment of heritable diseases. Whereas biochemistry already makes its pronounced mark on the pharmaceutical sector, gene « Sidney Brenner, "Loose ends", Current Biology 4,1994,188. 5 Francis Collins / David Galas, "New Five-Year Plan for the U.S. Human Genome Project", Science 262, 1993,43^6.

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therapy, thefirst outgrowth of molecular cell genetics in human medicine, has still to prove its strength6. Currently it is in a phase of eagerness. Somatic gene therapy was originally conceived for the treatment of patients with monogenic heritable diseases. However, it can be seen that strategies including somatic cell manipulations on gene basis will be used to treat the much more frequent patients of either infectious diseases like AIDS, or of multigenic and complex diseases like cancer, diabetes, rheumatoid arthritis and high blood pressure. Most gene therapy protocols today are for the treatment of cancer patients7. Cancer is mostly a somatogenetic disease. Currently those genes are identified which, when mutated in soma cells, give rise to a cancer causing deregulation of cell growth. As it is best known for colon cancer, mostly the successive mutation of 6 to 8 genes in a normaltissuecell leads to such a transformation event8. Close to 50 oncogenes, more than 10 tumor suppressor genes and some genes which are used to repair and stabilize DNA were found to be relevant in this respect. The time will come in which a direct replacement of mutated cancer genes will be tried9. Currently gene therapy protocols for cancer treatment are mostly aiming for a manipulation enhancing the immune response towards cancer cells. Foresight and optimism was heard already in the speech which Paul Berg, one of the founders of gene technology, presented when he received his Nobel Prize in 1980: "In future we will have to have physicians, who must be familiar with the molecular anatomy of chromosomes and genes, the same way as today the heart specialist is familiar with the structure and function of the heart and the system for blood circulation. Gene therapy will then be carefully considered as alternative to more conventional methods, the same way it is done today with heart or kidney transplantation". Today, 15 years later we have the first of these predicted genedoctors. The impact of the human genome project on medicine will surely be comparable to an event which took place 450 years ago in the culturally flourishing northern parts of Italy. 1543 Andreas Vesalius (1514-1564), a Flemish professor in Padua and later personal physician of emperor Karl V, published his "Anatomical Tabletsthe first textbook of human anatomy and rang the bell for a new round in human medicine. The US 'Time5 magazine recently published a wonderful photo of the Vesalius of our time, Francis Collins, the head of the US-American NIH-human-genome-project, riding his Honda Night Hawk 750 under the headline "Riding the DNA Trail" 10 .

« Eliot Marshall , "Gene Therapy's Growing Pains", Science 269, 1995,1050-1055. 7

Kenneth W. Culver/R. Michael Blaese, "Gene Therapy for Cancer", Trends in Genetics 10, 1994, 174-178. s Bert Vogelstein /Kenneth W. Kinzler, "The Multistep Nature of Cancer", Trends in Genetics 9,1993, 138-141. 9 Judith E. Karp/Samuel Broder, "Molecular Foundations of Cancer: New Targets for Intervention", Nature Medicine 1,1995,309-320. 10 J. Madeleine Nash, "Riding the DNA Trail", Time (USA), 1994,54-55.

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ΠΙ. Present Methodical Problems of Somatic Gene Therapy Before I come to the areas of gene therapy which I feel to be relevant for legal or ethical discussion, I want to introduce a few methodical problems of this new medical technique. 1. The Stem Cell Problem The cells of our body are very different from each other, even though they have basically all the same DNA information. Their phenotype is vastly different due to differential expression of their genes. Some cells, like most of our nerve cells, live all our life, some only a few hours, like the cells of the outer layer of our stomach lining. Our bone marrow contains pluripotent stem cells for the development of our blood system (hematopoietic system). These stem cells are both able to reproduce themselves and to differentiate via specific precursor cells into all the different mature cell types (8 types) of our peripheral blood, roughly a kilogram of new cells per day in an adult human. If a healthy gene is introduced into cells of the peripheral blood of a patient, at the most a transient recovery may occur. Only if pluripotent stem cells are reached, a life-long permanent or at least long lasting therapy of the entire organ system can be expected. The hematopoietic system is the best understood organ system of our body and an extensive methodical repertoire for treating it already exists, including autologous bone marrow transplantation. Stem cell gene therapy is merely the last consequent development in hematology. What is true for the hematopoietic organ system is true for most other tissues of our body. Stem cell therapy in most tissues is still far away. It is always technically more involved and more risky than gene therapy of mature tissue cells. In the first five years the Recombinant DNA Advisory Committee (RAC) of the USA had not approved any stem cell gene therapy protocols. Now it does, and has recently even approved the first protocol for in utero hematopoietic stem cell therapy11.

2. Cell-Type Specific Gene Transfer Gene therapy application depends on DNA-transfer to those cells which are compatible with a process of recovery. This doesn't have to be always the very cell-type which is responsible for a heritable or somatic deficiency. However, in some cases, for example cancer treatment, gene transfer to specific cells is necessary. In this respect, every different type of heritable disease poses a different problem. They cannot be discussed here in specific details. However, two general il Charles Cornette / Anne-Mane Douar/William H. Colledge/Ursula Challenge of Fetal Gene Therapy", Nature Medicine 1, 1995, 864-866.

Froster,

"The

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strategies are pursued for cell-type specific gene transfer. Firstly, the 'ex vivo ' strategy in which body cells are removed, eventually isolated, cultured and grown in vitro, DNA transfected and returned. This is often a technically involved and expensive procedure. Secondly, specific body cells in vivo are aimed at by the use of specific vector systems, mostly involving stereotactic physical methods or biotechnologically constructed viral systems which use cell-specific surface molecules of the target cell to deliver the foreign DNA construct. The latter procedure could become easier with progress in biotechnical research and could become the predominant approach, for some applications ultimately as easy as a vaccination today.

3. Transgene Regulation In the expanding field of medical gene therapy, whether in research or in actual trials in patients, it turns out that the correct desired regulation of the transferred gene construct in the target cell is currently the most limiting biological problem. Transgene regulation is my own field of basic research. In spite of my scientific background, I will try to be brief and limit myself to explaining the essentials of the control of transgene activity. Genes consist of two parts. One part codes for the gene product, RNA and protein. The other part consists of a collection of DNAsequence elements which are responsible for the control of gene expression. These regulatory elements of a gene are located in the closer and wider flanking regions upstream and downstream of a gene along the DNA strand and may occupy, especially in genes of higher organisms, a DNA region far exceeding the DNA size of the gene proper 12. This is one reason why only about 2% of human DNA codes for gene products and a good part of the rest for regulatory signals. These regulatory compartments harbor the information for the plot, the control of the meaningful harmony of the activities of all genes. Since we presently only have a rudimentary knowledge of this second code contained in the DNA sequence, it is not surprising that we have still great technical problems in controlling gene constructs which are re-transferred into the genome of target cells. In practice this means that transgenes are often inactive in their new environment, or are low or only transiently active and later shut down. However, my own insight into this field of research tells me that this is a current problem that will be overcome soon. New vector DNA constructs and new DNA insertion techniques are on their way, which will in future allow us to switch foreign genes on and off in the living organism anyway we want, ultimately by signals which will have no other target in the body beside the transferred gene construct.

12 Albrecht E. Sippel /Gabriele Schäfer /Nicole Faust/Harald Saueressig /Andreas Hecht/Constanze Bonifer, "Chromatin Domains Constitute Regulatory Units for the Control of Eukaryotic Genes", Cold Spring Harbor Symposium on Quantitative Biology, Vol. 58, 1993,37-44.

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4. Gene Addition and Gene Replacement Gene transfer into cells, as it is done in gene therapy today, leads to integration in the genome at random, not predetermined positions, with a certainrisk to inactivate or deregulate an endogenous gene. If for example an oncogene is activated by the integration event, this may lead to unwanted cancerous growth of the affected cell. On the other hand, if an essential gene is turned-off by the integration of foreign DNA, we call this insertional inactivation, the affected cell may die or counteract the therapeutic effect of the transgene. In any case random gene addition bears an albeit low but certain risk and must be taken into account when considering the expected benefit from gene therapy. Random gene addition may be good for treatment of patients of recessive heritable diseases, who will benefit from the activity of a new healthy gene. This is different with patients of diseases caused by dominant gene mutations. In this case it will be necessary to replace the mutated gene in the affected cells by the incoming DNA construct of the unmutated gene. Such a site-specific recombination is practically not possible in cells of the organism in vivo , but may be selected for in individual cell clones as part of an ex vivo gene therapy protocol. Targeted gene replacement is today already a common technique in mouse genetics13. For example, the construction of animal models for human genetic diseases is based on targeted gene inactivation and replacement techniques. When it comes to mechanisms in molecular genetics, the mouse is a close relative to our own species. On a wider perspective, the explosive development of new techniques in mouse genetics in recent years14 indicates that we are badly advised relying on putative biological barriers when it comes to discussing legal or ethical issues of medical genetics.

IV. Points to Consider in Somatic Gene Therapy As I have already mentioned, when it comes to legal and ethical issues in the new area of somatic gene therapy, there are hardly any which haven't been widely discussed with the problems of organ transplantation. However, since gene therapy is the first direct application of the central dogma of molecular genetics to human medicine and may be seen as the spear head of high tech medicine, it offers a new round of moral challenges for the medical profession and possibly for us all. Some aspects of gene therapy are more problematical than comparable aspects in organ transplantation and others are less problematical. Certainly excessive application of gene therapy will become more difficult to contain.

13 Mario R. Capecchi f "Targeted Gene Replacement", Scientific American 270,1994, 3441. 14 Janet Rossant /Andras Nagy, "Genome Engineering: The New Mouse Genetics", Nature Medicine 1, 1995, 592-594.

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1. No Donor Problem Let me start with a non-problem of gene therapy. In gene therapy the donor problem does not exist, whereas in organ transplantation it turns out to be the main problem. Gene-DNA is not a living matter. In fact it may be copied in test tubes, produced by bacteria to any amounts wanted, and can even be de novo synthesized chemically in DNA synthesizing machines. Gene-DNA should be compared more to a piece of tape with information to produce a certain compound in a specific cell. Legally, in respect to gene therapy, gene-DNA is treated today like a pharmaceutical substance. Whoever dealt recently with the political difficulties to formulate the new Transplantation Act in Germany must sigh with relief. There will never ever be a problem of donor with the new technique of gene therapy. As a scientist, I have often asked myself, when I listened to fundamentalist-like opponents of gene technology, whether these people actually know how much foreign DNA is being transferred to a patient undergoing organ transplantation. In the case of the unquestioned practice of kidney transplantation for example, we are speaking literally of gram amounts of foreign DNA.

2. Patenting Medical Therapeutic Procedures Everyone has heard of patenting genes, another topic of biotechnology with relevance to law and ethics, and a topic which I will not discuss in my contribution15,; However, patenting has recently become a legal issue also in gene therapy 16,17 . In March 1995 the US Patent and Trademark Office (PTO) awarded to the National Institute of Health a broad patent on all ex vivo manipulations in which malfunctioning human cells are genetically altered to produce therapeutic levels of protein outside the body and then are replaced. The listed inventors W. French Anderson, Steven Rosenberg and Michael Blaese, who were originally doing research together at the NIH and who were co-sponsored by Genetic Therapy Inc. (GTI), one of the new companies devoted to the somatic gene therapy, find themselves in the middle of a controversy. Scientists are disturbed by the broadness of the patent. It covers an entire basic technique in the field which had been conceived and been used over a decade before Anderson et al. filed their patent application. Physicians are irritated because they feel that here a medical procedure came under patent law, an unusual practice up to this point. This is analogous, said one, to giving someone a patent for heart transplants. It is obvious that patenting practice in the medical field becomes more and more guided by economical considerations and by the desire to help attract more capital for the development of the biotechnology industry. 15

"Patenting of Human Genes and Living Organisms", in: Friedrich Vogel /Reinhard Grunwald, eds: Heidelberg: Springer Verlag, 1994. 16 Rachel Nowak, "Patent award Stirs a Controversy", Science 267, 1995,1899. ι? Helen Gavaghan, "NIH Wins Patent on Basic Technique Covering all EX VIVO Gene Therapy", Nature 374,1995, 393.

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3. Safety , Efficacy, Informed Consent and Confidentiality Before the first somatic gene therapy trial was permitted in the U.S. in 1990 there had been a two decade ethical debate on the issue . After the "Dr. Cline case", in the early 1980's, the NIH added to the Recombinant DNA Advisory Committee (RAC) a Working Group on Human Gene Therapy. This so-called "Human Gene Therapy Subcommittee", chaired by the bioethicist, Leroy Walters, published the document "Points to consider in the Design and Submission of Human Somatic Cell Gene Therapy Protocols 19". In line with the general standards for human experimentation, as formulated in "The Second Declaration of Helsinki" and adopted by the World Medical Association in 1975, this document supplemented more specific ethical standards for gene therapy by outlining a custom-tailored review mechanism. The areas identified were the following: (1) Objectives and rationale of the proposed research; (2) research design, anticipated risks and benefits; (3) selection of patients; (4) informed consent; (5) privacy and confidentiality. The Working Group on Human Gene Therapy provided a public national review process for each gene therapy proposal. It gave all interested persons ready access to information about gene therapy proposals and the review process, and provided in advance some considerations of future questions for public policy - in my opinion a shining example for other countries when wanting to translate their ethical standards on human gene therapy into practical guidelines. As with any new clinical technique, the potential risks of gene therapy procedures must be weighed against potential benefits before clinical trials are begun. Firstly, the specific safety issues must be most carefully evaluated. Secondly, patients for gene therapy must be carefully chosen and be made aware that they may embark on essentially uncharted territory. Today recipients of this therapy procedure are preferentially selected from patients with those heritable diseases for which more conventional treatments offer little help, or in the case of cancer patients, from the pool of those who had received standard treatments but with no final success. With progress in gene therapy techniques, this situation is bound to change. Another safety aspect is the quality of reagents used for gene therapy, such as DNA constructs, vector systems and cell culture media. They should be produced under conditions of "Good Manufacturing Practice". It is likely, that a high standard of quality control can only be guaranteed by pharmaceutical companies, not by teams of changing research personnel in clinical university laboratories. For this reason and because of the responsibility involved, legal actions should be taken to

is John C. Fletcher, "Evolution of Ethical Debate about Human Gene Therapy", Human Gene Therapy 1, 1990,55-68. National Institutes of Health, "Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols", U.S.A., Fed.Reg. 50,1985, 33463-33467.

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ensure that gene therapy reagents used in clinical trials are produced by commercial laboratories only.

4. The Border between Therapy and Enhancement The word therapy implies a medical indication for the procedure applied. Under the roughly 4000 registered heritable diseases are some of questionable disease character. What defines a disease? Take the case of achondroplasia or dwarfism 20. The members of the Society of Little People of America (LPA) say: "We are not handicapped, we are given handicaps." They want prenatal screening for prevention of birth of lethal homocygotes, but they are strictly against any genetic intervention and would see gene therapy for themselves as succumbing to the terror of a genetic norm. On the other hand, the growth hormone somatotropin was one of the first drugs made by recombinant-DNA technology and sold to treat abnormally small people and those who felt uncomfortable with not being tall enough. Clinical hormonal enhancement has led to the severe problem of doping in the world of sport. Clinical organ transplantation developed a wide spectrum of procedures in cosmetic surgery. What then will the future hold for somatic gene therapy? Is it not reasonable to assume that it would have the same fate and would also be used for somatic cell enhancement engineering, a sort of gene cosmetics? Thefirst somatic gene therapy protocol ever considered and approved in January 1989 by the Human gene Therapy Subcommittee of the NIH's Recombinant DNA Advisory Committee was not a strictly therapeutical protocol21. The technique suggested was identical to those required for gene therapy, but used a bacterial indicator gene for cell marking, not a therapeutic gene to strengthen immune cells of a cancer patient. The trials with this protocol could be considered a borderline human experiment and was therefore only done with the informed consent of terminal cancer patients. Gene manipulation in somatic cells may in the future be a very uncomplicated procedure like vaccinating today. It will possibly be as easy as using a pistol to shoot gene-DNA intotissuecells, or even a simple do-it-yourself method (a DIYmethod). Whereas I would like to see clinical somatic gene therapy protocols continue to require official approval and be demanded to be strictly therapeutical, I believe that ultimately there will be no other way than to build and strengthen a barrier against genetic enhancement in form of somatic cell engineering in the minds of the people.

20 Jürgen Neffe,

"Die rotten uns aus", Der Spiegel 31, 1995, 136-140.

Ronald G. Crystal, "Transfer of Genes to Humans: Early Lessons and Obstacles to Success", Science 270, 1995,404410.

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V. The Border between Somatic and Germline Gene Therapy No aspect of gene therapy is more highly charged than that of human germline therapy. This short last chapter of my contribution can certainly not do justice to the involved academic discussion on the topic. Germline gene therapy involves a genetic cure of a heritable disease by replacing the mutated "bad" gene in germ cells or the fertilized zygotic cells of an early embryo, including the reproductive stem cells for the entire organism. Since such a gene replacement, if successful, would affect all future descendants, this could be, from a medical standpoint, the ultimate permanent genetic therapy. The Society's concern and uneasiness about germline gene therapy is, however, deeply rooted. We feel that with this intervention we would undermine the genetic roulette which stands at the beginning of each individual, a process considered intimately connected with our identity, our structure of existence, our being human. There is a general fear that germline manipulation is too hazardous to be tampered with, that the danger of misuse is too high a risk and that even the best therapeutic intention could be the beginning of a slippery slope. Our human mind has proven to be too weak to begin directly regulating our genetic future. The German Government was the first to ban human germline therapy, by strictly forbidding with the "Embryonenschutzgesetz " any experimentation with human germ cells22. France followed by more specifically prohibiting germline therapy. The US-American RAC has more pragmatically said that it would not consider any germline gene therapy protocols. Public policy on the subject in the Anglo-American world appears to rely more on a healthy evolution of the ethical debate about human gene therapy23. In the early eighties germ cell gene therapy seemed technically far away. As this changed, any genomic manipulation appeared to bear too great a risk of unintended, irreparable mistakes. Today, the full line of new genetic techniques to manipulate at will the germline of the mouse are developed and all technical barriers for disapproval of human germline therapy sound obsolete. Now, the problem of germline therapy has to be reevaluated because it may come through the backdoor with somatic gene therapy in its most advanced form 24 . With in utero somatic gene therapy there is a danger of unintentionally affecting germ cells of the fetus. It is as one could have predicted, there are fewer biological, medical or experimental barriers between somatic cell and germline manipulation than we had hoped for. Most of the discussion to this point has been centered on the question of where to draw the line 25 . Should the cut-off line be between an unambiguous therapeutic 22 Bundesrepublik Deutschland, "Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz = EschG), Bundesgesetzblatt 1, 1990, 2746-2748. 23 Nelson A. Wivel/LeRoy Walters, "Germ-Line Gene Modification and Disease Prevention: Some Medical and Ethical Perspectives", Science 262, 1993, 533-538. 24 Helen Gavaghan, "Future Perfect or Imperfect", Nature Medicine 1,1995,186-187.

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procedure and genetic enhancement engineering irrespective of whether it is a somatic cell or germ cell manipulation, or should it be between somatic cell and germ cell procedures? With my last point I want to argue that of the four options we have for human genome manipulation, we should only permit one. We should draw the lines, ethically and legally so that only somatic gene therapy is permitted and that the greatest care is given to avoid unintentional germ cell manipulation during the course of treatment. In my opinion there is no satisfying medical indication for germline therapy. Germline therapy protocols would always have to include early genomic screening procedures. Since one would neither want to manipulate a healthy zygote nor reimplant an embryo without having tested for successful gene manipulation, it is unavoidable to screen for the genomic status twice. Experimentally complicated as it may seem, such a screening would be possible. However, it would include separating the cells of the early embryo before they loose their totipotentiality, taking one cell, letting it divide, testing the genome of that cell clone, deciding accordingly to go ahead manipulating the genome of another one of the embryonal cells, then letting it grow and testing for the successful gene therapy procedure in another round of DNA assay. Finally, only if this second screening has turned out to be positive, the procedure could go on for embryo implantation. Notice that the procedure involves cloning and consumption of some of the totipotential cells of the early embryo (possibly of not later than the four-cell-stage). Presently I cannot see how this abortive consumption, which results from testing procedures, could ever be avoided without running therisk of doing unnecessary manipulations or reimplanting an unsuccessfully manipulated embryo. The reason why I have so explicitly outlined this procedure is to make it obvious that we have a better option. Early genetic testing and taking a choice, as we do it today, is a less complicated and safer alternative. The amount of handling of the early embryo in the outlined germline therapy procedure, including the risks involved, are completely unrealistic in the face of the relatively simple screening in utero by genetic testing and eventual abortion. In each case of monogenic heritable disease, it may be dominant or recessive in nature, there exists the possibility for healthy embryos, except on the one rare occasion, in which a couple who are both patients of a recessive autosomal heritable disease would want to reproduce. I have heard of couples of cystic fibrosis patients who have wanted to have children. CF-patients today are statistically reaching reproductive age and are frequently meeting each other in their organizations. Functional sterility of CF-patients can be circumvented by in vitro fertilization. In these situations screening for healthy embryos would be meaningless, as all descendants would have the condition. Is this constellation really a medical problem? Is this rare situation enough to argue for germline therapy having a medical indication? 25 W. French Anderson, "Human Gene Therapy: Why Draw a Line?", The Journal of Medicine and Philosophy 14, 1989, 681-693.

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I would like to repeat, in my opinion there is no satisfying medical indication for germline therapy. Do we really loose something if we, for the time being, legally ban a procedure which we do not need for medical purposes and for which otherwise we have currendy no desire that it be used?

Acknowledgements I would like to thank Ms. Elizabeth Herbrich for secretarial assistance. Research on eukaryotic gene and transgene regulation in the laboratory of the author is supported by grants from the Deutsche Forschungsgemeinschaft (SFB 364, A2 and SFB 388, C3), the State of Baden-Württemberg, the Fonds der Chemischen Industrie, Frankfurt/M. and the German-Israeli Foundation for Research and Development. Zusammenfassung Bevor der Autor, ein Grundlagenwissenschaftler auf dem Gebiet der Molekulargenetik, auf die für Recht und Ethik relevanten Fragen eingeht, behandelt er die Auswirkungen, die vom ,»Projekt Menschliches Genom" ausgehen und erläutert einige methodische Probleme der neuen Medizintechnik der somatischen Gentherapie. Da die medizinische Gentherapie sich nur auf Körperzellen auswirkt, bietet sie keine neuen juristischen und ethischen Probleme, die nicht schon für die Organtransplantation diskutiert worden sind. Jedoch könnte es in Zukunft schwierig werden, übertriebene Anwendungen zu begrenzen, und es wird nötig sein, die Grenzen zwischen Therapie und Verbesserung und zwischen Gentherapie von Körperzellen und Keimbahnzellen sorgfaltig zu erörtern. Es wird argumentiert, daß es keine befriedigende medizinische Indikaton für die Keimbahntherapie gibt und daß daher für die Medizin nichts verloren wäre, wenn wir durch Gesetz zwischen der medizinisch-somatischen Gentherapie und der Genmanipulation an der menschlichen Keimbahn eine Grenze ziehen würden.

Law and Ignorance: Genetic Therapy and the Legal Process Roger B. Dworkin*

Like most new developments in medicine and biotechnology, human gene therapy holds out the promise of substantial benefits to humanity while threatening both specific health hazards and fundamental damage to human dignity, and challenging us to consider the very limits of humanness. This combination of promise, threat, and challenge is what makes the subject interesting, not only because the advantages and disadvantages of gene therapy must be weighed and evaluated, but because the weighing and evaluating must take place in the face of overwhelming ignorance. That ignorance poses the most difficult kind of puzzle for persons who must consider what the social response to human gene therapy should be. In some sense, of course, social policy makers, law makers, always act in the face of ignorance. No matter how conscientiously lawmakers may have studied a problem, no one can foresee the full range of consequences that will follow from legal enactments or decisions. Ignorance, however, is a matter of degree. In most situations ignorance is a minor factor in the legal equation. Lawmakers usually know, or at least think they know, a great deal about the area under consideration. In considering gene therapy, however, ignorance is the essence of the legal dilemma. The question is whether and how to regulate in an area that is ill understood and whose ramifications can only be imagined. Regulating in the face of overwhelming ignorance presents the law with a terrible dilemma - balancing the imperative of protecting society from unknown, but imaginable evils with the imperative of refraining from adopting law that will be unwise, freeze the growth of * An earlier version of this paper was presented at a conference on Biotechnological Challenges for Law and Ethics, which was held in Milan and Bellagio, Italy from August 5 through 11, 1995.1 am grateful to the organizers of the conference and to the other participants in it for a very valuable opportunity to exchange views across national and disciplinary cultures. I wish to thank Ralph Gaebler, international law librarian at the Indiana University School of Law-Bloomington, for wonderful assistance and for service above and beyond the call of duty; my colleague, Professor David Fidler, for helpful and patient explanations of certain aspects of European legal institutions; Professor Gonzalo Herranz for generous and helpful explanations of Spanish law; Professors Luis Diez-Picazo and Derek Penslar and Ms. Robin Penslar and Ralph Gaebler for graciously providing translation services; and Peter Daniel DiPaola for veiy helpful research assistance. 4 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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science and technology, and deprive society of unknown, but imaginable benefits. How to resolve that dilemma is the subject of this paper.

Gene Therapy Broadly speaking, gene therapy may be classified either as somatic cell therapy or as germ-line therapy. Somatic cell therapy involves an effort "to treat an individual patient, e.g., by inserting a properly functioning gene into a patient's somatic [nonreproductive] cells".1 Germ-line therapy, on the other hand, involves an effort "to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed on to the individual's offspring." 2 Further classification that takes into account the purpose of the therapies is possible. Thus, one can subdivide both somatic cell and germ-line therapy into therapies intended to cure or prevent disease and those intended to enhance the characteristics of healthy persons.3 Despite the fact that successful somatic cell therapy will increase the number of homozygotes who will pass disease genes to their offspring 4 and some public uneasiness about such therapy,5 a broad consensus exists that somatic cell therapy to correct serious diseases of identifiable human beings is ethically acceptable.6 No such consensus exists about the acceptability of germ-line therapy,7 and most government, professional, and religious groups that have taken a position on germ-line therapy oppose its use.8 The few groups that have taken a position on the use of gene therapy for enhancement, rather than to cure or prevent disease, oppose that use of genetic technology.9 Indeed, concern that germ-line therapy will be used to 1 Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 59 Fed. Reg. 34496, 34529 (1994). 2 Id. 3 Nelson A. Wivel/LeRoy Walters, "Germ-Line Modification and Disease Prevention : Some Medical and Ethical Perspectives", 262 Science 533 (1993). 4 Burke K. Zimmerman, "Human Germ-Line Therapy: The Case for its Development and Use", 16 J. Med. & Phil. 593,594 (1991). s W French Anderson, "Human Gene Therapy: Why Draw a Line?", 14 J. Med. & Phil. 681 (1989). 6

Testimony of Dr. LeRoy Walters, U.S. House of Representatives, Committee on Science, Space, and Technology, Hearing, "Gene Therapy: Status, Prospects for the Future, and Government Policy Implications", 93,94 (Sept. 28,1994). 7 Id. β Id. 9

Id.; see Alex Mauron/ Jean-Marie Thévoz, "Germ-Line Engineering: A Few European Voices", 16 J. Med. & Phil. 649, 651 (1991), noting that a large consensus exists against the use of germ-line engineering to "improve" human beings.

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pursue genetic enhancement is one reason that some critics oppose germ-line therapy. Several different arguments are made against germ-line therapy. Eric Juengst has suggested that five basic arguments exist: (1) arguments based on scientific uncertainty and clinical risks; (2) "slippery slope" arguments based on the fear that germ-line therapy to fight disease will inevitably lead to its use for enhancement; (3) arguments based on the impossibility of obtaining the consent of future generations; (4) arguments based on the view that resources devoted to developing germline therapy could be better spent elsewhere; and (5) arguments based on the importance of maintaining the genetic patrimony.10 The resource allocation argument is neither very interesting, nor very important. One can always argue about whether it would be "better" to devote resources to feeding the hungry, preventive medicine, or research that is likely to help a large number of people than to developing an entirely new, problematic approach to confronting disease. Nothing about germ-line therapy makes that argument any different here than it would be in the case of somatic cell therapy or therapies that do not involve genetic technologies. Similarly, arguments based on scientific uncertainty and clinical risk usually attend efforts to develop new approaches tofighting disease. Well established ethical codes and legal procedures exist to govern the development of new drugs and medical devices. Elaborate procedures for the protection of human subjects are in place. To the extent that developing germ-line therapy involves experimentation with identifiable human subjects and efforts to develop new "drugs", existing procedures are no less adequate than they are in the context of developing other kinds of new therapeutic agents.11 Nonetheless, even the resource allocation and scientific uncertainty-clinical risk arguments are rooted in uncertainty. We do not know what the payoff for germ-line research will be or how its benefits will compare with those that could be achieved through different resource allocations. And, by definition, arguments about scientific uncertainty are arguments about what to do when we do not know what the outcome of different courses of action will be.

10 Eric T. Juengst , "Germ-Line Gene Therapy: Back to Basics", 16 J. Med. & Phil. 587, 590 (1991). See also Donald S. Rubenstein/David C. Thomasma/Eric A. Schon/Michael J. Zinaman , *'Germ-Line Therapy to Cure Mitochondrial Disease: Protocol and Ethics of In Vitro Ovum Nuclear Transplantation", 4 Cambridge Quarterly of Healthcare Ethics 316, 332334 (1995); Zimmerman, supra fn. 4, at 605-09. 11 In the United States the Food and Drug Administration regulates all efforts to introduce new drugs, including those that involve gene therapy, "Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products", 58 Fed. Reg. 53248 (1993). See Testimony of Dr. Nelson Wivel, U.S. House of Representatives, Committee on Science, Space, and Technology, Hearing, "Gene Therapy: Status, Prospects for the Future, and Government Policy Implications", 20, 22-23 (Sept. 28, 1994). 4*

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The other arguments against germ-line therapy require more attention. One major concern is that the use of germ-line therapy to cure disease will lead inevitably to its use for enhancement, that is, that germ-line therapy will become a tool of positive eugenics.12 This argument assumes (1) that enhancement, or at least enhancement that is not a form of preventive medicine,13 is so inappropriate that it ought not to be permitted regardless of what legitimate benefits are lost through the prohibition, and (2) that persons and society will be unable or unwilling to draw a line between medical and enhancement uses of germ-line therapy. Since the line cannot be drawn, all uses of germ-line therapy must be prohibited. Neither of these assumptions is susceptible to proof. Perhaps what seems an enhancement today will turn out to be a disadvantage; perhaps humans lack the wisdom to make wise choices about which traits to promote and at what rate; perhaps any change in the natural order of trait distribution will constitute an evil. But perhaps the opposite will turn out to be true. As Burke Zimmerman has argued, "There are no inherent objections to carrying out genetic 'enhancement' in individual cases ...". We must simply be especially careful in evaluating the criteria for deciding which enhancements are appropriate. 14 Will enhancement lead to the dehumanization of future generations as people come to see themselves as artifacts? Will enhancement lead to injustice in the distribution of opportunities for enhancement and the benefits that will flow from it? Or is Resnik correct in suggesting that these harms are either unrealistic or avoidable?15 One can have an opinion, but one cannot know. Similarly, the argument that it will be impossible to draw lines is an assertion that may or may not turn out to be correct. Somatic cell therapy is sometimes used for enhancement, as, for example, when genetically engineered human growth hormone is administered to short children who have no pathology in an effort to make them taller. Does that use of enhancement therapy prove that we cannot draw lines so that somatic cell therapy should not have been allowed? Or does the standard argument that treats somatic cell therapy and germ-line therapy as significantly different demonstrate that lines can be drawn? Berger and Gert argue that it is possible to define a "malady" and to limit germ-line therapy to the correction of maladies.16 Yet their distrust of human beings makes them unwilling to rely on people doing that and leads them to counsel against the use of germ-line therapy lest a

12 Edward M. Berger /Bernard M. Gert , "Genetic Disorders and the Ethical Status of Germ-Line Gene Therapy", 16 J. Med. & Phil. 667, 679-80 (1991); David Resnik, "Debunking the Slippery Slope against Human Germ-Line Gene Therapy", 19 J. Med. & Phil. 23 (1994). 13 See, W. French Anderson , "Human Gene Therapy: Scientific and Ethical Considerations", 10 J. Med. & Phil. 275 (1985). 14 Zimmerman, supra fn. 4, at 610. 15 Resnik, supra fn. 12. Berger/Gert, supra fn. 12, at 671.

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few people benefit at the expense of many.17 Which view is correct, the one based on the logical possibility of defining maladies, or the one based on a negative view of human nature? Nobody knows. Thus, both halves of the slippery slope argument are based on unproved assumptions. The lawmaker who acts out of concern for the dangers of the slippery slope will be acting on the basis of unfounded predictions, not on the basis of information. A lack of information also bedevils the claim that we should not engage in germ-line therapy because we cannot obtain the consent of the next generation. By definition, successful germ-line therapy will affect persons yet unborn. They are unable to decide whether to consent to the risks of germ-line therapy or its proposed benefits. Therefore, the argument goes, we should refrain from using germline therapy. On one level this argument is strikingly unpersuasive. Children cannot consent to any kind of therapy; their parents or guardians consent for them. Almost everything that a pregnant woman does may have an impact on her unborn child. That fact does not disable the woman from existing, and most maternal behavior is tolerated even if some other course of conduct would clearly be better for the fetus. 18 Even some experiments are allowed to be conducted on children.19 Thus, in other medical contexts the inability of a patient or subject to consent does not require us to refrain from action. Why should it do so here? Part of the problem of the inability of future generations to consent is based on factual ignorance. We do not know whether an unborn or unconceived person would consent to a particular procedure. But often in medicine we do not know what an incompetent person would consent to. In all other situations we solve this problem by assigning a surrogate decision-maker and adopting a substantive standard, typically either substituted judgment or the best interests of the patient, for the decision-maker to apply.20 Thus, ignorance about incompetent persons' preferences does not block action elsewhere, and, by itself, it seems insufficient to block it here.

" Id, at 680. 18 See generally Roger B. Dworkin, "Common Sense and Common Decency: Some Thoughts about Maternal-Fetal Conflict", 1991 Biomedical Ethics Reviews 9 (J. Humber/R. Almeder, eds.). 19 Department of Health and Human Services, Policy for the Protection of Human Research Subjects, Additional Protections for Children Involved as Subjects in Research, 45 C.F.R. §§ 46.401 et. seq. (1984). 20 This approach has been developed most fully in litigation about the so-called right to die. See generally, e.g., Cruzan v. Director, Missouri Department of Health, 110 S. Ct 2841 (1990); Superintendent of Belchertown State School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977); In re Quinlan, 355 A.2d 647 (N.J.), cert. den. sub nom. Garger v. New Jersey, 429 U.S. 922 (1976).

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Nonetheless, riding roughshod over persons who cannot consent is very worrisome, and the inability of a person to consent to a procedure that affects him or her should certainly give us pause. The problem here, however, is that we do not know whether there is any "person" or other entity deserving of moral consideration involved. Some forms of germ-line therapy involve manipulation of embryos, beings whose moral status is unclear and controversial. Other forms, however, would involve alterations to the cells of living persons with the purpose of affecting those persons' future, as yet unconceived offspring. What does it mean to talk about the consent or non-consent of an unconceived person, especially if the consequence of refusing to do germ-line therapy is that the person will never be born? The unconceived are not thought to have a right to consent to other decisions affecting their genetic makeup - whether their father or mother marries a blond or a brunette, an athlete or a scholar, a carrier of the gene for Huntington's disease or a non-carrier. What is the case for recognizing an entitlement to consent in the one instance of germ-line therapy, an instance in which the entire point of the intervention is to permit the unconceived person to be born and to be healthy? Perhaps the point is one that transcends the individual. Perhaps there is an obligation to maintain the genetic patrimony. Mauron and Thévoz describe the idea that there is a basic human right to one's unmodified genetic endowment, or "genetic patrimony". This right is a collective one; there is a "collective genetic heritage" that is worth more than any individual interest. "[0]ne cannot touch the 4genetic patrimony' even if some persons would benefit." 21 Why not? The "genetic patrimony" of all species has changed naturally over time. Only a mystic commitment to the natural would suggest that humanly caused alterations are somehow less acceptable than natural ones. Surely, the notion that natural is best is out of keeping with all developments in modern medicine and cannot be taken seriously.22 The argument, then, must be that in the area of germline therapy our unnatural interventions will take us down a path we cannot know, and that an unknown path is one we should not tread. This is, of course, the argument based on ignorance once again. Ignorance plus pessimism leads to the conclusion that germ-line gene therapy should not proceed. The arguments in favor of germ-line therapy are hardly more convincing. Here too Eric Juengst suggests that there are five basic arguments: (1) medical utility, 21

Mauron /Thévoz, supra fn. 9, at 654. Dorothy C. Wertz, "Leave the Door Open to Research", 13 Politics & the Life Sciences 235 (1994). "It is not clear why hazards of nature should necessarily be better than achievements of science This view overlooks the importance of artificial components in our lives and activities. We are artificial beings by our very nature. The human intelligence and consequent capability of innovation and creativity also belong to nature." Group of Advisors on Ethical Implications of Biotechnology of the European Commission, Report on Ethical Aspects of Gene Therapy 13 (1994) (Archer Report), quoted in: Note (Charles E DeJager), "The Development of Regulatory Standards for Gene Therapy in the European Union", 18 Fordham Internat'l L.J. 1303, 1334 (1995). 22

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(2) medical necessity, (3) prophylactic efficiency, (4) respect for parental autonomy, and (5) scientific freedom. 23 The first three arguments are all based on predictions about germ-line therapy that it will be useful for curing disease, that it may be the only way to cure some diseases, and that it will prove cheaper and safer in the long run than frequent use of somatic therapy. Maybe these predictions will turn out to be correct, but we do not know whether they will. Germ-line therapy is still remote. How useful, necessary, and efficient it will turn out to be if we allow it to develop remains to be seen. The last two arguments, like opponents' arguments about unconsenting future generations and the genetic patrimony, are simply assertions that one may or may not accept. Parental reproductive autonomy is hardly unquestioned in the world today. Even one who accepts the idea in the abstract may well think there is a difference between prohibiting the police from regulating activities in the marital bedroom and promoting research and therapy that will allow a parent to control the genetic makeup of his or her child. Indeed, the claim of parental autonomy is the argument that leads most obviously to the suggestion that germ-line therapy will be used for enhancement and that, therefore, it should not be permitted. Similarly, everyone now concedes that scientific freedom has limits. Some research is simply too awful to do, and many restraints are imposed on research with human subjects and with animals. Whether the research necessary to develop germ-line therapy is such research is a question . Its answer cannot simply be assumed. Thus, the arguments for and against germ-line therapy all rest on unprovable factual suppositions or arguable assertions of values. How ought a lawmaker to respond when confronted with such arguments?

Process Values The most obvious and tempting response, of course, is simply to choose one set of arguments to believe and adopt the policy that will promote one's point of view. A scientific optimist or adherent of parental or scientists' rights will support germline therapy and oppose its legal prohibition; a pessimist or advocate for the autonomyrightsof the unborn or the communal genetic patrimony will oppose the therapy and seek to have it banned. Indeed, an extreme adherent of this view will oppose all technological developments that pose even the slightest risk of catastrophic consequences.24 23 Juengst, supra fn. 10, at 589-90. See also Rubenstein/Thomasma/Schon /Zinaman, supra fh. 10, at 329-332. 24 See, e.g., Mauron /Thévoz, supra fh. 9, at 659, discussing the work of Hans Jonas.

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What these supportive and antagonistic positions about gene therapy have in common is that they are based exclusively on substantive considerations - the desirability or undesirability of germ-line therapy. What they both forget is that all law also involves another set of values, the values that underlie the legal system. A legal system has its own ends to serve and its own institutions for serving them. Law made without devoting attention to these process values will inevitably be unsuccessful from everybody's point of view, including the point of view of those who appeared to succeed in having the law adopt their position.25 Careful attention to process and to the characteristics of legal institutions suggests the lack of wisdom in adopting extreme legal positions in the face of uncertainty. Law is a collection of tools of limited utility, which can make only limited contributions to the resolution of social issues posed by rapidly developing medical technology. This is not surprising. All legal institutions are created and operated by human beings whose scientific knowledge, ability to predict the future, and wisdom about matters of ultimate moral significance are all extremely limited. Moreover, the institutions these human beings have created are not designed to choose between arguable positions in which much that is desirable inheres on both sides of the issue. The law can choose between right and wrong, but in the area of germ-line therapy, as in most of bioethics, there is right on all sides of the issue. The choice is not between right and wrong, but rather between ways to sacrifice the least that is right, or good, in all positions. As Paul Freund noted years ago, "The law is dialectic in a deeper sense than its adversary process. It mediates most significantly betweenrightand right".26 If the goal of the law is to mediate between right and right, then it makes little sense to think that the law should adopt an extreme position about germ-line therapy. Either prohibition or unfettered development will sacrifice all that is "right" about the other point of view. Thus, legislation or, at least in the United States, worse yet, constitutional adjudication that prohibits germ-line therapy or estab25 The great seminal work in establishing the overriding value of process to law is Henry M. Hart, Jr. /Albert M. Sacks, The Legal Process, which after circulating in mimeographed form for decades, is finally available in a hard cover, printed edition. (William N. Eskridge, Jr. and Philip P. Frickey, eds., 1994). For an effort to apply legal process analysis to the field of bioethics in general see, Roger B. Dworkin, Limits: The Role of the Law in Bioethical Decision Making, (forthcoming), which, among other things, explores at great length the Pyrrhic victory won by American abortion rights advocates who let their substantive goals blind them to the dictates of procedural good sense. Andrea Bonnicksen, who does not specifically mention process or process values, offers an interesting argument that national approaches to germ-line therapy are preferable to international ones for reasons that are rooted in considerations of legal process at the national and international levels. Andrea Bonnicksen, "National and International Approaches to Human Germ-Line Gene Therapy", 13 Politics & the Life Sciences 39 (1994). 26 Paul Freund, "Legal Frameworks for Human Experimentation," in: Paul Freund, Experimentation with Human Subjects 105 (1969).

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lishesrightsto pursue the therapy as a form of parental autonomy or scientific freedom would be a«serious mistake. In order to mediate betweenrightandright, the law should adopt the least intrusive institutional approach that can achieve the balance that is needed to avoid losing too much that is valued by persons on all sides of the issue. In this context what that suggests is the adoption of administrative regulations that will permit germline therapy to be developed and used subject to relatively easily changed controls to prevent abuse and reduce therisk of .injury. Common law case development, which in the common law world is generally the least intrusive form of law, will not suffice here. One of the primary goals in regulating germ-line therapy is to control the conduct of researchers and physicians. Common law adjudication, which operates after-the-fact, resolves cases one at a time, and is highly fact-specific, lacks the clarity, generalizability, certainty, and predictability to be effective at conduct control. Conversely, legislation, and especially criminal legislation, which is more effective than common law at controlling conduct, is both too political and too extreme to deal well with an area like germ-line therapy. Legislators are unlikely to be scientifically sophisticated; they make decisions that are partly based on political (i.e., irrelevant) considerations; their enactments are difficult to adopt and, therefore, difficult to change if they turn out to be ill-advised or if they become outdated; and the limitations of language and the abstract nature of their pronouncements make it difficult for them either to paint with a fine brush or to achieve the certainty that legislation seems to offer. Criminal legislation shares all these problems, but in criminal law they are exacerbated by the extreme, morally ambiguous venture on which the law has embarked - the intentional infliction of pain by the state. Only conduct that is almost universally condemned as immoral should be subjected to criminal penalties, and, even then, subject to numerous prudential constraints.27 Obviously, germ-line therapy, which offers potential for great human benefit, does not qualify. If legislation is an inappropriate response to germ-line therapy, then constitutional adjudication, the legal system's most extreme response, is even more so. Constitutional adjudication establishes principled, national, sweeping rules that are unlikely to be sound in areas that have little to do with the nature and structure of government, and that are characterized by intense moral conflict, rapidly changing facts, and scientific information which judges are ill-equipped to understand. Administrative agencies are the legal institutions best suited to consider the issues presented by germ-line therapy. First, agencies are staffed in part by persons with expertise in the fields being regulated. Therefore, they are more likely than inexpert judges or legislators to be able to understand the technical aspects of the 27 See generally, Herbert L·Packer, The Limits of the Criminal Sanction (1968); see also, Robert Mullan Cook-Deegan , "Germ-Line Gene Therapy: Keep The Window Open a Crack", 13 Politics & the Life Sciences 217,219 (1994).

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issues before them. Second, agencies are able to adopt regulations, which give them greater ability to control conduct than common law courts. Third, they also have the ability to decide specific cases, thereby giving them more ability to draw subtle factual distinctions than legislature. Fourth, they are staffed in part by civil servants who are better insulated from politics than legislators. To the extent that the civil servants are subject to political influence, at least it is political influence relevant to the broad mandate of their agency. That is, unlike a legislator, an employee of the Food and Drug Administration cannot be pressured to trade a vote about germ-line therapy for a vote on the location of a new military base. Of course, the time for an idealistic, romanticized vision of administrative agencies is long past. Everybody understands that agency proceedings can become bureaucratic nightmares and that industry groups can capture control of the very agencies that are supposed to be regulating them. The argument here is not that administrative agencies are ideally suited to deal with germ-line therapy, only that they are better suited than any other legal institutions. Surely agencies are more able than other institutions to make incremental, tentative, experimental steps in regulating germ-line therapy and to change their approach if it seems on reflection to be wrong or if scientific changes suggest the need for policy changes. Thus, if one focuses on process rather than substance, one comes to the conclusion that there should be no legislation about germ-line therapy, other than to assign authority to an administrative agency; that the agency should permit some development of germ-line therapy, subject to careful restrictions; and that as the scientific, social, and moral status of germ-line therapy becomes clearer, the agency should reconsider its position regularly and often.

Process versus Substance Focus on substance suggests to many people that germ-line therapy should be prohibited, and may suggest to a few that it should be permitted without restriction. Focus on process suggests that both of those positions should be rejected and that minimal legal involvement should be used to allow the technology to develop slowly while retaining the power to stop it if that becomes desirable. The question, then, becomes how is one to choose between substantive values and process values in deciding what to do about germ-line therapy? This may be the place at which ethics and law diverge. An ethical analysis may lead to a firm conclusion that one course of action is better than another. A person who comes to such a conclusion is likely to believe that this "correct" position should be adopted and imposed. Thus many ethicists have concluded that germline therapy ought not to be permitted.28 28 See, e.g., Marc Lappé, "Ethical issues in Manipulating the Human Germ Line", 16 J. Med. & Phil. 621, 638-39 (1991); C. Rehmann-Sutter, "Gentherapie in der menschlichen

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A lawyer, on the other hand, is likely to be doubly skeptical. The lawyer will be reluctant to believe that the ethical analysis has really reached the right answer; indeed, the lawyer is likely to doubt the ability of human beings to ascertain right answers to any questions worth asking. Thus, the lawyer will be reluctant to enshrine one viewpoint in the law. Second, the lawyer will be skeptical about the ability of the law itself. 29 Nobody understands the limitations of a set of institutions and procedures as well as those who work with them every day. Regardless of whether professional orientation predisposes to one course of action or another, something must be said about the relative importance of substance and process in the area of germ-line therapy. Substantive positions on the issue are, as we have seen, rooted in ignorance and bald assertion of preferences. This makes them a slender reed on which to rest public policy. Moreover, adopting a position based on the substantive arguments will have catastrophic results if the decision turns out to be wrong. Permitting unfettered development and application of germline therapy may lead to injury to living persons and to generations yet unborn. It may lead to dehumanization, to undesirable uses of genetic enhancement, and to the exacerbation of social inequity. It may lead to serious damage to our collective genetic essence. All of those consequences obviously should be avoided. On the other hand, prohibiting germ-line therapy will almost surely deprive medicine of an important tool in the fight against disease, squander an opportunity to eliminate some serious diseases altogether, leave many patients with the Hobson's choice of refraining from reproduction or deciding to propagate or risk propagating children with serious genetic disorders, and cost society large sums of money to treat avoidable conditions. Those, too, are obviously consequences to eschew. Following the dictates of process, on the other hand, minimizes the costs of mistakes. Adopting the administrative approach suggested above will provide some of the benefits of germ-line therapy with only minimal risk and will permit receipt of expanded benefits if therisksdo not materialize. It will not commit society to one course or another. It will act upon the recognition that the best course of action in the face of ignorance is to temporize until the ignorance is overcome. Thus, in the instance of germ-line therapy process values seem clearly to point toward a sounder direction for social action than substantive values do. This is one of the many areas in which how one proceeds is the surest guide to what one ought to do.

Keimbahn?", Ethik in der Medizin 3, 3-12 (1991), cited in: Maurice A. M. de Wächter, Ethical Aspects of Human Germ-Line Therapy, 7 Bioethics 166, 175 (1993); Mauron/Thévoz, supra fn. 9, at 659 (discussing the views of Hans Jonas). See, e.g., the views of Cecil Clothier, Chair of the British Committee on Gene Therapy, who called the law "a fairly blunt instrument," and stated, "As a lawyer, I would deprecate any sort of legal control [on gene therapy] at this stage, because we do not know what we are controlling." Phyllida Brown , "Gene Therapy Wins Official Blessing", 133 New Scientist 18 (Jan. 25,1992).

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Actual Legal Response To the extent that various nations and international groups have dealt with germline therapy to date, their record is mixed in terms of pursuing what I have suggested is the best approach. A few examples will illustrate the point. Germany has made it a crime to artificially alter "the genetic information of a human germ line gene" or to use "a human germ line gene with artificially altered genetic information". 30 This approach seems to be an overuse of the criminal sanction and to fail to take advantage of the benefits that greater attention to process values could provide. The United States has taken a somewhat more moderate position, but still one that effectively precludes germ-line therapy. Gene therapy at institutions that receive any National Institutes of Health (NIH) support for recombinant DNA activities is governed by NIH guidelines.31 In addition, the NIH and the Food and Drug Administration (FDA) collaborate to control research directed at the production of new drugs and other biological products.32 Gene therapy is regulated according to Appendix M. of the guidelines, the so-called "Points to Consider".33 Under the Guidelines gene therapy may not be performed unless the NIH's Recombinant DNA Advisory Committee (RAC) has approved the protocol. The Points to Consider state, "The RAC will not at present entertain proposals for germ-line alterations but will consider for approval protocols involving somatic cell gene transfer". 34 Thus, the current position in the United States is clear. No germ-line therapy may be performed except by somebody at an institution that neither receives NIH support for recombinant DNA activities, nor intends to seek approval for their approach from the FDA. Effectively, this means that germ-line therapy is not permitted in the United States today. In terms of the process oriented approach I have suggested, the American approach has some benefits. It remits decision making to an administrative agency with considerable scientific, legal, and ethical expertise. The agency recognizes the value of flexibility by stating plainly that its disapproval of germ-line therapy is its position "at present", leaving open the possibility of changing its position should conditions warrant. 35 On the other hand, NIH's blanket rejection of germline therapy squanders the RAC's opportunity to paint with a fine brush and exalts » Bundesgesetzblatt, Teil 1, 2746, 2747, Embryonenschutzgesetz § 5 (trans, by Ralph Gaebler). 31 Supra fh. 1,§I-C-1. 32 See, testimony of Dr Nelson Wivel, supra fh. 11, at 22-23. 33 Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into the Genome of One or More Human Subjects, Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), Appendix M., 59 Fed. Reg. 34496, 34528-34 (1994). 34 Id, at 34529. 35 Bonnicksen, supra fn. 25, at 43.

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the substantive values of those who oppose germ-line therapy over the values of those who support it. Thus, the American position is more rigid than it needs to be, and it impedes possibly useful scientific development more than is necessary to achieve adequate protectionfrom the feared evils of germ-line therapy. Spain has two relevant statutes, one on the donation and use of human embryos and fetuses, and one on assisted reproduction procedures. The former permits genetic technology to be authorized, For therapeutic purposes, principally for sex selection in the event of diseases linked to the sex chromosomes, particularly chromosome X, thereby avoiding their transmission; or to create beneficial genetic mosaics through surgery, by transplanting cells, tissues, and organs from embryos and fetuses into patients in which these are biologically and genetically modified or lacking;36

The assisted reproduction procedures statute permits intervention on a human pre-embryo only to treat the pre-embryo's disease or to prevent its transmission, The statute then establishes conditions for engaging in therapeutics with pre-embryos in vitro or on pre-embryos, embryos, or fetuses within the uterus. One condition is, That there is no influence on non-pathological hereditary traits, and no selection of individuals or of race is sought;38

If these provisions stood alone, they could be read as leaving open the door to germ-line therapy. The first statute authorizes somatic cell therapy, but it is possible to interpret the language about creating beneficial genetic mosaics for patients in whom their cells, tissues, or organs are "genetically modified or lacking" to permit some germ-line therapy as well. Moreover, the emphasis in the assisted reproduction statute on preventing the transmission of disease, and the prohibition against influencing non-pathological hereditary characteristics seems to imply that efforts to influence pathological hereditary characteristics are permissible. This interpretation would mean that germ-line therapy, but not enhancement, would be permitted in Spain. However, other statutory provisions make this interpretation unlikely.39 Article 14(3) of the assisted reproductive procedures law prohibits developing pre-em36 Act on the Donation and Use of Human Embryos and Fetuses or their Cells, Tissues, or Organs, Stat. No. 42/1988 Art. 8 § 2c (Dec. 28, 1988) (Official Bulletin of the State, Dec. 31, 1988), International Digest of Health Legislation 66-67 (1991). This statute mirrors Council of Europe, Parliamentary Assembly, Recommendation 1100 (1989) on the use of human embryos and foetuses in scientific research, Appendix G, Application of scientific research to the human being in thefields of health and heredity, ^ 18. 37 Act on Assisted Reproduction Procedures, Stat. No. 35/1988 Art. 13 § 1 (Nov. 22, 1988) (Official Bulletin of the State, Nov. 24, 1988), International Digest of Health Legislation 82, 86(1989). 38 Id, Art. 13 § 3d.

39 I am indebted to Professor Gonzalo Herranz of the Universidad de Navarra for the following understanding of Spanish law.

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bryos for procreation using gametes that have been used for experimentation.40 Article 20(2)(B)(i) declares transferring gametes or pre-embryos to the uterus without necessary biological or viability assurances to be a "very serious offense". 41 As there is no practical way to obtain the necessary assurances, this means that the transfers cannot be made. Finally, the statute forecloses the use of human gene therapy on embryos conceived through sexual intercourse by making it a "very serious offense" to obtain "human pre-embryos by uterine lavage for any purpose;"42 and by prohibiting experimentation on pre-embryos in the uterus or fallopian tubes.43 Thus, as a practical matter, Spanish law seems to be as restrictive as German law and perhaps more restrictive than the American. Israel deals with gene therapy through its control of research with human subjects. Any new procedure designed to affect the health, "including the genetic structure," of a person or fetus must be approved as a medical experiment on a human being.44 Any "experiment concerning the genetic structure of a person" cannot be approved unless the administrator has received a written opinion from a higher committee.45 This approach leaves open the question of whether the higher committee will ever approve a germ-line experiment and appears to give the administrative agency power to approve such an experiment if it thinks that doing so would be wise. At the inter-state level, the European Parliament has expressed its disapproval of germ-line therapy.46 Nonetheless, the European Union has not yet adopted Unionwide gene therapy regulation,47 and the Archer Report evaluating gene therapy, which was prepared at the request of the Commission, took the position that the great promise of germ-line therapy makes such therapy a "medical imperative".48 The Council of Europe has had considerable difficulty in deciding on a position regarding germ-line therapy. In 1982 the Parliamentary Assembly took the position that therightsto life and human dignity "imply the right to inherit a genetic pattern which has not been artificially changed".49 Nonetheless, the Assembly recognized the importance of not impeding the development of gene therapy50 and re40

Act on Assisted Reproduction Procedures, supra fh. 37, Art. 14 § 3. Id, Art. 20 § 2 Β i. 42 Id, Art. 20 § 2 Β b. 43 Id, Ait. 16 § 4. 44 The Laws of Israel, Chapter 12, Health, § 1.4 (1) (trans, by Derek Penslar). 45 Id, § 1.4(3)(b). 46 Parliament Resolution on Ethical and Legal Problems of Genetic Manipulations A2237/88 (1988), cited: in DeJager, supra fn. 22, at 1315, n. 99. 47 DeJager, supra fh. 22, at 1314. 4« Archer report, supra fn. 22 at 11, quoted in: DeJager , supra fh. 22, at 1333, n. 249. 49 Council of Europe, Parliamentary Assembly Recommendation 934 (1982) on genetic engineering ^ 4i. 50 Id, Κ 4.iii.

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commended that the Committee of Ministers recognize the right to a genetic inheritance that has not been interfered with "except in accordance with certain principles which are recognized as being fully compatible with respect for human rights (as, for example, in the field of therapeutic applications)".51 In 1986, the Parliamentary Assembly interpreted its 1982 position as recognizing "the right to a genetic inheritance which should not be artificially interfered with except for therapeutic purposes[emphasis added]52 Explicit recognition of an exception for therapeutic purposes seemed to be a rejection of absolutism and to leave open the door to geirm-line therapy. However, in 1989 the Parliamentary Assembly stated clearly, "Any form of therapy on the human germinal line shall be forbidden".53 Most recently, the Council of Europe has prepared a draft bioethics convention.54 That convention, if adopted, would authorize somatic cell gene therapy related to disease. It would, however, prohibit somatic cell enhancement therapy and all germ-line therapy.55 The drafters concluded that current scientific uncertainty about the effects of germ-line therapy on future generations56 and concern about imperilling the human species itself 5.7 required them to ban germ-line therapy. Thus, the present international situation with regard to genetic therapy is in flux. Somatic cell therapy for the treatment of disease seems to be widely accepted, although methods of regulating such therapy differ from country to country. Germline therapy is usually rejected. However, no ethical consensus opposed to germline therapy exists, and most countries have refrained from enacting a definitive ban on such therapy. A consensus that rejects enhancement therapy does seem to exist. A persuasive demonstration of the possibility of drawing a workable line between pathological and non-pathological conditions would probably go a long way toward removing opposition to germ-line therapy by removing the fear of the slippery slope to genetic enhancement.

si Id, ΐ 7b. 52 Council of Europe, Parliamentary Assembly, Recommendation 1046 (1986), Use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes Û 1. 53 Council of Europe, Parliamentary Assembly, Recommendation 1100 % 18 (1989), supra fn. 36. 54 Document 7124, Draft Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Bioethics Convention and Explanatory Memorandum, 6 Council of Europe, Parliamentary Assembly, Documents: Working Papers (1994). 55 Id, Art. 16 H 109-112. 56 Id, Art. 16 Κ 112. 57 Id, UK 10-11.

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Conclusion People and nations respond to uncertainty in different ways. As we have seen, the Council of Europe's response to scientific uncertainty about therisksof germline therapy is to suggest banning the therapy.58 Germany has done so.59 This is consistent with the view that a technology must be rejected if it presents even the slightest possibility of a catastrophic consequence.60 Other prohibitionist views can be traced to modesty about human abilities. Mauron and Thévoz have stated that germ-line therapy means curing tomorrow's people with today's techniques and conceptual tools. They argue that germ-line therapy should be rejected because it may give excessive, lasting power to a contingent state of medical science.61 Similarly, Berger and Gert argue that unless we have almost certain knowledge about the risks of germ-line therapy, no benefit to a small number of people can outweigh therisk to many 6 2 Conversely, some people respond to uncertainty by emphasizing the possibility of benefits rather than harms. In its extreme form this view leads to the assertion that not only is germ-line therapy ethically acceptable, but that medicine has a moral obligation to pursue it. 63 This article has argued that prudence dictates rejecting the arguments of both the genetic optimists and the pessimists, and that sound policy lies in attempting to reap the potential benefits of germ-line therapy while avoiding its dangers. It has suggested that elevating the values of process over substance is the best way to achieve this balanced middle view. Attention to process suggests that administrative regulation, rooted in expertise and committed to flexibility, is the most desirable way to respond to issues posed by the consideration of germ-line therapy. Adopting this approach would lead to reconsideration of the prohibition of germ-line therapy in countries like Germany and Spain, to rejection of the prohibition of germ-line therapy in the Council of Europe's proposed bioethics convention,64 and to loosening of administrative prohibitions of germ-line therapy in countries like the United States.

58

See fn. 56, supra , and accompanying text. See fh. 30, supra, and accompanying text. 60 See fn. 24, supra, and accompanying text. 61 Mauron /Thévoz, supra fn. 9, at 661-62. 62 Berger /Gert, supra fn. 12, at 680. 63 Ronald Munson/Lawrence H. Davis, "Germ-Line Therapy and the Medical Imperative", 2 Kennedy Inst, of Ethics J. 137 (1992). 64 Indeed, attention to process may suggest the wisdom of avoiding all multinational approaches to the regulation of germ-line therapy, at least for the present Bonnicksert, supra fh. 25, at 46-47.

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Modesty about our ability to understand science is a desirable attitude. So too is modesty about the ability of legal institutions to make positive contributions to the control of science. Regulation rooted in that modesty is likely to prove the soundest course.65

Zusammenfassung Die Gentherapie verschafft der Gesellschaft möglicherweise viele Vorteile. Zugleich birgt sie möglicherweise ernste Gefahren. Die Sorge über die möglichen Bedrohungen hat viele Menschen und Regierungen dazu bewogen, zumindest die Keimbahntherapie zu verbieten oder ihr Verbot jedenfalls vorzuschlagen. Auf der anderen Seite gibt es einige Leute, die die Ansicht vertreten, die Entwicklung der Keimbahntherapie sei ein moralischer Imperativ. Bei näherer Betrachtung zeigt sich, daß die Argumente für und wider die Keimbahntherapie auf Unwissenheit und bloße, unbestätigte Vermutungen zurückzuführen sind. Politische Entscheidungen, die auf ihnen beruhen, sind sehr wahrscheinlich verfehlt. Besser kann man mit den Problemen umgehen, die die Gentherapie aufwirft, wenn man den Wert rechtlich geregelter Verfahren in Rechnung stellt. Die Untersuchung der Stärken und Schwächen verschiedener rechtlicher Institutionen führt zu dem Schluß, daß flexible Verwaltungsregeln das beste Mittel darstellen, die Chancen für eine Nutzung der Gentherapie zu maximieren und zugleich ihre Risiken zu minimieren. Soweit nationale Regierungen und internationale Körperschaften sich mit Fragen der Gentherapie befaßt haben, haben sie im allgemeinen nur unzureichend auf Verfahrenswerte geachtet und auf Bedenken gegenüber der Keimbahntherapie mit einem Verbot derselben überreagiert.

« "Those entering this debate should recognize that their work is primarily in the realm of ideology, a treacherous territory. It is surely a realm where the full force of law should be left out, because of the lingering uncertainties, and where those engaged in the debate should proceed with due humility." Cook-Deegan, supra fn. 27, at 219. 5 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

Copernican Challenge of Genetic Prediction in Human Medicine Hans-Martin Sass

A revolution of Copernican dimensions is occurring in medicine and health care. Moleculargenetic information and prediction will change traditional concepts of, and attitudes towards, disease and health. We will depart from crisis-style acute intervention and develop towards non-acute predictive and preventive forms of health care. This trend will alter the way we see and determine ourselves. Individuals, as unique carriers of a genetic heritage, and society will confront challenges in health-risk literacy and responsibility as we all gain a new understanding of our individual genetic gifts and burdens. Genetic knowledge will increase the capabilities of modern medicine and call for the development of new forms of communication-in-trust and cooperation-in-trust between the lay and the professional. In part, this new knowledge will de-professionalize medicine and encourage a civil rights movement demanding the right to health education and information. It will also call for technical standards in quality control and safety to protect vulnerable persons and populations from exploitation by genetic research or from violations of confidential genetic information. Let me address only a few issues of special challenge to the global community: (a) health responsibility, (b) genetic manipulation, and (c) the culture of responsibility. The introduction of moleculargenetic prediction into human medicine creates a multitude of benefits, risks, uncertainty and even harm when compared to traditional understanding of health and disease. It affects our attitudes towards information and the self-determination and self-understanding of individuals, families, societies, cultures, and humankind. As far and as rigidly as possible, we should analyze and evaluate those challenges in open and global discourse among lay persons and experts prior to implementation and application of moleculargenetic prediction. It remains to be seen whether education, discourse and the powers of self-determination, on the one hand, or laws and regulations, on the other, will guide our choice in dealing with these new and truly Copernican challenges.

5*

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I. Health Responsibility and the Right and Duty to Know While genetic manipulation dominates public debate on the moralrisks of biotechnology, the more current and concrete challenges, benefits andrisksof genetic knowledge have not found the attention they urgently need. Knowledge facilitates exploitation and domination. But knowledge also provides power, and power increases opportunities for freedom and self-determination. The availability of oral contraceptives, for example, has done more for the liberation and emancipation of women than thousands of pages of articles, books and legislation, as it allows for differentiating between procreational and recreational forms of sexual intercourse. The truly revolutionary explosion of genetic knowledge and its challenges to competence in dealing with moral risk can best be demonstrated by developing moral and medical scenarios of predictive medicine based on genetic prediction and medical prevention. The medical and moral challenge in predictive medicine is to translate the certainties of hereditary and diagnostic facts into the uncertainties of quality-of-life parameters, health literacy and the individual citizen-patient*s self-determination, and the design of prevention and therapy [16;17]. The classical nosological difference between health and disease is no longer an adequate model for carrier-status prediction and prevention. Risk-factor medicine has started to revolutionize existing forms of medical treatment away from acute crisis-style intervention, where the physician is the prime moral agent and the patient's ethical tenets are reduced to compliance. We are moving towards non-acute long term prediction and prevention. Here, the pre-symptomatic citizen as the prospective patient is the prime moral agent in making and implementing preventive decisions. The physician becomes the expert partner for prediction, information, and education. Health-care financing systems based on principles of solidarity will have to incorporate the principles of responsibility and subsidiarity into the foundations of workable, affordable and fair systems of health-care financing. Individual decisions on leisure activities and carrier planning will have to be based on information on individual health risks. Traditional principles in medical ethics, such as truthfulness and confidentiality, will have to be re-formulated for these scenarios of prediction. As there is a right to self-determination and to protecting one's ovyn health, there has to be a societal and medical duty to inform, a professional obligation to tell the truth, and educational initiatives to teach the individual about his or her own health-risk parameters. Only in this way can we implementrightsto health and self-determination. As more sensitive information becomes available, data protection and confidentiality become prime technical and moral issues. Research in epidemiology and individual risk management requires that data be collected, stored, and accessed in a differentiated and controlled manner. Principles of privacy and respect for the individual, however, call for strict data protection. A third principle, the right to know, carries new weight. And, for the first time in modern medicine, it has become a leading principle in bioethics, particularly where knowledge relates to severe indi-

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vidual healthrisk or to the severest forms of genetic disorders in possible offspring. In my opinion, there is not only a right, but also a duty to know about one's own health risks, such as diabetes, hypertension, hypercholesteremia, and the risks of excessiveness, including smoking and heavy drinking. I also see a positive right, but not a duty to know, where risk prediction and knowledge cannot yet be translated into preventive scenarios, such as when the information regards one's status as a carrier of Alzheimer's. But I do see a definite duty to know about one's carrier status before making reproductive choices. The obligatory weight of this duty would range, depending on the health risk. It would be more imperative for some of the severest forms of genetic disorders, such as the Lesch-Nyhan Disease, or for severe disorders, such as Autosomal Dominant Polycystic Kidney Disease, the onset of which may be later in life or postponed by prudent risk management and dealt with by renal dialysis or organ transplantation. The obligatory weight of the duty would be less for genetic predispositions for hypercholesteremia or Alzheimer's. However, no obligation to live a 'healthy life' can be derived from the duty to be informed. On the contrary, imposing such an obligation would be in disrespect of the principle and culture of self-determination and self-responsibility and would lead to paternalistic and fascist dominance. The new scenarios of duty to know versus right not to know call for careful differential ethics. They cannot be based on moral generalizations, which involve the hazard of indoctrination and the risk of medically and ethically harming carriers, their quality of life and their reproductive choices. Nor do they call for eugenic governmental rules which would violate rights and interfere with the individual's own obligations of responsible parenting. Consequently, modern medicine and advanced knowledge in molecular genetics require a shift of emphasis in future medical ethics from physician ethics to lay ethics. This shift can be highlighted by the following interactive maxims in lay and expert ethics for health care, which I have structured after Dr. Gong Tingxian's famous two sets of ten rules each for the physician and the patient:

Eight Health-Care Rules for the Lay Person 1. Find truly educated and trustworthy health experts. 2. Develop competence and responsibility in healthrisk management. 3. Make extended use of predictive and preventive medicine. 4. Expect healing or relief from acute medicine, but be aware of the limits and risks of any medical intervention. 5. Expect information and advice from medical experts and be a fair partner with them. 6. Define and implement your sense of quality of life, from childhood to old age, in sickness and in health.

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7. Prepare advance directives and name proxy decision makers for circumstances of incompetence. 8. Act responsibly in the use of communal health-care funds.

Eight Health-Care Rules for the Health Expert 1. Treat your patient as a person, not just as a set of symptoms. 2. Assist your patient in developing health-risk competence. 3. Integrate the 'clinical status' and 'value status' of your patient into differential ethics, diagnosis and prognosis. 4. Be aware of the benefits, limits andrisksof acute intervention and discuss them with your patient. 5. Be an expert partner with your patient and respect his or her wishes and values. 6. Continuously educate yourself and provide the best possible clinical and personal service. 7. Assist your patient in preparing advance directives and in working with proxies for his or her own benefit. 8. Act responsibly in the use of communal health-care funds.

IL New Challenges: Healing or Enhancing? Knowledge is followed by action; action involves risks, namely technical risks and moral and culturalrisks.It is a public misconception, which has been nurtured by the media, that somatic gene therapy deals primarily with genetic diseases. Among the nine protocols approved by the Recombinant Advisory Committee (RAC) of the NIH in June 1994 there were seven cancer-related protocols, one dealing with autoimmune disease, and only one with monogenic disease (Biotechnology Watch, June 20, 1994). Worldwide, 74 protocols were approved by mid 1994, among them only 16 for conventional monogamie diseases [38,1:37]. It might very well be that somatic cell therapy will hold the clue to treating many cancerous diseases, as cancer itself and HIV are in essence genetic diseases if addressed on the genetic level. I do not see any new or sensational moral risks in promoting somatic cell protocols and in introducing somatic cell therapy, if safe and efficacious, into routine clinical practice [29;30;31], nor does the German Bundesärztekammer [6], an Enquete Commission of the German Federal Parliament [5], individuals and governmental representatives in many European countries [20], the most recent Nuffield Council on Bioethics Report [23], a preliminary draft by the International Bioethics Committee of UNESCO [38], a draft for a European Union Bioethics Convention [8], and review studies in the East [22] and

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the West [39]. Safety and quality control instruments are well in place in most countries promoting somatic cell therapy research [36;6]; most follow the blueprint of the early NIH 'Points to Consider* list. If we look into clinical application of genetic prediction, we are confronted with one of the more pressing issues in modern and future clinical ethics: the differentiation between healing and enhancement. This issue has not been addressed sufficiently enough. The transgression of modern medicine from curing and healing diseases towards improvement of capacities is not a new issue in germ-line intervention, but instead already has occurred in many forms of modern medicine [18;21;34]. Let us take the case of juvenile growth hormone deficiency and of inherited pathological or non-pathological hyposomia. Hyposomia today is treated through administration of biochemical growth hormones. Yet one day it may be treated through medical insertion of the growth hormone gene into the otherwise healthy child. Here is a story devised by David Allen and Norman Fost: 'Johnny is a short 11-year-old boy with documented GH deficiency ... His predicted adult height without GH treatment is approximately 160 cm (5ft 3 in). Billy is a short 11-year-old boy with normal secretion according to current testing methods ... He has a predicted adult height of 160 cm (5ft 3 in)' [1]. This case has recently been re-discussed by Carol Tauer. Her position is that there are entitlements for treatment only if there is (a) a GH deficiencey, or (b) other medical problems impinging on growth, but there should be no entitlement to treatment if there is growth delay or if the child will remain short because the parents are short [35]. This is a very conservative natural-law position. It suggests circumventing intervention conflicts by retreating to classical normative definitions of health and disease. What I find lacking in her position is a patient-oriented ethical responsibility to provide individualized treatment. I would suggest that the prime moral agent to decide whether or not GH should be used in either one of these cases would be initially the mother or the family, and thereafter physicians, who would propose standard routine quality proceedings. The state, or society in general, should never make these decisions. Entrusting the decision to the state would lead to an unacceptable heteronomous definition of an individual's quality of life, which can be defined autonomously only by the individual or by a valid surrogate decision-maker, such as the mother for a fetus or a young child [16;17]. To make the mother or the family the prime moral agent for decision-making follows the rules of subsidiarity, where social and moral issues are best dealt with by small and directly involved individuals and communities rather than by governments with their uniform laws and regulations [24; 17; 16]. While there is a moral challenge to develop better medicine, such an imperative should not lead to discrimination against those whose disorders cannot yet be treated [14]. What we have to develop is an integrated moral approach not to discriminate against certain disorders and handicaps and at the same time to promote and improve medical research [29;30;31;3]. Medical intervention on the basis of genetic prediction does not pose new ethical risks if compared to other forms of high-tech medicine. As for each and every form

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of medical intervention, we should recognize and respect human dignity, informed consent, special obligations towards vulnerable individuals, and the rights of the sick to adequate treatment at the highest attainable standards and to the benefits of biomedical research and its application.

ΙΠ. Germ-line Therapy and the Eugenic Caveat The majority of bioethicists now routinely defame and reject germ-line intervention as a pretext for refusing to discuss more positively the moral acceptance of somatic cell therapy [5;6;8]. I would suggest that there is no moral argument for, and no moral authority in, such uniform and generalized statements. Worst-case scenarios in human germ-line manipulation have been used to morally ban biotechnology in general, or at least in human medicine. Thousands of identically cloned soldiers or slaves, genetically designed laborers immune to pollution or simply socalled eugenic improvement of the human race or of some of the human races are the utensils in Dr. Mabuse's cabinet. But this is not a realistic picture of the future of germ-line modification in humans. Traditional forms of manipulating fellow human beings through indoctrination, exploitation, and the withholding of the means for individual self-determination are still, and will for the foreseeable future remain, the best methods for treating fellow human beings as means rather than respecting them as persons and ends in themselves. It is afiction that genetic manipulation can do the same jobs as well as withholding information and indoctrination can do. Years ago, the European Community appropriately included therightto a non-manipulated genetic identity in the list of civil rights. That position should be universally supported by all nations and cultures. But if and when reliable methods become available through genetic modification to 'heaT some of the severest forms of human genetic disorders in germ-line cells, then the benefits andrisks,medical and moral, will have to be compared to the benefits and risks of indirect 'prevention* through pre-implantation diagnosis [13; 17] or abortion, or to the benefits and risks of knowingly giving birth to severely handicapped offspring without any further moral ado. Germ-line therapy then will be an issue for responsible parents to decide whether or not germ-line intervention is a moral good or bad [2;40;16;41;3]. We are not there yet. Safe and efficacious germ-line intervention is not feasible. But it is necessary and proper that we discuss the risks and benefits of germ-line intervention today, as we need to draw a strict and distinct line between reproductive choice and responsible parenthood, on the one hand, and state administered eugenic programs on the other. It has been mentioned quite often that successful germ-line intervention will lead to discrimination of the handicapped I feel this is an ill-advised and invalid argument. The successful introduction of a polio vaccination has not led to widespread discrimination of polio victims. Provision of available and safe therapy never discriminates against anyone. On the contrary, healthy intellectuals' rejec-

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tion of medical research and the refusal to provide treatment discriminates against those who otherwise would have been healed. Discrimination against minorities, ethnic groups, the weak and the poor, in short against all 'others', is an unfortunate and unfair cultural and individual vice, which has to be addressed directly through family education, public education, and in public discourse. The law and the courts should also give it consideration, but it cannot be solved indirectly by outlawing certain forms of research, including research in gene therapy. There are five associated ethical issues related to germ-line research and it has to be determined whether or not they should be dealt with primarily within the framework of law and regulation: (1) Successful germ-line intervention will need extensive human germ-line research [3]. Such research is not acceptable for some individuals and groups, as they attribute filli moral status to the 'fertilized human egg' and recognize its right to be protected as any other person. These groups will never accept destructive research on the early embryo. Other individual and cultural positions do not see severe moralrisksin embryo research. Instead, some of them stress its probable benefits for the sick and the suffering. Both sides have their own sets of good anthropological and moral reasoning, but they defame and criminalize each other nationally and internationally. It will be a challenge to global dialogue and the individual conscience to find peaceful solutions to determining the moral status of unborn human life. This issue is too complex to be addressed here. Elsewhere I have proposed a pro-conscience model as a middle ground between the pro-life and the pro-choice groups [33]. (2) The second moral challenge rests with those who do not accept embryo research but would benefit from its results, a situation similar to cases of cruel medical research performed on unconsenting and uniformed prisoners in the Mandschury and in Germany during the Second Word War. I would like to call it the moral free-rider syndrome [3]. There are many theoretical articles in bioethics recommending that such results not be used. On the other hand, there are thousands of physicians caring for their dying or suffering patients under the therapeutic imperative, who feel they should not care how the remedies were obtained. This conflict cannot be solved by armchair ethicists. (3) Then, there is the bad guy argument : once a technology has been developed for a good purpose, it can be used for moral as well as for immoral purposes. The best example of this dilemma is the axe, developed to root out wilderness and to kill wild beasts, but then used to split the heads of foes and to kill the innocent and the weak. (4) The fourth argument is that of a slippery slope , holding that once a technology has been developed it will mushroom even within moral communities into yet unrecognized and unwarranted usage. (5) A fifth position argues that basic medical and technical needs of developing countries are so great that it would be immoral to spend so much ingenuity and

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money on highly advanced medical technologies for the very few in the rich and developed world. I take all five arguments very seriously, but they are neither new nor are they specific to germ-line intervention. I consider it malpractice in moral argumentation to resort to generalizations when particulars of moral assessment are required. Philosophical and theological generalizations are a moral and technical hazard and a great risk for those in need of medical help in the form of information and intervention [32;12]. Thomas Aquinas has already noted that generalizations lose their authority the more one moves to the details of moral scenarios, 'quanto ad particularia descenditur' [ThAq SummaTh Ι-Π 94 art 4], where particulars count in what I call differential ethics. A uniform and general ban on germ-line intervention research would be moral and cultural malpractice.

IV. Genetic Knowledge and Cultures of Responsibility The manipulation of nature mirrors human self-understanding, values, and morals. The clue to avoidingrisk in technology is to strengthen individual and cultural competence in moral risk assessment and personal responsibility. New knowledge and new forms of manipulation challenge the human race and culture with wider dimensions of responsibility and risk competence, not just in predictive medicine and in genetic modification and therapy. They call for the development of an ethos and ethics of responsibility, namely for improved forms of moral risk management in using tools, defining ends, and respecting limits. I take issue with those ethicists, such as Hans Jonas, who use worst-case scenarios to support their claim that the development and use of new technology, including not only biotechnology but also nuclear and information technology, should be banned or subjected to severe forms of governmental tutelage. Their thesis is that technological progress has outdistanced human moral capacities and therefore calls for a retardation in developing and applying modern technologies. I hold the contrary view based on the study of the history of moral and cultural risk management and on my own experience that regulating technology does not result in a morally and culturally lessrisky environment. On the contrary, heteronomous regulation involves its own moral hazards andrisks,as it reduces the individual's options to choose and to follow his or her conscience. The ethically beneficial response to increased technical capabilities is to increase education and support for individual risk competence and to provide training in moral responsibility. Moral and cultural traditions play an important role in shaping individual and societal competence to deal with new challenges. But tradition may not be used in an uncritical way, as traditions do not just contain truly moral values but also antiquated customs, which have to be cut off like the old queues once fashionable. There are at least three different ways of introducing moral traditions into modern discourse on moral assessment and of instructing the individual: (1) the authorita-

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tive and regulative way, which is favored by the patrons of hierarchical value assessment, such as recently expressed by the Vatican Encyclical Veritatis Splendor [21], (2) the educative and exhortative way, where the individual conscience seeks guidance from the wisdom of the past, often by seeking guidance from God in interpreting classical texts, and (3) the discursive and adjuvant way by making the best use of traditional forms of moral risk management. The risks inherent to the authoritative model include the suppression of individual conscience and the promotion of double standards, and the risk that the authorities might change the course of fatherly instruction. The discursive model fits best into the scenarios of moral assessment by educated andrisk-competentindividuals. It is the model of the future, but it needs to make good and more careful use of the treasures hidden in the moral history of many cultures [33]. Just as cultural traditions differ, so will the moral solutions which they will support or not support. Western definitions of brain-oriented models for death, which are based on concepts of a difference between the immortal soul and the mortal body or on concepts of understanding and self-understanding, face many obstacles in Asian cultures, which treasure the indivisible nature of the human being. The more moral issues are related fo the basics of life, death, pain, liberty and justice, the more we will find cross-cultural consensus for prima facie humanrights and obligations. The more the issues are culturally rather than biologically defined, the more widespread cultural diversity will be [28]. The recognition and protection of basic human and civilrightsis an issue of solidarity within pluralistic societies and among the plurality of cultures. Theserights can be called pre-cultural rights and obligations, as they have to be respected in all cultures of human dignity. The Human Genome is, first of all, a personal heritage from parents to children, and thus also a heritage of humankind. It has to be protected and treasured as such. Traditional moral principles such as autonomy, privacy, justice, equity, literacy, and responsibility have to be re-defined in the light of benefits, risks,and uncertainties of applying genetic knowledge. The principle of subsidiarity , first developed in social ethics but very well designed to handle bioethical issues as well, favors moral risk management by those who are directly involved and rejects heteronomous rules and requirements contained in general norms, which are imposed externally onto those who are the prime and personally challenged moral agents. The principle of subsidiarity relieves governmental and societal institutions from forming and implementing a consensus where a consensus cannot be achieved because each individual's conscience calculates the moral options differently based on his or her own set of moral priorities. It also strengthens the individual's conscience by requiring final moral responsibility rather than formal obedience to regulations and laws given by others. As long as therightsof other members of the moral community are not infringed, the principle of subsidiarity should allow individuals to make moral choices whenever theologians, ethicists, lawyers and politicians disagree on such crucial questions as when unborn life should be protected or when a human life is over,

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whether to give or receive organs, whether to differentiate between procreative and recreative forms of sexual intercourse, whether to have children and if so how many, and which genetic disorders warrant medical intervention. The principle of subsidiarity should also be employed within cross-cultural dialogues and intercultural conflict solutions within the global village. It will have to tolerate some unshared cultural attitudes and traditions held by others who have their own distinct set of rules, goals, and obligations, as long as those traditions do not violate individual human and civil rights. Cultures of responsibility are not threatened by giving individual conscience and risk management more rather than less responsibility. As Spinoza observed in his Tractatus Theologico-Politicus of 1670, the freedom of individual responsibility from indoctrination neither threatens truth nor society, but the destruction of the individual conscience will finally result in establishing the powers of destructive dominance. Legislating and regulating individual conscience in essential matters of moral concern and cultural goals has rarely worked. What we need is a culture which can deal with societal consensus as well as dissension. There are certain aspects of life, visions, responsibilities, and principles which are so important to us that we would rather disagree with others, than uniformly agree to the dominant powers of paternalism, religion, and fashion. Of course, there have to be some rules and regulations on how to handle machines, technologies, biotechnologies, and the technicalities of regulation and enforcement. Human and civil rights have to be protected by law, police, courts, and governments. But we must, above all, strengthen the ethos and ethics of responsibility in support of individual self-determination, cultural diversity and political stability. Let me conclude my reflections on the use and abuse of laws and regulations as elements for structuring human attitudes and cultures with a word from Lao Tzu: 'we make doors and windows for a room, but it is these empty spaces that make the room liveable' [19].

Zusammenfassung Die faszinierenden Fortschritte molekulargenetischen Wissens, vor allem die weitere Entzifferung des menschlichen Genoms, stellen das individuelle Selbstverständnis vor die Forderung nach einer kopernikanischen Revolutionierung der Denkungsart und führen die Anforderungen an Mündigkeit und Selbstverantwortung in neue Dimensionen von Aufklärung und Selbstbestimmung. Die rasante Entwicklung prädiktiver und präventiver Leistungen moderner Risikofaktorenmedizin fordert vom medizinischen Laien Gesundheitsmündigkeit und vom medizinischen Experten neue Formen beratender und begleitender Dienste. Genetische Prädiktion schwerer Erbkrankheiten macht eine ethische Diskussion des Begriffs verantwortlicher Elternschaft unerläßlich, ebenso die Zurückweisung von Forderungen nach einer staatlich administrierten oder geförderten Eugenik. Gesundheitspolitik und -Finanzierung werden deshalb Prinzipien wie Selbstbestimmung

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und Subsidiarität, sowie das traditionelle Prinzip der Solidarität, in der Diskussion um Verantwortung und Finanzierung von Gesundheit neu ausmessen müssen.

Literature [1] Allen, D.B ./Fost, N.C., "Growth Hormone for Short Stature", Journal of Pediatrics, vol. 117(1990), 16-21, at 18. [2] Bonnicksen , A.L., "National and International Approaches to Human Germ-Line Therapy", Politics and the Life Sciences, vol. 13 (1994), 39-49. [3] Bräutigam , H. H J Schnabel, U J Epplen, J./Sass, H.-M., "Darf man in Keimzellen eingreifenT, Die Zeit 26:35 [June 24,1994]. [4] Bundesrepublik Deutschland, Gesetz zum Schutz von Embryonen [Embryonenschutzgesetz, ESchG], vom 13. Dezember 1990 (BGBl. I, 2746). [5] Bundesrepublik Deutschland, Enquete Kommission Gentechnologie, Chancen und Risiken der Gentechnologie, Bonn: Heger [Bundestagsdrucksache 10/6775] (1987). [6] Bundesärztekammer, "Richtlinien zum Gentransfer in menschliche Körperzellen", Deutsches Ärzteblatt 92(11) (1995), C507- 512. [7] Council of Europe, "Council Directives on the Contained Use and on the Deliberate Release into Environment of Genetically Modified Organisms", Official Journal of the European Communities 17 (1990), (L):l-27. [8] Council of Europe, Draft Convention for the Protection of Human Rights and the Dignity of the Human Being: Bioethics Convention, and Explanatory Report, Strasbourg: Council of Europe, 1994. [9] Eschbach, J.W., "Nephrology Forum", Kidney International, vol. 35 (1989), 134-148. [10] Friedman , E.A., "Facing the Reality: The World cannot afford Uremia Therapy at the Start of the 21st Century", Artificial Organs 19 (1995), 481-485. [11] Fuchs, J., "Das Gottesbild und die Moral innerweltlichen Handelns", Stimmen der Zeit 6 (1984), 363-382. [12] Haering, B., Ethik der Manipulation, Graz: Styria, 1977. [13] Handyside , A.H., et al , "Birth of a Normal Girl after In-Vitro-Fertilization and Pre-Implantation Diagnostic Testing for Cystic Fibrosis", New England Journal of Medicine 327 (1992), 905-909. [14] International League of Societies for Persons with Mental Handicaps, Just Technology? From Principles to Practice in Bio-Ethical Issues, North York/Ontario: LTnstitut Roeher, 1994. [15] Jonas, H., Das Prinzip Verantwortung, Frankfurt/M.: Insel, 1979. [16] Kielstein y R , "Cultural and Individual Risk Perception in Human Germ-line Therapy Research", Politics and Life Sciences 13 (1994), 241-243. [17] Kielstein , R./Sass, H.-M., "Right not to Know or Duty to Know? Prenatal Screening for Polycystic Renal Disease", Journal of Medicine and Philosophy 17 (1992), 395-405.

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[18] - / - "From Wooden Limps to Biomaterial Organs", Artificial Organs 19 (1995), 475480. [19] Lao Tzu , Tao Teh Ching, Boston: Shambala, 1989. [20] Lenoir , N., Aux Frotiers de la Vie: Une Ethique Biomedicale a la Française, Paris: La Documentation Française, 1991. [21] Linke, D.B., "Die dritte kopemikanische Wende. Transplantationsmedizin und personale Identität", Ethica 1 (1993), 53-64. [22] Macer, D.R.J., "Perception of Risks and Benefits of In Vitro Fertilization, Genetic Engineering, and Biotechnology", Social Science and Medicine 38 (1994), 23-33. [23] Nuffield Council on Bioethics, Human Tissue. Ethical and Legal Issues, London: Nuffield Council, 1995. [24] Pius XII, Encyclica Quadragesimo Anno, Rom 1931. [25] Press , N./ Browner, C.H., "Risk, Autonomy, and Responsibility", Hastings Center Report Special, Suppl. May-June (1995), S9-S12. [26] Johannes Paul II, Encyclica Veritatis Splendor, in: Vatican: Libreria Editrice Vaticana, 1993. [27] Sass, H.-M., "Mensch und Landschaft", in: G. Höhl, ed: Landschaft und Mensch, Mannheim: Verlag Humboldt Gesellschaft, 1981, pp. 293-322. [28] - "The moral a priori and the Diversity of Cultures", Analecta Husserliana 20 (1986), 407-422. [29] - "Philosophical and Moral Aspects of Manipulation and Risk", Swiss Biotech 5 (2a) (1987), 50-56. [30] - "Methoden ethischer Güterabwägung in der Biotechnologie", in: V. Braun, et al., eds: Fragen der Gentechnologie und der Reproduktionsmedizin, München: Schweitzer, 1987, pp. 89-110. [31] - (ed.), Genomanalyse und Gentherapie, Heidelberg: Springer, 1991. [32] - "Generalisierender Moralismus und Differentialethik", in: K. Röttgers, et al., ed: Politik und Kultur nach der Aufklärung. Festschrift für Hermann Lübbe, Basel: Schwabe, 1992, pp. 186-205. [33] - Die Würde des Gewissens und die Diskussion um Schwangerschaftsabbruch und Hirntodkriterien, Bochum: Zentrum Medizinische Ethik, 1994. [34] Shapiro , M.H., "The technology of perfection. Performance enhancement and the control of attitudes", Southern California Law Review 65 (1991), 11-113. [35] Tauer , C.A., "Human Growth Hormone: A Case Study in Treatment Priorities", The Hastings Center Report. Spec. Suppl. May-June (1995), S18-S20. [36] US, National Institute of Health, "Points to Consider in the Design and Submission of Human Somatic Cell Therapy Protocols", Federal Register 50/160: 33463-33467,1985. [37] US, Office of Technology Assessment, Biotechnology in a Global Economy, Washington DC: Government Printing Office [OTA-BA- 494], 1991.

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[38] UNESCO , International Bioethics Committee, Proceedings 1995, vol. I and Π, Paris: UNESCO (DRG.95/WS. 1 and 2) (1995). [39] Wertz , D.C J Fletcher, J.C. / Mulvihill, J.M., "Medical Geneticists Confront Ethical Dilemmas: Cross-Cultural Comparisons among 18 Nations", American Journal of Human Genetics 46 (6) (1990), 1200-1213. [40] Wimmer; R., "'Kategorische Argumente' gegen die Keimbahntherapie?", in: J.P. Wils/ D. Mieth, eds: Ethik ohne Chance?, 1989, pp. 182-209. [41] Wivel , N.A J Walters, L., "Germ-Line Gene Modification and Disease Prevention: Some Medical and Ethical Perspectives", Science [Oct. 22,1993] (1993).

Clinical and Clinical-Ethical Aspects of Genetic Prediction The Case: Hereditary Kidney Disorders Rita Kielstein

Introduction: A Multi-Generational Family Story Mrs. Winter was 55 years of age in 1981, when she became a patient in our dialysis unit. As a carrier of Autosomal Dominant Polycystic Kidney Disease (ADPKD), she had developed renal insufficiency. In 1977, ultrasound diagnosis confirmed the presence of large cysts in both kidneys and in the liver. After Mrs. Winter became a dialysis patient, her four sons underwent ultrasound screening, which showed that all of them were pre-symptomatic carriers of ADPKD. At the time, they were all still living healthy lives. These were the reactions of the sons after they learned about their carrier status: First, the sons accused their mother for having as many as four children even though she knew that this severe disease ran in the family. Mrs. Winter's father and his two brothers had also died of renal insufficiency caused by ADPKD. Albert, 32, married, and father of a 6-year old son, committed suicide when he developed the first symptoms of pain and renal dysfunction three years later. Otto, 30, married, sold a house, which was half completed, when he learned about the diagnosis. He did not want to make long-term plans for his life and burden his family with a mortgage. Karl, 25, and his fiancée dissolved their engagement, because Karl did not want to have children, nor burden his fiancée with his own genetic predicament. Now, 15 years later, Karl has died suddenly of a rupture of an aneurysm in the blood vessels of his brain; he had never been a dialysis patient, and he had been fully employed as a construction worker up to the moment when he collapsed on his job. Paul, 21, the youngest and a student at the time, did not complete his studies and took a job in order to make money and enjoy life while it lasted. The Winter family story very clearly demonstrates different ways of translating DNA prediction into real life situations. That, in short, is the clinical and ethical challenge of DNA testing for severe human hereditary disorders. We are not just talking about genes and DNA, we are talking about fellow humans, brothers and sisters, mothers, families, with their hopes, fears, pain, satisfaction, and enjoyment and suffering in life, discrimination and denial, ethics, and sometimes, the law.

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I. DNA-Based Prediction of Severe Genetic Disorders Molecular genetics has identified over 4000 factors relevant for hereditary diseases, and every day new factors are described and identified. As far as our epidemiological information goes, every 90 seconds a child is born somewhere in the world with a severe hereditary disorder. Two percent of all newborns have genetic disorders of the highest severity, which are life-threatening, or reduce the quality of life or span of life. Severe genetic disorders occur in four groups of disorders: CBlum, 1993): (1) Hemoglobinopathy: sickle cell anemia, beta-thalassemia; (2) Enzyme disorders a) Carbohydrate metabolism: galactosemia; b) Amino acid metabolism: phenylketonuria; c) Lipid metabolism: Gaucher's disease, Tay-Sachs disease; d) Mucopolysaccharide metabolism: Hunter syndrome, Hurler syndrome; (3) Other Diseases in Metabolism: lack of alpha-trypsin, Lesch-Nyhan disease, Xeroderma pigmentosum, Duchenne's disease, Cystic Fibrosis; (4) Oncological and Other Diseases: Retinoblastoma, Leukemia, Lymphoma, Huntington's chorea, Alzheimer's disease, Hemophilia A and B, Neurofibromatosis Recklinghausen, Friedreich's Ataxia, and ADPKD. Not all hereditary diseases are of the severest form. Among the most severe is Cystic Fibrosis (autosomal recessive), a multi-system disorder which is characterized by an abnormality in exocrine gland function. Nearly all patients develop chronic progressive disease of the respiratory system. Pulmonary disease is the most common cause of death and morbidity. Multiple clinical features include disturbances of the gastrointestinal tract, reproductive system and skeletal system. Currently the median survival age is about 20 years. The majority of Cystic Fibrosis patients are diagnosed in infancy or childhood. One of the most brutal disorders is Huntington's Chorea, (autosomal dominant) characterized by a combination of involuntary choreoathetotic movements and progressive dementia, usually beginning in mid-adult life. Younger patients, with an onset of symptoms at the age of 15-40, suffer a more severe form of disorder than older patients, with an onset in the 50s and 60s. Lesch-Nyhan disease is an X-chromosomal-linked disorder of purine-metabolism. Affected patients have hyperuricemia and over-production of uric acid with uric acid stones. In addition, they have bizarre neurologic disorders, characterized by self-mutilation, hyperreflexia, choreoathetosis, spasticity and retardation of growth and mental function. The onset of symptoms begins at a young age, between 15 and 30. DNA factors inform us of the predictability of disorders, not of their severity, time of onset, severity of symptoms, or of the patient's expected life-span and quality of life, or of the availability of preventive options. Therefore genetic knowledge has to be translated into real life situations and predictions of the reactions of families and individuals to this knowledge. Genetic risk factors alone do not predetermine the individual quality and the personal fate of human life. That is the clinical and ethical challenge to carriers, physicians, and society.

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Π . Risk and Responsibility of Patients with ADPKD Individual, professional and societal challenges can be highlighted by ADPKD. This is a systemic disorder producing innumerable cysts of varying size in both kidneys, in the liver, pancreas and ovaries. There are also structural abnormalities in the gastrointestinal tract, e.g. colonic diverticulae, and in the cardiovascular system, e.g. cardiac valvular abnormalities, thoracic aortic aneurysm, berry aneurysm of blood vessels in the brain. About 5-10 percent of all patients on dialysis treatment suffer from cystic kidney disease. The countries of the European Union spend roughly 4 billion Ecu each year on renal replacement therapy, dialysis and transplantation. Thefrequency of ADPKD is 1:1000, which is more frequent than Cystic Fibrosis or Huntington's Chorea. An. estimated half a million people have the disease in the United States. It is inherited as an autosomal-dominant trait with 100 percent penetrance. Hence each child of a carrier has a 50 percentrisk of becoming a carrier her or himself. No sex preference is noted.

L Genetics and Prognosis Careful studies of patterns of DNA fragments have revealed consistent differences in the structure of DNA in the short arm of human chromosome 16 in association with ADPKD (Breuning, 1990). Recent observations (Kimberling , 1988) indicate, that at least two different defects can be responsible for a very similar clinical picture, which cannot be distinguished in a single patient. PKD-2-carriers live into their 7th to 9th decades and often die of non-renal causes. PKD-1-carriers have symptoms and signs of the disease in their 4th and 5th decades. It is the usual experience that knowledge about the nature of ADPKD, even in affected families, is poor. It was the European Kidney Disease Consortium, including researchers from Leiden, Cardiff, Oxford, and Rotterdam, which found the gene in 1994, located on the short arm of chromosome 16. Luckily the group found a large gene close to TSC2 in a Portuguese family; they called this gene PBP, the polycystic breakpoint gene. Thereafter this gene was isolated, sequenced and used in DNA screening for patients with PKD. Since then many small and new mutations have been found frequently in patients, and it is expected that one will find many more alterations in the gene (Breunings , 1994). Cysts are present in the kidneys from the 12th week of gestation. Very slowly these cysts grow in size and number, thereby destroying the functional tissue of the kidneys. End-stage renal failure usually occurs between age 40 and 60, but in fact varies considerably between patients, even between members of the same family. Autosomal dominant disorders are in general characterized by variability in age of onset and in phenotypic expression. The clinical age of onset is defined by the age at which symptoms appear or cysts can be found. The ages differ, depending upon the circumstances of inquiry (Gabow; 1993). The age of onset is also influenced by the technique used for screening. 6*

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The diagnosis of late stage ADPKD is easy: hypertension, abdominal pain, bilateral flank masses, hematuria or azotemia contribute to the typical clinical picture. Pre-symptomatic diagnosis can be done by ultrasonography, Computed-Tomography, or Magnetic Resonance Imaging. Since only about 60 percent of the patients will report a family history of this disease (Gardner, 1989), pre-symptomatic, and even prenatal and pre-implantation diagnosis, can be done by methods of molecular genetics. DNA-based diagnosis is superior to ultrasound or x-ray based diagnosis as it can be done much earlier, either by analyzing morula cells prior to implantation (Handyside, 1992) or by analyzing fetal cells collected from maternal peripheral blood by non-invasive methods (Kürten, 1993, Lo, 1993) or by amniocentesis or chorion villus biopsy.

2. Symptoms and Signs Pain, caused by expanding and large kidneys, is the most common clinical symptom of ADPKD in adults. Usually the pain is dull and constant, localized in the flank or lateral abdomen. Acute pain may arise from hemorrhaging into a cyst or passage of a blood clot or stone. Sometimes inflammations spreading to the renal bed from an infected cyst cause discomfort, usually in association with fever. Pain gradually increases over a patient's lifetime, ultimately affecting more than 50 percent of the individuals. Fifty percent of adult subjects with ADPKD experience hematuria at some time prior to diagnosis. Rupture of the cyst wall is blamed for the episodic hematuria in some patients. Episodes of gross hematuria can occur with strenuous physical activity and may last from days to weeks. Gastrointestinal complaints of nausea, vomiting, and diarrhea are less common than renal symptoms, but can pose significant problems for occasional patients. Headaches, often severe and recurrent, are a common occurrence unrelated to hypertension. Headaches may be caused by berry aneurysms of the blood vessels in the brain. They occur in 10-40% of affected persons and can rupture and cause sudden death. Palpable hepatomegaly can be found in approximately one-half of individuals with ADPKD. It rarely causes symptoms or hepatic dysfunction or pain. Hypertension is a common finding in otherwise healthy patients and occurs in approximately 60 percent of non-azotemic patients. There are no typical changes in blood chemistry (anemia, serum-creatinine and serum-urea levels) until the onset of renal insufficiency. (Grantham, 1984) We consider ADPKD to be a systemic disorder in which the phenotypic manifestation of the abnormal gene spans an array of organ systems. Not every affected individual manifests all possible aspects of the disorder. Both inter-familial and intra-familial variability occur in the extrarenal manifestation of ADPKD. Intra-familial variability is illustrated by differing manifestations and severities of structural defects despite similar ages. Such intra-familial variability may reflect the influence of the non-ADPKD allele, of other genes, or environmental factors.

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3. Risks and Patients ' Responsibilities As the Winter family story shows, clinical manifestation as well as pre-symptomatic knowledge about the ADPKD disorder translates into very different individual life stories. To be informed about one's own carrier status is important for good hypertension prevention and for avoidance of work-related or sports-related cyst ruptures; methods and responses in coping will be different individually. Pre-symptomatic knowledge also seems to be important for planning one's life in light of the probability of dialysis treatment or kidney transplantation. Decisions include carrier planning, occupational, professional, and recreational activities, family planning, and social and cultural interaction. Each individual will translate her or his carrier status and symptoms into different parameters of individual life, its qualities, goals, and limitations. Knowledge is important for adopting preventive life-style measures, for example and most essential, hypertension control. Heavy physical work and some recreational activities such as jogging, horseback riding, wrestling, and soccer are not recommended because they might cause hematuria. It is also important to know about one's carrier status when making reproductive choices. Self-determination requires each carrier to have adequate information, knowledge, and counselling in carrier planning, life style and family planning. My clinical experience leads me to conclude that persons at risk have a duty to learn about their carrier status and that clinicians, geneticists, and families are responsible for consulting with the carrier on medical and non-medical risks and decisions. The challenges for ADPKD-patients include the medical control of symptoms, and, even more importantly, the challenge of redefining their personal values and goals. These challenges can be summarized in an Action Guide' for ADPKD-patients: 1. Accept your disease and, within its limitations, redefine the parameters for your quality of life; 2. Redefine your roles within the family, among friends and peers. Be active, and find personal fulfillment and public recognition in achieving new goals set by yourself; 3. Be responsible in your compliance with your physician's advice; 4. Expect more than medical and technical intervention from your physician; expect advice and understanding regarding the side effects of your disease and its treatment; expect partnership and assistance in redefining your quality of life; 5. Define your concept of responsible parenthood in making reproductive choices.

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ΠΙ. Parents9 Risks and Responsibilities 1. The Case of Anita M. The ethical parameters of responsible parenthood for carriers of severe genetic diseases are well illustrated in the case of Anita M. Anita had been diagnosed as a carrier of ADPKD at the age of 16 when she was a subject in a research project which studied the family history of patients with this disease. Five years later she was 21 years old and pregnant. Her mother, 45, divorced, is a RDT-patient, and her grandmother has just died from liver complications after being in dialysis treatment for 14 years. Anita requested prenatal testing, which now can be done by genetic screening. She expressed an obligation not to give birth to a baby with definite diagnosis and prognosis of ADPKD, as that means dialysis dependency in later years, and the certainty of decreased life quality due to renal complications, pain, and hypertension. It also involves a form of suffering and dying which she had just witnessed in her grandmother's last years. The test identified the fetus positively as a carrier. Anita scheduled a counselling session prior to setting a date for selective abortion, but she missed this appointment, never called back, and probably has moved somewhere else and given birth to her child.

2. Values at Conflict In Anita's case there are at least four different values in conflict: respect for life, self-determination, responsible parenthood, and family planning. As in most cases of reproductive ethics, Anita faces a special challenge in balancing the respect for unborn life and responsible parenthood. This is a different situation from normal conflicts between right to choose (self-determination of the mother) and right to live (respecting the fetus's interest in potential life). Anita's fetus carries a severe genetic disorder which forecasts, if nothing else happens, uncomfortable dialysis treatment or transplantation, which reduces the quality of life, plus all other associated burdens and symptoms of ADPKD. (Kielstein, 1995) Aborting the fetus might be an ethical option of responsible parenthood, and, indeed, it was Anita's predetermined choice. The fact that she did not have the abortion might have been caused a) by emotional stress, b) by actual situational ethical uncertainty, c) by her expectations of becoming a mother and having a baby, no matter what the carrier status was, d) by a tendency to avoid making any decisions, or e) by having trust in the progress of ADPKD treatment over the next 30 years, until the onset of her fetus's symptoms. (Kielstein /Sass, 1992)

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3. Medical Moral Scenario for Responsible Parenthood I see at least 8 scenarios of decision making in reproductive ethics for severe genetic disorders in cases similar to Anita's: 1.) Give Birth : Giving birth and establishing a family is a very normal individual and cultural goal in a woman's life. An ADPKD carrier most likely will be 'healthy' and happy for a long period of time and might even die of other causes long before the onset of severe symptoms. The offspring might have a family of his or her own, and over the next few decades progress in medicine might develop new methods of prevention, healing, or treatment of kidney cysts. On the other hand, the mother knowingly gives life to a carrier of a very severe genetic disorder. Can she responsibly do that being aware of many future risks and uncertainties, including expensive and uncomfortable dialysis treatment or transplantation? Also accusations of irresponsible parenthood may come from the offspring, the spouse, the family, society and insurance companies. 2.) Abortion : Anita could have chosen abortion as her preferred means of contraception because she did not want to give birth to a child having the same disease as her mother, grandmother and herself. But other family planning methods such as sterilization, the use of contraceptives, or selective abortion only after prenatal diagnosis, would be more morally acceptable. 3.) Abortion after Prenatal Diagnosis: This decision would emphasize the principle of responsible parenthood more strongly than the principle of respect for life or giving birth in general. If parents have responsibilities toward their children, then there is a prime parental duty not to harm the unborn by an unhealthy life style, such as smoking cigarettes or drinking alcohol excessively. Consequently there might be a duty not to give birth to a child 'harmed' by one's own severe genetic disorder. 4.) Pre-implantation Diagnosis: Carriers of severe hereditary diseases might prefer pre-implantation diagnosis over selective abortion for medical, ethical, and emotional reasons. Pre-implantation diagnosis has been reported to be successful in Cystic Fibrosis {Handyside, 1992) and might become the ethical instrument of first choice in responsible parenthood decisions. 5.) Not Having Children: This alternative might be a choice for those who, for religious or ethical reasons, do not accept diagnosis or selection of unborn human life. 6.) Not Getting Married: This, or the choice to have no heterosexual partners, most likely will be based on decisions other than reproductive decisions but will have the side effect that carriers will not implant their own severe disorder into other (new) people. In the modern world the carrier status also could be used as an excuse for a responsibility-free single's life style. 7.) Adoption : Adoption of a non-carrier would allow for having a child of one's own who would not be a carrier, but family planning by adoption would come

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within the well-known parameters of the ethical and emotional 'pros and cons' of adoption.

8.) Giving birth to a carrier and letting the earner be adopted by others would be a worst case scenario for responsible parenthood. There are never uniform medical or ethical cases. Each case will be different medically and ethically, as will the family situation and the surrounding culture. I recommend that we avoid inflexible legal or medical standards for handling reproductive choices of ADPKD carriers or any other carriers of severe genetic disorders. Rather, I feel non-directive counselling would be the best ethical approach for clinicians and geneticists. In my opinion, severe genetic disorders are part of the family history and should be dealt with within the family and not regulated by governmental or medical authorities. In order to assist the patient in making responsible decisions and reproductive choices, a four-step approach in medical and ethical counselling can be used. This four-step method helps the carrier, pre-symptomatic or symptomatic, to make decisions for her or himself or in family planning. The first step identifies the problem by a) collecting DNA-based data and b) human data and c) identifying value elements. In a second step, the consultant a) establishes the medical prognosis for different future scenarios, b) identifies the ethical principles and problems for each scenario, and c) discusses medical, ethical and personal issues within each scenario with the patient. A third step addresses risks and risk management by a) discussing medical and moral uncertainties, b) identifying moral agents, and c) assisting the patient in defining 'the best solution.' In a final step, the consultant assists the patient in reviewing the patient's decision by a) asking her or him to clearly specify her or his reasoning, b) addressing uncertainties and risks associated with the patient's reasoning, and c) defending her or his decision. 4. Identifying

Risk Takers and Moral Agents

Moral agents for making decisions, exclusively or jointly, could be the legislature, insurance companies or health care systems, religious or societal groups, consulting professionals (clinician and/or geneticists, ethicist, or team), families, spouses, or women. In this and the following scenarios, my personal choice would be to make the woman the prime moral agent for reproductive choice and responsible parenthood. She is the nucleus, as she carries the future person in her; it is a part of her body, and no one has access to it. Other persons in a wider circle of those responsible would include primarily the spouse and then the family, physician (primarily clinicians rather than geneticists) and ethicists, who should have consulting but not decision-making authority (nondirective counselling!). I see some reasons for moral input on behalf of the health payment system (however that is organized), but very minimal staterightsto inter-

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vene in very private family matters. There might be a difference between post-Enlightenment European individualism and traditional Confucian and Asian thinking within theframework of family network and solidarity, which I hope we will address in detail in our discussions on the multi-cultural and cross-cultural nature of moral decision-making in reproductive ethics.

IV. Conclusions Let me conclude with questions rather than answers. Answers are not easy in modern pluralistic societies based on individual self-determination; they are even more complicated in the global, multi-cultural world. Predictive medicine presents new scenarios for physician-patient interaction and will change priorities among traditional principles, maxims, and models of medical ethics. As far as I see it, from the clinical point of view, modern biotechnology is more a challenge for ethics and attitudes than for the law. If politicians and legal experts succeed in regulating each and every issue in the clinical prediction of biomedical disorders and risks, we might destroy the individual responsibility of carriers, families, and physicians. Dealing with genetic heritage and with individual visions of life and quality of life is rarely something which is either right or wrong, as is the case in the law, but rather something related to responsibility, self-determination, advice, mistakes, and individual attitudes. Also, progress in DNA testing and in predictive medicine is more a challenge to the ethics of lay persons than to the medical profession. Acute crisis-style intervention, step by step, will have to be replaced by non-acute predictive or preventive discourse. New methods of assessing technical and ethical risks and probabilities will have to be developed in order to translate certainty and hereditary facts into uncertainty of prognosis and healthrisks,quality-of-life parameters, health literacy and self-determination of the citizen/patient, and the design of prevention and therapy. The clinical and ethical challenges of DNA-based predictive medicine can be summarized around five questions: (1) Who is the prime moral agent? Progress in genetic knowledge will make the carrier of genetic disorders the prime moral agent for prevention, treatment, and acceptance of individual health risks and disabilities. The health care establishment has to provide predictive information, consultation and treatment services. Society is responsible for allocating health care resources and health care services, and for the protection of individual data. (2) Is there a duty to know or arightnot to know? Carriers of health risks should have the right to full information, consultation and service in regard to their individual disorders. There is a duty to know about

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genetic healthrisksif such knowledge can be made instrumental in postponing, reducing, avoiding or preventing the acute outbreak of diseases or disorders. There is no obligation to know about the disorders which cannot be prevented, postponed or reduced by having such information. Nor can there be an obligation to live a healthy lifestyle. (3) How will predictive medicine influence future medicine? Predictive medicine will change the health care establishment by emphasizing prediction and prevention over acute care, and will require a change in traditional paternalistic relations between physician and patient. The medical establishment has an obligation in developing new forms of partnership in physician/patient interaction. (4) How will predictive medicine influence future medical ethics? Predictive medicine is a challenge to everyone, the healthy, the ill, the lay, and the experts. New forms of health literacy and health responsibility of the educated citizen have to be developed. (5) How will the 'global village' deal with moral issues? There will be individual and culturally different responses towards the challenges of genetic knowledge. Family and parents will have to redefine the concept of responsible parenthood. Individuals and cultures will have to realize that everyone is a carrier of one or another disorder, gift or burden, and have to develop a new dimension of understanding of responsible brotherhood, responsible sisterhood, responsible parenthood, and responsible 'love of your neighbour' and a new understanding of the precious gift of human individuality and family destiny, challenge, and opportunity.

Zusammenfassung Die Sicht des klinisch tätigen Arztes zu Problemen des Umgangs mit genetischen Kenntnissen wird geprägt von der täglichen Routine in der Behandlung der Patienten, die ein genetisches Leiden haben und vom Umgang mit den Menschen, die praesymptomatische Träger eines genetischen Leidens sind. Fortschritte in der Humangenetik erlauben die Erkennung von schweren vererbbaren Erkrankungen wie z. B. der Zystischen Fibrose, der Chorea Huntington, der Duchenn'schen Muskeldystrophie oder der Polyzystischen Nierenerkrankung vom Erwachsenentyp (ADPKD) mittels genetischer Analyse. Da für diese Erkrankungen derzeit weder effektive therapeutische noch praeventive Mittel zur Verfügung stehen, muß von Trägern einer solchen Erkrankung ein kompetenter und verantwortlicher Umgang damit entwickelt werden. Das betrifft sowohl die Kompetenz für die eigene Gesundheit als auch die Neudefinition einer verantwortlichen Elternschaft. In die-

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sem Zusammenhang scheinen aus heutiger Sicht die Praeimplantationsdiagnose oder der frühzeitige Schwangerschaftsabbruch bei Kenntnis der genetischen Diagnose als klinisch mögliche und ethisch akzeptable Instrumente der Realisierung einer neuen »Reproduktionsethik1. Am Beispiel der ADPKD wird die Bedeutung der genetischen Erkenntnisse auf die medizinische Ethik und die ,Trägerethik' erörtert.

Literaturverzeichnis Blum, H.E. / Weizsäcker, F. v. / Walter, F., „Gentechnologie und medizinische Bedeutung", Deutsche medizinische Wochenschrift 118 (1993), 629-633. Breunings M.H. / Snijdewint, F.G.M./Brunner, H ./Verwest, A ./Lido, S.W./Saris, J.J JDauwerse, Ì.G.I Blonden, L.t Keith, Ύ. /Callen , D.FJHyland V.J./Xiao, G.H./Scherer, G./ Higgs , O.K./Harris, ?./Bachner, L./Reeders, ST./Germino, G./Pearson, P.L./Ommen, G.J.B, van, "Map of 16 Polymorphie Loci on the Short Arm of Chromosom 16 Close to the Polycystic Kidney Disease Gene (PKD 1)", Journal of Medical Genetics 27 (1990), 603-613. Breuning , M.H ./Peters, D.J.M., "Polycystic Kidney Disease - What's New?", Nephrology, Dialysis, Transplantation 9 (1994), 1707-1708. Gabow, P.A., "Autosomal Dominant Polycystic Kidney Disease", in: Kenneth D. Gardner, Jr./Jay Bernstein, eds: The Cystic Kidney, Kluwer Academic Publishers, 1990, pp. 295326. Gardner, K.D., jr., "Hereditary and Congenital Renal Disease", in: Shoul G. Massry/Richard J. Glassock, eds: Textbook of Nephrology, vol. 1, 2nd Edition, Baltimore/Hongkong/ London/Sidney: Williams & Wilkins, 1989. Grantham , J.J./Slusher, S.L., "Management of Renal Cystic disorders", in: Suki, W.N./ Massry, S.G., eds: Therapy of Renal Diseases and Related Disorders, Boston: Martinus Nijhoff, 1984. Handy side, A.H ./Lesbo, J .G./Taris, J.J ./Robert, M.L. / Winnton, Hughes M.R., "Birth of a Normal Girl After In Vitro Fertilization and Preimplantation Diagnostic Resting for Cystic Fibrosis", New England Journal of Medicine, vol. 327, 13 (1992), 905-909. Kielstein, R., „Klinik, Genetik und Ethik der Autosomal Dominant Polyzystischen Nierenerkrankung", Medizinethische Materialien, Heft 82, Ruhr Universität Bochum: Zentrum für Medizinische Ethik, 1995. Kielstein , R. /Sass, H.-M., "Right not to Know or Duty to Know?", Journal of Medical Ethics and Philosophy, vol. 17, no. 4 (1992), 395-405. Kimberling, W.J. /Fain, P.RJKenyon, J.B. / Goldgar, D./Sujansky, E. / Gabow, P.A., "Linkage Heterogeneity of Autosomal Dominant Polycystic Kidney Disease", New England Journal of Medicine 319 (1988), 913-918. Lo, Y.M JPatel, ΡJBaigent, C.N. / Gillmer, M.D.G. / Chamberlain, P. / Travi, M ./Sampietro, M./Waincoat, J.S./Fleming, Κ.Α., "Prenatal Sex Determination from Maternal Peripheral Blood Using the Polymerase Chain Reaction", Human Genetics 90 (1993), 483-488.

Genetic Therapy, Disability and Enhancement Frances Myrna Kamm

Do commitments to an objective account of illness, disability and misfortune and to the elimination of disability imply not only a comparable objective account of health and superior functioning but also commitment to enhance normal species functioning? In this article, I will urge an objective account of disability, but attempt to distinguish morally between genetic therapy which eliminates disability and therapy which enhances normal species functioning.1

I. Disability Some discussions of genetic therapy involve the following inconsistency: While claiming that certain genetic conditions should be eliminated because of their effects, they deny that the effects of these conditions are bad. An analogous claim outside of genetic therapy would be that polio should be eliminated, but the effects of polio (e.g., paralysis) are not disabilities (i.e., impaired functioning). But should conditions be eliminated if their effects are not truly bad? A more extreme position which, however, eliminates the inconsistency just noted, claims that the genetics condition should not be eliminated since its effects are not truly bad. For example, some advocates for the deaf argue that deafness is not a disability, it is just the basis for another way of life, with its own culture. So any genetic causes of deafness should not be repaired in the individual or eliminated from the species. But if deafness were not a disability, just the basis for an alternative culture, why should deaf parents not be permitted to have their hearing children made deaf in order to raise them in deaf culture? And would a deaf person truly refuse a cure for her deafness? Perhaps someone who has lived all her life in deafness would refuse to hear (though I find this hard to believe). But the fact that it is hard to alter a life style built around a trait, and the fact that a trait may have further consequences which are good in themselves (e.g., artistic production), does ι This paper grew out of my reflections and comments on several papers presented at the Conference on Bioethics, Technology, and the Law at the Rockefeller Conference Center, Bellagio, Italy, August 1995. The papers I especially have in mind are by Dworkin, Sass, Herranz, and Kettner.

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not mean this trait would not be rejected when considered in its ownrightand prior to acculturation. One way to argue that some condition is a disability is to consider the range of worthwhile experiences and efficient exercises of function that are possible with and without the condition. Deafness robs one of the possibility of receptivity to sound, arguably a bad thing in itself. The use of sign language, which depends on visual attention and hand movements, contrasts with being able to focus on one thing visually while being free to receive information about another thing auditorially, and perform yet another function with one's hands. A third and yet more extreme position asks us to consider genes that lead to disabilities as a necessary part of natural variety, and hence instrumentally good since they lead to the good of variety. In this sense, it is said, there is no bad gene. Indeed, we may even admire the remarkable structure of the chemical processes that lead to blindness; in this sense, the gene leading to blindness is even intrinsically good. This most extreme position (which seems to be advocated by Lewis Thomas) makes the mistake of judging everything by its contribution to natural variety and the biological continuity of the species, or else by the standard of chemical elegance. But why should these be our criteria for ultimate goodness, more important than the development of such characteristics as consciousness, mobility, and language use? If certain traits are genuinely impairments, this will mean that individuals having those traits must accept that their natures are rightly to be discouraged in future generations, other things equal. But this does not mean that they as persons already in existence have fewer rights than others; indeed they may have greater rather than fewer claims on social efforts on their behalf. One can take greater liberties in acting on one's judgement that certain traits are worse than others when one's actions do not destroy persons who already exist, but merely alter genes for the better. Even if there is only a probability that a negative trait will arise, one can morally afford to use the easiest way of managing a possible problem.

Π . Enhancement Suppose we accept that certain genetic conditions lead to objectively bad states, such as disabilities. Then it is also likely that we can rank other states as objectively good to increasing degrees of goodness. This implies the rejection of completely relativistic views about which characteristics are better than others. Suppose we can reach rational agreement on ways in which our species could be better than it now is, or ways in which more individuals could be improved by having characteristics only a minority have now. If we believe that we should repair or eliminate genes leading to objective disability, are we then also committed to altering genes in order to objectively enhance an individual or species? (This enhancement might come about by altering genes so that the individual's phenotype changes or altering reproductive cells so that future generations have the improved characteristics.)

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There are at least two differences between treatment or elimination of disabilities and an enhancement policy. First, if it is morally right to help first those who are worst off before we make better off those who are alreadyfree from disability, this gives us a reason to emphasize genetic therapy for disability but not as strong a reason to emphasize genetic enhancement. (An exception to this would exist if enhancing some individuals was indirectly in the interests of others who weré worse off. For example, if producing superior intelligence in some leads to cures for illnesses in the worst off.) Secondly, many scientists consider alteration of reproductive cells a dangerous proposition. This is in part because it, unlike genetic treatment that affects only an individual, will alter future generations and, if done widely, the species as a whole. One is uncertain of what the long-range side effects will be of the removal of a gene that causes a harmful condition. Things may be made worse overall. Suppose there are suchrisks associated with changes in reproductive cells. It is a reasonable moral principle, I believe, that the more crucial a certain change is, the greater the risk we should be willing to bear to make the change. Comparably, the less crucial a certain change is, the fewer theriskswe should be willing to bear. to make the change. Therefore, we should engage in alteration of reproductive cells only for the sake of the most crucial changes in individual life styles, i.e., to help those who are worst off by eliminating their disabilities. This seems more crucial than improving by enhancement those who would be better off in any case. (Recall, however, that enhancement could still be justified if it served indirectly to improve the condition of the worst off.) Admittedly this argument depends on a moralistic and perhaps imaginatively limited notion of „urgency" as helping the worst off. It may not be unreasonable to at least be tempted by a rather more Nietzschean notion of urgency, according to which scaling new heights by creating the splendid and remarkable is urgently needed because it helps justify the continuing struggle of human life. Two points we have emphasized so far differentiate between disability and enhancement therapy by asking us to consider the urgency of treatment and the reasonableness of bearingrisks in accord with urgency. But there is a further distinction between eliminating disability and enhancing normal species functioning that bears on the question of personal autonomy. Given what it is to be free of an evil rather than to possess a great positive good, we may think it right to give individuals more choice as to whether they achieve the latter than whether they achieve the former. To be more specific, one of the things we should wish for our offspring, I believe, is autonomy: it is good and right that people decide certain things for themselves. Hence, there are good traits that we should not do all we can to bring about. When parents raise children, for example, there are many things they should properly do to determine the way their children turn out in later life. Helping them avoid disabilities seems to be one such.thing. But about some things, such as what

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career they will pursue, what opinions they form, etc., a liberal theory of education argues that we should do what we can to expose children to alternatives and engage in rational reflection with them on the merits and demands of options, but leave the ultimate decision to them. Suppose being an engineer is a worthwhile life. Suppose we could put a chemical in someone's juice that would make her an engineer and also give her the desire to be an engineer, so that she would never experience any frustration of desire to do something else. We still should not give the chemical, or so the liberal theory would argue. But genetic alteration, either of the individual phenotype or the reproductive cells, for purposes of enhancement may also eliminate individual choice about higher values and optional pursuits in life. (It would not do so, however, if the genetic alteration made one better able to consider options and rationally reflect.) Furthermore, the greater the degree of irreversibility in the genetic alteration we engage in, the more we eliminate choice for the individual. (It might even be better for an individual herself when making choices for herself to make choices that allow for reversibility, e.g., alter a condition by drugs rather than surgery or genetic manipulation. But many factors, such as the importance of commitment, may weigh on the other side.) There is more irreversibility if reproductive cells of all species members are affected since there is then irreversibility for every member of the species rather than just for one individual. (Why do I say „for every member of the species" rather than merely „for the species", even though the latter is true as well? Because the unit of moral concern is not the species per se, but rather individual persons.) But, it may be asked, need we take the autonomy of individuals seriously if we manipulate the genetic material of fetuses who are only potential persons, i.e., if we form the genetic code of individual persons who do not yet exist? It is obvious that we create people without asking their consent. Furthermore, if we refrain from creating people because they will have what we consider undesirable traits, we also do not get their consent to their noncreation. Why then should we worry about unconsented genetic determination, especially if we give the people-to-be preferences that match their attributes and give them objectively worthy attributes? My response is that the absence of consent weighs differently in different cases. Not creating a person results in no person, and hence in no one who could be wronged by noncreation. By contrast, creating someone who is determined to be a certain way when he should rightfully have had a choice whether to be that way results in someone's existing who has been wronged. One can be wronged even if one is not harmed; impermissible paternalism involves wronging someone by bringing about something that is good for him against his will, for example. A comparable wrong can exist if we make someone not have a will that could object to the traits we put into him. The fact that we do this by manipulating a fetus prior to the existence of a person is probably irrelevant since a person will ultimately be affected. Finally, we create people without their consent because it is the only way

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to create. This does not give us license to determine futures in all ways when there are alternatives to such determination, i.e., increasing choice by the individual. We have then noted an additional consideration, autonomy, which comes into play, I believe, more strongly when superior traits are at issue. This, along with urgency and the merit of risk in relation to urgency, may help us distinguish between genetic alteration for disabilities and such alteration for enhancement.

ΙΠ. Methodology In conclusion, let me emphasize that in this article I have offered first-order moral arguments. That is, I have tried to provide some morally relevant reasons for and against certain policies. This itself, I believe, contrasts with the approach taken by some other discussants.2 Their focus has rather been metaethical, describing „rules of discourse" in the belief that from such rule-governed public conversations correct answers to policy issues will follow. I have several concerns with this search for rules of discourse. First, the rules that are typically offered are too incomplete to determine unique solutions to policy problems, when this does nothing to show that there are no such unique answers. For the rules involve only requirements of respect for other speakers, full access to information, no time limits on discussion, etc. These rules, contrary to what some seem to believe, do not commit one to substantive moral views such as the equality of persons. An advocate of the slavery of black people might consistently agree to hear out a black opponent of slavery in a civil way, for example. At the very least, in order to have a reasonable hope of arriving at solutions to policy problems just by settling on discussion rules, one would have to supplement the sort of rules described above by standards which the proposals put forth by discussants would have to meet in order not to be reasonably rejected by other discussants.3 I have not pursued this venue of supplementation since I believe that first-order moral reasoning will be necessary in any discussion: someone will have to put forward a substantive proposal and the one backed by good enough reasons will not be reasonably rejected.

2 At the Bellagio Conference. See fn. 1. 3 This sort of supplementation is described most famously in Thomas Scanlon's , „Utilitarianism and Contractualism, „ in: A. Sen/B. Williams, eds: Utilitarianism and Beyond, Cambridge: Cambridge University Press, 1982.1 am grateful to William Ruddick for comments on a draft of this article. 7 Jahrbuch fui Recht und Ethik, Bd. 4 (1996)

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Zusammenfassung Gibt es objektive Begriffe von Körperbehinderung und körperlicher Überlegenheit, die in der Diskussion über genetische Veränderungen verwendet werden können? Der Beitrag behauptet, daß es solche objektiven Begriffe gibt. Trotzdem arbeitet die Autorin Gesichtspunkte heraus, die auf Unterschiede in der moralischen Beurteilung von gentherapeutischen Maßnahmen gegen Körperbehinderungen einerseits und von Verfahren zu genetischen Verbesserungen andererseits hinweisen. Zu diesen Gesichtspunkten gehören der Gedanke, daß den am schlimmsten Betroffenen zuerst geholfen werden muß, der Gedanke, daß zwischen den gesteckten Zielen und den Risiken, die zu ihrer Erreichung eingegangen werden, eine vernünftige Relation bestehen muß, und die Überlegung, daß bestimmten Arten von Autonomie eine sehr hohe Bedeutung zukommt.

Pränataldiagnostik und genetisches Screening im freiheitlich-demokratischen Rechtsstaat* Hartmut Kliemt

I. Einleitung In der Politik ist die Nachricht, daß der Gesetzgeber lieber nichts tun sollte, keine und damit aus Sicht der Politiker eine schlechte Nachricht. Das ist nicht Schuld der Politiker, sondern von uns Bürgern selbst. Die Politiker wissen, daß sie gesetzgeberische Aktivitäten der verschiedensten Art vorschlagen müssen, um in das allgemeine Bewußtsein vorzudringen. Wer vorschlägt, etwas zu tun oder zu verändern, kann viel eher damit rechnen, in die Medien zu gelangen, als jener, der das Gegenteil fordert. Gewählt wird aber letztlich nur der, der in den Medien präsent ist. Neben vielen anderen ist dies sicherlich eine der Wurzeln des geradezu dramatischen Anwachsens gesetzgeberischer und regulatorischer Aktivitäten, die wir in den freiheitlich-demokratischen Rechtsstaaten in den letzten Jahrzehnten zu verzeichnen hatten. Diese Entwicklung ist besorgniserregend und sollte uns insgesamt dazu führen, nicht so leichtfertig, wie wir das gern tun, bei jeder Gelegenheit nach dem Gesetzgeber zu rufen. Anstatt uns immer gleich zu fragen, wie eine nach unserer Meinung für alle verbindliche Politik und Gesetzgebung aussehen könnte, sollten wir uns häufiger fragen, ob und inwieweit wir nicht eine für alle verbindliche politische Entscheidung bestimmter Fragen überhaupt vermeiden können. Ohne eine solche kollektive Festschreibung allgemeinverbindlicher rechtlicher Normen können wir es vermeiden, als Mehrheiten den gegenteiligen Willen von Minderheiten zu mißachten. Gerade in den weltanschaulich stark besetzten Fragen, die das menschliche Fortpflanzungsverhalten betreffen, sollten wir soweit möglich auf die Anwendung der fundamentalen Zwangsgewalt des Staates verzichten (vgl. zum Konzept der fundamentalen Zwangsgewalt grundlegend Nozick 1974). Dieses Ziel ist Ausdruck jenes wechselseitigen Respektes, der in einer pluralen Gesellschaft allem öffentlichen * Ich danke Susanne Brüggemann und den Teilnehmern der von der Firma Milupa unterstützten Klausur- und Arbeitstagung: Pränatale Diagnostik - Individuum und Gesellschaft Staffelstein 26.-28. 5.1995 für Kritik und nützliche Hinweise. *

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Handeln zugrunde liegen sollte, jedoch leider nur zu leicht über dem Interessenkampf in Vergessenheit gerät. Meine Überlegungen zu,»Pränataldiagnostik und genetischem Screening im freiheitlich-demokratischen Rechtsstaat" orientieren sich an dem Grundwert des Respektes vor den Entscheidungen autonomer Personen. Gewisse Aspekte der medizinischen Forschung scheinen aus meiner politikphilosophischen und zugleich politikökonomischen Perspektive normativ besonders relevant. Die nachfolgende Skizze des medizinischen „state of the art" beschränkt sich in höchst selektiver Weise auf solche normativ relevante Aspekte. "Auf diese, nicht auf die medizinischen Einzelheiten kommt es letztlich an.

Π. Stand und voraussichtliche Entwicklung der pränatalen Diagnostik Traditionelle Vorgehensweisen der pränatalen Diagnostik beinhalten den Unterschied zwischen nicht-invasiven und invasiven Erkenntnismethoden. Nicht-invasive Erkenntnismethoden bedienen sich allgemeiner Indikatoren für bestimmte genetische Eigenschaften des Embryos, die man erheben kann, ohne zusätzliche Risiken für Embryo oder Mutter zu erzeugen. So kann man, wie es gängigen Praktiken entspricht, einfach das Alter der Mutter erheben und beispielsweise für alle Mütter, die älter als 35 Jahre sind, die Amniozenthese empfehlen. Soweit es dabei darum geht, das Downs-Syndrom zu diagnostizieren, muß man allerdings feststellen, daß etwa 75 bis 80 % der Träger dieses Syndroms von Müttern geboren werden, die jünger als 35 Jahre alt sind. Deshalb scheint es wünschenswert, über das Alter hinaus weitere Indikatoren zu berücksichtigen, die es erlauben, die betreffenden Risiken genauer zu erkennen (vgl. dazu und zum folgenden etwa Held 1994, Ganaits et al 1994). Im einfachsten Falle könnte man etwa die Familiengeschichte erheben. Von weit größerer praktischer Bedeutung und Voraussagekraft ist es jedoch, das Blut der Mutter zu untersuchen. Blutentnahmen werden während der Schwangerschaft ohnehin vorgenommen und sind in jedem Falle mit einem so geringen Risiko verbunden, daß sie ebenfalls als nicht-invasiv zu bezeichnen sind. Wenn man nun sogenannte multiparametrische Screening-Methoden zur Untersuchung des Blutes der Mutter anwendet, dann erlaubt das Voraussagen, ob ein Downs-Syndrom vorliegen wird oder nicht. Drei Parameter AFP, hCG und uE 3 sind von zentraler Bedeutung. Insbesondere hCG bildet einen signifikanten Prädiktor für das Vorliegen des Downs-Syndroms. Von den Schwangerschaften mit dem Downs-Syndrom führen etwa 50% zu einer Konzentration des hCG Serums im mütterlichen Serum, welche etwa zweimal so hoch ist wie der Medianwert bei normalen Schwangerschaften. Es gibt nach wie vor eine Kontroverse darum, ob unter dem Gesichtspunkt der Kosteneffektivität ein Zweifachtest, der auf AFP und hCG aufbaut, oder ein Dreifachtest, der auch uE3 einschließt, vollzogen werden sollte.

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Normativ fundamentaler als solche Finanzierungsfragen sind allerdings andere Probleme. Zunächst einmal muß man feststellen, daß die nicht-invasiven Methoden nur eine gewisse Wahrscheinlichkeit dafür bestimmen können, daß der Embryo oder Fötus gewisse genetische Eigenschaften besitzt. Ob etwa tatsächlich ein Defekt wie Trisomie 21 vorliegt, muß in aller Regel nach wie vor durch andere Verfahren wie insbesondere die Amniozenthese verifiziert werden. Das bedeutet, daß die traditionellen nicht-invasiven Methoden nur als erste bzw. als Vorstufe für invasive Verfahren sinnvoll sind. Auf der zweiten Stufe sind bislang die Risiken der invasiven Vorgehensweisen nicht vermeidbar. Hinzu kommen die psychischen Belastungen der werdenden Mutter, nachdem das nicht-invasive Screening-Verfahren der ersten Stufe Hinweise auf ein Sonderrisiko ergeben hat. Da die nicht-invasiven Screening-Methoden der ersten Stufe nur eine statistisch begründete Wahrscheinlichkeitsaussage zulassen, die sich in vielen Fällen nicht bestätigt, werden eine Vielzahl von Frauen aufgrund eines „blinden Alarms" beunruhigt. Will man hier Fehler erster (das Vorliegen eines Defektes wird übersehen) und zweiter Art (das Vorliegen eines Defektes wird zu Unrecht diagnostiziert) sinnvoll gegeneinander abwägen, werden jedenfalls jene, die eine Abtreibung von Föten mit genetischen Defekten für normativ gerechtfertigt halten, dazu neigen, nicht erkannte genetische Defekte für den gravierenderen Fehler zu halten. Dabei ist allerdings zu beachten, daß der Respekt vor der individuellen Entscheidungsautonomie der werdenden Mutter auch gegenüber jenen Frauen von durchschlagender Bedeutung sein muß, die bewußt aufgrund einer autonomen Entscheidung über die genetischen Eigenschaften des Embryos oder Fötus uninformiert bleiben wollen. Für jene, die die Gesichtspunkte der Autonomie des Patienten und damit der Mutter in den Vordergrund stellen, ergibt sich daraus die Notwendigkeit, eine informierte Zustimmung der Mutter vor Eintritt in die erste Stufe des Screening-Verfahrens - das heißt die nicht-invasive Stufe - einzuholen. Wenn es sich im Zuge der Einholung dieser Zustimmung nicht vermeiden läßt, die Mutter über bestimmte Risiken genetischer Defekte zu informieren - etwa die altersbedingten - , dann verletzt das zwar in gewisser Weise die Autonomie jener Frauen, die von der ganzen Angelegenheit einfach nichts wissen wollen, doch ist dies der Preis, den man notwendig zahlen muß, um anderen Frauen eine autonome, informierte Individualentscheidung überhaupt zu ermöglichen. Hier stehen Autonomierechte gegen Autonomierechte. Was die Respektierung des Willens anbelangt, uninformiert zu bleiben, so scheint es akzeptabel, den Wunsch, informierte Entscheidungen treffen zu können, dem Wunsch, ignorant zu bleiben, überzuordnen. Dann, wenn die beiden Wünsche einander ausschließen, ist dem Wunsch nach zusätzlicher Information bevorzugt Rechnung zu tragen. Denn autonomes Entscheiden in einer Sachfrage ist in der Regel wichtiger als autonome Entscheidungen über den eigenen Informationsstand. Da informierte Entscheidun-

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gen von Sachfragen jedoch nur möglich sind, nachdem man gewisse Informationen besitzt, läßt es sich nicht immer vermeiden, daß auch Individuen relevanten Informationen ausgesetzt werden müssen, die gänzlich uninformiert zu bleiben wünschen. Neue Verfahren des genetischen Screenings, die darauf abzielen, Embiyonaloder Fötalzellen aus dem Blut der Schwangeren zu isolieren, könnten im idealen Erfolgsfalle ohne Einsatz invasiver Methoden zu einer zuverlässigen Einschätzung der genetischen Konstitution des Embryos oder Fötus führen. Im Augenblick sind wir noch ziemlich weit von diesem Zustand entfernt. Soweit jedoch embryonales oder fötales Zellmaterial aus dem Blut der Mutter isoliert und tatsächlich jedenfalls auf gewisse genetische Eigenschaften hin mit gleicher Zuverlässigkeit untersucht werden kann, wie es durch traditionelle invasive Verfahren geschieht, besitzen die neuen Verfahren fundamentale Vorzüge aus Sicht der Patientin wie auch der Leibesfrucht: 1. Da während jeder Schwangerschaft Blut entnommen wird, bleiben etwaige Beunruhigungen, wie sie mit der Amniozenthese aufgrund einer vorherigen Indikationsstellung einhergehen, aus. 2. Die Gefährdung der Leibesfrucht durch invasive Maßnahmen wie die Amniozenthese kann u. U. vermieden werden. Können angesichts dieser Vorteile überhaupt Zweifel darüber bestehen, ob das Gesundheitssystem eines wohlhabenden freiheitlich-demokratischen Rechtsstaates die neueren Verfahren der pränatalen Diagnostik allgemein zur Anwendung bringen sollte? Unter der Prämisse des prinzipiellen Vorrangs der Patientenautonomie müssen wir in Beantwortung dieser Frage zunächst moralische Probleme untersuchen, die von der öffentlichen Finanzierung pränataldiagnostischer Verfahren durch Zwangsbeiträge von Versicherten aufgeworfen werden. Letztlich geht es darum, inwieweit man die pränataldiagnostischen Verfahren durch ein von Zwangsbeiträgen finanziertes öffentliches Gesundheitssystem unter den Rahmenbedingungen eines freiheitlich-demokratischen Rechtsstaates verfügbar machen darf.

ΙΠ. Zur Zwangsfinanzierung pränataldiagnostischer Verfahren 1. Versicherungen Angesichts der Bedeutung, die etwaige genetisch bedingte absehbare Behinderungen ihres Nachwuches für die betroffenen Mütter und Familien haben, hegt es nahe, allen Schwangeren ein entsprechendes Angebot zu machen. Die Schwangeren können selbst entscheiden, ob sie von den pränataldiagnostischen Verfahren Gebrauch machen wollen. Es steht ihnen überdies frei, im Rahmen des rechtlich Zulässigen aufgrund der ihnen so verfügbar gemachten Informationen unter Um-

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ständen gewisse Schritte wie den Abbruch der Schwangerschaft zu erwägen. Da die Kosten der entsprechenden Leistungen zwar nicht zu vernachlässigen, aber doch nicht exorbitant sind, scheint es vielen klar, daß pränataldiagnosüsche Verfahren grundsätzlich in den Pflichtleistungskatalog der öffentlichen Versicherungsträger einzubeziehen sind. Unter rechtsstaatlichen Prämissen ist es jedoch höchstfragwürdig, daß man etwa auch alle jene Pflichtversicherten, die aus fundamentalen weltanschaulichen Gründen jede Art der Abtreibung ablehnen, sofern diese nicht zur Rettung des Lebens der Schwangeren erforderlich ist, dazu heranzieht, sich an der Erbringung der Kosten für Abtreibungen zu beteiligen. Diese Fragwürdigkeit muß sich zunächst auch auf Screening-Programme übertragen. Denn solange Screening-Programme, die auf die Erkenntnis genetischer Defekte abzielen, ggf. nur zu einer Entscheidung zugunsten der Abtreibung führen können, ist es überaus problematisch, die Gewinnung solcher Erkenntnisse von der Versichertengemeinschaft finanzieren zu lassen. Die Finanzierung von Abtreibungen ist nur ein Beispiel für die vom Zwangscharakter der Versicherung erzeugte allgemeine Problematik, wenn auch ein besonders wichtiges und dramatisches. Sie spricht ein allgemeines Grundsatzproblem der Zwangsversicherung imfreiheitlich-demokratischen Rechtsstaat an. Wenn jemand aus prinzipiellen weltanschaulichen Gründen Abtreibungen ablehnt, dann sollte er grundsätzlich nicht dazu gezwungen werden, sich an der Finanzierung dieser Praktiken zu beteiligen. Das gilt jedenfalls so lange, wie wir überhaupt gewillt sind, an der Fiktion einer Versicherung im Gegensatz zu einer einfachen Steuererhebung mit Bezug auf die Finanzierung des öffentlichen Gesundheitswesens festzuhalten. Denn eine „Versicherung", die sich nicht auf das privatvertragliche Äquivalenzprinzip von Beitragsleistungs- und Beistandsversprechen, sondern auf die Zwangserhebung von Beiträgen stützt, verdient diesen Namen nur solange, wie es sich noch um eine grundsätzlich reziproke Beistandsbeziehung im Rahmen der jeweiligen individuellen Leistungsfähigkeit handelt (vgl. zu Reziprozität und Versichertensouveränität Breyer/Kliemt 1994). Es mag zwar sein, daß aufgrund unterschiedlicher wirtschaftlicher Leistungsfähigkeit und unterschiedlicher Fähigkeiten zur Einschätzung langfristiger Interessen ein Versagenfreivertraglicher Versicherungssysteme festgestellt werden und so ein Zwangsversicherungssystem gerechtfertigt werden kann. Dabei muß aber klar sein, daß die Zwangsmitglieder grundsätzlich ein gleichgelagertes Interesse am Erhalt der Leistungen haben. Sonst ist der Ausdruck „Versicherung" nur ein Euphemismus für eine zweckgebundene Steuer, von der überdies bei uns in Deutschland die Wohlhabenderen entbunden sind. Mit Bezug auf Schwangerschaftsabbrüche kann man von einem gleichgelagerten Interesse aller Zwangsmitglieder gerade nicht ausgehen. Daher kann in solchen Fragen wie dem Schwangerschaftsabbruch nicht von der Reziprozität der Beistandserwartungen ausgegangen werden. Damit ist auch klar, daß eine solche Lei-

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stung in einem öffentlichen Versicherungssystem im engeren Sinne des Begriffes nichts zu suchen hat. Diese Überlegung spricht a fortiori dafür, nicht nur den Schwangerschaftsabbruch, sondern auch Verfahren pränataler Diagnostik, die außer dem Abbruch der Schwangerschaft keine wirksamen Behandlungsschritte zulassen, aus der öffentlich-rechtlichen Zwangsfinanzierung herauszunehmen. Im weltanschaulich pluralen Staat muß es fragwürdig scheinen, Zwang zur Finanzierung von Maßnahmen anzuwenden, die fundamentalen weltanschaulichen Überzeugungen widersprechen. Gerade derjenige, der aus Respekt vor der Autonomie der Schwangeren glaubt, daß die Entscheidung über eine Abtreibung dieser allein zufallen muß, sollte es aus dem gleichen Respekt heraus den Individuen freistellen, ob sie an Versicherungssystemen teilhaben wollen, die für Abtreibungen aufkommen oder nicht. Wiederum gilt a fortiori das gleiche für alle pränataldiagnostischen Verfahren, die keine sinnvollen therapeutischen Interventionen zulassen, sondern nur zum Abbruch der Schwangerschaft führen können. Die Argumentationslage könnte sich möglicherweise dann ändern, wenn man Gesundheitsvorsorge als genuine Staatsaufgabe ansähe.

2. Staatsaufgabe Man kann plausibel argumentieren, es sei legitim, daß Pazifisten ebenso wie alle anderen Bürger zur Finanzierung der Bundeswehr herangezogen werden. Denn in dieser Frage gibt es tatsächlich nur die beiden Alternativen entweder keine oder eine Verteidigung. Niemand kann sich selbst ausschließen, noch ausgeschlossen werden. Schwangerschaftsabbrüche gehören jedoch offenkundig nicht in die Kategorie öffentlicher Güter, der Verteidigung und Umweltschutz zuzurechnen sind. Sieht man allerdings die Gesundheitsvorsorge ziemlich unplausiblerweise in allen ihren Bestandteilen als eine genuine Staatsaufgabe an, die letztlich aus Steuermitteln zu finanzieren ist, so kann man möglicherweise auch die steuerliche Finanzierung von Schwangerschaftsabbrüchen legitimieren. Das würde allerdings zum einen voraussetzen, daß es nicht mehr möglich ist, aus dem öffentlichen System bei Überschreiten von Einkommensgrenzen herauszuoptieren (für genuine Allgemeinaufgaben muß das unzulässig sein). Zum anderen wäre es wohl notwendig, daß Verfassungsgericht und Rechtsgemeinschaft insgesamt von der vom Verfassungsgericht jüngst wieder zementierten Auffassung Abstand nähmen, daß es sich beim Schwangerschaftsabbruch um ein moralisches und rechtliches Unrecht handelt. Denn es ist doch schwer einzusehen, daß der Staat seine Bürger dazu zwingen darf, an der Finanzierung von Maßnahmen teilzunehmen, die die Rechtsgemeinschaft als Unrecht betrachtet. Nun könnte man mit Bezug auf den letzten Punkt argumentieren, daß dieser Einwand die Pränataldiagnostik nicht betrifft. In ihrer Ausrichtung auf die eugenische

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Indikation könne sich diese ohnehin auf Akzeptanz durch die Rechtsordnung berufen. Denn der § 218a StGB läßt ja ausdrücklich einen Schwangerschaftsabbruch bis zur 22-ten Schwangerschaftswoche zu, wenn massive, unbehandelbare zukünftige Behinderungen des Embryos oder Fötus absehbar sind. Damit scheint das rechtliche Unwerturteil gegenüber insbesondere eugenisch indizierten Schwangerschaftsabbrüchen aufgehoben und damit a fortiori gegenüber den entsprechenden Teilen der Pränataldiagnostik. Von diesem Standpunkt aus könnte man dann eine direkte steuerliche Finanzierung der betreffenden Maßnahmen als einen zur Zwangsfinanzierung der Bundeswehr vergleichbaren Fall ansehen. Allerdings muß man sich darüber klar sein, daß man dann implizit eine gesellschaftliche Diskriminierung gegenüber bestimmten Embryonen und Föten aufgrund eugenischer Indikation absegnet (vgl. dazu Hoerster 1991). Wenn auch die Finanzierung des Schwangerschaftsabbruches aus der vorgetragenen Sicht heraus in keinem Falle durch die Versichertengemeinschaft zu tragen ist, könnte man für eine Finanzierung pränataldiagnostischer Verfahren allerdings immer noch mit einem statistisch-empirischen Argument plädieren. Es zeigt sich nämlich, daß von den ca. 200.000 Schwangerschaftsabbrüchen in der Bundesrepublik (auf ca. 520.000 Lebendgeburten; Zahlen für 1993) mit Verbesserung pränataldiagnostischer Verfahren weniger mit einer im nasciturus liegenden Behinderung begründet werden als zuvor. Der Grund für diesen Sachverhalt ist darin zu suchen, daß die Schwere der betreffenden Behinderungen mittlerweile in einem durchaus frühen Stadium abzuklären sind. Wo zuvor der Verdacht bestand, es könne sich um eine sehr gravierende Behinderung handeln, diese jedenfalls nicht ausgeschlossen werden konnte, kann nun häufig mit großer Sicherheit und Genauigkeit eine schwere Behinderung ausgeschlossen und eine leichtere, aus Sicht der werdenden Mutter hinnehmbare vorausgesagt werden. Diese genauere Abklärung hat dazu geführt, daß die Quote der eugenisch indizierten Abbrüche abgenommen hat. Aus dieser Sicht könnte die Pränataldiagnostik auch für Abtreibungsgegner hinnehmbar und die Beteiligung an der Finanzierung zumutbar sein, da die Anwendung der Verfahren de facto zu einer Verringerung der Anzahl der Abtreibungen führt. Das gilt wenigstens dann, wenn die Abtreibungsgegner konsequenzenorientiert denken. Zwar hat die werdende Mutter, die eine P-änataldiagnostik durchführen läßt, weiterhin im Regelfall das Ziel, ggf. eine Abtreibung vorzunehmen, zwar wäre es aus Sicht des Abtreibungsgegners besser, in einer Welt zu leben, in der überhaupt keine Abtreibungen vorgenommen werden (außer um das Leben der Mutter zu retten); doch ergibt sich in einer Welt, in der Abtreibungen nun einmal erlaubt sind, eine Verringerung dessen, was der Abtreibungsgegner als ein fundamentales Übel ansieht. Für den Rest meiner Überlegungen will ich mich gänzlich von Fragen des geltenden Rechtes lösen und grundsätzlicher über jene Prinzipien nachdenken, die langfristig für den Umgang mit Verfahren der Pränataldiagnostik im freiheitlichdemokratischen Rechtsstaat leitend sein können. Dazu werde ich von der Prämisse

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ausgehen, daß das Problem der Finanzierung der Leistungen dadurch gelöst ist, daß es sich entweder um freiwillige Wahlleistungen in der öffentlichen Krankenversicherung (vgl. dazu Breyer 1992) oder um privatfinanzierte Leistungen handelt. Was die freiwilligen Wahlleistungen anbelangt, gehe ich davon aus, daß spezielle Beitragssätze je nach persönlicher Einstellung zum Schwangerschaftsabbruch angeboten werden bzw. die Versicherten bei konstantem Beitragssatz selbst darüber entscheiden, ob sie etwa Zahnersatz oder Kuren bezahlt bekommen wollen oder Schwangerschaftsabbrüche bzw. bestimmte pränataldiagnostische Verfahren.

IV. Medizinische Intervention und pränatale Diagnostik Fragen wir uns zunächst, welche Entscheidung ein rationales, weltanschaulich ungebundenes Individuum in der Frage des Schwangerschaftsabbruches und der Möglichkeit einer pränatalen Diagnostik genetischer Defekte wohl treffen würde. Dabei gehe ich zugleich davon aus, daß die diagnostischen Verfahren in einer völlig utopischen Weise perfektioniert werden können, bzw. die Amniozenthese und ähnliche invasive Verfahren, die mit einem hohen Abortrisiko behaftet sind, universell angewandt werden, wann immer Schwangere dies wünschen.

1. Abtreibung Ohne die Möglichkeit, das Genom des Embryos zu verändern, müssen bestimmte genetische Defekte entweder hingenommen werden oder es muß ein Schwangerschaftsabbruch erfolgen. Wenn man nun davon ausgeht, daß der Embryo bzw. Fötus noch keine Personeigenschaften und keinerlei spezifische Identität besitzt, dann muß er insoweit prinzipiell als ersetzbar gelten (vgl. dazu etwa Glover 1987, Hoerster 1991). Ein Embryo oder Fötus ist eine bloß potentielle Person, deren Personeigenschaften gerade noch nicht vorliegen. Eine solche potentielle Person wird in ihren Interessen durch einen Schwangerschaftsabbruch nur in der gleichen Weise beeinträchtigt wie das Kind, das wir heute nicht zeugen, das wir aber hätten zeugen können, dadurch beeinträchtigt wird, daß wir auf seine Zeugung verzichten. In beiden Fällen entsteht eine potentielle Person nicht. Da wir im allgemeinen nicht annehmen, unter einer Pflicht zur Zeugung zu stehen, sollten wir zunächst auch annehmen, daß ein Embryo oder Fötus keinen in ihm selbst liegenden Anspruch auf Fortexistenz besitzt. Einen Embryo oder Fötus muß man dazu in einem prinzipiellen Sinne als ersetzbar durch einen anderen ansehen. Wenn sich herausstellt, daß er bestimmte genetische Eigenschaften aufweist, die nicht erwünscht scheinen, dann sollte es zulässig sein, den Embryo oder Fötus zu verwerfen. In einem Staat, der die Individualrechte

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ernst nimmt, sollte das Recht, über diese Frage zu entscheiden, bei den direkt betroffenen Individuen oder Personen und damit den Eltern liegen. Das gilt jedenfalls dann, wenn wir annehmen, daß sie das Recht haben, selbst darüber zu entscheiden, ob sie überhaupt Kinder zeugen wollen. Denn unter den hier gemachten Prämissen der Ersetzbarkeit eines Embryos oder Fötus sind die Fragen der Zeugung bzw. Nicht-Zeugung und der Abtreibung bzw. Nicht-Abtreibung weitgehend vergleichbar. Dieser Gedankengang bedeutet mit Bezug auf die Pränataldiagnostik, daß man diese ganz unbeschränkt auf Embryonen bzw. Föten anwenden und dann nach Maßgabe je selbstgewählter Kriterien über die Annahme oder Verwerfung des Fötus entscheiden darf. Je besser die pränataldiagnostischen und genetischen Diagnoseverfahren werden, desto stärker wird deren Anwendung im übrigen nicht nur zu der bei uns gesetzlich abgesegneten Diskriminierung gegen schwere Behinderungen führen, sondern unterschiedslos ganz allgemeine Eigenschaften berühren. Wer sich bei solchen Überlegungen gleich an die perverse Nazi-Eugenik erinnert fühlt (vgl. zu solchen abwegigen Argumenten die Dokumentation Anstötz et al 1995) und deshalb der individuellen Entscheidungsautonomie der Eltern kollektive rechtliche Schranken setzen möchte, der sollte bedenken, daß das Charakteristikum der Nazi-Eugenik gerade deren Kollektivismus war. Den Nazis galt der Wille der Eltern nichts. Was sie perverserweise unter Gemeinnutz verstanden, sollte gerade, wie sie immer wieder betonten, dem Eigennutz voranstehen. Ihre absurde Vorstellung von einer an der Population ansetzenden Bereitstellung eines Kollektivgutes der reinen arischen Rasse gesunder deutscher Menschen baute auf massivster kollektiv erzwungener Diskriminierung gegen Individuen auf und setzte sich dabei ruchlos über Personenrechte dieser und anderer Individuen hinweg. Bei den voranstehenden Überlegungen geht es hingegen um etwas vollkommen verschiedenes, nämlich um individuelle Entscheidungsbefugnisse von Eltern gegen jede Art kollektiver Bevormundung in solchen fundamentalen Fragen. Das heißt, es geht gerade darum, Eltern keinerlei Zwang in die eine oder andere Richtung aufzubürden. Ich meine, daß ein säkularer freiheitlicher Staat grundsätzlich Eltern das Recht zugestehen muß, über ihren Nachwuchs selbst zu entscheiden und damit darüber zu entscheiden, ob, wann und auch welcher Art ihr Nachwuchs sein soll. Das bedeutet, daß die Abtreibung von Embryonen und Föten generell erlaubt sein sollte (vgl. zur Verteidigung dieser Sicht umfassend Hoerster 1991). Da die Vornahme von Schwangerschaftsabbrüchen außer den Eltern noch andere Individuen involviert, welche die betreffenden Praktiken als außerordentlich belastend empfinden, bieten die neuen Verfahren der Pränataldiagnostik eine Chance, alle relevanten Informationen so früh zu gewinnen, daß der Zeitpunkt des Abbruches soweit vorverlegt werden kann, daß etwaige Belastungen für alle Beteiligten auf ein Mindestmaß reduziert werden können. Selbstverständlich muß es auch dann dem beteiligten medizinischen Personal unbenommen bleiben, sich der Beteiligung an den entsprechenden medizinischen Interventionen zu entziehen.

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Die augenblickliche Situation ist dadurch gekennzeichnet. daß eine auf geneti­ sche Eigenschaften abstellende Pränataldiagnostik neben der Abtreibung keine In­ terventionsmöglichkeiten bietet. Diese Situation würde sich ändern, falls man in der Lage wäre, die genetischen Anlagen des Embryos zu verändern und damit eine Behebung genetischer Defekte bzw. generell eine Veränderung genetischer Eigen­ schaften nach Befruchtung der Eizelle herbeizuführen. Von dieser doch weitgehend utopischen Annahme werden so interessante Fragen aufgeworfen, daß es sich lohnt. die Konsequenzen dieser Annahme etwas weiter zu durchdenken. Zur Heilung ist ein Eingriff in das Genom erforderlich. Könnte man beispiels­ weise die Chromosomensätze aller Zellen eines Embryos verändern, dann würde das die Frage nach der Identität des Embryos aufwerfen. Das führt für jene Abtrei­ bungsgegner, die einer genetischen Behandlung pränataldiagnostisch festgestellter genetischer Defekte zustimmen würden, zu einer schwierigen Situation. Wenn nämlich - wie sie annehmen müssen, um ihre prinzipielle Ablehnung der Abtrei­ bung zu verteidigen - bereits der Embryo schutzwürdig und nicht ersetzbar durch einen anderen Embryo ist, dann muß er eine spezielle Identität haben. Diese be­ steht aber letztlich in der Einzigartigkeit des Chromosomensatzes. Eine Identität des Embryos, die anderweitig bereits vorgeformt wäre, etwa durch Erlebnisse, Er­ fahrung und Persönlichkeit gibt es ja gerade nicht. Der Embryo ist in dem letzteren Sinne keine Person. Welche Person er werden wird und ob er überhaupt eine Person im Vollsinne werden wird, hängt davon ab, welche Chromosomen vorhanden sind. Das Einzige, was schutzwürdig sein kann, ist damit, um es zu wiederholen, bei metaphysikfreier Betrachtungsweise die Ein­ zigartigkeit des Chromosomensatzes. Dieser bestimmt im übrigen ja auch weitgehend das Entwicklungspotential des betreffenden Wesens. Dieses Potential ebenso wie die Identität des Embryos wird jedoch gerade durch den Schritt einer Behandlung auf der Ebene der Gene, sollte eine solche fundamentale Gentherapie jemals möglich sein, verändert. Es scheint mir daher ziemlich zwingend, daß derjenige, der von einem Schutz des Embryos vor Abtreibung ausgeht, auch annehmen sollte, daß man die geneti­ schen Anlagen des Embryos nicht verändern darf. Würde man nämlich eine Verän­ derung des Genoms zulassen, so könnte jedenfalls prinzipiell nach dem

Eingriff

ein ebenso verändertes Wesen entstehen wie bei Ersatz eines Embryos durch einen anderen. Durchdenkt man dies konsequent. dann endet man nicht nur beim Abtrei­ bungsverbot bereits der befruchteten Eizelle, sondern auch beim Verbot jedes Ein­ griffes in diese Zelle und vielleicht die Keimbahn überhaupt. Nun könnte man hier noch einwenden (diesen Einwand erhob der Kollege Loe­ wenich, Frankfurt), daß ein Ford, an den man einen Rückspiegel von Opel mon­ tiert. immer noch ein Ford bleibt und damit nicht zum Opel wird. Andererseits ist

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es jedoch so, daß etwa die Behebung einer Trisomie 21 und damit die Entfernung oder Neutralisierung eines überzähligen Chromosoms eine vollständige Verhinderung des Downs-Syndroms bewirken sollte und damit auch eine vollständige Veränderung der Persönlichkeit des betreffenden Individuums. Hier von den gleichen Personen zu sprechen, scheint mir äußerst willkürlich. Daher sollte gerade die Heilung der massivsten Fälle von genetischer Behinderung im Embryonalstadium ebenso abgelehnt werden wie die Abtreibung des Embryos oder Fötus. Eine Sicht, die nicht nur gegen jede Form der Abtreibung auftritt, sondern die zuvor angeführten Konsequenzen akzeptiert, ist intellektuell respektabel. Jeder sollte das Recht haben, nach ihr zu leben. Es scheint mir allerdings höchst fragwürdig, auf diese Sichtweise eine allgemeinverbindliche Gesetzgebung gründen und sie insoweit allen anderen aufzwingen zu wollen. Natürlich weiß ich, daß eine anderweitige gesetzliche Regelung in unserem Lande in absehbarer Zeit nicht zu erwarten ist. Ich glaube allerdings, daß sie im pluralenfreiheitlichen Rechtsstaat getroffen werden sollte. Zugleich müßten die voranstehenden Bemerkungen zur Finanzierung der betreffenden Verfahren aus den gleichen rechtsstaatlichen Gründen jedoch strikt beachtet werden.

V. Schlußbemerkungen Kommen wir also abschließend nochmals auf die Frage der Finanzierung zurück. Diese ist unter Bedingungen eines Zwangsversicherungssystems eben keine nur ökonomische Frage. Wenn die Auffassungen über die Akzeptabilität von Schwangerschaftsabbrüchen, die Anwendung pränataldiagnostischer Verfahren und andere fundamentale Wertprobleme auseinanderklaffen, dann sollte im freiheitlich demokratischen Rechtsstaat, der sich ja auch immer am Maßstab der Verhältnismäßigkeit orientieren muß, nach Möglichkeit keine gesellschaftliche Gruppe einer anderen ihren Willen aufzwingen dürfen - und zwar insbesondere auch hinsichtlich der Finanzierung strittiger Praktiken. In Fällen wie den zuvor diskutierten kann man zwar versucht sein, das relevante Wertproblem darin zu sehen, daß eine bestimmte Regelung für alle verbindlich durchgesetzt wird. Das öffentliche Gut wird in der Regel selbst gesehen. Auf der anderen Seite handelt es sich jedoch um einen zum Pazifismusproblem klar unterschiedlichen Fall. Denn man kann es den Individuen tatsächlich selbst anheimstellen, über Abtreibung und Anwendung pränataldiagnostischer Verfahren je für sich zu entscheiden. Es ist vollkommen möglich, in einer Welt zu leben, in der Abtreibungsgegner jede Art der Abtreibung ebenso wie jede Art der Pränataldiagnostik verweigern und zugleich andere Individuen davon extensiv Gebrauch machen. Für die Verteidigung gilt das nicht. Allerdings ist auch klar, daß es unter dem hier verteidigten Toleranzgebot illegitim ist, andere dazu zu zwingen, für die Verfolgung der je eigenen Werte mit zu

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zahlen, wenn das vermeidbar ist. Jedenfalls in weltanschaulich fundamental kontroversen Fragen müssen die Kosten von jenen getragen werden, die die betreffenden Verfahren anwenden bzw. nicht anwenden wollen. Nun mag man meinen, daß mit diesem Argument auch verlangt werden könnte, daß die Gruppe jener, die selektive Abtreibungen, pränataldiagnostische Verfahren, Eingriffe in die Keimbahn etc. ablehnen, selbst die Kosten dieses Verzichts tragen sollte. Man würde argumentieren, daß es einen Versicherungsvertrag geben sollte, in dem eventuell aufgrund genetischer Anlagen behinderte, bislang ungezeugte Kinder das Anrecht zum Beitritt zur Versicherung erwerben. Ein anderer Vertrag würde hingegen einen Katalog von genetischen Eigenschaften enthalten, deren kostenwirksame Folgen nicht mitversichert sind. Eine solche Art des Ausschlusses von medizinischen Leistungen mag man zunächst abstoßend finden. Solange wir ihn vermeiden können, sollten wir ihn vermeiden, da man kaum plausibel davon ausgehen kann, daß das Interesse an der Kostenvermeidung weltanschaulich ähnlich fundamental verankert ist, wie etwa die Ablehung der Abtreibung selbst. Auf der anderen Seite sollte man allerdings auch bedenken, daß ein derartiger selbstverantwortlicher Ausschluß gegenüber irgend welchen staatlich verordneten Beschränkungen medizinischer Ressourcen den gravierenden Vorteil hätte, selbst gewählt zu sein. Ein gewisses Maß an Wahlfreiheit im Gesundheitswesen ist selbst bei öffentlicher Zwangsversicherung in dem bereits angedeuteten Sinne möglich. Nur so kann man dem Ziel, im freiheitlich-demokratischen Rechtsstaat der Pluralität von individuellen Werten durch eine weitestmögliche Vermeidung von Zwang Rechnung zu tragen, gerecht werden. Summary The paper discusses pre-natal diagnosis and genetic screening from a classical liberal point of view. After sketching the most basic aspects of the medical state of the art, including some quite dramatic new developments as well as some possibilities merely on the horizon, it is argued that in the last resort parents should decide. Legal institutions should minimize on the application of fundamental coercive power in these matters. Accordingly, compulsory collection of contributions to the funding of pre-natal diagnosis and genetic screening is illegitimate. The fundamental coercive power of the state should not be used in funding practices deemed unacceptable by many citizens.

Literaturverzeichnis AnstötZy C.I Hegselmann, R. / Kliemt, H. (Hrsg.), Peter Singer in Deutschland. Zur Gefährdung der Diskussionsfreiheit in der Wissenschaft, Frankfurt/M. u. a.: Peter Lang, 1995.

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Brey er, F., „Wahlfreiheit in der gesetzlichen Krankenversicherung. Eine wohlfahrtstheoretische Analyse", in: G. Gäfgen (Hrsg.), Systeme der Gesundheitssicherung im Wandel, Baden-Baden, 1994, S. 33-52. Breyer, FJKliemt, H., „Lebensverlängernde medizinische Leistungen als Clubgüter?", in: K. Homann (Hrsg.), Wutschaftsethische Perspektiven, Berlin: Duncker & Humblot, 1994, S. 131-158. Ganiats, T. G. / Halverson, A. L. ! Bogart, M. H., „Incremental Cost-Effectiveness of Incorporating Oestriol Evaluation in Down Syndrome Screening Programmes", in: Prenatal Diagnosis, 14,1994, S. 527-535. Glover, J., Causing Death and Saving Lives, Harmondsworth: Penguin, 1987. Held, K. R , „Ethische Aspekte des Multiparâmeter-Screening", in: Med. Genetik, 6, 1994, 210-212. Hoerster, N., Abtreibung im säkularen Staat, Frankfurt/M.: Suhrkamp, 1991, S. 144-162. Nozick, R., Anarchy, State, and Utopia, New York: Basic Books, 1974.

Allocation of Scarce Resources

8 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

The Law and Ethics of Organ Sales

Keith N. Hylton

I. Introduction Suppose it were demonstrated that hair taken from a healthy New York City resident has life-prolonging properties, and that by waiving a handful of it under a cancer patient's nose, you could cure him? What should the government do? One solution would be to require New Yorkers to have their hair cut and given to the state, so that it could be put to the important end of curing cancer. Or the state could make "New York hair" the property of all, so that cancer victims could walk through the city and help themselves. However, there would be a number of objections to these solutions (though relatively few from clip-wielding cancer patients). Some individuals - e.g., fashion models, rock musicians, television news reporters - need their hair in order to make a living. They quite understandably would be reluctant to give up the one asset that might distinguish them from a random applicant for their position. A less controversial solution would be to encourage New York City residents to donate their hair to the war against cancer. The problem is that New Yorkers, true to their stereotype, would never get around to it. After all, it takes time to get your hair cut, and most New Yorkers are busy. The tragic outcome of the less controversial solution is easy to see. A relatively small number of New Yorkers would have their heads shaved and the hair donated to fight cancer, while the vast majority would give not a second thought to the problem. All the while, cancer would continue to kill people who could have been saved by a handful of New York hair. This is pure fantasy, but it is identical in its important respects to the real world problem of providing organs and tissue suitable for transplantation. In fact, in some ways the real world problem is more troubling. The New Yorkers in my hypothetical have a good reason for keeping their hair: it looks good on them. But a large percentage of potential organ providers have absolutely no use for the organ. The proposed solutions to my hair supply hypothetical, transfer of property and reliance on altruism, are essentially the only two solutions formally adopted in response to the real world "organ supply" problem.1 Because of the shortcomings of *

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these solutions, a number of commentators, myself among them, 2 have suggested the allowance of some limited commerce in body parts. This solution can be seen as a compromise between the extremes of transferring property rights and relying entirely on altruism. Property rights are maintained under the market system because anyone who wants the body part of another must gain the consent of the owner. Yet it is likely to be considerably more effective at increasing the supply of body parts than a system, such as the one currently observed in the United States, which relies entirely on the altruism of donors. In response to the market solutions proposed in recent years, 3 a number of commentators have raised moral objections to the notion of commerce in body parts. For example, two recent articles, one by Leon Kass,4 and the other by Stephen Munzer, 5 have presented various Kantian arguments against a market in body parts. 6 So far as I am aware, no economist has responded directly to this literature. 7 I intend to do so here. 1 Reliance on altruism is the approach in the United States, see, e.g., Jeffrey M. Prottas, "Obtaining Replacements: The Organizational Framework of Organ Procurement", Journal of Health, Politics, Policy and Law, vol. 8 (1983), pp. 235-239. Transfer of property is observed under "presumed consent" systems, where the state has the right to remove organs from a cadaver unless a family member objects. This is currently the law in Austria, Denmark, and France; see A J. Matas/ J. Arras/J. Muyskens/V. Tellis/F.J. Veith, "A Proposal for Cadaver Organ Procurement: Routine Removal with Right of Informed Refusal", Journal of Health, Politics, Policy and Law, vol. 10, pp. 231-244. There are some approaches that cannot be classified so easily. For example, reports suggest that in China, the state removes and sells the organs of executed prisoners, see Catherine S. Mane gold, "Senate Told of Chinese Death-Row Prisoners Shot for Organs for Transplants", New York Times, Friday, May 5, 1995, p. A5.

2 Keith Ν. Hylton , "The Law and Economics of Oigan Procurement", Law & Policy, vol. 12, no. 3 (July 1990), pp. 197-224. 3 The one that has attracted the most attention is Lloyd Cohen's proposal for a futures market in organs. See Lloyd R. Cohen, "Increasing the Supply of Transplant Organs: The Virtues of a Futures Market", George Washington Law Review, vol. 58, no. 1 (November 1989), pp. 1-51. For a similar proposal, see Henry Hansmann, "The Economics and Ethics of Markets for Human Organs", Journal of Health, Politics, Policy, and Law, vol. 14, no.l (Spring 1989), pp. 57-85. 4 Leon Kass, "Oigan for Sale? Propriety, Property, and the Price of Progress", The Public Interest, no. 107 (Spring 1992), pp. 65-86. 5 Stephen R. Munzer, "An Uneasy Case Against Property Rights in Body Parts", in: Ellen Frankel Paul/Fred D. Miller, Jr./Jeffrey Paul, eds: Property Rights, Cambridge University Press, 1994. See also, Stephen R. Munzer, "Kant and Property Rights in Body Parts", Canadian Journal of Law and Jurisprudence, vol. 6, no. 2 (July 1993), pp. 319-41. 6 Another article in this group is Ruth E Chadwick, "The Market foF Bodily Parts: Kant and Duties to Oneself', Journal of Applied Philosophy, vol. 6, no. 2 (1989), pp. 129-39. Although somewhat broader in scope, Margaret Jane Rodin's work is in the same vein, and deals directly at some points with the notion of property rights in organs. See her articles, "Property and Personhood", Stanford Law Review, vol. 34, no. 5 (May 1982), pp. 957-1015; and "Market-Inalienability", Harvard Law Review, vol 100, no. 8 (June 1987), pp. 18491937.

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Π . A Reassessment of Moral Objections to the Sale of Body Parts The Kantian critiques of organ selling are not easy to summarize because they consist of several major and minor arguments, not all of them directly traceable to Kant's comments on the sale of body parts. Moreover, for an economist, the literature is difficult to grasp firmly. Economists are used to working with models, and within a framework in which terms have a settled meaning. Economists who confront the organ shortage problem typically start by thinking of organ provision within a market; they think of supply, demand, and the loss in society's wealth that results from the undersupply of transplantable organs. It is a serious change of direction to then try to apply the thoughts generated within that framework to the seemingly less organized, lessrigorous, arguments of the ethics literature. However, in spite of the lack of a rigorous framework, the ethical critiques of organ selling seem to center around three major themes. The first and most important is the notion of personhood and dignity, the second is the theme of commodification and incommensurability, and the third is equity. Each of these headings needs to be defined with some care, and I will attempt to do that below. And there are other arguments presented in the ethics literature that cannot easily be placed under any of these headings. For example, some of the ethical arguments have more to do with difficulties in the implementation of a market in body parts than with moral concerns generated by the very attempt to introduce such commerce. I will consider these arguments in a later section.

A. Dignity, Personhood, and Human Flourishing The Kantian writers have presented several arguments against the sale of body parts, but the one proposition that is central to their criticisms is the claim that such commerce offends the dignity or personhood of the individual, and is inconsistent with "human flourishing." 8 Perhaps it is best, following Leon Kass, to put it in Kant's own words. In The Metaphysical Principles of Virtue? Kant states two propositions regarding the sale of body parts. 7 After submitting this paper to the journal, I came across a response by my former colleague Mark F. Grady, "Politicization of Commodities: The Case of Cadaveric Organs," vol. 20, J. Corporation Law, pp. 51-68 (Fall 1994) (the issue was not available until the Fall of 1995). Grady argues that governmental allocation schemes politicize allocational issues in a way that is damaging to our perceptions of ourselves and our values. While I find Grady's critique persuasive, he stops short of directly refuting the Kantian writers on their own terms. 8 Human flourishing is a term used by Chadwick, supra fh. 6, and in Radin, "Market Inalienability", supra fn. 6. 9 Immanuel Kant, The Metaphysical Principles of Virtue (Part Π of The Metaphysics of Morals) [1797], in: Ethical Philosophy, translated by James W. Ellington and introduction by Warner A. Wick, Indianapolis/Cambridge: Hackett Publishing Co., 1983.

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Kant's Proposition 1: To dispose of oneself as a mere means to some end of one's own liking is to degrade the humanity in one's person, which, after all, was entrusted to man to preserve. 10 Kant's Proposition 2: To deprive oneself of an integral part or organ (to mutilate oneself), e.g., to give away or sell a tooth so that it can be planted in the jawbone of another person, or to submit oneself to castration in order to gain an easier livelihood as a singer, and so on, belongs to partial self-murder. But this is not the case with the amputation of a dead organ, or one on the verge of mortification and thus harmful to life. Also, it cannot be reckoned a crime against one's own person to cut off something which is, to be sure, a part, but not an organ of the body, e.g., the hair, although selling one's hair for gain is not entirely free from blame.11 Proposition 1 can be taken as a general theorem and the second and elaboration on it. The first can be broken down into two subpropositions, one to the effect that selling a part of oneself degrades the humanity in one's person, and therefore is morally objectionable. It would certainly be objectionable, within Kant's framework, to cut off a part of another person and sell it. An individual is to be treated as within the "kingdom of ends;"12 the fundamental aspects of that person are not to be used as a means to some other end. It would seem a contradiction of that order for Kant to approve of an individual cutting off and selling a part of himself for gain.13 The second subproposition is that because the "person" was given to man to preserve, it would be wrong to degrade it, or the physical portion of it, by cutting off and selling body parts. Proposition 2 sheds additional and much needed light on the components of Proposition 1. We are tòld in the second that it is allrightto cut off body parts that are themselves dead, and thus harmful to life. In addition, there appears to be a sliding scale of seriousness in Kant's view. Cutting off hair is not objectionable. Cutting off hair for the purpose of selling it is troubling, but probably justifiable if the reason is sufficiently important, e.g., curing cancer. But it appears that the cutting off of body parts that are closely connected to one's personhood, such as a kidney, raises ethical problems of a higher order of magnitude. On the basis of these propositions, Leon Kass concludes that "[m]an contradicts his rational being by treating his body as a mere means."14 Stephen Munzer adopts »ο Id, p. 84. π Id. 12 Immanuel Kant, Groundwork of the Metaphysic of Morals [1785], translated by H. J. Paton as The Moral Law, London: Hutchinson's University Library, 1948, pp. 95-100. 13 Kant says so explicitly in a passage covering duties to oneself: "Suppose there were no such duties. Then there would be no duties at all, not even external ones. For I cannot recognize myself as bound to others except insofar as a I bind myself at the same time." Kant, The Metaphysical Principles of Virtue, at 78. 14 Kass, supra fn. 4, p. 73.

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a similar point of view but puts more emphasis on the sliding scale; and by stating his criticisms in a weak form, deliberately avoiding bold conclusions,15 suggests that the sale of even integral parts may not be morally objectionable under certain conditions. The range of views expressed by Kass and Munzer is suggestive of the number of different interpretations one defensibly could reach on the basis of Kant's propositions. Although a wide range of interpretations are possible, the extreme points are easy to define. One extreme is to read Kant as prohibiting the selling of organs, or, more generally, integral body parts, under any conditions. The other extreme which Munzer, though clearly not embracing, fails to,reject altogether - is that selling integral body parts is not morally objectionable as long as the reason for sale is sufficiently important. The first extreme view, that sales are per se objectionable, suggests an outright ban on the sale of integral body parts. The second extreme view, though never clearly embraced by any of the Kantian writers, suggests that certain sales of integral body parts should be permitted. According to this view, the sale of a kidney in order to save the life of another might not be morally objectionable. However, there are many examples that clearly would be morally objectionable; e.g., the sale of teeth in order to improve the appearance of another, the sale of a cornea to improve the vision of a person who could see quite well with eyeglasses, the sale of an Achilles tendon to improve an athlete's performance. An unfettered market in body parts might easily give rise to a new form of cosmetic surgery, in which the desirable physical traits of one person are purchased and transferred to another. Presumably this sort of commerce would be morally objectionable even to those Kantians who were willing to read Kant's propositions in a way that permitted some limited commerce in body parts. In assessing these interpretations of Kant's propositions, it is important to keep in mind that there are some proposals for commerce in body parts that meet (or seem to meet) the moral objections of some of the Kantian critics. Consider, for example, Lloyd Cohen's proposal for a futures market in body parts.16 Under Cohen's scheme, the removal of a body part would take place only after death. It would seem unlikely, under this scheme, that a physical transfer would take place where the reason was not of sufficient importance to be morally defensible. Given the alternative of putting an organ into the ground, or burning it, it seems clear that transplanting it to someone who has a need for it is a morally defensible action. Thus, if Wilt the Stilt, a. terrifically skilled basketball player plagued with weak Achilles tendons, acquired the tendons of another man, for no other reason than to

!5 "I do not offer knockdown arguments for bold conclusions. I do contend that it is morally objectionable for persons to sell their body parts if they offend dignity by transferring them for a reason that is not strong enough." Munzer, supra fn. 5, p. 260. 16 Cohen, supra fn. 3.

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make himself a better athlete, it would seem to me to raise no moral concerns if the transfer took place after the death of the tissue provider. It follows that we may define a weak Kantian position that suggests sharp limits on the cutting off and sale of body parts of living persons, but places relatively few restrictions on the cutting off and sale of the body parts of the dead. The weak Kantian position would presumably also allow certain sales where the harm to the provider is trivial and the benefit to the recipient substantial. Sales of blood, sperm, or bone marrow might fall within this category. Less clear, though probably still morally defensible, is the case of selling skin in order to save a life, or selling a sample of liver tissue containing cells that could be reproduced and used to cure thousands of a deadly diseases. It also follows that a strong Kantian position would hold that sales of integral body parts are morally objectionable, whether or not the physical transfer takes place after death of the provider. This view permits only the cutting off of certain non-integral body parts, and the sale of such parts only for sufficiently important reasons. Hence, thefirst substantial shortcoming of the Kantian critics is a failure on their part to recognize that Kant's propositions may be reconciled with limited versions of an organ market. It is possible to read Kant, and clearly Munzer has provided such a reading, in a way that permits a certain amount of commerce in organs. Of course, this interpretation of Kant may be incorrect, so it is worthwhile to consider interpretations that do not permit commerce in integral body parts. The strong Kantian position is one such interpretation. Generally, it is clear that Kant takes a more favorable view toward the cutting off of body parts that are not integral, such as hair, or the cutting off of even integral body parts that may harm the possessor, such as a severely frostbitten finger. Suppose we view Kant as going this far, but no further. The strong Kantian position runs us into such difficult moral and practical problems, that one has to seriously question whether Kant would claim authorship of this view if he were with us today. Start with the distinction between donation and sale. Kant tells us in the second proposition that to "give away or sell a tooth ... belongs to partial self-murder." In other words, Kant seems to draw no distinction between the donation and sale of integral body parts. However, Leon Kass explains that there is a difference; For in a gift of an organ - by its living "owner" - as with any gift, what is given is not merely the physical entity. Like any gift, a donated organ carries with it the donor's generous good will. It is accompanied, so to speak, by the generosity of soul of the donor. Symbolically, the "aliveness" of the organ requisite for successful transplantation bespeaks also the expansive liveliness of the donor - even, or especially, after his death. Thus, organ removal, the partial alienation-of-self-from-body, turns out to be, in this curious way, a reaffirmation of the self's embodiment, thanks to the generous act of donation.17

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The question, of course, is why these things are not also true of an organ that is sold. Isn't the "aliveness" of a sold organ an extension of the "liveliness" of the seller? It would seem that the organ provider transfers some of his "liveliness" to the recipient whether the organ is donated or sold. And assuming a substantial moral distinction exists between the sale and the donation of integral body parts, how broad is its scope? Suppose, for example, the seller accepts half the price his organ could fetch? Is that to be treated as a sale or a donation? Is it half a "reaffirmation of the self's embodiment," or is it half of an "offense to dignity," or, yet again, is it one hundred percent insult to dignity because the provider tried to sell it but failed to get full price? Consider also, the fact that the National Organ Transplant Act, 18 a federal law which, among other things, prohibits commerce in body parts, does permit compensating organ providers for travel, missed work days, and other expenses connected to organ donation.19 What is the difference between a donor who receives such limited compensation, and one who receives the same compensation plus ten percent of the market value of the organ? Is one a donor and the other a seller? More generally, if it is morally permissible to compensate a donor for travel, housing, and lost wages connected to the act of donation, what of a decision to include compensation for forecasted future lost wages attributable to the act of donation? For example, suppose a kidney donor incurs $2000 in travel and housing expenses required by the act of donation, and loses two weeks of time from work. Let his salary be $1000 a week. But suppose it is virtually certain that the loss of one kidney, as a result of donation, will reduce his expected future working years by one half year, and he has ten years before retirement. The total loss in wages is then $2000 (immediate expenses), plus $9,639 (future losses, equal to $25,000 discounted at an interest rate of 10 percent and assuming 50 weeks of work per year). Suppose the recipient pays the organ provider $11,639, which just compensates the provider for the costs of donation. Is this, on moral grounds, to be considered a sale, or a donation? The difficulty can be stated at an even more general level: If one accepts the principle that it is morally defensible to not require an organ donor to suffer substantial losses in connection with donation, so long as the donor does not make a profit, then it becomes very hard to maintain the moral distinction between organ donors and organ sellers. In the example just discussed, the only difference between an organ provider who received compensation only for out-of-pocket expenses ($2000), and one who received that plus an amount designed to cover future expenses ($11,639), is that thefinancial loss to the donor is larger in the former than in the latter. But what moral principle requires the state to ensure that organ providers suffer the maximum financial loss as result of their decision to supply an organ? 17

Kass, supra Fn. 4, p. 75. is 42 U.S.C. §§ 273-274e (1994). «9 42 U.S.C. §274e(c)(2).

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How, one might ask, can one practically distinguish sales and donations under the framework I have proposed? The distinction is drawn by taking into account the difference between compensating the donor for costs incurred in the act of donation, and requiring the recipient to pay for the full benefits of receiving a new organ. To economists, this is the difference between maximum offer and minimum asking prices. Compensating a donor for the full costs of donation is equivalent to meeting the minimum asking price of an organ seller. Again, unless one holds that a donor must suffer the maximum financial loss, then it is does not seem inappropriate to call an organ provider a "donor" when he is compensated only for the costs of donation. Trades can occur at prices above the minimum asking level, until the maximum offer price of the buyer is reached. Compensation that exceeds the minimum asking price rewards the organ provider and therefore introduces a profit consideration into the decision to provide an organ. Thus, if, as is true of all of the Kantian writers, one accepts the premise that donation of body parts is morally defensible while sale generally is not, one may still arrive at the conclusion that some commerce in organs is morally defensible. Commerce is permissible under this framework as long as organ providers are limited to receiving their minimum asking prices. Indeed, if one reads Kant's propositions carefully, the framework proposed here seems to be implicit in his words. Kant's Proposition 1 speaks of disposing of oneself "as a mere means to some end of one's own liking ," and Kant's Proposition 2 refers to "selling one's hair for gain (emphasis added)." It should be clear that compensation for the costs of losing an integral body part, i.e., meeting the minimum asking price, is not equivalent to "selling for gain" or for "one's own liking." For if compensation is limited in this fashion, there is no gain to the organ provider, and it is therefore unlikely that he will, rationally, sell an organ in order to reach a desirable end. A promise to compensate only for the costs of losing a body part does not create the lure of a desirable end relative to the status quo. A committed opponent to organ sales could respond that this view is overly simplistic. I have ignored the likelihood that organ providers will be uninformed, and unable to accurately assess the expected future costs resulting from the loss of an integral body part. 20 One could also argue that they may suffer from time-inconsistent preferences, 21 and will act myopically in making the decision to provide an organ in exchange for compensation. But these arguments are closer to the realm 20 Thus, although they may perceive themselves to be better off as a result of selling an organ, they really are not. This argument was introduced as a powerful justification for strict products liability in A. Michael Spence, "Consumer Misperceptions, Product Failure and Producer Liability", Review of Economic Studies, vol. 44 (1977), pp. 561-572. 21 R. H. Strotz , Myopia and Inconsistency in Dynamic Utility Maximization, Review of Economic Studies, vol. 23 (1951), pp. 165-180; J. Elster , Ulysses and the Sirens: Studies in Rationality and Irrationality, New York: Cambridge University Press, 1979.

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of administration than that of morality. One could require physicians and others connected with the transplantation network to provide proper information and counseling to all potential organ providers. Alternatively, one could lessen the severity of these problems by adopting a program, such as the one proposed by Lloyd Cohen, in which transfer takes place only after the death of the provider. Informational disparities might still exist under such a program, but at least they would not give rise to the presence of people who have mistakenly compromised their own lives by selling an integral body part. Thus, unless one demands that organ providers suffer the maximum financial loss in connection with provision, there seems to be no moral case against compensation of organ providers for the costs of provision. Indeed, the moral case for any sort of price regulation in the market for body parts rests on a weak foundation. As a practical matter, it will be difficult to determine whether a provider has been compensated for costs or has received a windfall. The reason is that the costs of organ provision are both objective , and easily measurable, and subjective , or nonmeasurable. Generally, the minimum asking price of an organ provider will be the sum of three components: immediate or out-of-pocket expenses (P 0 ), estimated future costs (P/), and a subjective element (P 3). Thus, if Pa represents the provider's minimum asking price, P A = P 0 + Pf + P 3.

The subjective element, P Si will reflect the provider's valuation of perceived subjective benefits and costs resulting from the act of providing an organ. If the subjective benefits are greater than the subjective costs, P s will be negative. For example, if the organ is going to the spouse or child of the provider, the subjective element will reflect a substantial perceived benefit, which reduces his minimum asking price. In most cases such as this, the subjective benefit to the provider far exceeds the objective costs (i.e., — P s > P 0 + P/), which explains why donation among family members accounts for the vast majority of organ transplants. However, in some cases the subjective element will reflect a perceived cost rather than a benefit. For example, suppose a family, following the wishes of the provider, donates organs from his cadaver for the purpose of transplantation. Other relatives, who learn of the decision after the fact, are so upset that they refuse to have any further dealings with the family of the donor. To the extent that this is a foreseeable outcome, it is an additional cost to organ providers, which will increase the minimum asking price. Because of the existence of a subjective component in the minimum asking price, an organ provider who holds out for a price that exceeds the sum of out-ofpocket and estimated-future expenses (P 0 + P/) may not be seeking to gain from the transaction. He may be seeking only to be compensated for subjective costs. A

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regulator who prohibited compensation for subjective costs would therefore discourage some individuals from providing organs, when they only sought to have their costs covered. Thus, on administrative grounds it may be best to permit transactions in which the price exceeds objective measures of cost. In any event, the foregoing suggests the question whether to permit compensation for subjective factors - in other words, trades in which the price exceeds the objectively measured costs of the provider - is an administrative rather than moral concern. Put another way, if one accepts the principle, implicit in existing law, that morality does not demand an organ provider to suffer substantial losses in connection with the provision of an organ, then there seems to be no sound moral argument for prohibiting compensation for subjective costs. And if morality does not require prohibition of compensation for subjective costs, then any degree of price regulation would be morally problematic. To this point I have assumed the ethical wisdom and correctness of Kant's propositions and argued that they do not clearly rule out all commerce in body parts. Indeed, I doubt that if Kant were with us today, he would look at the long lists of potential organ recipients and hold that is better to let them suffer, 22 so that we can more effectively maintain our sense of propriety. I would now like to reconsider the validity and usefulness of Kant's propositions; especially Proposition 1, which tells us that (1) selling a part of oneself degrades the humanity in one's person, and (2) man has a duty to preserve this humanity. Let us start with the second component: the duty to preserve one's personhood. As a suggestion on how to run one's life, this is unobjectionable, but as a rule for crafting legislation, it is quite worrisome. 23 How far does the duty to preserve one's personhood extend? If cutting off and selling afinger violates the duty, then what of other decisions that subject an individual to harm or the risk of harm in exchange for money? For example, a large number of workers hold jobs which expose them to serious risks of harm, such as amputation, or lung cancer from second-hand smoking. In many of these instances, the workers have made a rational decision to accept the risk of harm in exchange for a larger wage than they would receive in a safer alternative.

22 How many are suffering? Consider the kidney recipient registry alone. In 1987, there were eleven thousand on the list in the United States, but if one expands the registry to include dialysis patients who would benefit greatly from a new kidney, thefigure exceeds thirty thousand, see Hylton , supra fn. 2, p. 205. I cannot overemphasize the distinction between moral advice and legislative rules. If the Kantian critics of organ sales limited themselves to a discussion of morals, I would find it harder to criticize their writings. In The Metaphysical Principles of Virtue, Kant distinguishes legal and ethical rules, and addresses most of his arguments toward the latter. The Kantian critics of organ sales, however, are writing against a background in which organ sales are illegal, and their arguments defend the existing order.

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What is the moral difference between the decision to work in a potentially hazardous environment and to cut off and sell a body part? In both cases one chooses to harm oneself, to compromise or degrade one's personhood, in order to receive a certain sum of money. If there is no important moral difference, does this suggest that Kant'sfirst proposition applies to all choices among alternative jobs? Have we then discovered that it is morally objectionable for an individual to accept a job in a hazardous working environment when he could have minimized the risk to his personhood by accepting welfare payments from the government? The charge "preserve the humanity in one's person" suggests a much broader prohibition of activity than the mere cutting off and selling of body parts. And yet if we pursue this line of reasoning consistently, we quickly find ourselves regulating decisions that the vast majority of individuals would prefer to be left free to make on their own, in accordance with their preferences. The fundamental problem with the preservation goal, as a guide for legislators, is that it crosses the line John Stuart Mill drew between directives that aim to prevent one person from harming another, and those that attempt to improve individuals by bringing them up to higher standard.24 Laws in the former category were quite sensible, indeed necessary, in Mill's view; while laws of the latter were neither necessary nor likely to contribute to welfare. It is more likely that laws of the latter type would become instruments of coercion, at the service of either democratic majorities or self-interested government officials. Now consider the first component of Kant's proposition, that selling a part of oneself is degrading to one's personhood. As Munzer reminds us, Kant distinguished things that had a price, such as a chair, from things that had "dignity," such as a rational human.25 Things that have dignity belong in the kingdom of ends; and it is therefore morally objectionable to trade them in the market, for they are to be treated as ends in themselves, not used as a means to some other end. From this reasoning it follows that one degrades the personhood of another individual by selling him into slavery, or by cutting off and selling an integral body part. And one degrades one's own personhood by selling one's whole self, or part of one's self. The argument strikes an intuitive chord in all of us, but again one must ask how far this principle is to be extended. It was taken to its limit, long ago, by Plato, who told us in The Republic that the virtue of the guardian class should not be compromised by allowing them to take part in the market. Plato's guardians were the leaders of the state, and embodied the desirable virtues of honesty, bravery, and the moral fiber to fight for their principles. These virtues, it is perhaps all too obvious, are compromised by the market. Market participants learn to balance the 24 John Stuart Mill, On Liberty (1859). 25 Munzer, supra fn. 5, pp. 266-267. Kant, Groundwork of the Metaphysic of Morals, p. 102.

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costs against the benefits of their actions; some learn that the truth may be too costly to tell at times. Hence, the market, in Plato's ideal world, was a plane of activity that could only be inhabited by those who were unfit to lead. While it is true that markets often require the compromise of principle, the general notion that there is an inherent conflict between market activity and the development and maintenance of virtue is a proposition that must be rejected firmly and unambiguously. The theory of an inherent conflict, which had a noble birth with Plato, has inflicted enormous misery on mankind over the years. Indeed, if one takes a glance at the remaining states in the world in which this theory remains a fundamental doctrine of government, onefinds remarkably little evidence that the desirable virtues are developed and maintained by narrowing the scope of market activity.26 Property rightsand markets are not inconsistent with the development of morals. Kant recognized this; however, the Kantian critics of organ sales, perhaps with the exception of Margaret Jane Radin,27 seem to be unsure of this proposition. Although Kant seemed to think that property rightsexisted in order to permit individuals to develop and extend their personalities; a more basic reason is that without suchrights,moral development would be impossible.28 In the absence of property rights, each individual would be compelled to devote a large share, if not all, of his time to defending against the expropriative efforts of others. In such an environment, it is impossible to make long term plans of improving oneself. The general insecurity in one's person and things would encourage an increasingly narrow and short-term view of one's interests. The existence of property rightsis a necessary condition for the development and maintenance of virtue, as envisioned by Plato. What about selling property? The act of selling sometimes requires the compromise of certain ideals; as when a person trying to sell his house decides, against his preferences, to water his lawn so that the grass looks greener. But people sell their property in order to acquire new property for which they have a greater need or 26 Quite the opposite appears to have happened. There are numerous accounts of spectacular corruption and the generally low state of public morals in communist and former communist countries; for one recent account, see Thomas L. Friedman, "Russian Roulette", New York Times, Wednesday, May 3,1995, at A15. 27 See Radin, "Property and Personhood", supra fn. 6. Radinfinds clear moral justifications for protecting the right to exclusive possession in certain items. However, the right to exchange an item on the market is not viewed by her as deserving the same level of legal protection. See Radin, "Market Inalienability", supra fn. 6. This distinction between the moral claims to hold and to sell items is also found in Kant's writings. However, what is novel in the writings of some of the modern Kantians is an aggressive denunciation of the moral appropriateness of market transactions in certain items, and even of economic terminology in general.

^ Sheldon Amos, Science of Law, New York: D. Appleton & Company, 1881, pp. 155156.

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desire. The option of taking property to the market gives the owner incentives to preserve and improve the property, i.e., to maximize its productive capacity. In addition, because the option of selling opens the possibility of Pareto improving transactions, men learn to cooperate in order to produce a joint surplus. Still, one might say that this seems fine for houses, or furniture, but what about body parts? I fail to see why many of the virtues encouraged in markets for real or personal property would not also be encouraged by a limited market in human body parts. The right of exclusive possession has been recognized for quite a long time, so there is nothing controversial in that aspect of property rights in the body.29 The right to sell would introduce a new feature to the law, and this feature could encourage desirable traits; provided, of course, the market is regulated in an appropriate manner. Consider, for example, Lloyd Cohen's futures market proposal. Those who chose to enter into such contracts would have greater incentives to maintain the health of their organs. Where prohibitions against drugs, alcohol, smoking, and prostitution have generally failed to eliminate the injuries associated with such activity, recognizing the market value of body parts would encourage those at risk for engaging in such behavior to give more thought to the hazards. It would be foolish, of course, to think that recognition of value in body parts would lead to the elimination of vices that have been with us since the dawn of intelligence. But it would alter incentives on the margin, in ways that would benefit all. Prostitutes probably would not exit their trade altogether, but they would have a greater incentive to minimize the health risks. The liability facing potential injurers would also be larger in such a regime, enhancing their incentives to take care in order to avoid injuring others. Physicians, aware of the potential market value of human organs, would have an additional reason, on the margin, to take care in performing invasive procedures. Of course, as soon as we mention the incentives of individuals to maintain their organs, we see the question on the other side: what kind of person wants to think of himself as a collection of valuable body parts? Framed in this manner, most people would object. But markets do not frame questions in this manner. Just as there are different ways to frame a question, there are individuals who will reach different conclusions if given the choice to participate in a market for organs. For those who find unbearable the very thought of themselves as carrying valuable parts, they need not participate. Their preferences, however, should not govern the decisions of others. Though Leon Kass expresses concern that the Uniform Anatomical Gift Act (UAGA) has distorted the law seriously by recognizing a property in the body, see Kass, supra fh. 4, p. 79. It is sometimes said that the common law recognized no property in the body, save a "quasi-property" recognized in relatives with respect to the body of the deceased. However, it is clear that the common law protects the right of exclusive possession of body parts, so in this sense, it does recognize a limited property in the body.

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It should also be noted that we already have active markets in which people are led to think of themselves as having a certain value. Consider, for example, life or disability insurance. A working father who purchases life insurance is very definitely encouraged by participants in that market to think of himself as an earnings stream dedicated to the benefit of his wife and children. As competition expands in the health care industry, people will be led, more and more, to associate their physical condition with a certain price. One could object that these markets encourage people to think of themselves and their bodies as decomposable into valuable assets. However, participants in these markets seem not to be troubled by these concerns. Indeed, markets for life, disability, and health insurance encourage desirable conduct. By pricing risks to health, they ensure that risk levels are communicated through market prices. Employees are therefore led to employment decisions that minimize risk, and employers are encouraged to design worksites in order to minimize the risk of injury to employees. To the extent people are encouraged through risk pricing to avoid imposing risks on others, except in cases where the potential benefits justify the imposition, markets for insurance reinforce incentives created by tort law. Finally, cooperative behavior in the organ procurement process itself would be encouraged by the introduction of commerce. In the distribution of organs, markets would encourage standardization of procedures among organ procurement agencies, so that procurement networks could work more effectively. 30 In addition, some commentators have suggested that the low rate of organ donation by members of racial minorities may reflect a general distrust of actors within the health care system.31 This distrust enters into the minimum asking price as a subjective cost. Compensating providers for these costs would increase rates of donation within these groups. As black Americans, for example, learned from experience that the relevant actors could be trusted, the need to compensate for the subjective distrust element would decline to zero over time.

B. Commodification

and Incommensurability

The notions of commodification and incommensurability are so closely related that I will deal with them at the same time. While it is possible to distinguish some of the concerns raised under the two headings, the overlap is substantial. Commodification is a problem in the area of organ sales because by permitting this sort of commerce, we suggest to ourselves that body parts should be treated as ordinary commodities, like apples and oranges. One of the reasons for not doing this is that

30 See Hylton, supra fn. 2, p. 207. 31 Jeffrey M. Prottas, "Encouraging Altruism: Public Attitudes and the Marketing of Organ Donation", Milbank Memorial Fund Quarterly/Health and Society, vol. 61 (1983), pp. 278-306.

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the human body is incommensurable with other commodities. I will elaborate on these criticisms. One can think of the commodification critique as another angle on the degradation argument of the previous section. According to Kant's first proposition, we degrade our persons by selling body parts in the market. Integral parts of the body, like the body itself, are important aspects of one's person, and should therefore be treated as within the kingdom of ends. The incommensurability argument is itself an elaboration of the commodification critique. We start with the premise that certain items cannot be properly accounted for by stating their value in dollar terms. There is too much involved in the "trade" of these items to reduce all of it into a price. It may help to consider a few examples that illustrate the inappropriateness of trading goods of this sort for money. Suppose, for example, you offer to pay a next-door neighbor $10 to shovel the snow in your yard. The fee may be on the high side for snow-shoveling, but the neighbor will probably be deeply offended by the action. Or suppose, instead of taking a date to dinner, you offer a certain sum of money as a substitute; or to express your gratitude for going to dinner with you, you offer your date a certain sum of money. In each of these transactions the recipient of the offer is likely to be deeply offended. Why? Some have argued that there are limits to the range of the market, and to economic concepts in general.32 Some items cannot be priced, it seems. This argument is extended, of course, to bodies, and to body parts.33 The body itself, according to this view, is an asset that cannot be reduced to a price, like an automobile. Neither should we think that parts of the body can be similarly reduced. Further, by stating prices for bodies and body parts, we give support to a view of ourselves as a collection of parts, which is demeaning. Let us return to the examples of offensive price offers. Why were they offensive? Because in each case, the offer of payment sends the signal that the offeror sees the transaction as complete, while the sort of exchange envisioned by the other party is of a reciprocal and long-term nature. Consider farmers living next to each other. It is an accepted norm in such communities that they will help each other if, say, one experiences a break-down in his equipment when the crop must be harvested. But the norm is understood as a reciprocal promise that extends indefinitely into the future. In other words, to attempt to use price as a means of effecting such an exchange would be inconsistent with the understanding of the other party. It would suggest to the other party that you do not recognize your

32 E.g., Cass R. Sunstein, "Incommensurability and Valuation in Law", Michigan Law Review, vol. 92 (1994), pp. 779-861. 33 See Kass, supra fh. 4; Munzer, supra fn. 5; Radin, "Market Inalienability", supra fn. 6. 9 Jahrbuch fur Recht und Ethik, Bd. 4 (1996)

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responsibility to comply with the norm. By offering payment you send the signal that you view your duty to your neighbor as closed by the payment of a fee. 34 The point is that there are some settings in which the exchange is assumed to be of a reciprocal and possibly long-term nature. That is true of neighbors living next to each other, of friendships, of marriages, and even of certain one-shot transactions. In these settings, market prices have no place because they send the wrong signal, a signal that is inconsistent with the assumptions underlying the transaction or relationship. But to say that such settings exist does not imply that prices always send a signal of devaluation. Return to the example of the farmers. The fact that a neighbor may help for free does not mean that a farmer should not pay someone else who offers, for a fee, to provide the help that might have been provided by the neighbor. And the fact that it would insult my neighbor if I offered him $10 to shovel my snow does not mean that it would insult a teenager who knocks on my door and offers to shovel the snow for a negotiable fee. The existence of a fee-for-service market for services that are also provided within long-term, reciprocal exchange relationships widens the set of options available to people, which is a benefit. The existence of such a market need not imply a devaluation of the reciprocal relationships, and neither is it a perfect substitute for the reciprocal relationship. For example, the existence of prostitution need not imply a devaluation of marriage. People are intelligent enough to distinguish between the marriage relationship and the typically shorter transaction with a prostitute. Similarly, the existence of a market in body parts need not imply a devaluation of the body. If this were so, the body would have been devalued long ago by the existence of markets in blood and sperm. Yet in spite of the long existence of a blood market, people generally do not view their blood as a commodity, like orange juice. Moreover, they continue to donate blood, even though they are aware that it can be sold. This suggests that the introduction of commerce in body parts would not lead to a devalued or corrupted view of the body. If we were all part of one family, there would surely be no need for prices to motivate the supply of certain items, and it would be insulting to members of the group to offer to pay for the supply of goods. But after moving beyond items that can be supplied at relatively low cost, people do not, in general, voluntarily incur 34 There are plenty of examples in life in which certain contract offers are not made because they send the wrong signal. John Donohue, for example, asks why people do not propose agreements to shift fees in the course of settlement negotiations, see John J. Donohue, ΕΠ, "Opting for the British Rule, or if Posner and Shavell Can't Remember the Coase Theorem, Who Will?", Harvard Law Review, vol. 104 (1991), pp. 1093-1119. The likely answer is the inappropriateness of the signal: to present a fee shifting proposal in the course of settlement negotiations suggests an intention to litigate rather than settle the dispute. See Keith N. Hylton, "Fee Shifting and Incentives to Comply with the Law", Vanderbilt Law Review, vol. 46, pp. 1069-1128, at 1080. See generally, Kathryn E. Spier, "Incomplete Contracts and Signalling", Rand Journal of Economics,, vol. 23 (1992), pp. 432-443.

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substantial costs in order to supply goods to people outside of their families, free of charge. The price system motivates individuals to supply goods to people who are not family members. No one has suggested that the existence of these incentives has somehow weakened families. I see no reason not to expect the same pattern in the market for body parts.

G Equity The third general theme running through the Kantian critiques of organ selling is the claim that it violates basic notions of fairness and equity. Critics point to the potential for inequitable outcomes on the demand side and on the supply side. On the demand side, the organ market violates notions of equity because items as vitally important as human organs would be distributed on the basis of willingness and ability to pay. On the supply side, notions of equity are violated by the phenomenon of poor people selling organs to the rich, a practice which seems uncomfortably close to slavery. Let us consider the demand side argument first. It is true that organs are vitally important, but so are some other items, such as food and housing. With respect to such items, economic theory suggests that there may be a trade off between equity and efficiency. The efficient allocation of resources is best achieved through the price system. However, there is no guarantee, in theory, that the market allocation will be equitable or fair. In particular, there is nothing in the theory that suggests that a market will not lead to an allocation in which poor families receive inadequate or only low-quality food, while a handful of wealthy adults receive far more food than they can consume. Concern for the potentially inequitable results of the market has led governments over the years to intervene in markets by setting price ceilings or requiring distribution without charge, on the basis of some measure of need. The various experiments in socialism are important examples of this, but even in the United States there are many jurisdictions in which certain prices are capped, as in the case of rent control. The theory underlying these efforts is that with respect to certain commodities, the price system should not be relied upon as an allocation mechanism because it is important that everyone obtain a fair share. In other words, there are some items that are too important to have their allocation left to the market. Hayek referred to this theory as the "fatal conceit."35 It is fatal because when put into practice, it often results in misery. It is based on a conceit because economists have long been aware that the equity-efficiency trade off does not require one to forgo the benefits of the price system as an allocation mechanism. The price 35 F.A. Hayek "The Fatal Conceit: The Errors of Socialism", in: W.W. Bartley, ed: Collected Works, vol. 1. 9*

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system can be maintained while equity concerns are met through a system of lump-sum transfers among households. The conceit implicit in the theory is the notion that an alternative administrative mechanism can be developed, run by government officials, that would work as well as the market without raising troublesome concerns over equity. In actual experience the equity-efficiency trade off has not been so severe that alternative governmental allocation schemes seem preferable. Consider the paradox of food supply. Perhaps no category of goods has a greater claim to being called a necessity than food. In other words, if, because of equity concerns, there is a set of goods too important to leave their distribution to the market, food should certainly be within that set. However, one finds generally that market economies produce and distribute a greater per capita quantity and quality of food than is produced in socialist systems. In the United States, where except for the government's attempts to regulate agriculture, the price system largely governs the allocation of food, the cost of food as a percentage of the typical family's budget is considerably lower than in socialist Cuba. And the quality of food available to a family well below the poverty line in the United States would seem fantastically high to a middie-class Cuban. Some of the important efficiencies observed in the market for food in the United States probably would be observed in a market for body parts. At present, as many commentators have noted, a significant percentage of transplantable organs are wasted because of incomplete standardization of procedures among participants in the organ supply network in the United States.36 High wastage rates are also a common feature of food supply networks in socialist countries. It is quite possible that the wastage problem observed in the organ supply process in the United States is, like that observed in the food networks of socialist countries, a byproduct of the absence of property rightsand enforceable claims on the demand side.37 What about the problem of equity on the demand side; i.e., the possibility that all of the organs for transplantation will end up in the bodies of the rich? If that happened, the best solution would be to subsidize organ purchases by the poor, not to abandon the price system as a method of allocation. However, there are good reasons for believing that this is a problem that would not materialize, as I hope to make clear in an example considered below. Now let us consider the supply side equity argument. The equity concerns would be raised by the phenomenon of poor people selling their organs to therich. Is this likely to occur? To get some sense of the likely participants, let us return and further develop one of our earlier examples. Suppose a kidney provider incurs $2000 in travel and 36

Prottas, supra fn. 31. See R. Schwindt/A.R. Vining, "Proposal for a Future Delivery Market for Transplant Organs", Journal of Health, Politics, Policy and Law, vol. 11 (1986), pp. 483-500. 37

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housing expenses required by the act of donation, and loses two weeks of time from work, and his salary is $1000 a week. It is virtually certain that the loss of one kidney, as a result of donation, will reduce his expected future working years by one half year, resulting in a loss of $9,639 in present value terms. Suppose these are all of the costs connected to the donation, so full compensation of the provider requires payment of $11,639. Is it possible that a less well-off individual might purchase the kidney? Consider the interests of the potential recipient. Suppose he has, in expectation, five years left to work (given the illness), and finds that his work life can be extended, in expectation, by five years as a result of a kidney transplant. How much would this potential recipient be willing to pay for a new kidney? He should be willing to pay up to an amount equal to the present value of the increase in his lifetime earnings. Suppose he, like the provider, works fifty weeks a year, and the interest rate is ten percent. If X is his weekly wage, the present value of the increase in earnings is 50X[(1/1.10)6 + (1/1.10)7 + (1/1.10)8 + (1/1.10)9 + (1/1.IO) 10 ], which is also the maximum offer price of the recipient. Equating this with $11,639, we find that if the potential recipient makes a salary in excess of $99 a week, he will be willing to offer a price in excess of the full compensation fee to the organ provider. Recall that the organ provider's salary is $1000 a week. I have just described a transaction in which a relatively poor individual buys an organ from one who is considerably wealthier. Was this just a numerical slight of hand? No. The features of this example are quite general as descriptions of a transaction for a body part. The general features suggesting the possibility of transactions similar to the one in my example are: (1) the gain in the organ recipient's working years is larger than the loss in the organ provider's work years, and (2) the interest rate is positive. The latter factor, though unimportant in my example, is important generally because the gain to the organ recipient ordinarily will be immediate, while the loss to the provider will be experienced in the distant future. The general lesson of this example is something that is observed in markets all of the time. Willingness to pay is a function of wealth, but it is also a function of interest, need, and the size of the benefit to the buyer. For these reasons, there is likely to be a substantial percentage of transfers in which relatively poor individuals are acquiring organs, sometimes from wealthier providers. Whether in fact the pattern that results raises fairness concerns is, in the end, an empirical matter. The pattern will depend on the composition of organ recipient registries and the type of body part that is being transferred. The composition of the kidney recipient registry in the United States does not suggest that an organ market would result in transfers from the poor to the rich: black Americans, a relatively poor group, make up roughly thirty percent of the registry. 38 38 Prottas, supra fn. 31, p. 293.

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A tissue such as bone marrow, which can be extracted relatively easily, may develop into a market which resembles the current market for blood. In the blood market, therich generally donate, and some of the poor sell. Indeed, few of the rich would sell their blood for fear of the reputational damage that might result if it were known that they were selling blood, a sure sign of financial distress. The same sort of bifurcation might eventually be observed in a market for bone marrow. Finally, suppose the resulting pattern is in fact one in which relatively poor people sell body parts to the rich. Is this a problem? If so, what distinguishes it from the fact that relatively poor individuals often accept dirty or hazardous work that the rich generally avoid? Surely the distinction cannot be based on the degree of risk incurred: many lines of work presentrisksmore serious than those incurred by an individual who donates a kidney. I suspect that "the problem" in the eyes of the Kantian critics is not that the sellers in organ market would not be as wealthy as the buyers, but that the sellers may be seriously compromising the quality of their lives.39 But this problem can be avoided by adopting a system, such as the Cohen proposal, in which physical transfers take place only after the death of the organ provider. D. Some Notes on Implementation In spite of my efforts to counter the arguments of the Kantian critics, I do not believe that an unfettered market in body parts would be a good idea. Indeed, some of the problems identified by the Kantians are important and need to be taken into account in any market-oriented organ supply system. The general thrust of my argument is that the serious problems are largely on an administrative level. In short, the ethical case against any commerce whatsoever in body parts is weak. The important problems are of a utilitarian, administrative nature, and concern the optimal design of a market-based system. Since I have discussed many of these problems elsewhere, I will deal with only four of them briefly here. One question that must be addressed is who can claim property in body parts. It is an obvious concern because one undesirable result of a system in which body parts have value in the market is the incentive given to unscrupulous characters to kill and dismember people in order sell their parts. 40 Alternatively, will a creditor, 39 For example, Leon Kass, discussing the equity problem, notes that as he "read[s] about the young healthy Indian men and women selling their kidneys to wealthy Saudis and Kuwaitis, I can only deplore the socioeconomic system that reduces people to such a level of desperation." Kass, supra fn. 4, p. 76. However, the sale of kidneys by the young and healthy can be prohibited without banning any sort of commerce in organs. ^ One is reminded of the scene in a Monty Python movie in which organ traders show up on a man's doorstep. After explaining their purpose, they force their way into his house and restrain him as they remove a kidney with a chain saw. As one might imagine, there are real life stories that are not much milder. The most famous is the story of Burke and Hare, a team

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under such a system, claim ownership of the bodies of his debtors? Will the guardian of a mentally retarded teenager sell parts of his body? Although there are a number of ways to avoid these outcomes, one easy solution would be to prohibit all such vicarious sales. Only the possessor should be permitted to claim property in his body parts while alive. Where the possessor has not entered into a contract to sell body parts, the common law "quasi-property" rule granting theright to possession of the cadaver to the next of kin for burial purposes should remain the law. A second problem, often considered a serious ethical concern, but actually belonging in the administrative category is the problem of "coercion." Writers who refer to this are usually discussing the problem of deals in which the seller realizes, after agreeing to sell the body part, that is was a mistake. Either the compensation turns out to be inadequate, or he misunderstood the down-siderisks,or he simply failed to realize what was best for his long- term interests at the time he entered into the agreement. Should people be held to these bargains? Absolutely not. The common law has shown a deep respect for bodily integrity; no court would enforce a contract requiring a party to cut off and transfer an integral part of his body.41 The problem is a little more complicated where the seller is dead. The common law rule grants the family quasi-property in the body of the deceased, for the purpose of arranging burial. Here the question arises whether the wishes of the family members are to be respected if they refuse to hand over the body. The case for changing the common law rule, which grants theright to the family, is not entirely clear. For if the common law rule were kept intact, the parties involved in a sales transaction would know that they would have to get approval from close relatives in order to have an enforceable claim to the body parts of the seller. This may be a desirable rule because it would in effect require the seller to discuss the matter with his family before entering into a sales agreement. The family would prefer the advance notice, and the seller would benefit from hearing their views. Indeed, the "coercion" potential - i.e., the problem of mistaken deals - might be eliminated altogether through these early discussions among family members. A third frequently discussed issue is that of quality deterioration. The fear is that in a market-oriented system, there would be a dramatic increase in the percentage of diseased organs and tissue offered for transplantation. The problem is observed, of course, in the blood market. The answer is that there are a number of market mechanisms for controlling the problem of quality deterioration. For example, under a system in which sellers contract to provide body parts after death, organ procurement firms could screen for the quality of organs initially and monitor quality through the term of the contract. Through the development of stable registries of of murderers who killed more than sixteen people to sell their bodies to medical institutions. For an inappropriately lively account of their story, see W. Roughhead, Classic Crimes, New York: Vintage Books, 1951, pp. 68-104. 41 On the common law respect for the life and limbs of individuals, see William Blackstone, Commentaries on the Laws of England, vol. 1, p. 126.

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suppliers, a practice observed in the blood market, quality deterioration could be largely avoided. In addition to this, organ providers will have incentives, under a market system, to develop reputations for quality and to provide warranties. Finally, a fourth problem is market structure, and it is closely related to the quality deterioration issue. At present organ procurement agencies in the United States are local monopolies, are required to be so in order to receive federal support. Clearly the United States government would have to reverse this policy if a market-based procurement system were ever developed. Quality in the provision of goods is enhanced by competition, and there is little reason to think that organ supply is different in this respect.

ΙΠ. Conclusion It is easy for an economist or philosopher who approaches this subject to march quickly into an abstract discussion of the limits of the market, but we are dealing with a simple policy issue, the answer to which would dramatically effect the quality of the lives of thousands on organ donor recipient registries. Should body parts be sold? Or, alternatively, should body part providers be compensated for their costs? The ethical case against sales for gain is difficult to make, or to accept, and I find the case against full compensation entirely wanting. The serious grounds for objecting to a limited market in body parts are not on a moral level, but almost entirely on the level of administration.

Zusammenfassung Es gibt Autoren, die gegen den Handel mit Körperteilen moralische Einwände anführen. Der Beitrag untersucht diese Einwände im Hinblick auf die wirtschaftlichen Beweggründe sowohl von Organempfangern als auch von Organspendern. Im Lichte der dabei angestellten Überlegungen vertieren die Einwände erheblich an Gewicht.

The Efficiency /Equity Puzzle and the Race Issue in Kidney Allocation: A Reply to Ayres, et al. and UNOS Lloyd R. Cohen1 and Melisa Michelsen

Imagine two queues of potential kidney transplant recipients, one White and the other Black. Patients are smoothly distributed along each queue from highest priority, in terms of expected medical benefit, at the top to lowest priority at the bottom. Consider the following hypothetical "facts" about dialysis and kidney transplantation in the United States: (1) Whites, on average and at the margin, do better on dialysis than do Blacks, that is, they live longer and have fewer medical and psychological problems; and (2) Blacks, on average and at the margin, do better with kidney transplants than do Whites, that is they have higher graft survival rates. In other words, the last kidney given to a Black person ("last" not chronologically, but in terms of medical priority) is more likely to still be functioning in one, two and five years after transplant than the last-kidney given to a White person, and the last White person denied the kidney is likely to survive and tolerate dialysis better than the last Black person who is similarly denied. What do these facts imply about the efficiency and ethics of kidney transplant allocation? To answer that question you need to know the goal of the kidney allocation policy. We have not provided one, and you are free to choose your own. We suspect, however, that virtually all thoughtful modem observers would assent to a goal something like the following: all organs should be allocated on the basis of medical need and benefit without regard to race. Now, what do the above facts suggest? It appears that there is discrimination against Blacks in kidney transplants allocation. If the next Black person in line is likely to do better with a transplant and worse on dialysis than the next White person, then he is likely to stand in the same relation to the last White person to have received an organ. Thus transplant organs have been and are being allocated to White people who are less deserving than Black people in the sense of being less likely to get medical benefit from the transplant. Given the goals of maximum medical benefit and racial neutrality one would be justified in being, at a minimum, suspicious of the allocation mechanism that resulted in this anomalous result.

ι I wish to thank the Law & Economics Center of George Mason University School of Law for its generous financial support.

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We can now reveal the truth. The two "facts" with which we began this article are the exact opposite of reality. The truth is that Blacks do better with dialysis than Whites and Whites do better with kidney transplants than Blacks.2 Thus it seems that applying reasonable notions of equity, the current allocation system discriminates against Whites and in favor of Blacks. Into the teeth of the above analysis march Ian Ayres, Laura Dooley, and Robert Gaston with the thesis that the system of kidney allocation in the United States, though facially neutral, unfairly discriminates against Blacks. They then propose a number of policy changes that they believe will improve the prospect of Black patients receiving organs.3 Unfortunately their proposal and reasoning, or something like it, has not fallen on deaf ears. As Dr. Lawrence Hunsicker in his presentation at the Bellagio conference "Biotechnological Challenges for Law and Ethics" reported, the United Network For Organ Sharing (UNOS) has adopted changes in the allocation scheme much like those favored by Ayres and for precisely the purpose he views as laudable. In this article we will seek to do three things. Our primary task will be to criticize Ayres* thesis and argument. In the process, we will explore the efficiency implications of some of the specific kidney allocation rules of the past and present, the proposed changes favored by Ayres, and the actual changes adopted by UNOS. It is our belief that Ayres* proposal is not merely thoroughly incorrect but that it and the rule changes adopted by UNOS are evil and pernicious as well. Second, we will use the Ayres' thesis as a vehicle to explore the more general ethical and economic questions of what a system of organ allocation should seek to accomplish. Third, we will suggest, if only briefly and in passing, that the ethical morass that we have entered in government allocation of kidneys demonstrates the moral virtues of allocation by the market. We have divided the remainder of our presentation into nine sections. We begin in section I with a general discussion of the state of the kidney shortage in the United States. In section Π we provide a short discussion of the medical aspects of kidney transplantation and kidney allocation, and in section ΙΠ a similarly limited discussion of the regulatory and legal framework in which kidney allocation takes place in the United States. These medical and legal facts are the background against which the ethical and economic arguments are played out. In section IV we present Ayres' thesis and policy goals and proposals. In section V we respond to Ayres' claim that less weight should be given to HLA matching because the use of immuno-suppressant drugs such as Cyclosporin and its progeny makes such matching superfluous. In section V I we explore in some depth one of the themes on which Ayres' thesis rests, the supposed dichotomy between equity and effi2 See infra fn. 129 and accompanying text. 3 Ian Ayres/Laura Dooley / Robert S. Gaston , "Unequal Racial Access to Kidney Transplantation", 46 Vand. L. Rev. 805 (1993). Hereinafter for purposes of ease of exposition I will refer to and treat the article as written only by the first named author, Ayres.

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ciency. In section VII we examine two operational policies incorporated in the current allocation scheme that Ayres believes reflect a concern with what he calls "equity": (1) the 0 rule; and (2) the preference for pre-sensitized patients. Ayres incorrectly believes that these policies provide a precedent for favoring Blacks. In section Vin we explore the differences and relationship between theoretical standards and operational measures and the propriety of the use of race in either role in kidney allocation. In section EX we argue that the adoption by UNOS of a racial agenda in kidney allocation demonstrates that the supposed moral high ground occupied by public allocation as opposed to a system of private property and market allocation is a fraud.

I. The Kidney Shortage We are witnessing an evolving medical miracle. The improvement in technique, the routine use of the ventilator and respirator, and the development and refinement of immuno-suppressant drugs, particularly the introduction of cyclosporin-Α in 1980 and prednisone and OKT-3 more recently, have combined to make the transplantation of human tissue almost routine.4 At least twenty-five different body parts and fluids have now been transplanted in human beings, including parts of the inner ear, a variety of glands (pancreas, pituitary, thyroid, parathyroid, and adrenal), blood vessels, tendons, cartilage, muscles (including the heart), testicles, ovaries, fallopian tubes, nerves, skin, fat, bone marrow, blood, livers, kidneys, and corneas.5 4

Although the successful transplantation of human organs, i.e., bones, began in 1878, it was only when the process of rejection began to be understood during World War Π that real progress could be made. The first major and vital organ to be transplanted successfully was the kidney in 1951. By the late 1960s, with the improvement in technique and the availability of immuno-suppressant drugs, the procedure was successfully extended to large-scale transplantation from unrelated cadavers. See Bergan , "History of Renal Transplant Registry", in: U.S. Kidney Transplant Fact Book, at v, 10 (1972) (United States Department of Health, Education, and Welfare Publication Number (NIH) 73-335). By 1976 there were 301 kidney transplant teams operating throughout the world, and over 25,000 kidneys had been transplanted. In the mid- and late 1960s, the transplantation of livers and hearts began, but only in the 1970s was the technique perfected to a degree that allowed for widespread use. The oneyear transplant survival rates reached the following levels by 1985: kidneys 92-95%, hearts 75-85%, livers 60-70%, pancreas 75-80%, and heart-lung combinations 50%. See Task Force on Organ Transplantation , Organ Transplantation: Issues and Recommendations 17 (1986) [hereinafter Task Force Report]. With improved survival rates has come an enormous increase in the frequency of organ transplants. Between 1981 and 1983, kidney transplant operations in the United States increased 40%, heart transplants 700%, and liver transplants 1100%. White , "Update: A Review of Organ Transplantation Policy", Health Affairs, Winter 1985, at 109. By 1986 there were 8960 kidneys, 1,368 hearts, 924 livers, and 45 heart-lung combinations transplanted in the United States, New York Times, Sept. 6, 1987, § 1, at 26, col. 1. And, by 1993 the number of transplant procedures had increased to 10,928 kidneys, 2,298 hearts, 3,442 livers, 60 heart-lung combinations, 664 lungs, 772 pancreata, and 6,300 bone marrows, UNOS Scientific Registry Data as of May 27, 1994.

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The markedly improved success rate of organ transplantation over the last 15 years has exacerbated what was recognized as a serious problem twenty-five years ago: the shortage of available transplant organs.6 The shortage of transplant organs is not merely large, it is individually tragic. The demand for transplant organs by the sick and dying captures our attention with its all too human face. As of October 19, 1994 the transplant waiting lists were as follows: kidneys, 26,845; livers, 3,836; hearts, 2,866; heart/lungs, 207; lungs, 1,561.7 These numbers have not only been increasing over time, but represent an ever changing set of people. Individuals are scratched from the UNOS National Transplant Waiting List principally as a result of death and transplantation, at the rate of about sixty per day, only to be more than replaced by others, who enter at the rate of seventy per day. The patients on the lists or third parties such as insurance companies or the federal government representing them have been willing to pay for a transplant operation but have been forced to wait because of an insufficient supply of organs. Thus the size of the waiting list is something akin to a measure of the shortage of transplant organs. As large as the numbers on the waiting lists appear, however, the true shortage in transplant organs is actually considerably larger. The size of the waiting lists is artificially constrained, especially in the case of the kidney, because entry onto the lists depends on an endogenous and arbitrary definition of clinical suitability. As of December 31, 1993, 171,479 people were on long-term dialysis in the United States. The number of people so afflicted has been rising steadily since dialysis became available.8 While a large proportion of these patients would probably benefit from a kidney transplant if one were available, it is understood that there is a limited supply of transplantable kidneys and that most of those on dialysis have little chance of receiving one. Judgments are made as to who is in most dire need

• s R. Scott , The Body as Property 19 (1981). See also, Rene Kuss/Pierre Bourget, An Illustrated History of Organ Transplantation: The Great Adventure Of The Century, Sandoz 1992. 6 See, e.g., Dukeminier, "Supplying Organs for Transplantation", 68 Mich. L. Rev. 811 (1970). The shortage of cadavers for medical applications is not an entirely new phenomenon. During the 18th and early 19th centuries in England, the illegal disinterment of corpses by "resurrectionists" for sale to medical schools and practitioners was common. This practice was completely eliminated by the Anatomy Act of 1832, which provided for the orderly donation of bodies to medical schools by those in lawful custody. An Act for Regulating Schools of Anatomy, 1832, 2 & 3 Will. 4, ch. 75, § 12. 7 UNOS National Patient Waiting List. Compare thesefigures to the corresponding numbers as recently as July 22, 1992: kidneys, 21,120; liver, 2,183; pancreas, 783; heart, 2,257; heart-lung, 166; and lung, 889. C. £. Orians/R. W. Evans /N. L·Ascher, "Estimates of Organ Specific Donor Availability for the United States", 25:1 Transplantation Proceedings 1541 (1993), and September 1987: kidney, 10,000; heart, 450; liver, 300; heart/lungs, 91. New York Times, Sept. 6,1987, § 1, at 26, col. 1. 8 Annas, "Regulating Heart and Liver Transplantation", 25 Jurimetrics J. 249, 254 (1985) [hereinafter Annas, "Regulating Transplantation"].

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of an organ and who can profit most by receiving one, and the names of the others never appear on the waiting list. A very conservative estimate of the cost in terms of human suffering of the shortage can be inferred from the number of people dying while on the waiting list for an organ transplant. (See Table 1). This measure of the human cost of the shortage in transplant organs is conservative in two respects. First, as mentioned above, it neglects to take account of all those who, at present levels of medical expertise, could benefit from an organ transplant but whose names never appear on a waiting list. Second, it fails to account for the suffering of those who remain alive but in perilous health while awaiting an organ transplant.

Table 1 Reported Deaths on the UNOS Transplant Waiting List 1988-1993 Organ

1988

1989

1990

1991

1992

1993

Kidney Kidney & Pancreas Liver Intestine Pancreas Heart Heart-Lung Lung Total

721 0 193 0 6 492 63 15 1481

749 0 281 0 20 519 75 39 1660

915 0 316 0 24 611 68 50 1959

975 1 436 0 37 779 44 139 2360

1045 15 492 0 33 774 44 219 2564

1275 59 558 3 3 762 51 252 2887

Each category of organ has its own story. The kidney was the first, and is the easiest, cheapest, and most successfully transplanted major organ. It is also the only major organ for which medical technology has succeeded in developing a long-run substitute, albeit a less than totally satisfactory one, dialysis. The binding constraint in kidney transplantation is the number of available organs. Despite various public initiatives such as advertizing campaigns, imposing the obligation on doctors and hospitals to request donation of next of kin, and substantial government support, the number of donated cadaveric kidneys has increased only modestly over the last half dozen years and stood at 9,152 in 1993.9 Thus, the general problem that we address is how to allocate a less than adequate supply of life saving and health restoring kidneys among a much wider population of deserving patients, that is, who should be offered kidneys first, and on what ba-

9 United Network for Organ Sharing: UNOS Scientific Registry Data as of May 27, 1994.

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Π. Medical Aspects of Kidney Transplantation and Allocation The great success of organ transplantation is a recent phenomena. In prior years and centuries there were many reasons for failure. But, by the middle of the twentieth century all save one barrier had been overcome, rejection of the transplant organ by the patient's immune system. The immune system has the ability to target, isolate, and destroy foreign invaders; thereby, protecting us from infection. Were it not for its effectiveness we would all quickly succumb to one disease or another. The rub for transplant patients is that the immune system does not distinguish among foreign protein. And so it will attack and destroy a transplant organ with the same vigor as a staph infection. 11 The specific process of rejection commences when the patient's immune system recognizes that the surface antigens on the donated organ are not the same as its own surface antigens.12 The patient's immune system cannot accept these new proteins, and so its Β and Τ cells become activated and attack the foreign organ.13 The proteins (termed tissue or histo-compatibility antigens) that Β and Τ cells can identify are categorized as either major or minor. 14 The major antigens fall into two groups. The first is the ABO blood grouping with which we are all familiar. The second subset of major histo-compatibility antigens consists of the human lymphocyte antigen (HLA) system made up of the glycoprotein gene products of loci in the major histo-compatibility complex (MHC). 1 5 There are a number of different HLA antigens on the surface of each human cell. Similar to blood typing, HLA antigens can be classified into groups: Class I type contains A, B, and C antigens and Class Π type has DR, DQ, and DP antigens.16 Antigen matching is more quali-

!0 One of the authors of this paper has argued elsewhere that the development of an options market in organs would do much to increase the supply of cadaveric organs and relieve human suffering. A further exploration of this position will not be addressed in this article. See, Lloyd R. Cohen, Increasing the Supply of Transplant Organs: The Virtues of an Options Market (R. G. Landes 1995); L Cohen, "A Futures Market in Cadaveric Organs: Would It Work?", 25 : 1 Transplantation Proceedings 60 (1993); L Cohen, "The Right of Healthy People to Contract for the Sale of Their Organs Post Mortem", 8:1 Transplantation & Immunology Letter 8 (1992); L Cohen, "A Market Proposal for Increasing the Supply of Cadaveric Organs", 5 : 6 Clinical Transplantation 467 (1991); L· Cohen, "The Ethical Virtues Of A Futures Market In Cadaveric Organs", in: Ethics, Justice and Commerce in Organ Replacement Therapy, Heidelberg: Springer-Verlag, 1991, p. 302; L Cohen, "Increasing the Supply of Transplant Organs: The Virtues of a Futures Market", 58:1 Geo. Wash. L. Rev. 1 (1989). n See, generally, H. F. Pizer, Organ Transplants: A Patient's Guide 11 (1991). 12 Id., at 18. 13 Id. ι* Id., at 19. 15 William E. Braun, M.D., "Molecular, Genetic, and Clinical Aspects of the HLA System", in: Oigan Transplantation and Replacement 162 (1988) [hereinafter Braun, HLA System]. 16 Id.

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tative, less binary, than blood group matching. In other words, when doctors say that there is a match, it means that the donor's and the patient's tissues carry many, not necessarily all, of the same HLAs. 17 Organ transplant success rests on stopping rejection. There are two paths to this goal. The principal one over the last fifteen years has been the development of powerful drugs that disable the organ rejection process. The second and supplementary route is to genetically match organs and recipients. Minimizingtissueincompatibility reduces the frequency of early organ rejection, and has been associated with improved patient survival both in the short-term and the long-term.18 Blood group matching is both more important and less problematic than HLA matching. A person's blood group is determined by the A and Β antigens appearing on the surface of their red blood cells. People with blood type A have the A antigen, those with type Β blood have the Β antigen, those with type AB have both A and Β antigens, and those with type 0 blood do not have either antigen.19 These antigens are also present in the organs of the body. People also have, as a companion to their blood group antigens, vigorous antibodies in their blood against the blood group antigens they do not have. Blood group matching is more important than HLA matching because antibodies against blood group antigens will cause hyperacute rejection of a transplanted organ.20 Thus, as a practical matter, with the exception of organs from type 0 patients, who have no antigens, patients cannot receive organs from donors of a different blood group. On the other hand, blood group matching is less problematic than HLA matching because there are only four blood group types: Α, Β, AB, and 0. Thus given a fairly large supply of potential recipients there is little difficulty in finding an exact blood group match for a potential organ. In addition to testing potential recipients and determining what antigens they may have and seeking to find a close match, another way of matching patients to avoid rejection is to test for the appearance of antibodies that react in the HLA system through a process called a crossmatch.21 Crossmatching entails mixing a small blood sample from the patient with cells from the donor. If the donor's cells die when mixed with the patient's blood, the crossmatch is positive. A positive crossmatch means that the patient's antibodies are vigorously reacting to the antigens on the surface of the donor's cells and the transplant is likely to result in hyperacute rejection and a transplant would quickly fail. 22 Each time a kidney is do17 Pizer, supra fn. 11, at 19. 18 Braun, HLA System, supra fn. 15, at 179. See also, Gerhard Opelz, M.D., et al. , "The Influence of HLA Compatibility on Graft Survival after Heart Transplantation", 330 New Eng. J. Med. 816 (1994). Pizer, supra fn. 11, at 23-24.

20 Id. at 24. 21 Id. at 26-27. 22 Id. at 27.

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nated, a crossmatch is performed to screen blood samples from potential recipients. Only those patients with negative crossmatches are regarded as potential recipients for that organ. Those with positive crossmatches are deemed to be sensitized to that donor.23 We have spent some time and space discussing antigen matching in kidney allocation because it is in large part arguments about the value of such matching on which the Ayres' thesis turns. Keep in mind, however, that there are numerous other relevant medical considerations such as age and medical condition that we will not discuss in any detail, or in some cases even mention, that speak to the efficacy of allocating organs to particular patients.

ΠΙ. Legislative and Regulatory Background The federal government first entered the area of organ allocation in 1984 with the passage of the National Organ Transplant Act (NOTA). 24 NOTA provided funds to the Department of Health and Human Services (HHS) to develop a national system to assure the fair distribution of organs,25 and created a Task Force on organ transplantation to consider the problem of organ scarcity. Under the auspices of HHS, the task force approved the establishment of the nationwide organsharing system, Organ Procurement and Transplantation Network (OPTN) 2 6 The OPTN was established under section 372(b)(2) of the Public Health Service Act (PHSA), as enacted by NOTA. 27 In 1986, HHS awarded the first contract to the United Network for Organ Sharing (UNOS) to operate the OPTN and to develop a system that allocates donated organs "equitably among transplant patients according to established medical criteria". 28 Section 1138 of the Social Security Act 29 requires hospitals to comply with UNOS policies or risk losing Medicare and Medicaid payment for all services.30 Nonetheless, UNOS at its discretion permits individual regions and centers to vary from the established organ allocation scheme.31 23 Id.

24 Pub. L. No. 98-507, 98 Stat. 2339 (1984), codified at 42 U.S.C. §§ 273, 274(a)-(e)(1988 and Supp Π 1990), amended by Pub. L. No. 100-607 and Pub. L. No. 101-616. 25 Id. at § 274. 26

Gerald Leinwand, Transplants: Today's Medical Miracles, 41 (1992). 27 59 Fed. Reg. 46482 (1994) (proposed Sept 8,1994). 28 Pub. L. No. 98-507, 98 Stat. 2339 (1984), codified at 42 U.S.C. §§ 273, 274(a)-(e)(1988 and Supp. Π 1990). In 1986, the Department of Health and Human Service awarded the Organ Procurement and Transplantation Network contract to the United Network for Organ Sharing (UNOS), an already instituted organ procurement entity. James E Blumstein, "Federal Organ Transplantation Policy: A Time for Reassessment?", 22 U.C. Davis L. Rev. 451, 463 (1989). 29 42 U.S.C.A. § 1320b-8 (West 1994). 30 42 U.S.C.A. § 1320b-8(b)(l)(D).

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The Organ Transplant Amendments of 1988 32 amended section 372 of PHSA to require that the OPTN establish membership criteria and subject its policies to public review and comment.33 HHS and UNOS have had numerous discussions concerning the policies that should constitute a rule or requirement of the OPTN. 34 In December, 1989, HHS issued a notice stating that UNOS policies will be promulgated in accordance with Administrative Procedure Act 35 regulations for proposed rulemaking and be published in the Code of Federal Regulation (CFR). 36 In September, 1994, HHS published a notice of proposed rulemaking.37 Proposed § 121.7 maintains that the OPTN Board of Directors shall develop policies for distributing organs for transplantation. Such policies must "be patient-based and take into account established medical criteria for transplantation, the length of time potential recipients have been on the national list, and potential recipients whose immune system makes it difficult for them to receive organs, while minimizing wastage of the scarce supply of human organs for transplantation and improving the outcomes of transplantation".38

UNOS Policies UNOS created a national system of uniform policies of distribution to replace those previously employed by the plethora of procurement agencies. UNOS claims five goals for its organ allocation system: 1) to apply equitable medical criteria, 2) to serve patients fairly, 3) to maximize the chance of a successful outcome, 4) to minimize organ wastage, and 5) to encourage organ donation.39 In order to better allocate organs UNOS maintains a computerized, nationwide list of patients waiting for organs. These patients are ranked on a point system that includes likelihood of medical success, time on the waiting list, and urgency of need.40 In its simplest formulation the general policy goal of the UNOS allocation scheme that existed up until 1995 was that organs be allocated to those who can make best use of them. That theoretical goal was advanced by a series of specific operational rules. UNOS policy required kidneys (with the minor exception of 31 32 33 34 35 36

59 Fed. Reg., supra fn. 27, at 46487. Title IV of Pub. L. No. 100-607, 42 U.S.C. § 274(c) (1988 and Supp Π). 59 Fed. Reg., supra fn. 27, at 46482. Id. 5 U.S.C. § 501 et seq. 54 Fed. Reg. 51802,51803 (1989).

37 59 Fed. Reg., supra fn. 27, at 46482. 38 Id. at 46485 (emphasis added). 39 Martin Benjamin , et ai, "What Transplantation Can Teach us about Health Care Reform", 330 New Eng. J. Med. 858, 859 (1994). 40 59 Fed. Reg., supra fn. 27, at 46486. 10 Jahrbuch für Recht und Ethik. Bd. 4 (1996)

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some 0 kidneys) to go to patients of the same blood type group, i.e., A donor organs to A recipients, Β to Β, AB to AB, and 0 to 0. Finer discriminations were made on the basis of point allocations. Points41 were allotted to potential kidney recipients based on waiting time, age, pre-sensitization42, and antigen (HLA) matching.43 The last category, genetic matching, was determined by the classification of six HLA antigens, two A, two B, and two DR, located on the surface of cells.44 UNOS recognized the positive effects of HLA matching on graft survival and established a hierarchical point system to take advantage of its benefits. A sliding scale from 10 points for zero A, B, or DR mismatches, to one point for no more than three Β and DR mismatches were allotted to patients.45 (see table 2.) Four points were given to patients who were deemed to be pre-sensitized, i.e., they demonstrate a significant likelihood of reacting to more than 80% of the potential donor population, and have a negative crossmatch with this particular kidney.46 Patients would receive .5 points for each year on the waiting list, and the patient with the longest time on the waiting list received an additional point and all other potential recipients acquired fractions of a point proportioned to their length of time on the list. 47 Patients 11 years old or younger were allotted three additional points and patients who are 11 years or older but less than 18 receive two additional points.48 Children received these additional points because they do not do well on dialy-

UNOS Policy 3.5.6 (1994). Patients with high antibody levels often prove incompatible to the donor organ and cannot receive the organ because the patient's immune system would reject it. Patients are deemed to be pre-sensitized if they have a panel reactive antibody level of 80% or greater. UNOS Policy 3.5.6.3. (1994). 43 Antigens are cell markers that distinguish between a body's own tissues (self) and foreign tissues (non-self). Any antigen not recognized as a self will provoke an immune response that induces the production of antibodies. These antibodies are designed to seek out and bind with great specificity to a particular non-self antigen, leading to its destruction. Dan L· Burk, "Introduction: A Biotechnology Primer", 55 U. Pitt. L. Rev. 611, 615 (1994). Thus, in organ transplants, the organ is rejected when the recipient's immune system recognizes that the surface antigens on the replacement organ do not match his own surface antigens. Pizer, supra fn. 11, at 18. 42

44

UNOS Policy 3.5.6.2 (1994). * Id. 46 UNOS policy 3.5.6.3 (1994).

4

47 UNOS Policy 3.5.6.1 (1994). For example, if there are 75 potential recipients in blood group A on the list for kidneys, the patient with the longest time would receive 1 point (75 divided by 75). Patient number 50 on the list would receive 0.33 points ((75-50) divided by 75). Id.

« UNOS Policy 3.5.6.5. (1994). These points are assigned when the child is registered on the UNOS waiting list and are retained until the candidate reaches 18 years of age. UNOS changed its policy in regards to pediatric kidney transplant candidates. The new policy took effect August 1, 1994. Id. 49 54 Fed. Reg. 46487 (1989).

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Table 2 UNOS HLA Point System Prior to 1995 Revisions HLA Matching

Points

0 - A, B, DR mismatch 0 - B , DR mismatch 0 - A, Β mismatch 1 - B, DR mismatch 2 - B, DR mismatch 3 - B, DR mismatch

10 7 6 3 2 l50

Dr. Hunsicker reported that in 1995 UNOS revised its point allocation scheme in the direction of giving fewer points for HLA antigen matching (a maximum of seven points for a perfect match) and more points for waiting time (one point for every year on the waiting list). More importantly he also acknowledges that the motivation is to change the racial distribution of kidneys in the direction of providing more kidneys for Blacks.51

IV. The Ayres Thesis and Policy Proposal Ian Ayres has written extensively on the subject of racial discrimination. The subjects that have drawn his attention have ranged from assignment of bail for criminal defendants to discrimination by auto dealers in the prices they charge.52 In 1993 he turned his attention to kidney allocation. Ayres' thesis was that Blacks suffered discrimination in kidney allocation. His policy proposal was to change the system of allocation to eliminate that discrimination. Ayres did not argue that organs allocated to Whites had a greater likelihood of success if transplanted in Blacks. He acknowledges that the opposite is the case. Nor did he assert that a greater number of organs from Black donors were going to White recipients than vice versa. Once more he admits that the reverse is true. Ayres' allegation of discrimination is limited to an assertion that Black patients had to wait longer for a kidney than White patients. Ayres does not argue that this greater wait was the result of individual invidious discrimination, or of a policy so UNOS Policy 3.5.6.2 (1994). 51 Lawrence Hunsicker, M.D., "Practical Consequences of Ethical Decisions in the Allocation of Organs for Transplants", forthcoming. UNOS Policies 3.5.6.1 & 3.5.6.2 (1995). 52 See, e.g., Ian Ayres , "Epstein's Discrimination Analysis in Other Market Settings", 31 San Diego L. Rev. 67 (1994); Ian Ayres/Joel Waldfogel , "A Market Test for Race Discrimination in Bail Setting", 46 Stan L. Rev. 987 (1994); and Ian Ayres, "Fair Driving: Gender and Race Discrimination in Retail Car Negotiations", 104 Harv. L. Rev. 817 (1991). 1

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decision to disadvantage Blacks. On the contrary he believes that it was a direct result of the neutral UNOS point allocation scheme. As Ayres says, the HLA matching policy is a " 'but for' " cause of the disparity between Blacks and Whites in kidney allocation.53 That is, were we to eliminate the use of HLA matching "discrimination" against Blacks in kidney allocation would disappear. Antigens are distinctively proportioned among the races. So, White patients are more likely than Black patients to match White donors.54 Therefore, since a disproportionate number of organs are donated by Whites55 and because Blacks are especially prone to hypertension and therefore have nearly four times the rate of kidney failure as Whites, Blacks had to wait almost twice as long as Whites to receive their first kidney transplant.56 Although Ayres asserts this longer waiting period as fact, its accuracy is still debated. Some studies have found that Blacks waited longer for transplantation than did Whites after being ranked on the waiting list; 57 however, another study revealed no difference in waiting times for Blacks and Whites when the beginning of hemodialysis was used as the starting point.58 Ayres recognizes that HLA matching is a predictor of organ graft survival; but for him it is a question of magnitude. He is willing to trade off some organ graft survival for other non-medical values. In Ayres view, the organ graft survival advantage that HLA matching provides, though real, is not so medically significant that it can justify its disparate racial effect. 59 He concedes that the benefits of six antigen matching are substantial.60 What he disputes is the awarding of points for 53 Ayres , et al., supra fn. 3, at 806, 861. 54 Id. at 808-809. The HLA matching policy will inherently tend to allocate kidneys to recipients of the same race, since the frequencies of HLA antigens are more similar among members of one race. Steve Takemoto, et ai, 44Survival of Nationally Shared, HLA-Matched Kidney Transplants from Cadaveric Donors", 327 New Eng. J. Med. 834, 838 (1992). 55 Ayres, et al., supra fn. 3, at 808-809. Although Ayres, indicates that donations from Whites are ninety percent of the total, Dr. Suthanthiran states that it is about eighty percent. Manikkan Suthanthiran, et ai, "Renal Transplantation", 331 New Eng. J. Med. 365, 368 (1994). Ayres contends and we believe correctly that, although desirable, efforts to increase organ donations among the black population will not erase the disparate effect of antigen matching rules. Ayres, et ai, supra fn. 3, at 860. 56 Id. at 808. 57 See eg., Racial Discrepancies in U.S. Organ Allocation, 11 Contemp. Dialysis Nephrol. 14-15 (1990). 58 Donald E. Butkus, et ai, "Racial Differences in the Survival of Cadaveric Renal Allografts", 327 New Eng. J. Med. 840, 841 (1992). 59 Ayres, et ai, supra fn. 3, at 860. 60 A study of approximately 500 kidneys transplanted since 1987 under the UNOS compulsory sharing policy of six antigen-matched kidneys revealed one year survival rates 10 percent higher than lesser matched kidneys. Steve Takemoto, et cd., "A Report of 504 Six Antigen-Matched Transplants", 23 Transplantation Proc. 1318 (1991); See also, Braun, HLA System, supra fn. 15, at 179 and infra text accompanying fn. 74-86.

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partial antigen matches. He argues that the effect of HLA matching on graft survival is a matter of considerable controversy in the medical community, and that some researchers believe that less than excellent matches confer no important medical benefit. Ayres cites a study by Hunsicker and Held concluding that cadaveric kidney "transplantation with lesser degrees of matching offered very little gain at all". 61 In addition, Ayres refers to a multivariate regression analysis of data from Michigan contending that "the presence of three or four antigen mismatches on the A and Β loci did not increase risk of graft loss".62 Ayres cites several other studies claiming to show no statistically significant difference in graft-survival as a function of number of HLA mismatches when those mismatches exceed a relatively small number. Ayres does admit, however, that other studies purport to show a medically and statistically significant relationship between HLA matches and graft survival for less than excellent matches. He believes, however, that the overall results demonstrate that HLA matching below the level of excellent matches is not a powerful predictor of graft survival. Ayres not only views the advantages of partial antigen matching to be small, but thinks they are declining over time as well. 63 He believes that the advancing technology in immuno-suppressant drugs, such as cyclosporin, has made the allocation system's strong preference for HLA matching an unwarranted anachronism.64 He therefore proposed that points for those good but not great matches be eliminated from the UNOS system. Ayres does not dispute the direction of the effect of HLA matching on graft survival, only the magnitude. But even a trivial effect in the right direction should not be sacrificed unless there is some compensating benefit or other reason for doing so. One possible reason would be that the HLA antigen matching points were a mere sham. He could have argued that a facially neutral standard had been imposed for racially invidious reasons. But, that is not his position. At several points in his article Ayres goes out of his way to declare that the UNOS system was not merely facially neutral but neutral in intent and motivated by good faith. Ayres has a track record on the subject of racial issues in law and policy. Whether it is auto

61 Ayres, et al., supra fn. 3, at 831-32 (citing L G. Hunsicker/Philip J. Held, "The Role of HLA Matching for Cadaveric Renal Transplants in the Ciclosporine Era", 12 Seminars in Nephrology 293 (1992)). 62

Ayres, et al., supra fn. 3, at 831. (citing John M. Weller, et ai, "Influence of Race of Cadaveric Kidney Donor and Recipient on Graft Survival: A Multifactorial Analysis", 9 Am. J. Kidney Disease 191, 193 (1987)). However, Ayres concedes that the results of this study have been partially contradicted by an Alabama study indicating that matching at least one antigen on both the A and Β loci can enhance one and two year graft survival by 10 percent. Id. at fn. 124 (citing Bruce O. Barger, et al., "Influence of Race on Renal Allograft Survival in the Pre- and Postcyclosporine Era", in: Paul I. Terasaki, ed: Clinical Transplants, 217 (U.C.L.A. Tissue Typing Laboratory, 1987)). 63 Ayres, et ai, supra fn. 3, at 831-32. 64 Id. at 811, 860.

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sales or bail for criminal defendants, Ayres is particularly sympathetic to the plight of Blacks and his senses are attuned to detect evidence of racial discrimination. Given that in other contexts Ayres has not been shy about discovering invidious discrimination masquerading as neutral policy,65 one can take his ascription of innocent motives at face value. Thus Ayres must find some other reason to reject HLA antigen matching. Ayres' justification is that as a theoretical matter he thinks it appropriate that weight be given to more general concerns of "racial justice", where that odd phrase means something like special consideration be given to Blacks based on the history and legacy of Negro slavery in the United States.66 Ayres further supports his case by arguing that the incorporation in the UNOS allocation system of two criteria that are inconsistent with the "efficiency" goals of organ graft and patient survivals precludes efficiency as an exclusive explanation and justification of the allocation system. He ascribes the origin of these two allocation criteria to a wider set of ethical concerns that he describes as "equitable" as opposed to "efficient". He then argues that if one set of equitable concerns can trump efficiency (i.e., medical) criteria, then a more powerful set of equity concerns on behalf of Blacks should also be given weight. The two suspect allocation criteria are the assignment of 0 organs to 0 recipients (hereinafter, "the 0 rule"), and the granting of four points to pre-sensitized patients, (i.e., those patients who, because they have already rejected a transplant, are hyper-sensitive to foreign protein and can accept a smaller range of possible transplants).67 Ayres argues that these two policies are inconsistent with a pure efficiency regime of organ allocation, because the organs in question will do equally well when transplanted into other patients who do not meet the criteria in question. Ayres therefore concludes that the justification for the 0 rule and pre-sensitization points must rest on some sort of equitable concern for the welfare of these particular patients, as though UNOS were saying that it would not be "fair" to patients in the 0 blood group if 0 organs went to non-0 patients, because the 0 patients are medically precluded from similarly dipping into the pool of non-0 organs. Ayres is correct that such universal matching is not necessary with respect to organs from 0 donors. Blood type 0 patients are regarded as "universal" donors since recipients with blood types A, Β and AB can accept organs from 0 donors. Nonetheless, with one small exception UNOS policies require that kidneys go to patients of the same blood type group. The one significant exception to this rule is that 0 organs that have a zero mismatch with non-0 potential recipients may be given to such patients.68 Likewise, a pre-sensitized patient will, ceteris paribus , do 65

See, supra fh. 52 and accompanying text. Ayres, et ai, supra fn. 3, at 842. 67 Id. at 839-40. 66

68 UNOS Policy 3.5.1 (1994).

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no better with a crossmatched kidney than will a non-pre-sensitized patient and yet pre-sensitized patients receive four additional points. Because he can find no efficiency justification, in the sense of enhanced graft survival, for these allocation rules Ayres concludes that they must rest on "equity" concerns. That being the case, UNOS* neglect in addressing the more significant equitable concerns of Black patients "becomes suspect".69 The equitable concerns of Blacks are more significant in that the 0 race was not brought to the United States in slave ships and kept in bondage for over 200 years. Although Ayres' entire argument is rooted in the question of racial equity and he favors changing the allocation system so that Blacks would be allocated more organs, he does not argue for including race as an express criteria in the organ allocation system. He eschews the subject of race entirely in his operational/policy proposals. Instead he makes four facially neutral proposals: (1) revoke the points allotted to patients with two or more mismatched antigens; (2) give more points based on length of time on the transplant waiting list; (3) assign substantial points to patients with rare antigens;70 and (4) retain the local, as opposed to a national system of organ allocation.71 The purpose, and expected effect, of these proposals he admits is to allocate more organs to Blacks and fewer organs to Whites.

V. The Efficacy of HLA Antigen Matching Ayres argues that medical evidence does not support the efficacy of HLA matching for more than two mismatches, and that the development of immuno-suppressant drugs suggests that antigen matching will become progressively less important with the passage of time. We believe he overstates his case on both points. Despite the almost miraculous benefits of cyclosporine and other immuno-suppressants, these drugs are not a panacea. Rejection remains a critical problem, and while some researchers espouse the view that HLA matching has no influence when CsA is taken as an immuno-suppressant,72 there is much evidence on the other side suggesting that partial HLA matches offer significant medical benefits in terms of organ graft survival.73 Further, immuno-suppressant drugs are extraordinarily power69

Ayres, et al, supra fn. 3, at 842. Ayres displays some ambivalence on the subject of the motives underlying the current system. On the one hand he states that he considers the system to be in "good faith" without any "racial animus or bigotry." Id. at 813. And yet elsewhere he states that "[i]f the roles were reversed and white patients had lower chances of matching antigens, we believe that the point system might give less weight to matching." Id. at 841-42. 70 Id. at 861. Id. at 848-49. See e.g., Ronald M. Ferguson, "A Multicenter Experience with Sequential ALG/Cyclosporine Therapy in Renal Transplantation", 2 Clinical Transplantation 285 (1988); and 7. Cicciarelli, "Is Cyclosporine a Match for Tissue Typing Centers? Role of the Zero HLA-A, B, and DR Mismatch Effect", in: Paul I. Terasaki, ed: Clinical Transplantation 647 (1987). 73 See, studies cited in fh. 76-89 infra. 72

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fui chemicals. They have vicious side-effects. 74 Patients who, because they have received a better matched kidney, require less immuno-suppression can enjoy a significantly better quality of life. We note as well that immuno-suppressants are quite expensive and that resources not spent on one medical treatment are available for other treatments.75

74 Cyclosporine (CsA), is a central component of the standard immunosuppressant regime. It and the other drugs used to suppress the immune system are extremely powerful. Initially many researchers hoped that patients could be taken off CsA once the first critical 90 days had elapsed. This has not proven to be the case. Patients in a collaborative, comprehensive transplant study who were taken off the drug lost the benefit of CsA within thefirst year, and by the fifth year paralleled patients under past immunosuppressant drug therapies. Teri Randall "Cyclosporine: Vital in Today's Transplantation, But Questions Remain about Tomorrow", 265 JAMA 1794 (1990). Thus, it now appears that to prevent rejection, transplant patients must take immuno-suppressive drugs for as long as the patient has the replacement organ. Pizer, supra fn. 11, at 32. Thomas Starzl, Director of Transplantation at the University of Pittsburgh Medical Center and deemed the "father of liver transplants," has expressed concern for the long-term effects of CsA and other immuno-suppressive drugs. Mark Dowie, We Have A Donor: The Bold New World of Organ Transplanting 32 (1988). Starzl wonders how effectively will the new immunosuppressants protect the transplanted organ and what will be the price for their use. Randall, supra at 1797. Whatever the long-term consequences of CsA use will be, the short term consequences are serious. CsA produces scarring of the kidneys, yielding chronic injury and lowered function that may not be reversed even if the dose is lowered. Pizer, supra fn. 11, at 42. CsA induces kidney problems in about 35 percent of all cases in which it is used. Dome, supra at 76. Another problem with CsA is that the pace of rejection for a patient taking the drug is much slower than it is for a patient taking another immunosuppressant Id. While in some sense, slower rejection is a benefit, it makes rejection much harder to diagnose, and therefore, harder to correct. If reduced kidney function is a result of rejection, the dosage needs to be elevated; whereas, if the problem is due to the side effects of CsA, the dose should be reduced. Pizer, supra fn. 11, at 42. Other side effects may occur as well: studies have linked CsA to serious, albeit treatable, cancers, Dowie, supra at 76; See also, "Relation Between Skin Cancer and HLA Antigens in Renal-Transplant Recipients", 325 New Eng. J. Med. 843 (1991) (recognizing immunosuppressant therapy to be an important risk factor in the development of skin cancer); seizures and tremors; elevated blood pressure (hypertension)-high enough to demand medical care; increase in blood levels of potassium; thickening of the gums; increased hair growth; abnormalities in liver function, (Pizer, supra fn. 11, at 43); anemia (reduction of red blood cells); gastrointestinal distress; hyperuricemia (found in 84 percent of kidney transplant patients) and gout. Hsiao-Yi Un, M.D., et ai, "Cyclosporine-Induced Hyperuricemia and Gout", 321 New Eng. J. Med. 287, 290 (1989). The problems associated with CsA use are sufficiently troubling that some clinicians have questioned its continued use. Dr. Brian D. Meyers, Chief, Division of Nephrology at Stanford University Hospital, calls for a withdrawal of CsA use, particularly in patients who display symptoms of impaired renal function. Randall, supra at 1794. Studies show that heart recipients who were treated for 8 years or more with CsA, amassed occurrences of end-stage renal failure of 10 percent. Id. at 1797. Although doses of CsA have decreased over the years, both high and low doses of CsA have revealed similar renal injury. Id. Dr. Meyers estimates that the occurrence of end-stage renal failure will probably increase significantly in the next two decades; thus, he concludes that CsA use is unjustified when the patient is presumed to survive more than 10 years. Id. at 1794.

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It would be imprudent as lawyers/economists for us to attempt to resolve the question of how much H L A matching improves organ graft survival. Nonetheless, we think it important that we cite and briefly report some of the studies that offer empirical evidence that supports the use of H L A matching in general, and partial H L A matching in particular. The longest collaborative study conducted in the United States indicates that patients with 0 to 1 H L A -A, -B mismatches had an 80% one year graft survival rate while those with 3 to 4 incompatibilities had a 70% graft survival rate (ρ < 0.02). 7 6 And, every one of the eight major studies on the effects of H L A on long-term graft survival rate has shown a significant benefit in its use. 7 7 A study conducted by Dr. Butkus of the University of Mississippi Medical Center also confirmed a statistically significant correlation between the degree of H L A matching and overall graft survival. 78 Dr. Butkus' study revealed that patients with mismatches of four or five H L A antigens had significantly lower graft survival rates than those with three mismatches or fewer; while those with mismatches of six antigens had significantly worse survival rates than all others. 79 Another study by a Dr. Opelz claimed "irrefutable evidence that H L A matching . . . exerts a powerful effect even with the use of CsA". 8 0 And, a study conducted 75 Depending on the dosage needed, CsA costs between $4,000 and $7,000 a year for the rest of the patient's life. Dowie, supra fn. 74, at 76. The company that produces CsA claims that costs will decrease once development costs have been amortized. Id. Analysts predict that the price could decline when the patent runs out and others who have synthesized it can enter the marketplace; however, that has yet to materialize. Id. Until recently Medicare only paid for CsA for the first year after transplantation. 42 U.S.C.A. § 1395x(s)(2)(J)(i) (West 1994). The Social Security Act has now been amended to extend the payment of immunosuppressant drugs for future transplant recipients. 42 U.S.C.A. § 1395x(s)(2) states in pertinent part: (J) prescription drugs used in immunosuppressive therapy furnished, to an individual who receives an organ transplant for which payment is made under this subchapter, but only in the case of drugs furnished(i) before, 1995, within 12 months after the date of the transplant procedure, (ii) during 1995, within 18 months after the date of the transplant procedure, (iii) during 1996, within 24 months after the date of the transplant procedure, (iv) during 1997, within 30 months after the date of the transplant procedure, and (v) during any year after 1997, within 36 months after the date of the transplant procedure. These two factors seem to account for the high rate of noncompliance with taking CsA in patients of low income levels. Butkus , supra fn. 58, at 844. ™ Braun, "HLA System", supra fn. 15, at 179. 77

Id. at 184. ® Butkus, supra fn. 58, at 840. 79 Id. at 842. See also, Suthanthiran, et ai, supra fn. 55, at 370 (citing Cicciarelli, "HLA Matching: Univariate and Multivariate Analyses of UNOS Registry Data", in: Paul I. Terasaki, ed: Clinical Transplants 325-33 (1991)) (questioning whether there is a threshold for HLA matching and finding that allografts that are matched for 4 or more HLA antigens (or that have no more than 2 mismatches) have better outcomes than those with fewer than 4 matches (or more than 2 mismatches)). 7

et al.,

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by Dr. Gianello indicated that CsA offers a lower risk of acute rejection "provided ... there is good HLA matching".81 The Gianello study noted that CsA treated patients, who also match for the HLA-DR antigens, had a significantly lower rate of rejection.82 In light of the fact that the success rates associated with CsA were spurring variations in policies and procedures of individual transplant centers, J. Tiwari examined the prognostic factors known to affect graft survival, e.g., HLA matching, to determine if CsA therapy changed the influence of those factors. 83 Tiwari concluded that the variables identified as significant factors affecting graft survival in the post-CsA era are essentially the same that were found to be significant in non-CsA treated patients recently studied at UCLA. Thus, HLA was determined to still be a predictor of graft survival in patients taking CsA. While Ayres cites several studies showing no statistically significant benefit to partial HLA matches, an equal number of studies indicate that partial HLA matching does produce medical benefits. For example, a study by the Southeastern Organ Procurement Foundation (SEOPF) concluded that at 4 years there was 44 percent graft survival for patients with 4 antigens of the A and Β series antigens matched compared with only 18 percent for those with 0 matched A or Β antigens.84 Another study examined the 8-year graft survival in 2069 recipients of a first cadaveric allograft. 38% of those recipients who were matched for 3 or 4 A and Β series antigens had a functioning allograft after eight years; 34% of those matched for 2 A and Β antigens; and 20% of those matched for just 1 or 0 A or Β antigens .(ρ < 0.001). 85 And, still another clinical study demonstrated that overall graft survival correlated with the total number of HLA-antigen mismatches.86 Patients with mismatches of 4 or 5 HLA antigens had significantly lower graft-survival rates than those with 3 mismatches or fewer; those with mismatches of 6 antigens (total mismatching) fared significantly worse than all others (p = 0.005). Furthermore, this study found no significant difference in graft survival between the racial groups at any level of HLA mismatching, although more blacks than whites had more than three mismatches (84 percent vs. 56 percent) (ρ = 0.004).87 so G. Opelz for the Collaborative Transplant Study, "Effect of HLA Matching in 10,000 Cyclosporine-Treated Cadaver Kidney Transplants", in: Paul I. Terasaki, ed: Clinical Transplantation 641, 646 (1987). si P. Gianello , et ai, "Cyclosporine-Steroids Versus Conventional Therapy in Cadaver Kidney Transplantation: Analysis of a Randomized Trial at Two Years", in: Paul I. Terasaki, ed: Clinical Transplantation 1867, 1871 (1987) (emphasis added). 82 Id. 83 J. Tiwari , et al. , "Factors Influencing Kidney Graft Survival in the Cyclosporine Era: A Multivariate Analysis", in: Paul I Terasaki, ed: Clinical Transplantation 1839 (1987). 84 Braun, "HLA System", supra fh. 15, at 184. 85 Id. (citing the 1980 annual report of France Transplant). 86 Butkus, supra fn. 58, at 842. 87 Id.

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Finally, a study by Dr. G. Melville Williams demonstrates the additive effects CsA has on HLA matching, and vice versa™ Dr. Williams.is "forced to conclude that patients will have better results by combining the advantages of good matching and cyclosporine".89 Ayres is aware of this evidence and admits that "[b]oth [medical] groups can produce scientific evidence supportive of their respective positions".90 But, what is one to make of this concession? After all this is not a debate between those who think that HLA matching matters and those who believe it does not, but rather a debate over whether it matters a lot or a little. What does it mean to say that a given increase in the likelihood of graft survival is small? Small in relation to what? Small has one meaning in a debate over medical tactics and suggested research protocols, but a thoroughly different meaning in a question of allocating kidneys to patients. In the former case the size of the improvement in graft survival occasioned by a closer HLA match may speak to the question of whether the most significant improvements have been in tissue matching or in new drugs, or whether there are prospects for medically significant and cost effective further developments in tissue matching. But it seems a complete non-sequitur to say that because the benefits of tissue matching are small that therefore less weight should be given to such matching in organ allocation. We ask again, small in relation to what? To say that the benefits are small in organ allocation suggests that there is some other variable against which it is to be weighed and some scale on which the two or more variables are to be compared. Unless there is such a variable, and more importantly some grand scale that embraces the two there is no small or large about it. We have no trouble imagining an appropriate scale. It is the grand goal to whichtissuematching is directed, probable medical benefit. On that scale the benefits of tissuematching should be weighed against such variables as medical need. And as difficult as such comparisons may be they are at least all made in the same currency, probable medical benefit. But, Ayres has in mind some other sort of scale on which medical benefit itself is weighed against some variable such as racial justice, where that means some special consideration for Blacks. He might as well have told us that the variable against which HLA matching was to be weighed was the wealth of Bosnian Serbs. We have no idea how to compare the two, and are more than a trifle disinclined to give any weight to the latter variable. Unlike Ayres, we are grateful from a moral and policy perspective that there is any relationship between HLA matching and graft survival, and wish to make full use of it. There are over 170,000 people on long-term dialysis in the United States w G. Melville Williams, "Results of Kidney Transplantation", in: Organ Transplantation and Replacement 471, 474 (1988). 89 Id. at 475. w Ayres, et ai, supra fh. 3, at n.28.

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and only some 9,000 organs available each year. Most of those 170,000 would benefit greatly from a successful transplant and the choices among them will always be difficult. We are grateful for an objective, rational, easily measured medical criterion that allows us to choose which of these desperate deserving people should receive a kidney. In the absence of such a variable medical personnel are left to subjective values and perhaps personal prejudice to decide the issue. While the future of immuno-suppressant drugs will continue to change transplantation, it would be both imprudent and unnecessary to alter the kidney allocation system now based on projections and aspirations for future immuno-suppressant drug therapy. Based on the same data that Ayres uses to argue for less weight to HLA matching, one might instead conclude that better matching needs to be achieved in order to decrease reliance upon immuno-suppressant drugs. CsA is not an easy drug to use, and practice with it in organ transplants dictates caution.91 There is no need to jump the gun. Should the time come when HLA matching is no longer efficacious, the UNOS governing committee, or we hope its successor, could change the allocation policy in an afternoon. Our position on the value of HLA matching, admittedly that of only partially informed laymen, is borrowed from a respected researcher in the field, Dr. Willaim Braun, who has written: "[a]n ounce of histo-compatibility is worth a pound of immuno-suppression".92

VI. The Equity/Efficiency Dichotomy A central thread of Ayres' argument is his judgment that the UNOS system already incorporates a set of non-efficiency ("equity") concerns and that therefore a precedent exists for incorporating a concern for the "equitable" treatment of Blacks. Ayres' premise is wrong. He both misunderstands and mischaracterizes the current system and thus his policy conclusions can not rest on those premises. But, even were his premise correct his conclusions are a non sequitur. Ayres characterized the UNOS allocation system as being generally concerned with what he calls "efficiency", that is designed to allocate organs to those who can get the greatest benefit from a particular organ, but tuned with a layer of some ethical concerns that he refers to as "equity". The specific operational policies that Ayres considers to be motivated by equity rather than efficiency are: (1) the allocation of organs from 0 donors exclusively to 0 patients (with the exception of zero HLA mismatched organs); and (2) the granting of four points to patients who are

Robert G. Luke, "New Issues in Therapy After Renal Transplantation", 331 New Eng. J. Med. 393, 394 (1994). 92 William E. Braun, M.D., "Every Kidney Counts", 327 New Eng. J. Med. 883, 884 (1992).

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pre-sensitized as a result of having already rejected an organ. Ayres asks why if the current system gives weight to the equity claims of 0 and pre-sensitized patients, it gives no weight to the equity claims of black patients?93 Ayres contends that race should be as much an issue of concern in the kidney transplant community as anywhere else, and that the effort to eradicate the vestiges of past racial discrimination are equally appropriate here. 94 Ayres makes three fundamental errors in his argument:first, his characterization of the dichotomy between equity and efficiency is incorrect; second, he misunderstands the function of the 0 rule and the point allocation for pre-sensitization, and therefore mischaracterizes the efficiency of the UNOS allocation system; and third, to the extent he is correct that at current levels of organ scarcity the point allocation for pre-sensitized patients is unjustified on efficiency grounds, his conclusion that this supports granting special standing to Blacks is a complete non sequitur. Ayres treats efficiency and equity as two distinct concerns existing in separate realms that are traded off against one another. Were that the case, any social philosophy that attempted to value both would have to employ some higher order scale or standard of justice, duty, or social policy on which these two concerns could be weighed or ordered. Ayres cannot be strongly faulted for not offering such a scale or standard. His is not an essay in social philosophy but rather one in social policy, and a very limited one at that. He is simply arguing that more organs be allocated to Blacks and justifying it on the basis that other non-efficiency (and therefore equity?) claims are already incorporated into the system, and therefore a precedent exists for a claim of more organs for Blacks. Nonetheless, his failure to offer some higher order goal or standard permits him to leave unexamined this supposed dichotomy. The notion of such a dichotomy and tradeoff between equity and efficiency has been a common theme in much of social welfare writing. With respect to kidney allocation, even more than in other contexts, it is our view that such a tradeoff is an illusion. It leads both the writer and the reader to misunderstand and mischaracterize the problem. Efficiency properly understood and equity or justice properly formulated are one and the same.95 What efficiency means in this context is that solution which maximizes social wealth or social welfare. That is, we ask of each proposed policy choice who gains and how much and then aggregate those gains across all individuals. To choose the efficient policy is to choose the one that maximizes social wealth. 93 Ayres, et al. , supra fn. 3, at 841-42. w Id. at 842. 95 See, L Cohen, "A Justification of Social Wealth Maximization as a Rights-Based Ethical Theory", 10:2 Harv. J. of Law & Public Policy 411 (1987); L Cohen, "Of Special Interest", 39:5 The Freeman 192 (May 1989).

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When we lack a metric with which to measure people's valuation of specific outcomes we can often derive the same result more easily by asking what policy choice people would make beyond the veil of ignorance, the veil that conceals from them the particulars of their individual condition.96 The set of rules they would choose in such a position maximizes their personal welfare. But, when so positioned they become everyman. Their personal interests incorporate the interests of everyone simultaneously. Leaving aside any practical consideration, the moral appeal of efficiency is that it is on a very obvious level grandly neutral, fair and equitable. It values each person's interest the same. From beyond the veil of ignorance we look forward not only at the prospect of perhaps needing an organ at some future time, but at the much more likely event of being one of the great majority of people who will not personally require an organ. While a proper efficiency calculation would give great weight to each person's interest in receiving an organ if they are in need of one, it would also give appropriate weight to each person's interests as a spectator. As spectators we have three sets of interests in organ allocation. First, it is in our interest to lower the public cost of organ transplantation. Therefore we would prefer that organs be allocated to those who can pay their own way. Second, we would have some interest in the organs going to those who, if returned to health, are likely to add to the net wealth of the rest of society. A patient's probability of earning a high income would be a good rough and ready proxy for ordering the material dividend that he might provide for the rest of us, though not of its magnitude, because those who earn more are likely to consume more as well. Finally each of us would prefer that our family and friends receive an organ ahead of our enemies or even a stranger. Aggregating that interest over the entire population results in those with friends and family receiving organs ahead of solitary or despised individuals. In theory, all three of these considerations could legitimately enter the calculus of efficiency in kidney allocation. In fact no weight has ever been given to any financial considerations in the UNOS scheme. Nor is any explicit consideration given to whether the potential recipient is a well liked, respected, and valued member of society, his community, and his family. From one perspective the failure to account for such third party considerations is puzzling. Were we deciding between allocating federal resources to build a dam in Colorado versus a highway in Tennessee, it would be proper to give equal weight to the interests of those only indirectly affected by these projects as to those directly affected. Why then does the UNOS kidney allocation system only give weight to the interests and welfare of potential transplant recipients? The justification may be more an operational concession than a theoretical objection. The third party considerations are both too messy and too controversial, 96

We are ignoring in this discussion the distinction between maximizing wealth and maximizing utility. It simplifies the inquiry without any important consequences for the choices one would make beyond the veil of ignorance.

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and probably not of sufficient weight to be worth operationalizing. How so? As for ability to pay, given that both dialysis and kidney transplants are paid for by the federal government there is a similar gain to the public fisc regardless of whether a pauper or a plutocrat receives an organ. Even if we could exact a premium from some recipients of a transplant the economic effect on the rest of us would be trivial. The cost of a kidney transplant is less than $50,000 and fewer than 10,000 kidneys are transplants each year in the United States. Thus even if we went from a system of all organs going to paupers to all going to people who pay their own way the annual saving for the rest of us would amount to $2 per American. Moving on to the question of any surplus that might be achieved for the rest of us by giving organs only to the most productive, here too the effect is trivial. While there are exceptions, the vast majority of potential recipients will yield no significant surplus to the rest of the community. Why? First, and most important, because even healthy people spend most of their income on themselves, and second because transplant recipients tend not to earn incomes as great as healthy people of similar age and circumstance. Thus, as a general matter we can ignore this consideration for little practical effect. Finally, we have the question of the existence and intensity of friendships and family relations. Ignoring this consideration is a far more weighty matter than the trivial monetary concerns addressed above. The loss of some people will be felt far more strongly and widely than the loss of others. There are, however, two good reasons for ignoring these differences in deciding how to allocate kidneys. First, how can we reliably, honestly, and accurately measure this loss? Were it to be incorporated into a point allocation scheme patients and their families and friends would have a strong incentive to exaggerate the number and intensity of the relationships that are affected by the health of the patient. Second, on what scale could we incorporate such values alongside the purely medical concerns already being addressed. The obvious answer - dollars - follows from the very nature of a social wealth calculus. Were we to denominate in dollars the gain to potential recipients in terms of their greater prospects for life and health, we could similarly rank the weight of the preferences of friends and family. And both of these could be measured reasonably accurately by willingness to pay if we actually required people to pay for their own transplant and if we measured the benefit to third parties by their willingness to contribute. But we do not require that patients pay, nor do we solicit donations from their friends. Thus we are left with apples and oranges: medical considerations to express the intensity of the potential recipients' desire for organs and protestations of loss by friends and family. We have no scale with which to weigh these fruit. Given these myriad difficulties it is prudent to ignore the number and intensity of affective and consanguineous relationships. We emphasize, however, that the decision to disregard these third party concerns is not one of principle but of pragmatism. After all, if the organs are indeed the property of the collective then we who make up the. collective should certainly have the right to choose between the worthy and the unworthy. When the occa-

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sional case comes up of some degenerate criminal receiving an organ ahead of more honorable and valued people, claims that considerations of personal virtue should, as a matter of principle, not enter into the calculation of who receives an organ will ring hollow to most reasonable people. In sum then, the reason that so few wider societal concerns need enter is that the stakes for the rest of us are so small. We are left then with a decidedly limited efficiency inquiry. The only issue we must consider from beyond the veil of ignorance is how we will be treated if our kidneys fail. One effect of this is to make the allocation scheme in a sense more egalitarian than it otherwise would be. Each individual's desire for a kidney stands alone to be weighed against every other individual's desire. The next question is how weight is given to the relative desires of various potential recipients for a kidney. Here too the UNOS system could give weight to some measure of the intensity of one's desire to live. And once more a proxy for this measure could be willingness to pay. All else constant, those who desire something more will be willing to pay more. Precisely because all else is not constant, however, and individual wealth bulks large in one's willingness to pay for something that will preserve life and restore health, UNOS eschews the use of willingness to pay or any other metric of the intensity of desire for life or health. The UNOS system thereby embodies another egalitarian principle. It in effect assumes that every potential kidney recipient's desire for life is of identical intensity. So, if we disregard third party interests, and give no heed to individual differences in the desire for life and health, then all that is left to weigh is prospective medical need and benefit. The only variation in the weight assigned to potential recipients is the likelihood that a transplant will extend life and reduce physical suffering. It rests exclusively on the pre- and expected post-transplant medical condition of potential recipients. If transplant organs belong to, and are to be allocated by, the state then the state must allocate them justly or equitably. Following a well worn philosophical tradition, we believe that a system of allocation in order to be just must correspond to the choice one would assent to beyond a veil of ignorance. Given the pragmatic and prudential adjustments discussed above, the just system is the one each of us would choose knowing only that we were one of many people who will need a kidney transplant at some future time. Given that what drives the desire for a kidney transplant is the longing for life and health, it is hard to imagine anyone so placed not assenting to a system of allocation that maximized their ex ante prospects of those precious commodities. It is therefore an equity claim, and nothing more nor less, that efficiency, in the sense of maximum medical benefit, be pursued as the singular goal of society allocation policy. Thus, rather than efficiency and equity being in conflict, they are simply two ways of saying much the same thing.97

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So what sense are we to make of Ayres' supposed tradeoff between efficiency and equity in the allocation of organs? What does he mean by equity? At one point Ayres asserts that a pure waiting list would be the most equitable of systems.98 Given that he provides no definition for the word equitable and the lack of precision with which he employs the word we suspect that Ayres is using it as a synonym for the simpler concept, equal. If so, he is wrong. Equity and equality are not synonymous. The similarity between the two words and the relationship between the two concepts causes much confusion and mischief. Allocating organs based on length of time on a waiting list may in some limited sense be more egalitarian than allocating based on willingness to pay, or age, or race, or expected medical benefit, but it is certainly not the most egalitarian of allocation mechanisms. We say that not to necessarily fault a waiting list on that ground. Extreme egalitarianism is not a virtue in organ allocation. For a system of allocation to be truly egalitarian access to organs should be tied to no circumstance of the patient's life other than that he desires an organ. Allocation based on length of time on a waiting list does not pass that test. How long a patient has wanted a kidney is as much an accidental and differential circumstance of his life as any other. The one allocation system that allocates organs with equal probability amongst all those who want one regardless of any circumstance of their life is a lottery. Those who want a transplant could have their names placed in a hat and the first name drawn would have a right to the next organ. It is the very equalitarianism of a lottery that is the root of both its inefficiency and its moral defect. A lottery would result in severe misallocations of resources. Organs would go to those in less need or less likely to tolerate the organ than others. There is nothing inherently just or equitable about equal claims to valuable resources. Justice and equity require that equals should be treated equally and that unequals should be treated unequally. A less strict use of the word equality in the distribution of transplant organs does not demand a lottery, but simply declares out of bounds allocations based on certain suspect criteria. Here each reader must bring his own values to bear. While for some allocation by willingness to pay would be "unequal" for others the suspect category might be age, and we hope for still more it would be race. It is difficult, 97 Nor are we alone in seeing a moral obligation to allocate organs on the efficiency basis of medical need and benefit. See e.g., Peter Übel, M.D., et al, "Rationing Failure: The Ethical Lessons of the Retransplantation of Scarce Vital Organs", 270 JAMA 2469 (1993). Dr. Ubel maintains that several theories of justice support the distribution of kidneys based on efficiency. He argues that a rational planner devising general rules for organ allocation, and operating behind a "veil of ignorance", would out of self-interest look to efficiency as his standard. Those rational planners, not knowing if they will need a kidney in the future, would increase their own likelihood of benefiting from a transplant by establishing an allocation system that distributed kidneys to those most likely to gain a benefit. Id. at 2473.

Ayres et ai, supra fn. 3, at 844. 11 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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however, to imagine any reasonable reader believing that expected medical benefit is an inherently unequal allocation mechanism. So we ask once more what sense are we to make of Ayres* supposed tradeoff between efficiency and equity in the allocation of organs? The "equity" claims that Ayres' cites as precedent and the one he raises as a candidate for incorporation in the system of organ allocation are of a most peculiar sort. He argues that under the current allocation scheme some groups of potential recipients (blood group 0, and pre-sensitized) are given preferred treatment that they are not entitled to on a purely medical basis, and that therefore another orthogonal group of patients, (Blacks) should also receive preferred treatment. If these "equity" claims do not derive from some calculation of the system of allocation one would choose beyond the veil of ignorance and if they are not grandly neutral and egalitarian like a lottery, then in what sense are they equitable? They might more properly be called inequity claims, for they are claims as Orwell might have said that "some are more equal than others". Ayres' "equity" claims stand in opposition to the rules one would choose beyond a veil of ignorance, before you knew whether you were a man or woman, young or old, Black or White, rich or poor, 0 or B, pre-sensitized or not. They are claims that ex posi circumstances of particular persons should trump such neutral rules.

VU. The 0 rule and the Pre-Sensitivity Preference If likelihood of medical benefit from a transplant is the sole legitimate element in the efficiency / equity calculus, then what sense are we to make of the 0 rule and pre-sensitization point allocation? We can sympathize with Ayres' need to cleave these from an efficiency calculus. They are clearly considerations that do not speak to the relative benefits that different patients will receive from any particular organ. For him to call them equity considerations, however, seems perverse. Based on his own analysis they are so obviously inequitable in that they advance some patients in the queue ahead of others more deserving of the organs. Giving points for pre-sensitization seems particularly inequitable in that it gives a second bite of the apple to some while others must wait in line for theirfirst bite. As for the 0 rule how are we to understand it? Is this some theater of the absurd variation on a racial entitlement rule? Is it based on a notion that 0 people have a claim to 0 organs in the same sense that the UNOS equivalent in Bosnia might establish an allocation mechanism in which Moslems have arightto Moslem organs, Croats to Croat organs, and Serbs to Serb organs? The absurdity of such a scheme with respect to 0 organs is not that giving priority to one's own kin is preposterous, but rather that blood type is the most socially meaningless way of designating one's kin. If you had to select some set of people beyond your immediate family to share in your estate is there anyone who would elect those with his blood type? We think not.

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So what sense are we to make of the 0 rule and the points for pre-sensitization? It appears to us that Ayres is entirely correct that the points for pre-sensitization speaks not at all to the value to be received by the individuals in question from the organ. As for the 0 rule, as we will discuss below, there may be reason to believe that giving 0 organs to 0 patients does, all else constant, confer some medical benefits to the individual patient. Nevertheless, for the sake of the argument we will assume that that is not the case. His conclusion from these premises that neither the pre-sensitization points nor the 0 rule serve an efficiency goal, however, is incorrect. Ayres' error is that he is examining the allocation system on too micro a level. It is because of his failure to see the efficiency gain of these policies that he mistakenly ascribes them to an "equity" claim.

A. The 0 Rule UNOS policy requires that donated kidneys, with the exception of 0 organs that have a zero HLA mismatch with non 0 patients, go to recipients of the same blood type. This rule has an obvious medical rationale for organs from donors with blood types A, B, and AB, but has no apparent justification for type 0 organs. Ayres interprets the 0 rule as designed to alleviate the hardship that 0 kidney patients would experience if they had to share type 0 kidneys with patients of blood types A, Β and AB. Thus, he characterizes it as an equitable claim." Ayres displays some inconsistency with regard to the 0 rule. On the one hand he wishes to bootstrap his special preferences for Blacks on the equitable considerations already in place. That is, he argues that if we are already giving medically unjustified weight to the particular needs of 0 recipients let us give similar weight to Blacks. On the other hand he argues that the 0 rule reduces the number of organs going to Blacks. Blacks are almost twice as likely as whites to have blood type B. And so with the 0 rule in place Black dialysis patients with blood type Β must wait for a relatively small supply of type Β kidneys. If the rule were rescinded, Black patients would have a much larger kidney pool since 45 percent of White donors have blood type O. 1 0 0 Ayres makes no mention of the 0 rule when he outlines the specific allocation rules he would institute.101 From this it is fair to conclude that because he believes it is medically unjustified and reduces Black access to organs that he would eliminate it from his allocation scheme. The elimination of the 0 rule would also benefit patients with Blood type A. As these patients are predominantly White, that effect carries no weight in Ayres' analysis. It is worth noting, however, that this somewhat undercuts any intimation of a racially discriminatory purpose to the 0 rule. 99 Ayres et al, supra fn. 3, at 839-41. 100 id. at 821-22, 840. ιοί Id. at 844. 11

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Cohen and Melisa Michelsen

Ayres is wrong in treating the 0 rule as rooted and justified on an equity claim of 0 patients. His error results from focusing on each particular organ. From that per­ spective the 0 rule indeed makes no efficiency sense. From the perspective of max­ imizing the return to the universe of organs, however, the 0 rule results in an ex ante optimal use of all organs. A pair of hypotheticals will illustrate this principle. lmagine two equally sick potential recipients; one of whom has blood type 0 and the other blood type B. A kidney is donated for transplantation and it is blood type 0. Both can accept the kidney. How should one decide who receives it? If this were the last kidney ever to be donated, it might make sense to flip a coin. No greater benefit arises from giving the kidney to one patient than the other. But that hypothetical does not describe the world in which we live. In our world we fully expect that there will be a constant, albeit insufficient, flow of organs of unknown and varying blood type. So, Iet us change the hypothetical. Imagine that we know that another kidney will soon be available, but the blood type of that organ will not be known until it arrives on the scene. Now we ask whether the prospects for the patient who is denied the frrst organ differs depending on who is denied. If the first kidney goes to the 0 patient, the next organ can be implanted into the B patient if it is either 0 or B. Whereas if the first organ goes to the B patient then the second organ can only be accepted by the 0 patient if it is a type 0 organ. Thus there is a greater probability of two patients receiving a compatible kidney if the frrst 0 or­ gan goes to an 0 patient. If we wish to make the most efficient use of all the organs we can not treat each kidney in a vacuum. The 0 rule is fully justified not on the equitable basis of a particular concem for 0 patients but rather because it does equity by doing efficiency, i.e., maximizing graft survival and beneficial use of not merely

a

particular kidney but of the universe of kidneys.

Another justification of the 0 rule is that 0 kidneys apparently do not do as weil in non-0 patients as they do in 0 patients. One study has shown that at 4 and 5 years post-transplant, the actuarial survival of ABO-matched kidneys was significantly 102 better than that of kidneys that were compatible mismatches. We hesitate to rely too heavily on this study because we can not exclude the possibility that compati­ ble mismatching is endogenously determined rather than

a

random procedure. Spe­

cifically, we wonder whether those A and B patients who received 0 organs may have been a selected sample, perhaps those in most desperate need of a new organ. If that were the case it would hardly be surprising that they did less weil post-trans­ plant than less desperate patients. On the other band the scientific/medical basis of organ compatibility is still something of a black box. It would hardly be surprising

if medical scientists eventually discover some previously unknown chemical or ge­ netic reason for the higher graft survival rates of 0 organs in 0 patients.

102 P. Stock, et al.," Detrimental Effect of ABO Mismatching in Renal Transplantation", in: Paul I. Terasaki, ed: Clinical Transplantation 711 (1987) (patients from July 1979 througb

1985 wbo received cyclosporine exhibited graft surviva1 in compatible-mismatcbed tbat was significantly poorer when compared witb tbat of matched kidneys).

kidneys

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Ayres says that the 0 rule is "an example of equity trumping efficiency because it potentially favors an 0 blood type recipient with a zero-antigen match over a B 1 3 blood type recipient with a five antigen match". 0 He is correct that such an out­ come is a possibility. It is, however, an extra-ordinarily remote possibility. There are only four blood groups and 0 is the most common (approximately 47% of the patient population). Given the large number of potential recipients the likelihood that the best fit with an 0 patient would be a zero HLA antigen match while there is a five antigen match with a B or A patient is remote indeed. The zero HLA anti­ gen mismatch exception to the 0 rule reflects the UNOS policy choice that even minor differences in the number of HLA matches between 0 and non-0 recipients were not to be favored. Even ignoring the effects of blood matehing on the graft-survival of individual A and B patients, cited above, 104 it is clear that if the goal is to get the most out of

the pool of available organs, then on efficiency grounds substantial weight should be given to exact matehing of blood types. One can quibble over whether this should be a strict binary rule or a point allocation but for the purpose of Ayres' thesis that is of no import. His point was not that on efficiency grounds the 0 rule gave too much weight to blood matehing but rather that there was no efficiency justification for the 0 rule at all. A justification for using a rigid blood typing rule with an exception for zero HLA mismatched organs, rather than a more flexible point system to capture the efficiency justifications of blood matehing is that a binary rule is easier to adminis­ ter and probably yields much the same allocation as a more subtle point allocation. Although the ratios of donors to patients in each of the blood groups are not identi­ cal, they are not so different that substantially healthier 0 patients are receiving Or­ gans than A and B patients. Thus, even granting a few points to 0 patients would ·

have much the same effect as creating a strict rule.

B. Pre-Sensitization

The blood of every patient on the waiting Iist is tested for antibodies against HLA antigens approximately once a month. A panel of blood cells from roughly 105 40 random donors are compared to the potential recipient's blood sample. The patient's panel reactive antibodies (PRA) Ievel is determined by dividing the num­ ber of reactions with the total number of samples. So, if the patient's blood reacts with 16 out of the 40 donors, he has a PRA of 40%. Patients with 80% and greater PRA are classified as pre-sensitized and granted 4 additional points if they have a 1 6 negative crossmatch with a particular donor. 0 As with the 0 rule, Ayres charac103

Ayres, et al., supra fn. 3, at 839-840.

104 See supra fn. 102 and accompanying text. 105 Pizer. supra fn. 11, at 27. 106 UNOS Policy 3.5.6.3 (1994).

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terizes the granting of extra points to pre-sensitized patients, alternatively, as either an equity based preference, or a concession to a special interest. In either case it is an allocational rule that he believes provides a benefit to some patients by bumping others down the queue and lowering overall graft survival. 107 As in the case of the 0 rule, so too with points for pre-sensitization, Ayres ignores a possible efficiency justification, and instead describes the rule as purely "equity" driven. Once more imagine two patients waiting for a kidney; one is presensitized while the other is not. A kidney is donated against which both patients have a negative crossmatch; accordingly, both can accept the kidney, leaving the same dilemma as with the 0 organs as to who should receive this particular kidney. But, since patients with greater than 80% PRA have a much lower probability of being HLA compatible with the next donor organ than do non-pre-sensitized patients,108 efficiency dictates that ceteris paribus the pre-sensitized patient should be given preference for a compatible kidney. In the case of pre-sensitization, however, the efficiency justification is considerably weaker than in the case of the 0 rule. The difference is that pre-sensitized patients have a considerably greater likelihood of rejecting a new organ than nonpre-sensitized patients.109 So, despite Ayres* neglect of the efficiency gains of finding a match for a hard to match pre-sensitized patient and thereby removing him from the pool, Ayres is probably correct that points for pre-sensitization can not be justified on pure efficiency grounds at current levels of supply and demand . The qualification in the last clause highlights one interesting property of the efficiency calculus; the optimal allocational rules are endogenously determined. In particular, they are a function of the relative supply and demand. There are now over 170,000 people on long term dialysis in the United States, and more people enter dialysis each year than either receive a transplant or die. At the same time less than 10,000 kidneys are available for transplantation each year. Every organ that is wasted means that someone who could likely make good use of it is condemned to do without for the rest of their life. Imagine a different world in which the supply per year is 10,050 and the demand is 10,000. In such a world the points for pre-sensitization would make perfect sense. Our concern would then be with sorting rather than rationing. We would want to allocate the available organs so that all potential recipients received a suitable kidney, and giving additional points to pre-sensitized patients would achieve that goal. At current levels of supply and demand, however, we are forced to agree with Ayres that such generosity to pre-sensitized patients is not justified on efficiency grounds, and based on our view of the intimate relationship between efficiency and 107 Ayres, et ai, supra fn. 3, at 840-41. 108 J.C. Scornik, "Cross-Reactive Antigens and HLA Matching", in: Paul I. Terasaki, ed: Clinical Transplantation 693 (1987). 109 See, M. Aprile /J. Rochon/ C. Cardella, "The Effect of Peak PRA's on the Outcome of Cadaver Kidney Transplants", 21 Transplantation Proceedings 735 (1989).

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equity we are inclined to say that such points are equally unjustified on grounds of equity. The supposed equity rationale for these points is "medical justice" to compensate for "medical bad luck". 110 Dr. Hunsicker makes use of the same phrase, "medical bad luck", in his justification of giving special consideration to the plight of Black kidney patients.111 This rationale makes no sense to us. Neither Ayres nor Hunsicker are making arguments based on notions of relative fault in which one patient is blameworthy because he brought on his condition himself while another was merely unlucky, e.g., liver failure brought on by excessive consumption of alcohol versus that caused by genetic disease. Ayres and Hunsicker are simply comparing the paths that various innocents have taken to this disease and declared some to reflect worse luck than others. We disagree. Everyone with end stage renal disease (ESRD) has had "medical bad luck" in equal measure. Their bad luck is in no longer having properly functioning kidneys. If a young girl of mixed Korean and Irish descent suffers end stage renal disease (ESRD) because some gene allele passed along from Jong Sou You from 18th century Seoul has now linked up with a gene from Seamus O'Brien from 17th century Cork, is she any less or more unlucky than anyone else who has ESRD? We think not. As for "medical justice", it is hard to see how that is furthered by granting pre-sensitized patients a second or third bite of the apple when other patients have not received theirfirst bite. If the tilt toward pre-sensitized patients is not justified by efficiency/equity and is offensive to an equal distribution notion of equity then why does UNOS grant such a preference? Two special interest arguments come to mind. The obvious explanation, and one mentioned by Ayres, is that this favoritism reflects effective lobbying by pre-sensitized patients and their families. 112 Special interests are most effective in getting their way when they have time and opportunity to coalesce and join forces. On the one hand pre-sensitized patients and their families are a diverse and dispersed group of people. Thus it would be difficult for them to join forces. On the other hand precisely because they must wait a longer time for a wellmatched kidney they have more time to seek each other out and form an effective lobby. Nor does effective special interest lobbying necessarily rest on coalition building. Instead, it may reflect the powerful voices of a handful of sympathetic patients. A less obvious special interest coalition may also lie behind the pre-sensitization points. Transplant doctors and surgeons have powerful psychological and perhaps financial reasons for favoring, or at least not opposing , a preference for pre-sensitized patients. Most pre-sensitized patients have become so as a result of a prior rejected transplant. Why did their bodies reject the prior transplant? Was it medical miscalculation by their physicians? Was the chosen organ not a close enough Ayres, et ai, supra note 3, at 840 (citing J. Michael Dennis, "A Review of Centralized Rule-Making in American Transplantation", 6 Transplantation Rev. 130, 133 (1992)). 111 Lawrence Hunsicker, M.D., supra fn. 51. "2 Ayres, et ai, supra fn. 3, at 841.

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match? Was the immuno-suppressant mix too weak? or poorly timed? or the wrong mixture? The cause may be any of these or none. And, regardless of the cause the patient's current pre-sensitized condition in a world with an overwhelming shortage of transplant organs is a serious iatrogenic condition, i.e., a worsening of the patient's condition as a result of medical treatment. No one likes to be confronted by their failures and the suffering it causes. It would hardly be surprising if transplant physicians and surgeons had a preference for undoing their failures, mistakes or not, ahead of treating new patients. If this argument reflects, at least in part, some of the real motives of the medical professionals it reveals an important truth about the organ allocation process and the UNOS committee. Dr. Hunsicker in response to a question about the make-up of the UNOS committee remarked that although it was desirable to have disinterested people serve on the committee, the problem with disinterested people is that they are too often uninterested as well. Well, the contrapositive is also true. People who are not uninterested are often also not dis-interested. Further, the nature of the particular interest and bias is often not immediately apparent. We will return to this theme again in section nine to argue that the patients and their families who serve on the UNOS committee also represent a special interest. We repeat that on net we are persuaded by Ayres' argument that the points for pre-sensitization, at least at current levels of supply and demand, are inequitable because they are unjustified on efficiency grounds. Ayres also thinks that pre-sensitization points are inefficient, but does he think they are inequitable? On this point he is purposely and studiously vague. He closes his section on pre-sensitization with the following: The "near universal sympathy for the plight" of presensitized and blood type 0 recipients which gaverise to these equitable exceptions to the UNOS allocation system, also might be seen as an instance of effective interest group lobbying. ... As in other contexts, one person's equity is another person's private interest.113

Well, which is it equity or special interest? Ayres seems to want to ride the fence, and in that shadowland between equity and special interest to hitch a preference for Blacks to the preference for pre-sensitized patients. But remaining in that shadowland obscures a simple truth. The pre-sensitization points are either fair, just, and equitable or they are an unwarranted privilege awarded to a special interest. In either case they provide no support for granting a preference to Blacks. If pre-sensitization points are justified on some efficiency or other moral basis, those who favor a preference for Blacks must still make their case stand on its own moral legs, and the moral case for pre-sensitization points, if there is one, lends no support whatsoever to that of Blacks. The only connection is the demand for consistency in the treatment of the claims of pre-sensitized and Black patients. But consistency is a requirement of only limited power. It certainly does not mean that if Π3

Id.

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one moral claim successfully trumps efficiency that another putative moral claim is equally entitled to. On the other band if pre-sensitization points are inequitable and merely reflect special interest lobbying it lends even less support to the claims ofBlacks. If pre­ sensitization points are unjustified then we should forthwith get rid of them, not create another unjustified preference. What sort of strange argument is Ayres mak­ ing to those of us who are neither pre-sensitized nor Black? One of the authors of this article has three children of mixed Irish-Jewish descent. He finds it unambigu­ ously to be in bis interest that lexical preference be given to bis children over a1l other potential recipients. Given the stakes, he is just barely :willing to acquiesce in some other allocation scheme if he is persuaded that it accords with bis sense of justice. But, if he is persuaded that the current allocation scheme gives an unjusti­ fied special privilege to some it will not coax him to grant similar privileges to others. On a selfless day it willlead him to work for the elimination of the unjusti­ fied privilege, and on a less selfless one it willlead him to seek a similar privilege of bis own for bis own.

Vlll . Theoretical Standards and Operational Measures

in Kidney Allocation Consider the following two questions: (1) what if any purpose is served by Ayres and UNOS eschewing any mention of race in the allocational rules and pro­ cedures that he proposes or they adopt when the goal of both is to allocate more organs to Blacks? and (2) given that ceteris paribus Blacks do less weil with kid­ ney transplants than Whites, is it legitimate to make use of this infonnation to allo­ cate fewer organs to Blacks? These questions turn on the relationship between the­ oretical standards and operational measures. Every system of organ allocation, indeed every public and private policy, is mo­ tivated by some ultimate goal. It is that goal that is the theoretical standard. The journey from the theoretical standard to the ultimate operational ordering is rarely a single step. More often it is a process of ever more refined and usually explicit operationalization, in which the theoretical goal is partitioned and translated into measurable concepts. But in that translation we are forced by circumstance to mea­ sure what we can measure and choose among and combine a variety of imperfect measures. For example, with respect to kidney allocation we make the claim that the appropriate theoretical standard is the scheme one would choose from beyond the veil of ignorance, and that that scheme is the one that would maximize the ben­ efit to the universal man who embodied and aggregated the interests of everyone within society. As we discussed earlier, the UNOS scheme ignores the interest of third parties and so shall we. We flesh out the theoretical standard a bit more by urging that the interests of people in a transplant organ is the prospective medical benefi.t they will receive. But how should we allocate kidneys so as to maximize

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the expected medical benefit to the universe of potential recipients? There is no operational measure equivalent to a blood test, temperature reading, or pulse rate, that assesses "expected medical benefit". We are forced to look to a variety of medical and social characteristics of potential recipients that, at best, individually and in combination correlate with expected medical benefit. Consider, for example, how the age of the patient should enter the mix. Maximizing expected medical benefit implies increasing the number of years of life that kidney grafts function. Leaving aside considerations of the more powerful immune response of young patients, increasing years of life implies a preference for the young recipient over the old. The younger recipient is probably in otherwise better health and thus is more likely to tolerate the transplant procedure, and is also likely to live longer and thus to get more years out of an organ transplant. In addition, children, for purely medical reasons, do not thrive and properly develop on dialysis. But deciding to give a preference to the young still only moves us along the path, it does not get us to our destination. What sort of preference is best? Should it be a sliding scale of points based on youth? Or should it be a binary preference excluding patients past a certain age? Or should it be a combination of the two? And, with either choice we are still left with the question of how many points and what age cutoff? In the case of organ transplants too muchrideson the choice of the theoretical standard and its operationalization. Life and death turn on what standards and measures are applied. Under one treatment of age the sixty year old is precluded from receiving an organ, under another his chances are slim, and under still another his prospects are good. When so much turns on the ultimate ordering it is vital that both the theoretical standard and the operational rules be beyond reproach. Otherwise public support will dissolve, andrightlyso. In order to be beyond reproach organ allocation, like all other public allocations, must satisfy two conditions. First, and more fundamentally, the theoretical standard must appeal to a fundamental notion of fairness or justice. We all implicitly recognize this. Even policies that are clearly designed to serve the interests of some narrow sub-group of the population will invariably be defended on the basis of an appeal to some general interest. For example, on a recent news telecast a peanut farmer, who was the beneficiary of a government allotment program that permitted him to sell peanuts in the United States at an inflated price while his neighbor was forced to export his peanuts abroad at a lower price, defended the program on the grounds that it served the interest of consumers and the nation . Even when what actually motivates a particular allocation of resources is naked self-interest it masquerades as some species of the general interest. How can such a masquerade succeed? The answer rests on the second moral condition that an allocation scheme must satisfy, or rather the difficulty of recognizing whether it has satisfied it. The second condition is that the operational rules must be accepted as an honest attempt to realize the theoretical goal. It is here that

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there is substantial scope for disingenuous prevarication. Whether it be a preference for the young, or for the very ill, or for those well matched to donor organs, or any of the factors that enter the calculus, the form and the magnitude that the preference should take are not revealed by God. So, reasonable men and women will accept a variety of different operational schemes. Thus it is possible for an operational procedure designed for an unacceptable theoretical goal to masquerade as one that originated and is designed to serve a different and acceptable goal. For example, if Amelia Cohen, the twelve-year-old daughter of one of the authors of this article were to need a kidney, her father might well seek to design an allocation scheme that would place her name as close to the top of the priority list as possible. Such a theoretical goal would not have wide appeal. Recognizing that, he might instead contend that the current allocation scheme was giving insufficient weight to maximizing the expected life years of organ transplant recipients, a goal that would have universal appeal. He would argue that increasing life years argues for more points for children than others, and more points still for girls on the verge of puberty for some plausible medical reason. Thus although the actual theoretical standard motivating the argument is "get an organ for Amelia as soon as possible", he can mask this in terms of a seemingly neutral operationalization of an acceptable theoretical goal. Because many operational rules will be reasonable, albeit, partial and somewhat inaccurate measures of the theoretical goal of maximizing medical benefit, the game can beriggedby cleverly choosing and manipulating operational measures to achieve the allocation that one wishes. Note as well that an operational measure, like the theoretical standard, need not be explicitly stated or acknowledged. It may instead be implicitly applied. The notion that the operational standards may be implied rather than express may sound odd with respect to kidney allocation. After all, the very notion of the UNOS point allocation scheme is that it incorporates a uniform easily administered system of ranking prospective transplant recipients. But, embedded in any system of medical care are many subjective decisions and judgment calls. The patient's medical condition is the single most important determinant of whether they ever appear on the waiting list, and medical condition is an elusive concept not easily reduced to an objective quantitative measure. Assigning points to patients based on medical condition is much like numerical grading of essay exams. It is possible and perhaps appropriate to do both, but do not harbor the illusion that the ordinal - and a fortiori the cardinal - ranking of kidney recipients or of students' papers that results from the process is either accurate or immune from bias.

A. Race as a Theoretical Standard for Kidney Allocation Ayres is explicitly in favor of giving more organs to Blacks. That is the central motivation of his article. Such preference for Blacks is the theoretical goal that he is seeking to satisfy. His specific policy proposals illustrate how it is possible to

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achieve virtually any theoretical goal, no matter how invidious, by the judicious use of facially neutral operational rules. Ayres makes the following fivefold proposal: 1. the system of local organ allocation be retained; 2. the Ο rule be eliminated; 3. points for less than excellent HLA matches be eliminated; 4. points for time on the waiting list be increased; and 5. points be awarded to those who have rare antigens. None of these policy proposals mentions race, and each of them could plausibly, if not correctly, be defended as consistent with a more generally acceptable theoretical goal than racial preference. Had Ayres' purpose been purely pragmatic in the sense of wishing to provide more organs for Blacks without expressly admitting that that was his goal he could have done so, for there is nothing obviously, or even not so obviously, racial in any of the proposals that he makes. But Ayres is writing as an honest academic, not a disingenuous lobbyist. His theoretical goal is more organs for Blacks and so he expressly admits that his operational proposals are chosen to achieve that goal. It may seem curious to some readers that Ayres does not openly and expressly operationalize his racial preference. He could have done so by simply assigning points for Blackness. Ayres must implicitly recognize that such an explicitly racial consideration would be offensive to most people. He harbors the illusion that somehow gussying up his unacceptable theoretical goal with facially neutral operational procedures cleanses it of its odor. It does not. Note as well that there could by chance be a coincidence between the operational rules that result from an invidious theoretical goal and those that flow from a benign goal. In Ayres' case his goal is to get more organs for Blacks. His claim of inequitable treatment of Blacks is that they must wait longer for transplants. What would Ayres' reaction to the prior UNOS point allocation and the efficacy of HLA matching have been if the effect on Black and White allocation and graft survival had been reversed, i.e., if Blacks donated more organs than they received, and more importantly if Black graft survival rates were higher than White? We strongly suspect that Ayres would be strenuously, and we think correctly, arguing that there was invidious racial discrimination in organ allocation against Blacks, and that he would be lobbying for greater weight being given to HLA matching. But his position would flow from a special sympathy and concern for Blacks as opposed to Whites, while ours would derive from the interests of the universal man. Our criticism of Ayres' racial agenda is not meant to imply that all manner of racial considerations in kidney allocation are equally unacceptable and offensive. A Bosnian solution to kidney allocation, for example, entailing allocating Croat organs exclusively to Croats, Muslim organs to Muslims, and Serb organs to Serbs has much to recommend it in some settings. When a region is occupied by two or more distinct ethnic groups that are hostile or indifferent to one another, a regime of ethnically directed organs would have the virtue of increasing donation; mem-

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bers of each group would be assured that their argans would only be used to help a kinsman. It is true that some Americans of all races have the same hostility to those of other races

as

do the peoples of Bosnia. But the numbers are not so large

as

to

provide any likely gain in donation if argans were racially restricted. Were we to choose a Bosnian solution in the United States Blacks would be entitled to Black argans and Whites to White organs. Blacks would then receive many fewer argans than they do now because they donate approx.imately 10 percent of the total kid­ 114 neys harvested, but receive about 20 percent of the kidneys transplanted. Although we think that there is nothing morally reprehensible in a Bosnian solu­ tion to organ allocation, we do not favor such a policy for the United States. It is our conviction that the United States is not a nation in the sense of sharing a com­ mon racial or historical experience. Its nationhood rests instead on a shared politi­ cal ethic and aspiration. That ethic does not permit a treatment of its citizens by their govemment on the basis of race. Whatever virtue there might be to the Bosnian solution to organ allocation that 115 solution. Ayres

is not Ayres' solution. His is what might be called the "racist"

does not wish to give each race a claim to the argans of its race but rather to give Blacks a preference to argans over Whites. Unlike a purely racist allocation scheme in which Blacks have a claim to all Black argans and all White organs, Ayres' scheme is not one of absolute priority, but rather of relative preference. Medical benefit is to be given substantial weight but so is race. When medical ben­ efit is not large and the medical criteria in play discriminate against Blacks then medical benefit must give way to racial preference. We will offer no extensive argument against such a theoretical use of race. Our characterization of it as a racist proposal captures the moral odium with which we view it. We are sure that to Ayres, Dooley and Gaston characterizing their recom­ mendations as a racist proposal is outrageous. Given that they are not Black and that Blacks as a group have suffered slavery and discrimination in the United States they think that tipping the scales in favor of Blacks is eminently justified. We cannot concur. We hold in our minds the image of a ten-year-old girl whose parents emigrated from Poland fourteen years ago who must wait Ionger for an or­ gan and may ultimately be denied one because the allocational rules that Ayres fa­ vors have as their very purpose to allocate more organs to those of a more favored race. While writing this article we were saddened and shocked to leam that UNOS had adopted the same theoretical goal as Ayres. Though UNOS has not gone as far as Ayres' favors in amending their point allocations, the changes they have insti­ tuted are in the same direction, and motivated by the same invidious goal. In doing 114

Suthanthiran, supra fn. 55, at 368.

ns

The word "racist" has become little more than

an

empty Janus like epithet, which we

normally disdain the use of. In this case we employ the term in the strictly limited sense of pursuing a policy of racial preference.

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so they have violated their own Statement of Principles and Objectives of Equitable Organ Allocation , which clearly states that, "The UNOS definition of 'medical criteria* does not include economic status or social criteria such as race , gender, ethnic origin, social class or status, educational level, marital or family status, or social worth or usefulness". As in Orwell's Animal Farm we expect that the next time UNOS publishes the Statement of Principles race will have disappeared from the list. Ayres* policy proposals and UNOS' new rules are clever, facially neutral, operationalizations of their goal of assigning more organs to Blacks. Some of the proposals - those adopted by UNOS - are rather straightforward in their effect. The reduction in points for HLA matches means that Whites, who are more likely than Blacks to have good matches with donor kidneys, will lose the priority they otherwise would have received based on their greater likelihood of graft survival. The additional points for length of time on the waiting list also favors Blacks because their poorer HLA matches with donated organs means they tend to wait longer for an organ. One initially puzzling aspect of Ayres' policy recommendations is his advocacy of maintaining a system of local use of organs rather than moving to a system of national allocation. When the system of local preference was initially created, kidneys were the only organ regularly transplanted by a variety of programs across the country. For the other organs, a few regional programs dominated. For them, there was no true local use of kidneys. Local meant regional. Now for hearts and livers as well as kidneys there are a plethora of programs and so local really means local. 116 The local use of organs had considerably more medical justification when initially instituted than it does now. Using organs locally reduced the time that an organ had to sit in preservation fluid without an oxygenated blood supply (cold ischemia time). Ischemia time is critical to organ viability. In the early days the advantages of national matching were more than outweighed by the benefits of getting the organ into someone fast. Now, however, due to improved preservation solutions, transplant organs' tolerance - kidneys in particular - of ischemia time have dramatically increased.117 Kidneys remain viable even after 48 hours if kept in potassium solutions. Given that an ordinary commercial plane can travel coast to coast in four hours, transportation time is no longer a barrier to a national system. A system of national allocation allows for a better matching of patients with organs, both in terms of tissue typing and medical condition. Under the system of local preference patients who are on the appropriate waiting list are sometimes 116 See, Scott McCartney , Defying The Gods: Inside The New Frontiers of Organ Transplantation (1994), at 96. id.

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called to the hospital from the golf course while an equally compatible patient is allowed to die because he is on the waiting list in the wrong locality. Although Ayres recognizes the efficiency and equity of a national system, he still advocates maintaining the local system. Why? Ayres states that the issue of the geographic scope, i.e., a local vs. national system, of kidney allocation "is analytically distinct from the question of the appropriate bases for awarding points".118 True enough, but both should be driven by the same concerns for efficiency/equity. Given that the central theme of the Ayres article is racial preference, we believe that what motivates Ayres opposition to a national system is his belief that it will disfavor Blacks. But how? From one perspective, a national system would help Blacks not merely as much as whites, but more. A national system will provide more opportunities for those with rare antigens, to obtain better matched kidneys.119 Given that: (1) Blacks are but 13% of the population; (2) Whites donate at higher rates; and (3) Blacks have a more diverse and different genetic background than Whites, many more Black patients than White patients have rare antigens in relation to the donor population. Thus, if Blacks are to receive well matched kidneys, they need a large pool from which to draw. A national system would provide that large pool, and increase the number of Black recipients with rare antigens undergoing transplantation. One would think that that is exactly what Ayres would favor. Why then does he oppose a system of national allocation? His opposition rests, we believe, squarely on the likelihood of more excellent, matches. The HLA matching system will naturally tend to disburse kidneys to recipients of the same race, due to thefrequencies of HLA among the races, 120 but this is as true of a local system as a national one. Under Ayres scheme, however, points would only be allocated for excellent as opposed to merely good matches. In a local system because each organ is matched with a smaller pool of potential recipients fewer excellent matches will be found. Therefore the organs must be allocated on the basis of other criteria. The criterion Ayres favors is waiting time, which will allocate more organs to Blacks. The number of zero-mismatched organs that would be sacrificed to retain a local system of allocation is substantial. Dr. G. Melville Williams in a study supporting a move to a national system of organ allocation examined the tradeoff between increased cold ischemia time and better HLA matching. Two conclusions emerged from his study.· First, the data demonstrate that the benefit of a high HLA match more than offsets the drawbacks of protracted cold ischemia; more organ grafts will survive longer with a national system.121 Second, there will be a particular improvement in finding truly excellent tissue matches. If the 8700 recipients across ne Ayres, et ai, supra fn. 3, at 847. Takemoto, et ai, supra fn. 54, at 838. See also, David Gjertson, et ai, "National Allocation of Cadaveric Kidneys by HLA Matching", 324 New Eng. J. Med. 1032, 1035 (1991). 120 Takemoto, et ai, supra fn. 54, at 838. 121 Williams,

supra fn. 88, at 475.

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the country in a given year were to comprise a single unified recipient pool of a national allocation system, a 6 HLA match (zero mismatch) will occur with 1 in 4 cadaver donors. Thus, since each cadaver contains two kidneys at least 1 patient in 8 would receive a zero-mismatched kidney. 122 Another recent study concluded that there can no longer be any doubt that HLA matching for the Α, Β, and DR loci is sufficiently standardized throughout the United States to serve as the basis for kidney allocation.123 Experience with modest pools of recipients has revealed that only with a large national pool can sufficient numbers of well matched transplants be provided. 124 And, a variety of empirical studies show that a national system: (1) is not more costly than a local system and (2) offers gains as a result of HLA matching that outweigh the medical costs of increased cold ischemia time. 125 A second possible justification for a local strategy is the belief that donations are stimulated by the public seeing organs go to their neighbors and by doctors and nurses seeing the results of their procurement efforts. 126 Some argue that if a national system were established donations might decrease and organs would not be as aggressively harvested. Ayres refers to this as the procurement effect. 127 This supposed procurement effect seems highly doubtful. While it is true that people are usually more willing to help someone they know than a stranger, it is fatuous to suggest that a potential donor will have a significantly stronger affinity for someone who resides in the same city than someone in a neighboring state. Regional loyalty does not appear to be a very powerful force in contemporary America. As the recent floods in Iowa, Georgia, and Texas, or the bombing in Oklahoma City illustrate, when Americans hear of tragedy, they help their fellow American. We find it hard to believe that someone in East St. Louis, Illinois would be more inclined to donate their deceased relative's organs to help their "neighbor" in St. Louis, Missouri than they would to help a patient in Pittsburgh, Pennsylvania. It is equally hard to believe that doctors and hospital staff would not as actively pursue organs if they were going to be allocated nationally. Hospital staff involved 122 Id. 123 Takemoto , et al., supra fn. 54, at 838. 124 Gjertson, et al, supra fn. 119, at 1032. 125 Takemoto, et al., showed that the need to ship kidneys and the attendant longer period of cold ischemia time did not cancel out the benefits obtained from 6 HLA matching and that despite concerns that kidneys harvested by different centers might be of low quality, their shipment from 108 diverse centers resulted in a high rate of graft survival in matched recipients. In fact, the one-year survival rate of matched kidneys transplanted after 36 hours was higher (84 percent) than that of mismatched kidneys transplanted within 24 hours (81 percent). Takemoto, et al, supra fn. 54, at 838. Additionally, Gjertson, et al.'s study concludes that despite the costs associated with matching and sharing on a national level, no increase in overall costs occurred due to better matching. Gjertson, et al, supra fn. 119, at 1035. 126 id.

127 Ayres, et al, supra fn. 3, at 849.

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in organ procurement are, as a matter of policy, not those actively involved in transplantation. It is precisely to preclude any inference of mixed motives in the care of the patient that those doctors who care for patients are permitted to have no stake in some alternative use of the patient's body. We would have to ascribe the same knavish regionalism to doctors as to donors to generate a procurement effect. Ayres calls for more empirical evidence to consider the ramifications of the procurement effect before moving to a national system. What sort of empirical evidence would be persuasive? Both the Red Cross and the Salvation Army collect and distribute their resources nationally. They must believe that people are not narrowly geographically motivated with respect to charity to unseen and unknown victims. Moreover, the argument for more empirical evidenceringshollow in light of the fact that Ayres does not call for the need for additional empirical evidence to study hierarchical HLA matching, but instead demands sweeping changes. This brings us to Ayres* most clever policy proposal, and one that was not adopted by UNOS. Ayres proposed giving 4 points to patients who have rare antigens. Giving an advantage to those with a rare condition has an initial moral appeal. But in this case it is a perverse policy. As we argued with respect to pre-sensitization points, the operational rules of organ allocation can not be evaluated in isolation. In the case of pre-sensitization the reasonableness of granting points for the condition depends on the relative supply and demand of organs. In the case of those with rare antigens the reasonableness of granting such patients a preference is a function of what other operational rules are also in effect. If we retained the system of giving substantial points for less than perfect HLA matching, granting a point or two for those possessing rare antigens would be in accord with maximizing expected medical benefit. How so? The analysis is much the same as that with respect to the 0 rule and pre-sensitization points. Imagine that there are two patients each with 2 mismatches with a particular donor organ, one of the patients has rare antigens and the other does not. If denied the organ, the patient without the rare antigens is more likely to achieve a 2 or better HLA mismatch with some future organ than the rare antigen patient. Ayres proposed, however, and UNOS partially adopted, not merely reducing the points allocated for less than perfect HLA matches, but eliminating them entirely. With that change in the rules what is the effect of granting not merely 1 point, but 4 points, to patients with rare antigens? Those with rare antigens will usually have more mismatches with donor organs than other patients, thus were we to grant them 4 points we would be giving a preference to transplanting mismatched organs over well matched organs. That policy would be perverse. Ayres favored it for a very straightforward reason: it helps Blacks get more organs. The rareness of one's antigens is in relation to the universe of donor organs. Given that almost 90% of all donors are White, Blacks in general have rarer antigens in relation to the donor population. 12 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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Ayres notes that he has eschewed the use of race as an explicit criteria of kidney allocation so as not to dissuade Whites from donating organs.128 This raises two questions. First, as a practical matter does he believe that he can keep the rationale of his proposed - now UNOS adopted - allocation scheme secret? Such secrecy would have been impossible even without his article specifically justifying his proposals on racial grounds. Dr. Hunsicker is not shy about attributing the changes in the allocation rules to racial concerns. The second question that Ayres leaves unanswered is what is his moral evaluation of this feared response by Whites. Is there something morally questionable in Whites not donating because they believe that they are being treated unfairly per se in the allocation of kidneys? Can he make a convincing argument to them that it is just andright that a transplant organ go to a Black child when their child would likely gain more medical benefit from it? We fear that we have already bestowed too much dignity on Ayres* argument in favor of a racial preference. One does not require great imagination, intelligence, or moral sense to recognize it as morally grotesque and abhorrent. We think it beyond argument among decent Americans that the decision as to who among those desperate sick people waiting for kidneys should receive one should in no way turn on whether they share genes with Simon Legree or Uncle Tom.

B. Race As An Operational Tool in Kidney Allocation The previous section focused on race as a theoretical standard of allocation. Ayres' proposal and UNOS' amendments apply facially neutral operational measures to reach a racially non-neutral theoretical result. An ethically more interesting issue involves the use of race as an operational tool. Some people do better with transplants than others. There are a variety of patient characteristics that predict prospective medical benefit and likelihood of organ graft survival. These include, but are not limited to, age, medical condition, and degree of tissue matching. But, the objective medical variables we can name do not exhaust the field of predictors. It is not merely conceivable that race could predict graft survival; it is an empirical fact. Ceteris paribus Blacks have lower organ graft survival rates than Whites and Blacks do better on dialysis than Whites. 129 12

8 Ayres, et al. , supra fn. 3, at 846.

ι 2 * It is estimated that blacks experience a 10 to 20 percent lower graft success rate than whites. Wayne Β. Arnason, "Directed Donation", 21 Hastings Center Report 13, 14 (1991) (citing United States Renal Data System, Annual Data Report, National Institute of Diabetes and Kidney Disease, Bethesda, Maryland, National Institute of Health, August 1989). Terasaki, et al., found that during the period 1965-85 white recipients had an average kidney graft half-life of eight years, while black recipients had an average half-life of five years. They stated that the most important factors in determining short-term (one year) success rate of a

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Why? There are a plethora of theories. Perhaps it is because they receive their transplants at less accomplished centers, or perhaps because they fail to take their medication as scrupulously, or perhaps they are inherently more susceptible to rejection. Blacks and Whites differ on a whole panoply of social and biological dimensions. Which one or set of those differences is the cause of the greater success of organ transplants in Whites remains a mystery. The interesting moral and policy question is whether it is permissible, desirable, perhaps even required, that we employ race as an operational proxy for this subset of differences between the races that might predict organ graft survival. Even were there no taint to the use of race in organ allocation, some possible sources of the difference in organ graft survival preclude the use of race. For example, if Blacks do less well because they receive their kidneys at less skilled transplant centers, the appropriate policy response is to allocate fewer organs to those centers and not fewer organs to Blacks. But if Blacks do less well than Whites for some as yet undefined genetic reason, what then? There is much that medical specialists do not know about immunology, and still less is known about racial differences in immunological response. There may be inherent differences between the races such that rejection is more of a problem with Blacks. If so, then on net lives could be saved and suffering ameliorated by using race as an operational determinant of organ allocation. The use of race in this way involves no invidious discrimination. The goal is not to give fewer organs to Blacks, but rather to give fewer organs to those less likely to do well with a transplant. Race may be a cheap and powerful proxy for whatever variable it is that makes some people do less well with transplanted organs. Even so, is it morally acceptable to use race as an operational measure of organ graft survival? If the differences in organ graft survival after three years were 80% for Whites and 20% for Blacks it seems to us that the answer is clear. Many more suffering people can be helped by using race as an operational measure of prospective medical benefit. But what if the difference is not 60%, but a reliable 6%? We offer the reader no answer, but merely point out that to fail to use race under those circumstances is to sacrifice true racial neutrality in the allocation of organs for the appearance of racial neutrality. Nonetheless, given the less than stellar history of the United States on the subject of race, many readers may think it prudent to eschew the use of race in any form.

kidney graft to be: a) quality of the transplant center; b) histo-compatibility; c) first versus second graft; d) sensitization; and e) race. They concluded that "the time has come to implement cadaver kidney sharing on the basis of histo-compatibility, for this is the best method for determining late failures." Id. (citing Paul I. Terasaki , et al, "Long-Term Survival of Kidney Grafts", 21 Transplantation Proc. 615,617 (1989)). 12*

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IX. Reform UNOS or Abandon It? By examining the arguments of Ian Ayres and the other authors of Unequal Racial Access to Kidney Transplantation in favor of a preference for Blacks in organ allocation in the United States we have learnt much. That they think it appropriate for the United States to embrace a racial agenda in kidney allocation brings into sharp focus that the rest of us do not, that we demand a system of kidney allocation that is racially neutral. Their description of the current system as heavily weighted to "efficiency" led us to ask what is it that we wish to be efficient about. The answer is maximizing the ex ante benefit to the universal man. Their misunderstanding of the 0 rule and the pre-sensitivity points highlights how operational rules may have their origin in a variety of different theoretical goals some of which are benign and others malicious, and that the relationship between the theoretical goal and its operationalization are often difficult to discern. And, their policy proposals demonstrate how facially neutral and seemingly innocent operational rules can be made to serve any invidious theoretical goal. Their proposals with respect to HLA matching, waiting time, national allocation, and rare antigens, are all facially neutral, but they are derived from, and well serve, a racially preferential motive. That UNOS has adopted the same theoretical goal favored by Ayres and amended its operational rules to serve that purpose is both shocking and lamentable. It has led us to seriously question the entire organ allocation scheme in the United States and survey various policy alternatives to see if we canfind a path out of this quagmire. Perhaps the allocation rules should be amended less frequently? The more often the rules are changed the more often mischief can be done. Special interests of one sort or another will seek every opportunity to get their way, and constant vigilance is difficult to maintain. But amending the allocation rules very rarely and adhering to them very strictly forfeits too much. If we are to achieve efficient allocation of this precious resource, altering the UNOS allocation rules should be a constant ongoing activity. The change in relative supply and demand, the development of new drug therapies and other medical technologies such as better preservation solutions, deeper insights into tissue matching, and better empirical data all alter the optimal allocation. As the optimal allocation changes, so should the concrete allocation rules. Perhaps there is some way to insulate the rule making process from invidious and pernicious forces? But to refer to "the rule making process" obscures that at bottom it is people who make the rules. We know of no method of choosing people to make those decisions who are both sufficiently concerned about the issue to do a careful and conscientious job and yet without an agenda other than serving the interests of the universal man. UNOS* amendment of its rules to favor Blacks and decrease expected graft survival has led us to wonder what special interests or other invidious forces might have been at play on the UNOS coùimittee. As our earlier discussion of physicians not being entirely disinterested on the issue of preferences for pre-sensitized pa-

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tients reveals, sometimes neither the nature of the personal interest nor how it will express itself in the rule making process is initially or readily apparent. The UNOS board of directors consists of no less than 34 nor more than 40 members, no more than 50% of whom may be transplant doctors or surgeons. UNOS seeks directors from a variety of backgrounds including patient representatives. At first blush it might seem eminently appropriate that ESRD patients and their families not only be members of the committee but that they make up the lion's share. After all, the very purpose of the committee is to devise rules that serve the aggregate interest of patients. On closer examination however it becomes clear that these people comprise a biased subset of the population to be served. The role of the UNOS committee is to formulate rules to allocate kidneys among all those who will need one in the future. Those who currently need a kidney are only a subset of that group, and their interests are not identical with those of the entire group. Those currently in need of a kidney will want to give priority to those on a waiting list, thereby giving themselves a1 leg up on future ESRD patients. Further, those who have been on the waiting list for a long enough time to serve on the UNOS committee are likely to have antigens that do not match up well with the donor population. It is therefore in their interest to give less weight to HLA matching. And what of the medical professionals on the UNOS board of directors? In response to a charge that the prior allocation scheme was racially discriminatory, the UNOS board changed the allocation rules to give more organs to Blacks. What subtle and pernicious form did self-interest play in how the physicians and surgeons weighed this charge? Michael Wilhams, a Black official in President Reagan's Department of Education has remarked that many White men suffer from what he calls "White Men's Disease. [They have] such profound fear of being called a racist that they will sacrifice anything, especially principle, to avoid it". 1 3 0 We suspect that such fear played a role in the UNOS decision. There is very little personally at stake for the medical professionals on the UNOS board. Why should they suffer personal grief when acquiescence in facially neutral rule changes is so easy? If the public believes that specific allocational rules derive from an acceptable theoretical goal it is willing to grant reasonable latitude to medical and scientific specialists to achieve that goal. Dr. Hunsicker argues that, based on his experience on the UNOS board of directors, agreeing on the theoretical goal of allocation is too difficult, that instead if the committee focuses on the operational rules it can reach a consensus. We cannot fathom what he is talking about. How can people who fundamentally disagree on the theoretical goal of organ allocation proceed? If they disagree on whether organs should be allocated to benefit Americans or Swedes, can they sensibly agree 130 Lisa Schiffren, tember 1995).

"The Man from Tennessee", 28:9 The American Spectator 33, 37 (Sep-

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on any operational rules? The way in which Dr. Hunsicker's consensus was achieved at UNOS, we believe, is by various members of the board averting their eyes and pretending that the allocational rules, because they were facially neutral, were actually serving an acceptable theoretical goal. Perhaps now is a good time to not merely argue for marginal changes in UNOS policy but to seek a revolutionary change in organ allocation entirely. As a matter of philosophical principle we are favorably disposed to the institutions of private property, personal liberty, and freedom of contract. As a general matter therefore we approve of markets. One of us has written extensively on the subject of creating a market to increase the supply of organs.131 But using a market to allocate organs is a different matter. While we believe there are substantial reasons for doing so, until now we did not think it worthwhile to expend effort making the point. Those who decried markets, and argued for allocation by a quasi-official body on the basis of criteria other than ability to pay, claimed the moral high ground, 132 and as a practical political matter it seemed too hard to dislodge them. That is no longer the case. Ayres, Dooley, and Gaston, and the UNOS committee have provided us with unequivocal empirical evidence of: (1) the great moral divide that separates us, and thus makes agreement on a common standard of fairness in organ allocation impossible; (2) the facility with which facially neutral operational criteria can be employed to serve invidious theoretical goals; (3) the seeming impossibility of choosing a body of decision-makers that are informed, concerned, disinterested and courageous; and (4) the evil results that have emerged from the non-market mechanism of allocating kidneys. With a given supply of transplant organs the sole claim for public allocation of organs as opposed to a market is that the former results in a fairer allocation, not that more patients will be treated. Various commentators have characterized cadaveric kidneys as a national resource. 133 If so they must be allocated to serve the national interest, and the principle national interest is that the organs be allocated »31 See, supra fn. 10. 132

Consider for example: Rationing byfinancial ability says that we do not believe in equality and that we do believe that a price can and should be placed on human life and that it should be paid by the individual whose life is at stake. Neither belief is tolerable in a society in which income is inequitably distributed. Excerpts from the Report of the Massachusetts Task Force on Organ Transplantation, in: Human Organ Transplantation 211, 233 (1987). 133 For an example of how commentators have struggled with the question of fairness in allocating medical resources, see Brock, Ethical Issues in Recipient Selection for Organ Transplantation, in: D. Mathieu, ed: Organ Substitution Technology, 1988, 86; Roberts, "The Economics of Organ Transplants", 25 Jurimetrics J. 256, 258 (1985) (analyzing the costs of organ transplantation); see generally Task Force Report, supra fn. 4 (adopting the view that donated organs should be viewed as scarce public resources to be allocated in accord with standards of justice).

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justly. Fairness of allocation is not merely a putative benefit of public allocation, it is a requirement. The knavish capitulation of UNOS to claims of racial discrimination is but the latest, and perhaps the most egregious, illustration of the impossibility of any quasi-public body satisfying the goal of fairness in allocation of transplant organs. The UNOS point system is only half of the problem. The other half is the discretion of committees of medical professionals at transplant facilities. Individual doctors and transplant teams decide whose name is entered on a waiting list, and where on the list they are placed. 1 3 4 The public is only dimly aware of the standards employed and is led to believe that the cutoff points are clear, constant, and exogenous, rather than fuzzy, fluid, and endogenous. The process creates the illusion that those who are denied organs are clinically unsuitable. As Dr. Geroge Annas observed a number of years ago: [T]here are ... 80,000 individuals on dialysis in the United States today, yet only about 7,000, or less than 10 percent, are on waiting lists for kidney transplants. Because of the shortage of available organs, physicians have determined that more than 90 percent of all possible kidney transplant candidates are not 'clinically suitable\ 135 Many of those who understand the system well believe that "the present mechanisms for rationing access to needed transplants - subtle, surreptitious, not publicly discussed - are ethically wrong". 1 3 6 The current corrupt allocation regime is the strongest argument in favor of removing kidneys from the grasp of quasi-public agencies and returning them to private hands. The private market realizes justice by side-stepping the question of a fair allocation rather than answering it. The central ethic of the market is that it is 134 Scott McCartney, a sympathetic observer described the process at Baylor as follows: " And while professionalism and strict guidelines are the order of the day, arbitrary and capricious reasoning can play a role, and issues become murky and contrived. 'This guy deserves a liver* someone declares. Ί don't like him,1 or Ί don't trust him,' says someone else." McCartney, supra fn. 116, at 128. 135 Annas, "Regulating Transplantation", supra fn. 8, at 254. See also, Annas, "Allocation of Artificial Hearts in the Year 2002: Minerva v. National Health Agency ," 3 AM. J.L. & MED. 59, 67 (1977); Annas, "The Prostitute, the Playboy and the Poet: Rationing Schemes for Organ Transplantation", 75 Am. J. of Pub Health 187, 188 (1985); Bayer, "Justice and Health Care in an Era of Cost Containment", 9 Social Responsibility: Journalism, Law, and Medicine 37, at 38-42; Evans/Yagi, "Social and Medical Considerations Affecting Selection of Transplant Recipients: The Case of Heart Transplantation", in: Human Organ Transplantation 27,30 (1987). 136 Arthur Caplan, "Obtaining and Allocating Organs for Transplantation", in Human Organ Transplantation 5,8 (1987). We are assuming that the allocation decision is made in good faith. It should be recognized, however, that the more open ended and amorphous the criteria, the greater the possibility and likelihood that they will be ignored in favor of a narrower, more private motive. "Numerous reports have appeared in the popular press concerning favoritism shown to those persons who can make significant contributions, either monetary or in terms of favorable publicity, that wiU benefit the medical centers where transplants are performed." Id. at 7.

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just that a property owner dispose of his property as he sees fit. Owners of kidneys, like owners of other life preserving commodities such as food, clothing, or shelter, are neither expected nor required to allocate them fairly. Indeed, it is hard to know what fairness means in such a context. Aside from the moral and legal obligation to commit no tort or crime in the process, the owner of the property need only serve himself. A market solution to the problem of organ allocation is also egalitarian in a different sense of the term. It treats kidneys as a good that we all have an equalright to acquirefrom the current owner through voluntary transactions. None may be excludedfrom bidding because others think him unworthy. It is untrue, however, that a market would result in an allocation sharply at variance with most people's intuitions as to the proper allocation of organs. The market implicitly responds to the same set of fairness concerns that should motivate an ideal public body, and perhaps appraises them more accurately. The price that an individual will be willing to pay for a particular organ will be a function of the likelihood that that organ will add substantially to the quality and quantity of his life. Thus, between two candidates of approximately equal wealth, the one who would be willing to pay more will usually be the one who can make best use of it. There is also the matter of the social value of the potential recipient. Despite the fact that UNOS has eschewed such considerations, the justice of not taking a person's value to, and standing in, the community into account in allocating transplant organs is less than obvious to us. That an indigent, solitary criminal, who is almost indifferent to the prospect of receiving the liver, is as likely to receive a transplant as a wealthy young scientist with family responsibilities who could and would surrender a great deal of his wealth in exchange for the liver does not seem to us to be a morally compelling result. A market approach gives real weight to the intensity of the desire of both the recipient and others that the recipient's life continue. Far more than moral posturing, the willingness to contribute is powerful evidence of the desire that a particular patient secure a better quality of life.

X. Conclusion The choice of how to allocate kidneys will always have tragic consequences. However we allocate them, someone will be denied. While we believe that market allocation is ethically superior to public allocation, that is not what motivated this article. If organs are to be allocated by a quasi-governmental agency they should be allocated on the basis of purely prospective medical considerations. Allocating organs in order to give one race or another an edge should be beyond the pale. Is it really necessary to write an article that asserts the position that one should not decide which of two twelve-year-old girls should receive a kidney transplant on the basis of which continent their ancestors emigratedfrom, or whether the emigration was voluntary, or how recently their ancestors were enslaved?

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Zusammenfassung Im Jahre 1993 vertraten die Autoren des Aufsatzes „Unequal Racial Access to Kidney Transplantation" die These, daß das scheinbar neutrale Verteilungssystem für Nieren in den Vereinigten Staaten Schwarze ungerechtfertigt benachteilige. Deshalb forderten sie, die Verteilungsrichtlinien so zu revidieren, daß die Aussichten Schwarzer auf ein Organ verbessert würden. 1995 änderte das United Network for Organ Sharing (UNOS) seine Verteilungsrichtlinien, und zwar in weitgehender Übereinstimmung mit den Vorschlägen des Aufsatzes. Der Beitrag setzt sich mit der Frage auseinander, ob dieser Schritt richtig war und was ein Organverteilungssystem überhaupt leisten soll. Dabei legt er die Annahme zugrunde, daß das Ziel einer Organverteilung die Maximierung des ex ante Nutzens der gesamten Menschheit sein sollte. Vor diesem Hintergrund werden Effizienz und ethische Implikationen der früheren und der gegenwärtigen Verteilungsregeln, der in „Unequal Racial Access ..favorisierten und der vom UNOS beschlossenen aktuellen Änderungen geprüft. Die Überlegungen, die den vorgeschlagenen und den tatsächlich erfolgten Änderungen zugrunde liegen, sind nicht nur völlig unzutreffend, sondern darüber hinaus auch schädlich und gefahrlich. Dann werden die Unterschiede und die Beziehungen zwischen theoretischen Zielsetzungen und den Verfahrensregeln zu ihrer Umsetzung sowie die Möglichkeit untersucht, im Rahmen einer der beiden Kategorien Rasse als ein Kriterium für die Verteilung von Spendernieren einzusetzen. Gerade das Beispiel des UNOS, bei dem rassisch bestimmte Ziele verfolgt werden, zeigt, daß die These, ein öffentliches Verteilungssystem sei einem System moralisch vorzuziehen, das sich auf privates Eigentum und auf Marktmechanismen stützt, grob unredlich ist.

Patients' Rights

Experimentation on Trial Why Should One Take Part in Medical Research? David Heyd The Ethical Basis of Experimentation on Human Subjects Like its modern English analogue "drug", the Greek word pharmakon denotes both poison and medicine. This dangerous double meaning is given a philosophical account in one of Plato's numerous discussions of the benefits andrisksof medical practice. In theïïmaeus Plato starts with the metaphysical proposition that of all motion that is the best which is produced in a thing by itself, for it is most akin to the motion of thought and of the universe, but that motion which is caused by others is not so good, and worst of all is that which moves the body, when at rest, in parts only and by some external agency.1

Plato then proceeds to draw the medical conclusion, namely that inducing external (and local) movement in the body by surgical or pharmaceutical intervention is clearly inferior to internal movement like gymnastics (which we would today call "natural medicine"). The "purgative treatment of physicians", says Plato, should be applied only in "extreme necessity", since "diseases unless they are very dangerous should not be irritated by medicines". The theoretical assumption behind this cautious view of the benefits of medical intervention is that diseases, like any living being, have a fixed span and that the attempt to subdue them by medicine only "aggravates and multiplies them". Without having access to modern scientific knowledge, Plato had already twenty-four centuries ago a clear sense of the iatrogenic dangers of aggressive medical practice. But how are we to know the difference between the beneficial and the harmful uses of medicines? How are we to judge when a drug is poisonous or healing? The very precarious line between the toxicity which eradicates the source of the disease and that which destroys the whole body is exactly the concern of much medical practice throughout the ages. The attempt to systematize our knowledge of this borderline is the primary goal of medical experimentation. Modern medicine has at its disposal much better methodological tools for conducting experiments than existed in Plato's time, but the dramatic growth in the effectiveness of its means is paralleled by the growth in therisksof using them. ι Timaeus , 89a (Jowett translation).

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Experimental research on human subjects obviously raises ethical questions which do not arise in other fields of scientific investigation. Like "pharmakon", the word "subject" is typically ambiguous, denoting both the being which is passively "subjected" to the experimental procedure and the person who is the putative beneficiary of the procedure as well as the active maker of the choice to take part in it. 2 Paradoxically, as we shall see, the more sophisticated research protocols become in their methodology, the more difficult it is to justify them ethically. In other words, in modern clinical trials which are controlled and statistically cogent, the human beings taking part in them are more subjected to anonymous scientific principles and less treated as autonomous moral subjects, at least in comparison to traditional retrospective uncontrolled trials. The issue of medical experimentation on human subjects is particularly sensitive, since there is a tension between the high esteem in which we hold the experimental method characterizing modern science and the deep suspicion with which we view any attempt to use human beings for purposes other than their own individual welfare. We are aware that the achievements of modern medicine are mostly the result of experimental methods, but we can never forget the widespread abuse of human beings by either maliciously driven "researchers" or by well-meaning but over-zealous scientists. It is historically striking that the first randomized clinical trial and the first formal attempt to address the ethical boundaries of medical experimentation came at the same time, that is immediately after World War Π. This attests to the tacit co-incidence of sophisticated methodology and ethical sensitivity. There are two levels on which the issue of the ethics of experimentation can be discussed: the general moral basis for the practice of experimenting with human beings and the particular conditions which should be satisfied for the practice to be considered morally acceptable. The vast majority of writings on the subject belong to the second level. Much attention has been given, both by medical practitioners and medical ethicists, to the nature of informed consent, to the validity of various versions of randomization, to the means by whichrisks can be minimized and the danger of abuse prevented, to the procedural aspects of the regulation of experimentation, to the ways of compensating subjects injured by experiments, etc. I am going to avoid all these issues and concentrate on the relatively neglected topics pertaining to the first, more general level, namely the ethical basis of the practice of experimenting with human beings. This topic can be approached from two perspectives: from the point of view of society and the medical profession or from that of the individual subject. The for2

In the terms of one of the versions of the Kantian Categorical Imperative, we may say that the two senses of "subject" may be reconciled in taking the individual patient "not merely as a means, but as also as an end". The distinction between the use of people in experiments and their abuse lies in the conditions of consent and intended benefit, which relate to their being subjects in the second, morally indispensable sense.

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mer consists of the attempt to justify experimentation as a social good or as a means to promote public health or as a necessary condition for the advancement of knowledge. This is the legitimate perspective for legislators, public health administrators and scientists. The latter focuses on the question why should the individual take part in medical research, as it is asked either in first-person terms or as it should be asked by the doctor, who beyond her interest in research is the trustee of the individual patient. My concern will be primarily with this latter perspective. It should be noted that this distinction between the impersonal and the first-person justifications of medical experimentation is a basic tenet of the liberal view, which requires a tolerant attitude to the split between what is good or justified for society and what is good, rational, or obligatory for the individual. Thus, on the one hand the fact that there are good social or moral reasons for carrying out experiments does not in itself impose any moral duty on individuals to take part in them;3 on the other hand, the good reasons patients may have to serve as subjects in high-risk trials does not entail that the law should permit them to do so. This does not mean that the two kinds of reasons are not closely related and often serve to strengthen or to restrain each other. But medical experimentation is a subject in which the gap between what is rational and good for the collective and what is rational and good for the individual is markedly wide, since the stakes are high for both parties. I propose to discuss the individual-oriented issue, namely why should one take part in medical experiments, in three stages or levels: I. Rationality: does one have good self-regarding reasons to subject oneself to medical experimentation? Π. Justice: does one have a duty or an obligation to take part in experimental medical research? ΙΠ. Virtue: ought one to contribute to the long-term attempt to promote medical knowledge and the overall health of human beings? The three questions are ordered in a hierarchical way: prudence, moral duty, and supererogation; or, in terms of three alternative bases of moral theory: rational choice, social contract, and value; or, in other words, what is worthwhile for me, what I owe to others, and the best way in which I can serve a human ideal. From the point of view of motivation, the subject is driven on the first level by egoistic concern, on the second by the demands of duty and obligation, and on the third by the free choice to volunteer. These are three distinct grounds for expecting people to take part in medical trials, in which the second is built on the failure of the first,

3 Although the Hippocratic oath does not mention experimentation, it places in the first section the duty of the doctor to transmit medical knowledge to the next generation. This is a professional educational duty, which could be interpreted also as including experimentation. But although the oath gives priority to the impersonal duty of the doctor to secure medical knowledge, it then proceeds to list the personal duties of the doctor to his patients which might be seen as constraining his "research activities".

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and the third is advanced as an admission of the shortcomings of the second. In other words, I propose to show that the appeal to self-regarding reasons cannot suffice to serve as a justification of medical experimentation, and that the morallybased reasons of justice and fairness cannot play this justificatory role either. This will lead us to view the individual's involvement, at least in some medical experiments, as a matter of Good Samaritanism.

I. Rational Choice Prudential reasons are methodologically superior to moral reasons; Their force is usually less controversial and their motivational effectiveness more direct. Thus, the attempt to justify the recruitment of human subjects to medical experiments on the basis of the potential benefit to them is particularly attractive. But of course there are different levels of rationality, from the most direct short-term egoistic benefit to the highly abstract long-term probabilistically supported expected utility. Every individual has a deep interest in getting the best medical treatment possible. But the best treatment a doctor can offer is based on long experience, that is on a haphazard or systematic series of cases from which conclusions as to the effectiveness of the treatment are drawn. The words "experience" and "experiment" are derived from the same Latin etymology, "experiri", to try. In that respect, every medical treatment by an individual doctor is an attempt, an "experiment" in the minimal sense that if it "works" the doctor continues to apply it, and if it fails the doctor seeks an alternative to it. In this minimal sense, every patient has an interest in participating in the process of experimentation. The doctor tells the patient, "let's try this medication for your syndrome", and the patient agrees on the basis of being the primary and direct beneficiary of this "trial". It is the most basic kind of experiment which is designed purely with the individual patient in his unique condition in mind. This is the most primitive kind of experiment from the point of view of scientific rationality, but the easiest to justify as rational from the point of view of the subject. But is it really so? It is a commonplace truth that the dramatic advances in modern medicine are at least partly due to the systematization of medical "experience". Experimentation has become a collective enterprise of the profession rather than the personal concern of individual practitioners; and the population of subjects through whom new knowledge is gathered is nowadays organized in controlled groups, breaking up the traditional doctor-patient relation. Experiments are not conducted ad hoc, but in a pre-designed manner; not as an inductive collection of cases, but as a systematic testing of hypotheses. The epitome of this development is the fifty-year old method of Randomized Clinical Trials (RCT), which has become the privileged and most reliable means of attaining new knowledge in many fields of medical research. Randomization of the grouping of human subjects neutralizes all sorts of interfering, "irrelevant"

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variables, which have in the past distorted scientific results. It allows the researcher to design the experiment in such a way that only the relevant factors play a role in effecting the different results and the researcher has full control over them. Conducting the RCT in a single, or preferably double-blind manner secures this purity of relevance of the variables. But both randomization and blindness open a significant gap between the patient's direct interest in getting the best treatment for her condition and the overall potential of advancing medical knowledge. The individual rational chooser is left with a dilemma: should he opt for the traditional experience-based trials of his individual doctor, or rather for the doubleblind randomized clinical trial. The former, personalized method is superior in its therapeutic potential since it is sensitive to the particular conditions of the individual patient and promises an immediate effect for the individual. On the other hand, only the latter, impersonal method of the RCT can be expected to yield the rationally supported breakthrough in the treatment of a disease. The situation is reminiscent of the Prisoner's Dilemma, in which two principles of rationality conflict with each other. I have good reasons for preferring a treatment based on a "trial" specifically designed for my particular condition; but this is a rational choice only if others , by taking part in impersonalized, randomized trials, contribute to general medical knowledge, including that of my own doctor. Thus, if everybody opted for the same personalized treatment, as I do, there would be no advance in medical competence, which would make the choice ultimately irrational also from the point of view of the individual chooser. One way to overcome this paradox of rationality is to narrow the gap between the two principles of rationality by allowing for therapeutic experimentation only. If I take part in an experiment which seeks a new drug for the condition from which I am suffering, it is true that I cannot be guaranteed the best treatment which suits my individual case (which might even be already known to the doctor), but I still stand to benefit personally from the research in the longer run. Provided that certain restrictions are placed on the research protocol so as to ensure that I do not risk my health to an unreasonable degree, it could be easily conceived that a rational chooser has good reason to take part in such an experiment. Experiments on new drugs for hypertension are a typical example for such reasoning. Hypertensive patients who are selected for a randomized trial, even if they are temporarily assigned to a group which receives a placebo, are given priority in the future use of a new drug proven to be more effective than present medications. However, not all medical experimentation is therapeutic in nature. There are experiments in which it cannot be shown that the subjects stand to benefit from them even in the longer term. One clear example is the mastectomy-lumpectomy controversy in the treatment of breast cancer. Women in a group treated with the radical surgery cannot gain anything by the discovery of the superiority of the more modest intervention. Furthermore, there are experiments in which patients who suffer from syndromes other than those investigated or who are even completely healthy are called to take part. Is it rational for a person with a normal cholesterol level to 13 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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take part in a controlled trial for drugs affecting cholesterol levels? It has also often been noted that even within the group receiving the new drug there are significant differences between the chances of success in those getting the hypothesized optimal dosage and those who get a larger (possibly riskier) dose or a smaller (less effective) one. As in other Prisoner's Dilemma situations, there are ways in which the prudential reasoning of the individual can be regulated through the manipulation of the conditions under which the choice is made. Thus, society may resort to negative incentives (such as sanctions for not participating), or to positive incentives (such as monetary compensation or early release from prison). These are means which in the past have proved very effective in recruiting subjects for experiments, but like direct deception or physical enforcement, are considered morally unacceptable by any enlightened society today. A possibly less repugnant proposal is to let the patient choose between a "research hospital" and a "non-research institution". The former would offer a better, more up-to-date treatment, but the patient would be committed to take some part in new research.4 These examples serve to show that rational choice cannot be defined in a context-neutral way. The conditions under which the choice is made by the individual are constitutive of its "rationality"; that is to say, if we wish to justify medical experimentation in terms of its rationality for the subject, we must specify certain conditions of autonomy characterizing the subject making the choice. But the basic criticism of some of these "solutions" refers to the unfairness of the conditions themselves.

Π. Justice and Fairness There is a long tradition starting with Hobbes which tries to articulate the conditions for rational choice in terms of the ultimate rationality of all the parties concerned. This is the beginning of the idea of the social contract, in which individuals construct a political system which radically constrains their individual freedom to exercise their choices so as to achieve overall benefits. This approach could be translated in the present context to imply that the sovereign (state) is given absolute power to compel individuals to participate in medical experiments in every case in which this can be shown to contribute to an overall promotion of health. Now, such a system would be far from absurd, since it would force individuals out of a situation in which no one is willing torisk oneself in an experiment, leading to the stagnation of medical science which would be bad for everybody. 4 See, for example, F. Gijford, "Randomized Trials and the Therapeutic Obligation"; Journal of Medicine and Philosophy 11 (1986): 361-3. This tacit contract can solve also the problem of using patients for pedagogical purposes in university hospitals or using cadavers for post mortem study to which some people object on religious grounds. As long as patients have the option to choose another hospital, in which these practices do not take place, such tacit contracts may seem justified by the principle of fairness.

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Furthermore, the rationality of such a system consists in its impartiality. In a Rawlsian version of such a contract, no one would know in advance the chances of being closer to the giving or to the receiving end. The scheme seems to be fair in the sense that it contains the elements of a lottery in which people have equal chances overall. Healthy people are summoned to take part in control groups; ill people are called to take part in research done on the disease from which they are suffering; and no one knows in advance whether she will be healthy or ill. Thus, the artificially induced randomness of the selection of subjects in RCT complements the natural lottery which distinguishes between the ill and the healthy. Furthermore, the fact that modern experimentation is randomized makes the distribution of risks and benefits fair, since participants are not only given an equal chance to belong to either of the randomized groups, but there is absolutely no trace of favouritism or bias in the selection. No one is singled out for the experiment except for the group of the ill patients who are usually the scientifically eligible subjects, and even this apparent bias is compensated for by including healthy subjects in control groups. This approach may provide a way out of the dilemma of "equipoise" or what has been referred to as the "null hypothesis". If the two competing hypotheses to be tested in an experiment (e.g. alternative drugs or methods of surgery) are not equally supported by the existing evidence, how can the doctor justify using a randomized method in which half of his patients are going to get a treatment which is in his own opinion less than the optimal?5 One condition for making an experiment morally acceptable is that even though individual doctors may have a preference for one of the alternatives, others might have the opposite preference, or in other words there is no "standard" treatment or accepted practice.6 In such a case even from the point of view of the patient, the fact that she is consulting one doctor rather than another makes it a matter of "luck" that she gets one treatment rather than another. And if that is the case, the "luck" involved in taking part in a scientifically randomized protocol is no less rational than accepting the subjective preference of one's own doctor.

5 C. Fried, Medical Experimentation; Amsterdam: North HoUand, 1979; pp. 5Iff. Later in the book Fried argues that even in cases where a "professional equipoise" can be established, the patient should be given the right to choose between the two alternatives, which from the point of view of his subjective values might be of a significant difference (p. 153). 6 Κ. F. Schafner, "Ethical Problems in Clinical Trials"; Journal of Medicine and Philosophy 11 (1986): 310-11. Schafner rightly asks whether subjects would be willing to participate in experiments which are justified by the existence of a single doctor in a panel who sticks to that "arm" in the trial which is considered by all the other doctors as the relatively inferior one. Fred Gifford forcefully chaUenges the "community equipoise strategy" in his "Community-Equipoise and the Ethics of Randomized Clinical Trials"; Bioethics 9 (1995): 127-48. One of his principal arguments is that even if the existence of some experts who prefer treatment A to Β justifies the randomized trial, they might be convinced by the experiment itself that Β is superior long before the experiment proves it in the strictly statistical sense.

13*

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Of course such an approach is not always psychologically possible, since patients under stress expect their doctors to show professional confidence rather than appeal to ignorance of the relative merits of alternative treatments. They do not perceive the "incidental" aspect involved in their choice in consulting a particular doctor as they see it in the participation in a RCT. 7 Furthermore, a more substantive problem relates to the difficulty of drawing the borderline between standard effective treatment which should not be tested in the light of a poorly supported alternative and a controversial and risky procedure to which an alternative might prove worth testing. The difficulties in the rational choice approach to the justification of experimentation lead to the idea of a social contract based on the extra-rational notion of fairness. The idea in a nutshell is that being a beneficiary of past medical research, one is under an obligation to give "one's share" by taking part in further studies. The process of medical advance is understood as an ongoing enterprise which is necessarily based on cooperation. Cooperation is a framework for a social interaction in which gaining without contributing is considered unfair, taking a free ride.8 There is nothing irrational in taking advantage in such an unfair way, but it is nevertheless morally wrong. In Rawlsian terms, the obligation to take part in experimentation is derived not from the long-term overall expectation of a personal gain, but from the choice behind a "veil of ignorance" to establish a system of cooperation in which people will invest time, forgo comfort or even risk their health so as to guarantee a fairly distributed collective effort to promote public health. There are, however, theoretical problems in applying the contractarian justification to the issue of experimentation, which is an enterprise that crosses generations. The point is that standard systems of cooperation, that is contracts, refer to individuals existing roughly at the same time. In other words, contracts are based on the principle of mutuality ; or the mutual dependence of the parties to the contract. Cooperation is rational only between people who stand to lose from uncooperative behaviour. Now, much of medical experimentation is long-term, that is its benefits can be expected to be reaped only by people not yet born. Unlike military service, in which soldiers and those whose lives and property they defend exist simultaneously and where a fair division of labour can be devised, future generations are dependent on our present willingness to take part in medical experiments, but not vice versa. Thus, from the point of view of prudential rationality, we can lose nothing by benefiting from thefruits of past medical progress without giving anything of our own to later generations. And from the point of view of fairness, it is logically hard to describe us as owing anything to anyone: our ancestors who did us good by taking part in experiments could be the object of our duty of mutual bene7

Thus, Arthur Schäfer contends that the subject is entitled to be informed of the fact that the experiment is randomized, even if there are no rationally significant differences between the two "arms" of the trial. His autonomy consists of making the choice even in cases of a scientific "tie". A. Schäfer, "The Ethics of Randomized Clinical Trial"; New England Journal of Medicine 12 (1982) 719-24.

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fit, but they are not araund anymore; and to those whom we are able to benefit, the next generation, we owe nothing, since they have not benefited us in any way. En­ forcing a vaccination program, even if individuals run a certain degree of risk, may be justified in contractarian terms of fairness in a way which does not apply to the apparently similar case of experimentation. We are thus left with an extended notion of a trans-generational contract, which at least metaphorically tries to view humanity in its history as a community. John Rawls's analogy to families and family lines is an attempt to make this historically defined community more intuitive. But unlike our commitment to our own chil­ dren and grandchildren, even in circumstances in which the condition of mutuality is not satisfied, we have no analogaus motivation to take part in experiments whose beneficiaries are by definition completely unknown to us. In any case, de­ scribing our refusal to give our share to medical research may be described as "un­ fair'' only if we are entitled to assume that our ancestors' condition for benefiting us was that we do the same for our descendants. This is usually not the case and hence hardly a reason grounded in justice that warrants risking our health for the 9 sake of future people. But of course there are experiments which yield more immediate results and from which present people may benefit. Do these fall into the framework of a so­ cial contract? Almost all ethicists believe that experimentation is not analogaus to military service or to taxation, that is to systems of fair distribution of burdens from which the whole community benefits. Experiments are more risky and inva­ sive of our privacy than paying taxes and their goal is less existentially urgent than that of military defense; it seems therefore that no social contract can justify enfor­ cing participation in them as in the two other cases. But this distinction between the two kinds of contribution to the public good may change in the future, particu­ larly since medical experiments are becoming so crucial for the progress of medi­ cine and the promotion of public health.

s

10

There was in the not-too-distant past a widespread use of the principle of fairness as jus­

tifying the conscription of prisoners in times of war to medical research. The idea was that prisoners can be expected to contribute to the war effort just as soldiers

are

drafted to fight on

the front. For a survey of a variety of such abuses see P. M. McNeill, The Ethics and Politics of Human Experimentation; Cambridge: Cambridge University Press, 1993; eh. l. Despite the repugnancy of the appeal to these. applications of the social contract to force prisoners to "volunteer" to participate in medical experiments, the theoretical distinction between con­ scription to risky military service and the recruitment of subjects to experimentation is not easy to draw. One might hypothesize that in cases of medical emergency and a threat to the survival of society, medical experiments might be "forced" on people (as long as the burden is distributed fairly and the goal of the experiment promises to be of a vital value). 9

For a detailed discussion of the limitations of contract theory in inter-generational con­

texts, see D. Heyd, Genethics: Morallssues in the Creation of People; Berkeley: University ofCalifornia Press, 1992; pp. 41-51. 10 A notable exception to the almost universal agreement on the ethical difference between military service and medical experimentation is Guido Calabresi, who both in bis work on

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However, there is one general principle of fairness which cannot be doubted: the wider the group of potential beneficiaries of the experiment, the more difficult it is to justify the expectation to take part in it in terms of fairness. Thus, the narrowest group is the individual himself: when I stand to benefit directly from an experimental procedure, the expectation that I take part in it is fair. The next group is that of people suffering from the syndrome studied by the investigator. Beyond their medical eligibility, it is accordingly fair to recruit people suffering from migraine to test a new drug for headaches, since they stand to benefit from the new discovery more than other people. Finally, we may consider all contemporary people, who stand a chance to gain something from new medication for diseases which one day they might contract. Here the mutuality condition is satisfied only in a very remote and abstract way, and hence society tends not to impose a duty to take part in experimentation. As for future people, by definition, they can only be beneficiaries but not participants in present medical research, and hence our relations with them cannot be a matter of justice at all.

ΠΙ. Virtue and Solidarity We have so far shown the serious difficulties in justifying experimentation in terms of either rational choice or of duties of justice. This does not mean that there is no way to justify compelling people to take part in medical research on the basis of the overall good or utility which could arise. But recall that we are restricting our discussion to the point of view of the individual and her reasons, putting aside the otherwise legitimate perspective of the policy-maker or legislator. It should again be emphasized that typically liberal principles (such as the right of an individual over his body and privacy) call for special protection of individuals from the otherwise legitimate concern for the promotion of public good and health. The almost sanctimonious condition of informed consent in the recruitment of subjects for experiments typically indicates that primacy of the point of view of the individual over general utilitarian considerations. Such consent is never called for in the case of other serious invasions by the guardians , of the collective interest into the life of the individual, as in military conscription or the financing of public projects through taxation. Consent in the case of taxation and military conscription experimentation and on road accidents forcefully argues that the difference is only symbolic or psychologically valid. We do not risk the life of the individual patient in an experiment even if it could lead to saving the lives of many future "statistical" people, as we invest huge amounts of money to save the life of a single trapped miner but are reluctant to invest it in preventing future mine catastrophes. This cannot be justified in terms of cost-benefit analysis or even in those of fairness, but the salience of the identified individual and the symbolic commitment of society to the value of life make us act in a way which diverges from that by which we distribute the costs of accidents. G. Calabresi, "Reflections on Medical Experimentation in Humans"; in: R A. Freund, ed: Experimentation with Human Subjects; London: George Allen and Unwin, 1972; pp. 178-84.

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is given in the indirect, collective way of the democratic process. Participation in medical experiments, however, cannot be enforced through majority vote. What reason, then, does an individual have to enter a medical experiment? To help us move to the third stage of the analysis, consider as an analogy the traditional system of blood donation: the entire medical demand for blood being supplied by voluntary donations from individuals who with no incentive (such as money or a family insurance for blood) come every year to the blood bank to contribute that fluid which is precious for the recipient but almost costless to the donor. Their act is highly valuable though typically non-obligatory. It is what is referred to in ethical theory as an act of supererogation. n Most societies today have been forced to abandon this voluntary system in favour of a more commercialized alternative, since the demand for blood has drastically grown and the extent of pure altruism proportionally diminished. But it is widely agreed that the traditional system was superior both in medical and ethical terms. Now, taking part in a medical experiment is obviously a different case. It involves a much higher risk to the subject and a much lower certainty of benefit to the (unidentifiable) recipient. But it shares with blood donation the altruistic motive, free giving with no expectation of return, an unenforced contribution to the welfare of others. The particular value of volunteering to subject oneself to a medical trial lies in its being completely beyond the call of duty, that is beyond the legitimate moral requirements of justice and fairness. Volunteering is optional not only from the legal point of view, but equally from the moral perspective. This implies that medical researchers cannot blame or morally criticize individuals for refusing to take part in experimental procedures. The answer to the question why take part in a medical experiment is simply "Good Samaritanism", in the original New Testament sense of the term, that is to say, an act which is neither legally enforced, nor morally required. Among supererogatory actions, there are those motivated by a particular concern for a particular individual or a group of individuals. This category includes the act of a soldier who volunteers to sacrifice his life in order to save those of his friends or a ruler's act of pardoning a criminal. But there are supererogatory actions which are partly or completely anonymous, that is there is no personal relationship between the donor and the donee, who remain "unidentified" to each other. Maimonides ranks anonymous acts of charity, in which the donor does not know the recipient and the recipient does not know the donor, as the· highest in the "scale of charity". Similarly we can say that both blood donation and participation in medical experiments are supererogatory acts of the purest kind, since they are not motivated by any personal or class interest. 11 For a systematic analysis and justification of supererogatory conduct, see D. Heyd, Supererogation: Its Status in Ethical Theory; Cambridge: Cambridge University Press, 1983. For the role of supererogation in medical ethics, see D. Heyd, "Obligation and Supererogation" in the new edition of Encyclopedia of Bioethics (forthcoming, 1996).

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What then is the motive behind these acts of supreme charity? One possible an­ swer is solidarity. By taking part in an ongoing enterprise such as medical progress, people express their solidarity with their society or indeed with humanity at large. Another possible altruistic motive is identification with the medical profession. In­ dividuals who are not themselves scientists but subscribe to the general ideal of scientific advance, can partake in the process of the growth of knowledge by being 12 part of the experimental adventure. This may explain why members of the medi­ cal profession, as well as students of the discipline, are natural candidates for volunteering in experiments. Some patients, despite the fact that they happen not to be potential beneficiaries of

an

experiment, may develop a personal interest in

the long-term progress of medical science. In bis classical article on the ethics of experimentation on human subjects, Hans

Jonas proposes a view which is close to the supererogatory model of free giving, though still containing some elements of a moral requirement. 13 Jonas seems to argue that there is no justification for placing anyone under a duty to take part in an experiment, since no advancement of inedical knowledge (unless it is vital for saving the life of the whole society in emergency situations such as plagues) justi­ 14 fi.es putting at risk the life and health of individuals; on the other band, he is aware of the high value of such progress, and of the special duty it imposes primar­ 15 He is thus led to treat the call to take part in

ily on the community of researchers.

experimentation as noblesse oblige, a particular "duty" derived from the privileged status of a certain class in society. Its basis is typically religious, and Jonas expli­ citly identifies the realm beyond the call of duty as that of the holy. This is a typically elitist approach, which on the one band tends to impose a qua­ si-moral duty on a small number of "interested" parties, yet not only exempts all 12 L Kopelrnan, "Consent and Randomized Clinical Trials: Are There Moral or Design Problems?"; Journal ofMedicine and Phi losop h y 8 (1983): 327-8. 13 H. Jonas, "Philosophical Reflections on Experimenting with Human Subjects ; in: P. A. Freund, ed: Experimentalion with Human Subjects; London: George Allen and Unwin, 1972; pp. 17-19. "

14

There seems to be a basic conceptual inconsistency in Jonas' generat distinction be­

tween duties of preservation and duties of melioration (p. 14).Jonas believes that we ought to transmit to the next generation(s) what we received from the previous one(s), but that we do not have any duty to improve on OUT (scientific or technological) heritage. But this seems to be an inconsistent, half-way solution to the problern of inter-generational justice. If future people are not parties to the "social contract" we do not owe them anything whats oever, even not preserving what we have; whereas if they have a moral status and should be counted in OUT moral reasoning, why are they not entitled to some "meliorative" acts as are OUT contem­

poraries? In other words, considering futUTe generations as beyond the pale of justice-rela­ tions means that any contribution on OUT part (including conservation) for their sake is super­

erogatory.

1s For a critical reading of Jonas' article, see A. Schafer; "Experimentation with Human Subjects: A Criti q ue of the Views of Hans Jonas"; Journal of Medical Ethics 9 (1983): 76-9. Schafer shows how Jonas is gradually led to abandon bis initially absolutist prohibition on experimentation to a more concessionary principle of a "descending order of permissibility".

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others from the duty to participate, but even excludes them altogether from the op­ portunity to volunteer, on the grounds of the risk of being exploited or of having the wrong kind of motivation. The ignorant, the poor, the siele. and the young are all "captive" groups, which usually should not be petmitted to take part in the

otherwise noble enterprise of the advancement of knowledge and the contribution to the health of future people. This is a highly restrictive view of autonomy, in which only the idealistically motivated reasons are allowed to play a role in human choice. However, the purely supererogatory approach to experimentation and that based on the "duties of the chosen few" share the view that through voluntary partici­ pation in this worthy but risky enterprise individuals express their virtue, their par­ ticularly noble traits of character, their solidarity with humanity at large. One sig­ nificant implication of such a view is that it lays a particularly heavy responsibility on the scientist and researcher: it is based on trust. Relations founded on super­ erogatory volunteering are less controlled by rules and conditions than relations based on commercial interests or principles of distributive justice. In medical ex­ perimentation the subject has virtually no way to know when she is exploited, and she is dependent on the protection of the ethical committees that assess the validity of the experiment. Worse, the committees themselves are dependent to a large extent on the conscientiousness of the experimenters who are expected to apply the conditions of the experiment faithfully. A violation of the trust of the volunteer is destructive of the likelihood of the future cooperation of well-motivated sub­ jects. Replacing the expression "experimentation

on

human subjects" with the idea of

"experimentation with human subjects" is the epitome of the supererogatory mod­ el of the justification of medical research. 16 lt treats research as a cooperative en­ terprise in which the role of the subject undergoing the experiment is no less active than that of the experimenter, despite the unbridgeable gap in skill and expertise. 1t forms certain bonds of partnership between the two parties. This implies primarily that the group of scientists should be the first to volunteer (whenever possible) to undergo the experiment, thus serving both as role models and as personal guaran­ tors for the patients' trustP But, contrary to Jonas, it seems that within a demo­ cratic idea of human autonomy, there is no justification to restriet volunteering to the "elite", and that the very opportunity for all members of society to take part in a voluntary venture expresses the equal respect which a liberal society wishes to accord to everyone in it.18 16 I am borrowing this linguistic shift fromM. Mead, "Research with Human Beings"; in: P. A. Freund, ed: Experimentation with Human ,Subjects; London: George Allen and Unwin 1972; pp. 152-77. Mead emphasizes the active participation based on altruism, social com­ ,

mitment, and intellectual curiosity. 17 B. W. Cromiel P. L Freedman, "Medical and Ethica1 Decisions in the Pharmaceutical Industry"; in: G. R. Dunstan/E. A. Shinebourne, eds: Doctors' Decisions: Ethical Conflicts in Medical Practice; Oxford: Oxford University Press, 1989; p. 172.

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The supererogatory analysis of experimentation also means that the doctor has special duties of care and compensation to participants in experiments. Although, by definition, subjects cannot always expect to benefit from the experiment, they are entitled at least to be informed of the results of the research and be given ap­ propriate credit for it. Supererogatory behaviour, more than the fulfilment of a moral duty, calls for gratitude. But unfortunately scientists who stand to benefit from the voluntary exposure of patients to medical trials often neglect to fulfil this duty.

Conclusion The ethical basis of experimentation on human subjects has been examined in this article under three alternative models: rational choice (prudence), justice and faimess (social contract) and supererogatory giving (charity). The first proved to be deficient in its narrow applicability, that is to say, only part of medical experi­ mentation can be treated as serving, even in an indirect way, the interests of the subject. The second tumed out to be lacking in its applicability to inter-genera­ tional relations, that is in the theoretical problern of treating past and future people as partners to a social contract. The third model seems to be superior to its two alternatives in its correspondence with our intuitions that usually no public good may justify forcing or even expecting individuals to risk their health and bodily integrity. But its shortcoming was shown to lie in the danger of social elitism and the exclusion of whole sectors in society who out of a sense of identification and solidarity wish to contribute to a valuable human enterprise. It seems, then, that different contexts give rise to different grounds for expecting people to subject themselves to medical research. There are cases in which self­ interest plays a dominant role; there are others in which

a reconstruction

of a hy­

pothetical contract might serve to justify a distribution of the burden of experimen­ tation for the good of everybody; there are, however, situations in which only an altruistic motive, a concem for unidentified future people or a wish to promote the abstract value of the advancement of knowledge, can account for the act of volun­ teering. But we remain with one main philosophical problern which is of a second-order epistemological kind: how do we know to which of these categories a particular experimental situation belongs. This is not a simple empi,rical problem. It is a con­ ceptual difficulty, since we have a chance of knowing the answer only after the •s Fethe points out that for Jonas infonned consent means commitment rather than just un­ coerced agreement. But identification with the goals of the experiment are not, according to Fethe, a guarantee of the authenticity of the consent, and we may want to protect individuals not only from what Jonas treats as illegitimate se1f-interested temptations but also from over­ enthusiastic "identifications". C. Fethe, "Beyond Vo1untary Consent: Hans Jonas on the Moral Requirements of Human Experimentation"; Journal of Medical Ethics 19 (1993): 99103.

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experiment has taken place and yielded results. The prudential benefit of a research project can be only assessed post hoc, as can its benefits to contemporary people who live under the conditions of mutuality. This problem adds to the superiority of the last, supererogatory model. But as with blood donation, the model of charity, despite its clear moral attraction, is highly precarious: it works only if enough people are moved to volunteer of their own accord.19 Once the voluntary system is eroded, society has no alternative but to resort to undesirable economic incentives or even to partly coercive measures, lest medical progress stop altogether. But while in cases like blood supply (or care for the poor) commercialization involves "only" the abandonment of noble moral ideals, subjecting medical experimentation (like the supply of live organs) to the forces of the market may directly lead to the violation of the most basic humanrightsand dignity.

Zusammenfassung Der Beitrag untersucht die Frage, ob und wie medizinische Versuche an Menschen aus der Sicht des einzelnen Teilnehmers gerechtfertigt werden können. Die Diskussion dieser Frage wird auf drei Ebenen geführt, die sich in einem Stufenverhältnis darstellen lassen, I. der Ebene der Zweckrationalität: Gibt es gute Gründe, und zwar durchaus des individuellen Eigennutzes, sich selbst für medizinische Versuche zur Verfügung zu stellen? Π. der Ebene der Gerechtigkeit: Besteht eine Pflicht oder eine Verbindlichkeit zur Teilnahme an medizinischer Forschung? ΙΠ. der Ebene der Tugend: Soll man zu dem auf lange Sicht angelegten Versuch beitragen, das medizinische Wissen und die Gesundheit der Menschen insgesamt zu fördern? Es wird gezeigt, daß das Argument der Zweckrationalität für eine mögliche Rechtfertigung nur von begrenzter Bedeutung ist. Denn viele Experimente dienen den Interessen des unmittelbaren Teilnehmers nachweislich in keiner Weise. Das Argument der Gerechtigkeit hat zwar eine etwas größere Kraft, weil Gerechtigkeit auf der Idee eines Gesellschaftsvertrags beruht, die über den Horizont individueller Klugheit hinausreicht. Da aber viele medizinische Experimente nur die Gesundheit zukünftiger Generationenfördern, ist die Bedingung der Gegenseitigkeit, die eine der Grundlagen des Gesellschaftsvertrags bildet, nicht erfüllt. Der dritte und letzte R. M. Titmuss, The Gift Relationship; Harmondsworth: Penguin, 1973; ch. 12. Titmuss shows the superiority of the voluntary system over the market system in terms of efficiency and costs; but we are no less interested in the ethical advantages of the voluntary model in both experimentation and blood donation. See also, R A. Freund, "Legal Frameworks for Human Experimentation"; in: P. A. Freund, ed: Experimentation with Human Subjects; London: George Allen and Unwin, 1972; pp. 107ff.

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Grund für eine Teilnahme an medizinischer Forschung steht deshalb in enger Verbindung mit dem freiwilligen supererogatorischen Verhalten von Leuten, die durch den Wunsch motiviert sind, ohne Aussicht auf Gegenleistung zu einer höchst wertvollen Unternehmung etwas beizutragen. Die drei Arten von Gründen ergänzen sich mehr, als daß sie sich ausschließen. Ein mögliches Scheitern aller dieser Gründe könnte zu einer unerwünschten Kommerzialisierung der Teilnahme an medizinischen Experimenten führen.

Should We Take Part in Medical Research? A Commentary on David Heyd's Experimentation on Trial" Jan C Joerden L In his detailed and interesting paper, Professor David Heyd has dealt thoroughly with the ethical problems of medical research. I can therefore limit my commentary to a few additional remarks and shall closely follow Professor Heyd's suggested structuring of the issues. Thus I shall deal firstly with the question of whether a patient should consent to taking part in medical experimentation or, in Kantian terminology, examine the question Kof whether there is a hypothetical imperative to do so (Π). Next, I shall discuss whether there is a categorical imperative indicating that a patient should participate in medical experimentation. In a certain deviation from the structure of Professor Heyd's paper I shall also pose the question of whether there is a categorical imperative which would forbid a person from taking part in medical experimentation (ΠΙ). Finally, I shall be concerned with the question of how far participation in medical experimentation can be regarded as supererogatory (IV).

Π.

1. Firstly, let us consider the rational selfishly acting potential patient. A patient will ask himself when faced with an experiment on a new medication, which advantages, disadvantages andrisksthe medication could bring him. These questions can only be answered by assessing probabilities, which naturally will affect the decision. The patient is dependent here on the information the doctor gives him, and thus he has to trust the doctor to be able to make any decision at all. The basic problem here is no different to making other decisions in whichrisksare involved where one - for instance as an airline passenger - entrusts oneself to another person. The situation is fundamentally different, however, for so-called "blind" or even "double-blind clinical trials". With blind trials the patient does not know exactly whether he is undergoing a medical experiment at all or simply receiving a placebo

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as part of a so-called control-group. He is part of the experiment because the testing of new medication requires the participation of a control-group to test effectiveness, but the patient himself is not provided with the new medication. With the "double-blind trial", in which even the doctor does not know ex-ante which patients belong to the placebo-group, there is of course a (usually 50%) chance of belonging to the group receiving the medication. One could therefore say that, at least in relation to this 50% chance, it would be rational to take part in the experiment. However, one must concede that from a purely selfish perspective it would be more rational to insist on belonging to the group receiving medication, because only in this way will treatment of the illness take place. One could argue that the medication could turn out to be harmful and thus it would be more rational to preserve the 50% chance of escaping the (potentially) harmful medication. This objection, however, is not valid. For, should the medication really be harmful then it would not be rational to expose oneself to it at all. He who thinks rationally would therefore - according to how promising he judges the medication - decide either for or against taking it and not gamble by including the possibility of taking a placebo. This would be just as rational or irrational as placing £100 on the colour red in a game of roulette. Leaving the zero aside, there is a 50% probability of winning alongside a 50% probability of losing the money. For a gambler it may seem quite rational to enter into such a risk because this is the only way he can make any profit at all according to the motto "nothing ventured, nothing gained". For the cautious it seems rational not to bet at all in order to avoid the risk of losing money, at least when the chances are 50:50. If, however, the chances of winning change in such a way - which is what the patient undergoing a medical experiment hopes for and counts on - so that, staying with my example, the colour red has better chances than black, then it would only be rational to place on red. On the other hand, it would not be rational to expose oneself to a type of game in which one does not know whether one is placing on red or not. In this regard, Professor Heyd questions whether it could be rational on a second level (similar to the situation in the Prisoner's Dilemma) - at least when one needs the potentially effective medication oneself - to take part in such experiments from the point of view that effectiveness tests are necessary in order to discover whether the medication is suitable. Here the situation is different to that of the Prisoner's Dilemma, where on the basis of a definite payment-matrix it is clear for all participants in which cases there will be a loss and in which a gain, for it is exactly this information which is lacking in the situation of medical research. At best negative effects of the medication can be ruled out in certain constellations, although this may typically not be the case. Even then the outcome of the experiment is uncertain. Which, in this light, means that it can only be judged to be rational if one takes the medication, but not if one participates in an experiment not knowing whether one is receiving the medication or a placebo. Again the situation is similar to the already mentioned game of roulette. At best it can be said that it is rational to take part in medical experimentation so that medical research at least takes

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place, and thus new effective medication is discovered. It appears to me that Professor Heyd argues in this direction. However, in contrast to the situation of the Prisoner's Dilemma, medical research takes place anyway, even when the concrete individual does not participate. This is because there will always be ill people who participate in medical experiments in order to receive a medicine for their (already existing) illness. And when an effective medication is discovered everyone has the right to share its benefits, regardless of whether he took part in the experiment or not. And thus - in my opinion - even a second level of rationality does not deliver a convincing argument for the selfish person to take part in medical experimentation. 2. Apart from the already mentioned problems, I would further like to point out that it is often not at all easy to recognise which is the most rational choice in each individual case. To illustrate this point I shall make use of an example widely known under the name "goat problem"1. Imagine the following case: Hospitals A and Β decide to jointly test a new medication. For this purpose hospital A sets up test-group A and hospital Β test-groups Β ι and B 2 . The participants in this test, who must decide for one of the groups, know that only one group will receive the test medication (medication-group) whereas the other groups will receive placebos (placebo-groups). This is a blind experiment and so none of the participants are told which group will receive the test medication. After the hospitals have decided jointly - and due to organisational reasons definitely - which group is to receive the medication, hospital Β finds itself suddenly forced to cancel one of its groups due to financial restraints. It is decided that group B 2 will be disbanded. When making its decision hospital Β obviously must ensure that the group most indispensable to the test, i.e. the group receiving the medication, will not be the one cancelled. Patient P, who originally chose to join group A, is asked shortly before the tests are due to begin, if he would like to change to group Bi. The question is then, is it more rational for P, who would like to receive the test medication in his own interest and in the light of the above information, to stay in group A or to switch to group Bi? P's thoughts may be so: It is clear that the cancelled group B 2 was a placebogroup. Group Bi is therefore either the medication-group or the remaining placebo-group. The same applies to group A. The apparent conclusion may therefore be that Ρ neither increases nor decreases the chances of receiving the medication by switching groups because the chances of group A or group B! receiving the medication are each ρ = V 2 (in other words a chance of 1:1 or a fifty-fifty-chance). However, it is actually more rational - if we may believe probability theorists - to switch groups: With P's original choice of A, the probability of choosing the medication-group out of all three groups was ρ = V 3 (this is equivalent to a chance of 1:2). The probability of the opposite being the case, i.e. of not being in the medicai See further Gero von Randow, Das Ziegenproblem. Denken in Wahrscheinlichkeiten, Reinbek bei Hamburg: Rowohlt, 1993 (and the authorities cited therein).

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tion-group, was % (this is equivalent to a chance of 2:1). This probability of ρ = 2 / 3 that one of the original two groups of hospital Β was designated the medication-group concentrates itself after the cancellation of group B 2 solely on group Bj. This conclusion is to be drawn from the following considerations: (1) The probability of the medication-group being one of those groups at hospital Β is ρ = 2/3. (2) If the medication-group is one of the groups at hospital Β then it is clearly group B^ because - according to the later information - group B 2 was a placebo-group. Therefore the probability of Ρ receiving the medication by switching to group B! is ρ = 2 / 3 and is thus double so high as the chances of receiving the medication by staying in group A. With this example I do not wish to maintain that - if one participates at all in such a trial constellation - there is no rational way of choosing. Rather it should merely be made clear that even in simple choice situations it can be extremely difficult to make a relatively rational decision. Hence, it seems most rational not to bring oneself into a situation in which one does not know for what - and thus for whichrisks- one is deciding. As a consequence it would appear to me to be more rational to decide against taking part in blind experimentation because the possible gain of an open-experiment is always more probable. Whether it is rational to take part in an experiment where the patient knows at least that he will receive the medication depends on what return is to be expected: either curing the illness from which the patient himself suffers or other advantages granted for participation in the experiment. In this respect there is, however, no difference to other choice situations entailing risks. ΠΙ.

When dealing with the participation in medical experimentation based on moral-ethical grounds two different questions arise: (1) May one take part in medical experimentation if there is a danger to one's own health? and, (2) Must one - presupposing that one may - take part in medical experiments? If I understand correctly Professor Heyd dealt in depth only with the second question. 1. To pose the first question may seem unfounded at afirst glance, but I would like to deal with the point of view that the participation in such medical experimentation can have a seriously adverse effect on the patient's own interests. One can therefore ask, in relation to Kant's work Die Metaphysik der Sitten , whether the person who is prepared to take part in a medical experiment is not perhaps delivering himself to another as a mere means without being at the same time an end. Kant regarded such conduct as morally forbidden, as revealed by the following

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passage: "Do not make yourself a mere means for others but be at the same time an end for them."2 Against applying this passage to the problems of medical experimentation one could object that here we are dealing with nothing more than a service contract. The patient provides a service - namely participation in the experiment - and receives (perhaps) payment in return. Yet the typical service contract is different to the agreement to participate in medical experimentation. With a contract of service the service provider commits himself to provide a certain service which - at least in principle - is not designed to affect his health and physical existence; should this exceptionally be the case then such contracts of service raise doubts equivalent to those doubts surrounding medical experiments. By participating in the experiment the patient makes himself the object of another, namely the person conducting the experiment, and has - in contrast to usual contracts of service - no influence at all on the way in which the experiment is carried out. Or formulated differently: He simply allows something to happen to him and no longer has any active effect on the occurrence. Even though he may receive a payment, he has still sold himself and not just his labour. I would not like to venture to say that it is morally wrong to take part in any medical experimentation, but some misgivings may arise about the carrying out of such medical experiments from the consideration that one should not deliver oneself to others for experimentation purposes, to be used, as it were, as a guinea-pig. It is quite clear to me that such a point of view if strictly followed would lead to frictions with our usual evaluation of self-sacrificing conduct. Thus, we would regard that person as a hero, as the perpetrator of a supererogatory deed, who rescues the lives of others by sacrificing himself for experimentation purposes. However, the typical case thought of here would be a doctor who tests the medication on himself. And so in exactly this case the objection that someone makes himself merely an object of another does not apply. A final reflection on the already mentioned misgivings is that we would not accept operations inflicting severe harm on the patient within the framework of consensual medical experimentation. At least according to German criminal law there is a basic principle that consent to bodily injury is no longer a valid justification when the person giving consent would suffer serious bodily harm3. 2. If one presupposes that the answer to question (1), whether one may consent at all to medical experimentation is positive, then there remains question (2), whether there are moral-ethical arguments that a person must undergo medical experimentation. I will not go into this question in depth, because in my opinion Pro2 Immanuel Kant , Die Metaphysik der Sitten, Akad.-Ausg., Bd. VI, S. 236, cited from Mary Gregor's translation, Kant, The Metaphysics of Morals, Cambridge/New York: Cambridge University Press, 1991. 3 a . e.g. Karl Lackner, StGB, 20th ed., München: Verlag C.H. Beck, 1995, § 226a η. 10; RG DRiZ 1932, Nr. 444. 14 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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fessor Heyd has mentioned almost all the relevant points: Quite correctly he has emphasized the main problem here, whether there is some sort of generation contract which obliges us to take part in medical experiments so that future generations may profit from the fact that prior generations underwent medical experimentation, in the same way that we have profited from past generations undergoing medical experimentation. I agree with the view taken that there is no such moral or even legal obligation. The question of whether there is in general an obligation not to burden the future generation is problematic enough. An obligation to give up one's own interests to relieve others in future generations cannot, in my opinion, be justified even if past generations have done the same for us (not to mention the fact that they probably took part in medical experimentation out of their own interests and not in order to help us). This is no different to the case where A gives Β a present. It may be so that Β is obliged to be thankful to A but he is in no way under the duty to give C a present. There may be, with regard to living contemporaries, an exception to this principle in the form of a general duty to help those in danger; but then for different reasons and in a different way. For example when one can help someone ill by participating in a test to find an effective medication without putting one's own health at risk; another standard may also apply to family relationships where it is generally accepted that there is an increased duty to render aid.

IV· 1. If one therefore assumes that there is (at least usually) no duty to take part in medical experimentation then it seems that such participation constitutes a supererogatory act. However, one must keep in mind that participation when it is merely in one's own interests to do so is not supererogatory. He who therefore only participates in a medical experiment because he himself (and only he himself) hopes to gain from it does not act supererogatorily, at least not in the usual sense of the word. He may have done more than can be morally demanded of him, but the immanent altruism of a supererogatory act, which apparently is a necessary condition of such an act, is lacking. Before I move on to the actual meaning of supererogatory conduct I would like to draw attention to a problem related primarily to participation in medical experiments in one's own interest. This problem relates to the validity of the consent to participate in an experiment. Firstly, it is of course presumed that the patient was informed of the foreseeable risks when he consented to participating in the experimentation. In the absence of informed consent the medical experimentation may not take place under any circumstances. This follows from general principles of criminal law. Also the consent must not, of course, be given due to mistake if it is to be regarded as valid. The

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patient must know the type and extent of the experiment, and be informed of any possibly connectedrisks.If consent is not given free from mistake4 then the medical experiment may not take place. Apart from problems5 which are not so relevant for our discussion, these questions can be answered relatively clearly; more difficult is, however, the following constellation: A patient decides to participate in a medical experiment for the very reason that he himself is ill and hopes to be cured by the test medication. This case is especially problematic when at the same time the patient takes considerable healthrisks(side effects) in order to preserve at least the chance of being cured. It is questionable here whether the patient's consent to medical experimentation in the face of such plight can be seen as valid at all. Even in the, in some respects parallel, case where A points a pistol at Β and threatens to kill him if he does not give him money, one could hardly maintain that Β gave valid consent to the money transaction which he was prepared to make due to the threat6. One could therefore question whether a patient in danger of dying really gives valid consent to medical experimentation if he only does so in order to escape impending death. Thus there is only a superficial difference to the case of A and Β in that the doctor leading the experiment is not the one threatening the patient with death. Decisive is the question whether the patient agrees to participate in the experiment freely and thus validly. If I maintain that the answer to the question is "yes" then it is based on the following point: The plight in which the patient finds himself is not dependent on the will of another, it simply exists. So far as the patient is here still of sound mind (compos mentis) and declares that he is prepared to participate in the experimentation according to the doctor's aim of making him well again, then the consent is valid. It would be different if the doctor made the possible chance of being cured depend on the participation of the patient in an experiment not designed to heal him. The consent would be given here out of necessity which is solely dependent on the doctors will, because he could make treatment available without forcing the patient to take part in an experiment. It also seems to me to be the reason why the case - also addressed by Professor Heyd - appears so problematic to us in which a prisoner's consent to participation in medical experiments is "bought" by exemption from imprisonment. An objection to such a procedure is the completely unjustified linking of medical experi-

4

A problem here is, however, which mistakes are to be regarded as relevant. Certainly, when the person consenting does not know of the range or extent of his consent, the mistake is relevant and the consent is invalid. Mistakes concerning motive, such as when the person consenting is mistaken about the purpose of relinquishing his legally protected rights, are more problematic; see further Joerden , "Einwilligung und ihre Wirksamkeit bei doppeltem Zweckbezug", Rechtstheorie 22 (1991), p. 165 et seq. 5 See Joerden, op. cit fn. 4. 6 Cf. the interesting contrary position put forward by Jakobs , Strafrecht. Allgemeiner Teil, Berlin/New York: Walter de Gruyter, 2nd ed. 1991, 14/8, which cannot be dealt with here due to space limitations. 14*

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mentation to conditions of imprisonment, conditions which are dependent on the will of a third party and do not simply exist. 2. I would like to add only a few remarks to the considerations of Professor Heyd concerning the supererogatory level of medical experimentation: It seems to me that altruistic participation in medical experimentation is clearly supererogatory. A supererogatory act usually implies the obligation of the person favoured by this act to be thankful. In as far as a concrete person favoured by the act cannot be determined, then society must be regarded as favoured. And society can only really show its gratitude in two ways: by honours (medals,titlesetc.) or - more profane by money. Society is committed to one or the other. If the state offers money, which is probably more of an incentive to act these days, then one must ask whether the person who acts with the reward in mind is really still acting supererogatorily, for the altruistic element of his act is lacking. I think that merely the degree of supererogatorism is perhaps decreased, for it makes no difference to the fact that: The act was neither required nor forbidden but allowed and probably even not morally indifferent 7.

Zusammenfassung Der Beitrag setzt sich mit dem vorangehenden Artikel von David Heyd zum Thema der Zulässigkeit medizinischer Versuche am Menschen auseinander. Dabei wird u.a. der Frage nachgegangen, ob es aus rational-egoistischen Motiven heraus vernünftig sein kann, sich an sog. Doppelblind-Versuchen als Proband zu beteiligen; diese Frage wird im Ergebnis verneint. Ebenso wird eine gesellschaftliche Verpflichtung des Einzelnen zur Teilnahme an derartigen Versuchen diskutiert und im Ergebnis bestritten. Schließlich wird die These vertreten, daß nur auf dem Wege über die Inaussichtstellung einer entsprechenden Belohnung, die auch in einer bevorzugenden Behandlung desjenigen liegen kann, der sich einem medizinischen Versuch unterzieht, ein Anreiz zur Teilname an medizinischen Versuchen geschaffen werden darf.

7

I would like to thank Arno Baltes , Thomas Crofts , Peter Stanglow and the participants in the symposium in BeUagio for helpful criticism of earlier versions of this paper.

Patients' Right to Die in Dignity and the Role of Their Beloved People Raphael Cohen-Almagor

I. Introduction The aim of this paper1 is to ponder the intricate issue of theright to die in dignity by focusing attention on the role of the patient's beloved people. I first consider some of the arguments advanced by Ronald Dworkin. Specific attention is given to what Dworkin terms 'critical interests' and to the notion of dignity. My discussion intends to refute Dworkin's contentions that a life that comprises only thin pleasures is not worth living, and that a person's past priorities when competent should be held decisive in determining whether to treat him or her upon becoming incompetent. We should continue to appraise a person's best interests over time to determine whether he or she is revoking previous statements and priorities. I proceed by an examination of three American court cases. The first case, Saikewicz, concerns a patient who had no family or other beloved people. I observe that this fact had a significant bearing on the court's ruling not to provide him treatment. The second case, Spring , involves a patient whose family wanted to withhold treatment from him. I argue that we should be cautious of incidents in which the best interests of the patient's beloved people come at the expense of the best interests of the patient. Spring is an example of such a case. The third case, Gray , serves as an example whereby the best interests of the patient coincide with the best interests of her beloved people. I conclude by arguing that consideration has to be given to the question of whether the patient's beloved people demonstrate a unified position in regard to the destiny of the patient. I should note that I prefer to speak of the patient's beloved people (or close-ones) than to speak of the family. The term 'the patient's beloved people' refers to persons who are emotionally closely related to the patient in concern. This close relation does not necessarily mean that only those who have biological and marital attachments should give their consent and advice. The opin-

1 Several people have read previous drafts of this paper: Avner de-Shalit, Sam LehmanWilzig, Jack Pole, Isaiah Berlin, Geoffrey Marshall, David Heyd and Daniel Sinclair. I am most grateful to them for their advice and criticism. The paper was prepared for the Symposium on Biotechnological Challenges for Law and Ethics, Bellagio, Italy (August 1995) and was subsequently presented at the Centre de recherche en droit public, Universite de Montreal (September 1995). I thank the audiences of both forums for their contributions.

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ion of a person who lived with the patient for the past five years without formal ties will be much more germane than the opinion of the patient's sister who lived abroad and used to see the patient only once in a while. The opinion of a very close friend with whom the patient used to confide and consult is much more important than the opinion of his or her father who broke relations with the patient. Some further clarifications have to be made concerning the scope of the analysis and the terms 'respect' and 'concern', which are in the foci of the discussion. First, my point of reference is limited to liberal societies. Other societies do not place emphasis on the individual and may apply different rules and codes of behaviour from those which I take for granted as underlying liberal democracies, i.e., respect and concern for others and not harming others. I believe that there are some basic universal needs that all people wish to secure such as food, raiment and shelter. But we cannot speak of universal values that underlie all societies. Thus my concern is with liberal democracies which perceive human beings as ends and which respect autonomy and variety. Moreover, in a liberal society basic health is seen as one of the necessary conditions for the exercise of personal autonomy. Liberal societies acknowledge that individuals have a right to health care. The prevalent assumption is that this right generates an obligation or duty for the state to ensure that adequate health care is provided and that there should be equal access to whatever health-care resources are provided out of the public purse. The state has no obligation to provide a health-care system itself, but to ensure that such a system is provided. Basic health-care is now recognized as a 'public good' rather than a 'private good' that one is expected to buy for oneself. 2 As the Constitution of the World Health Organization put it: "The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition".3 The further clarification relates to the terms 'respect' and 'concern'. Respect for a person means conceiving of the other as an end rather than as a means to something. As Immanuel Kant explains, rational beings are called persons inasmuch as their nature alone indicates that they are ends in themselves, i.e., as something which is not to be used merely as a means. Hence a limit is imposed on all arbitrary use of such beings, which are recognized as objects of respect. Persons are, therefore, not merely subjective ends, whose existence as an effect of our actions has a value for us; but such beings are objective ends, i.e., exist as ends in themselves. 2 Max Charlesworth, Bioethics in a Liberal Society, Cambridge: Cambridge University Press, 1993, p. 108. For further discussion on the duties of the liberal state in maintaining the health of its citizens see Twyen A. Brennan, Just Doctoring, Berkeley: University of California Press, 1991, esp. chaps. 3,4, 8, 9. 3 Adopted by the International Health Conference held in New York from 19 June to 22 July 1946 and signed by the representatives of 61 States, in: The United Nations and Population: Major Resolutions and Instruments, New York: Dobbs Ferry, 1974, p. 204.

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Such an end, Kant maintains, "is one for which there can be substituted no other end to which such beings should serve merely as means, for otherwise nothing at all of absolute value would be found anywhere".4 According to Kant, to respect a person is to treat him or her as a human being, as an autonomous being who is acting upon recognition of the moral law. The assumption is that beings are moral and Kant's demand is that people act in accordance with the Categorical Imperative. The Categorical Imperative refers to the will itself, not to anything that may be achieved by the causality of the will. Morality, according to Kant, cannot be regarded as a set of rules which prescribe the means necessary to the achievement of a given end, whether the end be general happiness, human perfection, self-realization, or anything else. Moral rules must be obeyed without consideration of the consequences that will follow from doing or refrainingfrom doing something. Moral rules guide our actions and are observed as a precondition for compatibility with the actions of other people.5 Kant does not speak of the process of decision making. Unlike him, I wish to lay emphasis on the very process of reaching a decision. In this process we exercise our faculties, using concepts, categories, principles, norms and to some degree (whether we like it or cannot help it) our emotions. We construct and de-construct realities, converse and exchange ideas, listen to the advice of others and share our opinions with people we appreciate. At least on matters we conceive to be of importance we strive to reach the right decision. As long as people accept the two basic principles that underlie liberal society, respect for others and not harming others, we accord others respect when we respect their right to make decisions, because they are their decisions, regardless of our opinions of them. We simply assume that each person holds his or her own course of life as intrinsically valuable, at least for himself or herself, and in most cases we respect the individual's reasoning.6 We should give equal consideration to the interests of others and should grant equal respect to their life projects as long as these projects do not deliberately undermine the interests of others by interfering in a disrespectful manner. In this context, may I further refer to the writings of John Rawls and Ronald Dworkin. Rawls asserts that "the public culture of a democratic society" is committed to seeking forms of social cooperation that can be pursued on a basis of mutual 4 Immanuel Kant, Foundations of the Metaphysics of Morals, trans: Lewis White Beck, Indianapolis, Indiana: Bobbs-Merrill Educational Publishers, 1969, Second section, esp. pp. 52-53. 5 The postulate, "You ought never to tell lies" is an example of the Categorical Imperative. There is no way of evading the command or the moral requirement of practical reason which it expresses, for no end is mentioned and there is therefore no end which can be given up. For further discussion see J. Kemp, The Philosophy of Kant, Oxford: Oxford University Press, 1979, p. 58. 6 On some issues the liberal state adopts a paternal approach that overrides individual decision making. Thus, for instance, to protect our security the liberal state requires us to fasten seat-belts when we travel by car and to wear crash helmets whenriding motorcycles.

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respect between free and equal persons.7 And Ronald Dworkin regards the entire political morality as resting on the single fundamental background right of everyone to human dignity and to equal concern and respect.8 The notion of 'concern* signals the value of well-being: we ought to show equal concern for each individual's good, to acknowledge that human beings are not only rational creators but also emotional creatures. Treating people with concern means to treat them with empathy, to view people as human beings who may be furious and frustrated, who are capable of smiling and crying, of careful decision making and of impulsive reactions. By 'concern* is not meant anything so demanding as giving equal weight, utilitarian fashion, to the welfare of a stranger as a person does to the welfare of his or her own children.9 Instead, it is giving equal weight to a person's life and autonomy. Let me now proceed by introducing some of Ronald Dworkin's contentions. These contentions will serve as a spring-board for exploring the complexities involved in the debate on therightto die in dignity and more specifically on the role of the family and the patient's loved-ones in deciding the future of patients, especially of deformed and unconscious patients.

Π. Dworkin's Contentions In his most recent book, Life's Dominion, Dworkin contemplates a case where a person named Margo had executed a formal document directing that if she should develop Alzheimer's disease or any other life-threatening disease she should be killed as soon and as painlessly as possible. Dworkin asks whether autonomy requires that her wishes be respected now when she is ill even though she seems perfectly happy with her dog-eared mysteries, the single painting she repaints, and her peanut-butter and jelly-jam sandwiches. In such a case, an apparent contradiction seems to exist between past and present wishes, between past and present autonomy. Dworkin endorses respecting Margo's past wishes, arguing that a competent person making a living will providing for her treatment if she becomes demented is making the kind of judgment that autonomy, on the integrity view, most respects: a judgment about the overall shape of the kind of life she wants to have 7 John Rawls , "Liberty, Equality, and Law", in: Sterling M. McMurrin, ed: Tanner Lectures on Human Values, Cambridge, England: Cambridge University Press, 1987, pp. 1-87, sect. 3; "Justice as Fairness: Political not Metaphysical", 14 Philosophy & Public Affairs, No. 3 (1985), 223-251. 8 By backgroundrightsDworkin meansrightsthat provide a justification for political decisions by society in the abstract, without connecting them to any specific political institution. See R. M. Dworkin, Taking Rights Seriously, London: Duckworth, 1977, pp. 150-183, 266-278; "Liberalism", in: A Matter of Principle, Oxford: Clarendon Press, 1985, pp. 181204. 9 Cf. James Griffin, Well Being, Oxford: Clarendon Press, 1986, chap. IX.

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led. 10 This is a central point in Dworkin's argument and I will criticize it later on. But first I wish to introduce Dworkin's other themes. Dworkin explains that most of us think it is important to achieve something in our lives. We all have ambitions. We all want a decent life upon which we could look with pride and satisfaction. We have two kinds of interests: we want pleasure and enjoyment in virtue of desires and ambitions. We also want to live a worthwhile life. That is, we look at our lives as a kind of assignment, a mission. The first kind of interests is called experiential ; the second critical interests.11 In considering the Margo case, Dworkin implies that a life which does not include critical interests is a poor life, in terms of its quality. What we seek is not just any form of life but rather life in earnest. This reasoning brings Dworkin to conclude that a life that includes peanut-butter-and-jelly sandwiches and similar trivial things is not worth living. Eating these sandwiches cannot bring a person to consider his or her life as a kind of assignment, as a mission. Dworkin further emphasizes the notion of dignity. Dignity is the central aspect of the intrinsic importance of human life. 12 A person'srightto be treated with dignity is the right that others acknowledge his or her critical interests: that they recognize that he or she has a moral standing, and that it is intrinsically, objectively important how his or her life goes. Bearing this view in mind I ask you to consider the following issue. Most of us have a critical interest in having a family. This critical interest is connected to our convictions about the intrinsic value of our own lives. We are concerned with how people look at us. We all have an interest in the kind of memories that will survive after death. We do not want to be remembered as people who were dependent on others, unable to perform the simplest actions. Moreover, most of us care about our families and we would not like to cause them suffering. Sometimes patients are in agony not only because of the disease that causes them pain but also from the bare knowledge that their anguish torments their families. It is among the patient's interests to have the memories of his or her loved-ones filled predominantly with thoughts about his or her past vitality, rather than with his or her present condition. Thus, many are inclined to minimize the burden that their illness imposes on others. Dworkin writes that many people do not want to be remembered living in circumstances conceived by them as degrading. At least part of what people fear about dependence is its impact not on those responsible for their care but on their own dignity. Dworkin contends that some people are horrified that their death might express the idea which they detest as a perversion: that mere biological life - just hanging on - has independent value.13 10 Ronald Dworkin, Life's Dominion, New York: Knopf, 1993, pp. 226-233. 11 Dworkin (op.cit. fn. 10), pp. 201-213. 12 Dworkin (op.cit. fn. 10), p. 236. 13 Dworkin (op.cit. fn. 10), pp. 210, 212.

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Dworkin maintains that when we think of dignity, it is not just life in any form that is important. Anyone who believes in the sanctity of human life believes that once a human life has begun it matters, intrinsically, that that life goes well, that the investment it represents be realized rather than frustrated. 14 Dworkin's contention comes close to that of a recent British court's decision. In deciding the best interests of Post-Coma Unawareness (PCU) patients, the court counted among the relevant considerations the avoidance of invasive and undignified procedures, which would have an adverse effect upon the way the patients concerned would be remembered by their loved ones.15 I will reflect on Dworkin's contentions anon, but first let me say few words on PCU patients. The case of PCU patients is one of the difficult cases bioethics is being confronted with in this era. Current technology enables people to remain alive in circumstances that at least some of them earlier dreaded. Due to speedy evacuation of patients with brain injuries, well-equipped medical centres, early diagnosis by computerized tomography, advanced surgical methods, and finer intensive care and post-operative care, technology has increased the number of survivors following the acute phase of trauma, strokes or heart failures. Many of these survivors remain in a state of deep sleep. The term PCU is used in referring to these patients who are in the twilight zone between life and death. PCU patients suffer from a serious damage that is inflicted on their brain cerebrum. They are unconscious, unresponsive to external stimuli, but capable of independent spontaneous respiration and a regular heart beat. It is the combination of reflexive activity in the absence of sensation or conscious activity that characterizes the PCU situation. Injuries inflicted on the brain cerebrum are not the same as injuries inflicted on the brain stem. Current medicine declares as dead any person whose brain stem activity is absent. This is not the case when the brain cerebrum is damaged. The brain stem controls basic reflexes, including breathing, heart activity, the sleep/ awake cycle, reflexive activity in the upper and lower extremities, some swallowing motions and eye movements.16 The brain cerebrum controls sensations, volun14

Dworkin (op.cit. fn. 10), p. 215. »5 Cf. Airedale NHS v. Bland [1993] 1 AU ER 821, at 870.

16 Responses to confirmatory tests to examine whether the brain stem is injured include: fixed pupils with no response to light; corneal reflex absent; vestibulo-ocular reflexes absent; no motor responses elicited within the cranial nerve distribution; no gag reflex or response to bronchial stimulation by a suction catheter passed down the trachea; no respiratory movements when the patient is disconnected from the mechanical ventilator for long enough to ensure that the arterial C 0 2 rises above the threshold for stimulating respiration. Cf. E. McClatchey, "Some Aspects of Euthanasia from the Point of View of a Family Doctor", in: Amnon Carmi, ed: Euthanasia, Berlin: Springer-Verlag, 1984, pp. 103-109, at 106. See also Alan C. Hoffman, J.D./Mark X . VanCura, "The Brain Criteria", in: Andre de Vries/Amnon Carmi, eds: The Dying Human, Ramat-Gan: Turtledove, 1979, pp. 325-343, at 337-338; and Coordinating Council on Life-Sustaining Medical Treatment Decision Making by the Cour

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tary and conscious activities. Unlike patients whose brain stem is injured, PCU patients may show some progress in their situation and the possibility of awakening is present. I should further clarify that I prefer the term TCU' to the widely used term TVS' (Persistent Vegetative State). This is because the term 'vegetative' strikes me as dehumanizing the patients in concern. Dworkin has no qualms referring to some patients as vegetables.17 He assumes that harm is being done when a patient is living on as a vegetable.18 As I related earlier, in his criticism of the Cruzan ruling Dworkin asserts that if a person (Margo) has stated while in good health, and after careful deliberation, that she would not care to have her life extended if she becomes demented, able to enjoy only trivial things such as peanut-butter-and-jelly sandwiches, that declaration should be rendered as determinative and be respected even if, when the time comes, she seems to be happy enough andfinds some value in her demented state.19 Contrary to Dworkin's arguments, my contention is that a thin pleasure of the kind of peanut-butter and jelly-jam is worth having. Evidence shows that many people who reach the stage of permanent dementia and live non-autonomous life nevertheless cling to life and find pleasure in things that had no importance for them in the past. Their present order of priorities should win over past considerations. Dworkin seems to think that one's directives are predetermined and unchangeable, but this is not necessarily the case. We are not able to know how our lives will look when we are about to die. We are not able to say that values and priorities that are important to us now will be as important to us until the very last day. The notion of an unchangeable, unified personality is doubtful. People do change and these changes may become meaningful to us in circumstances that we cannot envisage. The very idea of autonomy reflects our ability and want to construct and reshape realities, to re-evaluate values and ideas, to renounce old beliefs and to accommodate ourselves to new situations. Dworkin assumes that people, as rational agents, may have certain attitudes regarding dementia and decide beforehand that some forms of life are repugnant, meaningless, not worth living. People try to assess how their situation might look in the future and decide on their destiny according to the data they have on the demented state. However, people are not only thinking creatures. Not all factors could be grasped by our rational faculties. Not all data could be digested by applying reason and judgment. Sometimes we do things we could not imagine doing. Sometimes people act in accordance with their sentiments, not brain. Sometimes people are pushed to do something by their instincts, their impulses, factors that they find difficult to explain in rational terms.

Guidelines for State Court Decision Making in Authorizing or Withholding Life-Sustaining Medical Treatment, Williamsburg, Virginia: The National Center for State Courts, 1991. » See, for instance, Dworkin (op.cit. fn. 10), at 180, 230-232. is Dworkin (op.cit. fn. 10), p. 232. 19 Dworkin (op.cit. fn. 10), chap. 8.

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On some occasions people are overpowered, overwhelmed by the reality they confront. They accommodate themselves to situations imposed on them. To conclude this critical point, the assessment process does not necessarily stop in the demented stage, as Dworkin would like to suggest. We should acknowledge that a person's priorities are not always fixed, and therefore we should not renounce the idea of having the ability to change them. People are not prophets. We can appraise possibilities upon evidence, data, experience, but we cannot know with absolute certainty that these assessments would prove to be true for us. Most people are willing to make a commitment which they think would last a lifetime, e.g., marriage, and many of these people prove to be wrong and at a later point in their lives ask for a divorce. One may try to imagine what he or she would feel in the future upon reaching a certain condition, but on many issues one's imagination does not suffice to fully comprehend the future new reality. A parallel example may be the thought of becoming a parent and actually being a parent. One may think that one understands what becoming a parent entails, what it involves. One may try to exercise one's cognitive capacities to put oneself in the position of a parent. But one would be able to really grasp the sense of obligation, of love and affection involved in becoming a parent only upon becoming a parent. This is because we are not merely thinking creators, but also passionate, emotional beings. We love and like to be loved, to give and to share, and these virtues could be appreciated only upon experiencing them. Applying cognitive faculties would be a good start to fathom what is involved in being a parent, but having experience is a different matter. The same reasoning holds for the thought of becoming demented to be distinguished from the actual suffering of dementia. In support I may add the words of two Israeli doctors, Dr. Nachman Wilensky, Director of Lichtenstaedter Hospital for chronic patients, and Dr. Zev Susak, General Director of Lowenstein Rehabilitation Centre, who contend that people have an impulse to cling to life which is stronger than any pain or suffering they are going through. We tend to emphasize the integrity of the body, autonomy, privacy and dignity. The question is whether these things are as important to the incompetent person as they are to the competent. In coming to decide the fate of incompetent patients such as those who are in PCU, consideration has to be given to whether the patient's condition is irreversible, whether a chance exists for rehabilitation of some constitutive, vital elements of human life, whether the patient expressed his or her desire to die upon reaching a certain state of living, and also whether we feel that the patient's current interests are similar to the interests he or she expressed in the past. These preconditions affirm values that liberals so much appreciate, i.e., autonomy and respect for others. Other relevant considerations include the opinions of physicians and of the patient's family and his or her beloved people. In the following section I wish to focus attention on one of the pertinent considerations that we should bear in mind when coming to decide the patient's destiny.

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I wish to consider the role of the patient's beloved people by contemplating relevant scenarios and examining exemplifying court decisions.

m . Best Interests of Whom? The Patient's Wants and his or her Beloved-ones' Commitments Reflect on the following instance. Sheila is gravely ill. She suffers from a progressive dementia and the attending physician is not able to provide her with treatment that may halt the progress of the disease. The physician is able only to relieve her pain. Sheila's condition continues to deteriorate and she is unable to perform the actions she had done in the past. In Dworkin's terminology, Sheila has reached a stage where she is incapable of actively advancing most of her critical interests. She is no longer able to pursue her career, to practice her religion the way she did in the past, and to maintain her friendship with most people she knows. Furthermore, Sheila's range of experiential interests becomes extremely limited. She is incapable of playing the guitar, walking, eating as she used to, or visiting the theatre. But Sheila has a family and she shows signs that her critical interest in having a family and enjoying its company is still present. Sheila feels the love of her family. She appreciates it and enjoys the constant company and support of her parents and her other close relatives. From time to time she expresses her feelings by a smile or a sound. Now, in the past Sheila has voiced a critical interest in not being sustained upon reaching such a stage in life. When competent, Sheila did not think that mere minimal communication with her family could constitute a worthwhile life. But her current behaviour gives members of her family (and other people who care about her) the impression that their company in itself makes Sheila's life worthwhile. Dworkin does not consider the possibility of a conflict between two critical interests, one indicated in the past, the other alluded to in the present. He may not see Sheila's present condition as a life which can be considered as an assignment, as a mission. Nevertheless, as far as people around Sheila can judge, she finds some value in her life. Should we respect Sheila's critical interest which was voiced in the past in not having her life sustained upon reaching such a condition, or should we respect the other critical interest which concerns Sheila's family and their mutual love? Which critical interest should have precedence over the other? Moreover, are the family's critical interests of any relevance? That is, in a case where physicians support discontinuation of life and the patient's close-ones object, are we to respect their critical interest in maintaining the patient's life? The described situation is not one in which the family makes Sheila feel that she constitutes a burden. The family does not exert social pressure on Sheila to die. The opposite is the case. If Sheila were to feel that she constituted a burden on her family and on other people she loves; if she were to feel that her family would rather see her dead, then Sheila might have decided to opt for dying. But if those

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who care for Sheila feel that her candle is still dripping; that, on balance, her life is still worth living, her pain is being controlled and her smiles reassure their support, then Sheila would have no social incentive to terminate her life before she feels her life were to become meaningless.20 Some explanatory words should be said regarding this sort of family's commitment. In the described scenario, members of Sheila's family practically live their lives around her bed. Obviously, their commitment places some restrictions on their variety of options for action. But they do not view these restrictions as impediments on their freedom or autonomy. Members of Sheila's family and others who care for her willingly accept sacrifices, thereby expressing themselves, their sense of giving, of sharing, of love and any other affective notion that is valuable for defining their world as autonomous agents. Many of us may have an interest in giving to others because the act of giving, and the recognition that we make others happy, contributes to our satisfaction, making us feel more humane, with a personality that has been bettered. Restricting ourselves in such cases does not go against our interests. Instead, it is conducive to promoting our position through the effort of contributing to others. We all have an interest in promoting egoistic motives, but for similar or other reasons we also have an interest in furthering altruistic notions. Thus we are willing to take on sacrifices and restraints. Comforting a severely ill patient does not necessarily have to be regarded as an imposition. Many would prefer this demanding sacrifice to the alternative. A caveat has to be made in this context. Not all families are like Sheila's family. Sometimes partisan motives (financial considerations, rivalries within the family, etc.) may influence the family's position. It is the task of social workers to verify that the family is, indeed, close to the patient. Physicians are preoccupied with other business and cannot spend time on inspecting the nature of relationships between the patient and his or her family. But physicians and social workers should not take for granted that the family truly cares for the patient in concern. Sometimes other people (friends, colleagues, past and present lovers) care more for the patient than the family. Someone has to verify that genuine interests are involved and, I submit, that person has to be the social worker assigned to the patient. I am not saying that the social worker should take detective courses or listen-in on confidential discussions. What I suggest is to have open and frank discussions with all those who claim to have close relationships with the patient. It is better to have these conversations than to leave the framework of relationships unexamined. Furthermore, even if we are convinced of the family's commitment to the patient we should not in all cases see the family's position as determinative. Sometimes 20

The factors of pain and suffering (physical, psychological and spiritual) are of crucial importance. If it became impossible to control Sheila's pain and suffering then she probably will not be able to enjoy the company and affection of her family as she does. Sheila's family, in turn, may come to the conclusion that, on balance, it is in Sheila's best interest to depart life.

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the family is incapable of rational decision-making. Sometimes the strain on the family is too severe for its members to cope. Evidence gathered in Israel shows that the closest ties are those between the patient and his or her parents. Thus whenever possible, it is preferable to ask for the opinion of not only the patient's spouse (when he or she has one), but also other members of the family, especially the parents. What I have in mind is a council of all those who step forward claiming to have close association with the patient, freely and openly discussing the future of their loved-one, bringing forward all considerations for and against the continuation of life. This gathering will take place after physicians have expressed the opinion that available medicine cannot cure the patient in concern, that his or her situation will deteriorate, and that no hope for recovery is present. Let me further consider the role of the patient's close-ones through a discussion of three American court cases. American law recognizes as valid an act of consent to treatment of an incompetent person given in a traditional manner by the family, next of kin, or a guardian.21 The President's Commission for the Study of Ethical Problems and Biomedical and Behavioral Research concluded in its resolutions that "the family is generally most concerned about the good of the patient"; that the family "will also usually be most knowledgeable about the patient's goals, preferences and values"; and that the family "deserves recognition as an important social unit that ought to be treated, within limits, as a responsible decision-maker in matters that intimately affect its members".22 The first case I examine, Saikewicz, involves a retarded patient who had no close-one to care for him. I argue that the absence of family and beloved people was of significance in deciding not to administer chemotherapy and let him die. In the second case, Spring, the family played a crucial role in convincing the court that the patient should not continue receiving dialysis treatments. Here I voice doubts as to whether that decision truly respected the best interest of the patient. This is a case where the best interests of the patient conflicted with the best interests of the family. The third case, Gray , serves as an example for what seems to be a positive role on the part of the family to let a patient die in dignity when no apparent contradiction exists between the patient's interests and the interests of her family.

21 Cf. John F. Kennedy Memorial Hospital Inc. v. Bludworth , 452 So 2d 921, (Fla 1984), at 926; In re Jobes, 108 NJ 394, 529 A 2d 434, (NJ 1987), at 444-447; In re LH.R. , 321 SE 2d 716, (Ga 1984), at 723. 22 The President's Commission for the Study of Ethical Problems and Biomedical and havioral Research, Deciding to Forego Life-Sustaining Treatment (1983), p. 28.

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IV. Court Cases L Saikewicz

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The Saikewicz case involves a sixty-seven-year-old patient who had been severely retarded since birth, whose I.Q. was of a ten-year-old and his mental age of approximately two years and eight months. He had never learned to talk and never had the capacity to form a view about his medical care. Mr. Saikewicz suffered from acute myeloblasts monocytic leukemia, for which chemotherapy was the only possible treatment. Despite the fact that most people in Mr. Saikewicz's position elect to suffer the side-effects of chemotherapy rather than to allow their leukemia to run its natural course, a guardian ad litem recommended withholding the treatment, and his recommendation was accepted by the Massachusetts Supreme Judicial Court. Justice Liacos, who delivered the opinion of the court, considered two factors in favour of administering chemotherapy: the fact that most people elect chemotherapy, and the chance of a longer life. These considerations were balanced against factors weighing against administration of chemotherapy. The court asserted that evidence that most people choose to accept the rigors of chemotherapy 44has no direct bearing on the likely choice that Joseph Saikewicz would have made" (at 430). The guardian ad litem explained that if Saikewicz were to be treated with toxic drugs he would be involuntarily immersed in a state of painful suffering, the reason for which he would never understand (at 430). In addition to these two factors, the certainty that treatment would cause immediate suffering and Saikewicz's inability to cooperate with the treatment, the court weighed four further factors against providing chemotherapy. These were: Saikewicz's age (persons over the age of sixty have more difficulty tolerating chemotherapy and the treatment is likely to be less successful than in younger patients); the probable side effects of treatment; the low chance of producing remission; and the doctors' opinion that a decision to allow the disease to run its natural course would not result in pain for the patient, and death would probably come without discomfort. The Saikewicz ruling is highly problematic. It is a case were paternalism was disguised as acting on the premise of the "autonomy principle". The court spoke of a "right of privacy" for incompetent individuals who cannot comprehend their situation and used the substituted-judgment doctrine to interfere with their privacy. The court recognized a general right in all persons to refuse medical treatment in appropriate circumstances without knowing, and without having the ability to know, what Mr. Saikewicz would have wanted. The court for its own reasons chose to stress this general right, ignoring the fact that most people choose to accept the rigors of chemotherapy, by saying that this "has no direct bearing on the likely 23 Superintendent of Belchertown v. Saikewicz , Mass. 370 N.E.2d 417 (1977).

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choice that Joseph Saikewicz would have made". The court contended that the recognition of that right to refuse medical treatment "must extend to the case of an incompetent, as well as competent, patient because the value of human dignity extends to both" (at 427). This has come to mean that the court should make that decision for incompetent wards because they themselves are unable to make rational decisions and decide their own fate. The court said that "the State must recognize the dignity and worth of such a person and afford to that person the same panoply of rightsand choices it recognizes in competent persons" (at 428). Yet many would regard the continuation of life rather than the discontinuation of life as better protecting the dignity of incompetent persons. The following statement encompasses many of the problems involved in the Saikewicz ruling. The court held that it believed the guardian ad litem should attempt "to ascertain the incompetent person's actual interests and preferences" and the decision should be that which "would be made by the incompetent person, if that person were competent, but taking into account the present and future incompetency of the individual as one of the factors which would necessarily enter into the decision-making process of the competent person" (at 431). It is very difficult to understand what the court meant by this mumbo jumbo formulation. Mr. Saikewicz was unable to express his preferences in the past. There is no plausible way to reconstruct his preferences from statements made at some earlier time, as there sometimes is for patients, as in the widely known cases of Quinlan and Cruzan. 24 How can the court "ascertain the incompetent person's actual interests and preferences"? Furthermore, what is the purpose of trying to assess which decision "woijld be made by the incompetent person, if that person were competent"? The court did not really believe in this exercise, for Justice Liacos maintained that we should also take into account "the present and future incompetency of the individual as one of the factors which would necessarily enter into the decision-making process of the competent person". Justice Liacos had to maintain this to rule as he did even though most patients in Mr. Saikewicz's situation will elect to go on with chemotherapy. The self-deception finds expression in the concluding remarks, "that the patient's right to privacy and self-determination is entitled to enforcement" (at 435). This comes to mean that Mr. Saikewicz is entitled not to receive chemotherapy, and to die. One crucial factor that is usually present in cases of the right to die in dignity that is totally absent from this case involves the family. Justice Liacos mentioned in his ruling the guardian ad litem. No word was said about Mr. Saikewicz's family, which brings us to the conclusion that he had no one who loved and cared for him. If Mr. Saikewicz had had a family and the family had requested chemotherapy treatment, the case would probably not have reached the court. The absence of 24 In re Quinlan 70 N.J. 10, 355 A.2d 647 (1976); Nancy Cruzan v. Robert Harmon 760 S.W.2d 408 (1988); Nancy Cruzan v. Director, Missouri Department of Health 497 U.S. 261 (1990), 110S. Ct. 2841. The Gray decision is another example to be discussed later on. 15 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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family decided, to a large extent, Mr. Saikewicz's fate. We can speculate that a caring family might have liked to enjoy Saikewicz's company for as long as possible and might have rejected the factors the court emphasized in deciding against treatment. Vulnerable, unwanted, abandoned, and may I say inconvenient classes of people may have to suffer the consequences of the Saikewicz ruling. 25 The family plays a crucial role in the two other cases which I would like to ponder. In the Spring case, the family decided to terminate hemodialysis treatments of the patient and the court concurred. I can understand the result, but the case raises doubts as to whether the role of the family should be considered most crucial. The further case, Gray v. Romeo, is, to my mind, a clear case, and I am using it to show when therightto die in dignity should be respected.

2. Spring

26

The case involved an incompetent person whose wife petitioned the court for an order that hemodialysis treatments, which were sustaining the life of the ward, be terminated. The court held that where it was established that 1) it would be the wish of the incompetent ward, if competent, to discontinue his or her dialysis treatments; 2) the ward's life was essentially behind him or her; 3) he or she was not a suitable candidate for a kidney transplant; 4) his or her remaining days were to be spent in an irreversible state of dementia; and 5) the physician treating the ward supported the yiew of the ward's family that further treatment was inappropriate, then the state's general interest in the preservation of life was not sufficient to warrant intervention in the treatment decision. Justice Armstrong, who delivered the opinion of the court, reviewed at a considerable length the relationships between Earl N. Spring, the patient, and his family (at 495,499). It was said that Mr. Spring was married to his wife Blanche for more than fifty-five years. Their son Robert had lived for more than fifteen years across the street from his parents' house and had visited them virtually every day during that time. Mrs. Spring and Robert Spring had been active participants in caring for the patient's needs since the onset of his precipitous physical and mental deterioration. The court was convinced that this was a case of a close-knit family unit, with 25

In her criticism of the Saikewicz decision Lynn D. Wardle writes that the "consent" of many incompetent individuals is nothing more than a shabby legal fiction, like the fiction of "separate but equal" which was adopted by the United States Supreme Court in Plessy v. Ferguson 163 U.S. 537 (1896) and which for decades was the justification for racial discrimination as officially accepted in the United States until its overruling nearly sixty years later in Brown v. Board of Education 347 U.S. 483, 495 (1954). Cf. Lynn D. Wardle , "Sanctioned Assisted Suicide: 'Separate But Equal* Treatment for the 'New Dlegitimates'", 3 Issues in Law and Medicine, No. 3 (Wmter 1987), 245-265, at 262. For further discussion see Ira Mark Ellman, "Can Others Exercise an Incapacitated Patient's Right to Die?", 20 The Hastings Center Report, No. 1 (January/February 1990), 47-50. 26 In the Matter of Spring, Mass.App. 399 N.E.2d 493 (1979).

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a long history of mutual love, concern and support. In a footnote (at 499) Justice Armstrong addressed the issue of financial considerations and said that such considerations were not involved because the dialysis treatments were paid for by social security. Justice Armstrong also emphasized the burden which Mr. Spring had imposed upon his family after he developed kidney failure. His wife and son had to transport him three times a week to a private kidney centre in another town for dialysis treatment (at 495, 496, 500). Those treatments last five hours each (at 495). Furthermore, Mr. Spring's physical deterioration was accompanied with mental disorientation. His behaviour at home became somewhat belligerent and destructive, and he could no longer care for himself. Mr. Spring was diagnosed as having "chronic organic brain syndrome". Later Mr. Spring's mental deterioration had progressed to the point where he was unable to recognize his wife and son. The crisis in the family had increased when Mrs. Spring suffered a stroke, temporarily losing her ability to speak. Robert Spring attributed the stroke to strain and exhaustion resulting from his father's behaviour and condition. After some six months, Mrs. Spring became well enough to be discharged from the hospital to her home. But she could no longer take care of her husband. She needed to devote all her energies to taking care of herself. At that time Mr. Spring was in a nursing home. His disruptive behaviour was controlled through heavy sedation. He had occasionally kicked nurses, resisted transportation for dialysis, and pulled the dialysis tubing from his body (at 496). Mrs. Spring and Robert Spring expressed the view that if Mr. Spring were competent to voice his opinion, he would wish to have dialysis discontinued, although that would result in his death. That view did not rest on any expression of such an intention by the patient (at 498). Nevertheless, the court accepted the view of the patient's family. The court held that in circumstances of a close-knit family unit "the decision of the family, particularly where that decision is in accord with the recommendation of the attending physician [as is the case here], is of particular importance, both as evidence of the decision the patient himself would make in the circumstances and, at a later stage of analysis, as a factor lending added weight to the patient's interest in privacy and personal dignity in the face of any countervailing State interests" (at 499). While in the Saikewicz case I argued that the absence of the family was one of the reasons why the court refused to order chemotherapy to sustain life, in this case it seems that the presence of the patient's family brought upon Mr. Spring the same result that was imposed on Mr. Saikewicz. However, while I strongly protest against the Saikewicz ruling and think the decision was* wrong, I cannot hold the same for Spring. 21 This case raises a vexatious moral dilemma. 27 If the conditions were to be different, a possible and preferable solution would be to relieve the Spring family from its responsibilities to Earl Spring by providing for him private nursing care. 15*

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While the result might seem to be disturbing, namely the outweighing of the countervailing State interest in the preservation of life, I can nevertheless understand it. In a sense the court had to balance the life of Mr. Spring against the life of Mrs. Spring. The situation as it developed had reached the point where one life went against the other, where one life came at the expense of the other. The court gave more consideration to the one who had a better chance to live a meaningful life. In this crude situation of a zero sum game, the court had to weigh all interests and reached the decision that the best alternative was to cease treatment for Mr. Spring. The court held: "When the treatments were initiated, it was hoped that they would restore the ward's ability to enjoy a relatively normal existence, subject of course to the burden of lengthy and uncomfortable treatments far from home three times a week, but otherwise permitting him the pleasure of life with his family in familiar and comfortable surroundings. Unfortunately, this hope did not and cannot materialize; he is, and must remain, institutionalized, heavily sedated to restrain his hostile impulses, uncooperative towards his arduous maintenance program, insensible of his family and his situation. There now obtains a very different set of circumstances from those in which the decision to undertake dialysis was made" (at 499-500). From the data as described by the court one can infer that the Spring family was, indeed, a close-knit family unit. One gets the impression that Mrs. Spring and Robert Spring loved Earl Spring. They found it terribly distressing to see the man they had shared their lives with for so many years fading away, failing to recognize them, acting brutally and becoming a different person. They could not cope with this situation. The appeal to the court was made also in order to keep their own sanity, their own lives. It seems that Mrs. Spring and Robert Spring sincerely thought that by withholding treatment from him they preserved his dignity. The question remains whether Mr. Spring himself would have preferred to die. I stress that Mr. Spring himself gave no indication, while competent, that he would rather die. From this case you may infer why I previously argued that even if we are convinced of the family's commitment to the patient, we should not see the family's position as obligatory in all cases. The family's role should be held as a prominent consideration, but we should take into account first and foremost the best interests of the patient. The family is not necessarily capable of rational decision making, and even if it is, its interests are not necessarily identical to the interest of the patient. Thus, against John Hardwig's contention that we should build our theory of medical ethics on the presumption of equality - the interests of patients and family members are morally to be weighed equally - my argument is that we should think in terms of hierarchy. 28 In some instances the patient's interests in the maintenance 28 Cf. John Hardwig, "What About the Family?", 20 The Hastings Center Report, No. 2 (March/April 1990), 5-10. For further discussion on the role of the family see Joseph Richman, "Sanctioned Assisting Suicide: Impact on Family Relations", 3 Issues in Law and

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of treatment and in a longer life may well be strong enough to outweigh the conflicting interests of other members of the family. Let me move on to discuss the third and last case which, to my mind, poses no difficulty and exhibits familial decision making on the right to die in dignity that has to be cherished and respected as the court, indeed, ruled.

3. Gray v. Romeo 29 This case involves Mrs. Marcia Gray who was diagnosed as a PCU patient. Her family, including her husband, her two children, her mother and her sister-in-law requested that her attending physician order that feeding be stopped and that Marcia Gray be permitted to die. Mrs. Gray's family was convinced that it would be her desire not to be sustained with artificial measures if her life were otherwise hopeless. The family relied on statements made by Mrs. Gray explicitly asking not to keep her alive by artificial means should she ever be in PCU. The court held that a person has a paramount right to control the disposition to be made of his or her body even if the decision results in that person's death. Marcia Gray's right to privacy encompasses the right to refuse life-sustaining medical treatment (at 586). The court was convinced by the evidence that Mrs. Gray, if competent, would refuse treatment. Her right to self-determination outweighed competing governmental interests that include the preservation of life, the prevention of suicide, the protection of innocent third parties, and the integrity of medical ethics. The court gave much emphasis to the role of the family. Justice Boyle, who delivered the opinion of the court, wrote that "the depth, quality, and reasoning of the family's prediction of Marcia Gray's intent is impressive. The family speaks with one voice and no apparent conflict of interest exists" (at 588). 30 This case, to my mind, raises no difficulties. It is an example of a family council, freely and openly discussing the future of a loved-one relative who exhibited no conscious, cognitive, sentient responses, bringing forward relevant considerations for and against the continuation of life. This consultation took place after physicians expressed the opinion that there was no reasonable likelihood of Marcia Gray's returning to a conscious state and that there was no chance of her recovery. So here we have a situation where 1) the patient's chances of recovery to a conscious state are "close to zero" (at 583); 2) the patient expressed her desire several Medicine, No. 1 (Summer 1987), 53-63, and Bruce Jennings , "Last Rights: Dying and the Limits of Self-Sovereignty", 2 In Depth, No. 3 (Fall 1992), 103-118. 29 Gray by Gray v. Romeo 697 F.Supp. 580 (D.R.I. 1988). 30 The court also addressed the question of whether nutrition and hydration supplied through a gastrostomy tube are a form of medical treatment that the ward may properly refuse. This issue, however, is beyond the scope of this essay and deserves separate analysis.

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times in the past not to be maintained upon reaching such a state; and 3) her family, which seems to be closely knit, with a history of mutual love, concern and support, exhibits a unified position that her dignity will be better served by letting her die. The court wasrightin honouring the family's request. One final thought on the role of the family is relevant. It insists on the idea of the patient's close-ones consilium. The immediate family and the patient's most beloved-ones should make the treatment decision, with all competent close members whose lives will be affected participating. In this regard the only case ever to appear until now before the Israeli Supreme Court comes to mind.31 The case involved a two-year-old baby, Yael Scheffer, who suffered from an incurable genetic disease commonly known as Tay-Sachs. Tay-Sachs causes neurological disorders and degeneration. Yael's mother appealed to the court, asking to terminate treatment other than that designated to relieve her suffering. Specifically, the appeal asked not to connect Yael to a respirator and not to provide her drugs through transfusion. Deputy President Menachem Elon, who delivered the judgment (Justices Jacob Meltz and H. Ariel concurred), rejected the appeal. Quoting the attending physician's testimonial, Justice Elon argued that Yael Scheffer did not suffer any pain. She was treated in a way that did not infringe upon her dignity. Yael was kept clean, did not suffer from pressure bruises, and on the whole she did not cry. Yael cried, like any other child, when she wanted to be fed or when she suffered, like any other child, from stomach-ache, constipation, ear-infection, and the like. Yael resembled a bright candle. Under these conditions, the sanctity of Yael's life should have been kept, and this was the only value that determined the Court's decision. Any interference that offended Yael's life was contradictory to the values of Israel as a Jewish democratic state (para 64). Justice Elon ended his very detailed ruling (150 pages long) by addressing the role of the family. The plea to refrain from treating Yael Scheffer was made only by the mother. The father did not join the petition, nor did he appear before the court. The mother explained this by saying that "he hates publicity". Justice Elon noted the fact that the father was the person who treated Yael each and every day, while the mother rarely visited her daughter in the hospital. The mother explained this by saying that she devoted her time to taking care of their other daughter, who was in a crisis. Justice Elon was not convinced that the father fully supported his wife's initiative. He said that in such matters concerning life and death, clear and explicit consent of both parents to the granting of such a petition is required (para 65). I concur in thinking that this consideration is crucial in estimating the role of the family. This is true for all cases and it is of crucial importance when the decision concerns the life of minors.

3i Civil Appeal 506/1988. Yael Scheffer, soning published in December 1993).

through Talila Scheffer

v. The State of Israel (rea

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V. Conclusions Let me sum up the considerations that we have to bear in mind in coming to decide on death with dignity. If the patient makes advance directives in the form of a living will, DNR order, a letter, etc. that he or she would wish to continue living, no matter what, then we should respect his or her wish.32 Therightto self-determination means that we should respect the patient's choice regardless of what he or she has chosen. To do otherwise would be to declare that thisright of self-determination is reserved only to cases where patients wish to cease or to withhold treatment. If the patient leaves advance directives that he or she would rather die upon reaching a certain situation, but upon reaching that situation the patient shows every sign that he or she wants to continue living, then we have to respect present autonomy, however marred the patient's autonomy might be. If we are uncertain about the patient's present wishes because, for instance, he or she is in PCU with limited communication capacities, and the attending physicians think that the situation is irreversible, then we should respect the advance directives and let the patient die. For persons who prepared advance directives asking to die upon reaching a certain situation death is not the worst situation one can be in when compared to being on the verge of death and then stabilized without hope of ever really getting better. The patients themselves may feel that their lives become transient and that the thought of death brings them more comfort than it alarms them. They feel that their dignity, their autonomy, their humanity is better served by letting them die. The patient's wish has to be respected. This is especially true if the patient has emphasized beforehand that his or her dignity cannot be separated from consideration of his or her beloved people. For some patients, the bare knowledge of the anguish their condition imposes on their families constitutes such a heavy burden on their conscience that they decide they would rather die and not be remembered in their weakness and impotence. If no advance directives are available, we should ask the advice of the patient's beloved people, who supposedly know the patient better than anyone else. If the patient's beloved people believe that a point exists in keeping the patient alive, then we should respect their decision. This is true even if the attending physicians seem to think that no point exists in keeping the patient alive. In the event that the patient's beloved people wish to withhold treatment and the attending physicians think that a hope still exists that the patient may recover, then we have to respect the physicians' decision. It is better, from the point of view of the patient's best interests, to err on the side of life. 32 I am well aware that some people will contest this assertion because of the costs involved in maintaining patients (especially PCU patients) alive. It is beyond the scope of this paper to discuss economic considerations. I intend to dedicate a separate essay to this complicated question. Here I only say that it is within the responsibility of the liberal state to care for its citizens and not desert them at the point when they need its support more than ever. A bond exists between the state and its citizens which does not expire on the verge of death.

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In the event that the patient's beloved people and the attending physicians believe that the patient's condition will only deteriorate and that that condition negates his or her dignity, the best interests of the patient may require allowing the patient die. I repeat, the best interests of the patient. Not the best interests of the family or his or her other close-ones, or the best interests of the physician (making room for another patient who has a better chance to enjoy life) or the hospital or the society at large. Zusammenfassung Gegenstand des Beitrags ist es, das schwierige Problem des Rechts, in Würde zu sterben, im Hinblick auf die Rolle der Personen zu überdenken, die dem Patienten nahestehen. Der Autor setzt sich zunächst kritisch mit einigen von Ronald Dworkin vorgetragenen Argumenten auseinander. Dann stellt er die relevanten Fallgestaltungen dar und untersucht drei Entscheidungen amerikanischer Gerichte: die Fälle Saikewicz , Spring und Gray. Der erste Fall, Saikewicz, betrifft einen Patienten ohne Familie oder andere ihm nahestehende Personen. Dieser Umstand hatte einen wesentlichen Einfluß auf die Entscheidung des Gerichts, von der Anordnung einer Behandlung des Patienten abzusehen. Im zweiten Fall, Spring, wünschte die Familie, daß der Patient nicht behandelt würde. Der Autor mahnt für alle die Fälle zur Vorsicht, bei denen die Umstände so beschaffen sind, daß das wohlverstandene Interesse der Angehörigen und das des Patienten kollidieren. Der Fall Spring ist ein Beispiel für eine solche Kollisionssituation. Der dritte Fall, Gray, dient als ein Beispiel, in dem sich das wohlverstandene Interesse des Patienten und das der ihm nahestehenden Personen decken. Zuletzt geht es um die Frage, ob die Angehörigen und andere dem Patienten nahestehende Personen in ihren Vorstellungen über das weitere Schicksal des Patienten übereinstimmen oder nicht. Die Frage verdient eine besondere Aufmerksamkeit.

Collaboration Between Psychiatrist and Patient: How Avoidable is Paternalism? Deborah Spitz Introduction Over the past thirty years in the United States, medicine has moved from a paternalistic view of patient care, in which doctors made decisions about how to treat patients and what to tell them, to a more collaborative process, in which doctor and patient work together to amass information, understand the meaning of historical material and diagnostic tests, and plan treatment strategies. Most recently, the doctor-patient relationship has had to accommodate a third party - the payor. What was once a dyadic and personal relationship is now dependent upon the bureaucracies of managed care, so that major decisions about history-taking, diagnostic evaluation and treatment are made not by doctor or patient or both but rather by thirdparty reviewers who decide what to allow based on cost.1 In psychiatry in particular, these changes have been profound. Advances in psychopharmacology have made possible the move into outpatient treatment and community residences of many patients who only a generation ago were consigned to lengthy or even life-long inpatient hospitalizations. With this enormous change has come the growth of the consumer movement in mental health, in which patients and families - often in league with psychiatric clinicians and sometimes in opposition to them - have joined together to advocate for funding, education and changes in legal status of those with psychiatric disorders. Patients with severe psychiatric disorders have become active participants in the treatment and management of their illnesses. With these advances have come complex dilemmas. All new psychopharmacologic agents, while powerful and potentially health-producing, have side effects which in some cases are severe enough to cause reasonable people to refuse treatment with those agents. De-institutionalization has placed a vulnerable population in often dangerous and even more vulnerable situations, in which individuals facing homelessness and lack of resources must be able to advocate for themselves to make the system of care function optimally. Conflicts between the patient's right ι Mark Siegler , "The Progression of Medicine - From Physician Paternalism to Patient Autonomy to Bureaucratic Parsimony", Archives of Internal Medicine 145 (1985), 713-715.

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to refuse treatment and society's interest in the safety of the patient and those around him or her have led to legal quandaries. Changes in mental health law designed to protect patients' rights have sometimes conflicted with more traditional interpretations of those laws. Finally, though patients most often can be true collaborators in treatment planning, at times they cannot be - they are dependent, sick, and vulnerable in their illnesses. And at those times, the psychiatrist must be able to move between the models of paternalism and collaboration, and must negotiate the political and economic complexities of managed care on behalf of the patient. In this paper I will address some of the issues of paternalism and collaboration as they pertain to the psychiatrist and the psychiatric patient. I will review the definition of paternalism as it might reasonably apply to the psychiatrist-patient relationship, and will attempt to define the problems that such a definition leaves unaddressed. In particular, I will question the tendency to consider autonomy and paternalism as dichotomous and mutually exclusive principles rather than as related points on a continuum. Especially relating to psychiatric problems, this issue is not peripheral but is at the core of treatment I will then examine aspects of a collaborative model of treatment, and will explore the limitations that such a model might entail. Finally, I will consider some proposals to support the collaborative model in furthering patient autonomy and patient care.

What is Paternalism? As a clinician, I have found traditional definitions of paternalism problematic. Either they are so extreme as to set up a straw man - that is, few reasonable physicians really believe or behave that way any more - or they are more theoretical than clinically informed. Certainly there is no general agreement in the literature over what we mean when we speak of paternalism, as can be seen in the variety of definitions that follow. Dworkin defines paternalism as the interference with a person's liberty of action, justified by reasons referring exclusively to the welfare, good, happiness, needs, interests or values of the person being coerced.2 An example in psychiatric care might be the forced hospitalization of a patient who is an imminent threat to himself, such as a suicidal patient in the midst of a clearly diagnosable and untreated episode of depression. Although there is an articulate minority of psychiatrists who would disagree with almost any limitations of a person's liberty, the majority of psychiatrists in the United States would support limitations of freedom when there is a clear threat to self or others as a result of a mental disorder. In the United States, legal grounds for involuntary hospitalization include dangerousness to self or others and, in many States, the inability to care for oneself as a result of a mental 2

Gerald Dworkin , "Paternalism", in: Richard Wasserstrom, ed: Morality and the Law, Belmont, Ca: Wadsworth, 1971,107-126.

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illness. However, Chodoff argues that there may be other clinically important reasons to hospitalize patients involuntarily, and that the legal requirement to justify abridgement of liberty only on the grounds of dangerousness does not adequately reflect those clinical realities.3 He points out that the need to demonstrate dangerousness can not only make psychiatrists into policemen enforcing preventive detention, but can also promote hypocrisy when, in order to effect what is viewed as a necessary commitment, dangerousness must be invented or exaggerated.4 It is possible to interfere with a person's liberty of action without coercion, or to be paternalistic without interfering with one's liberty of action.5 Buchanan expands the definition of paternalism to include cases involving deception: paternalism is the interference with a person's freedom of action or freedom of information, where the alleged justification of interfering or misinforming is that it is for the good of the person who is interfered with or misinformed. 6 This definition is in keeping with the practice, common among doctors in the United States more than a generation ago, of withholding information about serious illnesses or terminal diagnoses from patients. In an argument for what he calls "modernised paternalism", Weiss argues that this does not happen any more.7 He contrasts a survey of oncologists in 1961, when the vast majority of physicians withheld diagnostic information from cancer patients because they feared that knowledge would have an adverse effect on treatment, with a more recent survey of 1979 which demonstrated just the opposite. Few physicians today would find it acceptable to withhold diagnostic information from patients, not only because of laws which require informed consent, but also because many treatments require collaboration in planning and implementation. WQiile issues of information-sharing continue to be of ethical importance in genetic testing for such diseases as Huntington's, where family members may choose to know or not to know information gathered for research purposes, in most psychiatric and medical disorders it is essential to share diagnostic and treatment information because there are choices to be made, rather than only one path for the physician to recommend, and each choice is accompanied by particularrisksas well as potential benefits. Weiss suggests that traditional paternalism was vulnerable to many criticisms that no longer apply to modern paternalism, which takes into account the patient's values and interests. In Weiss's view, the physician trained in formal decision-making is better at deciding the course of treatment, is likely to be more objective, and 3 Paul Chodoff\ "Involuntary Hospitalization of the Mentally ΠΙ as a Moral Issue", American Journal of Psychiatry 141 (1984), 384-389, 386. 4 Ibid., 386. 5 Charles M. Culver / Bernard Gert , Philosophy in Medicine: Conceptual and Ethical Issues in Medicine and Psychiatry, New York: Oxford University Press, 1982, 127. 6 Allen Buchanan, "Medical Paternalism", Philosophy and Public Affairs 7 (1978), 370390, 372. 7 Gary B. Weiss , "Paternalism Modernised", Journal of Medical Ethics 11 (1985), 184187.

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is able to protect the patient from making decisions that favor immediate gratification over long-term benefits. The guiding principle of medical paternalism remains, however, that the physician decides what is best for the patient and tries to follow that course of action. In Weiss's view, the physician's goal is to improve care rather than promote patient autonomy. Weiss gives an example of a young man refusing treatment for a treatable cancer, a situation which he argues "requires the physician's encouraging, or, if necessary, coercing the patient to complete the therapy".8 What if anything requires the physician to coerce such a patient? In response to Weiss, Matthews points out that the debate between the principles of paternalism and patient autonomy is still a debate about power.9 While a doctor might be obligated to argue as strongly as possible for treatment, and to present information about what may happen without treatment, coercion requires much greater justification than Weiss has provided. Childress defines paternalism to include "the motivation and intention to prevent harm to or to benefit another person. ... [and] a refusal to accept or to acquiesce in an individual's choices, wishes, and actions.... It usurps arightof decision-making on the grounds that someone else can make better decisions".10 Hershey offers a related definition, that an action, x, initiated by A (an individual or group) with regard to Β (another individual or group) is paternalistic only if χ is primarily intended by A to benefit B, and B's consent or dissent is not a relevant consideration for A. 1 1 Culver and Gert contend that all paternalistic acts involve doing something that needs moral justification, because an essential feature of paternalistic behavior toward a person is the violation of one or more moral rules, such as those prohibiting deception, deprivation of freedom or opportunity, disabling, or causing physical pain or mental suffering. They believe the preceding definitions fail to stipulate clearly enough the requirement that there be violations of a moral rule. They offer the following definition: "A is acting paternalistically toward S if and only if (A's behavior correctly indicates that A believes that): 1. his action benefits S 2. his action involves violating a moral rule with regard to S 3. his action does not have S's past, present or immediately forthcoming consent 4. S is competent to give consent (simple or valid)." 12

» Ibid., 186. 9 Eric Matthews , "Can Paternalism be Modernised?", Journal of Medical Ethics, 12 (1986), 133-135. 10 James F. Childress , "Paternalism and Health Care", in Wade L. Robison/Michael S. Pritchard, eds: Medical Responsibility, Clifton, N.J.: Humana, 1979, 15-27, 18-19. h Paul Turner Hershey, "A Definition for Paternalism", Journal of Medicine and Philosophy 10(1985), 171-182, 180. 12 Charles M. Culver / Bernard Gert , (op. cit. fn. 5), 130.

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The Group for the Advancement of Psychiatry modifies Culver and Gert's definition significantly to accommodate the concept of partial competence. They assert that paternalistic behavior must satisfy four criteria: "1. it is carried out with the intention of benefiting the subject (the patient) 2. it involves the violation of a moral rule with respect to the patient 3. it is carried out without the consent of the patient 4. the patient is at least partially competent or is expected to become at least partially competent in the future"; and that it is ethically justifiable to treat against a patient's wishes only when "1. the harm or harms the treatment will probably avoid or ameliorate for the patient must be very great (for example, death or serious permanent disability) 2. the harm or harms imposed by the treatment must be by comparison very much less 3. the patient's desire not to be treated must be seriously irrational 4. rational persons would advocate always allowing forced treatment in cases having the same morally relevant characteristics described by thefirst three criteria." 13 Finally, O'Neill's definition also includes the motivations as well as the behavior of the paternalist: "The paternalist rather begins from a failure to acknowledge either what the other's ends are or that they are the other's ends. This failure of respect entails failures to share those ends, for to the paternalist they are either invisible or else not the other's ends but rather the ends to be sought for the other. The paternalist tries to express beneficence or love by imposing a conception of others' ends or interests. Lack of respect is then compounded by lack of love."14 In asking us to consider attitudes as well as behavior, and even assumptions that may not be recognized by the paternalist, this definition is illuminating, and bears directly on a central problem in the treatment of psychiatric disorders.

The Varieties of Doctor-Patient Relationships How well do these definitions describe and prescribe the actual practice of psychiatry and medicine? In an overview of the practices of general practitioners, McKinstry notes that proponents of paternalism in medicine tend not to use such specific definitions; they describe as paternalistic those occasions when the doctor assumes consent and does not ask. 15 For McKinstry, the central debate about pa13 Committee on Medical Education, Group for the Advancement of Psychiatry, in Psychiatric Ethics, New York: Brunner/Mazel, 1990,28-29. 14 Onora O'Neill , Constructions of Reason, Cambridge, Cambridge University Press, 120121. Brian McKinstry , "Paternalism and the Doctor-Patient Relationship in General Practice", British Journal of General Practice 42 (1992), 340-342.

Caseboo

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ternalism is whether doctors are justified in making decisions about patients' treatment to which they know the patients would object if they were properly informed, and whether doctors are justified in carrying out this treatment when they believe that it would serve the patients' long term interests and that eventually the patients would so agree. He gives as an example from general practice the case of the patient who has been off work for some time and resists the recommendation to return to work; the doctor refers the patient to the regional medical officer as a therapeutic measure, knowing it is against the wishes of the patient but in the belief that the patient will benefit. "The aim is to restore the patient's autonomy, the only justification for paternalism."16 McKinstry outlines four variations on the doctor-patient relationship. The autocratic doctor has little regard for the opinions of the patient, and views himself as the expert. The paternalist listens to the patient without real regard for the patient's opinions on serious matters, and might be willing to exaggerate or to distort facts so as to influence the choice the patient makes; he sees himself in a superior position, and may feel that patients do not have sufficient knowledge to make good decisions. The doctor as agent considers the patient to be the final arbiter of all important decisions and provides information to enable the patient to make decisions; here, the problem is to decide what information to give, and how detailed an explanation the patient would want. Finally, there is the situation of the patient who yields autonomy and asks the doctor to make decisions. There are psychiatrist-patient relationships that reflect each of these variations. The expert psychopharmacologic consultant who has no long-term relation with the patient but is used by psychiatrist and patient as a source of specialized information might be autocratic with impunity, in the sense that psychiatrist and patient could disregard the advice proffered - though one might prefer not to depend on such an expert. The other three relations, however, exist over time. And over time, patient needs alter as infirmities change. These vicissitudes require flexibility on the part of the psychiatrist, and a sophisticated understanding of paternalism and patient autonomy.

The Realities of Psychiatric Practice The nature of most severe psychiatric disorders is that they are chronic, characterized by relapses and periods of respite. The patient goes through episodes of incapacity and episodes of clarity, times of disorganization, psychosis, hopelessness and dependency and other periods of cogency, reflection and collaborative planning. The relationship between psychiatrist and patient shifts to mirror the changes in the patient's illness; neither the disease nor the doctor-patient relationship is static. 16 Ibid., 342.

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The patient with manic depressive illness, recurrent depression or transient psychosis, all of which affect judgment but which are intermittent or reversible, may behave in markedly different ways at different times. Psychiatrists cannot assume that each person holds his or her own course of life as intrinsically valuable at all times, given the fluctuating judgment and impulsivity of the patients we treat. A patient may express wishes in one state that are in conflict with the wishes and decisions in another state. In cases of grossly psychotic distortions we often accept the need for paternalistic decision-making on the part of the physician. A different dilemma is presented by the more moderate but potent conflicts which arise in states of hypomania or dysphoria, when the world looks either brighter or more hopeless than it does in the patient's euthymic (or normal mood) state. A hypomanic person may feel wonderful, sleep very little, eat a lot, make unwise investments, spend money recklessly, engage in risky and indiscreet sexual behavior, provoke conflicts with others because of aggressive behavior, yet technically understand the consequences of his choices. He simply may not exercise the caution he usually employs in his more euthymic states. Conversely in his depressed states he may feel overwhelmed by matters he normally handles easily, and wish to relinquish responsibilities. While from a legal point of view it may be necessary to accept the latest decision as the governing one, the psychiatrist cautions the patient against this. To accept the latest state unquestioningly is to overlook the patient's deep commitment to be master and not victim of his disease. Such shifts in mood and perspective demand a relation between psychiatrist and patient that permits flexibility and an ongoing reassessment of the current and future capacities and needs of the patient. McKinstry's account of doctor-patient relations falls short of describing a truly collaborative relationship in which the doctor not only helps to further the patient's goals but also participates in ongoing conversations with the patient to create a collaborative, shared plan for the future. Such a plan is not based on the doctor's needs or values but instead stems from the doctor's knowledge of the possible course of the patient's illness, and the planning that might moderate the effects of that course. However, the process of creating such a plan may involve confronting the patient's unrealistic ideas and challenging the patient's denial while offering an alternative of realistic hope. In addition to providing information, helping the patient to clarify his or her goals, and reminding the patient of those goals at times of great distress, dependency and hopelessness, the doctor is an interactive participant engaged in critical discussion and, at times, active disagreement with the patient. That disagreement then forms the basis for ongoing discussion. This differs from all four of McKinstry's models. It obviously differs from McKinstry's models of the doctor as autocrat, as paternalist, or as someone who willingly makes decisions for the patient when asked. It significantly extends McKinstry's concept of the doctor as agent. McKinstry's concept of agency is very limited, placing the doctor outside the decision-making process as a provider of information but little more. Perhaps because McKinstry considers medical patients,

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whom he describes as controlling the decision-making process, rather than psychiatric patients who are not always in control, McKinstry presents agency as a more limited concept, but even with medical patients doctors have a fuller and more complex role than his model allows. Collaboration requires an active relationship between two people, both committed to ensuring that the patient get good enough care - not necessarily the best care from a technical viewpoint (which might be the point of view of the autocrat) if the patient does not wish it, but the best care in terms of the patient's enduring values. 17 How might we approach truth-telling in this context? Culver and Gert state that a doctor is acting paternalistically if "he will proceed with what he thinks is best for the patient regardless of the patient's expressed wishes. If the patient wants to be told the truth, then to withhold it simply to prevent his suffering the effects of being told is paternalistic. But if the patient says that he does not want to be told the truth - say, about his having terminal cancer - then it is paternalistic of the doctor to cause suffering by forcing the truth on the patient on the grounds that it is better for him to face the painful truth now."18 The doctor who believes he knows what is best for the patient operates from a paternalistic stance. But the doctor might proceed instead from a collaborative stance, regarding discussion as the basis for any next step. If there is no one objective best treatment, the patient and doctor must collaborate in choosing which set of advantages and disadvantages to pursue. The doctor may be willing to choose for the patient if so requested but would prefer that the patient, who must experience the problems that occur, have the opportunity to select those disadvantages and risks most tolerable to him or her. In such cases deception cannot be justified, but the style of truth-telling matters a great deal. 1 9

17 Allen Dyer/Sidney Bloch , "Informed Consent and the Psychiatric Patient", Journal of Medical Ethics 13 (1987), 12-16. Dyer and Bloch argue similarly that thefiduciary principle, or partnership, offers a resolution to the conflict between the principles of autonomy and paternalistic beneficence with regard to consent. The doctor decides not for but with the patient, dependent on the patient's development of trust and the psychiatrist's demonstration of trustworthiness. In arguing against regarding autonomy and paternalism as mutually exclusive principles, they note that over time the static formulations of doctor as paternalistic or patient as autonomous may shift. To these authors psychotherapy represents an ideal model of partnership, in which the doctor attempts to identify specific needs of the patient and to respond to them - at times allowing the patient's dependence to express itself, recognizing its importance at that moment, but at other times encouraging the patient's autonomy. »8 Charles M. Culver/Bernard Gert, (op. cit. fn. 5), 130. 19 Bernard Gert /William A. Nelson/Charles M. Culver , "Moral Theory and Neurology", Neurologic Clinics 7 (1989), 681-696. The way one tells is not morally irrelevant. One must strive to cause no undue emotional pain, and also "to present all the relevant information in a manner that genuinely allows patients to make free, informed decisions based on their values or beliefs, but yet to present it forcefully enough that patients are most likely to make what doctors believe to be rationally acceptable decisions" (ibid., 696).

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This is a common situation in medicine. Many patients wish to know less than they might be told, because they are troubled, preoccupied, or first coming to terms with new and distressing information. A lengthy discussion about diagnosis, prognosis and treatment choices may be overwhelming or too complex for a person who is psychotic or severely depressed, but it need not take place in one setting or at one time. It can be told and retold as the patient is open to greater complexity and more information. That is an important role of treatment over time.

Must Paternalism and Autonomy Be Mutually Exclusive? Situations in which the physician disregards a patient's choice, or decides on a plan of treatment without knowing or attempting to know the patient's wishes, occur most often in psychiatric practice when a patient is incompetent or irrational and will likely become more competent or rational with treatment. Cases involving involuntary hospitalization or forced medication represent one extreme which many psychiatrists reluctantly support, although without unanimity and with serious reservations. But these extreme cases suggest a polarization of rationality and irrationality, competence and incompetence, which implies an equally clear polarization of autonomy and paternalism. Many authors have pointed to the range of functional capacities and areas of competence in patients with areas of deficit or incompetence, which require us to evaluate individuals within groups rather than to assume that entire groups of people are limited in particular ways. 2 0 The concept 20 The following authors approach this issue through a consideration of three very different clinical populations. Michael Weintraub ("Ethical Concerns and Guidelines in Research in Geriatric Pharmacology and Therapeutics; Individualization, not Codification", Journal of the American Geriatrics Society, 32 (1984), 44-48) reviews the high refusal rate among elderly patients asked to participate in various research projects, and finds autonomy alive and well. He suggests that many people in this heterogenous population understand issues of consent, risk, and research design, although some do not. He cautions against a "counter-productive paternalism" that leads to protection of all elderly patients rather than only those that are incompetent and must have their interests scrupulously protected. Ruth Macklin ("Reversing the Presumption: The IOM Report on Women in Health Research", Journal of the American Medical Women's Association 49 (1994), 113-121) points to a shift away from the traditional willingness to generalize about groups of people as needing protection, in discussions that resulted in the February, 1994 Institute of Medicine report entitled "Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies." This report was commissioned in part because there was a perception that biomedical research has focused more on the health problems of men than women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. The report reviews the historical and current status of women's participation in clinical studies and explores the requirements of justice in selecting subjects of research. It recommends that pregnant and lactating women be considered eligible for enrollment in clinical studies, effectively reversing the previously existing presumption that excluded pregnant women from most clinical studies and severely restricted enrollment of women of "childbearing potential". It explicitly rejects a view of pregnant women as vulnerable along with the paternalism inherent in denying women of childbearing potential the 16 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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of a division rather than a continuum between states of rationality and irrationality or competence and incompetence fails to account for many subtle but problematic situations that arise between psychiatrist and patient. In this sense the definitions of paternalism given by Childress and Hershey are limited, referring to one conflictual point in time in which the doctor rejects or fails even to consider the patient's point of view. The definition offered by Culver and Gert requires a competent patient, which limits its applicability to a small range of patients and problems psychiatrists face. That definition as modified by the Group for the Advancement of Psychiatry moves us closer to the realities of clinical practice, in which the psychiatrist must move between a collaborative and a more paternalistic stance. Here, the psychiatrist is pictured not as all-knowing but rather as one who must evaluate alternatives. The gains of one position must be weighed against the injuries of another, and secrecy gives way to public debate. The alternatives themselves are not good versus bad but have harms on both sides - in no way can the dilemma be simple or free from pain. There is no pretense that the patient's "consent or dissent is not a relevant consideration" for the doctor, as Hershey suggested. It is relevant as something to be considered and contended with, even if it is not always the decisive factor. In attempting to describe a more fluid relationship between psychiatrist and patient which is based on the patient's changing needs, it is helpful to consider the concept of partial autonomy. O'Neill raises this issue directly.21 She notes that while standard adult capacities for autonomy, which allow informed consent to be given or withheld, may differ from a patient's reduced capacities which demand paternalistic treatment, in fact patients may not differ so greatly from the rest of us in so far as all human capacities for autonomous action are variable and limited. According to O'Neill, "An adequate account of paternalism and the role that consent and respect for persons can play in medical and other practice has to be developed within an ethical theory that does not impose an idealized picture of unlimited autonomy but allows for the variable and partial character of actual human autonomy."22

When cognitive or volitional capacities are impaired, autonomous action is reduced. In those situations, she argues, "opposition to medical paternalism appears same autonomy granted to other competent adults enabling them to decide whether to volunteer as research subjects. Rebecca Dresser / Peter 7. Whitehouse ("The Incompetent Patient on the Slippery Slope", Hastings Center Report, 24 (1994), 6-12) argue that patients suffering from progressive dementia have a variety of thoughts, emotions, and perceptions. They offer ideas about how to gain some sense of the experience and levels of cognitive impairment in a severely limited patient, and argue that these should bear on decisions about life-sustaining treatment. 21 Onora O'Neill , "Paternalism and Partial Autonomy", Journal of Medical Ethics 10 (1984), 173-178. 22 Ibid., 173.

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to reflect an abstract and inaccurate view of human consent which is irrelevant in medical contexts".23 O'Neill observes that true respect for autonomy demands that the patient's refusal of or consent to fundamental aspects of treatment be made possible in ways the patient can understand. When patients' and doctors' goals are the same, there may be no apparent conflict, but where patients' and doctors' goals differ, often around quality of life, avoiding pain, or avoiding dependence, then respect for the patient requires that his goals not be overridden. O'Neill concludes, "By trying to incorporate concern for actual, partial capacities for autonomous action into an account of respect for patients and medical paternalism we find that we are left without a single boundary-line between acceptable and unacceptable medical practice. What we have are patterns of reasoning which yield different answers for different patients and for different proposals for treatment."24

This is a very important point about medical treatment, but it is especially important with regard to psychiatry, in which illnesses affect cognition, judgment and capacities for autonomous action to different degrees at different times. The psychiatrist must communicate with patients and approach them as their individual capacities permit. The following examples illustrate some of the issues that arise as the psychiatrist tries to do so.

Clinical Dilemmas of Collaboration and Paternalism Communication and collaboration may be particularly difficult at the beginning of a psychiatric treatment, when a person has not yet actually defined himself as a patient. It is not uncommon for a young person, newly diagnosed with bipolar disorder, to reject the diagnosis and refuse to take medication even though there is growing evidence that as more acute episodes occur, they become more refractory to treatment. One such college student had three brief hospitalizations in the space of two months because of paranoia, behavioral outbursts and delusional beliefs. In the hospital, however, she had minimal but adequate nutrition and was assessed not to be an imminent threat to herself or others. In the doctors' view, she was ill and in need of treatment, but not clinically impaired enough to meet standards for involuntary hospitalization. The patient saw things differently: she understood the doctors' diagnosis of manic depressive illness, but saw no need for psychotherapy and did not want to "pollute" her body with medication, so she left the hospital, left college and ran away from her family, jeopardizing a promising career and exposing herself to further risk. In such a case the psychiatrist can persuade, argue, educate and attempt to create an alliance with the patient, but cannot possibly coerce such a patient to take medication every day, even if there were a basis on 23 Ibid., 174.

24 Ibid., 177. 16*

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which to justify it. The inability to treat those who do not wish to be treated leaves psychiatrists with no simple solution. It does not relieve psychiatrists of the obligation to try, however. The case of a hypomanic physician offers a disturbing example of failure of responsibility. At the onset of a manic episode, this patient left his wife of many years, began an affair, spent lavishly and made grandiose decisions that bordered on the delusional, but his psychiatrist refused to discuss with the patient how different was his behavior from his normal self, and how clear was his need for medication, arguing that it was the patient's right to behave as he did. I do not think that relieved the psychiatrist of the responsibility to try to ally with the patient's more realistic and normally-held view of the world. The patient did not think so either, when he cycled back to euthymia. The psychiatrist has many roles - to evaluate and treat, to educate the patient about his illness, and over time to help the patient become aware of and weigh the wishes of one state against the wishes expressed in another.25 By making the patient aware of the role of mood in influencing those disparate points of view, the psychiatrist is speaking to what we call the patient's observing ego, however hard it may be to find. The responsible psychiatrist asks the patient to defer major decisions until such integration can occur, if the altered state is reversible. When the patient faces a deteriorating course, the psychiatrist tries to anticipate with the patient as clearly as possible what the future will hold - possibly less response to medication, or progressive cognitive impairment. This does not mean that the psychiatrist waits until the patient makes a rational decision with which the psychiatrist concurs. Rather, the psychiatrist's job is to help the patient at a more stable time to make decisions based on information gathered and preferences expressed in all states. Sometimes a patient may decide to stay off medication because life is too painful when delusions are well controlled or when a hypomanic, elevated mood is reduced to euthymia. But the psychiatrist's commitment to a collaborative relationship can help the patient preserve or regain autonomy in the face of an illness which threatens to destroy the patient's sense of autonomy and control, as the following example illustrates.

From Conflict toward Collaboration: One Patient A 35-year-old woman with manic depressive illness had a rapid cycling disorder, in which she could shift from depression to mania and back again in a matter 25 E. Cassell, The Healer's Art, Philadelphia: Lippincott, 1976. This echoes Cassel]'s belief that the physician enters into relationship with his patient as the "arbiter between the person and his body" (89); it becomes the doctor's responsibility to assist the patient in mending the rupture or managing the conflict between himself and his embodied distress, weakness or pain. In doing so, the physician helps to include aspects of the illness in the patient's definition of himself.

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of hours, sometimes cycling from one mood state to another every 24 hours or every several days. In those states, which were very difficult to control with medication, she swung from periods of grossly impaired judgment and elevated mood to hopelessness and suicidality. When more stable, she was able to maintain a responsible professional job with considerable direct and supervisory responsibility for periods of up to eight months at a time. She had many hospitalizations, usually marked by conflict with the hospital staff over wanting to leave the hospital when she was still emotionally labile, reckless, and at risk for suicide. In fact, she once eloped from the hospital and drove her car into a wall. At other times she left abruptly before her doctors felt that she was stable and then placed herself in risky situations, or withdrew large amounts of money from her bank accounts that she spentfrivolously and later regretted. While there were periods during her hospitalizations when she was clearly a threat to herself or others, and could have been legally held against her will had she not agreed to her hospital stay, there were other periods toward the ends of her hospital stays when she was hypomanic - less of a threat to herself, but vulnerable to impulsive and unpredictable behavior. Usually at those times she wished to leave, and argued that she could handle being alone, but her rapid speech, impatience, emotional lability and ongoing sleeplessness were not reassuring. Most of her hospital stays ended in anger and conflict. Finally at the end of one hospitalization her psychiatrist, who had worked hard to build an alliance, asked her whether she really thought she was ready to leave. She stopped. She had been so ready for a fight, the question brought her up short. She said she didn't know, and then quickly said yes. Then, slowly, she said that she wasn't sure, and she wanted the doctor to decide. The doctor refused to decide alone, insisting that this time it was a decision they would have to make together. The patient grudgingly admitted that it might be better for her to stay another day or two, until her sleep stabilized. Clearly the doctor cannot take only one position with respect to the patient at all times throughout the vicissitudes of her illness. Paradoxically there is the risk that the doctor's value of support for autonomy could be used paternalistically - that is, without the patient's consent - if the doctor pushes the patient too quickly from a position of necessary dependence. The dilemma for the psychiatrist is tofigure out what is the optimal amount of autonomy, or paternalism, in the care of the patient at any given time. Does it matter if the psychiatrist operates predominantly from a stance of paternalism or collaboration? The paternalist might ask what the patient thinks as a strategy to gain cooperation, but would not view the restitution of autonomy as important in its own right. However, since psychiatric disorders affect judgment and thereby the patient's confidence in her autonomous capacities, the return of autonomous capacities cannot be taken simply as a by-product of improvement, as it would be in the case of a medical illness. Instead, the return of autonomous capacities can be seen as a marker of the receding illness itself. Therefore fostering these autonomous capacities is an essential part of treating a psychiatric illness.

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Treatment Planning: A CoDaboralive Process When the psychiatrist cannot eure an illness but must help the patient to live with it and control it as much as possible, planning for episodes of relapse becomes

a central part of treatment. In non-psychiatric fields, the issue of advance directives has been given increasing attention. The use of stories to clarify possible medical Situations and dilemmas as realistically as possible has been suggested by Kielstein

and Sass, who believe that questions or check-lists may inadequately assess current values and future choices.26 For psychiatrists who work with patients over time, the goal is to make treatrnent options for the present and future as realistic as pos­ sible as weil. In any long-term psychiatric treatrnent, there should be a discussion of diagnosis, prognosis and treatment options for tbose times in the future when the patient is more impaired. Unfortunately too often these discussions do not oc­ cur, or they are not specific enough, failing to address in detail what in particular might happen, and in what particular manner the patient would like to be treated. Same patients believe they will not get sick again, but many are eager to plan for future episodes once they have experienced successful treatrnent. When treatrnent has been less successful, because of limited response to medication or overwhelm­ ing social problems, it is of course more difficult to plan with confidence what to do the next time, but it may be possible to plan what not to do. In the United States in the 198Ös the idea of a Ulysses contract, or prior consent

agreement, was introduced as a way of enabling patients in more stable periods to instruct families and clinicians how to proceed in an exacerbation of illness when the patient might refuse treatment or make unwise treatrnent decisions. This pro­ posal was challenged on various legal grounds, but remains clinically compelling in that, while not legally binding, it asks patient and psychiatrist to address issues of future care in a direct and open manner?7 In a discussion in Sch!zophrenia Bul­ letin, two mental health consumers express the concern that any acceptable form

of prearranged informed consent must countenance both acceptance and refusal of particular forms of treatrnent. They suggest creating

a

document that would in­

clude "a recital of our treatment choices, both pro and con, our related treatment history, a Statement of our understanding of our rights to choose and refuse, and some expression 28 of our concems about not having our wishes overridden or ignored."

They suggest obtaining witnesses among family and friends who will attest to their competency at the time of writing, designating a legal counsel in advance, 26

Rita Kielstein/Hans-Manin Sass,

"

Using Stories to Assess Values and Establish Medi­

cal Directives", Kennedy Institute ofEthics J oum al 27

Consent in Advance", Schizophrenia Bulletin 28

3 (1993), 303-325.

Marilyn K. Rosenson/Agnes M. Kasten, "Another View of Autonomy; Areanging for

17 (1991), 1-7.

Joseph A. Rogers IJ. Benedict Centifanti, "Beyond "Self-Patemalism": Response to

Rosensan and Kasten", Schizophrenia Bulletin

17 (1991), 9-14.

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and stipulating in which hospital and by which physician they would like to be treated. The prominent legal concerns of these authors stem in large part from the concern among some mental health consumer advocates that no matter how well prepared and clear they may be, their written choices will be ignored in favor of the "best interests" of the patient.29 If psychiatry is to do better than this, to serve the actual interests the patient has expressed and to respect the choices he or she has made at the time of greatest stability, there will have to be more explicit discussion between patient and psychiatrist about values and choices. Perhaps detailed stories such as those constructed by Kielstein and Sass, but focused instead on psychiatric disturbances, could serve to begin such discussions. No single path between paternalism and autonomy marks the appropriate direction for the psychiatrist, but rather what O'Neill calls "patterns of reasoning"30 create a terrain through which the psychiatrist and patient can and must move together.

Zusammenfassung Der Beitrag spricht für das Psychiater-Patient-Verhältnis verschiedene Fragen im Bereich von Paternalismus und Zusammenarbeit an. Einige gängige Definitionen von Paternalismus, soweit sie verständigerweise auf die Psychiater-Patient-Beziehung angewendet werden können, werden untersucht. Die Probleme, die diese Definitionen unausgesprochen lassen, werden diskutiert. Insbesondere kritisiert der Beitrag die verbreitete Neigung, Autonomie und Paternalismus eher als Prinzipien anzusehen, die sich gegenseitig ausschließen, denn als Gesichtspunkte, die zu einem Kontinuum gehören. Gerade im Zusammenhang mit psychiatrischen Problemen ist dies nicht etwa eine nebensächliche, sondern eine geradezu zentrale Frage. Psychiatrische Erkrankungen beeinflussen das Urteilsvermögen, die Stimmung und das Wahrnehmungsvermögen des Patienten und zeichnen sich durch Phasen sowohl der Verschlimmerung als auch der Besserung aus. Obwohl Patienten bei der Planung der Behandlung die meiste Zeit über zuverlässig mitwirken können, gibt es Zeiten, in denen sie dies nicht können - sie sind abhängig und krank, ihr Urteilsvermögen und folglich ihre Autonomie ist beeinträchtigt. Während dieser Zeiten muß der Psychiater die Möglichkeit haben, sich zwischen den Modellen des Paternalismus und der Zusammenarbeit zu bewegen. Er muß als der Hüter der Wünsche handeln, die der Patient in einem stabileren Zustand geäußert hat, und dabei zugleich die Bedürfnisse des nun in einem labilen Zustand befindlichen Patienten berücksichtigen. Der Beitrag untersucht die Verflechtungen und Beschränkungen, die einem auf Zusammenarbeit beruhenden Behandlungsmodell innewoh-

29 Ibid., 13. 30 Onora O'Neill (op. cit. fn. 21), 177.

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nen, und erwägt einige Vorschläge, wie im Hinblick auf eine Förderung von Patientenautonomie und Patientenfürsorge ein Modell der Zusammenarbeit vertreten werden kann.

Discourse Ethics and Health Care Ethics Committees Matthias Kettner I. Whence the Moral Authority of Consensus? The Problem Ethics committees, as Jonathan Moreno has convincingly argued in a recent book, are best seen as part of the bioethics social reform movement.1 Based on reports from American health care facilities, hospitals and others, it is estimated that between 80 to 90% have ECs. At present, all health care organizations accredited by the Joint Commission for the Accreditation of Health Organizations must have some mechanism to address ethical issues. The variety and sheer ubiquity of such committees makes them an important political factor in the institutional landscape of the health care system and now, managed care.2 Committees are bureaucratic creatures. They represent bureaucratic lines of authority and control. Viewed from this angle they are susceptible to a Foucaultian analysis of disciplinary and normalizing practices. However, they also represent an attempt to give authentic institutional expression to two moral values that are key characteristics of the normativity of secular bioethics, namely respect for the autonomy of the will of persons as individuals (private autonomy) and respect for decisions based on a rationally prompted consensus of all people concerned (public autonomy). The emergence of ECs over the last twenty years can be sociologically explained as a response to a number of medico-techno, medico-legal, health care political and broader cultural challenges that combine into a deep legitimation crisis of the medical profession. 3 Viewed from this angle, ECs should be analyzed as deliberating bodies that purport to extend moral reflection to, or make it bear on, institutionally constrained real life contexts. The overall aim of these deliberating bodies is to maintain or perhaps recover the moral integrity of what is by technical standards "good clinical practice" ι Jonathan Moreno , Deciding Together. Bioethics and Moral Consensus, Oxford: UP, 1995. 2 I am not sure how much of a factor ethics committees are in managed care at this time. Foreseeably, with the burgeoning of managed care there will be an increased interest in questions at the interface of business ethics and clinical medical ethics. 3 Cf. Wolfgang van den Daele & Heribert Müller-Salomon, Die Kontrolle der Forschung am Menschen durch Ethikkommissionen, Stuttgart: Emke, 1990 (esp. pp. 69-83). See also Joachim Czwalinna, Ethik-Kommissionen: Forschungslegitimation durch Verfahren, Bern: Lang, 1987.

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in a changing health-care system that is less and less supportive of the venerable physician's ethical attitude of patient-centered beneficence but cannot altogether dispense with this attitude on pain of losing the main moral source of societal acceptance of the whole profession. ECs are small-group arrangements that are installed in order to amplify a mandate whose origin is the patient-doctor relationship. ECs operate in many different ways. They differ in methodology, procedure, content and context. Some do little or no case consultation, some do only consultation. Some deliberate as a committee, some delegate consultation to a subcommittee. Very few are overtly decision making. Their operational diversity notwithstanding, the way ECs generally remain tied to that mandate which they amplify specifically in the face of moral uncertainty is not altogether different from the way other cooperatively deliberating bodies that have evolved in the history of the health care profession, e.g. case conferences and supervision, remain tied to the same mandate which they amplify in response to other challenges, e.g. in the face of scientific uncertainty, legal uncertainty, etc. As far as ECs are what their name and rationale suggests they are, they should be accessible to scrutiny in terms of their moral validity claims, i.e. (1) in terms of the ethics they allegedly practice and (2) in terms of an ethics they should practice.4 That is, the workings of ECs are amenable not only to the question how well they do in fact implement the normative principles, standards, values etc. that their members say they embrace. The workings of ECs are also amenable to the more encompassing critical question as to which moral standards, principles or commitments are adequate ones for grounding (i.e. constituting and delimiting) whatever moral authority ECs themselves claim for their operations and outcomes or are credited with from outside.5 What lends moral authority to whatever non-moral prescriptive force a group consensus may have?6 To explore this question is to throw open the philosophical pandora's box of so-called applied ethics. Applied ethics is notorious for its promise to bring something like street credibility to abstract moral philosophy. However, it is also notorious for its reluctance to invest much theoretical power into careful scrutiny of its own overt and covert theories of practice (implementation, application etc.). To think about the grounds for claims to moral authority of a group consensus is admittedly an abstract philosophical exercise. Yet it is more than that. Political and 4 For a very thin answer to a very promising question, cf. George P. Smith, "The Ethics of Ethics Committees", J. of Contemporary Health Law and Policy, vol. 6,1990, pp. 157-170. 5 Robert M. Veatch, "Consensus of Expertise: The Role of Consensus of Experts in Formulating Public Policy and Estimating Facts", J. of Medicine and Philosophy, vol. 16, no. 4, 1991, pp. 427-446.

6 Cf. the rather skeptical view of Peter Caws, "Committees and Consensus: How many Heads are Better than One?", J. of Medicine and Philosophy, vol. 16, no. 4, 1991, pp. 375392.

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legal systems abound with the vocabulary of consensus - consensus concepts and the way they are being interpreted condition and affirm an incredible range of legal and political consequences. This point is brought home when enlightened critics of the EC-movement question, for example, the rather indiscriminate recognition that consensus oriented deliberating bodies under the name of ECs increasingly enjoy in the legal system of judicial review of medical practice. Susan M. Wolf, for instance, has argued forcefully against tendencies in the jurisdiction of a number of states that accord a high degree of deference in court to ECs' determinations. Specifically addressing proper case oriented moral reasoning as a possible source of moral authority, Wolf cautions, "ethics committees should not be presumed to have expertise meriting deference. Because of their interdisciplinary membership, most members probably have had no formal training in moral reasoning. Their collective opinion adds only the element of consensus. Yet consensus does not mean that the group has reasoned rigorously or well; it simply means that the members agree. There is no reason to presume that a consensus of ethics committee members should carry more weight than the conclusions of a judge on moral questions, particularly since the judge follows public procedures, must give his reasons publicly, and is independent of the parties involved."7 Wolf's comment suggests that an EC group consensus is an inferior moral authority, or is at least not a superior one, compared to a judge's moral deliberation. Against Wolf's pledge for judicial rather than ethical review one might object that some of the seemingly positive aspects of judicial decision making make the judicial process inappropriate for momentous patient related decisions. The process exposes private matters to the scrutiny of a non-medical public, it is expensive, it is highly bureaucratic, it is adversarial, and it is time consuming. Concerning our leading question (as to the moral authority of group consensus), yet another objection must be raised. A judge's legal opinion is first and foremost a legally authoritative opinion and is as such usually not meant to be morally authoritative. What might add moral authority to a judge's legal opinion is that the legal procedures involved in, and the reasons considered in the course of, the legal process are reasons which people who have had formal training in moral reasoning would endorse. Of course, citizens should endorse them anyway from the political point of view of competent democratic citizenship. But the normative political perspective 7 Susan M. Wolf, "Ethics Committees in the Courts", Hastings Center Report June 1986, pp. 12-15. Wolf concludes: "The strength of ethics committees is their availability as a forum and whatever persuasive force each commands. Consequently, in litigated cases the courts should evaluate committee determinations case by case to decide what weight each deserves. The committee's efforts will count in each court case, but how much they count will be up to the court." Also cf. Susan M. Wolf, "Ethics Committees and Due Process: Nesting Rights in a Community of Caring", Maryland Law Review, vol. 50, 1991, pp. 798-858. For a German perspective cf. W. Weißauer, "Ethikkommissionen und Recht", Münchener Med. Wschr, vol. 121,1979, no. 16, S. 551-556.

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of democratic citizenship and the normative moral perspective need not and usually will not coincide. Whatever moral authority the judge's opinion beyond this formal requirement may possess must come, it seems, from the presumably high personal moral competence of the individual judge. But why credit judges with a higher than average personal moral competence? Susan Wolf's warning somewhat backfires as judges usually have had as little "formal training in moral reasoning" (let alone in medical ethics) as their poor cousins in the ECs. Perhaps it is the case that the professionalization of judges guarantees that when they pronounce on bioethically problematic cases their legal reasoning will have been conducted "rigorously and well"; but it certainly takes a lot of theoretical argument (on which Wolf is silent) to maintain that in such cases legality (i.e. legal validity) is not merely a surrogate for legitimacy (i.e. moral validity) but its proper substitute. After all, why should we accept a legally satisfying solution of a case as the best we can ask for when what we were asking for originally is a morally satisfying solution? Yet Wolf's criticism stands that as long as consensus "simply means that the members agree", the moral relevance (and, perhaps, authority) of consensus will remain obscure. That a group of people agree on how they will handle some case is moral news only in contexts which are clearly contractual, i.e. where it is morally permissible or even required that what is at stake be open for negotiation by all the parties involved according to their differential interests and bargaining powers (the economic model) or according to the reasoned and procedurally fair give-and-take of concessions and affirmations of each party's negotiable interests with an eye to the common good (the parliamentary model). Pitted against the usual range of cases that go to ECs, neither the economic contractual model nor the political contractual model appears very fitting. As particular paradigms of deliberation, they hardly provide helpful analogies for understanding the moral authority of ECs. ECs as deliberating bodies (1) are neither law courts nor, for that matter, (2) juries.8 Still less are they like (3) parliaments or (4) 8 What Bowen Hosford, Bioethics Committees. The Health Care Provider's Guide, Rockville Maryland: Aspen Systems Corporation, 1986, pp. 85-86, has to say about the "benefits" of diverse membership of ECs is simply beside the point: "One reason that bioethics committees have such appeal is that, theoretically at least, they represent the community. They have some of the attributes of juries, which Americans revere. '[W]e believe that the jury brings the life of the community and the compassion of the ordinary citizen to an otherwise impersonal process...,' commented Judge Irving R. Kaufman, of the U.S. Court of Appeals for the Second Circuit." First, it takes very little knowledge of history (certainly not even the experience of Nazi Germany) to stop being too sanguine about the prospects of bringing "the life of the community and the compassion of the ordinary citizen to an otherwise impersonal process". Maybe the impartial impersonality of due process ranks among the most valuable features of the juridical system. Be that as it may. Arguably, representing the spirit of the community of citizens in matters of law is all right in terms of law's own acceptability conditions: valid law should be acceptable to all citizens on which it is, after all, binding. Representing the spirit of community (which community?) in matters moral seems much less

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markets. Then what are they? And what ought they to be like? I have already given a two-word answer to the first question: ECs are deliberating bodies. 9 Here comes my two-word answer to the second question: ECs in their operations ought to be like practical discourse . Let me briefly criticize - admittedly all too briefly - two alternative accounts of the moral authority of EC consensus. Rawlsian liberals would certainly want to relate whatever moral authority EC consensus may have to what Rawls has termed the "overlapping consensus" of a liberal society, its shared kernel of political morality. The operations of deliberating bodies like ECs must include respect for the standards and values that are part and parcel of that overlapping consensus in a liberal pluralistic democracy, which made ECs politically possible in the first place. These are very general standards and values such as "non-violent methods, mutual respect, and a willingness to entertain new evidence, willingness to consider alternative points of view and to bear unpopular points of view."10 The deliberative processes of ECs are deliberative processes in a professionally compartmentalized particular public sphere. As this particular public sphere is nested within larger public spheres, consensus in the particular public sphere must at least negatively cohere with, or be compatible with, the larger public spheres in which the spirit of an overlapping consensus of a deliberative democracy is produced and continuously reproduced and reshaped. But through negative coherence EC consensus is normatively under-determined. As Moreno aptly observes: "even if we suppose that a certain set of rather abstract principles can be the object of an overlapping consensus, in practice decisions are going to have to be made that are relatively specific to content and that do not strictly follow from those principles."11 appropriate given the fact of moral diversity. The fact of moral diversity does not imply moral relativism. Normative universalists (as in discourse ethics, for example) can accommodate the fact of moral diversity without falling prey to moral relativism. But normative universalist do not need to appeal to a particular local community in thefirst place. 9 "Experience with a deliberative body, like a faculty senate, or even a committee, soon shows us that the kind of competition of ideas in which we can expect competitors to win on their merits, and not by accident or by foul play, is something for which we must make positive arrangements. It is not the kind of condition that is realized automatically, if we leave the competition alone. Rather, it is a delicate condition that requires careful promotion; it is a garden that must be cultivated lest it degenerate into a patch of weeds" F.L Will, "Philosophy, Institutions, and Law", Modem Age, vol. 16, 1972, pp. 379-386 (at p. 383). 10 Moreno, op. cit. fn. 1, p. 64. 11 Moreno, op. cit. fn. 1, pp. 6-7. Also cf. p. 63 where Moreno shows how some bioethics mantra principles dovetail certain values of the overlapping political consensus of liberal societies like ours. Matters get worse still with "overlapping consensus" when moral judgment has to be reached in cases of deep conflicts. Deep conflicts are conflicts that challenge an allegedly basic common framework of moral assumptions and political procedures because such conflicts are not about particular beliefs or principles but about standards for assessing proper principles as such. A case in point are parents who adhere to Christian Science and consequently refuse to seek or allow treatment of their children. In this particular example of deep conflicts, the very facts of disease are drawn into conflicting interpretations. Deep conflicts preclude a world without moral loss: in such conflicts all sides to the conflict have rea-

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Moreno's way out is a "naturalistic theory of consensus".12 According to this theory, "there is a common moral sense"13 as a matter of empirical psychological fact, and this nearly universal common moral sense explains, by reference to something which for lack of a better analogy one might call moral perception , how "individuals tend to agree aboutrightand wrong" even in very extravagant matters such as bioethically problematical clinical cases (and presumably also in cases of deep conflict). Moral sense theory had its heyday during the eighteenth century Scottish enlightenment. Moreno recovers the appeal of moral sense theory mainly by reference to evidence from sociobiology and social psychology. Unfortunately he does not take into account some of the best corroborated findings from cognitive developmental psychology in the vein of Jean Piaget and Lawrence Kohlberg and his school. As a cross-cultural invariant there appears to be an ordered sequence of at least 3, at most 6, developmental possibilities for drastically different ways or stages of perceiving moral dilemmata.14 Thus if Moreno's appeal to a homogeneous common moral sense as the bedrock of morally authoritative consensus is to work at all, the appeal would have to be either to developmentally stratified consensus groups or to the internally most differentiated and fully integrative but empirically least frequently realized developmental possibilities which Kohlberg describes as "post-conventional moral thinking". The latter is probably the only feasible way to go if we want to answer, both de facto and de jure , how any finite sons backed by their own moral framework. Hence there is not one single point of view available that everyone would recognize as impartial nor is there one set of moral reasons that would be overriding or categorical for every party concerned. Deeply conflicting frameworks do not even have straightforward morally compatible ways of assessing evidence or balancing reasons. "Common human reason" or "overlapping consensus" or "our basic moral sense" does not give us much to go on here. We are left with but one possibility: to reach a compromise at a moral level, i.e. a moral compromise. But how so? By bargaining? But the deep commitments in deep conflicts defy bargaining because they are neither negotiable nor are they flexible preferences. If they were then there would not be any deep conflict in the first place. Moral compromise can only be reached through the dialogical give-and-take of common deliberation through which a very minimal framework that all sides, despite their deep differences, recognize as common, i.e. their very commitment to common deliberation, gets modified such that "each can recognize the other's moral values and standards as parts of it." (This definition of successful moral compromise I take from James Bohman 's paper on "Public Reason and Cultural Pluralism. Political Liberalism and the Problem of Moral Conflict", Political Theory, vol. 23, no. 2, 1995, pp. 253-279.) Such mutual recognition that enables modifications of their common framework does not necessarily make this framework one and the same framework for every side. It will still represent their conflicting reasons, and thus continue to appear different to each side. But sufficient fusion of perspectives ("Horizontverschmelzung") will be achieved, enough broadening of horizons will have taken place, to make the commonality of that framework good enough for both sides to continue their joint deliberative effort instead of opting out or simply fragmenting discourse into mutually inaccessible strata. 12 Moreno , op. cit fn. 1, esp. pp. 106-124. 13 Ibid. p. 108. ι* Lawrence Kohlberg , "From Is to Ought", 1971, in: L. Kohlberg, The Philosophy of Moral Development, San Francisco: Harper, 1981, p. 180.

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consensus group can ever be justified in claiming that the consensus which they take to be valid can be projected through a virtually infinite community. I will elaborate the discourse ethics notion of a practical discourse as we go along. But in order to be able to connect what I have to say about practical discourse with the workings of ECs I will now try to analyze the operative structure of an EC in a way that I hope can help to highlight their morally relevant features. I will then introduce the idea of a discourse ethics and explain its distinctive validity criteria for rightly claiming that a consensus has moral (as distinct from other sorts of) authority.

Π . Carving H£Cs at their Moral Joints. An Analytic Framework "One can distinguish three different sorts of institutional committees in the American health care system which have more or less explicitly ethical charges concerning human beings: institutional review boards (IRBs), which, among other things, monitor the use of human subjects in research; infant care review committees (ICRCs), which consider questions about the care of newborns, especially in neonatal intensive care units; and health care ethics committees (HECs), which are mainly concerned with ethical questions involving adults and older children. IRBs, which have more of a policing function than ICRCs and HECs, are responsible for ensuring that the statutory requirements of specific federal legislation are respected. In this legal capacity clear-cut majority views become more important than in ICRCs, which are responsive mainly to rather general federal requirements ... to investigate complaints of non-treatment of handicapped infants. Since HECs are not usually associated with government regulation of health care, they have still more flexibility than ICRCs to determine their own functions, including the manner in which their collective views are to be determined."15 (In Germany there are at present only IRBs. It takes little predictive skill though to tell that soon we are going to get the rest of it too. 16 ) Counting out some unspecific activities like addressing communication problems, searching for additional facts, studying relevant literature, relieving stress, etc., the more characteristic activities of HECs are education, guideline writing, and case based counselling or consultation. With regard to consensus, the activity of counselling or consultation is of primary importance because both successful "education" and successful "guideline writing" will eventually be measured in terms of their contribution to (i.e. how they facilitate or fail to facilitate) the morally proper handling of cases encountered in clinical practice. 15 Moreno , op. cit. fn. 1, pp. 89-90. 16 For a brief and recent overview of the German EC scene, see Hanfried Heimchen, "Ziele, Beratungsgegenstände und Verfahrensweisen medizinischer Ethikkommissionen", Ethik in der Medizin, vol. 7, no. 2,1995, pp. 58-70.

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This level of description though seemingly quite concrete does not give one much to go on. In order to specify the morally significant features of HECs I propose to analyze HECs as a bundle of various rules. Let me explain. I maintain that IRBs and ICRCs can be reconstrued as somewhat specialized, thematically constrained versions or abbreviations of the more general structure that HECs instantiate. (Given a description of the features that are relevant for the moral authority of HECs we will also be able to analyze the moral authority of consensus in IRBs and ICRCs but not necessarily vice versa.) I cannot argue this point17 here. But let me at least note in passing that the usual contrast between IRBs and HECs in terms of their differently configured input-output modalities is a distinction following from thematic specialization rather than underlying it. Whoever can activate a HEC usually can choose whether to refer a case to the committee and then, after receiving a recommendation, has the option of whether to accept it. This input-output configuration is called an "optional-optional committee". Four different configurations are possible and IRBs sit on the other extreme: usually their input-output configuration is mandatory-mandatory. This distinction is often conflated with another one, namely the distinction between giving advice or recommendations or counselling, on the one hand, and decision-making or consultation, on the other hand.18 But why can asking for and receiving advice not be mandatory-mandatory? (Decision-making, this much is true, could hardly be optional-optional without overstretching our concept of decision-making.) Jonathan Moreno seems right when he notes that "the distinction between advisory and mandatory opinions is often more apparent than real. For example, under certain political conditions the supposedly advisory nature of an ethics committee's views could be difficult for the principals to ignore, as when the chair of the hospital board or the chief of the medical staff is also chair of the ethics committee."19 An ECs opinion will have to have some moral authority no matter how its inputoutput rules are configured and the latter is not determined (though it is reasonably constrained) by the former. Here is an inexhaustive list of relevant rules: - Recruitment rules of personnel - Input rules : - Activation rules - Assignment of competencies

17

Namely the "thematic specialization thesis" I propose. A consultant is understood to be one who takes charge of a case or shares responsibility for the decisions in* a certain case. Counselling refers to guidance and advice, especially as given by a knowledgeable person. Counsellor and decision-maker are distinct actors (persons). ι* Moreno , op. cit. fn. 1, p. 90. For a similar view, see Ηοφτχί, op. cit fn. 8, pp. 94-95. 18

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- Output rules: - Display rules - Transference and channelling rules - Sanction-setting rules - Rules of self-control - (Other types of output rules) - Deliberation rules: - Problem-sorting rules - Thematic avoidance rules - Rules for the integration of non-moral normative sources - Rules for the integration of scientific or technical expertise - Normative moral theories - (Other types of deliberation rules) Recruitment rules of personnel specify the number and composition of the committee membership, how long and how strongly people will be associated with the committee. Input rules specify when, how and concerning what the committee becomes active. Output rules specify what is supposed to happen with a consensus prompted by the practical deliberations of the committee and whether (and if so how) the specified consequences are to be monitored. In other words, output rules program how the weak force of the good reasons which underwrite a rationally prompted consensus of the committee will go on to be processed in other branches and in further phases of the total institutional process. Output rules qualify the social bond that relates the party seeking advice or consultation and the deliberative body, somewhat analogous to how psychologists describe the ways ego and superego are related in the individual psyche. If the desirable role for HECs within the total institutional act is that of an auxiliary super-ego, then certain compliance and monitoring rules have to be set up and gauged accordingly. If this institutional auxiliary super-ego is too weak or too rigid, its overall contribution to morally better practice will be poor, no matter how well reasoned, principled, informed and insightful the deliberations on which its consensus is based may be. A moral view which an actor cannot sufficiently identify with is not the actor's own moral point of view. For reasons that have to do with the morally undesired effect of fragmenting or diffusing moral responsibility when being moral involves a systematically related chain of actors ("division of moral labor"), an institutional auxiliary super-ego must secure display rules that facilitate authentic appropriation of its output. Such display rules, above all, should facilitate repeated questions. Ideally, counselling terminates in the counselee's accepting or rejecting the counsellor's advice in full knowledge of the reasons that make the advice acceptable or unacceptable for him- or herself. 17 Jahrbuch für Recht und Ethik. Bd. 4 (1996)

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Moreover, the counselee (usually, but not always, a physician) will share his learning process with the counsellors who have shared their own learning process with the counselee. It ought to be the case - and this is a moral ought - that in many-person mediated moral judgments in case of consonant views (and still more important: in case of dissensus) leeway for mutual learning processes is assured. Mutual moral learning processes, to be sure. Pronouncements of HECs that do not allow the counselee who is confronted with a consensus output to sufficiently rehearse the reasoning and the reasoning principles that went into this consensus will remain alienated from the moral reflection that purports to enhance the counselee's own. 20 Deliberation rules are centrally important for the moral credit a group consensus may attain. Yet they are only necessary, not sufficient for the moral authority of consensus because an assessment of the moral authority of a deliberating body must cover the total institutional performance. An important type of deliberation rules are problem-sorting rules. It is easily said that, but seldom detailed how, HECs "should identify the ethical issues (as opposed to the emotional, legal, religious, or professional ones)".21 A "lot of questions in a hospital setting can end up being identified as ethics questions when they are actually interpersonal conflicts." 22 Any such classification already involves some substantive normative premises (about the nature of the moral) and can therefore lead, but ought better not to lead, to moral bias, moral paternalism or moral discrimination in certain problem contexts. The overall embedding of the committee's deliberations within the total institutional act ought to have communicative qualities that guard against this or at least make it unlikely that moral bias goes unchecked. HECs are continually challenged to identify and address "the ethical problem". By all standards, this makes it incumbent on them to bring their deliberations to an all-things-considered judgment. But how is the HEC to reflectively discriminate their focal problem ("the ethical problem") from legal questions, risk management questions, administrative policy questions, etc.? Another important type of deliberation rules are rules for non-thematization or gag-rules. They exclude certain themes from becoming the target of the committee's deliberations. Such rules are morally all right when they are pragmatically necessary (due to limitations of time and other resources) and when things are known to be such that the problems excommunicated by those rules are likely to 20 This raises the question of whether the patient (or family) is notified and included in the deliberations of the EC. Some ECs regularly notify patients' partners and perhaps require the treating physician to obtain consent for the EC consultation. Other ECs do not inform the patient (or family). Some do not even notify the physician if the request for consultation comes from a nurse or chaplain, etc. 21 Robert J. Levine , Ethics and the Regulation of Clinical Research, London: Yale U.P., 1986, p. 10. 22 Anonymous , "Forming an Ethics Committee: Make no Mistake about It", Medical Ethics Advisor, vol. 8, no. 7, pp. 73-84.

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be channelled into other tracks where they can be suitably processed. Rules for the integration of non-moral normative sources, and for the integration of scientific and technical expertise determine how the HECs deliberations reflect relevant legal constraints, professional codes, good clinical practice rules, cutting edge knowhow, etc. Moreover - and this point has tremendous moral bearing! - they determine the extent to which morally relevant learning processes are feasible among different HECs themselves. The centerpiece of the deliberation rules are, of course, the normative moral theories thatfigure in the committee's deliberations in articulated and non-articulated ways. Evidently there is great variety around, ranging from philosophically sophisticated types (diverse utilitarianisms, contractualisms, neo-Aristotelian virtue ethics, deontologisms) and religious doctrines to common sense moral intuitions. The literature is strangely mute on the morally significant question of whether and to what extent the committee's moral theories square with those of the counselee, or with those of the counselee and the committee's "moral patient". Deliberation rules ought to accommodate moral diversity or at least they ought to sustain an awareness of the moral costs of overriding discrepant moral theories when some of those concerned are actually identified with such discrepant theories. Deliberation rules are the core determiners23 of the moral authority of the HECs in whose deliberations they figure. Why? Because deliberation rules jointly determine what kinds of reasons the committee members can appreciate as good reasons that will work towards the emergence of a consensus. And whoever is affected by that consensus (e.g. treating physicians, treated patients) will be able to appreciate it only to the extent that they are able to interpret and assess the reasoning that has gone into, or is supposed to have gone into, the consensus.

ΠΙ. Discourse Ethics. Outline of a Solution In the remaining five sections I will sketch the role of discourse ethics vis-à-vis other paradigms of moral theory and its place within a broadly value pluralist and secular society. The discourse ethical rational for the moral considerations to which I have appealed at various points in the preceding section will become more clearly articulated, I hope, as we go along. 1. Argumentative

Consensus Building in the Face of Moral Pluralism

Ethics or morality - 1 use these terms here interchangeably24 - can be characterized as a social practice of governing one's doings by a concern for (certain aspects 23 I use this metaphor in order to avoid the necessary / sufficient conditions jargon. 24 By 'normative moral theory' we understand a reflective or otherwise theoretical elaboration of some ethical outlook that preserves the prescriptive force of that outlook though it 17*

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of) the well-being of (certain sorts of) beings. In all commonly recognized moralities the set of beings with moral standing includes people. Usually these will be the members of the same community of moral concern, or one's moral peers. Different moralities draw the boundaries of their respective communities of moral concern in different ways. Whereas "particularist" moralities draw the boundary narrowly it is also possible to extend the community of one's moral peers "universally" so as to encompass all human beings regardless of cultural differences and spatial or temporal distances between them. Such universalism, far from being a lofty idealism, is a built-in possibility of people's moral-cognitive development. This development is patterned into a number of stages in an invariant sequential order. There is ample cross-cultural evidence for this in cognitive developmental psychology.25 To say, as is often done, that a morality is a "normative system" regulating action by classifying it for "praise and blame" is overly general. For there are many different action-guiding normative systems (e.g. law, religion, prudence, mores, etiquette) none of which is identical with, though each is somehow related to, morality as we know it. 2 6 Moralities are complex socio-evolutionary constructions: A morality is a more or less integrated yet open-textured27 web of knowledge, emotional dispositions ("moral feelings"), action skills ("virtues"), motivational propensities ("altruism"), and interpretative resources ("moral thinking").28 This web provides us with moral reasons,29 moral judgments and moral norms. Moral reasons are reasons why certain things ought or ought not to be done, in a sense of 4ought' in which failing to do what one ought to do is morally wrong. Moral reasons in turn support our practice of moral judgments. Moral judgments are judgments on the moral tightness or wrongness of claims concerning what ought or ought not to be done. That something ought (morally) or ought not (morally) to be done is usually expressed in the format of a (moral) norm. A norm presents some way of action in certain circumstances as (morally) required of certain agents. There is, of course, a wide variety of norms only some of which are moral norms. Legal rules, rules of games, traffic regulations, and so forth, are all norms. may specify, qualify, explicate or limit that force. The theory /practice distinction thus does not coincide with the normative / non-normative distinction. - Not all moral theory, of course, is normative. Some is merely descriptive, some explanatory. 25 Cf. esp. Anne Colby & Lawrence Kohlberg, "The Measurement of Moral Judgment", Cambridge: UP, vols. 1 & 2 (1987). See also Thomas E. Wren, ed.: The Moral Domain. Essays in the Ongoing Discussion between Philosophy and the Social Sciences, Cambridge: ΜΓΓ Press (1990). 26 Hector -Neri Castaneda, The Structure of Morality, Springfield, 111.: Charles Thomas Publisher (1974). 27 JM. Brennan, The Open-Texture of Moral Concepts, London: MacMillan (1977). 28 Allan Gibbard, Wise Choices, Apt Feelings: A Theory of Normative Judgment, Cambridge: Harvard UP (1990). 29 Jonathan Dancy, Moral Reasons, Oxford: Blackwell (1993); David Copp, Morality, Normatività and Society, Oxford: UP (1995).

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Moral as opposed to other sorts of norms are norms which are inter-subjectively recognized as "categorical",30 i.e., to the extent that people are unwilling or unable to respect them (minimally as negative constraints, maximally as positive ideals) in their deliberations about what they should do, people will either be taken to act immorally ("morally wrong") or will not count as moral agents at all. That some norm Ν (e.g. "do not lie!") is categorical does not mean that one is obliged to replicate what Ν manifestly requires one to do in all situations in which it would be possible to act according to N. That Ν is categorical does mean, however, that one must at least consider Ν and the reasons Ν gives in the actual situation which is the source of one's perplexity. The concrete situation S might be such that a number of norms N 1 . . . Nn are relevant in it. Yet N 1 . . . Nn might fail to jointly adjudicate that a certain range of actions is permissible. Hence if N1... Nn differentially bear on the question of what one is permitted to do in S then an inter-subjectively respectable consensus has to be worked out concerning the proper determination of the norms held relevant in S and concerning the determination of what would be considered - by everyone affected by the outcome of these deliberations - a proper response in S to all the norms (and hence values) relevant in S and to the particular ways in which each of them individually is, and all of them jointly are, so relevant. For instance, the four cherished "principles" of biomedical ethics ("autonomy", "non-maleficence", "beneficence", and "justice", as set out by Tom Beauchamp and James Childress31) are very abstract norms; and they are categorical for members of the profession who identify with, i.e., who are determined to reproduce in their actions, their profession's self-constructed moral profile. Obviously then, the four "principles" will have some role to play in the deliberations of ethics committees that deal with medical matters. To bring out more clearly the sense in which moral reasons, judgments and norms differ from non-moral reasons, judgments, and norms, it is helpful to consider the notion of moral responsibility. Moral agents are persons who bear, and take their moral peers to bear, moral responsibility.32 A person's moral responsibility is a responsibility that is neither exhausted by that person's causal role in the outcome of actions nor in that person's liability that is relevant to juridical assessment of actions. Rather, the bearing of moral responsibility consists in taking seriously how the outcome of one's conduct, i.e. of possible actions or omissions, affects oneself and others for good or ill. 3 3 30 Alan Gewirth, Reason and Morality, Chicago: UP (1978). 31

Cf. "Principles of Biomedical Ethics", Oxford: University Press, 1994 (4th edition). 32 John Ladd, "Philosophical Remarks on Professional Responsibility in Organizations", Int. J. of Applied Philosophy, vol. 1, no. 2 (1982) p. 67; Harry G. Frankfurt, "What we are Morally Responsible For.", in: L.S. Cauman, ed.: How many questions?, Indianapolis: Hackett (1983); Peter French, "Fishing the Red Herrings out of the Sea of Moral Responsibility", in: E. Le Pore, ed.: Actions & Events, Oxford: Basil Blackwell (1985). 33 More precisely: Anyone's bearing of moral responsibility consists in his or her taking seriously (= as seriously as we think anyone of us should) how the outcome of anyone's con-

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Different moralities, of course, assign different contents to the structure of such responsibility: different ways of acting ("conduct"), different reference groups ("others"), different significant values ("good or ill"). For instance, someone who endorses the medical ethos (whose intra-professional profile is aptly captured by the requirements to act 1. beneficently, 2. respectful of personal autonomy, 3. nonmaleficently, and 4. in accordance with justice) might think it is her duty to use mice (rather than men) for certain medical experiments, whereas someone who endorses a utilitarianism-based animal ethics might condemn such practices as morally outrageous preferential protection of humans over other sentient animals. Or take the abortion issue: Two persons can both uphold the morally significant value of personal human life as a morally significant value and yet one of them might conjoin this value with another morally significant value, e.g. personal self-determination, and interpret this value-complex in totally different deontic moral terms ("to permit abortion is morally right") from the second person who might absolutize the morally significant value of human life ("for everyone, abortion is morally wrong"). This diversity of interpretations implies moral pluralism. From pluralism we have to distinguish moral relativism. Diversity and pluralism do not at all imply relativism. Consider: Like natural languages, moralities are a pervasive feature of human culture. Yet whereas cross-translatability between any two natural languages seems to be feasible in principle without any limitation, the fact of moral diversity (and value pluralism) has been taken to support the view that it makes sense to speak of justified moral claims or commitments only with reference to particular cultures: cultural moral relativism. However, strong moral relativism (and incommensurability of values across deeply different cultures or across subcultures) is a self-refuting theoretical view, as is the view that understanding across different value-horizons is impossible. I cannot discuss these points here. Suffice it to say that the worldwide recognition of those deontic reasons and morally significant values which we abbreviate as human rights in fact contradicts any strong relativism and incommensurabilism. At a sufficiently abstract level (where moral deontic reasons take the form of "moral principles") thete is considerable overlapping consensus across diverse cultures despite disagreement over their more finegrained interpretation, their respective ranking and the extent to which real social practices ought to be governed by which principles.34 A certain range of values (e.g. freedom, the provision of basic needs, integrity of primary affective bonds, sanity)35 bear moral significance virtually everywhere. Yet the determinate interduct, i.e. of possible actions or omissions (= one's own or someone else's) affects oneself and others for good or ill (= as considered impartially between oneself and others). 34 Gene Outka & John P. Reeders, eds.: Prospects for a Common Morality, Princeton, N.J.: UP (1993). For a less sanguine view see EE. Snare, "The Diversity of Morals", Mind, vol. 89,1980, pp. 353-369. 35 Bernard Gert, "Rationality, Human Nature and Lists", Ethics, vol. 100, 1990, p. 279300.

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pretations that one gives to them in terms of moral action requirements, or moral norms, may differ drastically across different cultures. The acknowledgment of moral core-values underlies our moral judgment concerning the moral wrongness and lightness of norms. Moral core-values translate into the very principles which govern our judgmental practices, e.g. principles of justice, benevolence, non-maleficence, and respect for personal autonomy. The fact of moral diversity (even at the level of principles) should not obscure another important fact, namely that the common object of any morality is the facilitation and enhancement of human flourishing36 - even in borderline cases where such flourishing is interpreted, as in some "cosmocentric" ethical outlooks, to amount to a concern for the integrity of inanimate components of nature. The fact of moral diversity needs to be sensibly accommodated in any morality and normative moral theory with universal aspirations. To see why, consider that universal moral claims make a claim on everyone who properly considers them. They purport to command the assent of whoever is a morally responsible agent. Yet someone making such claims is always a member of some particular community in space, time, and culture. Hence such members run the risk of imposing the claims of what they take to be their universal morality on others whose moral view, if only it were allowed to express itself, could be seen to differ from or really to defy those claims. Owing to the universalism inherent in our notion of rational validity, a rational morality will also aspire to universalism. Yet a sensible universalism in morality, it seems, must not run rigid moral principles over a moral world of heterogeneous moral views. Doing so would buy uniformity at the cost of dogmatism or paternalism. Both are associated with unnecessary "moral costs". They are therefore wrong according to the very standards of a rational morality. To the extent that an allegedly rational morality or moral theory is insensitive to its own impact, or lacks the conceptual resources for the moral assessment of such impact in its application, it is seriously inadequate to the modern pluralist condition.

2. Moral Perspectives A moral point of view is a stance that someone who identifies with some morality M (e.g. by "having been brought up" in the spirit of M, byfinding M convincing, etc.) can take in order to assess the impact of activities and the reasons for which people take themselves to be justified in doing what they do. A moral point of view discloses the "moral costs" (according to the value standards acknowledged in M) which accrue to people's transactions. By taking a moral point of view one assesses impacts of, and reasons for, actions with an eye to minimizing whatever their moral costs are seen to be. Being a moral point of view, it discloses what is right or wrong (as judged by its avoidable moral costs) and thus what ought to 36

J.L. Mackie, Ethics. Inventing Right and Wrong, London: Penguin (1977).

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be done or ought not to be done (on moral grounds). Being a point of view no moral perspective is all-encompassing. Being a point of view any moral perspective, to the extent that it can be called rational, admits of controversy and consensus, questions and answers, argument and counter-argument. Naturally, there are many different points of view, moral and non-moral: we can assess actions and the reasons for which people perform them from, e.g., a prudential, a technical, a legal, a moral, an economic, a religious and, no doubt, from many more points of view. For instance, some new medical technique may be ingenious and highly recommendable on prudential grounds when seen from a techno-economic point of view (e.g. because it saves resources) and yet be disreputable and wrong on grounds of its moral costs when seen from a moral point of view (e.g. because it subverts patient autonomy); a law might be legitimate from a juridical point of view (e.g. because it has passed parliament) and yet be illegitimate morally considered (e.g. because it violates humanrights),etc. To trace out what is morally problematic in some target matter (e.g. whether a certain living patient's will, or a certain comatose patient's living will, should or should not be complied with) is to look for perplexities from the point of view of moral lightness and wrongness. For the reasons given in the next section, I assume that discourse ethics is center-stage among all reasonable moral perspectives. This is not to say that discourse ethics replaces them. It is to say, rather, that discourse ethics is central in its capacity to synthesize and gauge different other moral perspectives. How important people take a moral perspective as compared to non-moral points of view will depend, of course, on how much they care about moral Tightness concerning the issue at hand. Taking a moral point of view certainly is no privileged shortcut to an all-things-considered judgment about anything. It is not the job of an ethics committee to deliver narrow moral advice of a kind that cannot stand up as valid when more and more features of the concrete perplexing situation are taken into account. Sound moral advice is bound to be advice that is sound in the way of an all-things-considered judgment. Usually, sound moral advice is not merely all-moral advice.

3. Discourse Ethics and other Moral Paradigms Roughly, four paradigms of normative moral theory and their respective central principles are at present in the foreground of philosophical ethics.37 These paradigms are the following. (1) Kantian deontology with its principle thai persons ought to be respected as ends-in-themselves,38 (2) utilitarianism with its principle 37 For the first three, see Gilbert Harmon , The Nature of Morality. An Introduction to Ethics, Oxford: UP (1977).

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that utility ought to be impartially maximized,39 (3) contractualism with its principle that explicit or tacit agreements for mutual benefits ought to be honored,40 and (4) consensualism with its principle that all normative arrangements ought to be procedurally governed through free and open argumentative dialogue ("discourse"), ideally with proper participation of everyone who is concerned with or is otherwise affected by the particular arrangement in question.41 Of these, consensualism as developed into a "communicative" or "discourse ethics" (Apel, Habermas) is the most integrative and most flexible position. Its central principle is that the reasons on which people claim that something is morally right must be such as to be acceptable from the first-person plural perspective ("we") of everyone concerned by the practice, activity or regulation whose moral lightness is at stake. Moral lightness then is a property of action-norms that ultimately depends on the cooperative discursive practice of free and open dialogue. This is not to say that all moral content is held to be generated in dialogue42 or that we would have to devote all our moral life to argumentation. Instead, the discourse principle is a problem-driven principle, i.e. its critical force is invoked only when particular issues cannot be satisfactorily handled by the conventional resources which the people concerned are already used to taking for granted. Hence it operates on subject matters which are always already preinterpreted by whatever determinate moral intuitions the participants happen to bring to the fore. Practical discourse is the medium to modify and reshape them. In practical discourse, people work through their various moral perplexities in a cooperative effort at reaching a maximally value-respecting practical deliberation which everyone can support though it need not totally coincide with their own particular moral point of view. A second point deserves mentioning. Consensus building constrained by discourse ethics allows the emulation of central principles of other moralities. For instance, if everyone whose needs and interests are affected by some practice ρ were to agree in a practical discourse to regulating ρ by utilitarian standards then the discursively prompted consensus about the morally right way of regulating ρ will 38 Onora O'Neill, Constructions of Reason. Explorations of Kant's Practical Philosophy, Cambridge: UP (1989). 39 Amartya Sen & Bernard Williams, eds.: Utilitarianism and Beyond, Cambridge: UP (1982); Richard Hare, Moral Thinking. Its Levels, Methods and Point, Oxford: Clarendon Press (1981). 40 David Gauthier, Moral Dealing. Contract, Ethics, and Reason, Ithaca: Cornell UP (1990). 41 Karl-Otto Apel, Towards a Transformation of Philosophy, London: Routledge (1980); Karl-Otto Apel, "Is the Ethics of the Ideal Communication Community a Utopia?", in: S. Benhabib & F. Dallmayr, eds.: The Communicative Ethics Controversy, Cambridge: ΜΓΓ Press (1990) pp. 23-60; Jürgen Habermas, Justification and Application: Remarks on Discourse Ethics, Cambridge: ΜΓΓ Press (1993). 42 For this misunderstanding see Michael Walzer, Thick and Thin. Moral Argument at Home and Abroad, Notre Dame: UP (1994) esp. pp. 7-15.

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result in p's being so regulated. However, whatever substantial moral principle people would want to adopt gets constrained in discourse ethics by respect for the capacity of people to reach a common understanding about how they want to treat and be treated by others, regardless of egocentric positional differences. Note that discourse ethical consensus-building is not equivalent to a unanimity requirement, nor to majority vote, nor to any preference-aggregative decision procedure (e.g., bargaining). The dynamics of consensus-building in practical discourse does not guarantee a unique "solution" to all moral issues. Staking out a range of permission is often the best we can come up with. No morality is an algorithm for solving problem cases. To some extent, morality must countenance tragic choices and persistent tensions. These will at best admit of alleviation but hardly ever of total resolution, and never without at least some moral costs remaining unjustified. However, a consensus sufficiently sensitive to the constraints of practical discourse guarantees to all parties who mutually recognize one another as having a credible stake in the outcome that they are mutually aware of all their different "moral costs" as well as theright-makingand wrong-making reasons from every participant's particular moral point of view. This is the best outcome that a rational morality can realistically aim at. The possibility of reasonable disagreement (dissensus) exists alongside the possibility of reasonable agreement (consensus), but the latter envelopes the former. On this basis, discourse ethical consensus may well encompass some justified dissensus and, perhaps, even dissensus amounting to moral compromise, yet one in which no one's morally significant values will be unduly compromised. As I see it, at the heart of morality as a rational enterprize there is neither obedience to rigid moral duties ("categorical imperative", "divine commands", "natural law"), nor strict adherence to the moral rules of one's society ("moral code", "conventional morality"), nor simply a bag of virtues of doing good, nor merely prereflective intuitions aboutrightand wrong. Returning to the structure of moral responsibility already introduced, the following point emerges. A threefold moral responsibility takes center-stage in any rational moral outlook shaped by discourse ethical constraints: The responsibility (a) to care about whatever activity one is in a position to influence or, as in the case of one's intentional actions, to control. The responsibility (b) to represent fully and truthfully to oneself and others this activity's total impact on the well-being which, by the light of one's moral commitments, one ought to respect. The responsibility (c) to act in ways that would be impartially justifiable, given their impact, in a consensus-building process in which all those on whose well-being the activity in question impacts could debate their respective concerns over (a + b) on an equal footing. 43 43 In this formula I render in terms of moral responsibility the gist of the five discourse constraints introduced in section 3.5. infra. - Notions like 4total impact', 'consensus of all concerned', 'debate on an equal footing' are, of course, idealizations, or aspirational stan-

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4. Disputing Norms, Values, and Facts There are no moral problems per se, i.e. independent of people who are morally perplexed by what their taking a moral point of view discloses to them about some of their practices. As substantial interpretations of moral responsibility differ, what is a moral problem to one person is not always a moral problem to another, though both parties take a moral view of things. An atheist, for example, will have no moral qualms about sacrilege, because for her the concept of the holy (on which the characterization of a certain transaction as sacrilege depends) will be an empty concept. A Roman Catholic's belief that one ought not engage in sexual activity unless the two values of possible procreation and marital affective solidarity are jointly served will bear heavily on her moral evaluation of the impact of contraceptive practices as such practices ply apart ("de-naturalize") procreation and the pursuit of sexual happiness, two endeavors whose natural nexus is a morally significant fact when considered from the Catholic faith perspective. We find moral problems when we find people in doubt about whether a course of action is right or wrong. Hence if we want to understand moral problems, we must find out the rationale for why people are perplexed about what is right or wrong. A good deal of an answer to why we are better off having ethics committees in medical contexts than not having them lies in the fact that people who cooperatively discuss a case that is seriously perplexing to at least one of them will often do much better in discerning and interpreting real and apparent perplexities than individual persons all by themselves. People's disputing what they take as proper responses to their moral perplexity, to the extent that such disputes are rational, is governed by a logic of discourse. This logic of discourse revolves around our powers of raising and answering: - questions of fact (senses in which something to believe can be the case) - questions of value (senses in which something to appreciate can be good), - questions of norms (senses in which something to do can be required of someone): Questions of fact and their associated truth-claims can be disputed with reference to the availability and convincingness of the evidence for establishing what is the case. Questions of value and their associated claims of evaluative commitment can be disputed with reference to the appropriateness and importance of the properties by which something is held to be valuable in the disputed sense of good. Whether the purportedly good-making or value-giving properties are really present is then again governed by questions of fact. Questions of norms can be disputed with ref-

dards for, rather than descriptive features of, real discourse processes. Idealizations are every bit as indispensable in ethics as they are in science. For an illuminating analysis of idealizations in ethics see Dorothy Emmet, The Role of the Unrealisable, N.Y.: St Martins Press (1994).

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erence to the values a norm is held to serve or express. Whether the values supporting the claim that certain agents ought to do certain things really authorize the norm in the disputed sense of requiredness is then again governed by value questions and by factual questions. Two people in disagreement about what one ought to do must consider whatever other norms they subscribe to and link with the norm in question. Norms face the tribunal of discourse and experience corporately: A commitment to some norm Ν may turn out to mean, on pain of incoherence, subscription to (or refusal to accept) some other norm N \ Furthermore, people turn to what each of them takes as the relevant values that bear on the norms, i.e., on what one ought to do. And two people in disagreement about why they have reason to consider something good must be prepared to scrutinize themselves, or have others scrutinize, as many of their other evaluations as are found to be somehow related to the one in question. Values, like norms, face the tribunal of discourse and experience corporately. Hence the cherishing of some value V may turn out to mean, on pain of incoherence, commitment to sustain (or repudiate) some other value V \ Furthermore, people discuss what they take to be the relevant facts and their relations, which they think explains why they suppose something in question to be good.44 The unfolding dialogical dynamics of sensibly relating factual, evaluative and normative questions, if need be by successively modifying them, makes for rational inquiry in the perplexity-driven discourse processes taking place either in mente or, as the case may be, interpersonally in groups (e.g. ethics committees, public policy making bodies) or in long-term public debates. The argumentative process that unfolds in the format of an ethics committee does not start from scratch. It is but a phase of an ongoing, sometimes very smooth, sometimes very unruly process of collective governance of the norms we live by, especially of the moral norms to which we accord a sort of organizing, controlling or constraining position concerning many other norms that make up the fabric of the forms of life that we individually and collectively accept. The ethics of ethics committees, as it is articulated, reproduced or modified in the dialogical processes of these committees, feeds into the larger social life of the institutions into which the committees are integrated and in turn is fed by the moral views found within the smaller or larger communities in which these institutions (e.g. neonatal care units, emergency rooms, hospices) serve their accepted purposes.

44 Using technical terminology, we can sum up this section by saying that normative differences supervene on evaluational differences, which in tum supervene on factual differences. 'Supervenience* here is a conceptual relation such that if properties of kind χ supervene on properties of kind y then there can be no difference in χ without some relevant difference in y. Properties of kind χ cannot be defined in terms of, nor reduced to, properties of kind y; but they are determined by the latter.

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Discourse ethics attempts to delineate a range of prescriptive contents for which a rationally definite grounding can be expected, to spell out such contents, and to establish their presumably universal validity by ascertaining their rationally definite grounds. Such grounds, it is claimed by Apel, can be found in the very activity of argumentation itself. They can be ascertained when people involved in the argumentative assessment of validity claims (e.g. that some proposition ρ is true, that some normative arrangement η is right, that some course of action a is wrong) think about which operative presuppositions they have to share in their exchange of argumentative speech acts in order for their exchange to be a meaningful bit of argumentation. If there are such discernible presuppositions of argumentation then they are thus non-contingently related to argumentation. Apel maintains that there are morally significant non-contingent presuppositions of argumentation. He calls them "transcendental-pragmatic" presuppositions: "pragmatic" in as much as they pertain to and are operative in a communicative praxis , namely argumentation; "transcendental" in as much as commitment to those presuppositions is unavoidable for any speaker who intends his or her speech acts to be communicatively rational. Communicative rationality, and some concept of it, is indispensable for, and irreplaceable in, every possible discursive world. 45 In argumentation, we are dialogically and cooperatively trying to trace out the best reasons. The very idea of a reason's being good or bad, and being assessable as good or bad, is an idea of a communal practice that is charged with morally relevant presuppositions.46 Argumentation, it seems, is a dialogical procedure whose outcome tends not so much to reflect the participants' unequal powers, differences in social status or divergent intellectual abilities but rather the force of the better argument only. Apel and Habermas call argumentation operating under this regulative ideal "argumentative discourse". Consider, for example, the fact that participants in discourse necessarily presuppose, with regard to all beings capable of speech and argumentation, their reciprocal recognition as free and equal persons, namely as persons who are equally entitled to, and equally free to, express entirely on the basis of their own rational evaluations of reasons and arguments consent or dissent to any discursively raised validity claim. Furthermore, in argumentation over validity claims we presuppose

A "discursive world" is a world in which (1) there is an exchange of speech acts between at least two persons P] and P 2 that we (you or I, here and now) can conceptualize as an episode of argumentation (about an utterance for which universal validity claims are raised); (2) such that Pi and P 2 (and we with them) mutually share an understanding of their exchange as an episode of argumentation; (3) and they, Ρ χ and P 2 , could share their mutual understanding with us. 46 Cf. Bruce Jennings , "Possibilities of Consensus: Toward Democratic Moral Discourse", J. of Medicine and Philosophy, vol. 16, No. 4, 1991, pp. 447 et seq.

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that the intrinsic aim of our activity is the settling of disputed validity claims by rational agreement reached entirely through uncoerced dialogue. Although dialogue in the actual world is always bound to be dialogue within a limited community of particular persons, the audience addressed in terms of counterfactual intentions is a "virtually infinite community of communication".47 Discourse ethics imposes a number of morally relevant constraints on the rational acceptability of any proposed or already entrenched substantive moral principles, concrete norms of action, value-orientations, etc. Discourse ethics constrains the rational acceptability of any deontic judgment or institutional arrangement whose nprmative force can be expressed in deontic judgments,48 by requiring it either to have a consensual etiology, or to be conceivable as, or be an equivalent of, something else which in its own turn has or could have a consensual etiology. (The idea of a consensual etiology should not be misunderstood for a Utopian idea. Rather, the idea of a consensual etiology of χ is a critical yardstick for evaluating the moral acceptability of x.) I will now explicate five constraints that provide content to the notion of a practical discourse. Moreover, these constraints make clear some important respects in which practical discourse differs from less demanding moral "conversations" and from practical deliberation in general. 1. Autonomous Articulation of Need-Claims: That all participants be capable of reasonably interpreting their own need-claims so that interpretative authority ultimately rests with each individual. 47

Cf. Karl-Otto Apel, Towards a Transformation of Philosophy. London: Routledge (1980). See also Apel, "Types of Rationality Today", in: T. Geraets, ed.: Rationality Today, Ottawa: Univ. Press, 1979, pp. 307-340; Apel, "The Problems of Philosophical Foundations in light of a Transcendental Pragmatics of Language", in: K. Baynes & J. Bohman & T. McCarthy, eds.: After Philosophy. End or Transformation?, Cambridge: ΜΓΓ Press, 1987, pp. 250-290. 48 Deontic judgments are judgments people make when they express action requirements and their rational attitudes toward such requirements. Rational attitudes are those based on the evaluation of reasons; they are reflected in people's judgments concerning whether, given certain reasons, certain requirements do or do not hold. A deontic judgment Ν is a judgment that under certain circumstances certain types of action are required, in some qualified sense of a deontic modality, of certain agents. Ν makes a certain way of acting into a norm for certain people. For a person to sincerely accept (or "endorse") Ν (that S under circumstances C ought to do X) is to think of the person who is the logical subject of Ν as someone who ought to do what according to the intentional content of Ν someone is to do. For a discussion of deontic judgments in discourse ethics, cf. M. Kettner, "Wie ist eine diskursethische Begründung ökologischer Rechts- und Moralnormen möglich?", in: J. Nida-Rümelin & D. v.d. Pfordten, eds.: Ökologische Ethik und Rechtstheorie, Baden-Baden: Nomos, 1995, pp. 301324; M. Kettner, "Individualisierung im praktischen Diskurs", in: J.-P. Harpes et al., eds.: 25 Jahre Diskursethik. Ein Kolloquium, LIT-Verlag: Luxemburg, 1996, pp. 35-53; M. Kettner, "The Disappearance of Discourse Ethics in Habermas' 'Faktizität und Geltung'", in: R. von Schömberg, ed.: Reading Habermas' Recent Philosophy of Justice, Albany, N.Y.: SUNY Press (forthcoming 1997).

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2. Bracketing of Power Differentials : That differences in (diverse sorts of) power existing between participants give none of the participants good reasons for accepting any deontic judgment. 3. Nonstrategic Transparency: That it be feasible for all participants to be able to convey to one another without strategic manipulation of one's commitment to truthfulness how one interprets need-claims, one's own or those of others. 4. Polycentric Role-Taking: That the capacity for temporarily bracketing one's own need-claims in favor of hypothetically stepping in someone else's shoes (in order to understand that particular other's need-claims) be sufficiently exercised among the participants. 5. Comprehensive Inclusion: That the community of argumentation (as represented in particular by the discourse participants) take care that everyone who foreseeably could be affected for (their) good or ill by the participants' consensual acceptance of some deontic judgment Ν be included (or be in some other way properly represented) as a participant in the community of argumentation (about the moral assessment of N).

But why does governance by the five constraints lend moral authority to a group's practical deliberation leading to the consensual acceptance of some deontic judgment N? The answer is this: By virtue of being prompted by deliberations governed by those constraints, a consensus to accept Ν will be such that each person's practical deliberations (for either recognizing or rejecting N) will have been shared, or be capable of being shared, with each other person's practical deliberations. This maximal shareability of their practical deliberations for N vis-à-vis every person who is called on or affected by Ν is the property of moraltightnessas construed by discourse ethics.49 A deontic judgment Ν that is so shareable is morally right because in the process of reaching a common understanding of Ν in practical discourse no relevant problemizing reason will have been unjustifiably excluded, everybody with a stake in the matter will have had a chance to communicate all their justifying reasons to everyone else and vice versa, respond to all their criticisms (e.g. by modifying their own or someone else's position) and the communicative actions in the argumentative discourse will not have been massively influenced by some participants' rigidly self-interested strategic reasons. The moral significance of practical discourse then lies in its dynamic and self-correcti construction of impartiality , of solidarity , and of collective moral responsibili

49 For the purpose of a systematic introduction of discourse ethics this construal of moral lightness would have to be compared with how other normative moral theories conceive of moraltightness.A full-blown defense of discourse ethics vis-à-vis rival moral theories would establish that the property of moral lightness as defined by discourse ethics is sufficient for (i.e. establishing) moral lightness, where no competing concepts of moral lightness are part of the moral perplexity to be addressed, and necessary (i.e. constraining) where dissonant diversity of conceptions of moralrightnessis part of the very problem to be addressed.

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the sense of our taking seriously how our actions affect good or ill 50

ourselves and others

Zusammenfassung Institutionalisierte Formen moralischer Reflexion sind ambivalent. Befürworter sehen darin professionsinterne moralische Sensoren der Zivilgesellschaft, Gegner betonen die Bürokratisierungstendenzen, Machtstrategien und mangelnde Legitimation solcher Gebilde. Der Artikel vertritt und diskutiert die These, daß für die Legitimität von medizinischen Ethik-Komitees (klinischen: Health Care Ethics Committees = HECs; forschungsbezogenen: Institutional Review Boards = IRBs) die Frage entscheidend ist, welche Art von Argumentation in ihnen normalerweise stattfindet, strukturell gefördert oder aber behindert wird. Besondere Aufmerksamkeit wird der Frage nach Art und Quellen der Autorität von Konsensen, die in HECs gefunden werden, gewidmet. Die normative These wird vertreten, daß die Konsensbildung in HECs am idealtypischen Modell „praktischer Diskurse" auszurichten ist. Ein analytischer Rahmen zur Beschreibung von HECs als Bündel diverser Verfahrensregeln wird eingeführt (Rekrutierungs-, Eingangs-, Ausgangs-, Überlegungsregeln). Diese Regeltypen werden sodann inhaltlich spezifiziert und normativ begründet, und zwar auf der Basis der „Diskursethik" in ihrer von KarlOtto Apel entwickelten, transzendentalpragmatischen Gestalt. Die Grundlagen der Diskursethik werden vor dem Hintergrund moralischer Pluralität und diverser Paradigmen philosophischer Ethik eingeführt. Fünf normative Parameter, mit deren Hilfe das prozedurale Ethos der Diskursethik in realen Verständigungsverhältnissen zur Geltung gebracht werden kann, werden dargestellt. - Der Artikel beschreibt und begründet ein diskursethisches Design von Ethik-Komitees.

» I thank Sharon Byrd and Louise Lears for valuable comments.

Patient-Physician Communication and the Law's Requirements1 Dieter Giesen I . Introduction A medical intervention without an informed patient's consent is unlawful. This principle is central to all medical decision-making and its legal regulation. It is not within the scope of this treatise to examine the substance of the principle and the varying manner in which it is interpreted and applied in a number of leading Civil Law and Common Law jurisdictions 2. It can safely be stated, however, that while these legal rules share a common ethical foundation, the variable standards of disclosure 3, which physicians are expected to meet in order to ensure the validity of consent, afford an uneven measure of protection to patients' fundamental interests4. ι For ordinary legal and other abbreviations applied in this treatise cf. the List of Abbreviations used in D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) xxix-xlvi. The following abbreviations are also used throughout this treatise: D. W. Louisell & H. Williams , Medical Malpractice, 4 vols. (New York 1995) [cited with authors* names, volume and section number]; MHCD - [United States'] President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Making Health Care Decisions, 3 vols. (Washington 1982) [cited with volume and page number]; H. L & J. Mazeaud & F. Chabas, Traité théorique et pratique de la responsabilité civile delictuelle et contractuelle, Tome ΙΠ.2 (6th ed. Paris 1978) [cited H. L & J. Mazeaud & F. Chabas with volume, page and section number]; G. Mémeteau , Le droit médical (Paris 1985) [cited as G. Mémeteau with page and subsection number]; X. Ryckmans & R. Meert-van de Put , Les Droits et les Obligations des Médecins, 2 vols. (2nd ed. Bruxelles 1971-1972) [cited as X. Ryckmans & R. Meert-van de Put with volume, page and subsection number]; Mtinchener Kommentar zum Bürgerlichen Gesetzbuch. Band 3 - Schuldrecht. Besonderer Teil, 2. Halbband (§§ 652-853, § 823 by //. Mertens) (2nd ed. München 1986) [cited MünchKomm (- H. J. Mertens) with note[s] to BGB-section referred to]; E. L Picard , Legal Liability of Doctors and Hospitals in Canada (2nd ed. Toronto, Calgary & Vancouver 1984) [cited as E. I. Picard with page number]. 2 For a recent discussion of some of the more important issues and comparative law developments in this context, cf. D. Giesen , "From Paternalism to Self-Determination to Shared Decision-Making in the Field of Medical Law and Ethics", in Patient's Rights: Informed Consent, Access, and Equality, ed. L. Westerhäll & Ch. Philips (Stockholm 1994) 19-38. 3 As for the possible standards of disclosure from a comparative law perspective, cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 505-669. 18 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

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Discussion of the question of consent to medical treatment is generally focussed upon the patient's interest in his best health (salus aegroti), and his interest in deciding for himself what is to be done to his body (voluntas aegrotif. The outcome of any such discussion, which may take place on an ethical as well as a legal plane, will depend upon whether the possibility of a conflict between these interests is acknowledged and the relative weight attached to each. Medical ethics, from the Hippocratic Oath 6 onward, has taken a thoroughly paternalistic position7, emphasizing the patient's somatic well-being above his dignitarian interest in determining whether and to what extent he shall undergo any recommended medical procedure. A doctor's primary ethical duties within this framework are owed to his fellow medical professionals, his obligation to his patient (merely) being to apply his training and skills with competence and diligence to ensure attainment of the unshakeable goal of full health 8 . Such professional norms and paternalistic attitudes, transmitted from generation to generation of doctors, were of little significance in former centuries when medical knowledge was scant and the usage of health care services was infrequent 9. But in our contemporary, medicalized society, health care is a large and ever-expanding sector of the economy and doctors have become a select and powerful élite, truly standing as the gatekeepers of life and death 10 . The

4 For a more detailed discussion, cf. D. Giesen & John Hayes , "The Patient's Right to Know - A Comparative View", (1992) 21 Anglo-Am LR 101-122; D. Giesen , "Vindicating the Patient's Rights: A Comparative Perspective", 9 The Journal of Contemporary Health Law and Policy 273-309 (1993). 5 For a full comparative discussion of the law governing consent to medical treatment, cf. D. Giesen, International Medical Malpractice Law (Tiibingen, Dordrecht, Boston & London 1988) paras 482-729; also cf. D. Giesen, "Zwischen Patientenwohl und Patientenwille. Aufklärungsrechtliche Entwicklungen in der höchstrichterlichen Rechtsprechung Deutschlands, Österreichs und der Schweiz in rechtsvergleichender Sicht. Eine Bestandsaufnahme", JZ 1987, 282-290; Ù. Giesen, "Zwischen ärztlichem Patemalismus und Selbstbestimmungsrecht des Patienten - Ärztliche Tätigkeit im Lichte der Rechtsprechung in Deutschland, Österreich und der Schweiz", in Rozprawy ζ polskiego i europejskiego prawa prywatnego. Festschrift für JosefSkapski (Krakow 1994) 45-72. 6 The original Greek version of the oath, as well as Latin, English and German translations may be found in D. Giesen , Medical Malpractice Law (Bielefeld 1981) 423-426. 7 For details, cf. D. Giesen , International Medical Malpractice Law (Tubingen, Dordrecht, Boston & London 1988) paras 1417-1527 (refs.). 8 It has been pointed out that a doctor generally views his relationship with his patient as governed by an aesthetic code commanding technical proficiency, rather than by a set of ethical principles requiring respect for the patient as a self-determining moral agent, cf. W. F. May , "Code and Covenant or Philanthropy and Contract?" 5 / 6 The Hastings Center Report 29-38 (1975). 9 Cf. E . /. Picard , "The Liability of Hospitals in Common Law Canada" (1981) 26 McGill U 997-1019. 10 On the evolving status of doctors vis-à-vis their patients, the legal profession and society in general cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 1417-1527; /. Kennedy , The Unmasking of Medicine (London 1981); on the role of doctors as gatekeeper-physicians at the edges of life, cf. D. Giesen, "A

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potential for medical paternalism is increased by the growing informational imbalance that exists between doctor and patient, extending the power of the former and the dependency and vulnerability of the latter 11. In the medical context, where individuals often make the most significant decisions of their lives, professional tradition and technological progress have combined to frustrate any notion of patient control 12. In the words of a French writer on the subject, "the patient, accustomed to being considered as a pawn on the chessboard of medical circumstance, brings himself more often to suffer the therapy than to take part in it" 13 .

right to health care? A comparative perspective", in Justice and Health Care: Comparative Perspectives, ed. A. Grubb & M. J. Mehlman (London 1995) 287-304; D. Giesen , "DecisionMaking and Problems of Incompetence: Comparative Legal Developments", in DecisionMaking and Problems of Incompetence, ed. A. Grubb (London 1994) 7-26; D. Giesen, "Menschenwürde und Recht am Anfang und Ende des Lebens", in: Archivum Iuridicum Cracoviense Bd. ΧΧΙΠ (1990) 40-59; D. Giesen , "Biotechnologie, Verantwortung und Achtung vor dem menschlichen Leben", in: Staat, Kirche, Wissenschaft. Festschrift für Paul Mikat zum 65. Geburtstag, hgg. D. Schwab, D. Giesen, J. Listi & H.-W. Strätz (Berlin 1989) 55-79; D. Giesen , "Ethische und rechtliche Probleme am Ende des Lebens", JZ 1990, 929-943; D. Giesen , "Der Wert des Lebens - wie weit reicht die Verpflichtung, Leben zu erhalten? Juristische Aspekte", in: Hilfe zum Sterben? Hilfe beim Sterben!, hgg. von H. Hepp (Düsseldorf 1992) 10-49; D. Giesen , "Law and Ethical Dilemmas at Life's End", in: Council of Europe, XXth Colloquy on European Law [Glasgow, 10-12 September 1990]: Law and Moral Dilemmas affecting Life and Death, Strasbourg, 13 June 1990, CJ-DE/ XX (90) 2; reprinted in: Law and moral dilemmas affecting life and death. Proceedings of the 20th Colloquy on European Law, Glasgow, 10-12 September 1990 (Strasbourg 1992) 82-110; D. Giesen , "Dilemmas at life's end: a comparative legal perspective", in Euthanasia Examined. Ethical, clinical and legal perspectives, ed. by J. Keown (Cambridge 1995) 200-224; for a broad .American presentation of the problems referred to in the text, cf. Β. R. Furrow , Th. L. Greaney , S. H. Johnson, Th. S. Jost & R. L. Schwartz, Health Law, 2 vols. (St. Paul [Minn.] 1995) i 351-447; ii 318-446; also cf. references in note 12, infra. 11 Cf. D. Giesen, "Zwischen ärztlichem Paternalismus und Selbstbestimmungsrecht des Patienten - Ärztliche Tätigkeit im Lichte der Rechtsprechung in Deutschland, Österreich und der Schweiz", in Rozprawy ζ polskiego i europejskiego prawa prywatnego. Festschrift für JosefSkapski (Krakow 1994) 45-72. 12 As for some of the many aspects important in this context, and in addition to the references already given in note 10, supra , cf. D. Giesen, "Recht und medizinischer Fortschritt. Höchstrichterliche Entscheidungen zur Arzthaftung im Zeitalter der Entfaltung neuer biomedizinischer Technologien", JR 1984, 221-229 (on all the legal implications of wrongful birth and wrongful life cases); D. Giesen, "Rechtsprobleme modemer Gentechnologien Ι-Π", Berliner Anwaltsblatt 1985, 91-94, 115-118; D. Giesen, "Probleme künstlicher Befruchtungsmethoden beim Menschen", JZ 1985, 652-661; D. Giesen, "Moderne Fortpflanzungstechniken im Lichte des deutschen Familienrechts", Festschrift für Cyril Hegnauer zum 65. Geburtstag (Bern 1986) 55-78; D. Giesen, "Ethische und rechtliche Grenzen biomedizinischer Verfahren", in: Lebensbeginn und menschliche Würde, hgg. Stephan Wehowsky (München 1987) 109-118; D. Giesen, "Developing Ethical Public Policy on Reproduction and Prenatal Research: Whose Interests Deserve What Protection?" Paper presented at the Second International Conference on Health Law and Ethics, London 1989, in: (1989) 8 Medicine & Law 553-565, reprinted in: H. Krause (ed.), Family Law. Society and Family* 2 vols. (Aldershot 1992) i 451-463; D. Giesen & S. MacLean, "Legal and Ethical Considerations of the Human Genome Project", (1994) 1 Medical Law International 159-175.

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These strong currents of medical paternalism run counter to the principle of individual autonomy embodied in the right to self-determination, which is recognized as fundamental to the legal and political order in many democratic societies 1 4 . Thus, the German Federal Supreme Court (Bundesgerichtshof) has stated that "to respect the patient's own will is to respect his freedom and dignity as a human being. This shows that by protecting the patient's right to self-determination the courts do not worship a mere formality. The courts rather protect the person's autonomy to secure that self-determination is as much respected as good health" 1 5 . And according to the French Supreme Court (Court de Cassation), the obligation imposed on doctors to obtain the patient's consent prior to an operation is generated by "respect for the human being" 1 6 . As a matter of legal principle, therefore, it should be the case that the patient's decision, in exercise of his right to self-determination, should be decisive in the patient-doctor relationship, in other words that "the doctor's duty arises from his patient's rights"17. The days of paternalistic medicine are numbered indeed. So are the days of unquestioning trust of the patient, and the days of complete consent to anything a doctor cared to do appear numbered, too 1 8 . There is much to be said, from a comparative law point of view, in favour of considering the patient-doctor relationship afiduciary one 1 9 , a 13 Λ. Dorsner-Doliveu Contribution à la restauration de la faute, condition des responsabilités civile et pénale dans Γ homicide et les blessures par imprudence : à propos de la chirurgie (Paris 1986) 316. 14 E.g., England: Sidaway ν Bethlem Royal Hospital Governors [1985] AC 871, [1985] 2 WLR 480, [1985] 1 All ER 643 (HL per Lord Scarman at 649g-h); United States: Schloendorffv Society of New York Hospital 211 NY 125, 105 NE 92 (1914), per Cardozo J at 93; Germany: Grundgesetz (Constitution; Basic Law) Artt. 1 and 2; as for the existence and scope of the concomitant right to health care , cf. D. Giesen , "Health Care as a Right: Some Practical Implications", (1994) 13 Medicine and Law 285-296; D. Giesen , "A right to health care? A comparative perspective", in: Health Matrix: 4 Journal of Law-Medicine (Case Western Reserve University School of Law) 277-295 (1994). 15 BGH, 9 Dec 1958 V I ZR 203/57 BGHZ 29, 46 (54); for a discussion of this classical German case cf. D. Giesen & Κ. Walter , "Die klassische Entscheidung: Ärztliche Aufklärungpflicht und Selbstbestimmungsrecht des Patienten (BGHZ 29,46)", Jura 1991,182-186. 16 Cass req, 28 Jan 1942 DC 1942.63.

ι? Sidaway ν Bethlem Royal Hospital Governors [1985] AC 871, [1985] 2 WLR 480, [1985] 1 All ER 643 (HL per Lord Scarman at 654c); a broad American perspective can be found in Β. R. Furrow , S. H. Johnson, Th S. Jost & R. L. Schwartz , Health Law. Cases, Materials and Problems (2nd ed St Paul [Minn.] 1991) 283-378; B. R. Furrow , Th. L Greaney , S. H. Johnson, Th. S. Jost & R. L Schwartz , Health Law, 2 vols. (St. Paul [Minn.] 1995) i 351447 (on physician's liability for patient injury in general and on physician's obligations to obtain informed consent in particular). is Cf. M. D. Kirby , "Informed Consent: What does it mean?", (1983) 9 JME 69-75. 19 Mclnerney ν MacDonald (1992) 137 NR 35, [1992] 2 SCR 138, (1992) 93 DLR4th 415, (1992) 12 CCLT2d 225 (SCC); Norberg ν Wynrib [1992] 4 WWR 577, (1992) 12 CCLT2d 1 (SCC, per McLachlin J.), where the Supreme Court of Canada identified a mutual trust-relationship to exist between patient and doctor which determines the obligations owed by the doctor to the patient; also cf. Hodgkinson ν Simms (1994) 22 CCLT2d 1 (SCC, per La Forest J.); for a comparative discussion, cf. D. Giesen , International Medical Malpractice Law

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trust-relationship which ought to characterize relations between patient and doctor, and must be earned by the doctor through communicating with his patient properly and consulting with him in a way that is regarded by the individual patient as acceptable20. The patient's decision is crucially dependent upon the extent to which the doctor makes known to him the risks accompanying a given procedure, the risks of foregoing therapy and the alternatives to the recommended course of treatment21. Given the ingrained paternalism of the medical profession, which we have already noted, the standard of disclosure imposed by law will largely determine the extent to which the patient's right to self-determination is vindicated in any particular legal system. This in turn depends upon the extent to which judges uncritically adopt the standards of the medical profession into law 22 . Modem comparative law research invariably points to the conclusion that it has been those courts and those judges who have been willing to look beyond their own jurisdictions who have been most successful in identifying the important ethical and political values at issue in this area 23. Medical negligence is by no means a problem confined to just one jurisdiction and the law, therefore, may have insights or solutions to offer that invite serious consideration by judges and others as to whether experience gained elsewhere can, if adopted, be of advantage in one's own legal environment. In establishing disclosure requirements and in propounding tests of causation, for example, courts both from Civil Law and Common Law jurisdictions have demonstrated the adaptability and continuing vitality of their own respective law 24 and the possibility of achieving desirable solutions to legal problems by what could be called comparative law endeavours taking advantage of

(Tübingen, Dordrecht, Boston & London 1988) paras 871-882; the text-related statement also applies to Australia, cf. Breen ν Williams [1994] 35 NSWLR 522, [1995] 6 MedLR 385 (per Kirby P.) and M. D. Kirby , "A Patient's Right of Access to Medical Records", 12/1 Jnl of Contemporary Health Law & Policy 93-111 (1995) (Festschrift D. Giesen). 20 D. Giesen , "Patient's Rights: Informed Consent, Access, and Equality: Overview", in Patient's Rights: Informed Consent, Access, and Equality, ed. Lotta Westerhäll & Charles Philips (Stockholm 1994) 1-17 (12); M. D. Kirby , "Informed Consent: What does it mean?", (1983) 9 JME 69-75. 21 Cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 647-669 (on treatment andrisk commensurateness). 22 D. Giesen , "Legal accountability for the provision of medical care: a comparative view", (1993) 86 Journal of the Royal Society of Medicine 648-652; D. Giesen , "Medical Malpractice and the Judicial Function in Comparative Perspective", (1993) 1 Medical Law International 3-16. 23 Cf. D. Giesen & John Hayes , "The Patient's Right to Know - A Comparative View", (1992) 21 Anglo-Am LR 101-122; D. Giesen , "Vindicating the Patient's Rights: A Comparative Perspective", 9 Jnl of Contemporary Health Law & Policy 273-309, 293 (1993). 24 On the flexibility and adaptability of the judge-made common law down the centuries, cf. Sidaway ν Bethlem Royal Hospital Governors [1985] AC 871, [1985] 2 WLR 480, [1985] 1 AU ER 643, 1 BMLR 132 (HL, Lord Scarman at 650h-j) Gillick ν West Norfolk AHA [1986] AC 112, [1985] 3 WLR 830, [1985] 3 A11ER 402, (1985) 2 BMLR 11, (HL, Lord Scarman at 419h, 42 lg).

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other people's l a w 2 5 and legal experience and, at its best, contributing to cross-cultural enrichment especially in areas of law where interchange is promising and may continue to be, or may become, reciprocal 26 . Thus, to give but one or two examples of many, the German Federal Supreme Court (Bundesgerichtshof) greatly benefited from American case law in areas like product liability 2 7 and from other common law decisions in wrongful birth and life cases 28 ; the High Court of Australia recently expressly decided in medical negligence (malpractice) cases not to apply the professional disclosure standard still prevailing in England 2 9 and Scotland 3 0 and instead 31 to adopt a patient-orientated standard of disclosure 32 similar to the ones adopted by the South Australian Supreme Court 3 3 , the Court of Appeal in New Zealand 34 , the Supreme Court of Canada 35 and its counterpart in South Africa 3 6 , and highly influential courts in the United States of America 3 7 and con-

25 Cf. Lord Kilbrandon , Other People's Law (London 1966). J. G. Fleming , "Comparative Law of Torts", (1984) 4 OJLS 235-243 (243); as for some of the other areas worth considering, cf. J. G. Fleming , "Is There a Future for Tort?", (1984) 58 A U 131-142 (142). 27

The German leading case on products liability drawing heavily on American jurisprudence here is BGH, 26 Nov 1968 V I ZR 212/66 BGHZ 51, 91; for the background of this case, cf. y. G. Fleming , "Comparative Law of Torts", (1984) 4 OJLS 235-243. 28 The leading German case relevant here is BGH, 18 Jan 1983 V I ZR 114/81 BGHZ 86, 240 (wrongful birth claims accepted, wrongful life claims refused). For the background and for cases from other jurisdictions referred to by the German Federal Supreme Court cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 120, 124-126, 248, 230, 292, 347, 407, 462, 464, 465, 471, 476-481, 607, 676, 1393,1404,1411; D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 64 & 260. 29 Bolam ν F Hern Hospital Management Committee [1957] 1 WLR 582, [1957] 2 AUER 118 (QB, McNair J at 121-122); affd for diagnosis & therapy in Maynard ν West Midlands Regional Health Authority [1984] 1 WLR 634, [1985] 1 A11ER 635, (1983) 1 Β MLR 122 (HL); affd for disclosure in Sidaway ν Bethlem Royal Hospital Governors [1985] AC 871, [1985] 2 WLR 480, [1985] 1 All ER 643,1 BMLR 132 (HL). 30 Goorkani ν Tayside Health Board [1991] 3 Med LR 33 (Court of Session, Outer House); Moyes ν Lothian Health Board, 1990 SLT 444 (CS). 31 For the reasons behind this development cf. the Chief Justice of Australia, The Hon. Sir Anthony Mason, "The Tort Law Review", (1993) 1 The Tort Law Review 5-13 (10-12). 32 Rogers ν Whitaker (1992) 175 CLR 479, (1992) 67 ALJR 47, (1992) 109 ALR 625, (1992) Aust Torts Reps § 81-189 (HC of A). As for the development of the possible standards of disclosure in medical law from a comparative law perspective, cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 505-525, 551-601. 33

F ν R (1983) 33 SASR 189 (FC). Smith ν Auckland Hospital Board [1965] NZLR 191 (CA) reversing [1964] 241 (SC). 3 5 Reibl ν Hughes (1980) 1 SCR 880, (1980) 114 DLR3rd 1, (1980) 14 CCLT 1, (1980) 33 NR 361 (SCC). 3 6 Daphne Castell ν Andrew de Greef (1992), 1994 (4) SA 408 (C) (Case # 976/92). 34

37

Canterbury ant case.

ν Spence, 150 AppDC 263,464 F2d 772 (DC Cir 1972) is the most import-

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tinental Europe including France, Germany, Austria and Switzerland 38 . The Supreme Court of South Africa by an impressive act of judicial creativity not only followed the High Court of Australia's Rogers decision 39 , but also expressly adopted disclosure and causation standards developed by the German Federal Supreme Court (Bundesgerichtshof), thus giving further weight to an increasing practice by leading courts all over the world of taking comparative law advantage of other legal systems and especially of new frontier areas of torts in fields such as the breathtakingly fast-developing area of professional, especially medical, negligence 40 , including problem areas such as prenatal research 41, reproductive medicine and gene technologies42 and the human genome project 43 . Advances in artifi38 Cass.civ.lre, 29 May 1951 D. 1952.53 (R. Savatier)\ 21 Feb 1961 JCP 1961.12129 (Λ Savatier ); 11 Jan 1966 D. 1966.266; BVerfG, 25 July 1979 2 BvR 878/74 BVerfGE 52, 131; BGH, 9 Dec 1958 VI ZR 203/57 BGHZ 29, 46; 16 Jan 1959 VI ZR 179/57 BGHZ 29, 176; 22 Jan 1980 VI ZR 263/78 NJW 1980, 1333; 7 Feb 1984 VI ZR 174/82 BGHZ 90, 103 (105-106, 107, 109-110); 7 Feb 1984 V I ZR 188/82 BGHZ 90, 96 (101-102); BG, 12 Jan 1982 BGE 108 Π 59 (expressly following the German Federal Supreme Court, BGH, 22 Jan 1980 V I ZR 263/78 NJW 1980, 1333 [1334]); OGH, 23 June 1982 3 Ob 545/82 SZ 55/ 114, JB1 1983, 373 (W. Hölzer); 19 Dec 1984 3 Ob 562/84 SZ 57/207, JB1 524, 548 (551); also cf. D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 524, 560-601; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 203-211, 214-216, 225-226, 277, 307 (refs.). 39 Rogers ν Whitaker (1992) 175 CLR 479, (1992) 67 ALJR 47, (1992) 109 ALR 625, (1992) Aust Torts Reps § 81-189 (HC of A). 40 For a full discussion of Common Law and Civil Law decisions in this field, cf. D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 481-623 (refs.); D. Giesen, "Recht und medizinischer Fortschritt. Höchstrichterliche Entscheidungen zur Arzthaftung im Zeitalter der Entfaltung neuer biomedizinischer Technologien", JR 1984, 221-229; D. Giesen, "Rechtsprobleme moderner Gentechnologien Ι-ΙΓ, Berliner Anwaltsblatt 1985,91-94,115-118;/). Giesen, "Probleme künstlicher Befrachtungsmethoden beim Menschen", JZ 1985, 652-661; D. Giesen, "Rechtsprobleme künstlicher Befruchtungstechniken, in: Im Spannungsfeld zwischen Können und Dürfen. Zur Christlichen Berufsethik (Essen 1986) 24-35; D. Giesen, "Ethische und rechtliche Grenzen biomedizinischer Verfahren", in: Lebensbeginn und menschliche Würde, hgg. Stephan Wehowsky (München 1987) 109-118; D. Giesen, "Genetische Abstammung und Recht", JZ 1989, 364377; D. Giesen, "Das Arzthaftungsrecht des Bundesgerichtshofs in der Rechtsprechung des Auslands", in Festschrift für Erich Steffen, hgg. E. Deutsch, E. Klingmüller & H. J. Kullmann (Berlin & New York 1995) 159-176; D. Giesen, "Liability for the Provision of Services under German Law", in: La Responsabilité des prestataires de services - Liability for Services Rendered. Colloque de Association Internationale des Sciences Juridiques at Lausanne, 1-3 Septembre 1993, Société de législation comparée (Paris 1994) 91-107; also cf. D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) vii-ix. 41 D. Giesen , "Developing Ethical Public Policy on Reproduction and Prenatal Research: Whose Interests Deserve What Protection?", in: (1989) 8 Medicine & Law 553-565, reprinted in H Krause (ed.), Family Law. Society and Family, 2 vols. (Aldershot 1992) i 451463. 42 D. Giesen, "Biotechnologie, Verantwortung und Achtung vor dem menschlichen Leben", in: Staat, Kirche, Wissenschaft. Festschrift für Paul Mikat zum 65. Geburtstag, hgg. D. Schwab, D. Giesen, J. Listi & H.-W. Strätz (Berlin 1989) 55-79; D. Giesen, "Rechtsprobleme moderner Gentechnologien Ι-Π", Berliner Anwaltsblatt 1985, 91-94, 115-118; D. Giesen,

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rial reproduction and gene technology are likely to give rise to new problems in the law of negligence and damages44. It goes without saying that the physician will be liable for any damage he may cause in accordance with the general principles of medical malpractice45. The prowess of medical science has always had its price, and, as far as artificial reproduction is concerned, the price has been very high indeed46. EL Legal Requirements concerning the Communication between Patient and Doctor The notion entertained in most jurisdictions that the same facts in a given medical negligence case may give rise both to contractual and tortious (or delictual) responsibility (concurrent liability)47, does not preclude courts from preferring the latter to the former. Indeed, the commonest and today by far the most potent basis of tort (delict) liability in medical malpractice cases is negligence, in other words conduct falling below the standard demanded for the protection of others against unreasonable risk of harm, which does not cease by repetition to remain negligence, and as a tort is the breach of legal duty to take care which results in damage, undesired by the defendant, to the plaintiff 48. Negligence liability consequences can arise both from substandard or non-existent organizational rules in health care centres49 governing responsibility for disclosure to patients and, where general and acceptable rules exist, from a disclosure practice found wanting by the courts in the specific circumstances of the individual case. This is especially true where a physician under a duty of disclosure has failed to inform his patient about significant facts of the procedure recommended, its inherentrisks,and its alternatives50. "Probleme künstlicher Befruchtungsmethoden beim Menschen", JZ 1985, 652-661; D. Giesen, "Ethische und rechtliche Grenzen biomedizinischer Verfahren", in: Lebensbeginn und menschliche Würde, hgg. Stephan Wehowsky (München 1987) 109-118. 43 D. Giesen & S. Mac Lean, "Legal and Ethical Considerations of the Human Genome Project", (1994) 1 Medical Law International 159-175. 44 D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 119-126, 481. 4 5 D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 1391-1416. 46 For a detailed discussion, cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 1349. 47 For the exception (France, where according to case law delictual liability can only exist where contractual liability does not: alternative liability), cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 48-59 (refs.). 48 D. Giesen , International Medical Malpractice Law (Tubingen, Dordrecht, Boston & London 1988) para. 38. 49 Cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 86-103, 214-223. 50 Cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 602-669.

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It is of course clear that the proper discharging of the duty of disclosure will depend on the patient's nature and mentality, his experience and education, the timing of disclosures51, and must, in general, be adapted and be commensurate with the seriousness of the patient's health condition and the possible hazards arising from the procedures proposed and, alternatively, from no procedure. The duty of disclosure, in other words, demands a sensitive, understanding, tactful, and reasonable approach meeting the requirements of the individual patient52. To achieve the goals of adequate communication and shared decision-making in medical care, not only must physicians possess certain interpersonal skills and attitudes, but patients must also be willing and able to participate. The patient therefore must be given the proper time and setting to absorb information, to think about procedures proposed by the physician53, and to discuss questions arising with family members and friends. The physician would indeed be wise not to neglect the patient's family in the course of communicating various aspects of the treatment, especially where a patient will be undergoing a serious operation54. Discussion with third parties is helpful not only in providing further sources of information but also in revealing issues about which the patient is still unclear and which he may wish to raise again with his physician before he makes his informed decision55. It will be apparent, then, that the required disclosure will more often than not consist of an informational process, rather than a single bombardment of the patient with all the details necessary to discharge what the physician may often consider irksome and superfluous legal requirements. It may be doubtful, indeed, whether such a single act of disclosure will ever suffice if made only shortly before the proposed treatment, such as on the very eve of an operation which has already

si MHCD i 118-119; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 213-236 (refs.). 52 White ν Turner (1981) 31 OR2d 773, (1981) 15 CCLT 81, 99, (1981) 20 DLR2d 269, (Ont HC), affd (1982) 47 OR2d 764, (1982) 12 DLR4th 319 (CA); McKinney ν NasK 174 CalRptr 642 (App 1981); Wilkinson ν Vesey, 295 A2d 676, 690 (RI 1972); MHCD i 33, 96; BGH, 16 Jan 1959 VI ZR 179/57 BGHZ 29, 176 (184); 7 Feb 1984 (VI ZR 174/82) BGHZ 90, 103 (108); MünchKomm (- Η /. Mertens ) notes 435-435a to § 823 BGB; also cf. H. L Hirsh , "The Physician-Patient Relationship: The Art and Science of Communication", (1986) 5 Med & L 477-88 (refs.). Also cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 510-514,604-623,792. 53 Ferguson ν Hamilton Civic Hosp (1983) 40 OR2d 577, (1983) 144 DLR2d 214, (1983) 23 CCLT 254 (Ont HC, Krever J at 299); MünchKomm (- H J. Mertens) note 442 to § 823 BGB. 54 1 DW Louisell & H Williams § 5.05; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) para. 235. 55 MHCD i 118; BGH, 12 Feb 1974 VI ZR 141Π2 VersR 1974, 752 (753-4); Stuttgart, 7 Dec 1977 VersR 1979, 1016; comparative: D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 793.

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been scheduled56, and the information will undoubtedly come much too late when given to a patient already under sedation57, or to a patient on his way to the operating theatre58, or to a patient in the anteroom of the operating theatre59. "A patient is entitled to have enough time and an environment to enable him or her carefully to consider his or her position."60 Upsetting diagnoses,risks,uncertainties and other information which may provoke anxiety in the patient should in particular be discussed over a period of time whenever possible. Disclosure and communication procedures must be fair and appropriate both in time and place61. The physician's duty, however, is not limited to providing the patient with a sound informational basisfrom which to make a balanced decision62. Disclosure is meaningless unless properly grasped by the patient. The physician must, therefore, communicate information in non-technical terms and pitched at the level of comprehension of the individual patient in his or her particular circumstances63. It is, however, an experience, shared by many courts, that the communication between physician and patient with regard to the information required by the law is not infrequently found wanting in terms of clarity and comprehensibility. Courts have often expressed their view that physicians must not use medical jargon when imparting "information" to their patients. Rather they must help their patients, 56 D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 235-236; BGH, 21 June 1983 VI ZR 108/82 VersR 1983, 957; 8 Jan 1985 V I ZR 15/83 JZ 1986, 241 (243); 7 Apr 1992 VI ZR 192/91 JZ 1993, 312 (313); 14 June 1994 V I ZR 178/93 NJW 1994,3009. 57 Beausoleil ν Soeurs de la Charité (1964) 53 DLR2d 65 (Que CA); Gravis ν Physicians & Surgeons Hosp t 415 SW2d 674 (Tex Civ App 1967); BGH, 21 June 1983 VI ZR 108/82 VersR 1983, 957 (958, where the Federal Supreme Court is on record as vituperating "this widespread bad medical habit" in a case where the patient was already under sedation, was being carried on a stretcher to the operating theatre and was asked to sign a consent form without her glasses on or available to look at what she was signing). 58 Stuttgart, 7 Dec 1977 1 U 46/77 VersR 1979, 1016. 59 Ferguson ν Hamilton Civic Hospitals (1983) 40 OR2d 577, (1983) 144 DLR2d 214, (1983) 23 CCLT 254 (Ont HC); BGH, 10 Mar 1987 VI ZR 88/86 NJW 1987, 2291 (2293) ("disclosure" between two operations when patient has not recovered yet from first one: unacceptable). » Ferguson ν Hamilton Civic Hospitals (1983) 40 OR2d 577, (1983) 144 DLR2d 214, (1983) 23 CCLT 254 (Ont HC, Krever J at 257); MünchKomm (- H. J. Mertens) note 442 to § 823 BGB (refs.). 61 D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 795. 62 Canterbury ν Spence, 464 F2d 772, 784, 786 (DC Cir 1972); MHCD i 113 ff.; also cf. Sidaway ν Bethlem Royal Hosp Govns [1985] 1 All ER 643, (HL, Lord Templeman at 666); BGH, 18 Mar 1980 V I ZR 155/78 NJW 1980, 1903; 21 Sept 1982 (VI ZR 302/80) VersR 1982,1193 (1194); Karlsruhe, 25 Jan 1978 7 U 299/76 VersR 1979,58 (59). 63 Cf. D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 602-623, 796; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 39, 235-236, 262-268, 368.

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who are often inexperienced in both medical matters and medical language, properly to understand the information provided to them, and they must endeavour to understand and answer clearly any further questions patients may want to ask in order to receive more comprehensible (and, as the case may be, also more comprehensive) answers but have personal difficulties in formulating 64. As has appropriately been said by the leading American medical malpractice law authority, "a telling test of true professional competence, in medicine as in law, is the capacity to put aside professional jargon and to explain the realities in language comprehensible to the patient. The value of a good "bedside manner" as a vehicle for avoiding potential litigation is overly neglected by the medical profession" 65. It is the responsibility of the physician, then, to ensure that he or she is sufficiently understood66. It is true indeed that "from the viewpoint of the health care system as a whole, a physician's saving time by failing to educate a patient may be a false economy"67. As was emphasized in Wilkinson ν Vesey , more communication between physician and patient may indeed mean less litigation between patient and physician68. Again, medical education in its own turn seems often to fall short of what is expected by society or required by the law 69 .

1. Practical Difficulties Unfortunately, there are still many physicians who believe information to be superfluous, because having performed a particular technique, treatment or operation many hundreds of times they feel completely confident and furthermore fear « Sidaway ν Bethlem Royal Hospital Governors [1985] AC 871, [1985] 2 WLR 480, [1985] 1 All ER 643,1 BMLR 132 (HL, Lord Keith at 659e, Lord Bridge at 661d, Lord Tern pieman at 665a-b, 666g); Canterbury ν Spence, 464 F2d 111, 780-2 (DC Cir 1972, per Robinson J); Cobbs ν Grant , 104 CalRptr 505, 513 (1972); BGH, 9 Dec 1958 VI ZR 203/57 BGHZ 29, 46; 16 Jan 1959 VI ZR 179/57 BGHZ 29, 176; 26 Sept 1961 VI ZR 225/60 VersR 1961, 1039; 22 June 1971 VI ZR 230/69 VersR 1971, 929 (930); 12 Feb 1974 VI ZR 141/72 VersR 1974, 752 (752); 21 Sept 1982 VI ZR 302/80 VersR 1982, 1193 (1194); BG, 12 Jan 1982 BGE 108 Π 59 (61-64). 65 1 D W Louisen & Η Williams § 5.05 (Rei. 20-10/84); D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 797. 66 Reibl ν Hughes (1980) 14 CCLT 1, 99 (SCC); BGH, 10 July 1954 VI ZR 45/54 VersR 1954, 496; 9 Dec 1958 VI ZR 203/57 BGHZ 29, 46; 22 June 1971 VI ZR 230/69 VersR 1971, 929 (930); W. Dum, Aktuelle Fragen zum Arzthaftungsrecht (Köln 1980) 40; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 256-261, 272-276; MünchKomm (- H. J. Mertens) notes 435a, 444 to § 823 BGB. 67 MHCDi 115 ff. (119). 68 Wilkinson ν Vesey, 295 A2d 676,690 (RI 1972). 69 Battersby ν Tottman (1985) 37 SASR 524 (FC, Zelling J at 537); Β. Bromberger, "Patient Participation in Medical Decision-Making", (1983) 6 UNSWLR 1-23; MHCD i 129 ff. (135 ff.); comparative: D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 798, 1514-1527.

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that a long "preamble" would make the patient feel needlessly insecure70. It is often suggested that trust and confidence will wither away if physicians are asked to disclose more than they wish to 7 1 . But it is submitted that the opposite is true. "Confidence and trust can only prosper if the patient is treated as a partner, to be taken into confidence by his doctor, to be trusted to participate in the enterprise called treatment. What empirical evidence there is confirms this unreservedly."72 Thus, studies undertaken in the United Kingdom73, in the United States74, and in Germany75 demonstrate quite clearly that people wish to be given information by their physicians and resent being ill-informed. "Even more compelling is the evidence which any medico-legal analyst will vouchsafe, that the vast majority of complaints made against doctors, whether or not resulting in litigation, arise precisely from the doctor's failure properly to communicate with his patient, particularly by withholding information. So far from enhancing doctor-patient trust, the affirmation of a professional standard for disclosure is, therefore, more likely to corrode it." 76 Indicative here is the result of an enquiry into medical disclosure practices in Germany undertaken by a leading medical journalist, according to whom a bare half of all the sample patients stated that they had received thorough, comprehensive, and prompt information. In 14 per cent of the cases no explanation whatsoever had been provided, in 22 per cent only a rather superficial and brief one, in 2 per cent the explanation was too brief, and in 11 per cent it was detailed but incomprehensible. Information appeared to be more satisfactory in private

70 Cf. D. Giesen, Arzthaftungsrecht (Bielefeld 1981) 175-176 (refs.). Unfortunately, eminent members of the bench sometimes also adhere to this paternalistic fallacy, thus coming close to denying the very existence of the principle of self-determination: "The only effect that mention of riskscan have on the patient's mind, if it has any at all, can be in the direction of deterring the patient from undergoing the treatment which in the expert opinion of the doctor it is in the patient's interest to undergo." (Lord Diplock in Sidaway ν Bethlem Royal Hosp Govns [1985] 1 All ER 643, HL, at 659 c); if this reasoning were taken to its logical conclusion, all the decisions about what would be best for us in the course of medical treatment would be made by physicians in their unchallengeable wisdom and Doctor-Knows-Best paternalism. Cf. also D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 601 note 135. 72 /. Kennedy , "The Patient on the Clapham Omnibus", (1984) 47 MLR 454 (466); also cf. M. Brazier , "Patient autonomy and consent to treatment: the role of law?", (1987) 7 LS 169fiF. (174-9), and, for a Civil Law view on very similar lines, BGH, 9 Dec 1958 V I ZR 203 / 57 BGHZ 29,46 (54); 23 Nov 1982 VI ZR 222 / 79 BGHZ 85, 327 (332). 73 Report of the Royal Commission on the National Health Service (London 1979), Cmnd 7615, 41-50 (§§ 5.1-5.34). An impressive and comprehensive review of the empirical evidence on medical disclosure practices can now also be found in the (British) Institute of Medical Ethics' Bulletin Supplement No 3 (Dec 1986). 74 MHCDi 55-111. 75 Cf. D. Giesen, Arzthaftungsrecht (1981) 175-176; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 227, 280 (refs.), and text following. 76 /. Kennedy , "The Patient on the Clapham Omnibus", (1984) 67 MLR 454 (467); also cf. 1 D W Louisell & H Williams §§ 5.02-05 (refs.).

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practice than in public hospitals77, and this also appears to be the case in England 78 . The patient-physician relationship seems to be far from a relationship based on mutual trust, and is more often disturbed by misunderstandings than medical professionals would have us believe. Thus, during the Second Congress for Clinical Psychology and Psychotherapy in Berlin (Germany) 1982, it was shown that considerable discrepancies exist between, on the one hand, the desire for information on the part of seriously ill patients with a diagnosis of heart attack, cancer or paraplegia and, on the other hand, the assessments of physicians of all ranks, as to the likely therapeutic consequences of providing the patient with information. High up on the patients' priority list concerning their doctors' attitudes towards them, was the desire that doctors be honest, sincere and truthful. More than half of the physicians included in the survey believed that seriously and often fatally ill patients wanted to know the truth, but only half of the latter thought they had been given comprehensible information. (In contrast, two thirds of the physicians believed they had given exactly that information). Three quarters of the seriously ill anticipated that their fate would soon be death or (in cases of paraplegia) a considerable reduction in their quality of life, although almost half of those under survey thought they had never received any prognosis from their physicians as to their condition and prospects for the immediate future. The physicians, on the other hand, were of the opinion that they had in fact told their patients what they wanted to know. 20 per cent of all patients did not know about the purpose and the results of the diagnostic procedures to which they had been submitted. Only half the patients indicated that they could talk openly and confidentially to their physicians about their health problems79.

77

H. H. von Brandis, "Psychologische Gesichtspunkte zur Aufklaningspflicht", Arztrecht 1975, 292 ff. (296, 301), reporting on the survey conducted by Hans Mohl. 78 /. Kennedy , "The Patient on the Clapham Omnibus", (1984) 67 MLR 454 (467); also cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 486-492 (491). 79 D. Giesen , Aizthaftungsrecht (4th ed. Tübingen 1995) para. 227. In a study of the extent to which physicians talked with hospitalized patients (or their families or both) about whether they would desire cardiopulmonary resuscitation if it became necessary, the authors arrived at the conclusion that only 19 per cent (30 out of 154 patients who were resuscitated at the Beth Israel Hospital, Boston, in 1981) had discussed resuscitation before the arrest with an attending medical professional which reflects the fact that even physicians who believe the patients should participate in decisions about resuscitation, actually discussed the issue with their patients only rarely; the competent patients who survived cardiopulmonary resuscitation (24) were interviewed to compare their actual attitudes about resuscitation with their physicians' opinions about their attitudes. The physician's opinion about a patient's desire for resuscitation "correlated only weakly with the preference expressed by the patient" (E. Bedell & L DelbancOy "Choices About Cardiopulmonary Resuscitation in the Hospital", 310 New England J Med 1089-93 (1984) (refs.); D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 227, 333,479: comparative: D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 802.

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Misunderstandings in the communication process between physician and patient are alarmingly frequent, as the studies from England, the United States and Germany above referred to show. An example from German case law illustrates how easily these may arise, even where the patient is medically trained. A medical doctor underwent a mastectomy after tests had revealed that she might be suffering from cancer of the breast. After the operation, she claimed she had not been informed of the extent of the proposed mastectomy. The court held, dismissing the action, that where physician and patient were both doctors of medicine, technical terms used were understood in their objective medical sense. The patient had consented to a mastectomy, and the operation actually performed was one of several procedures included in that term and the one which, according to the testimony of the defendant surgeon, promised the best results in combatting the cancer, while the method which the patient contemplated was the least appropriate80. This case cannot be generalized, but it is illustrative of the dangers inherent in too great a degree of confidence on the part of the patient and insufficient awareness of the patient's subjective understanding of the situation on the part of the physician. Such dangers are naturally exacerbated in the case of lay patients who may be over-awed and ashamed of asking too many questions and in greater need of information than their demeanour, or even their apparent confidence, may indicate. As the United States President's Commission for the Study of Ethical Problems in Medicine & Biomedical & Behavioral Research stated in its Report on Making Health Care Decisions81: Patients may be naive and overly optimistic about their situation; they may not appreciate uncertainties and the probabilistic nature of medical knowledge. However, generally it has been found that having information and understanding its implications increases patients' self-confidence ... For the message to be understandable, health care professionals must be clear in their own minds about which information is most important. This process of self-scrutiny may have the additional benefit of causing them to rethink, or at least to review, their own diagnosis, prognosis, and recommendations. Meaningless reassurances82 or extravagant or inadequate prognoses designed to lull the patient into a false sense of security and inhibit further questioning83 will «ο Karlsruhe, 25 Jan 1978 7 U 299/76 VersR 1979, 58. It is, of course, otherwise where a lay patient with no medical knowledge did not understand the meaning of the word "mastectomy" which appeared in her signed consent form: Corn ν French , 289 P2d 173 (Nev 1955) (motion for new trial successful). 81 M H C D i 116-117. 82 Like the 4Old-Chap-within-a-couple-of-days-you-will-be-back-home..." story in Smith ν Auckland Hosp Bd [1965] NZLR 191, 197 (CA); for similar Canadian and German cases cf. Haughian ν Paine (1986) 46 SaskR 186, (1987) 40 CCLT 13 (Sask CA); BGH, 23 Sept 1980 VI ZR 189/79 NJW 1981,633 (634). 83 1 DW Louisell & H Williams 1995) paras 259-260, 331.

§ 5.04; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen

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amount to a breach of the physician's duty of disclosure. In a recent German case, a physician told his patient: "if things come to the worst, you risk an unsuccessful operation but no further deterioration in your state of health." The Federal Supreme Court held that in the circumstances this amounted to a cover-up of the true position "intended to reassure a patient who did not question the physician's authority and in fact trusted his medical experience and sense of professional responsibility and to deter him from asking further questions; whereas, in the context of the difficult decision as to whether the patient should undergo the operation at all, the physician should have discussed the possibility of an adverse result and its consequences for the patient's state of health"84.

2. Communication Aids In order to improve the communication process between physician and patient, various written and audiovisual materials are now increasingly used by both health care centres and individual practitioners 85, inviting further questions from the patient and explaining treatment options in a way which the patient understands and can better cope with than in circumstances in which he is bombarded with information at a single "disclosure session". There is really nothing wrong with this stepby-step approach if and as long as such aids serve to prepare, improve, and enhance the personal communications within the all-important and sensitive patientphysician relationship86. m BGH, 23 Sept 1980 VI ZR 189/79 NJW 1981,633 (634) (non-urgent heel-callus operation); also cf. Celle, 10 July 1978 1 U 40/77 NJW 1979, 1251 (1252); D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 49-50, 212, 249, 330-336. A very impressive case comes from Canada: Haughian ν Paine (1986) 46 SaskR 186, (1987) 40 CCLT 13 (Sask CA) (where in the situation of a disc problem the surgeon recommended disc surgery only whereas the option of conservative treatment was a viable alternative before surgery ought to have been contemplated; failing to inform the patient about the alternatives of conservative management or leaving the problem untreated was deemed negligent: Sherstobitoff JA at 41: "One cannot make an informed decision to undertake arisk without knowing the alternatives to undergoing the [surgery] risk"; comparative: D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 805-806. 85 H. W. Griffith, D. Hayes &L Ρ Hyde , "Let Printed Aids Work for You and Your Patients", 21 Patient Care 119 (1973); G. L Barbour Se M. H. Blumenkrantz , "Videotape Aids Informed Consent Decision", 240 JAMA 2741 (1978); E . E. Bartlett , "Selection of Education Strategies", in Health Education Planning: A Diagnostic Approach, ed W. Green et alii (Palo Alto 1980) 86-115; D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 332336, 468-470; W. Wachsmuth & H L Schreiber , "Die Stufenaufklärung - ein ärztlich und rechtlich verfehltes Modell", Der Chirurg 1982, 594-6 (against such step-by-step aids), and W. Weissauer , "Erwiderung", Der Chirurg 1982, 597-8 (in favour; we generally share the latterà view as described in D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 807; MünchKomm (- Η. J. Mertens) note 444 to § 823 BGB. 86 MHCD i 117; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 93, 272, 274, 276, 335-336,468-470.

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Physicians and lawyers alike have, however, sometimes described these forms as a further path "into defensive medicine"87 and as a deplorable exacerbation of the existing anonymity of the patient-physician relationship88. Some writers consider these methods to be a reaction on the part of the medical profession against the all-too-exacting disclosure duties imposed by the courts, and they believe their abandonment might restore the good old personal relationships which once existed between patient and physician89. Serious efforts made at improving information aids can commend themselves as enabling patients to read, hear or watch the written or audiovisual materials again, and together with family members and friends, and to discuss them, and if necessary to come back to their physician with questions revealing the need for further information or clarification. The better these information forms and other aids augment the continuing process of information exchange between physician and patient, the more acceptable they are. Their indispensable and most important function is, of course, to prepare the patient to better understand what then will follow by way of personal communications between physician and patient. Information materials, in other words, if clearly understandable and if to the point of the specific case, are welcome as supplements to a personal face-to-face communication between the physician and his patient90. But they will never be legally acceptable as a substitute, nor as to circumscribe the standard and scope of legally required disclosure91. However, if properly conceived and used, they have the advantage of preparing the patient for an active rather than a passive role in the communication and decision-making process. And they may even help develop the physician's own disclosure skills and sense of the objective information needs of the individual patient92. 87

E. Deutsch, "Theorie der Aufklärungspflicht des Arztes. Ethische und rechtliche Grundlagen der Information des Patienten", VersR 1981, 293 (297); W. Wachsmuth & H. L· Schreiber, "Das Dilemma der ärztlichen Aufklärungspflicht", NJW 1981,1985-1987. 88 E. Deutsch, "Theorie der Aufklärungspflicht des Arztes. Ethische und rechtliche Grundlagen der Information des Patienten", VersR 1981, 293 (294). 8 9 Cf. W. Wachsmuth, "Ein falsches Bild vom Patienten und seiner Belastbarkeit", NJW 1982, 686-7. 90 MHCD i 117; W Dum, Aktuelle Fragen zum Arzthaftungsrecht (Köln 1980) 46; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 333-335. 91 BGH, 9 Nov 1982 V I ZR 23/81 VersR 1983, 151 (152); 8 Jan 1985 V I ZR 15/83 JZ 1986, 241 (D. Giesen); W Dum, Aktuelle Fragen zum Arz6thaftungsrecht (Köln 1980) 46; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 333-336; MünchKomm (- H. Mertens) note 444 to § 823 BGB. 92 "With regard to patient understanding and recall, again the evidence highlights the discrepancy between the doctors's beliefs about what patients understand and the real extent of their understanding. The confusion between recall and comprehension, together with the lack of detail in many studies about what doctors actually tell their patients makes many of these studies hard to interpret. It appears that (as one might expect) the level of comprehension is largely a function of the method and effectiveness of the communication rather than of patients' inherent ability (or lack of it) to understand. The optimal combination appears to be

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3. Consent Forms It is a rather common practice now on the part of hospitals and other health care providers to ask the patient to sign a form containing information about the procedures proposed to him and documenting his consent, especially for major treatment such as surgery and anaesthesia93. According to a study conducted for the American President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, written consent is now obtained in the great majority of cases for general anaesthesia (83 per cent of all the cases surveyed), for surgery (81 per cent), and for radiation therapy (63 per cent); in cases of diagnostic X-rays involving injections the percentage of cases in which written consent is asked (and obtained) is 45 per cent, for setting bones it is 39 per cent, for local anaesthesia it is 21 per cent, while written consent is only rarely sought in the case of blood tests or prescriptions (2 and 1 per cent respectively) 94 . The legal consequences of such signatures will, however, depend on what the patient understood he was signing and, most of all, on the law's acceptance of what the patient was asked to sign 95 . Although one should always advise the physician to make notes on information given and consent obtained 96 , and although there are some positive experiences with printed forms for standard operations in some hossimple written information combined with opportunities for dialogue with the doctor." - Institute of Medical Ethics Bulletin Supplement No 3 (Dec 1986) at 14; as for the text-related statement, cf. also A. Laufs, "Grundlagen und Reichweite der ärztlichen Aufklärungspflicht", in Arzt und Patient zwischen Therapie und Recht, hgg. H. Jung & H. L Schreiber (Stuttgart 1981) 71 ff. (82-3); comparative: D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 807-810. w J. Salmond & R. F. V. Heuston , Law of Torts (20th ed. London 1992) § 22.2 (1) at 486; S. R. Speller , Law of Doctor and Patient (London 1973) 24-5, 162-74 (App A, with examples of recommended forms); S. R. Speller , Law Relating to Hospitals and Kindred Institutions (6th ed. London 1978, by J. Jacob) 111-112, 703-709 (App D, same docs.); B. Bromberger , "Patient Participation in Medical Decision-Making", (1983) 6 UNSWLR 1-23 (6): "Hospitals are continuing to use the same ubiquitous consent form that they have used for over forty years. From this they obtain much comfort even though by any test it is of limited value", and ibidem (7) for a frequently used but valueless Australian Consent Form; E. I. Picard 4445; F. A. Rozovsky , Consent to Treatment. A Practical Guide (Boston 1984, and 1985 Supplement) 633 ff. (on documentation of consent and practical rules for consent); A. Laufs , Arztrecht (5. Aufl. München 1993) § 266 (for a German consent form). w MHCD i 108, ii 168. 95 Not on the medical profession's sometimes rather ill-conceived acceptance of what the law requires, cf. Β. Bromberger , "Patient Participation in Medical Decision-Making", (1983) 6 UNSWLR 1-23 (8-13); G. Robertson , "Informed Consent in Canada: An Empirical Study", (1984) 22 Osgoode Hall U 139; Bickford ν Stiles (1981) 36 NBR2d 328, (1981) 128 DLR3d 516 (NB QB); D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) para. 336. 96 This is particularly emphasized in German law: BGH, 27 June 1978 V I ZR 183/76 BGHZ 72, 132 (137); 23 Nov 1982 VI ZR 222/79 BGHZ 85, 327 (330); 2 Oct 1984 V I ZR 311/82 JZ 1985, 286 (Ζλ Giesen). 19 Jahitouch für Recht und Ethik, Bd. 4 (1996)

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pitals 9 7 , the value of such consent documents should not be overrated 98 . It is submitted that the approach of one court, which dismissed the patient's claim never to have consented to an operation because the routine procedure of obtaining written consent was overlooked, on the basis of his failure to object, is a problematic one 9 9 . A conclusive presumption that a patient who signs a consent form for a medical procedure has given a valid consent is offensive 100 . Printed forms are often drafted too generally, do not contain quite the information which later turns out to be relevant or even decisive, do not provide sufficient detail, and are not infrequently presented to the patient by persons not qualified to give adequate additional and, thus legally acceptable, explanations 101 . A broadly-worded consent form might also be so vague that a court would and should give little weight to i t 1 0 2 . As was neatly said by Professor Picard , "[a] piece of paper is not a substitute for the rapport of doctor and patient which should precede the obtaining of consent" 1 0 3 .

97 s. R. Speller , Law of Doctor and Patient (London 1973) 24-25, 162-167; S. R. Speller , Law Relating to Hospitals and Kindred Institutions (6th ed. London 1978, by J. Jacob) 111112, 703-709. 98 Bickford ν Stiles (1981) 36 NBR2d 328, (1981) 128 DLR3d 516, 520 (NB QB); Hajgato ν London Health Assn (1982) 36 OR2d 669, 679 (HC), affd (1983) 44 OR2d 264 (CA); Kelly ν Hazlett (1976) 15 OR2d 290, (1976) 1 CCLT 1 (Ont HC); Pegram ν Sisco , 406 F Supp 776 (WD Ark 1976), affd 547 F2d 1172 (8 Cir [Ark] 1976); Sard ν Hardy , 379 A2d 1014 (Md 1977); BGH, 9 Nov 1982 V I ZR 23/81 VersR 1983, 151 (152); OGH, 19 Dec 1984 3 Ob 562/83 JB1 1985,548 (549). 99 Cf. Hernandez ν United States, 465 F Supp 1071 (D Kan 1979). 100 Cunningham ν Parikh , 472 So2d 746 (Fla App 1985) (statute which presumes valid consent where patient signs consent form invalidated), revd , however, sub nom Parikh ν Cunningham, 493 So2d 999 (Fla 1986) (pointing out that the statute required the consent form to meet the requirements of another statue requiring physicians to inform patients of risksand alternatives of proposed procedure; in the Supreme Court's view, this requirement necessitates a jury finding that the physician had obtained the patient's informed consent before the statutory presumption is applicable that, in the absence of fraud, a patient who signs a consent form for a medical procedure has given a valid consent and may not bring an action for disclosure malpractice. Thus, the court found that the statute merely codified the Common Law doctrine of informed consent and did not allow a defendant to substitute a written consent form for a showing that a patient's informed consent was obtained; the Court itself opined that the whole statute was "virtually incomprehensible" and remanded the case for a new trial; with respect: a hardly illuminating guidance for courts below); for further details: D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 811-813. ιοί BGH, 22 June 1971 V I ZR 230/69 NJW 1971, 1887; Celle, 10 July 1978 1 U 40/77 NJW 1979,1251 (1252). 102 Hajgato ν London Health Assn (1982) 36 OR2d 669, 679 (HC), affd (1983) 44 OR2d 264 (CA); Kelley ν Hazlett (1976) 1 CCLT 1 (Ont HC); Rogers ν Lumberman's Mutual , 119 So2d 649 (La App 1960); BGH, 9 Nov 1982 V I ZR 23/81 VersR 1983, 151 (152); Hamm, 19 Dec 1979 13 U 268/78 VersR 1981, 686 (687-8); LG Memmingen, 19 Nov 1984 2 Ο 14392/83 VersR 1985, 349 (350); OGH, 19 Dec 1984 3 Ob 562/84 JB1 1985, 548. 103 Ε. 1. Picard 43-44.

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What a court will want to do is to "look at the reality of the situation. Did the patient really understand? Was he too ill to understand? Was it thrust at him at the last minute as he was to be wheeled into the operating theatre" 104? In the words of the Ontario High Court, "a standard form of authorization and consent" in which a patient acknowledges prior to the operation that "the nature of the operation had been explained to her satisfaction... does not protect a doctor from liability unless the patient has been informed to the satisfaction of the court" 105. Or in the words of the Maryland Court of Appeals in Sard ν Hardy 106, "[u]nless a person has been adequately apprised of the material risks and therapeutic alternatives incident to a proposed treatment, any consent given, be it oral or written, is necessarily ineffectual", and this applies particularly to consent forms 107 . It should be noted that in a decision from Virginia, a surgeon was held liable (and rightly so) for operating without the consent of the patient, in spite of the fact that she had signed a consent form, where the evidence was clear that the patient had insisted more than once that she was not to be operated upon in the absence of her own gynaecologist and that all parties were aware of this proviso 108. It should also be noted as setting a proper standard in this context that the German Federal Supreme Court has increasingly tended to put the burden of proving consent onto those physicians or health care institutions who, with the intention of excluding liability, have made use of consent forms which are difficult to understand or contain clauses unacceptable to the courts on grounds of public policy 109 . Such clauses may, also on grounds of public policy, be equally unacceptable in other countries110. Consent forms should never be regarded as general business

«* Λ. Samuels, "Medical Negligence: A Review", (1985) 129 SJ 819-820, 843-850 (819). ios Hajgato ν London Health Assn (1982) 36 OR2d 669 (HC; Callaghan J at 679), affd (1983) 44 OR2d 264 (CA); also cf. Bickford ν Stiles (1981) 36 NBR2d 328, (1981) 128 DLR3d 516 (NB QB); Casey ν Provan (1984) 47 OR2d 147, (1984) 30 CCLT 169, (1984) 11 DLR4th 708 (Ont HC, Callaghan J at 716); BGH, 7 Feb 1984 V I ZR 174/82 BGHZ 90, 103 (110); 8 Jan 1985 VI ZR 15/83 VersR 1985, 361 (362). 106 Sard ν Hardy 379 A2d 1014,1019 η 3 (Md 1977). 107 Lipscomb ν Memorial Hosp, 733 F2d 332, 335 (4 Cir 1984), referring to Sard ν Hardy, 379 A2d 1014 (Md 1977). 108 Pugsley ν Privette, 263 SE2d 69 (Va 1980) (during a laparotomy in which patient's ovaries were removed, the ureter was nicked and a fistula developed). 109 BGH, 29 Oct 1956 Π ZR 79/55 BGHZ 22, 90 (94); 17 Feb 1964 Π ZR 98/62 BGHZ 41, 151 (154); 11 Nov 1968 V m ZR 151/66 BGHZ 51, 55 (59); 8 May 1973 IV ZR 158/71 BGHZ 60, 377 (380); 8 Feb 1978 V m ZR 240/76 BGHZ 70, 304 (310); 22. 12. 1992 VI ZR 341 /91 BGHZ 121, 107; also cf. Celle, 10 July 1978 1 U 40/77 NJW 1979, 1251 (1252): a signed consent form covers only risks patient was informed about and understood; it is for the physician to prove that the relevant information was in fact given to the patient); further refs. to case law from the German-speaking countries: D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 18-20. no J Chitty, On Contracts (25th ed. London 1983 with 1987 supplement) §§ 1031 ff; J. Salmond & R. F. V Heuston, Law of Torts (20th ed. London 1992) § 22.2 (at 484); G. H. 1*

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terms designed to promote the interests of one party to a transaction, but will only serve as acceptable documentation if they can be looked upon by the courts as an adequate proof of a personal patient-physician relationship in which the necessary information had in fact been given to the patient 1 1 1 . Courts have every reason to be critical and sceptical whenever pre-printed "fill-in-the-blank" consent forms with the patient's signature appendaged are presented as evidence of the patient's consent 1 1 2 . The reasons for this are manifold. a) First, there is strong evidence that many existing consent forms are written in extremely turgid language and that patients, even if they do not admit it, have a great deal of difficulty in understanding them 1 1 3 . A study undertaken for the American National Commission for the Protection of Human Subjects found that "overall, no more than 15 per cent of the consent forms were in language as simple as is found, for example, in Time Magazine. In more than three-fourths of the consent forms, fewer than 10 per cent of the technical or medical terms were explained in lay language" 114 . b) Secondly, while the law on informed consent does not normally distinguish between oral and written consent in judging its legal validity 1 1 5 (so that, in other

Treitel, The Law of Contract (9th ed. London 1995) 200, 221; Spurting ( J) ν Bradshaw [1956] 1 WLR 461, [1956] 2 All ER 121 (CA); Η. Luntz & D. Hambfy , Torts. Cases and Commentary (3rd ed. Sydney, Adelaide, Brisbane, Canberra, Hobart, Melbourne & Perth 1992) § 18.1.6 (p. 942); W L Prosser & W. P. Keeton , The Law of Torts (5th ed. St. Paul [Minn.] 1984) 482. m Hajgato ν London Health Assn (1982) 36 OR2d 669, 679 (HC), affd (1983) 440 OR2d 264 (CA); Ε. Ι. Picard 43-44; Keane ν Sloan-Ketterìng Institute , 464 NYS2d 548 (App Div 1983) ("standard" consent form containing no description of proposed operation is ineffectual as consent, in the absence of evidence that patient was adequately informed orally as to scope of surgery proposed; patient with an ulcer believed a biopsy was to be performed whereas surgery actually consisted of removal of stomach, omentum, spleen and part of pancreas); Cross ν Trapp , 294 SE2d 446 (W Va 1982) (signing of hospital consent form indicating that patient consents to treatment and surgery invalid where form does not specify operation properly); D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) para. 335. h 2 The signing of a blank form does certainly not constitute a valid consent, especially where no treatment information was given to the patient: Kdrp ν Cooley , 493 F2d 408 (5 Cir 1974); Powers ν United States , 589 F Supp 1084 (D Conn 1984); La Caze ν Collier , 434 So2d 1039 (La 1983); Cross ν Trapp , 294 SE2d 447 (W Va 1982); 1 D W Louisell & H Williams § 8.09; D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) para. 336 (refs as to Civil Law). 113 MHCD i 110; also cf. WK Mariner & PA McArdle , "Consent Forms, Readability, and Comprehension: The Need for New Assessment Tools" 13 Law, Med & Hlth Care 68-74 (1985). 114 United States Department of Health, Education and Welfare, Protection of Human Subjects: Report and Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 43 Fed Reg 56.174, 56.189 (1978); G. R. Morrow , "How Readable are Subject Consent Forms?", 244 JAMA 56 (1980); Τ M. Grundner , "On the Readability of Surgical Consent Forms", 302 New England J Med 900 (1980); MHCD i 110.

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words, written consent is not required where oral consent has been given 1 1 6 ), signed written consent forms are likely to make legal proof of consent significantly easier, at least in the absence of other complicating factors. Physician's prevailing consent practices apparently reflect this assumption. Almost four-fifths of the public (79 per cent) and 55 per cent of the physicians asked about the purpose and effect of consent forms thought that this was to protect physicians from law suits 117 . As the President's Commission observed, "this finding seems to reflect more the advice of lawyers who represent health care professionals than the ethical basis of informed consent, in which the role of the consent form is to protect patients by ensuring that they have full information and are participating voluntari l y " 1 1 8 . In another survey, 62 per cent of physicians and 86 per cent of the public thought that a patient's signature established the individual has given consent 119 . But on the other hand, discussion prior to consent form signing was more often than not non-existent or brief 1 2 0 . It would appear that the courts will have to insist that the primary purpose of consent forms is not to protect the physician from law suits but to summarize previous discussion and, ideally, to stimulate additional questions where informational problems still remain. Accordingly, consent forms must not be misunderstood as a substitute for patient-physician communication, and courts will have to see to it that they are not allowed to replace such communication or to cut it off prematurely 121 . c) Thirdly, in states with informed consent statutes, it is incumbent upon the courts to construe them in a way which allows the ethical basis of self-determination and shared decision-making to prevail over considerations focused on protecting physicians from law suits. A written consent, although sometimes statutorily presumed to be valid in the absence of fraud and misrepresentation 122 , does not preclude a court's inquiry into whether the patient adequately comprehended the

"5 MHCD i 107. π* Maerklein ν Smith , 266 P2d 1095,1099 (Colo 1954); Hernandez ν United States , 465 F Supp 1071, 1073 (D Kan 1979). in MHCD i 108-109; ii 17-316. us MHCD i 108. 119 MHCD i 108-109; ii 17-316. 120 C W Lidz & A Meisel, "Informed Consent and the Structure of Medical Care", in MHCD ii 317-410; BGH, 7 Feb 1984 VI ZR 174/82 BGHZ 90, 103 (110); 8 Jan 1985 VI ZR 15/83 VersR 1985, 361 (362). 121 MHCD i 111, 153-155. Also cf. Hajgato ν London Health Assn (1982) 36 OR2d 669, 679 (HC); BGH, 9 Nov 1982 VI ZR 23/81 VersR 1983, 151 (152); Hamm, 19 Dec 1979 13 U 268/78 VersR 1981, 686 (687-8); D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 333, 335-336; D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 818-821. 122 Cf. Florida Stat Ann § 768.46(4); Idaho Code § 39-4305; Louisiana Rev Stat § 40:1299.40; North Carolina Gen Stat § 90-21-13; Ohio Rev Code § 2317.54; Utah Code Ann § 78-14-5(2) (e); MHCD iii 206-245.

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physician's information and explanations 123 . Thus, in Pegram ν Sisco 124 it was held that a standard consent form signed by the plaintiff was ineffectual where it did not indicate that she had in fact received sufficient information about all material risks of the radium implant procedure to be performed on her. In Sard ν Hardy 125 the Maryland Court of Appeals stated that any consent, oral or written, was ineffectual unless accompanied by adequate information about material risks of, and therapeutic alternatives to, a proposed procedure. Where a patient signed a consent form to undergo an exploratory laminectomy under the impression that the word "exploratory" meant only "to look for" while to the surgeon it meant "to look for and correct if possible", the surgeon was held liable when the patient was subsequently paralyzed as a result of the operation 126 . The German Federal Supreme Court has held that consent forms will never in themselves set conclusive disclosure, information and consent standards in an individual case 1 2 7 . Further, standard forms by which a patient consents in general terms to all "additional operations or procedures considered therapeutically necessary" 128 , or to "all necessary or advisable treatments or operations", or to "further steps which become necessary or advisable during the original operation consented to", have also been subject to critical scrutiny by the courts in the course of determining whether the patient effectively understood the nature of and risks inherent in the procedures proposed to h i m 1 2 9 . The most convincing rule applied by the courts in cases where the reality of consent is in doubt, would appear to be: the broader and vaguer the wording of a consent form, the less the weight to be attached to it. Blanket consents authorizing un»23 Hajgato ν London Health Assn (1982) 36 OR2d 669, 679 (HC); BGH, 8 Jan 1985 VI ZR 15/83 VersR 1985, 361 (362). 124 Pegram ν Sisco t 406 F Supp 776 (WD Ark 1976), affd 547 F2d 1172 (8 Cir 1976). 125 Sard ν Hardy , 379 A2d 1014 (Md 1977). 126 Gray ν Grunnagle , 223 A2d 663 (Pa 1966); for similar cases in Civil Law cf. RG, 8 Mar 1940 RGZ 163, 129 (136); BGH, 28 Nov 1957 4 StR 525/57 BGHSt 11, 111; 2 Nov 1976 VI ZR 134/75 NJW 1977, 337; Z>. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 237-238. 127 BGH, 9 Nov 1982 VI ZR 23/81 VersR 1983, 151 (152); 8 Jan 1985 VI ZR 15/83 VersR 1985, 361 (362). 12« This was the formulation in Hutcheson ν McGoogan , 292 SE2d 527 (Ga App 1982) (performance of a haemorrhoidectomy and excision of an anal fistula on patient who had consented to surgery on a scrotal cyst was held not to be surgery "without consent" where patient signed the consent form the text-related broad [it is submitted: too broad] authorization). 129 Cf. Prìdham ν Nash (1986) 57 OR2d 347, (1986) 33 DLR4th 304 (Ont HC) (patient signing consent form consenting to abdominal examination and "additional procedures as may be necessary or medically advisable during course of* examination; general words justifying minor but not major surgical procedures); text-related statement also borne out by: E. /. Picard 43-44; 2DW Louisell & H Williams § 22.03; W Dunz Aktuelle Fragen zum Arzthaftungsrecht (Köln 1980) 46; W. Dunz, "Operationsabbruch zu Aufklärungszwecken", DMW 1978, 1226 (1227); D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 330-336.

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specific additional or alternative procedures, or containing information which is but insufficiently (if at all) related to the specific informational needs of the individual case and patient, will not be looked upon by the courts as adequate or as conclusive proof of a legally acceptable consent 130 . On the other hand, of course, if the consent form contains clear information pertinent to the individual case, the court will probably conclude that such information was in fact given and understood, and that the patient consented to the procedures and inherent risks mentioned therein. As consent constitutes a defence to a procedure on the part of the physician which would otherwise be illegal, the onus lies on the physician to establish that proper information had been given and valid consent obtained 131 .

4. Waiver It is, of course, possible that a particular patient may be quite prepared to submit to treatment or surgery irrespective of the risks involved 1 3 2 . Provided a waiver can be clearly established, such a situation presents little difficulty. A patient, as part of his right to self-determination, has the right to refuse to be told of any risks inherent in a proposed procedure, or to learn everything material about the recommended and alternative procedures 133 . No act is actionable either in contract or in tort at the suit of any person who has expressly or impliedly assented to it: volenti non fit iniuria. No man can enforce a right which he can legally waive or abandon and, indeed, has waived or abandoned 134 . The waiver must however be volunt a r y 1 3 5 , and real 1 3 6 .

"ο £. /. Picard 43; Hamm, 19 Dec 1979 13 U 268/78 VersR 1981, 686 (687, 688); D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 468-473. 131 BGH, 10 Mar 1981 VI ZR 202/79 VersR 1981, 730 (732); 14 Apr 1981 VI ZR 39/80 VersR 1981, 677; 21 Sept 1982 V I ZR 302/80 VersR 1982, 1193 (not in BGHZ 85, 212); 28 Feb 1984 VI ZR 70/82 JZ 1985, 236 (D. Giesen); 8 Jan 1985 VI ZR 15/83 VersR 1985, 361 (362). For a full discussion of the text-related statement for both Common and Civil Law, cf. D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 486-514, 670-702, 822-826. 132 M. Brazier , "Patient autonomy and consent to treatment: the role of law?", (1987) 7 LS 169 ff. (178): "The patient who elects to entrust all the necessary decisions to his doctor is entitled to do so." The text-related statement is borne out by decisions both at Common Law and from Civil Law jurisdictions: Reibl ν Hughes (1980) 1 SCR 880, (1980) 114 DLR3rd 1, (1980) 14 CCLT 1 (SCC, Laskin O C at 17); BGH, 9 Dec 1958 V I ZR 203/57 BGHZ 29, 46 (54); also cf. D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 619 note 58. 133 Henderson ν Milobsky , 595 F2d 654, 656 (DC Cir 1978); Grain ν Allison, 443 A2d 558, 562 (DC 1982); also cf. Reibl ν Hughes (1980) 14 CCLT 1, 17 (SCC); E. /. Picard 97; BGH, 9 Dec 1958 VI ZR 203/57 BGHZ 29,46 (54). 134 Buckpitt ν Oates [1968] 1 AU ER 1145, 1148; Chapman ν Ellesmere [1932] 2 KB 431, 436; Smith ν Baker [1891] AC 325 (Lord Herschell at 360); J. Salmond & R. F. V. Heuston, Law of Torts (20th ed. London 1992) § 22.3 (at 485-486); J. G. Fleming 73-77; A. M. Linden

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Information can thus be omitted if the patient has waived his right to obtain (more) information before he decides to undergo treatment 137 . Knowledge of the risk of injury is, however, not enough; nor is willingness to take the risk of a medical mishap. Nothing will suffice short of a clear agreement to waive any claim for disclosure malpractice or negligent failure to disclose what the law requires 138 . A real waiver of a claim to information with regard to therapeutic treatment would be legally valid, whether the waiver be expressis verbis or per implicationem 139. It

57-63, 146; W. L Prasser &W.P. Keeton § 18; Rest2d §§ 49, 892 A; H., L & J. Mazeaud & E Chabas ii 28-9 (§ 2592-2) (case law); X. Ryckmans & Λ Meert-van de Put i 457-60 (§§ 589-591); also cf. D. Giesen , "Civil Liability of Physicians with Regard to New Methods of Treatment and Experimentation", (1976) 25 ICLQ 180-213 at 186-187, with further refs. as to German and French law. 135 it is not voluntary (or free) if induced by misdescription, misrepresentation or fraud, cf. (in the consent context also applicable where waiver is the issue) Freeman ν Home Office [1984] QB 524, [1984] 2 WLR 130, [1983] 3 All ER 589 (McCowan J at 593d), affd [1984] 2 WLR 802, [1984] 1 All ER 1036, CA; Reibl ν Hughes (1980) 1 SCR 880, (1980) 114 DLR3rd 1, (1980) 14 CCLT 1 (SCC, Laskin CJC at 13); BGH, 9 Dec 1958 V I ZR 203/57 BGHZ 29,46 (54); 28 Nov 1972 VI ZR 133/71 VersR 1973, 244 (246); D. Giesen , Arzthaftungsrecht (4th ed. Tübingen 1995) paras 261, 328; BG, 13 Nov 1980 BGE 105 Π 284 (288); OGH, 18 Mar 1981 1 Ob 743/80 JB1 1982, 491 (494); also compare Cass civ, 29 May 1951 D 1952.53 (R. Savatier) with Cass civ 1 re, 7 Nov 1961 Gaz Pal 1962.1.219; X. Ryckmans & R. Meert-van de Put i 455 (§ 587). 136 Cf. Chatterton ν Gerson [1981] QB 432, [1981] 3 WLR 1003, [1981] 1 All ER 257; Hills ν Potter [1984] 1 WLR 641, [1983] 3 All ER 716 (as to consent, equally applicable, it is submitted, to waiver as one of the possible forms of consent), also cf. J Charlesworth & R A Percy §§ 3.60-63; J. Salmond & R. F. V. Heuston , Law of Torts (20th ed. London 1992) § 22.3; Ρ H Winfield & J A Jolowicz 700-701, 706-707; Morrison ν Union Steamship Co [1964] NZLR 468; Wilson ν Darling Island Stevedoring (1965) 95 CLR 43, 82; Beausoleil ν Soeurs de la Charité (1964) 53 DLR2d 65 (Que CA); E. /. Picard 53-115; Rest2d §§ 49, 892 A: it is for the defendant to establish the defence that the waiver (as one of the forms of consent) was real and fully and freely given; comparative: D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 827. 137 P. D. G. Skegg , "A Justification for Medical Procedures performed without consent", (1974) 90 LQR 512 (waiver is, however, an exercise of the right to self-determination and, thus, consent); J. G. Fleming 3, 63, 73-7; Lyon, 12 Jan 1951 D 1951.323; D. Eberhardt, Selbstbestimmungrecht des Patienten und ärztliche Aufklärungspflicht im Zivilrecht Frankreichs und Deutschlands (Karlsruhe 1968) 117, 125-126 (as to French and German law); G. Mémeteau 359-364 (§§ 535-6); X. Ryckmans & R. Meert-van de Put i 437 (§ 569); BGH, 22 June 1971 VI ZR 230/69 NJW 1971, 1887; comparative: D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 828. 138 Scienti nonfit iniuria just will not be a sufficient defence at law: Nettleship ν Weston [1971] 2 QB 691, [1971] 3 WLR 370, [1971] 3 All ER 581 (Lord Denning MR at 587 b-c). It goes without saying, of course, that the consent to a treatment or operation is neither the same nor can it be construed as constituting a waiver of theright of legal action on the part of the plaintiff patient: that would be against public policy: Workman ν Greer (1978) 90 DLR3d 676, 682 (Man CA); BGH, 9 Dec 1958 VI ZR 203/57 BGHZ 29, 46 (54); MünchKomm (- Η J. Mertens) note 447 to § 823 BGB. 139 j . Charlesworth & R. A. Percy , On Negligence (8th ed. London 1990 with 3rd cumulative suppl. 1993) § 3.60; MünchKomm (- H. J. Mertens) notes 34-35 to § 823 BGB; D. Gie-

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would appear, however, that the practical importance of the defence of a valid waiver is in inverse proportion to the attention it has received from academic writers. Even in countries with medical negligence case law galore the defence appears not to have been successfully raised at a l l 1 4 0 . The impact on the defence is that if a waiver is properly obtained the patient remains the ultimate decisionmaker, but "the content of his decision is shifted from the decisional level to the metadecisional level - from the equivalent of 4 I want this treatment (or that treatment or no treatment)' to Ί don't want any information about the treatment'" 141 . There is substantial reason to assume that the courts would respect waivers of certain information such as disclosure of particular risks, or the delegation of certain decisions to others 142 . But whether the patient actually has waived his claim to information depends on the circumstances of the case and the interpretation of them by the court. It may be questionable whether patients should be permitted to waive disclosure of fundamental information about the nature and implications of more serious procedures 143 . There will always be some uncertainty, therefore, with regard to the possible outcome in a given case; deplorable as this uncertainty is for all those involved, especially for the members of the medical profession, it is inevitable. Health care professionals will, therefore, be well advised to be circumspect in allowing or disallowing, encouraging or discouraging a patient's use of waiver in any given case 1 4 4 . It should be added, however, that the physician's difficulties could be ameliorated by the existence of regularly kept-up records about the details of the treatment he gave, after informed consent had been received, and it is really very difficult to understand why such records with details about the information given, the consent obtained, the diagnostic procedures performed and the treatment provided are all too often not kept 1 4 5 . Stricter rules, however, would apply to waivsen, International Medical Malpractice Law (Tubingen, Dordrecht, Boston & London 1988) paras 891-931. 140 Ε. I. Picard 97; D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 261, 328 (no such exceptional case on judicial record in Germany). »41 A. Meisel , "The 'Exceptions' to the Informed Consent Doctrine: Striking a Balance Between Competing Values in Medical Decisionmaking", Wis LR 413 (459) (1979); comparative: D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) para. 829. »42 MHCD i 94. 143 MHCD i 94. 144 MHCD i 95. 145 Cf. Sidaway ν Bethlem Royal Hospital Governors [1985] AC 871, [1985] 2 WLR 480, [1985] 1 All ER 643, 1 BMLR 132 (HL, Lord Scarman at 645d, remarking that with regard to the two critical issues i) what advice, including any warning of inherent risk the defendant surgeon gave Mrs Sidaway before surgery and ii) his assessment of her mental, physical and emotional state, the trial judge had been unable to accept the plaintiff's evidence and the defendant surgeon was dead at time of trial, and regretting that "the medical records afforded no sure guide on either matter"); also cf. MacKinnon ν Ignacio (1978) 29 NSR2d 656, 687 (SC); Meyer ν Gordon (1981) 17 CCLT 1 (BC SC); E. /. Picard 330-333 (refs.); 1 D W Louisen & H Williams § 7.08 (refs.); W. Dunz> Zur Praxis der zivilrechtlichen Arzthaftung (Karls-

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ers of a claim to information with regard to therapeutic treatment with innovative methods 1 4 6 and, a fortiori, with regard to non-therapeutic research treatment 147 .

ΙΠ. Conclusion The legal requirements as to disclosure and consent have frequently been described by doctors as a myth or a fiction 148, and even by courts sometimes as too exacting and unrealistic in the routine daily work of health care centres 149 . It is true that judicial demands on health care providers must not be unrealistically exacting: the German Federal Supreme Court (Bundesgerichtshof), one of the more progressive courts under review, has expressly acknowledged that a tendency in this direction might be developing 150 . But the same court also deplored the disregard of the medical profession 151 , manifested in inadequate disclosure practices, of the patient's right to self-determination in health care matters in accordance with his or her personal value commitments. While such a "community of silence" among the medical fraternity so evidently prevailed 1 5 2 , it was, regrettably, the German Federal Supreme Court insisted, indispensable that the courts insist, in the interest of due process and equality before the law, that physicians do not look upon their ruhe 1974) 16-17, 32-34; H. & D. Franzki, "Waffengleichheit im Arzthaftungsprozeß", NJW 1975, 2225 (2227); D. Giesen, Arzthaftungsrecht (4th ed. Tübingen 1995) paras 212, 420428; Berner Komm (- G. Gautschi) 31 η to art 398 OR, 7b, 22d to art 400 OR; OGH, 23 May 1984 1 Ob 550/84 JB1 1985, 159. 146 Cryderman ν Ringrose [1977] 6 AR 21, [1977] 3 WWR 109 (Alta DC), affd [1978] 3 WWR 481, (1978) 89 DLR3d 32 (Alta CA); Zimmer ν Ringrose (1981) 28 AR 69, [1981] 3 WWR 75, (1981) 24 DLR3d 215, (1981) 16 CCLT 51 (Alta CA); E. 1. Picard 118-21 (refs.); G. Mémeteau 313 (§ 470); X. Ryckmans & Λ Meert-van de Put i 457-460 (§§ 589-591). 147 Halushka ν Univ of Saskatchewan (1965) 52 WWR 608 (Sask CA); OGH, 11 Sept 1984 9 Ob 121/84 JB1 1985, 304 (306). As for French and German law, cf. Z>. Eberhardt, Selbstbestimmungrecht des Patienten und ärztliche Aufklärungspflicht im Zivilrecht Frankreichs und Deutschlands (Karlsruhe 1968) (1978) 191; G. Mémeteau 313 (§ 470); comparative: D. Giesen, International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 827-832; D. Giesen, "Civil Liability of Physicians for New Methods of Treatment and Experimentation: A Comparative Examination", (1995) 3 Medical Law Review 22-52. 148 H. K. Beecher , "Consent in Clinical Experimentation - Myth and Reality", 195 JAMA 34-35 (1966); W. Wachsmuth , "Ein falsches Bild vom Patienten und seiner Belastbarkeit", NJW 1982,686-687. 149 Celle, 15 June 1981 U 34/80 VersR 1981,1184 (1185). ι » BGH, 10 Mar 1981 V I ZR 202/79 VersR 1981, 730 (732); 21 Sept 1982 VI ZR 302/ 80 VersR 1982,1193(1194). 151 BGH, 14 Mar 1978 VI ZR 213/76 VersR 1978, 542 (544); 1 July 1980 V I ZR 261/79 VersR 1981, 42. 152 Abounding citations to jurisprudence and literature referring to this "community" or "conspiracy of silence" can be found in D. Giesen , International Medical Malpractice Law (Tübingen, Dordrecht, Boston & London 1988) paras 888,1496-1499.

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duty of disclosure in terms of professional privilege but of their obligations towards their patients, and, indeed, towards the community as a whole, in which self-determination is preferred to paternalism and shared decision-making the desired g o a l 1 5 3 .

Zusammenfassung Das Verhältnis zwischen Ärzten und Juristen ist seit jeher gespannt gewesen. Ist es doch Sache der Juristen und insbesondere der Richter, ärztliches Handeln unter rechtlichen Gesichtspunkten zu beurteilen und dabei rechtliche Anforderungen an ärztliches Handeln zu stellen. Aus Sicht vieler Mediziner handelt es sich dabei um das Hineinregieren in den beruflichen Alltag eines anderen Standes, das schon deswegen nicht zu sachgerechten Ergebnissen führen kann, weil den Juristen die nötige medizinische Sachkunde und Berufserfahrung fehlt, um ärztliches Handeln richtig beurteilen zu können. Viele Ärzte sind sogar der Auffassung, daß es sich bei der Medizin insbesondere im Spannungsfeld zwischen Patientenwillen und Patientenwohl um einen Lebensbereich handele, der eine „Verrechtlichung" überhaupt nicht vertrage. Ein ausschließlich medizinisches Urteil über die Erforderlichkeit einer bestimmten Therapie kann der Wahrung des Patientenwohls aber in den seltensten Fällen gerecht werden. In der Regel ist der mündige Patient umfassend in seiner gesamten Persönlichkeit mit all ihren - auch außerhalb medizinischer Kategorien gelebten und entfalteten - Lebensgewohnheiten, Wertvorstellungen und Prioritäten betroffen, und deswegen kann allein er endgültig abwägen und entscheiden, ob die Therapie, der Eingriff, tatsächlich seinem Wohl dient, kann deshalb umgekehrt auch der Arzt die Frage, was dem Wohl seines Patienten dient, nur

in Zusammenarbeit mit seinem Patienten und in Achtung und Respekt vor sein Wünschen ermitteln, selbst wenn er selbst andere und vom Patienten sogar abweichende Vorstellungen über das Erforderliche hat. Das heißt nichts anderes, als daß der Arzt ohne Berücksichtigung des Patientenwillens im konkreten Einzelfall gar nicht in der Lage ist, das Patientenwo/z/ zutreffend zu definieren. Bezogen auf die Aufklärungspflicht des Arztes bedeutet das: Da eine umfassende Aufklärung dazu dient sicherzustellen, daß der Patientenwille (und damit sein Selbstbestimmungsrecht) gewahrt wird, dient die Aufklärung letzten Endes auch dem Patientenwohl. Für einen Arzt, der in Anspruch nimmt, primär das Wohl seines Patienten zu verfolgen, muß also eine angemessene Aufklärung selbstverständlicher Bestandteil 153 D. Giesen, "From Paternalism to Self-Determination to shared Decision-Making", in (1988) Acta Juridica (Land and Medicine [Cape Town]) 107-127; D. Giesen, "From Paternalism to Self-Determination to Shared Decision-Making in the Field of Medical Law & Ethics", in Patient's Rights - Informed Consent, Access and Equality, ed. L. Westerhäll & Ch. Philipps (Stockholm 1994) 1-17; D. Giesen, "Zwischen ärztlichem Paternalismus und Selbstbestimmungsrecht des Patienten - Ärztliche Tätigkeit im Lichte der Rechtsprechung in Deutschland, Österreich und der Schweiz", in Rozprawy ζ polskiego i europejskiego prawa prywatnego. Festschrift für Josef Skapski (Krakow 1994) 45-72; D. Giesen, Arzthaftungsrecht (4th ed Tübingen 1995) paras 321-329.

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seiner Behandlung sein und darf nicht als lästige, rechtlich vorgeschriebene Pflicht empfunden werden. Der Beitrag entfaltet vor diesem Hintergund jene Problemfelder ärztlicher Aufklärungspraxis, bei denen es ausweislich der richterlichen Spruchpraxis des In- und Auslandes noch besonders häufig an einer angemessenen Selbsteinschätzung der Berufspflichten im Arzt-Patienten-Verhältnis und den aus ihnen resultierenden Konsequenzen hapert. Er zeigt auf, welche Orientierungsmarken im Spannungsfeld zwischen ärztlichem Paternalismus einerseits und Selbstbestimmungsrecht des Patienten andererseits im Vordergrund stehen müssen, damit das erstrebenswerte Ziel einer auf Wahrhaftigkeit, Loyalität und Vertrauen gründenden Zusammenarbeit zwischen Arzt und Patient näherrückt. Den in bezug hierauf sorgfältigen und gewissenhaften Arzt, der sich jederzeit der Tatsache bewußt ist, daß sein Patient als Rechtssubjekt Anspruch auf Achtung seiner Persönlichkeit hat, bringt das Recht keinesfalls in Bedrängnis; es schützt vielmehr auch ihn.

Aufklärungspflicht zwischen Informationsrecht und begrenzter Belastbarkeit des Patienten1 Gabriele Wolfslast

L Der Pflicht des Arztes zur Aufklärung seines Patienten kommt hohe rechtliche Bedeutung zu. Ohne hinreichende Aufklärung ist die Einwilligung in eine Behandlung unwirksam, und das heißt, daß eine solche Behandlung eine tatbestandsmäßige und rechtswidrige Körperverletzung ist 2 , unabhängig davon, ob sie erfolgreich war oder nicht 3 . Klagen wegen Verletzung der Aufklärungspflicht machen einen erheblichen Anteil der Prozesse gegen Ärzte aus. Freilich geht es dabei der Sache nach meist um behauptete Behandlungsfehler, die dem Arzt nur nicht nachgewiesen werden können. Wird hingegen der Vorwurf unzulänglicher Aufklärung erhoben, so muß im Zivilprozeß der Arzt die Einwilligung des Patienten und damit dessen ausreichende Aufklärung beweisen. Für den Patienten ist dieser Weg also der leichtere und erfolgversprechendere, wenn er auf Schadensersatz klagen will 4 . Es ist aber weniger das sogenannte Einwilligungskonzept, also die Rechtsauffassung, daß der ärztliche Heileingriff eine der Rechtfertigung bedürfende tatbestandsmäßige Körperverletzung darstellt, das hinter dem Erfordernis der Aufklärung steht. Vor allem geht es darum, daß der Bürger, den man heute ganz selbstverständlich und in eigentlich allen Lebensbereichen als mündig ansieht, d. h. als fähig, sich selbst zu bestimmen, für sich selber sorgen und sprechen zu können, daß 1

Überarbeiteter Text der Antrittsvorlesung an der Universität Rostock vom 5. 12. 1995. St. Rspr., s. ζ. B. Entscheidungen des Bundesgerichtshofs in Zivilsachen (BGHZ) 29,46; Entscheidungen des Bundesgerichtshofs in Strafsachen (BGHSt) 11, 111; Münchener Kommentar-Mertens, 2. Aufl. 1986, § 823, Rn. 370ff.; Laufs, Arztrecht, 5. Aufl., München: Verlag C.H. Beck, 1993, Rn. 177, weist aber darauf hin, daß die Rechtsprechung, speziell der Bundesgerichtshof (BGH), den Terminus Körperverletzung vermeidet; zur Entwicklung der Rechtsprechung und zur Kritik am Einwilligungskonzept Eser, „Medizin und Strafrecht: Eine schutzgutorientierte Problematik", Zeitschrift für die gesamte Strafrechtswissenschaft (ZStW) 97(1985), 17 ff. 3 S. ζ. B. BGH, Versicherungsrecht (VersR) 1989, 1150; Giesen, Arzthaftungsrecht, 3. Aufl., Tübingen: C.J.B. Mohr, 1990, S. 104. 4 S. dazu Laufs (Fn. 2), Rn. 173 f.; Franzki, „Von der Verantwortung des Richters für die Medizin - Entwicklungen und Fehlentwicklungen der Rechtsprechung zur Arzthaftung", Medizinrecht (MedR) 1994, 173. 2

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dieser Mensch auch als Kranker und Leidender als „ganze Person" gesehen und respektiert wird. Deshalb und weil, wie Honnefelder formuliert hat, Leib und Leben Bedingungen des sittlichen Subjektseins und mit der Person eng verbunden sind, darf der Arzt nur denjenigen Eingriff in die leibliche Integrität vornehmen, den der Patient selbst verfügt 5. Auch der Bundesgerichtshof legt dieses Bild von der Person seinem Verständnis vom Arzt-Patienten-Verhältnis zugrunde: Die ärztliche Behandlung müsse über das medizinische Anliegen hinaus dem personalen Anspruch des Patienten gerecht werden, nicht Objekt, sondern Subjekt der Behandlung zu sein. Einwilligung sei Gegengewicht zur medizinischen Autorität; medizinische Indikation und Patienteneinwilligung bildeten ein Junktim der ärztlichen Behandlung. Die medizinische Behandlung habe den Entschluß des Patienten als personalen Faktor einzubeziehen6. Die Konsequenz aus diesem „Leitbild" 7 ist eine weitreichende Aufklärungspflicht. Dabei lassen sich verschiedene Arten, man könnte auch sagen verschiedene Bezugspunkte der Aufklärung unterscheiden. Im Brennpunkt der Diskussion und für das vorliegende Thema vor allem interessant sind die verschiedenen Formen der sog. Selbstbestimmungs- oder Eingriffsaufklärung. Sie vermittelt das Wissen, das zur Wahrnehmung des Selbstbestimmungsrechts durch Einwilligung erforderlich ist 8 . In bezug auf die Diagnose bedeutet das die Information des Patienten über den medizinischen Befund; er muß erfahren, daß er krank ist und an welcher Krankheit er leidet. Die Aufklärung hierüber ist Hauptpflicht aus dem Diagnoseund Behandlungsvertrag; soweit die Kenntnis des Befundes auch für die Entscheidung des Patienten von Bedeutung ist, wird sie notwendiger Bestandteil der Selbstbestimmungsaufklärung 9. Außerdem muß der Arzt den Patienten über Art, Umfang und Durchführung des Eingriffs aufklären 10 . Er muß ihn darüber informieren, was mit ihm geschehen soll und wie seine Krankheit voraussichtlich verlaufen wird, wenn er dem Eingriff zustimmt. Der Arzt muß dabei weder alle Einzelheiten des Verlaufs noch medizinische Kenntnisse vermitteln, sondern er soll das Wesen des Eingriffs im großen und ganzen erläutern 11 , er muß, mit anderen Worten, dem Patienten eine ausreichende, tragfahige Basis für seine Entscheidung verschaf-

5 Honnefelder, „Die ethische Entscheidung im ärztlichen Handeln. Einführung in die Grundlagen der medizinischen Ethik", in: Honnefelder/Rager (Hrsg.), Ärztliches Urteilen und Handeln, Frankfurt/M. u.a.: Insel-Verlag, 1994, S. 158 f. 6 Steffen, Neue Entwicklungslinien der BGH-Rechtsprechung zum Arzthaftungsrecht, 6. Aufl., Köln: Verlag Kommunikationsforum Recht, Wirtschaft, Steuern, 1995, S. 123. 7 Ebd. 8 BGH, Neue Juristische Wochenschrift (NJW) 1987, 2923; vgl. auch Laufs (Fn. 2), Rn. 168 ff.

9 BGH, VersR 1972, 153, 155; Oberlandesgerieht (OLG) Stuttgart, VersR 1988, 695; s. auch Kim, Aufklärungspflicht im Arztrecht, Diss, jur., Göttingen 1989, S. 63 ff. 10 BGH, VersR 1971, 929. h Deutsch, Arztrecht und Arzneimittelrecht, 2. Aufl., Berlin u.a.: Springer-Verlag, 1991, S. 58; Steffen (Fn. 6), S. 129 m.w.N.

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fen 1 2 . Ziel der Aufklärung soll sein, die sinnvolle Wahrnehmung des Selbstbestimmungsrechts zu ermöglichen 13 . Eine wirksame Einwilligung in eine Behandlung setzt damit voraus, daß, so eine gängige Formel der Rechtsprechung, der Patient Wesen, Bedeutung und Tragweite des ärztlichen Eingriffs in seinen Grundzügen erkannt hat 1 4 . Zu dieser Verlaufsaufklärung gehören insbesondere Informationen über sichere Eingriffsfolgen (ζ. B. Narben; Unfruchtbarkeit bei Gebärmutterentfernung; Lücke im Gebiß bei Zahnextraktion 15 ), den postoperativen Zustand 16 , den Grad der Erfolgschancen im konkreten Fall und die Versagerquote sowie die Letalitätsrate und über das Risiko erheblicher Schmerzen 17 . Die sog. Risikoaufklärung, die ebenfalls zur Selbstbestimmungsaufklärung gehört, soll die Risiken nennen, die mit einem Eingriff verbunden sein können und die normalerweise einem Patienten wesentlich erscheinen oder jedenfalls für den jeweiligen individuellen Patienten bedeutsam sein können 18 . Daher ist auf die Möglichkeit eines Fehlschlagens des Eingriffs hinzuweisen, sofern das ernsthaft in Betracht zu ziehen ist, wie auch auf mögliche Nebenwirkungen und dauerhafte Folgen der Behandlung 19 . Beispiele für die Risikoaufklärung sind die Aufklärung über die Gefahr einer HIV- oder Hepatitisinfektion durch Bluttransfusion 20, die dauerhafte Nervschädigung nach Extraktion eines Weisheitszahnes21 oder die Querschnittslähmung nach einer Bandscheibenoperation 22. Auch hier gilt grundsätzlich, daß die Risiken ,»nicht medizinisch exakt und nicht in allen denkbaren Erscheinungsformen" dargestellt werden müssen, sondern es genügt ein allgemeines Bild von der Schwere und Richtigkeit des „konkreten Risikospektrums" 23. Das Maß der Aufklärung wird nicht nur durch den konkreten Eingriff, sondern auch durch die berufliche und private Lebensführung des Patienten, durch seine erkennbaren Entscheidungspräferenzen bestimmt 24 ; dabei ist die Erfahrung zu berücksichtigen, daß ungünstige Nebenwirkungen für die Entscheidung des Patienten um so weniger gravierend sind, je schwerer die Folgen einer Nichtbehandlung für ihn wären; er andererseits das Für und Wider um so genauer abwägen wird, je we12 H.-L Schreiber, „Die Patientenaufklärung in juristischer Sicht", Internist 1983,185. 13 Ebd. 14 BGH, NJW 1956, 1106 (1. Elektroschockurteil). 15 S. bei Laufs (Fn. 2), Rn. 205. 16 OLG Köln, VersR 1978, 551. π BGH, NJW 1984, 1395; OLG Köln, VersR 1984,1094; Steffen (Fn. 6), 129f. is H.-L Schreiber, „Aufklärung: rechtlicher Zwang zur Wahrheit?", Münchener Medizinische Wochenschrift (MMW) 138 (1996). 19 Deutsch {¥n. 11), S. 58. 20 BGH, NJW 1992, 743. 21 BGH, NJW 1994, 799; OLG Düsseldorf, VersR 1989, 290. 22 BGH, NJW 1991, 2346; NJW 1984, 2629. 23 Steffen (Fn. 6), S. 129 m.w.N. 24 S. etwa BGH, NJW 1984,1397; Laufs (Fn. 2), Rn. 187.

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niger dringlich der Eingriff, je fragwürdiger die Prognose ist 25 . Freilich ist auch über seltene Risiken aufzuklären, wo sie, wenn sie sich verwirklichen, die Lebensführung schwer belasten und trotz ihrer Seltenheit zwar für den Eingriff spezifisch, für den Laien aber überraschend sind26, etwa facialis- und trigeminus-Verletzungen bei Eingriffen im Ohr- und Kieferbereich 27 oder eine dauerhafte Nervschädigung nach einer Hüftgelenksoperation 28. Risikostatistiken, die die Komplikationsdichte angeben, kommt für den Umfang der Aufklärungspflicht kaum Bedeutung bei 29 .

Π.

Diese ausschnittweise wiedergegebenen, abstrakt formulierten Grundsätze der Rechtsprechung zum Umfang der Aufklärungspflicht des Arztes sind seit jeher heftiger Kritik von Ärzten und auch Juristen ausgesetzt. „Primum nil nocere" sei der Grundsatz, der als leitend für ärztliches Handeln gelte, oder, in einer anderen Fassung: „salus aegroti suprema lex", das Wohl des Kranken sei oberstes Gebot. Der Patient dürfe nicht als abstrakt Vernünftiger, sondern müsse als konkret Leidender gesehen werden, dessen Möglichkeiten seiner Selbstverfügung durch eine erhebliche Krankheit gemindert seien30. Vor allem Krebskranke wollten häufig die Augen verschließen und sich täuschen lassen31; kläre man sie schonungslos auf, so werde ein Grundprinzip ärztlichen Handelns, die Fürsorgepflicht, verletzt. „Schonungslose Offenheit" gegenüber dem Patienten wird interpretiert als Unfähigkeit, Verantwortung zu übernehmen und sich dem stärkeren persönlichen Engagement und der stärkeren Einfühlung in die Person des Kranken und seine Bedürfnisse zu stellen32. Es sei die Angst vor der eigenen Subjektivität und damit dem potentiellen Schuldigwerden-Können, der eigenen Fehlbarkeit, die zumrigorosen Verfechten einer auf uneingeschränkter Information beruhenden Selbstbestimmung führe. Der Position des Vertragsethikers, der dem Patienten die gesamte Last aller medizinischen Fakten einschließlich der „gelegentlich fatalen Prognose" aufbürde, hält Dichgans die „klassisch-europäische Position eines ,Verantwortungsethikers"' ent25 BGH, NJW 1979, 1933; 1991,2349. 26 BGH, NJW 1984, 1397. 27 BGH, VersR 1986, 183; NJW 1980, 1905. 28 OLG Koblenz, VersR 1992,963. 29 So jüngst wieder BGH, NJW 1995, 3043; vgl. auch Steffen (Fn. 6), S. 130; Deutsch (Fn. 11), S. 60, 62; eingehend Kim (Fn. 9), S. 131 ff. Das bedeutet freilich, daß unter Umständen auch über extrem geringe Risiken aufgeklärt werden muß. 30 Wachsmuth/Schreiber, „Der unheilvolle Weg in die Medizin", in: Wachsmuth (Hrsg.), Reden und Aufsätze 1930-1984, Berlin u.a.: Springer-Verlag, 1985, S. 182 (auch abgedruckt in Arzt und Krankenhaus 2 (1981), 75 ff.). 31 Wachsmuth/Schreiber (Fn. 30), S. 101. 32 S. Dichgans, „Der Arzt und die Wahrheit am Krankenbett", in: Honnefelder (Fn. 5), S. 194.

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gegen: „brüderlich stellvertretend, einfühlsam, vorentschieden und ungefragt" solle nur mitgeteilt werden, was für die aktuelle Entscheidung, auch bezüglich ihrer Konsequenzen, notwendig und »heilsam* sei33. Als Beispiel dafür, was mit dem ,»Rigorismus der Wahrheit" angerichtet werden könne, wird immer wieder verwiesen auf die mißglückte Aufklärung des Juristen und Schriftstellers Theodor Storm: Er sei, so heißt es, schwer depressiv und arbeitsunfähig geworden, als ihn sein Hausarzt darüber aufklärte, daß er an Magenkrebs leide. Daraufhin sei ein Ärztekonsilium einberufen worden, das ihn erneut untersucht und dem Kranken dann wider besseres Wissen erklärt habe, die erste Diagnose sei falsch gewesen, er sei nicht unheilbar erkrankt. Lebensfreude und Arbeitskraft des Dichters seien wieder erwacht, der „Schimmelreiter" vollendet worden 34 . Theodor Storm starb im selben Jahr, 1888. Von einem ungleich dramatischer verlaufenen Fall hat, ebenfalls im letzten Jahrhundert, der Chirurg Billroth berichtet: Ein im Krieg wegen Tapferkeit ausgezeichneter Offizier habe sich noch im Krankenhaus aus dem Fenster gestürzt, nachdem ihm die bösartige Natur seiner Erkrankung mitgeteilt worden war 35 . Beide Fälle zeigten beispielhaft, daß es dem Kranken schade, wenn bei der Aufklärung vorrangig auf seinen Willen abgestellt werde 36. Gewarnt wird vor einer „fatalen Euphorie der Selbstbestimmung, die unsere gegenwärtige Rechtsprechung trage" 37; ein extensiv interpretiertes Selbstbestimmungsrecht stürze den Menschen in informierte Isolation und Ausgesetztheit 38 . Jedenfalls bei schwerwiegenden Diagnosen müsse dem Kranken in seinem Interesse die belastende „Wahrheit am Krankenbett" vorenthalten werden. Ein solches „therapeutisches Privileg", worunter das Recht des Arztes verstanden wird, im Interesse des Patienten auf eine Aufklärung zu verzichten39, lehnt der BGH jedoch, zumindest dem Wortlaut nach, ab 40 . Schon 1954 hieß es im sog. 1.

33 Dichgans (Fn. 32), S. 195. 34 S. bei Deutsch (Fn. 11), S. 70 f. 35 S. bei Aleker, Ethische Probleme der Patientenaufklärung - am Beispiel der Multiplen Sklerose, Diss, med., Tübingen 1989, S. 84. 36 Wachsmuth/Schreiber (Fn. 30), S. 187. 37 Ebd., S. 188. 38 Dichgans (Fn. 32), S. 195. 39

S. dazu Deutsch, „Der Zeitpunkt der ärztlichen Aufklärung und die antezipierte Einwilligung des Patienten", NJW 1979, 1905, 1906; ders., „Das therapeutische Privileg des Arztes: Nichtaufklärung zugunsten des Patienten", NJW 1980, 1305 ff.; kritisch zu dem Begriff H.-L Schreiber, „Kontraindikationen und Verzicht bei der ärztlichen Aufklärung aus der Sicht des Juristen", in: Gramberg-Danielsen (Hrsg.), Rechtsophtalmologie, Stuttgart: Ferdinand Enke Verlag, 1985, S. 21 ff., 23; HE. Ehrhardt, „Patientenrechte und Arztpflichten", in: Pohlmeier/Deutsch/Schreiber (Hrsg.), Forensische Psychiatrie heute, Festschrift für Ulrich Venzlaff, Berlin u.a.: Springer-Verlag, 1986, S. 69; ausführlich zum ganzen auch Kim (Fn. 9), S. 160 ff. 40 S. Steffen (Fn. 6), S. 148, der freilich zwischen „therapeutischem Privileg", das es „keinesfalls" geben könne, und Aufklärung aus therapeutischen Rücksichten" unterscheidet, die zwar möglich, bisher vom BGH aber noch nicht anerkannt worden sei. 20 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

306

Gabriele Wolfslast

Elektroschockurteil: „Soweit die mit der Einholung der Einwilligung verbundene Aufklärung auch über mögliche schädliche Folgen der Therapie die Stimmung oder sogar das Allgemeinbefinden herabdrückt, handelt es sich um unvermeidbare Nachteile, die in Kauf genommen werden müssen"41. Dieser Grundsatz gelte auch für psychisch Kranke. In dem der Entscheidung zugrundeliegenden Fall ging es um eine 58 Jahre alte Patientin, die wegen involutiv-endogener Depressionen mit Elektroschocks behandelt worden war. Infolge der lege artis durchgeführten Therapie kam es zu einem Bruch des 12. Brustwirbels, einer Lähmung des rechten Beins, Darmstörungen, Herzbeschwerden und Erwerbsunfähigkeit. Angekündigt worden war der Patientin eine „elektrische Behandlung", und in die hatte sie eingewilligt. Der BGH bestätigte die Verurteilung zu Schadensersatz und Schmerzensgeld, da die Frau über Art und Risiken des Eingriffs nicht aufgeklärt worden sei. Ist also über Diagnose und Risiken, die wohl heikelsten Bereiche, ohne Rücksicht auf eine möglicherweise oder bekanntermaßen eingeschränkte Belastbarkeit des Patienten aufzuklären? Ist das konkrete Wohl des Patienten zugunsten seines abstrakten Selbstbestimmungsrechts - das er als Folge der schonungslosen Offenheit vielleicht gar nicht mehr ausüben kann! - , zugunsten seines Willens zu vernachlässigen? Oder umgekehrt: ist dem Willen zulasten des Wohls der Vorrang zu geben? Man täte dem BGH meines Erachtens Unrecht, wenn man aus der oben zitierten Äußerung folgern wollte, daß er ganz pauschal und um jeden Preis Aufklärung verlangte. Zwar ist nicht zu leugnen, daß dem Selbstbestimmungsrecht, der Autonomie des Patienten zunehmend mehr Gewicht beigemessen und daß damit zwangsläufig der ärztliche Handlungsspielraum eingeschränkt wird; denn ob ein Patient informiert wird über sein Leiden, über die notwendige Behandlung, über die Risiken und Folgen einer vom Arzt für erforderlich gehaltenen Behandlung, ist nicht mehr allein seiner, des Arztes, Entscheidung überlassen. Aber die Rechtsprechung läßt nicht nur eine Einschränkung der grundsätzlich verlangten vollen Aufklärungspflicht dann zu, wenn, wie es in einer seit Ende der fünfziger Jahre angewendeten Formel heißt, „die mit der Aufklärung verbundene Eröffnung des Leidens zu einer ernsten und nicht behebbaren Gesundheitsschädigung des Patienten führen würde" 42. Sie hat darüber hinaus immer wieder darauf hingewiesen, daß dem Wie der Aufklärung erhebliche Bedeutung zukommt: Aufklärung darf eben nicht schonungslos sein, sondern es kann im Gegenteil in einer „überzogenen Aufklärung" ein Behandlungsfehler liegen43. Verlangt wird eine „patientenbezogene Aufklärung" 44, die in einem Aufklärungsgespräch erfolgen müsse; der Aufklärung durch Formulare steht die Rechtsprechung - glücklicherweise - zurückhaltend gegenüber 45. 4i « 43 44

BGH, NJW 1956, 1106. BGH, NJW 1959, 814; weitere Nachweise bei Laufs (Fn. 2), Rn. 203 Fn. 83. BGH, NJW 1981,2002; 1984, 1397. Steffen (Fn. 6), S. 130.

Aufklärungs p flic ht

307

Auch wenn die von der Rechtsprechung akzeptierten Einschränkungen der Auf­ klärungspflicht damit deutlich enger gehalten sind, als es in der Literatur für erfor­ derlich gehalten wird- dort heißt es, daß die Gefahr einer schwerwiegenden, er­ 46 -,so zeigen sie doch die richti­

heblichen Störung des Befindens genügen müsse ge Richtung

an

und bedeuten m.E.,daß Rechtsprechung und Literatur in der Sache

gar nicht so weit auseinander liegen, wie gemeinhin angenommen wird.

m.

Selbstbestimmung des Patienten ist ja kein Selbstzweck, ebenso wie ,,Aufklä­ rung" keine feststehende Größe ist. Die Aufklärung des Patienten durch seinen Arzt soll ihm eine Entscheidungsgrundlage geben, sie soll ihm ermöglichen, die

für ihn, subjektiv, richtige Entscheidung im Zusammenhang mit seiner Erkrankung zu treffen. Die über sechzig Jahre alte, an Diabetes leidende Patientin, die lieber sterben als, wie sie es bei ihrem Vater erlebt hat, beinamputiert leben möchte, hat eine Entscheidung getroffen, die bei einem anderen Menschen vielleicht anders ausgefallen wäre. Für sie als Person,mit ihrer Geschichte,ihren Erfahrungen, war sie richtig. Die Frau,die nach einer ohne ihre Zustimmung erfolgten Gebärmutter­ entfernung ihren Arzt verklagte, weil er sie nicht darüber aufgeklärt hatte, daß ein Myom so mit der Gebärmutter verwachsen sein kann, daß es nur zusammen mit 47 , hätte diesem Eingriff nicht zugestimmt, wenn sie von

ihr entfernt werden kann

seiner möglichen Notwendigkeit gewußt hätte. Sie wollte lieber vor der Operation beunruhigt werden als später eine irreversible, über ihren Kopf hinweg getroffene Entscheidung ertragen zu müssen. Bei der Forderung, das Selbstbestimmungsrecht auch Kranker und auch einge­ schränkt belastbarer Patienten zu respektieren - und respektiert werden kann es nur,wenn der Kranke ,,Bescheid weiß"-,geht es nicht um eine ,,Mündigkeitsideo­ 48 logie" , sie ist vielmehr Ausdruck eines veränderten Selbstverständnisses. Was vor hundert, vor achtzig oder auch noch vor fünfzig Jahren richtig war,ist es heute nicht mehr. "Selbstbestimmung" und ,,Mündigkeit" sind weder Ideologie noch mo­ derne Mythen,sondern Begriffe, die ein verändertes Menschenbild und Selbst-Be45 Zur Formular- bzw Stufen aufkl ärung s. We!ßauer, ,,Aufklärungspflicht des Chirurgen", Langenhecks Archiv 3 4 5 (1977), 471; ders., ,,Die Problematik der ärztlichen Aufklärungs­ p fli c ht", Arzt und Krankenhaus 1980, 345; Schaffer. ,,Die Aufklärungspflicht des Arztes bei invasiven medizinischen Maßnahmen", VersR 1993, 1462; ablehnend bzw. kritisch Schrei­ ber/Wachsmuth, ,,Die Stufenaufklärung- ein ärztlich und rechtlich verfehltes Modell", Der Chirurg 53 (1982), S. 594ff.; Steffen, ,,Der ,verständige Patient' aus der Sicht der Juristen", MedR 1983, 91; Kemll.Aufs, Di e ärztliche Aufklärungs p flicht, Berlin u.a.: Springer- Verlag, 1983, S. 46; lAufs (Fn. 2), Rn. 2 78ff. m.w.N.; s. auch OLG München, VersR 1991, l89f. .

46

Buchbom, ,,Die ärztliche Aufklärung bei infauster Prognose", Internist 1981, 165;

Deutsch (Fn. 11), S. 71; H.-L Schreiber (Fn. 18).

47 BGHSt 11, 111 (Myom-Urteil). 48

Buchborn (Fn. 46), S. 163.

308

Gabriele Wolfslast

wußtsein in der modernen Gesellschaft jedenfalls westlicher Prägung widerspiegeln. Die Empfindlichkeit des einzelnen gegenüber „Fremdbestimmung" ist gewachsen. Das hat Auswirkungen vor allem im staatlichen Bereich; Datenschutz", „Recht auf informationelle Selbstbestimmung" und „gläserner Bürger" sind Stichworte dafür. Aber auch die Medizin ist von dieser Entwicklung nicht verschont geblieben. Patienten fühlen sich nicht ernstgenommen, sind bestenfalls verärgert, schlimmstenfalls gedemütigt, wenn der Arzt ihnen nicht sagt, woran sie leiden, wie eine Krankheit verlaufen wird oder verlaufen kann oder welche Risiken mit einer Behandlung verbunden sein können. Sie wollen wissen, jedenfalls in der Mehrzahl, was mit ihnen geschieht, wollen Subjekt der Behandlungsbeziehung sein. Hinzu kommt ein weiteres: Eine Diagnose, die noch vor gut zwanzig Jahren mit baldigem Tod und schwerem Leiden gleichgesetzt werden konnte, muß heute kein Todesurteil mehr bedeuten. So sind ζ. B. bei zahlreichen Krebsarten heute Heilungen möglich49, und wenn das nicht der Fall ist, dann kann doch stärker als früher eine Verbesserung der Lebensqualität erreicht werden, etwa bei Niereninsuffizienz oder auch bei Multipler Sklerose. Schließlich hat sich die Einstellung nicht nur des einzelnen, sondern vor allem der Gesellschaft gegenüber schweren Erkrankungen ganz wesentlich geändert. Früher hat man schwere Erkrankungen wie Krebs, aber auch Behinderungen, oft verheimlicht; die Krankheit führte leicht ins soziale Abseits, weil niemand damit umgehen konnte - man sprach ja nicht darüber - , und sicher auch, weil die materiellen Konsequenzen härter waren als heute: Lohnfortzahlung im Krankheitsfall, Krankengeld usw. sind sozialpolitische Errungenschaften - die wir hoffentlich nicht bald schon wieder der Vergangenheit zurechnen müssen - , die einer Ausgrenzung entgegenwirken. Auch die Rahmenbedingungen - zu denen ich auch ζ. B. behindertengerechte Einrichtungen und Vorrichtungen zähle - haben sich also geändert, und zwar so, daß mehr Offenheit im Umgang mit schweren Erkrankungen möglich und üblich geworden ist. Daß es immer noch Krankheiten gibt, die die Betroffenen stigmatisieren - heute vor allem Aids, aber auch geistig-psychische Behinderungen - , steht dem nicht entgegen. Mit alledem will ich sagen: wir sind „reifer geworden für Mündigkeit", der Patient von heute kann die Wahrheit über sich eher ertragen als früher, umgekehrt kann er paternalistische Haltungen weniger akzeptieren. Verschiedene Untersuchungen aus den achtziger Jahren über die Aufklärung von Patienten mit Multipler Sklerose mögen das, bei allen Vorbehalten gegenüber der Methode50, als „Trend" verdeutlichen. Danach wünschen international ca. 80% der Patienten eine frühzeitige Mitteilung der Krankheitsdiagnose51, nur weniger als 20% wollten möglichst 49

S. ζ. B. van de Loo/Wörmann, „Ärztliche Aufklärung über die Krankheit zum Tode", Deutsches Ärzteblatt 1992, S. A 1415. 50 Aleker (Fn. 35), S. 92, 117, weist auf die eingeschränkte Aussagekraft solcher empirischer Untersuchungen hin, da sie nur bereits aufgeklärte Patienten über ihre retrospektive Einschätzung der Aufklärung erfassen, nicht aber das Informationsbedürfnis des noch nicht aufgeklärten Kranken. Einzelheiten bei Aleker (Fn. 35), S. 56 ff.

Aufklärungspflicht

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wenig oder zumindest nicht jede Einzelheit wissen52. Von Zahlen derselben Größenordnung ist für Akutkrankenhauspatienten verschiedener medizinischer Disziplinen53 auszugehen, ebenso wie der weit überwiegende Teil von an Krebs Erkrankten in vollem Umfang aufgeklärt werden möchte54. In der medizinischen Literatur und zum Teil wohl auch in der Praxis beginnt diese Einsicht sich durchzusetzen55. Zwar haben Ende der siebziger Jahre - neuere Untersuchungen sind mir nicht bekannt - nur 47% von befragten Krankenhausärzten angegeben, die Diagnose einer bösartigen Erkrankung unaufgefordert dem Patienten mitzuteilen56. Es gibt aber bemerkenswerte Stellungnahmen im Schrifttum 57 und ebensolche mündlichen Äußerungen, die deutlich machen, daß auch Ärzte, und gerade diejenigen, die mit schwer Erkrankten zu tun haben, in der Aufklärung nicht nur ein notwendiges, ihnen von der Rechtsprechung oktroyiertes Übel sehen, sondern einen unverzichtbaren Bestandteil der Behandlung und des Arzt-Patienten-Verhältnisses.

IV. Wie also muß Aufklärung aussehen, wie kann dem Spannungsfeld zwischen Informationsrecht einerseits und eingeschränkter Belastbarkeit des Patienten andererseits Rechnung getragen werden? Nur ,»fürsorgliche Aufklärung" kann eine Aufklärung sein, vor der weder Arzt noch Patient Angst haben müssen. Dem Kranken darf nicht die Wahrheit „vor den Kopf geknallt" werden nach der Devise: Wenn sie es unbedingt wissen wollen: Sie haben Krebs58. Aufklärung, die dem Patienten eine tragfahige Grundlage für seine Entscheidung und damit eine ausreichende Basis für eine wirksame Einwilligung in eine Behandlung gibt, ist ein Akt der Kommunikation59. Sie setzt Vertrauen voraus auf seiten des Patienten und Einfühlungsfähigkeit und Ernstnehmen auf seiten

52 Aleker (Fn. 35), S. 62. 53 S. bei Aleker (Fn. 35), S. 62. 54 Aleker (Fn. 35), S. 91 m.w.N. 55 Skeptisch insoweit allerdings Franzki (Fn. 4), S. 176: Es wäre ein Trugbild, von der Wirklichkeit anzunehmen, die Anforderungen der Rechtsprechung hätten sich im Bewußtsein der Ärzteschaft durchgesetzt und würden im medizinischen Alltag regelmäßig befolgt. 56 Raspe, Aufklärung und Information im Krankenhaus, Göttingen: Vandenhoeck & Ruprecht, 1983. 57 Z.B. van de Loo/Wörmann (Fn. 49). 58 Vgl. Beispiel bei Aleker (Fn. 35), S. 51; zutreffend insoweit der Hinweis Buchborns (Fn. 46), S. 168, daß bei fehlenden therapeutischen Möglichkeiten die seelisch verstörende Aufklärung bereits selbst zu einem Eingriff in die körperliche Unversehrtheit führen könne. 59 Vgl. auch Aleker (Fn. 35), S. 100 ff., der von einem „Gemeinschaftsakt" zwischen Arzt und Patient spricht.

310

Gabriele Wolfslast

des Arztes 60. Aufklärung ist Information über einen dem Patienten in aller Regel fremden und dazu noch angstbesetzten Sachverhalt. Das macht deutlich, daß Aufklärung jedenfalls über belastende Diagnosen oder schwerwiegende Risiken nicht auf schriftlichem Wege, über ein Formular erfolgen kann, sondern meist schrittweise erfolgen muß 61 . Der Arzt muß sich seinem Patienten behutsam nähern, oftmals wohl mehr erfühlen denn erfragen, was dieser wissen will, was er wissen muß, um zu seiner Entscheidung zu kommen, und was er ertragen kann. Aber ist das nicht gerade dann ein Problem, wenn es um konstitutionell „eingeschränkt belastbare" Patienten geht, zum Beispiel um alte Menschen, die - vielleicht - nicht mehr die volle Wahrheit ertragen können, oder um psychisch Kranke? Trifft nicht gerade für diese Patientengruppen die Sorge zu, daß sie die Wahrheit über ihre Erkrankung oder, vielleicht eher noch, die Information über die entfernten Risiken einer notwendigen, eigentlich nicht riskanten Operation nicht verkraften? In bezug auf die Diagnoseaufklärung scheint mir die Frage einfacher zu beantworten zu sein. Ich glaube, daß man auch einem eingeschränkt belastbaren Menschen, der einsichtsfähig ist (wenn nicht, ist grundsätzlich ein Betreuer zu bestellen), einen ausreichenden Eindruck von seiner Krankheit und gegebenenfalls der notwendigen Behandlung vermitteln kann. Aufklärung, auch über eine schwere Erkrankung, ist ja nicht nur als Belastung zu sehen. Sie hat auch wesentliche positive Auswirkungen: sie kann Angst abbauen, indem sie dem Patienten Wissen über den eigenen Zustand und damit Sicherheit vermittelt; denn wer spürt, daß er nicht in Ordnung ist, aber nicht weiß, was es ist, ist ja auch vielfachen Belastungen ausgesetzt. Der Patient, der seine Diagnose kennt, weiß endlich, daß er sich nichts einbildet, daß er kein Hypochonder ist, sich nicht „anstellt"; er muß nicht (mehr) das Gefühl haben, wie ein Kind, eben als unmündig behandelt zu werden und, was sich oft genug bewahrheitet, der einzig Unwissende zu sein62. Der Patient, der aufgeklärt wird, braucht keine Angst zu haben, belogen und getäuscht zu werden 63; die Krise, in die das Vertrauensverhältnis nicht nur zum Arzt, sondern unter Umständen auch zum Partner, zur Familie geraten kann, wenn das „Netzwerk von Halbwahrheiten" dann doch zerreißt 64, ist nicht zu befürchten. Der Patient, der aufgeklärt ist, hat Vertrauen zu seinem Arzt und wird sich mit medizinischen Problemen an ihn wenden und nicht sichfragwürdige Informationen durch Laien beschaffen. Nur wer aufgeklärt wird, und damit meine ich immer angemessene, den Patienten weder emotional noch intellektuell überfordernde Aufklärung, kann an der Behandlung, so sie möglich ist, mitwirken, bzw. kann der Arzt sie ihm oft überhaupt 60 So auch H.-L Schreiber, „Wahrheit am Krankenbett bei infauster Prognose - juristische Aspekte", HNO-Informationen 4 (1989), 38. « S. oben bei Fn. 45 sowie z. B. Giesen (Fn. 3), S. 140. 62 Vgl. van de Loo/Wörmann (Fn. 49), S. 3; zu allem auch Aleker (Fn. 35), S. 108. 63 S. van de Loo/Wörmann (Fn. 49), S. 3. 64 Van de Loo/Wörmann (Fn. 49), S. 2f.

Aufklärungspflicht

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nur dann plausibel machen; und der aufgeklärte Patient wird sich nicht oder weniger verunsichern lassen durch Nebenwirkungen, z. B. einér medikamentösen oder Strahlentherapie65. Und schließlich hat nur der aufgeklärte Patient bei infauster Prognose eine Chance, sein Leben noch zu ordnen und familiäre oder berufliche Entscheidungen zu treffen 66. Dies alles kann freilich nicht absolut gesehen werden. Aufklärung ist kein Selbstzweck; das Selbstbestimmungsrecht darf nicht in eine dem Patienten aufgezwungene, unerträgliche Last umschlagen67. Behält man im Auge, daß sie die Selbstbestimmung des Patienten ermöglichen soll, so wird deutlich, daß auf Aufklärung auch ganz oder teilweise verzichtet werden kann - wenn der Patient das wünscht. Der Patient, der deutlich macht, daß er nichts wissen will, muß bzw. darf weder über die Natur seiner Erkrankung noch über Verlauf, Risiken etc. aufgeklärt werden. Das durch das Grundgesetz garantierte Selbstbestimmungsrecht gibt auch die Freiheit des Nichtwissens68. Ob der Patient auf die Aufklärung verzichtet oder nicht, kann er ausdrücklich erklären - das ist wohl eher selten der Fall - , aber auch stillschweigend zum Ausdruck bringen, zum Beispiel dadurch, daß er nie fragt, Hinweise des Arztes auf eine schwerwiegende Erkrankung ignoriert oder selbst immer wieder betont, daß ihm ja nichts Ernstes fehle. Gewarnt werden muß freilich davor, Zurückhaltung des Patienten vorschnell als Verzicht auf Aufklärung zu werten, denn ein solches Verhalten kann auch auf Ängstlichkeit, Unsicherheit, auf der letztlich und unvermeidbar doch hierarchischen Struktur des Arzt-Patienten-Verhältnisses beruhen. Die Frage nach der Risikoaufklärung gerade eingeschränkt belastbarer Patienten ist wohl schwieriger zu beantworten. Sind nicht vor allem diese Kranken überfordert, wenn sie über ein Risiko aufgeklärt werden, das zwar selten ist, aber, „wenn es sich verwirklicht, die Lebensführung schwer belastet und trotz seiner Seltenheit für den Eingriff spezifisch, für den Laien überraschend ist"?69 Wenn schon der Beipackzettel eines Medikaments von vielen Patienten nicht gelesen wird, oder, schlimmer, wenn notwendige Medikamente von normal belastbaren - was immer das heißen mag - Patienten nicht eingenommen werden, weil sie den Beipackzettel gelesen haben und sich vor den ,»Risiken und Nebenwirkungen" fürchten, was darf

65 Van de Loo/Wörmann (Fn. 49), S. 3; s. auch Wolfslast, »Juristische Aspekte der Diagnose und Therapie psychischer Störungen", in: Faust (Hrsg.), Psychiatrie, Stuttgart u.a.: Fischer, 1995, S. 850 f. 66 Vgl. die Beispiele bei Aleker (Fn. 35), S. 56 ff.; s. auch H.-L Schreiber (Fn. 60), S. 36. 67 H.-L Schreiber (Fn. 60), S. 35. 68 So ζ. B. Kern/Laufs (Fn. 45), S. 118; Deutsch, „Haftungsfreistellung von Arzt oder Klinik und Verzicht auf Aufklärung durch Unterschrift des Patienten", NJW 1983, 1351, 1354; Tempel, ,»Inhalt, Grenzen und Durchführung der ärztlichen Aufklärungspflicht unter Zugrundelegung der höchstrichterlichen Rechtsprechung", NJW 1980, 609, 614; Schaffer (Fn. 45), S. 1462; Laufs (Fn. 2), Rn. 207. 69 S. die Formulierung bei Steffen (Fn. 6), S. 131.

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man dann von Patienten erwarten, denen zumuten, die man, aus welchen Gründen auch immer, als „eingeschränkt belastbar" einschätzen muß? Eine Patentlösung gibt es, ebensowenig wie bei der Diagnoseaufklärung, nicht. Auch hier gilt aber, daß, im übertragenen Sinne, der aufklärungspflichtige Arzt zum Patienten gehen muß. Er muß ihm auf dessen Niveau vermitteln, daß etwas und was passieren kann. Dabei darf er seine eigene Einschätzung des Risikos durchaus zum Ausdruck bringen70. Er darf also zwar sagen, daß es nach einer Hüftgelenksoperation zu einer dauerhaften Nervschädigung kommen kann, aber auch, daß nach seiner persönlichen Einschätzung dieses Risiko nicht groß bzw. hinzunehmen ist im Vergleich zu den Vorteilen: daß man, wenn alles gut geht, besser oder überhaupt wieder laufen kann, daß mit der Operation wieder eine gewisse Selbständigkeit erreicht wird und daß der Kranke damit seine alten sozialen Kontakte aufrechterhalten oder wiederherstellen kann. Auch bei der Risiko-NutzenAbwägung also muß der Arzt Hilfestellung leisten, auch das gehört zu seiner ärztlichen Hilfeleistungs- und Fürsorgepflicht. Freilich dürfen Risiken nicht verniedlicht werden: Ein Lähmungsrisiko darf nicht als „Schlägle, das man medikamentös beherrschen könne", bezeichnet werden 71, und das Risiko einer Querschnittslähmung nicht als „vorübergehende Verschlechterung des Leidens"72. Mein Resümee aus alledem: Salus und voluntas aegroti sind grundsätzlich kein Gegensatz. Es dient dem Wohl des Patienten, seinen Willen zu respektieren, wenn ihm in angemessener Weise die Informationen gegeben werden, die er benötigt, um für sich seine Entscheidung zu treffen. Und in vielen Fällen schadet es dem Patienten, wenn ihm nicht die Möglichkeit gegeben wird, für sich selbst zu entscheiden, mit Hilfe seines Arztes. Dem Arzt nützt die „fürsorgliche" Aufklärung, weil sie ihm das Täuschen und Verheimlichen erspart und weil sie die Grundlage für die Behandlung darstellt, sofern eine solche möglich ist; daneben mindern eine korrekte Aufklärung und ein Vertrauensverhältnis zum Patienten erheblich das Risiko, mit einer Strafanzeige oder Klage auf Schmerzensgeld und /oder Schadensersatz konfrontiert zu werden. Ich bin optimistisch, daß wir uns allmählich verabschieden können von der schon fast historisch zu nennenden Kontroverse um die Aufklärungspflicht des Arztes. Der Patient wird mündig, sein Selbstbestimmungsrecht immer selbstverständlicher akzeptiert, und dazu hat die oft geschmähte, weil eine zeitlang vielleicht übers Ziel hinausgeschossene Rechtsprechung ebenso ihr Teil beigetragen wie die oftmals sehr harsche Kritik von Ärzten und Juristen73. 70 Vgl. auch Steffen (Fn. 6), S. 151; nach Deutsch (Fn. 11), S. 64, darf er das Risiko sogar „angemessen herunterspielen". 71 OLG Stuttgart, VersR 1988, 832. 72 OLG Hamm, VersR 1988,1133, beides bei Steffen (Fn. 6), S. 151. 73 In diesem Sinne dankt auch der Oberlandesgerichtspräsident a.D. Franzki auch der Rechtswissenschaft, die in ständig wachsendem Maße die Rechtsentwicklung vorbereitet und kritisch begleitet habe.

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Summary Contrary to the traditional reservations expressed by physicians and lawyers, salus and voluntas aegroti are not incompatible principles even among patients who can only bear a limited psychological burden. Instead, being informed rather than at the mercy of a doctor's determinations, being the subject and not the object of the treatment relationship correspond to the altered self-understanding of modern man. „Careful, solicitous information" can and should be integrated as a therapeutic factor into the treatment of basically every person who is ill. Even though this information may be burdensome, it has important positive effects on patients and their relation to their physicians.

Die Integrität der Arztrolle in Zeiten des Wandels Urban Wiesing

Unter dem Druck zunehmender Finanzierungsschwierigkeiten hat sich der Gesetzgeber zu einer weitreichenden Reform des Gesundheitswesens entschlossen, die - in Stufen fraktioniert - in einen Dauerzustand überzugehen droht. Wo ein Ende nicht abzusehen ist, drängt sich die Frage auf, ob und, wenn ja, wie die Rolle des Arztes in ihrer gegenwärtigen moralischen Konstruktion aufrechterhalten werden soll. Genau dies sei hier erläutert: Wie kann unter dem Druck ökonomischer und gesellschaftlicher Interessen die moralische Integrität der Arztrolle gewahrt bleiben, wenn sie denn gewahrt bleiben soll? Um diese Frage beantworten zu können, wird zunächst die moralische Grundlegung der Arztrolle dargestellt; anschließend seien Konfliktfelder systematisiert. Danach wird eine Präferenz in Konfliktfallen vorgeschlagen und unter dem Gesagten ein Blick auf Allokationsentscheidungen geworfen. Derartige Überlegungen ergeben jedoch nur einen Sinn, wenn die vorgängige Frage geklärt wurde, ob die Arztrolle in ihrer jetzigen moralischen Ausrichtung weiterhin bestehen bleiben soll oder ob nicht auch hier angesichts weitreichender Reformen Veränderungen anzustreben wären.

I. Die moralischen Grundlagen der Arztrolle: ^Freiwilligkeit, Vertrauen und Integrität 4 Wenn ein Mensch zu einem Arzt geht, dann geschieht etwas, das genau betrachtet einigermaßen erstaunlich ist: Es begegnen sich zwei Menschen, die sich - so bei einem Erstbesuch - überhaupt nicht kennen. Der Patient bittet den Arzt um Hilfe, teilt ihm gegebenenfalls sehr vertrauliche Informationen mit und läßt sich zuweilen auch unangenehm untersuchen. Sofern der Arzt es für erforderlich hält und der Patient zustimmt, begibt sich der Patient temporär in eine vollständige Abhängigkeit, so etwa bei einer Narkose. Ja, häufig weiß der Patient noch nicht einmal, welcher Arzt ihn operiert und welcher ihn narkotisiert, da die aufklärenden Ärzte nicht zwangsläufig die Maßnahmen durchführen müssen. Man stelle es sich bildlich vor, um ermessen zu können, was geschieht: Der Patient läßt sich von einer ihm namentlich und persönlich unbekannten Person gegebenenfalls den Leib eröffnen und nach chirurgischer Intervention wieder verschließen. Das alles läßt ein Patient in dem Vertrauen zu, daß es zu seinem Nutzen und nicht gegen seinen Willen geschieht. Freilich kann er in den allermeisten Fällen gar nicht überprüfen,

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ob der Arzt dieses Vertrauen rechtfertigt. Nur weil er es mit einem Arzt zu tun hat, verläßt sich der Patient darauf, daß dieser bestrebt ist, ihm zu nutzen und nicht zu schaden, und daß er seinen Willen respektieren wird, von wenigen Ausnahmen einmal abgesehen1. Zudem kann der Patient damit rechnen, daß grundsätzlich nichts von dem Gesagten nach außen dringt und daß er bei Teilnahme an einem wissenschaftlichen Versuch vorab umfassend aufgeklärt wird und seine Zustimmung geben muß. Auch kann der Patient gewiß sein, daß die Gesellschaft diese Beziehung bislang jedenfalls ausdrücklich gebilligt und vor äußerem Einfluß weitgehend geschützt hat. Hingegen kann sich der Patient nicht darauf verlassen, daß er wieder gesund werden wird, daß der Arzt seine Krankheit heilen oder sie zumindest erfolgreich lindern wird. 2 Auch wenn die moderne Medizin über ein breites Spektrum an Therapien verfügt, so kann doch niemand dem einzelnen Patienten einen Erfolg zusichern; zu ungewiß und zu unsicher ist die ärztliche Kunst. In der Medizin gibt es keine Garantien auf Erfolg. Alle Technologien und wissenschaftlichen Erkenntnisse haben daran nichts geändert. Gleichermaßen läßt sich die ärztliche Vorgehensweise nur sehr bedingt standardisieren; stets verbleibt dem Arzt ein Ermessens- und Abwägungsspielraum im einzelnen Fall. Die ärztliche Praxis hat sich einer Mathematisierung bislang strukturbedingt weitgehend verweigert. Die alltäglichen und geradezu selbstverständlichen Verhaltensweisen bei einem Arztbesuch werden also durch ein rollengebundenes, antizipatorisches Vertrauen erst ermöglicht. Dieses Vertrauen basiert streng genommen nicht auf dem Erfolg der ärztlichen Maßnahmen, da er nicht garantiert werden kann, sondern auf der moralischen Integrität, die durch die Zugehörigkeit zum Beruf ,Arzt* erwartet werden darf. 3 Ein Arzt wird in dieser Rolle gewisse moralische Verhaltensweisen einhalten4 - er wird versuchen, dem einzelnen Patienten zu nutzen und nicht zu scha1 Wichtigste, auch rechtlich sanktionierte Ausnahme ist die psychiatrische Zwangseinweisung. 2 Siehe Richard Toellner, „,Der Geist der Medizin ist leicht zu fassen4 (J. W. v. Goethe) Über den einheitsstiftenden Vorrang des Handelns in der Medizin", in: Herbert Mainusch/ Richard Toellner (Hrsg.), Einheit der Wissenschaft, Opladen: Westdeutscher Verlag, 1993, S. 21-36. 3 Nur indem die ärztliche Ethik für einen ganzen Berufsstand verbindlich ist, ermöglicht sie es, „dem personalen Vertrauen den Charakter eines Systemvertrauens zu verleihen" (Wolfgang Schluchter, Rationalismus der Weltbeherrschung. Studien zu Max Weber, Frankfurt a.M.: Suhrkamp, 1980, S. 191). 4 Zumindest graduell hat sich hier seit der Mitte des 19. Jahrhunderts, mit dem Selbstverständnis der Medizin als angewandter Naturwissenschaft, eine Verschiebung ergeben. „Alte und neue Professionen zeigen denn auch verschiedene Strukturprofile: Während jene Integrität als Verhaltensbeherrschung betonen, setzen diese auf Kompetenz als Wissensbeherrschung" (Schluchter 1980 (Fn. 3), S. 201). Daß der Anspruch der Medizin, eine angewandte Naturwissenschaft zu sein, trügerisch ist und entsprechend die daran anknüpfende Legitimation, scheint sich zumindest in der Medizintheorie als mehrheitsfahig durchgesetzt zu haben; vgl. Urban Wiesing, „Medizin zwischen Wissenschaft, Technologie und Kunst", Zeitschrift für medizinische Ethik 39 (1993): 121-130.

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den, er wird sein informiertes Einverständnis einholen und verschwiegen sein ... Wenn durch Krankheit das Leben zumindest verändert, wenn nicht gar bedroht wird, und wenn gleichzeitig von den Fähigkeiten eines Arztes statistisch gesehen zwar Besserung erwartet werden darf, im Einzelfall aber nichts garantiert werden kann, so verbleibt dem Patienten nichts anderes, als sein antizipatorisches Vertrauen auf der moralischen Integrität des Arztes aufzubauen, die durch die Zugehörigkeit zu einer Profession erwartet werden darf. Dieses Vertrauen wiederum ist keineswegs als nostalgisch-verklärende Beigabe an ein Dienstleistungsverhältnis zu verstehen, sondern nimmt eine zentrale Stellung in der Arzt-Patient-Beziehung ein. Als eine conditio sine qua non ermöglicht es erst den üblichen Ablauf:,,Für dieses Verhältnis, das den Patienten mit dem Arzt verbindet, steht der Begriff,Vertrauen 4. Dieses Vertrauen ist durch nichts zu ersetzen. Es gibt zu ihm schlechterdings keine Alternative."5 Und das antizipatorische Vertrauen wird zumeist auch nicht enttäuscht. Trotz einzelner Verfehlungen und trotz der allgegenwärtigen Medizinkritik erfreuen sich die Ärzte nach wie vor bei jeder Umfrage der höchsten Wertschätzung. Die moralische Konstruktion der Arzt-Rolle hat sich zumindest als Norm erstaunlicherweise sehr lange Zeit bewährt. „Das Leitbild des in seiner unvertretbaren Individualität die ungeteilte Verantwortung tragenden Arztes, dessen Tun zugleich durch den Patienten und sein Vertrauen legitimiert ist, hat ein außergewöhnliches Beharrungsvermögen bewiesen."6 Die normativen Grundzüge der gegenwärtigen Arzt-Rolle, sieht man vom informierten Einverständnis einmal ab, sind bereits weitgehend im Hippokratischen Eid zu finden. Es sei an dieser Stelle nicht verschwiegen, daß die skizzierte moralische Konstruktion der Arzt-Rolle aus Sicht der Ärzte auch nicht ganz uneigennützig verfolgt wird. Denn letztlich ermöglicht die Integrität der Arzt-Rolle und „ihre sozial dramatisierte Verpflichtung auf Selbstkontrolle"7 auch die Integrität des Ärztestandes mitsamt der gewährten Autonomie und Privilegien bis hin zum fast uneingeschränkten Monopol. Denn die Medizin ist in mindestens dreierlei Hinsicht eine vergleichsweise gering kontrollierte Disziplin, wenn man sich die Bedeutung dieser Profession einmal vor Augen führt. Schluchter spricht aus soziologischer Sicht von drei Asymmetrien: Der funktionalen Bedeutung der Medizin steht keine entsprechende Kontrolle der Gesellschaft gegenüber, da der Profession eine weitgehende Autonomie bis hin zum Standesrecht zugebilligt wird; die Bedeutung des einzelnen Experten für den Klienten wird nicht durch eine entsprechende Kontrolle des Klienten gedeckt, und auch die Kontrollmöglichkeiten der Berufsverbände 5 Dietrich Rössler, ,Ärztliche Ethik aus anthropologischer Sicht", in: R. Gross/H. H. Hilger/W. Kaufmann/P. G. Scheurlen (Hrsg.), Ärztliche Ethik, Stuttgart/New York: F. K. Schattauer Verlag, 1978, S. 17-24, S. 22. 6 Wolfgang Wieland, Strukturwandel der Medizin und ärztliche Ethik. Philosophische Überlegungen zu Grundfragen einer praktischen Wissenschaft, Heidelberg: Carl Winter, 1986, S. 60. ? Schluchter 1980 (Fn. 3), S. 189.

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über die einzelnen Ärzte sind vergleichsweise gering. Wie kann unter diesen Bedingungen eine Profession auf soziale Akzeptanz hoffen? Nur durch eine ganz bestimmte Berufsmoral: „Solche Asymmetrien sind sozial prekär und müssen gerechtfertigt werden. Die Legitimationsmechanismen sind Freiwilligkeit, Vertrauen und Integrität, gestützt vor allem durch eine Berufsmoral, deren oberste Maxime das Wohl des Klienten ist."8 Kurzum: Die moralische Integrität des Arztes ermöglicht letztlich auch die funktionale Stellung seines Berufsstandes. Zwei Bemerkungen zur Moralität der Arzt-Rolle seien ergänzt. Erstens: In seiner Rolle obliegt dem Arzt eine verminderte gesellschaftliche Verantwortung als vergleichsweise in seiner Rolle als Bürger. Ein Beispiel mag diesen Sachverhalt erläutern: Wahrend ein Bürger verpflichtet ist, ein geplantes Verbrechen, von dem er Kenntnis bekommen hat, durch geeignete Maßnahmen so weit wie möglich zu verhindern, ist es einem Arzt in sein Ermessen gestellt, ein geplantes Verbrechen seines Patienten, von dem er im therapeutischen Gespräch erfahren hat, der Polizei zu melden.9 Zweite Bemerkung: Wenn der Arzt das Wohl des einzelnen Patienten vor Augen hat, so muß sich nicht zwangsläufig der kollektive Nutzen optimieren. Denn der Nutzen für ein Individuum muß nicht unbedingt auch ein Nutzen für die Gesellschaft sein. Eine auf das individuelle Wohl ausgerichtete Medizin kann durchaus paradoxe Ergebnisse erwirken, gemäß der Erkenntnis, „daß der einzelne gesünder wird, während gleichzeitig die Gesundheit aller Überlebenden im Durchschnitt schlechter wird" 10 . Damit sei keineswegs gesagt, die ärztliche Tätigkeit schade nur der Gemeinschaft. Für einige Bereiche müssen wir allerdings davon ausgehen, daß eine auf das Individuum ausgerichtete Medizin die Zahl der Kranken und Pflegebedürftigen einer Gesellschaft erhöht. Die Verpflichtung, das Wohl des Einzelnen zu mehren und dessen Willen zu respektieren, kann durchaus andere Vorgehensweisen erfordern als die Verpflichtung, das kollektive Wohl zu optimieren. Soweit zur Arztrolle, nun zu den Konflikten: Der Arzt ist nicht nur in der oben beschriebenen Weise seinem Patienten verpflichtet. Denn er steht zwangsläufig mit anderen Personen und anderen Gruppen in Verbindung. Er berührt mit seiner 8 Ebd, S. 192; ob dieses Ethos reicht, um die genannten Asymmetrien angemessen abzugleichen, wird auch bezweifelt; siehe Eliot Freidson, Der Ärztestand: Berufs- und wissenschaftssoziologische Durchleuchtung einer Profession, Stuttgart: Enke, 1979; Walther Schaupp, Der ethische Gehalt der Helsinki Deklaration, Frankfurt a.M.: Peter. Lang, 1994, weist auf den Eigensinn des ärztlichen Ethos hin: „[...] wenn im expliziten Ethos der Patient und das Wohl der Gesellschaft im Mittelpunkt stehen, dann steht umfassender gesehen doch die Profession selber im Mittelpunkt" (S. 25). 9 Die Berufsordnung stellt es dem Arzt anheim („ist befugt"), die Schweigepflicht zu brechen, „soweit die Offenbarung zum Schutze eines höherwertigen Rechtsgutes erforderlich ist" (§ 2 Abs. 4), Ärztekammer Westfalen Lippe, ,3erufs- und Weiterbildungsordnung der Ärztekammer Westfalen-Lippe vom 23. April 1977 in der Fassung der Bekanntmachung vom 28. Dezember 1990", Westfälisches Ärzteblatt, Sondernummer Juni 1991, S. 51-79, S. 51. 10 Walter Krämer, Wir kurieren uns zu Tode. Die Zukunft der modernen Medizin, Frankfurt/New York: Campus, 1993, S. 35.

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Tätigkeit nicht nur die Belange seines Patienten, sondern auch die Interessen anderer, denen gegenüber er jeweils eine gewisse Verantwortung trägt. Ja, es scheint gerade für den Arztberuf typisch zu sein, daß seine Verantwortung Eigenschaften annimmt, die man gern mit dem Begriff »komplex4 bezeichnet. Dies wird sehr schnell deutlich, sofern man nur einmal grob schematisch die Personen oder Gruppen auflistet, mit denen ein Arzt in Kontakt tritt: Patient: - Sonderfall Paartherapie: zwei Patienten - Sonderfall pränatale Medizin: zusätzlich das ungeborene Kind - Sonderfall Reproduktionsmedizin: zusätzlich das zukünftige Kind andere Personen: - Angehörige - Kollegen, Lehrer - Personen anderer Berufe Gruppen/Institutionen : - Standesorganisationen - wissenschaftliche Organisationen - Kostenträger - Gesellschaft Leicht ist zu ersehen, daß sich allein die Verantwortung für den Patienten in Sonderfallen als durchaus zwiespältig erweist. Und selbstverständlich kann sich die ärztliche Verantwortung gegenüber den einzelnen Personen und Institutionen ganz unterschiedlich ausgestalten, so daß Lenk/Lenk zu Recht im Plural von „Verantwortungen" des Arztes sprechen11. Die Interessen eines Angehörigen können die Interessen eines Patienten beschränken und umgekehrt. Welchen soll der Arzt Vorrang gewähren? Durch die moralischen Verpflichtungen des Arztes, ζ. B. die Verschwiegenheit, können andere Personen Schaden nehmen. Wie ist zu gewichten? Oder, um ein aktuelles und politisch kontrovers diskutiertes Beispiel aufzugreifen: Die Interessen der Kostenträger unterscheiden sich verständlicherweise von denen der Patienten.

Π. Begrenzung der ärztlichen Verantwortung Wie ist auf Konflikte zu reagieren, wenn die Interessen einer anderen Person oder Institution das Verhalten des Arztes gegenüber seinem Patienten beeinflussen? Wie läßt sich die Integrität der Arztrolle unter vielfältigen Interessenskonflikten erhalten? Überzeugende Argumente unterstützen eine Arzt-Patient-Beziehung, die einen vorab festgelegten Spielraum hat, der von gesellschaftlichen Reglemenh Hans Lenk/ Ulf Lenk, „Zur Integration der ärztlichen Verantwortungen", Wiener Medizinische Wochenschrift, Diskussionsforum Medizinische Ethik 11/12 (1993): LVm-LXI.

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tierungen weitgehend freigehalten wird und in dem der Arzt auf Wohl und Wille seines einzelnen Patienten verpflichtet ist. Für sich abzeichnende Konflikte zwischen Erwägungen, die den Patienten, andere Personen oder Institutionen betreffen, sollte eine klare, für alle Beteiligten nachvollziehbare Regelung vorab angestrebt werden. Auf der einen Seite sollte der Ermessensspielraum des Arztes weitgehend freigehalten werden und der Wille und der Nutzen des Patienten die ärztlichen Überlegungen leiten. Auf der anderen Seite sollte die Gesellschaft die Grenzen des Freiraums unmißverständlich vorweg festlegen, ohne jedoch das Ermessen des Arztes in diesem Bereich direkt zu beeinflussen. Was die Gesellschaft nicht als Handlung innerhalb der Arzt-Patient-Beziehung akzeptieren kann, sollte sie oberhalb dieser Beziehung so regeln, daß der Arzt in seinen Erwägungen des Einzelfalls nicht damit belastet ist, weil es vorgängig eindeutig verboten ist. Gesellschaftliche Regelungen können den Freiraum zwar begrenzen, sollten aber nicht in den Freiraum selbst eindringen. Nur so ist die Arzt-Patient-Beziehung von Einflußnahmen freizuhalten, die ihr Fundament zerstören würden. Für die Fälle, in denen keine eindeutige Regelung oberhalb der Arzt-Patient-Beziehung besteht, sollte man grundsätzlich die Ausrichtung der Arztrolle als »Anwalt des Patienten4 wahren. Durch diesen Vorschlag ist die ärztliche Verantwortung sicher nicht in allen Fällen eindeutig zu klären; es werden Konflikte verbleiben, die durchaus dilemmatische Formen annehmen können und die moralische Urteilskraft des Arztes nachhaltig herausfordern. Dieses Problem läßt sich allerdings bei kaum einer groben Regulierung vermeiden und vermag von daher nicht als Argument gegen den skizzierten Vorschlag zu überzeugen. Dieser kann andererseits - wohlverstanden als grobe heuristische Maxime - zahlreiche Argumente für sich verbuchen. Insbesondere die Abweichungen von der dargestellten moralischen Ausrichtung seien hier erwähnt. Wenn es sich bei der skizzierten Arztrolle um eine historisch bewährte handelt, so sind gleichwohl Phasen bekannt, in denen an entscheidenden Punkten abgewichen wurde. Die Medizin in der Zeit des Nationalsozialismus drängt sich als abschreckendes Beispiel auf, da sie genau beim primären Verantwortungsadressaten eine einschneidende Änderung zuließ - er wurde erweitert: Der Arzt war nicht nur seinem einzelnen Patienten verpflichtet, sondern darüber hinaus auch dem ,Volkskörper'. Die Verdoppelung der ärztlichen Aufgabe bedeutete für die Ärzte freilich einen Machtzuwachs, von dem sich viele verführen und „zum Werkzeug von Herrschaftszielen" 12 umfunktionieren ließen. Doch die Folgen waren verheerend; die beiden unterschiedlichen Adressaten der ärztlichen Verantwortung (Patient und Volk) ermöglichten bei gleichzeitiger Aufhebung von Patientenrechten in letzter Konsequenz die absurde und verhängnisvolle Argumentation, daß die Selektion an der Rampe in Ausschwitz eine ärztliche Tätigkeit sei, da es auch hier um Heilung »2 Richard Toellner, 1433, S.C-1431.

.Ärzte im Dritten Reich", Deutsches Ärzteblatt 86 (1989): C-1427-

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gehe, allerdings um die Heilung des Volkskörpers, um das „Kurieren der Gene", um das „Kurieren der Rasse".13 Selektionen, so forderten die beteiligten Ärzte, seien nur von ihresgleichen auszuführen. Das heißt, in der vermutlich größten Vernichtungsmaschinerie der Menschheit tauchte in der verqueren und absurden Legitimation der beteiligten Ärzte tatsächlich der Gedanke des,Heilens4 auf. 14 Die Vernichtung durch Gas als ,Sonderbehandlung' zu bezeichnen, ist nicht nur eine schreckliche und heuchlerische, sondern zugleich eine höchst aussagekräftige Verharmlosung. Durch die Ausweitung des Verantwortungsadressaten über den einzelnen Patienten hinaus war eine vermeintlich »medizinische4 Legitimation des „Paradoxons des Heilens durch Töten"15 möglich geworden. Diese Änderung der ärztlichen Verantwortung, die Verdoppelung des Verantwortungsadressaten, läßt sich nicht nur an der Extremsituation eines Vernichtungslagers festhalten, sondern durchzog im Dritten Reich nach offizieller Lesart alle Bereiche der ärztlichen Tätigkeit. Diese gravierende Abweichung vom Arztbild lieferte eine der Legitimationen für die Greueltaten der NS-Medizin. Die Medizin im Nationalsozialismus ist ohne Zweifel ein Extrembeispiel aus der Geschichte. Gleichwohl läßt sich das Prinzip an alltäglichen, gegenwärtig diskutierten Beispielen erläutern. Auch ein vielzitierter zeitgenössischer Philosoph kommt zu durchaus fragwürdigen Ergebnissen, erwähnt sei Hans Jonas. Denn Jonas will die Erwägungen des Arztes im Einzelfall auch mit weitreichenden Erwägungen belasten; er sieht für die neue Medizin eine „andere Dimension der Verantwortung 4416, „ganz neue Horizonte der Verantwortung 4417, eine JernVerantwortung4'18 oder eine Mitverantwortung an der „planetarischen Verantwortung 4419. Um die Fragwürdigkeit dieser Verantwortungszuschreibung zu beleuchten, sei ein von Jonas selbst gewähltes Beispiel untersucht. So bemerkt er zur hormonellen Kontrazeption: „Ja selbst gegen die »Pille*, von der man sagen kann, daß der Aizt nur über ihre medizinische Unschädlichkeit zu wachen habe, ihr Gebrauch im übrigen Privatsache sei selbst gegen sie kann seine menschliche Verantwortung einwenden, daß ihre unterschiedslose Verabreichung in einer ohnehin hedonistischen Gesellschaft der geschlechtlichen Libertinage Vorschub leistet"20. u Robert Jay Lifion, Ärzte im Dritten Reich, Stuttgart: Klett-Cotta, 1988, S. IX; siehe auch Toellner 1989 (Fn. 12). 14 Was sich in grotesken Szenen widerspiegelte; Lifton 1988 (Fn. 13) berichtet von Ärzten, die einerseits Selektionen vornahmen, sich andererseits .sorgsam4 (für KZ-Verhältnisse) um einzelne erkrankte Patienten bemühten, is Ufton 1988 (Fn. 13), S. 178. 16

Hans Jonas, »Ärztliche Kunst und menschliche Verantwortung", in: ders. (Hrsg.), Technik, Medizin und Ethik. Zur Praxis des Prinzips Verantwortung, Frankfurt a.M: Suhrkamp, 1987, S. 146-161, S. 156. π Ebd., S. 151. 18 Ebd., S. 157. 19 Ebd., S. 157. 21 Jahibuch für Recht und Ethik, Bd. 4 (1996)

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Hier zeigt sich, wie gefährlich eine Ausweitung der ärztlichen Verantwortung durch eine vermeintlich »menschliche4, eine ,planetare4 »Verantwortung werden kann. Es ist eine Angelegenheit der Gesellschaft, festzulegen, welche »geschlechtliche Libertinage4 sie zulassen will und welche nicht. Dieses gesellschaftliche Problem - von dem man auch behaupten kann, daß es faktisch kaum eines darstellt sollte in die Erwägungen des Arztes gerade eben nicht einfließen. Ist die hormonelle Verhütung erlaubt, dann darf der Arzt sie verschreiben, und zwar ohne die gesellschaftlichen Folgen in seine Entscheidung beim konkreten Einzelfall einfließen zu lassen. Wenn ihm hier auch noch gesellschaftspolitische Aufgaben zukommen sollten, dann wäre die moralische Ausrichtung seiner Tätigkeit ad absurdum geführt. In diesem Zusammenhang sei auf das bundesrepublikanische Ärztegelöbnis verwiesen, denn es beginnt - zumindest in der Ärztekammer Westfalen-Lippe - mit dem Satz: „Bei meiner Aufnahme in den ärztlichen Berufsstand gelobe ich feierlich, mein Leben in den Dienst der Menschheit zu stellen.4421 Das ist zum einen übertrieben, zum anderen zweideutig: 1. Es reicht, wenn sich die ärztliche Verantwortung auf die Berufstätigkeit konzentriert. Es gibt wohl kaum überzeugende Argumente, denen zufolge die ärztliche Verantwortung auf das ganze Leben des Berufsangehörigen auszudehnen wäre. 2. Auch der Verantwortungsadressat - die Menschheit - sollte genauer hinterfragt werden, zumal der § 1 Abs. 1 der Berufsordnung differenziert und zwei Verantwortungsadressaten benennt: „Der Arzt dient der Gesundheit des einzelnen Menschen und des gesamten Volkes.4422 Das ist zumindest zweideutig. Es ist nicht klar zu erkennen, daß die Gesundheit des Volkes zwar aus der Verpflichtung gegenüber dem einzelnen Patienten mit einer Besserung rechnen darf, dies jedoch keineswegs als notwendige Konsequenz aus der primären Verpflichtung anzusehen ist. Erinnert sei an die erwähnten paradoxen Effekte. Somit sind es zwei grundlegend unterschiedliche Verpflichtungen, ob der Arzt zuerst den Nutzen des einzelnen Patienten mehren oder vorrangig das durchschnittliche Gesundheitsniveau der Bevölkerung optimieren soll. Letztere Maxime ist aufgrund ihrer fatalen Konsequenzen mit der Arztrolle nicht zu vereinbaren. 23 20 Ebd., S. 154. 21 Berufs- und Weiterbildungsordnung der Ärztekammer Westfalen-Lippe, Präambel. Im Mustergelöbnis der Bundesärztekammer hat der Arzt sein „Leben in den Dienst der Menschlichkeit [!] zu stellen" (Bundesärztekammer, „Berufsordnung für die deutschen Ärzte", Deutsches Ärzteblatt 91, 1994, S. A-53-62, S. 53); der englische Begriff lautet „humanity". 22 Berufs- und Weiterbildungsordnung der Ärztekammer Westfalen-Lippe (Fn. 9), § 1 Abs. 1. 23 Im ,Gesundheitspolitischen Programm der deutschen Ärzteschaft' von 1994 erscheint eine Präferenzregel: „Im Konflikt zwischen Patienten- und Gemeinschaftsinteresse muß der Arzt die Interessen des Patienten wahren und die Regeln der ärztlichen Kunst einhalten." (Bundesärztekammer, „Gesundheitspolitisches Programm der deutschen Ärzteschaft. Beschluß des 97. Ärztetages vom 11. bis 14. Mai 1994 in Köln", Deutsches Ärzteblatt 91, 1994, Heft 24, Supplement, S. 3). Außerdem ließe sich aus der Präambel der Berufs- und Weiterbildungsordnung eine Präferenz ableiten, wenn die deutsche Übersetzung des Genfer Gelöbnis-

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Es wäre wünschenswert, daß sich die Berufsordnung mit einer der Bedeutung des Textes angemessenen Präzision äußern würde.

ΠΙ. Soll die Arztrolle erhalten bleiben? Neben den negativen Beispielen seien auch positive Argumente für die skizzierte Verantwortung des Arztes angeführt. Das entscheidende moralphilosophische Argument ist die Tragfähigkeit der Rolle, die zerstört würde, wenn man dem Arzt eine weitreichende gesellschaftliche Verantwortung in den Erwägungen des einzelnen Falles zuschreibt. Damit beruht dieser Vorschlag argumentativ letztlich auf der Rollenintegrität, und es stellt sich natürlich die vorgängige Frage, ob die Arztrolle überhaupt gewahrt bleiben soll, ob dieses wünschenswert ist, oder ob nicht eine andere Arztrolle anzustreben ist. Die Antwort fallt recht eindeutig aus. Erstens: Trotz der allgegenwärtigen Kritik an der Medizin wird die Rolle des Arztes, der sich in einer geschützten, personalen Beziehung vor allem dem Patienten widmet, weit mehrheitlich gewünscht. In einer Demokratie ist dies stets ein gewichtiges Argument. Zweitens: Die Arztrolle hat sich - wie bereits erwähnt - historisch bewährt. Die Phasen, in denen an entscheidenden Punkten von dieser Rolle abgewichen wurde, gelten heute als ausgesprochen ablehnenswert. Drittens: Das moralische Prinzip, welches in den letzten Dezennien die größte Aufmerksamkeit und Umbewertung erfahren hat, die Autonomie des Patienten, dieses Prinzip läßt sich am besten mit einer Arztrolle realisieren, die den individuellen Patienten in den Mittelpunkt der Erwägungen stellt. Die Selbstbestimmung des Patienten kann am besten gefördert werden, wenn sich der Arzt „als Treuhänder der Interessen des Patienten"24 versteht. Und viertens: Die Verantwortung des Arztes in der skizzierten Form ist einerseits in bezug auf den Patienten von anderweitiger Einflußnahme weitgehend freigehalten, andererseits eng begrenzt auf diesen Bereich. Diese klare Beschränkung ärztlicher Verantwortung scheint auch geboten, als es gilt, eine „letztlich zerstörerische Allzuständigkeit der Medizin" 25 zu vermeiden.

ses den Singular „the health of my patient" nicht in den Plural übertragen hätte: „Die Erhaltung und Wiederherstellung der Gesundheit meiner Patienten [!] soll oberstes Gebot meines Handelns sein." (Präambel der Berufs- und Weiterbildungsordnung der Ärztekammer Westfalen-Lippe, Fn. 9). 24 Dieter Birnbacher, „Welche Ethik ist als Bioethik tauglich?", in: Johann S. Ach /Andreas Gaidt (Hrsg.), Herausforderung der Bioethik, Stuttgart-Bad Cannstatt: FrommannHolzboog, 1993, S. 45-67, S. 54; siehe auch Urban Wiesing, Zur Verantwortung des Arztes, Stuttgart-Bad Cannstatt: Frommann-Holzboog, 1995. 21

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IV. Allokationen und die Integrität der Arztrolle Das zuvor skizzierte Schema sei nun abschließend genutzt, in Allokationsfragen erste Präferenzen zu benennen. Es sei einmal unterstellt, daß es aus politischen Gründen vertretbar ist, die ansteigenden Ausgaben für medizinische Dienstleistungen zu begrenzen. Doch die politischen Aspekte sollen hier ausgespart bleiben; es ist vielmehr zu fragen, wie sich mögliche Regelungen auf die Integrität der Arztrolle auswirken sollten. Solange das Verhalten des Arztes gegenüber dem Patienten durch Erwägungen der Sparsamkeit nicht beeinträchtigt ist, bestehen kaum Bedenken dagegen, wenn sie etwa lauten würden: Der Arzt ist gegenüber den Kostenträgern zur Sparsamkeit und zur effektiven Nutzung der Mittel verpflichtet, zudem muß er darüber Auskunft erteilen. Dies vom Arzt zu fordern, beeinträchtigt keineswegs seine Verantwortung gegenüber dem Patienten, sondern ist auch der Verpflichtung zu entnehmen, begründet zu handeln. Unwirksame Maßnahmen durchzuführen, belastet nicht nur die Solidargemeinschaft, sondern widerspricht auch der Verantwortung des Arztes gegenüber seinem Patienten, der vernünftigerweise erwartet, mit wirksamen Mitteln behandelt zu werden. Es ist zudem moralisch unbedenklich, den Arzt zu verpflichten, nutzlose, aber angenehme Dienstleistungen nicht zu verschreiben. Also: Sparsamkeitserwägungen bedrohen nicht die Integrität der Arztrolle. Hingegen ist dem Arzt auf keinen Fall die Verantwortung für Rationierungen zuzuschreiben, weil ihn dies in den Konflikt bringen würde, einzelnen Patienten zu schaden. Wenn Rationierungen im Gesundheitssystem für notwendig erachtet werden, dann sollte der Arzt diese Aufgabe strikt von sich weisen. Die Instanz der Verteilung, der Kostenträger, sollte die Verantwortung für die Verteilung übernehmen und sie oberhalb der Arzt-Patient-Beziehung eindeutig regeln. Anderenfalls würde man die Integrität der Arztrolle zerstören, sofern man den Arzt dazu zwingt, eine Auswahl unter seinen Patienten zu treffen. Der Arzt als ,gate-keeper4 für begrenzte Leistungen würde zu Begleiterscheinungen führen, die niemand wünschen kann. Man stelle sich nur das Buhlen eines Patienten um eine Entscheidung des Arztes zu seinen Gunsten und zu Ungunsten eines anderen Patienten vor. Wenn das Verhalten des Patienten von diesem Bestreben geprägt ist, dann fehlt jede Basis für eine sinnvolle therapeutische Beziehung. Oder, aus der Sicht des Arztes: Ihm die Mittel für 8 Behandlungen zu geben, aber 10 Patienten zuzuweisen, überfordert ihn und zerstört die Integrität der Arzt-Rolle. Deshalb gilt: Die Makroallokation sollte auf einer Ebene oberhalb des Arzt-Patient-Verhältnisses geregelt werden, denn alles andere würde das Verhältnis zu sehr belasten und überfordern. Das antizipatorische Vertrauen der Patienten, jene conditio sine qua non für die ärztliche Tätigkeit, wäre gefährdet. Dies entbindet den Arzt jedoch nicht von Entscheidungen in seinem Zuständigkeitsbereich; Verantwortung ist dem Arzt in seiner Rolle als Verteiler vor Ort für

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die Mikroallokation zuzuschreiben. Er muß die ihm zur Verfügung stehende Zeit, seine Energie und vor allem seine Konzentration gerecht und angemessen verteilen. Wieviel Geld eine Gesellschaft für medizinische Technologie ausgeben will, sollte hingegen nicht in die Einzelfallentscheidung des Arztes einfließen, sondern unmißverständlich oberhalb dieser Ebene von der Instanz entschieden werden, die das Geld zur Verfügung stellt. Dafür spricht die Integrität einer Rolle, von deren moralischer Grundkonzeption nicht ohne zwingenden Grund abgewichen werden sollte.

Summary The article is devoted to the question of how the moral integrity of the physician's role can be maintained under the pressure of economic and social interests. First, the moral basis of the doctor's role is discussed and areas of conflict are systematized. Second, a preference for cases of conflict is recommended and allocational decisions are examined. The primary question of whether the doctor's role in its current moral orientation should be maintained is answered clearly in the affirmative under reference to history, to the patient's self-determination and to undesirable results that are to be feared.

Advance Directives in Multicultural Perspective

Regelungsbedarf bei Patienten Verfügungen und klinisch-ethischen Entscheidungskonflikten? Hans-Martin Sass

,Recht auf Leben' ist ein hohes verfassungsrechtlich und zivilrechtlich geschütztes Rechtsgut, dessen Verletzung strafrechtlich geahndet und polizeilich verfolgt wird. ,Recht auf Sterben4 wurde demgegenüber traditionell nie als Rechtsgut beschrieben oder eingefordert. Sterben und Tod waren natürliche Fakten, Räume einer natürlichen »Freiheit4, in welche menschliche Handlungsmöglichkeiten im Guten wie im Bösen nicht hineinreichten und für die deshalb auch kein Rechtsschutz gefragt war. Hochwirksame medizinische Eingriffe in die präfinalen und finalen Lebensphasen manipulieren im Guten wie im Bösen aber heute auch Sterben und Tod. Die beiden klassischen arztethischen Prinzipien des salus aegroti suprema lex und des primum nil nocere, welche das Wohl des Patienten und das Verbot der Schadenszufügung zu den obersten Richtlinien für Intervention oder Interventionsverzicht machten, fragen deshalb an, ob der totale Einsatz der technisch möglichen Interventionen tatsächlich dem salus der Patienten dient oder ob er diesem nicht vielmehr schadet. Klinisch-empirische Studien dokumentieren, daß Patienten gewisse Interventionen und medizinisch ermöglichte Formen des Lebens mehr fürchten als den Tod [4]. Erst dort, wo Lebensende und Sterbeprozeß zum Gegenstand medizinischen Manipulationshandelns werden, kann die Frage nach einem ,Recht4 auf Sterben laut werden, das den eigenen Interessen, Werten und Rechten nicht im Weg steht. Das, was als ,Recht auf den eigenen Tod4 eingeklagt werden soll, ist also ein Anspruch gegen Maschinen, Einrichtungen und Ärzte, welche dem Leben und der Würde des Menschen schaden können. Nur unter den Herausforderungen durch Entscheidungskonflikte in der modernen Medizin konnte deshalb der 9. US State Court of Appeals in einer nunmehr klassisch werdenden Argumentation in Compassion in Dying ν. State of Washington [8] von einem in der Verfassung garantierten Recht auf »physician assisted suicide4 für selbstbestimmungsfähige Patienten sprechen, ähnlich wie das in Roe ν. Wade für das Recht auf Schwangerschaftsabbruch geschehen war [8]. Von Juristen [6] und von Laienorganisationen [3] formulierte rejektionistische ,Patiententestamente4 waren vor 20 Jahren erste Instrumente, die mit der Sprache und den Mitteln des Rechts das medizinische Handeln in solchen Situationen klinischer Konflikte zu steuern suchten. Der Bundesgerichtshof entschied 1994, daß in Interventionskonflikten bei entscheidungsunfahigen Patienten von diesen früher

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geäußerte Wünsche und Werte handlungsleitend sein müssen und daß nur beim Fehlen solcher subjektiver Kriterien auf objektive zurückgegriffen werden darf [2]. In den USA gibt es seit vielen Jahren in allen Bundesstaaten Modelle für Patiententestamente, die den jeweiligen bundesstaatlichen Anforderungen genügen; der US Congress hat 1990 im Patient Self-Determination Act ein Rahmengesetz zur Durchsetzung des Patientenwillens auch für die Stunden künftiger Inkompetenz beschlossen [7]. Der Yokohama District Court hat 1995 festgelegt, daß es straflos bleiben muß, wenn dem Wunsch schmerzgeplagter entscheidungsfähiger Patienten nach Sterbehilfe in ihrer letzten Lebensphase entsprochen wird [9]. Außerhalb des Arzt-Patient-Verhältnisses im engeren Sinne und ohne Bezug auf berufsständische oder berufsethische Regelungen haben also in drei Ländern mit sehr unterschiedlichen individuellen, öffentlichen und Berufskulturen Richter oder Gesetzgeber Veranlassung gesehen, in einen Raum einzugreifen, der mit Absicht und mit gutem Recht traditionell gegen gesellschaftliche, rechtliche, auch ethische oder religiöse Eingriffe von außen geschützt war. Aber sind Rechtsinstrumente die adäquaten Mittel, in solche sehr persönliche Interaktionen von Dienstleistungserbringem und Dienstleistungsnachfragern medizinischer Dienste einzugreifen? Sind nicht vielmehr überkommene Interaktionsmodelle, die auf Vertrauen basieren und in welche die Beteiligten klassische Tugenden einbringen - die Ärzte das Hilfsgebot und das Schadensverbot und die Laien die Tugend der »Compliance4 - , geeignetere Szenarien, Handlungen und die sie begründenden Werte und Prinzipien einer kritischen Untersuchung und gegebenenfalls einer Modifikation zu unterziehen? In den USA ist im Gegensatz zu Japan und Deutschland das Konzept der »Vorsorglichen Verfügung 4, basierend auf dem Autonomieprinzip, selbstverständlicher ein Teil der öffentlichen und individuellen Kultur. Die Zahl derjenigen, die »Vorsorgliche Verfügungen 4 oder »Bevollmächtigungen für Stellvertretende Entscheidungen4 unterzeichnet haben, ist höher als in Deutschland oder gar in Japan, wo die Infragestellung professioneller Autorität ethisch und kulturell problematisch ist; sie ist jedoch auch in den USA nicht so hoch, wie man das erwarten sollte. Liegt das an dem Tabu, das in einer erfolgs- und lebensbetonten Kultur die Beschäftigung mit künftigen Szenarien eigener Schwäche, eigenen Leidens und Sterbens umgibt? Ware ein solcher kulturell bedingter Verzicht auf Selbstbestimmung dort, wo ihre Einforderung ganz eindeutig im eigenen Interesse liegen würde, ein Anlaß, entweder rechtliche oder berufsständische Regelungen stellvertretend ,im besten Interesse4 des auf Selbstbestimmung verzichtenden Bürgers zu veranlassen? Oder ist es ein Mißgriff, traditionelle Verhaltensregelungen, auch wenn sie derzeit umstritten sind, durch Rechtsregelungen zu ersetzen und nicht vielmehr auf die Kraft der Modifikation etablierter Verhaltensmuster zu setzen? Und wo Selbstbestimmung prospektiv sich in der Ausfertigung von Betreuungsverfügungen festgelegt hat, wird sie von der herrschenden Kultur des medizinischen Establishments überhaupt akzeptiert? Die Bundesärztekammer [1] fordert vom Arzt die Orientierung am mutmaßlichen Willen des Patienten zum Zeitpunkt der Intervention und will frühere Äußerungen lediglich als Indiz gelten lassen, weil

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sie ja jederzeit widerrufen werden könnten, während der Bundesgerichtshof [2] solche Erklärungen für bindend erklärt, solange sie nicht de facto widerrufen sind. Sensationell in bezug auf die faktische Irrelevanz vorhandener Informationen über Wünsche und Wertvorstellungen von über 9000 schwerstkranken Patienten mit einer Lebenserwartung von unter sechs Monaten auf faktische klinische Entscheidungen sind die Ergebnisse der Study to Understand Prognosis and Preferences of Outcomes and Risks of Treatment (SUPPORT): nur 47% der Ärzte gaben an zu wissen, daß ihre Patienten keine Wiederbelebung wünschten, sollte eine solche erforderlich werden; 50% der Patienten mit Bewußtsein klagten über mittlere bis schwere Schmerzen in den letzten Lebenstagen; intensive Versuche der Verbesserung der Kommunikation zwischen Arzt und Patient hatten in der zweiten Phase des Projekts nur marginale Erfolge. Die Autoren der Studie fordern engagiertere und schärfere Maßnahmen und mehr gesellschaftliches und persönliches Engagement zur Verbesserung der Behandlung von schwerstkranken und sterbenden Patienten [5]. Hätte dann doch das Recht eine Steuerungsfunktion dort, wo traditionelle Verhaltensmuster sich als unfähig zur Selbstkritik und Selbstveränderung erweisen? Werden neue Rechtsnormen gegen den Verhaltenskontext oder mit ihm entwickelt werden? Die Autoren der folgenden Beiträge untersuchen am Beispiel von Betreuungsverfügungen und Stellvertretenden Entscheidungen die Entstehung und Veränderung rechtlicher Normen im Kontext des Verhaltens von Ärzten, Patienten, Familien und Rechtsinstanzen und die mögliche Steuerungsfunktion des Rechts. Sie diskutieren Verhaltensphänomene und -mechanismen bei Nachfragern und Anbietern klinischer Dienstleistungen und fragen, inwieweit Verhalten rechtserzeugend wirken oder die Fortentwicklung von Recht begleiten oder bestimmen könnte. Rothenberg u. a. untersuchen empirisch in vier unterschiedlichen Kulturen (Chile, Deutschland, Japan, USA) menschliche und ethische Erwartungen an klinische Versorgung und Begleitung und die Spannungen zwischen den unterschiedlichen Kulturen von Medizin und Recht und der Erwartung von Laien und Familien. Meran diskutiert aus der Erfahrung des Mediziners die ethischen und philosophischen Konflikte zwischen medizinischer Intervention und Interventionsverzicht und die sich aus diesen Konflikten ergebenden unterschiedlichen rechtlichen Fragen und Antworten im englischen und deutschen Rechtssystem. Bemat u. a. legen einen Rechtsvergleich in bezug auf Voraussetzungen, Möglichkeiten und tatsächliche Relevanz des Rechtes in Japan, Deutschland und den USA vor; dabei wird die unterschiedliche Funktion der jeweiligen Rechtskultur im Verhältnis zu materiellen von Tradition und Ethos geprägten Verfahrensmodellen deutlich. Sass u. a. vergleichen individuelle und öffentliche Auseinandersetzungskulturen mit Sterben und Tod und sich daraus ergebende Verhaltensmuster und untersuchen die Möglichkeit der Erstellung multikultureller Vorsorgeinstrumente. Die Beiträge von Powers u. a. und von Olick u. a. beschäftigen sich mit krankheitsspezifischen Konfliktsituationen, mit AIDS und ALS, Krankheiten unterschiedlich in ethischer Bewertung und im klinischen Erscheinungsbild. Interessant ist, daß Powers u. a. die Methode der

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Fallstudie zur Diskussion ethischer und klinisch-rechtlicher Entscheidungskonflikte anwenden und Olick u. a. sehr differenzierte klinische Überlegungen im Vorlauf vor ethischen Urteilen und rechtlichen Vorschlägen anstellen. Gibt es einen Regelungsbedarf bei klinischen Interventionen am Lebensende und bei entscheidungsunfähigen Patienten? Gibt es überhaupt einen Konsens in bezug auf das, was zu regeln wäre? Es scheint, daß trotz vorherrschender Kommunikatonsschwierigkeiten zwischen öffentlicher Kultur, Laienkultur, Rechtskultur und Arztkultur die Instrumente der Vorsorglichen Verfügung und der Stellvertretenden Entscheidung um so konsensfähiger werden, je konkreter sie sind, je weniger technische Expertise sie dem Experten wegnehmen und je mehr sie ihm in Entscheidungskonflikten Informationen über subjektive Kriterien an die Hand geben. Krankheitspezifische Betreuungsverfügungen als Teil eines vor allem bei progressiven chronischen Krankheiten gemeinsam von Arzt und Patient aufgestellten und fortgeschriebenen Behandlungsplanes scheinen solchen Kriterien am ehesten genügen zu können und deshalb nicht nur ethische und klinische, sondern auch rechtliche Autorität beanspruchen zu können. Olick legt für die grausame Krankheit der amyotrophen Lateralsklerose einen solchen krankheitsspezifischen Selbstbestimmungsentwurf vor, während Sass u. a. in den von ihnen vorgelegten Modellen ebenfalls teils kasuistisch, teils narraüv situationsspezifisch Wünsche, Werte und gegebenenfalls Festlegungen erfragen. Das hier vorgestellte Projekt, in dessen Rahmen die erwähnten nachfolgenden Beiträge entstanden sind, ist von der Stiftung Volkswagenwerk im Schwerpunktbereich „Recht und Verhalten" gefördert worden (Projektnummern Π/68-273 und Π/ 68-274). Literatur [1] Bundesärztekammer, „Richtlinien für die ärztliche Sterbebegleitung", in: Deutsches Ärzteblatt 90 (37), 1993, C1628-1629. [2] Bundesgerichtshof, Urteil vom 13. September 1994 (Az. 1 StR 357/94), abgedruckt in: Neue Juristische Wochenschrift 1995, 204 ff. [3] Concern for Dying, To My Family, My Physician, My Lawyer And All Others Whom It May Concern, New York, Concern for Dying. An Educational Council [250 W 57 St, New York NY 10107]. [4] Pearlman, Robert A ./Cain, K. CJPatrick, D. L., et al., „Insights Pertaining to Patients Assessment of States Worse than Death", in: Journal of Clinical Ethics 4 (1), 1993, 3341. [5] The SUPPORT Principal Investigators [Connors, F./Dawson, Ν. V., et al., , Λ Controlled Trial to Improve Care for Seriously 111 Hospitalized Patients", in: Journal of the American Medical Association, 274 (20), 1995, 1591-1598. [6] Uhlenbruch Wilhelm, „Der Patientenbrief - die privatautonome Gestaltung des Rechtes auf einen menschenwürdigen Tod", in: Neue Juristische Wochenschrift, 1978, 566-570.

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[7] US Congress, „Patient Seif Determination Act", in: US Omnibus Budget Reconciliation Act of 1990, Public Law No. 100-508, sec. 4206,4751. [8] Compassion in Dying v. State of Washington (US State Court of Appeals for the Ninth Circuit), US State Court of Appeals, 1996, No. 94-35534. D.C.No. CV-94-119-BJR Opinion 3109 ff., 3161ff., 3219 ff. [9] Yokohama District Court Decision, reported in: The Japanese Times, March 29,1995.

The Relationship of Clinical and Legal Perspectives Regarding Medical Treatment Decision-Making in Four Cultures* L.S. Rothenberg, Jon F. Merz, Neil S. Wenger, Maijorie Kagawa-Singer, Darryl R.J. Macer, Noburu Tanabe, Shunichi Fukuhara, Kiyoshi Kurokawa, Hernan L. Fuenzalida-Puelma, Patricio Figueroa, Johannes G. Meran, Erwin Bemat, Takashi Hosaka, Grant N. Marshall

I . Introduction The analysis of the practice of medicine and the various health care systems by social scientists has yielded a rich treasure of insights about the reality of a process often obscured by the emotional concerns of sick or anxious patients and harried physicians. Freidson, a sociologist, has drawn on anthropological research to offer the following insights: [C]lients often have ideas about what they want that differ markedly from those supposedly held by the professionals they consult. As anthropologists have so copiously illustrated, the client's choice is guided by the norms that differ from culture to culture and even within a single complex culture. And, after the client has exercised his choice to see a practitioner, normative or cultural differences between patient and physician qualify the relationship considerably. These characteristics, in the client, are a systematic source of pressure on the practitioner.1 * Acknowledgment: The study was funded, in part, by grants of the Volkswagen Foundation [in the program area "Law and Behavior"] to the Kennedy Institute of Ethics, Georgetown University, Washington, DC, United States and to the Institute of Philosophy, Ruhr University, Bochum, Germany. The authors acknowledge with gratitude the assistance provided by Prof. Rihito Kimura, Waseda University, Tokyo, Japan; Prof. Dr. Hans-Martin Sass, Ruhr University Bochum, Germany; Prof. Robert M. Veatch, Georgetown University, Washington, USA; Prof. Dr. Armando Roa, Universidad de Chile, Santiago; Dr. Alejandro Serani, Universidad Catolica de Chile, Santiago; Dr. M. Antonieta Munoz, Universidad de Concepcion, Chile; Dr. Jaime Duclos, Universidad de Valparaiso, Chile; Cand. med. Katja Bieda, Dünsen, Germany; Dr. Andreas Freiherr v. Aretin, Bonn, Germany; Dr. med. Matthias Volkenandt, München, Germany; Dr. Elizabeth Khuenburg, Wien, Austria; Prof. Dr. Gen Ohi, University of Tokyo, Japan; Yuki Nümura and Takayoshi Umeno of the University of Tsukuba, Japan; and Peter D. Jacobson of RAND Corporation, Santa Monica, California, USA. ι Eliot Freidson , "Client Control and Medical Practice," in: E. Gartly Jaco, ed.: Patients, physicians and illness: a sourcebook in behavioral science and health, New York: The Free Press, 1972, pp. 214-21, at 214.

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The manner in which these choices and differences are either communicated or consciously not communicated is through language (as well as by facial expressions, body language, and other non-verbal cues). As Gesler has pointed out, however, the mere fact that people talk to each other in a clinical setting doesn't necessarily mean that they are communicating: People use language to communicate with one another along cultural traits from generation to generation. Language is a key way in which people relate to one another as they carry out their daily activities. Within any health care delivery system, of course, communication is essential if providers and patients are to understand one another... Unfortunately, healers and those in need of healing often express themselves in different ways and thus talk at cross-purposes when they come into contact.2

Anthropologists have helped us to understand that a society's health care system cannot be studied in isolation from its other cultural aspects with special focus on social, religious, political, and economic factors because they are all infused with the same assumptions, values, and world view.3 Similarly, we have been cautioned not to assume that all the people in a given community or cultural group share "a common set of beliefs about any particular illness;" and that while in a given community or nation there may be a single "explanatory model" or common set of beliefs, we should determine that reality from research data about individuals rather than from an initial assumption.4, 5 The nature of the physician-patient relationship must clearly be understood for what it is and for what it is not. As Wolinsky notes, "this relationship, although mutually expected, is not an egalitarian one," and the advantageous and superior position of the physician rests on what he analyzes as three interrelated points of leverage in the relationship: 1. the physician's professional prestige and 2. "situational authority," and 3. the patient's "situational dependency."6 Patients are often acutely aware of this power imbalance in the relationship, and researchers have found in interviewing U.S. patients that they view "being on good terms" with the physician as crucial to their physical welfare with the potential sanction of professional services being withheld if they are deemed to be unacceptable or problem 2 Wilbert M. Gesler, The Cultural Geography of Health Care, Pittsburgh, PA: University of Pittsburgh, 1991, p. 124. 3 Cecil Helman, Culture, Health and Illness: An Introduction for Health Professionals, London: John Wright & Sons Ltd., 1984, p. 42. 4 Periti J. Pelto, Margaret E. Bentley and Gretel H. Pelto, "Applied Anthropological Research Methods: Diarrhea Studies as an Example," in: Jeannine Coreil and J. Dennis Mull, eds.: Anthropology and Primary Health Care, Boulder, CO: Westview Press, 1990, pp. 25377, at 261. 5 Marjorie Kagawa-Singer and Rita Chi-Ying Chung, "A Paradigm for CulturaUy Based Care in Ethnic Minority Populations", Journal of Community Psychology 22 (1994), pp. 192208. 6 Fredric D. Wolinsky, The Sociology of Health: Principles, Professions and Issues, Boston, MA: Little, Brown and Co., 1980, p. 163.

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patients.7 A study of cancer patients in Hannover, Germany, found that patients rated as most important "placing trust in doctors" and "having a good relationship to the medical staff." 8 Although modern commentators are quick to point out the moral relationship between physicians and patients, Jordan has observed the importance of looking at the precise parameters of the special human relationship governed by such moral principles and has concluded that, despite appeals to the autonomy principle, which would require a focus on the authority of the patient with decision-making capacity to make such decisions for him or herself, physicians' moral obligations are often perceived as requiring actions toward the patient in a particular way "or in keeping with certain principles which the physician holds or which society prescribes. They are not obligations to act for the patient."9 These relationships are also affected by changing public attitudes toward physicians. In the United States and some parts of western Europe at least, observers have detected a growing deterioration in the physician-patient relationship attributable to such factors as unreasonable patient expectations for high-tech medicine, the significant degree of specialization in medicine and corresponding fragmentation of treatment, and the declining continuity of medical care by a single professional deeply rooted in the patient's community who would make house calls at all hours.10 Also, unlike physicians in the U.S., community-based physicians, with few exceptions, in the other three countries studied do not have staff privileges in local hospitals and thus provide only ambulatory care. 11 Thus, they lose continuity of medical care over their hospitalized patients. Juxtaposed alongside this clinical reality are a series of diverse legal systems [three of the countries - Chile, Germany, and Japan - follow the civil or Roman law tradition; the United States follows the common law or British tradition] which, since ancient times, have both upheld the cultural and social aspects of the predominant health care mechanism and imposed limits on the authority of physicians.12, 1 3 While the civil law tradition countries historically dealt with physi-

? Daisy L Tagliacozzo and Hans O. Mauksch, "The Patient's View of the Patient's Role," in: E. Gartly Jaco, ed.: Patients, Physicians and Illness: A Sourcebook on Behavioral Science and Health, New York, NY: The Free Press, 1979, pp. 185-201, at 190. 8 Johannes G. Meran and Christopher Schnorr, "Comparative Evaluation in Quality of Life Assessment", Diskussionsforum Medizinische Ethik (in press). 9 Shannon M. Jordan, Decision Making for Incompetent Persons: the Law and Morality of Who Shall Decide, Springfield: Charles C. Thomas, 1985, p. 87. 10 Edward J. Hart , "Effect of Ligitigation on the Practice of Medicine," in: Clive Wood, ed.: The Infuence of Litigitation on Medical Practice, London: Academic Press, 1977, pp. 45-56, at 48-9.

u See, e.g., Deborah A. Stone, The Limits of Professional Power: National Health Care in the Federal Republic of Germany, Chicago, IL: University of Chicago Press, 1980, pp. 56-7. 12 Helman (op. cit. fn. 3), p. 43. 22 Jahrbuch fïlr Recht und Ethik, Bd. 4 (1996)

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cian error on the basis of criminal liability, most legal systems, and U.S. courts and legal scholars in particular, have evolved over the past four decades an elaborate negligence law doctrine of "informed consent" by which that society can regulate relationships between physicians and patients, and the threat of malpractice lawsuits and professional discipline, while generating anxiety among health professionals, has served, some say, to make physicians "more sensitive to patients' needs and expectations."14 Despite the distinctions between the civil and common law systems, therefore, most countries today handle medical malpractice litigation on a civil (negligence) basis, perhaps being reluctant to find a doctor acting in good faith guilty of criminal battery despite the absence of consent. For example, the German doctrine of informed consent, in general terms, is quite similar to the U.S. model. Perceptive commentators, however, have noted the limitations and consequences involved in trying to use the law "as the mechanism for bringing about massive changes in an entrenched system."15 Law inevitably lags behind technological developments because it emerges only after the social and political evaluation of those developments and requires some public discussion and debate, or what Kennedy describes as "an intellectual breathing space."16 It is a difficult process precisely because law and medicine both share "such mystical origins, such metaphysical underpinnings, such secret and symbolic rituals and such economic overtones that the relationship of one to the other could not be anything but traumatic."17 Given those perceived realities about the relationship of law and medicine, and the ability of law to effect changes in the practice of medicine, it should not be surprising that some would question the feasibility of theoretically assigning law that goal: It is one thing to articulate a social plan and design the improvement on paper, it is quite another to implement it and make it work. We have learned in race relations, environmental pollution, urban affairs and in a number of other areas of social, economic and political concern, that the law can point to change, but it alone is rarely capable of transforming entrenched institutions, systems and mythologies that act as operational hypotheses for action.18

13 President's Commission for the Study of Ethical Problems in Medicine and Biomedi and Behavioral Research, Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship, Washington, DC: Government Printing Office, 1982, vol. 1, p. 16. 14 Ibid., pp. 16, 151. Eric W. Springer , "Law and Medicine: Reflections on a Metaphysical Misalliance," in: John B. McKinlay, ed.: Law and Ethics in Health Care, Cambridge, ΜΑ: ΜΓΓ Press, 1982, pp. 1-31, at 3. 16 lan Kennedy , Treat Me Right: Essays in Medical Law and Ethics, Oxford, UK: Clarendon Press, 1988, p. 5. 17 Springer (op. cit. fn. 15), p. 3. ι» Ibid., p. 31.

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Indeed, the U.S. President's Commission for the Study of Ethical Issues in Medicine and Biomedical and Behavioral Research, which in the early 1980s endorsed advance directives and surrogate decision-making in a series of very thorough reports, also acknowledged that the Commission's "vision of the patient-professional relationship [cannot] be achieved primarily through reliance on the law" and that efforts to use the legal system to further regulate the physician-patient relationship "may prove ineffective, burdensome, and ultimately counterproductive."19 All of this is made more complicated, of course, by the perception that not only do most non-professionals have as much accurate information about "the law" as they do about "medicine or life on Venus," but also that both physicians and lawyers "suffer from more ignorance [of the other's professional field] than is good for them."20 With this background information in hand, we now commence a country-bycountry analysis, largely based on a literature review, that seeks to understand the unique features in the four countries under study that are either shared or distinct. This analysis is divided into discussions of the relevant clinical and legal realities in these nations, as well as the extent to which the topics of advance directives and surrogate decision-making have been articulated to this time. Finally, conclusions will be drawn in a closing section on the potential exportability of the U.S. legal model of formal doctrines such as advance directives and surrogate decision-making to these other countries.

Π. National Analysis We will use the following template for assessing the status of advance directives in each country. This template will facilitate comparison of relevant features across countries and hopefully shed light on similarities and differences in the evolution of medical thought and legal doctrine relevant to advance directives. This approach also will enable us to clearly identify gaps in our knowledge so we may focus our research in these areas in the future. First, we examine the clinical settings in each country. Characteristics that we believe are relevant include: (a) the structure of the medical delivery system, such as whether it is a government provided service or a largely unregulated contractor service; (b) the payment mechanisms, such as private insurance or socially supported; (c) measures of individuals' access to health care services; (d) measures of the existing technology and quality of care delivered; and (e) a cultural assessment of the relationships between patients and their physicians. 19

President's Commission for the Study of Ethical Problems in Medicine and Biomed and Behavioral Research (op. cit. fn. 13), p. 152. 20 Jon R. Waltz and Fred E. Inbau, Mediçal Jurisprudence, New York: Macmillan Publishing Co., 1971, p. vii. 22*

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Second, we explore the medico-legal history and characteristics relevant to patient autonomy and decision-making. Here, we are interested in: (a) the type and rigorousness of regulation of physicians' practices; (b) the enforcement mechanisms, such as criminal or civil sanctions, available to deter malpractice and compensate injured parties; and (c) the evolution and status of consent and informed consent doctrines in the ethical and legal domains. Third, we look specifically at the status of advance directives in each country. We are interested in: (a) whether directives are accepted and used by physicians and patients; (b) physicians' and patients' reliance upon surrogates for decisionmaking; and (c) the development and status of the law regarding the need for and enforceability of advance planning documents and decisions of surrogates.

A. Chile 1. Clinical Features Chile was one of the first countries in Latin America to establish modern social welfare programs, including state health plans in the early 1920s. In recent years, it has also pioneered in developing private health insurance schemes. Chile's tradition of organized medicine and social welfare dates back to 1924 when social insurance schemes were established to provide health services to blue-collar workers (Caja de Seguro Obrero Obligatorio, Law 4.054 of 1924). The Ministry of Hygiene, Social Assistance and Prevention was also created at that time, the precursor of the cuirent Ministry of Health. In 1938 the Law on Preventive Medicine was enacted,, and in 1942 a government-administered health insurance plan for whitecollar workers and their dependents was created, the Servicio Medico Nacional de Empleados. The year 1952 is a landmark in the history of Chilean health care with the visionary creation of the National Health Service (NHS) (Servicio Nacional de Salud), following the model of the National Health Service of the United Kingdom, and consolidating several institutions under one unified health care service structure. This service played a critical role in the improvement of Chilean health status, and it is still regarded as a symbol of the golden years of Chilean public health care. Major institutional reforms were introduced in 1979 with the reorganization of the health care system, including (i) decentralization of the NHS into a national Health Service System (NHSDS) with 26 autonomous regional health care services plus an environmental health service in Santiago; (ii) the transfer of responsibility, infrastructure and personnel to municipalities for the delivery of primary health care; (iii) the creation of a financial entity (FONASA) to administer the sector's financial resources, particularly a preferred provider system; and (iv) the promotion of private health care insurance schemes with the corresponding legislative

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and financial framework. Seventy-one percent of the population is covered by health services provided by the NHSS, 13% by the FONASA-administered preferred provider system, and 16% by private health insurance schemes. 2 1 The Chilean government is the major source of hospital care, and the private sector plays a significant role in outpatient care and laboratory/diagnostic services. Chile's National Health Service has until recently been responsible for the reduction in infant mortality (partly through the decrease in infectious diseases, particularly diarrhea), the low maternal mortality rate, and the high rate of immunization. Tuberculosis rates have also been reduced. Chile is an upper middle-income country with a GNP per capita of US$ 3,170 and a population of 13.8 million, of which 85% is urban. The crude birth rate is 22/1.000, and the crude death rate is 6/1.000 with a natural population increase of 1.7%/year. The age structure of the population is 0-14 years, 30.5%; 15-64 years, 63.5%, and 65 years and over, 6%. The total fertility rate has fallen from 4 children/average woman/lifetime in 1970, to 2.5 children in 1993. Health status has improved substantially in recent years, with infant mortality falling from 77/1.000 in 1970 to 16/1.000 in 1993. Life expectancy at birth has increased for males from 59 years in 1970 to 71 years in 1993, and for females from 66 years in 1970 to 78 years in 1993. 22 This low population growth rate, together with a growing elderly population, suggests future geriatric issues, including problems related to terminal care. In spite of these gains, impressive imbalances and inefficient use of resources prevail and imply serious constraints for sector productivity and quality of service. There are many pockets of poverty where the health status indicators are not represented. Chile has gained a reputation of a country trying to maintain macroeconomic stability with the promotion of social justice. The macroeconomic part of this difficult equation is working very well, but the promotion of social justice is still more at the level of rhetoric than in concrete measures. Redistribution of wealth and improvement of social services lags behind what the country can and should afford. The gap between the rich and the poor is greater than ever. During the period that the military regime of General Augusto Pinochet Ugarte ruled Chile from September 1973 to March 1990, observers saw u a severe deterioration in numbers and quality of health personnel" with a resulting need to emphasize primary health care and develop a national network of ambulatory (outpatient) facilities. 23 This is not the result of a shortage of physicians in Chile, howWorld Bank, Chile: Health Sector Refprm Project, RepórJ.No. 10987-CH, Latin America and the Caribbean Region, Country Department IV, Human Resources Operation Division, Washington: World Bank, 1992, pp. 4-7. 22 World Bank, World Development Report 1993: Investing in Health, New York: Oxford University Press, 1993, tables 1,26,27,28, pp. 238,288,290,292. 23 Alejandro Jadresic, "[Towards a Policy of Human Resources Development for Health (engl, abstr.)]", Revista Medica de Chile 119 (1991), pp. 589-99.

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ever, as its rate of physicians per 1,000 inhabitants is one of the highest in Latin America, after that of Argentina. Primary health care for adults in Chile "is delivered mostly by young physicians, who work with little or insufficient interaction with their referral centers and with the main teaching hospitals," "have no defined expectancies of a professional career in the field of primary care," and "generally resent the lack of programmed post-graduate education."24 There is also a major shortage of modern diagnostic equipment, and treatment options are quite limited, in both public hospitals and outpatient clinics. The fact of the matter is that in spite of the decrease of state resources to social sectors and to health in particular under the Pinochet regime, basic indicators of health status did not decline. What was affected was the quality of service within the NHS. However, the emphasis on primary health care contributed to mitigate the problems. There is little doubt that the medical profession was affected financially, and that the middle and upper segments of Chilean society are suffering the consequences of a deteriorating national health service. Recently there was a physicians' strike for several days protesting the low salaries they are paid in the public sector. The Pinochet reform aimed at solving all of these problems altogether, by rationalizing and decentralizing public health care services, and by satisfying the affluent classes and the medical profession. The system is in place and working, but curiously enough, health continues to be signaled as the second or third issue of concern in public polls.

2. Medico-Legal Features Although there has been a recent increase in medical liability lawsuits in Chile, the causes of which have been analyzed by Chilean researchers, a tradition of health law litigation has not been established. Health law and bioethics, two necessary companions, are not the subject of teaching at Chilean law schools (bioethics is taught at medical schools by medical doctors with a medical perspective), and health law and bioethics should not be assumed to be part of the body of knowledge of Chilean lawyers and judges. Cases do arrive at the court system, and they are debated and resolved within the constraints of a civil law system which is not open to interpretation of the dilemmas posed by modern biotechnology and their social and ethical consequences. Medical malpractice is considered within the context of criminal law, and injuries and bad faith beyond the mistakes of the practice of medicine as an art must be proven. Medical doctors are the expert witnesses, and they are very conservative in their opinions as they could affect their own profession. Commentators H. Reyes , "[Can We Improve Primary Adult Medical Care? (engl, abstr.)]", Revista Medica de Chile 120 (1992), pp. 57L-6.

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(mostly physicians) have recommended a series of strategies to prevent this phenomenon including "an improvement in patient-physician relationships, a better alliance among physicians, a correct certification of medical specialties, the demand of adequate technological and human resources to perform medical functions optimally, the supervision of legal work and the legal support and advice of medical societies."25 However, the issues at stake are more profound, and they need to be considered in a more holistic fashion comprising the revision of medical ethics standards, the promotion of consumerrights,the creation of clinical ethics committees (multidisciplinary and with lay participation), and the reform and modernization of the judicial system in a new understanding of the role of the rule of law in a modem society in need of new standards of governance.

3. Experience with Advance Directives and Surrogate Decision-Making While, to our knowledge, the formal concepts of advance directives and surrogate decision-making have not been institutionalized in Chile, there has been a discussion of the relevant issues in the medical schools and journals of Chile. In one published study involving the discontinuation of chronic kidney dialysis, the authors noted that out of 11 cases studied, the patient initiated the decision to stop treatment in 2 .instances, the patient's family (together with the medical team) in 5 instances (perhaps the five cases noted by the authors to involve patients who were incapable of making treatment decisions), and the medical team alone in the remaining 4 cases.26 A recent article on common ethical problems in daily medical practice emphasized the need to restore a personal dimension to medical care in order "to get a dignified renewal of medicine" as well as to deal with "health care costs and abusive patient-doctor relationships."27

25 D. Montoya, A. Rosmanich , V. Velasquez, Lopez, J-> "[Medical and Legal Aspects of Medical Liability Lawsuits (engl, abstr.)]", Revista Medica de Chile 121 (1993), pp. 679-85. 26 Jaime Duclos, M. Gomez and C. Olea, "[The Discontinuation of Chronic Dialysis Treatment (engl, abstr.)]", Revista Medica de Chile 118 (1990), pp. 1000-05. 27 E. Rosselot, "[Ethical Problems in Daily Medical Practice (engl, abstr.)]", Revista Medica de Chile 122 (1994), pp. 88-94.

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L Clinical Features West Germany (Federal Republic of Germany, FRG), before the reunification with East Germany (German Democratic Republic, GDR), had one of the highest physician-to-population ratios in the world, higher than that of the United States, and exceeded in Western Europe only by Austria. In today's Federal Republic of Germany, health insurance is mandatory for "all workers and employees earning below a certain level of income geared to the cost of living".28 Employees above that income level are exempt from the program, and they and the self-employed are usually covered by private insurance with roughly the same coverage as the government insurance programs. Approximately 90 percent of the population is covered by the mandatory government programs, and the Federal Republic pays about 90 percent of all medical care costs of its people. Half of the mandatory insurance premium is paid by the German employer, the other half by the employee. There has been a complex transition in the former East Germany (GDR) from the trade union-managed free universal health care system to the Federal Republic's model.29 In terms of the physician-patient relationship, Meran and Poliwoda note that Germany is in the midst of a "paradigmatic change" from paternalism toward patient autonomy, but that German patients, in fact, have less actual influence on their own treatment than is generally accepted, because the majority of patients will usually rely on their doctors' advice without asking about alternative choices. As in other countries, German physicians are much more willing to discuss beginning or increasing potentially curative therapies than in acknowledging that they have no further effective therapies to offer. Patients are rarely told that a "do-notresuscitate" order has been written concerning their care, and such conversations, perhaps involving the perceived futility of further treatment, are seen as "taboo" by most German health professionals. 30 Meran and Poliwoda believe that there are generational differences in this behavior, that younger physicians are more forthcoming than older ones, and that sometimes German physicians find it easier to disclose a bad prognosis to the patient's family than to the patient.

28 George H. Kirby, "Germany - Government and Social conditions - Health and Welfare," The New Encyclopaedia Britannica, Chicago: Encyclopaedia Britannica, Inc., 1993, 15th ed., vol. 20, p. 62. 29 Ibid. 30 Johannes Meran and Hubert Poliwoda, "Clinical Perspectives on Advance Directives and Surrogate Decision Making," in: Hans-Martin Sass, Robert M. Veatch and Rihito Kimura, eds.: Advance Directives in Transcultural Perspective, Dordrecht: Kluwer, Forthcoming.

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They argue that for physicians in Germany, telling the "full truth" and explaining every little, tiny risk of a planned diagnostic or therapeutic procedure is seen as more a legal requirement than an ethical value. There still remains, in their view, a kind of paternalistic information practice, probably best described as a very broad interpretation of the "therapeutic privilege," thus trying to avoid any information that may worry the patient. German physicians, they say, are concerned about malpractice, and there are approximately 7000-8000 civil cases and 500-1000 criminal cases against physicians annually (300,000 physicians in a population of 80 million people). Therefore, consent, Usually in written form, will be obtained in one way or the other to render the treatment lawful. 31 German law places the burden of proof on the doctor to show that adequate information has been given to the patient.32 Besides the legal constraint, it seems that German physicians have increasingly become aware of additional goals of such truth-telling: to aid decision making by the patient and to further patient compliance with the treatment plan. As in Japan, Meran and Poliwoda note, physicians in Germany are much more likely to tell the prognosis to cancer patients when the cancer is curable than when it is incurable.33 Medical sociologists who have studied German hospital patients and their perceptions of staff-patient interaction and the processes of communication have concluded "that lack of information is associated with a high degree of dissatisfaction and anxiety, as well as with a patient's poor emotional well-being." Kohlmann and Siegrist identified four strategies used by Gertoan physicians in dealing with severely ill and incurable patients: a show of ignorance, a switch of topic or of the person speaking, a comment on the relationship instead of on the question asked, and a communication of "functional uncertainty."34 German gerontologists are also concerned that the fate of indigent elderly and severely disabled patients in Germany is also threatened by a lack of respect for human dignity, brought on by social and economic concerns, 35,36 a fear articulated in other countries. These bioethical concerns are more difficult to discuss in Ger31 Ibid.

32 Adolf Laufs and Wilhelm Uhlenbruch Handbuch des Arztrechts, München: Beck Verlag, 1992, p. 350. 33 Meran and Poliwoda (op. cit. fn. 30). 34 Thomas Kohlmann and Johannes Siegrist, "Beyond the Anglophone World: Sociology of Hospitals and Physician-Patient Interaction in West Germany", Social Science and Medicine 29 (1989), pp. 107-08. 35 E. Rabenstein and U. Schwarzer, "[Human Dignity and Aging: Social Ethical Comments on Insuring Nursing Care Risk (engl, abstr.)]", Zeitschrift für Gerontologie 25 (1992), pp. 18-24. 36 Ulrich Eibach, "[Human Dignity and Human Rights of Severely Disabled Persons: On the Significance of the Current "Quality of Life Discussion" for Treatment and Care of Elderly Incurable Patients (engl, abstr.)]", Zeitschrift für Gerontologie 25 (1992), pp. 3-9.

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many because of the history of the Euthanasia Program under National Socialism from 1939-1945.37 It should be noted, however, that the German Constitution has a prominent provision protecting the dignity of all people ("The dignity of man is inviolable," Deutsches Grundgesetz, Artikel 1, Absatz 1) as a direct response to the violation of human dignity during the Nazi regime. Furthermore, the question of whether economic concerns in Germany today threaten the health care of the elderly is quite controversial with some observers arguing that the issue of limited resources has simply become more contentious because of the recent health law reform (Gesundheitsstrukturgesetz). 2. Medico-Legal Features German legal theory provided Japan and other countries with a civil law tradition and the concept of informed consent by linking up two requisite acts or duties: the physicians duty of disclosure (Aufklärungspflicht) and the patient's consent (Einwilligung). 38 Technically, the modem doctrine of informed consent was introduced in Germany in 1894 by judicial mandate in a criminal decision of the German Reichsgericht, not by legislation. Lohmann describes the situation as follows: On a preliminary and informal level, the physician-patient relationship begins with an exchange of information, the appropriate counsel by the physician, and acceptance and permission by the patient. Physicians ... see this exchange primarily in a therapeutic light, but as part of a contract to obtain certain agreed-upon results it is of legal relevance. The duty to advise and inform ... includes informing the patient of the diagnosis, the process, and the prognosis of the disease, and the appropriate medical measures. Thus, the patient is thought to participate in and further the therapeutic process.39

The most important element of the physician"s duty under German law, at least according to Franzki, is the "disclosure of therisks incidental to treatment," for a violation of this duty subjects the physician to liability for battery under German law, even if the procedure involved is flawlessly performed. 40 Disclosure of risks (Risikoaufklärung), supplemented by information about the diagnosis CDiagno37 Bettina Schone-Seifert and Klaus-Peter Rippe, "Silencing the singer: antibioethics in Germany", Hastings Center Report 21 (1991), pp. 20-27. 38 Hiroyuki Hattori, Stephan M. Salzberg, Winston P. Kiang, Tatsya Fujimiya, Yutaka ma, Junji Furuno, "The Patient's Right to Information in Japan: Legal Rules and Doctors' Opinions", Social Science and Medicine 32 (1991), pp. 1007-16, at 1009. 39 Ulrich Lohmann, "Legal Aspects of the Physician-Patient Relationship," in: Donald W. Light and Alexander Schuller, eds.: Political Values and Health Care: The German Experience, Cambridge, ΜΑ: ΜΓΓ Press, 1986, pp. 425-41, at 429. 40 Harald Franzki , "[Intensive Care for Geriatric Patients-Legal Problems (engl, abstr.)]", Fortschritte der Medizin 110 (1992), pp. 231-34.

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seaufklärung ) and about the nature and purpose of the treatment (Verlaufsaufklärung ), which are summarized as "Selbstbestimmungsaufklärung ," should enable the competent patient to choose on his or her own responsibility.41 Austrian law also makes the physician subject to punishment if treatment is performed without the patient's consent and if the physician acts, even at the patient's request, to intentionally shorten the patient's life. 42 This may be overstating the point, however, since the more practical consequence is that a patient's consent is invalid if risks, even small ones, are not disclosed if they are material and unexpected by the patient.43 It is also possible that German physicians overestimate potential legal liability, as do physicians in other developed countries including the United States. In Germany (as in most European countries), there is no legislation recognizing advance directives, the "right to die," or any related issues, according to Koch. To the extent that terminally ill patients require medical decision making, those patients who are capable of making decisions are governed by the concept of "informed consent" previously discussed, and those lacking such capacity are governed by some form of surrogate decision making, usually by family members (although physicians may act in emergency circumstances in the best interests of the patient). Not all physicians in Germany accept surrogate decision making to the same degree that they accept the patient's direct decision, however. Koch argues that in the German-speaking countries, there is no focus in the law on "patient'srights,"but rather on whether the doctor violated a legal duty or committed a crime, particularly the latter. 44 There is a development in Austria, however, in an amendment to the (Federal) Hospitals Act which states that a patient can attach his/her living will to his/her medical case history, but there is no legal duty on the part of health care personnel to inform the patient about this opportunity (see Sec. 10, subsec. 1, para. 7, Hospitals Act as amended by Law No. 801,1993). In Germany, a majority of legal scholars believe that advance directives are already binding under commonly recognized principles (as, e.g., autonomy, self-determination, due process of law and the principles of binding force of juridical acts). Yet, Koch notes that "the prevailing position in German legal literature (still) remains critical toward the advance directive." 45 4

1 Laufs and Uhlenbruck (op. cit fn. 32), p. 352. A. Haslinger, "[Euthanasia-Limits of Therapy in Oncology: From the Viewpoint of the Attorney (engl, abstr.)]", Wiener Klinische Wochenschrift 102 (1990), pp. 564-66. « Laufs and Uhlenbruck (op. cit fn. 32), p. 355. 44 Hans-Georg Koch, "The Decision to Aid Dying and Related Legal Issues: Advance Directives and Durable Powers of Attorney Under German Law," in: Hans-Martin Sass, Robert A. Veatch and Rihito Kimura, eds.: Advance Directives in Transcultural Perspective, Dordrecht: Kluwer, Forthcoming. « Ibid. 42

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Eser has made the interesting observation that while the physician in Germany may presumably withhold further intensive therapy in order to allow a patient to die with the clear consent or the express request of the patient capable of making such treatment decisions, it is far less clear under German law that there are no potential legal consequences for a physician who, on his or her own authority and without the consent of the patient, allows a dying patient to die by terminating treatment. 46 However, the German Bundesgerichtshof (Federal Supreme Court) has recently recognized the validity in Germany of taking account of prior oral and written statements by patients regarding treatment preferences. 47

3. Experience with Advance Directives and Surrogate Decision-Making Meran and Poliwoda note the existence today in Germany of at least nine types of advance directives ["Patientenverfugung" from OMEGA e.V., "Freundschaftsvertrag" from OMEGA e.V., "Wertanamnese und Betreuungsverfügung" from H . M . Sass and R. Kielstein, "Patientenverfügung" from DGHS e.V., "Freitodverfugung " from DGHS e.V., "Patiententestament" from W. Uhlenbruck, "Eine Christliche Patientenverfugung " from the Evangelisch-Lutherische Kirche in Bavaria, "Patientenanwalt-Verfugung" from J. Hackethal, and "Persönliche Willenserklärung" from the Ärztekammer Hamburg]. Yet all of these "are hardly known in Germany and are used only by a small minority of patients .. .[F]ew doctors have had experience with ADs [advance directives] and.. .uncertainty about the legal implications is widespread." 48 Sass also notes that few German physicians publicly or professionally argue for advance directives, reflecting a traditional paternalistic attitude, and they "do not care much about the law either." 49 As indicated above, however, "the law" has now given some approval to advance directives in Germany.

46 Albin Eser , "Functions and Requirements of Informed Consent in German Law and Practice," in: Lotta Westerhall and Charles Phillips, eds.: Patient's Rights: Informed Consent, Access and Equality, Stockholm, Sweden: Nerenius & Santerus Publishers, 1994, pp. 235-53, at 252. 47 Germany, BGH, decision of 13 Sept 1994, reprinted in: Neue Juristische Wochenschrift 1995, 204ff; on this case see also Erwin Bernât , "Behandlungsabbruch und (mutmasslicher) Patientenwille," Recht der Medizin 1995,51-61. 48 Meran and Poliwoda (op. cit. fn. 30). 49 Hans-Martin Sass, "Images of Killing and Letting Die, of Self-Determination and Beneficence: The Ethical Debate on Advance Directives and Surrogate Decision Making in Germany," in: Hans-Martin Sass, Robert M. Veatch and Rihito Kimura, eds.: Advance Directives in Transcultural Perspective, Dordrecht: Kluwer, Forthcoming.

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C. Japan 1. Clinical Features Japanese health care has been described as a "pluralistic system with a high degree of private producers," centrally regulated as to price through a mandatory employer-based health insurance system which allows patients the freedom to choose their physicians and hospitals, and in which "80 percent of the hospitals [typically less than 100 beds] and 94 percent of the clinics are privately owned." 5 0 When compared to citizens of the United States, the health of the Japanese people (based on such factors as infant mortality, number of premature infants, and life expectancy at birth and at ages 20 and 65) is superior. 51 Since 1961, all Japanese have been covered by their governmental health insurance system. 52 Ikegami and Campbell have contrasted the clinical setting of physicians in private practice from those caring for hospitalized patients: Virtually all physicians are in solo practice, and most hospitals are small, family enterprises that developed from physicians' offices. However, most large hospitals are owned by the national or local governments, voluntary organizations, and universities. Forprofit investor-owned hospitals are prohibited. Private practitioners cannot attend hospitalized patients, and hospital physicians (other than the owner) work for a salary not tied to their practice loads. In contrast to the situation in the United States, physicians in private practice working mainly in primary care have roughly double the income of specialists, who are employed in hospitals. However, the latter are compensated by higher status and the chance to provide specialty care, which can be professionally rewarding. 53 Almost all office-based private practitioners do have to practice primary care medicine, regardless of their specialty training, because they are deprived of access to major procedural treatments done in hospitals. There is an extraordinary higher ambulatory patient-contact rate in Japan, as compared to the United States, and this in part may be attributable to the extremely low consultation fee (universal fee) in the Japanese health care system, which may encourage physicians to increase the volume of patients that they see. 54 The nature of the doctor-patient relationship in Japan has been described and analyzed in recent years by numerous observers. Powell and Anesaki describe it in the following way: so O. Anbacken, "Japanese Hospitals-Culture and Competition: A Study of Ten Hospitals", International Journal of Health Planning and Management 9 (1994), pp. 87-101. 51 Toshide Tsuda, Hideyasu Aoyama and Jack F room, "Primary Health Care in Japan and the United States", Social Science and Medicine 38 (1994), pp. 489-95. 52 Yasuo Masai, "Japan - Government and Social Conditions - Health and Welfare," The New Encyclopaedia Britannica, Chicago: Encyclopaedia Britannica, Inc., 1993,15th ed., vol. 22, pp. 274-5, at 274. 53 Naoki Ikegami and John C. Campbell, "Medical Care in Japan," New England Journal of Medicine 333 (1995), pp. 1295-9. 54 Ibid.

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L.S. Rothenberg et al. The doctor-patient relationship in Japan is one of trust Wordless communication, so-called "belly talk" (hara gei), is a distinctive feature of personal communications in Japan and is aided by the intrinsic ambiguities of the Japanese language. Doctors tend to explain away the problem in soothing terms without necessarily providing precise information about what exactly the problem is. For the patient to ask for this information directly might be seen as questioning the doctor's knowledge, authority and judgment. To ask too many questions is as likely to bring about a rebuttal or even a refusal to caiTy on the consultation. Difficulties of this kind are not unknown in other countries, of course, but the medical profession in Japan remains more entrenched in its views than is the case elsewhere.55

Another view is offered by Ishiwata and Sakai: "Given the strong paternalism, patient passivity, and the exclusiveness among medical professionals in Japan, there is scarcely any opportunity for patients to participate in medical decision making." 56 In an International Bioethics Survey conducted in ten countries including Japan in 1993, one of the questions dealt with the degree of trust that people had in authorities who were making statements about the safety of various biotechnology products. In Japan respondents said they trusted physicians least of all groups of authority figures making such statements. This lack of trust was most striking in Japanese medical student respondents, of whom only 10 percent said that they had a lot of trust in medical doctors in contrast to 12 percent for the general Japanese public. These responses were some 20 percent lower for physicians than for any other group of authorities evaluated. 57 The explanation for this clinical behavior, even assuming the accuracy of the descriptions, is far more complex, however, and rooted in Japanese culture and religion. Kimura has written of the importance of Confucian teaching regarding the "fiduciary relationship" (Shinrai-Kankei) in professional as well as social relationships in Japan, and of the description of medicine by a seventeenth-century Japanese Confucian scholar-physician, Ekiken Kaibara, as a humanitarian art (.Jin-jyut su)> leading physicians in Japan to conclude that they must act benevolently toward, and earn the trust of, their patients. 58 Ohi has noted that Japanese, in a manner similar to those of other peoples in East and Southeast Asia, have historically demonstrated what he calls a "relational 55 Margaret Powell and Masahira Anesaki, Health Care in Japan, London: Routledge, 1990, p. 174. 56 Ryuji Ishiwata and Akio Sakai , "The Physician-Patient Relationship and Medical Ethics in Japan", Cambridge Quarterly of Healthcare Ethics 3 (1994), pp. 60-66, at 61. 57 Darryl R.J. Macer, Bioethics For the People By the People, Christchurch/Tsukuba: Eubios Ethics Institute, 1994, p. 212. 58 Rihito Kimura, "Fiduciary Relationships and the Medical Profession: A Japanese Point of View," in: Edmund D. Pellegrino, Robert M. Veatch and John P. Langan, eds.: Ethics, trust and the professions, Washington, DC: Georgetown University Press, 1991, pp. 235-45, at 236, 238.

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type ethical orientation" that puts a premium on avoiding confrontation and maintaining a smooth relationship with others, emphasizing the ethical principles of non-maleficence and beneficence. 59 When the physician-patient relationship is forced to deal with issues of possible or impending death, Tsuchida argues that to Japanese patients at least, "death is too solemn a moment to be reduced by any rational consideration to a biomedical phenomenon" and that it is the family, not the patient, which is "the agent of decision making, putting the meaning of each individual's life in perspective." 60 Another explanation of the traditional approach to medical decision making is that the head of the traditional Japanese household (ie) was powerful and family members were seen as dependent on and responsible for each other; this dependence (iamae) continues into adulthood; and if a family member is faced with death, he or she should be allowed to "die in peace" (Yasurakani ) without being burdened by the knowledge of his or her disease and prognosis. 61 Yet, these traditional views are being influenced by major generational and cultural changes in Japan. Japanese families, as other families in urbanized and industrialized societies, are not as cohesive as in the past, and the economic affluence of Japan as well as Western influences have led to a more autonomy-focused ethical approach, 6 2 , 6 3 a change seen in most aspects of Japanese life. Local physicians, as in the United States, have also lost touch with their patients and families. 64 Furuhata also notes that these social changes are producing a marked effect on the nature of the physician-patient relationship itself: In fact, the pure relationship between doctor and patient appears to be collapsing in Japan, because the patient has increased his self-awareness and self-assertion and increasingly makes various demands of the doctor, demonstrating his lack of knowledge of medicine or medical treatment; or holds little respect for the doctor.65 A variety of surveys of both patients and physicians continue to reflect this ambivalence in preferences and behavior. Eighty percent of the patients surveyed in two rural Japanese hospitals and one urban hospital preferred to have candid infor59 Gen Ohi, "Advance Directives and Japanese Ethos," in: Hans-Martin Sass, Robert A. Veatch and Rihito Kimura, eds.: Advance Directives in Transcultural Perspective, Dordrecht: Kluwer, Forthcoming. 60 Tomoaki Tsuchida, "Yet Ambivalent about Advance Directives," in: Hans-Martin Sass, Robert A. Veatch and Rihito Kimura, eds.: Advance Directives in Transcultural Perspective, Dordrecht: Kluwer, Forthcoming. 61 Hattori, et al (op. cit. fn. 38), pp. 1014-1015. 62 Tsuchida (op. cit. fn. 60). 63 Ohi (op. cit. fn. 59).

64 Hattori, et ai (op. cit. fn. 38), p. 1007. 65 Kazutaka Furuhata, "Relationship between Doctor and Patient," in: Wataru Mori and Saburo Homma, eds.: Medical Science and Health Care in the Coming Century: A Report from Japan, Amsterdam, The Netherlands: Elsevier, 1987, pp. 100-03, at 100.

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mation about their diagnosis and prognosis, regardless of the disease, but only half of their physicians correctly understood those preferences. 66 In a study by Sawaki of physicians' choices of the attributes of the most "desirable patient" and patients' choices of the attributes of the most "desirable doctor," 78-92 percent of the physicians chose patient behavior which represented "a strong trust between doctor and patient" and chose as undesirable those behavior traits (such as "questioning the doctor's treatment") which represented distrust of the physician, while 71 percent of the patients said that physicians who explained "the patient's disease in detail" were most desirable. 67 In a 1982 study at a general hospital in metropolitan Tokyo of 72 physicians, 202 nurses and 68 nursing students, only 3 percent of the respondents said they always would tell their patients their diagnosis of cancer, while 64 percent of the physicians, 68 percent of the nurses and 88 percent of the nursing students said that it would "depend on the circumstances " Asked what they would want if they were the patient, 16 percent said that they would not want to be told that they had cancer, while the majority indicated their wish to be told. I f the patient was a family member of the professional, however, then 19 percent of the respondents would more readily tell them their diagnosis while 35 percent would not. 6 8 Similarly, Tanida found that in a study of hospital patients and "clients" in a cancer screening survey, 72 percent of the patients and 83 percent of the clients wanted to be told "the truth," but only 33 percent and 34 percent, respectively, thought "that the truth should be told to cancer patients." 69 Since one out of every four deaths in Japan is due to cancer 70 and since Japanese have relatively high death anxieties when compared to Australians, 71 these ambivalent feelings about candid disclosure of a patient's diagnosis and prognosis have emotional consequences, as reflected in the public debate of the decision of his physicians not to inform the late Japanese Emperor Hirohito, who died in 1989, of his diagnosis of intestinal cancer. 72

66 Ichiro Kai, Gen Ohi, Eiji Vano, Yasuki Kobayashi, Tomoyo Miyama, Naokira Niino Koh-ichi Naka, "Communication between Patients and Physicians about Terminal Care: A Survey in Japan", Social Science and Medicine 36 (1993), pp. 1151-59. 67 Shuji Sawaki, "Desirable Patient and Desirable Doctor," in: Wataru Mori and Saburo Homma, eds.: Medical Science and Health Care in the Coming Century: A Report from Japan, Amsterdam, The Netherlands: Elsevier, 1987, pp. 103-07. 68 Keiko Takeo, Kazuko Satoh, Hironu Minamisawa, Takako Mitoh, "Health Workers' Attitudes toward Euthanasia in Japan", International Nursing Review 38 (1991), pp. 45-48. 69 Noritoshi Tanida, "Japanese Attitudes towards Truth Disclosure in Cancer", Scandinavian Journal of Social Medicine 22 (1994), pp. 50-57. 70 E Takeda and J. Uki, "Recent Progress in Cancer Pain Management and Palliative Care in Japan", Annals of the Academy of Medicine, Singapore 23 (1994), pp. 296-99. 71 John F. Schumaker, William G. Warren and Gary Groth-Marnat, pan and Australia", Journal of Social Psychology 131 (1991), pp. 511-18. 72 Hattori, et al (op. cit. fn. 38), p. 1007.

"Death Anxiety in Ja-

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Two recent studies reinforce this perception of ambivalence. Asai and colleagues surveyed 136 Japanese and 77 Japanese-American physicians on their responses to a number of clinical scenarios involving a patient with metastatic gastric cancer who did not know of his diagnosis or prognosis. Most Japanese respondents would recommend blood transfusions for gastrointestinal bleeding, total parenteral nutrition for malnutrition, and blood pressure medications for lifethreatening hypotension, even though significantly fewer Japanese physicians would want these interventions for themselves. By contrast, fewer Japanese-American physicians would recommend such interventions, despite their similar heritage but different culture. 73 Another study by Fukaura and colleagues of a policy on do-not-resuscitate (DNR) orders at a teaching hospital (Showa University Hospital, Tokyo) found a discrepancy in physician behavior toward dying patients, depending on whether their family members were present. They found, in effect, that physicians in Japan perform cardiopulmonary resuscitation for the benefit of family members, not patients, just as they discuss end-of-iife treatment decisions with family rather than with patients. While D N R orders were written for most patients (72%) who actually died in the hospital, only 5% of those patients actually participated in the decision about the writing of such orders. Moreover, "there was a tendency to allow patients to die without intervention when family members were present," but "efforts were occasionally made to resuscitate patients so that they would not die when family members were absent." 74 There may also be a generational difference in viewpoint among Japanese physicians, as in other countries, with younger physicians less in favor of continuing life-sustaining treatment.

2. and 3. Medico-Legal Features , and Experience with Advance Directives and Surrogate Decision-Making Respect for each person as an individual is guaranteed in Article 13 of the Japanese Constitution, and constitutional scholars interpret this Article to mean that each individual's right to self-determination is also guaranteed. 75 However, controversy exists as to whether the right to self-determination applies to issues that relate directly to advance directives, such as suicide, euthanasia, and

73 AtsushiAsai , Shunichi Fukuhara and Bernard Lo, "Attitudes of Japanese and JapaneseAmerican Physicians Towards Life-Sustaining Treatment", The Lancet 346 (1995), pp. 35659. 74 Asato Fukaura, Hiroki Tazawa, Hiroaki Nakajima, Mitsuru Adachi, "Do-Not-Resuscitate Orders at a Teaching Hospital in Japan", New England Journal of Medicine 333 (1995), pp. 805-08. 75 Toshihiko Nonaka, Mutsuo Nakamura, Katsuyuki Takahashi, Katsutoshi Takami, K pou I [Constitution I], Tokyo: Yuhikaku, 1992, pp. 254-5. 2

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refusal of medical care, and whether this right extends to other areas. These other areas range very widely, from the freedom to give birth or not give birth, freedom regarding contraception and abortion, freedom to rear and educate one's children, and problems in the preservation of family structure (marriage and divorce); to clothing, mode of dress and outward appearance, sexual freedom, sports, smoking, and drinking. 76 Unfortunately, as the right to self-determination in general is extended, the concept of the right to determine what to do with one's own life and one's own body becomes somewhat nebulous. The Japanese constitution regulates relations between the state and public authority, on the one hand, and the people, on the other; it does not directly regulate relations between private individuals, such as those between a physician and a patient. (The common v i e w 7 7 and judicial precedent 78 in Japan are that problems between individuals are only indirectly related to the constitution, and are handled as problems of public order and morals according to Article 90 of the Civil Code.) Thus, by not cooperating with a patient's refusal of life-sustaining treatment, a physician does not violate the patient's constitutional rights, to the extent that this lack of cooperation does not interfere with public order and morals. In present-day Japan, giving life-sustaining care against a patient's wishes is not likely to be seen as interference with public order and morals. The result of legal action alleging interference with public order and morals as specified in Article 90 of the Civil Code would be a decision in favor of the physician. When this law is applied, a patient (or a patient's proxy) who breaks a contract for medical diagnosis and treatment may be allowed not to pay for the treatment, but cannot expect any other compensation. O f course, arbitrary administration of medical care can violate Japanese law. Invasive medical procedures can be classified as crimes under the Criminal Code (Articles 199, 204, 205, and 208-211), because they may meet the criteria for injury or acts of violence, and because they can occasionally cause death. They can also constitute illegal activity under Article 709 of the Civil Code, because they may infringe on the patient's life and the patient's body. 79 Such actions are not illegal if they are done with the patient's explicit or implied consent, 80 or if they can be justified under Article 35 of the Criminal Code. In fact, there has never been a 76 T. Yamada , Shiji To Jikou Kettei Ken [Private Business and Law Business], Tokyo:Nihon Hyouronsha, 1987, pp. 8-10. 77 /. Sato , Nihonkoku Kempou Gaisetsu Dai 4 Han [Outline of the Japanese Constitution, Fourth Edition], Tokyo: Gakuyou Shobou, 1990, p. 154. 78 1973.12.12 Saikou Saibanso Dai Houtei Hanketsu (Mitsubishi Jushi Jiken) [Decisions of the Supreme Court, December 12, 1973 (Mitsubishi Resin case)], Minshuu, volume 27, number 11, p. 1536. 79 S. Machino , Kanja No Jikou Kettei Ken To Hou [The Law and Patients' Rights to SelfDetermination], Tokyo: The University of Tokyo Press, 1986, pp. 235-6. 80

M. Ohtani, Keihou Kougi Souron Dai Sai Han [General Lectures on Criminal Law, Third Edition], Tokyo: Seibandou, p. 284.

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case in which laws against causing injury have been applied to medical treatment undertaken by a physician without the patient's consent.81 Under the Civil Code, a person who arbitrarily administers medical care is not merely responsible for illegal activity. In Japan, a contract for medical diagnosis and treatment constitutes one type of quasi-authorization contract (Article 656), and a person who defaults on such a contract is liable to pay compensation for damages (Article 415). The chairman of the board of the Japan Society for Dying with Dignity, Mr. Narita, believes that giving life-sustaining medical care in defiance of a living will constitutes arbitrary administration of medical care and entails the liability and responsibility mentioned above. He also believes that patients have the right to demand consolation money for the suffering caused by pointless life-sustaining measures because they are illegal, and that this right passes on to the patient's family after the patient dies. 82 However, whether life-sustaining measures are or are not pointless is not a subjective matter to be decided by the patient. The patient's family may believe that the patient was allowed to die prematurely. They may then exercise their right to demand money to compensate for the added psychological suffering they endured after the patient's premature death (Civil Code, Article 711). Thus, it is very risky legally for a physician to end life-sustaining treatment only on the basis of a patient's living will. Another problem is the prohibition against participation in suicide, in Article 202 of the Criminal Code. To not continue life-sustaining measures at the request of a patient who has lost the ability to move, may fulfill the criteria for a criminal act of omission under Article 202. O f course, in this type of case such an act might not be considered illegal, 83 but there are no judicial precedents. (Of course, no public prosecutor is likely to indict a physician in such a case, and the case of socalled "positive euthanasia" that occurred at Tokai University on April 13, 1991, differs from those considered here.) Therefore, without legislation that would exempt them from responsibility, physicians naturally feel uncomfortable and cannot help being hesitant about the proposition that a patient's right to self-determination should be respected. Therefore, in Japan, the fact that advance directives may release physicians from responsibility for shortening a patient's life by an act of omission is more significant than the fact that they ensure a patient's right to self-determination. 84 ei Ibid., p. 293. 82 K. Narita , Ribingu Uiru No Kyouryoku Sono Houtei Sokumen: Ribingu Uiru [Legal Aspects of the Validity of Living Wills: Living Wills], Tokyo: Japan Society for Dying with Dignity, 1994, number 76, p. 2. 83 T. Miyano, Seimei Shiji Souchi No Torihazushi to Keiyou: Nihon Keihou Gakkai Dai 53 Kai Daikai Kyoudou Kenkyuu - Iryou To Keihou [Criminal Law and the Withdrawal of Life Support Apparatus: Fifty-third Congress and Collaborative Study - Medical Care and Criminal Law], Tokyo: Keihou-zasshi, 1987, 22:376-86. 2*

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The term "advance directive" is sometimes translated into Japanese as "seizen hakko yuigon " ["a will that comes into effect during one's lifetime"], and is considered as a form of the conventional last will and testament. The discussion of patients' rights, to use an American term, in Japan is said to have begun in 1968 "when a physician was accused of violating a potential organ donor's right to life by arbitrarily employing brain-based criteria in his determination of death." 85 Kimura has noted the existence since 1976 of the previously-mentioned organization, the Japanese Society for Dying with Dignity (formerly called the Japanese Euthanasia Society), and its published form, "Dying with Dignity Declaration (Living Will)," which he reports is rarely used and has no legal recognition. 86 Ohi believes that this could be attributable, in part, to a Japanese aversion to drafting a written document as contrasted with making an oral expression of one's views. 87 The concept of surrogate decision making by families appears to be the usual method of medical decision making, regardless of the patient's ability to make such decisions, but it is not by virtue of signed proxies by patients or the designation of individual family members or non-family representatives. In principle, estates in Japan are distributed according to a will whose form is designated in the Civil Code. Wills are divided into two types: regular and special. Regular wills can be written in one's own hand (Article 968), notarized (Article 969), or secret (Article 970). Special wills are divided into two types of wills written in emergency situations: those written in emergency situations in general (Article 976), and those written in shipwrecks (Article 979); and also into two types of wills written in isolated settings: those written in isolation caused by infectious disease (Article 977), and those written on ships (Article 978). These types will not be described in detail here, except to say that the form used by the Japan Society for Dying with Dignity falls in between that of a will written in one's own hand and a notarized w i l l . 8 8 However, these types of wills are used only very rarely. Wills must be affirmed (in cases of wills written in emergency situations) or probated (Article 1004, Paragraph 1) in Family Court. Therefore, their exact number can be found in the annual report of judicial statistics. In a normal year, the number is only between 3000 and 4000.89

w A. Ishihara, Makki Iryou To Keihou: Nihon Keihou Gakkai Dai 67 Kai Dakkai Waakushoppu [Terminal Care and Criminal Law: Sixty-seventh Congress and Workshop], Tokyo: Keihou-zasshi, 1992, 32:411-19. 85 Isao Morìkawa, "Patients' Rights in Japan: Progress and Resistance", Kennedy Institute of Ethics Journal 4 (1994), pp. 337-43. 86 Rihito Kimurciy "Death, Dying and Advance Directives in Japan: Socio-Cultural and Legal Point of View," in: Hans-Martin Sass, Robert A. Veatch and Rihito Kimura, eds.: Advance Directives in Transcultural Perspective, Dordrecht: Kluwer, Forthcoming. 87

Ohi (op. cit. fn. 59).

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To secure the true intent of the testator, the Civil Code requires the person who prepares the will to adhere to a strict format, and this may be one reason that the number of wills prepared is so small. In the case of advance directives, the object of the will is not one's property but the disposition of one's life, so it is natural to think that the format and procedures should be even stricter than for a conventional will. If advance directives were to be made legally binding, one question would be to what extent they would have to be put into written form. As mentioned briefly above, even when an advance directive has been prepared, the patient's will may be difficult to execute, to the extent that the advance directive does not contain a guarantee that the physician will be relieved of responsibility for acts of omission. In the Yamanchi case of so-called "positive euthanasia," 90 six conditions were put forth as necessary to negate the illegality of euthanasia. Two of those six conditions (imminence of death due to an incurable disease, and marked and outwardly obvious suffering), may be relieved by a so-called "death with dignity", but they would be exacerbated by the act of omission entailed in stopping dialysis. In the final analysis, the situations of the patient, of the patient's family, and of the physician in attendance all necessitate legislation to make advance directives legally binding. (In a nationwide survey of awareness of terminal health care, 48.5% of respondents wanted advance directives to be made legally binding. 91 ) In summary, as it now stands, the law does not clearly guarantee relief from criminal responsibility for shortening a patient's life by an act of omission. Therefore, the law does not motivate physicians to promote advance directives. Moreover, patients have difficulty making an advance directive as a legally binding will because the specified format is very strict. This problem is strongly influenced by the fact that there are far fewer lawyers in Japan than in the US. Overall, Japanese society is not very conscious of contracts of any type, and thus, people are quite averse to the idea of putting instructions regarding end-of-life issues in written form. Another difference between Japan and the United States is in the creation of legislation. Most legislation in Japan is created by bureaucrats and adopted by the Japanese Parliament without discussion. Even when debate takes place, it often has a political motive, rather than a focus on the terms or goals of the legislation. Also, the Japanese Medical Association has been much more powerful in the public are89

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K. Suzuki, Souzokohou Kougi [Lectures on Inheritance Law], Tokyo: Soubunshya, 1990, p. 130. 90 Nagoya High Court, December 22, 1962, decision, Koukeishyu [High Court Judgement Review, Criminal Law Version], vol. 15, issue 9, p. 674. Makki Iryou Ni Kansuru Kokumin No Ishiki Chousa Nodo Kentou Kai [Study Group for Research on Awareness of Terminal Care Among Japanese], Makki Iryou Ni Kansuru Kokumin No Ishiki Chousa Nado Kentou Kai Houkokusho [Report of the Study Group for Research on Awareness of Terminal Care Among Japanese], Tokyo: Shin Joho Center Corporation, 1993, pp. 1-31.

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na than the American Medical Association or similar groups and has been able to control much of the public debate, but that is changing as the public insists on an increasing role.

D. United States of America 1. Clinical Features The United States is the only one of the four countries under study that does not have a national health insurance system, but rather has a very complex system of public and private insurance mechanisms that is reported to leave about 37 million people uninsured. The employer-driven private insurance mechanism is the larger of the two types, with the Federal (national) Government paying totally for the costs of care for the elderly and permanently disabled (Medicare), for military veterans (the Veterans Administration) and for the families of active-duty military personnel (Champus) as well as the military personnel themselves. The Federal Government and the 50 State Governments share the cost of medical care for the poor, which also includes most long-term care for the elderly (Medicaid). Many minimum-wage jobs do not include medical insurance benefits, and on an uneven basis across the regions of the United States, a very cost-driven private market mechanism (known as "managed care" and often involving mechanisms such as "health maintenance organizations" or HMO's) is influencing the delivery of medical care by physicians, often restricting both the patients' access to physicians and to hospitals by threatening to withhold payment of fees for unauthorized care. Unlike physicians in the other three countries, U.S. physicians who are officebased usually have medical staff privileges at local hospitals and see their patients while they are hospitalized. It is often stated that U.S. physicians and hospitals are the most enthusiastic users in the world of high-technology medicine, followed by Germany and Japan, and that as a result, primary care medicine in the U.S. has not enjoyed the status it held prior to the 1960s and the introduction of greater medical specialization and clinically-available technology, such as intensive care units, kidney dialysis, and similar innovations. In a major multidisciplinary survey of the physician-patient relationship in the United States conducted at the University of Chicago beginning in 1989, a number of trends in such relationships were observed in the literature: -

that "increased specialization will continue to 'technologize' and 'compartmentalize' doctor-patient interaction,"

- that many physicians see the relationship as becoming "more adversarial and more contractual," - the rise of "medical consumerism" which challenges medical authority and shows "a steadily declining faith in physicians," and

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- the declining autonomy and authority of physicians who are constrained by governmental regulators and third-party payers, in addition to the decline in private practice in the United States with a growing number of physicians employed full-time by hospitals and health maintenance organizations. 92 In a development that began some three decades ago, influenced by the civil rights and consumers rights movements in the United States, Americans have increasingly asserted their legal "rights," including what they perceive as their right to be told medical information about their own diagnoses or prognoses as well as those of their family members. In a study that asked 224 U.S. adult patients waiting to see their physicians whether they would want to be told if their physician thought they had Alzheimer's disease, over 90 percent wanted to be told, and more than two-thirds of those who would want to be told said that they would be angry or frustrated if they were not told this information. 93 Whether such studies reflect patients' actual desires or potential behavior is, of course, uncertain. Similarly, a study of 396 U.S. adults waiting in an internal medicine academic clinic waiting room to see their physicians found that they had specific expectations for the content of such visits (that included a discussion of the patients' own ideas about medical management), that up to 38% of the patients reported not receiving elements of care that they considered necessary, and that this was associated with lower satisfaction with such visits. 94

2. and 3. Medico-Legal Features, and Experience with Advance Directives and Surrogate Decision-Making a) Discussion of Trends and Evolutions in Law and Medicine Changes in medical ethics and the law in the United States over the last several decades have refocused medical decision-making from a paternal model of "What is best for the patient?" to an individualized, subjective model, "What does the patient want?" This development arguably has empowered patients at the expense of physician autonomy and authority. What was the source and mechanism of this change, not only in the modes of care, but in the nature of the relationships between patients and physicians and their objectives in the health care process? If we start from the premise that ethical practices and legal obligations have altered at roughly the same pace, then we can 92

James Hughes , "A Short Review of Doctor-Patient Relationship Research", Doctor-Patient Studies 5.1 (November 1990), pp. 4-6. 93 Edmund L Erde, Evan C. Nodal and Theresa O. Scholl, "On Truth Telling and the Diagnosis of Alzheimer's Disease", Journal of Family Practice 26 (1988), pp. 401-06. 94 Richard L Kravitz, Dennis W. Cope, Vinni Bhrany, Barbara Leaks, "Internal Medicine Patients' Expectations for Care During Office Visits", Journal of General Internal Medicine 9 (1994), pp. 75-81.

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turn to the fundamental question of priority. Was it law that precipitated a change in medical practices? I f so, what moved the law in the direction it took? Was the recognition of patients' rights simply a small part of the evolution of consumer rights? Conversely, did developments in ethical debate ultimately factor into the law relating to physician practices? Did ethics and law move more or less hand in hand, reflecting common pressures and perhaps even co-dependence? These inquiries are important to understand the relative importance of law as a tool for effecting changes in the ethical practices of the medical community. Medical practices in many cultures, such as those of Chile, Germany and Japan (although to different extents), maintain a parentalistic approach to patient management (in the manner of a parent dealing with children), where power lies in the realm of one holding expert knowledge. Nonetheless, there are movements - in the consumer rights, medical ethics, and legal communities - to alter physicians' existing practice styles and to give patients more control over their own destinies)95'96·97'98·99·100·101 One of the more contentious areas at the intersection of the law and ethics of medical practice - exacerbated perhaps by the problematic cultural, economic, and religious questions that undergird opinions in this area - is that regarding end-oflife issues, and particularly the provision of life-sustaining care. The laws throughout the United States have certainly not resolved these issues to everyone's satisfaction, but they have developed a general solution that seemingly is acceptable to many in the medical and legal fields. 1 0 2 By looking at the development of law in the U.S., we may be able to place in perspective the relative effectiveness of and prospects for using law to induce change both in the U.S. and other countries. In this section, we review the evolution of advance directives in the United States, and comment on the role of law and medical ethics in that process. We comment on the present state of the law and its apparent effectiveness in altering medical practices relating to advance planning by patients, and discuss the implications of the U.S. experience for using law to modify the physician-patient relationship in other countries.

95 Hattori, et al. (op. cit. fn. 38). 96 Kai, et al. (op. cit. fn. 66). 91

Morikawa, et al. (op. cit. fn. 85). 98 Tanida (op. cit. fn. 69). 99 Ch. Brückner, "[Patients' WiUs: Legal Abstracts (engl, abstr.)]", Schweizerische Medizinische Wochenschrift 120 (1990), pp. 1166-70. 100 Franzki (op. cit. fn. 40). ιοί M. von Lutterotti, "[Patient's Living Will (engl, abstr.)]", Diskussionsforum Medianiche Ethik 3 (1991), pp. 13-15. 102 See generally Alan Meisel , The Right to Die, 2nd ed., New York: John Wiley & Sons, 1995; Henry R. Glick , The right to die: policy innovation and its consequences, New York, NY: Columbia University Press, 1992.

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Until about 40 years ago, a highly parentalistic model of physician-patient interaction was maintained in the U.S. Neither dominant ethical thought nor law placed on physicians a positive duty to tell patients about their disease, their prognosis, the risks and benefits of their interventions, or alternative forms of care available to them. While it was for the patient to say yes or no, the prerogative to make the ultimate treatment decision - and the details and information underlying that decision - was the physician's. Importantly, the law reflected dominant ethical thought of the time, although there has been a growing consumer-oriented movement throughout the 20th century challenging physicians' power. Further, the development of medical science during the same time period (and its discussion in the lay media) affected patients' automatic deference to their physicians' paternal approach to patient management, setting the stage for increased patient participation.103 In 1957, the first court decision expressly adopting a theory of "informed consent" appeared in an opinion of the California Court of Appeal. 1 0 4 Interestingly, the term "informed consent" was offered to the court in a brief filed by the American College of Surgeons. 105 The court thus did not simply expand on its own rationale the rights of patients to information, but instead it (quite literally) adopted the ethical position advocated in that brief. Since 1957, the doctrine of informed consent has been adopted by the courts and legislatures throughout the various states, with the last being Georgia in 1 9 8 8 . 1 0 6 Although the particular form of the law varies from state to state, generally these laws attempt to operationalize the ideal of patient autonomy, to greater or lesser extent, by requiring that physicians provide information to their patients with which the latter can make, or at least meaningfully contribute to, decisions regarding their medical care. Medical practices have evolved toward broader recognition of patient rights, although the model of an autonomous patient being given information and exercising decisional authority has rarely been realized. Physicians still wield a large amount of power in their interactions with patients. Patients (and their families) may be confused and perhaps upset by the setting, their health prospects, the medical jargon, and their lack of experience in making such important decisions and lack of knowledge (and self-confidence) to make difficult choices. 107 The law does not generally require that physicians facilitate informed decision-making by help103 See generally Jay Katz, The Silent World of Doctor and Patient, New York, NY: Free Press, 1984. κ* Salgo v. Leland Stanford Board of Trustees, 105 Katz (op. cit. fn. 103), pp. 60-65.

154 Cal.App. 2d 560, 317 P.2d 170 (1957).

106 Jon F. Merz and Baruch Fischhoff, "Informed Consent Doesn't Mean Rational Consent: Cognitive Limitations on Decision-Making", Journal of Legal Medicine 11 (1990), pp. 321-50. 1 07 Fran Carnerie, "Crisis and Informed Consent: Analysis of a Law-Medicine Malocclusion," American Journal of Law and Medicine 12 (1986), pp. 55-99.

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ing patients understand their options and the information relevant to a thoughtful choice between them, and, of course, the need for and ability to handle such information varies dramatically among individual patients. Over the last 30 years, the doctrine of informed consent in the United States was shaped by cases brought to the courts. In parallel, the courts have been faced with a growing number of cases involving patients' rights to refuse medical care. Under the common law doctrine of consent, physicians can not touch the person of a patient without the person's prior express or implied consent. 108 This has long been interpreted to imply that patients could refuse care their physicians thought to be necessary. A large number of cases presenting courts with questions about the right-to-refuse treatment involved Jehovah's Witnesses refusing blood transfusions for themselves, their spouses, or for their children. The conflict in these cases involved freedom of religion and rights of privacy against the perceived interest of the state in protecting children or in preventing suicides. Thé growing case load since about 1950 reflects two factors: (1) heightened public attention through the 20th century on child abuse and the care of the disabled; and (2) the proven benefits and reduced risks resulting from advances in scientific medicine. With advances in life sustaining technologies, issues rapidly arose regarding the withholding or withdrawing of care from terminally ill or severely incapacitated persons. The courts looked to the right-to-refuse precedent, the asserted U.S. Constitutional interests in privacy, and the common law (and ethical) principle of autonomy to outline the right of individuals to refuse even life sustaining medical care. The courts have balanced the individuals' interests against those of the state in preserving life, preventing suicide, protecting innocent people (including children and the infirm), and preserving the ethical practices of medicine. 1 0 9 This has effectively placed a limit on individuals' autonomous rights of choice. Recognition that a competent adult may refuse even life-saving or life-sustaining care created a further dilemma: what about patients who are unable to express their preferences for treatment at the time of need? The courts and legislatures have resolved this issue in various ways. Primary among them is giving effect to a patient's known desires regarding life-sustaining care, as expressed in an explicit directive or as voiced by an appointed surrogate decision-maker. I f the patient failed to make known his or her preferences, then a "substituted judgment" standard - the treatment decision the patient would have made - or in some cases, a "best interest" standard - the treatment decision perceived to be in the patient's best interests if the patient's wishes are unknown or unclear - may be applied. Historically, families were entrusted with authority to make decisions for incompetent loved ones - although the law did not directly address the issues of who has los Schloendorjf v. Soc. of N.Y. Hosp., 211 N.Y. 125, 129, 105 N.H. 92, 93 (1914), overruled on other grounds, Bing v. Thunig, 2 N.Y.2d 656, 143 N.Y.S. 2d 1,143 N.E.2d 3 (1957). 109 Rasmussen v. Fleming, 154 Ariz. 207, 741 P.2d 674 (1987).

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authority and in what order of consanguinity that authority would devolve from an incompetent until difficult issues of withholding and withdrawing life support presented themselves. Ethically, the physician's obligation to turn to a spouse, the parents, the children, or other kin who had a close relationship with their patient was clear - although ambiguous situations could and do still arise. Physicians and families turned to the U.S. courts in increasing numbers through the late 1970s and 1980s to resolve disputes about the scope of surrogate decision-making authority and physician's responsibilities to their patients. Many of these cases arose when patients or their families asked physicians to do something regarding which physicians did not feel ethically or legally comfortable. Perhaps because the law failed to give clear indication that the ethical course was also legally supported, physicians floundered, but the evidence suggests that the U.S. courts have, for the most part, supported physicians in their ethical practices. The exception may be the recent issue involving whether patients can demand "futile" care, as in the "Baby K" case involving a baby with anencephaly, 110 and there is a speculative argument that care may not be withdrawn or withheld from incompetent persons under the Americans with Disabilities A c t . 1 1 1 To help physicians and citizens resolve these issues, most states in the 1970s and 1980s enacted "living will" (a document expressing a person's choices about health care preferences) or "durable power of attorney for health care" (a document that also appoints a proxy or agent as well as stating treatment preferences) statutes. These laws give legal recognition to a person's advance directive regarding desires for treatment in cases of terminal illness or in cases where the person loses capacity to give consent, respectively. The term, "advance directive," covers all types of formal documents written in advance of medical incapacity, including the two types mentioned above and regardless of the extent to which they are legally recognized and enforced. More recently, a growing number of states (16 by recent count) have passed laws clearly establishing who has authority to make decisions for incompetent patients who did not complete advance directives. The general order typically is: (1) someone who has been appointed by a court; (2) someone appointed by the patient with a durable power of attorney; (3) spouse; (4) parents or children; (5) other family and people with whom the patient had a close relationship. Interestingly, these laws relate back to the common law approach to proxy consent, finally codifying for patients and their families - as well as physicians - a default ranking of potential medical decision making proxies. Also, to increase the use of advance planning documents by patients, the U.S. Federal Government enacted the Patient Self-Determination Act (PSDA) in no in the Matter of Baby K., 832 F. Supp. 1022 (E.D. Va. 1993), 16 F.3d 590 (4th Cir. 1994). i" The Americans with Disabilities Act, Pub. L. No. 101-336, 42 U.S.C, secs. 1210112213 (Supp. 1992).

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1 9 9 0 . 1 1 2 This Act requires that all health care facilities receiving federal monies apprise incoming patients about their rights to execute advance directives. The law, unfortunately, is ill-equipped to enhance patient and family decision-making about end-of-life medical care, because there is no obligation for physicians to communicate with their patients, and the point of intervention is admission to a facility as opposed to the primary outpatient care setting. Nonetheless, supported by dominant ethical thought, the law has appealed to many in the medical community who are trying to implement the "spirit" of this Act. Toward this end, a good deal of research has been undertaken to better understand patient, family, and provider preferences and decision-making regarding advance directives, interventions for increasing communications between patients and health care providers, and problems of interpretation and implementation of the directives in the clinics. A good deal of research was already occurring in the years before the PSDA was enacted, showing significant attention to these issues by those in the medical community. A Medline search (computer on-line search of journal articles listed by the U.S. National Library of Medicine) for "advance directives", "living wills", and "right-to-die" performed in late 1992 found that there were about a dozen articles per year in 1985 and 1986, roughly 25 per year in 1987 through 1989, and about 60 per year in 1990 and 1991 (the latter year is when the Act became effective). The topic, "advance directives," alone was the topic in 1994 of over 200 articles. Despite this burgeoning research, much remains unknown. What is known is that most people in the United States do not complete advance directives. Estimates of completion rates in the community are generally less than 20%. A recent U.S. Department of Health and Human Services survey found low completion rates in various patient populations, with lowest rates of completion for people cared for by home health agencies, a greater rate of completion rate for hospitalized patients, and the highest rate for nursing home residents. While completion rates increased with age and severity of illness, the rate in all settings never exceeded 5 0 % . 1 1 3 While we do not really know why most people do not complete directives, it is known that many elderly prefer to rely on their children and other loved ones to be there and to make the necessary decisions for t h e m . 1 1 4 , 1 1 5 We know also as a general matter that young people feel relatively immune from accident or injury, and 112 Patient Self-Determination Act, Omnibus Budget Reconciliation Act 1990, Pub. L. No. 101-508, sec. 4206,4751. 11

3 Office of Inspector General , U.S. Department of Health and Human Services, Patien Advance Directives: Facility and Patient Responses, Washington, DC: U.S. Government Printing Office, 1993. Dallas M. High, "A New Myth about Families of Older People?", Gerontologist 31 (1991), pp. 611-18. us Marshall B. Kapp, "Health Care Decision Making by the Elderly: I Get By With a Little Help from My Family", Gerontologist 31 (1991), pp. 619-23.

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are less prone to prepare advance planning documents. Further, most physicians do not broach the issue of advance directives unless there is some reason to think it is appropriate, such as with advanced age and terminal illnesses. Recent research shows, for instance, that physicians do not even initiate discussions about do-not-resuscitate (DNR) orders with patients until late in the end stage of their terminal illnesses. 116, 1 1 7 A study by Virmani and colleagues found little evidence that advance directives "are associated with enhanced communication between patients and physicians about end-of-life treatment decisions." 118 Even more to the point, many acutely ill patients likely to die in U.S. hospitals "lost their ability to make medical care decisions around the time of hospital admission," making a discussion in the outpatient setting even more crucial. 1 1 9 Another recent study suggests that a substantial percentage of physicians withhold or impose life sustaining care either without their patients' consents or even contrary to expressed wishes. 120 Finally, a major, multi-year, multi-center study of the role of advance directives in end-of-life decision making in the United States was just completed, disappointingly finding no changes in patient care attributable to advance directives despite the active intervention of a nurse provided specifically to facilitate communication between patients, families, and providers. 121 Thus, after nearly 40 years of watching the ethical and legal environments of medical practice evolve, it would be improvident to conclude that the law in the United States was used as an instrument of change. We think the law, as embodied in court decisions and legislative enactments of the type analyzed here, is more a 116 Robert L Jayes Jr., Jack E. Zimmerman, D. R Wagner, William A. Knaus, "Variation the Frequency of Do Not Resuscitate Orders in Intensive Care Units after Adjustment for the Severity of Illness: Findings from a National Study (abstract)", Medical Decision Making 14 (1994), p. 434. in Neil S. Wenger, Robert K. Oye, Paul E. Bellamy and Joan M. Teno, "Patient Age, Race and Perceived Health Status Are Associated with Preferences for Comfort Care'", Clinical Research (in press).

ne Jay a Virmani, Lawrence J. Schneiderman and Robert M. Kaplan, "Relationship of Advance Directives to Physician-Patient Communication", Archives of Internal Medicine 154 (1994), pp. 909-13. 115 Neil S. Wenger, Robert K. Oye, Paul E. Bellamy ; Joan Lynn, Russel S. Phillips, Nor A. Desbiens, Peter Kussein, Stuart J. Younger, "Prior Capacity of Patients Lacking Decision Making Ability Early in Hospitalization: Implications for Advance Directive Administration", Journal of General Internal Medicine 9 (1994), pp. 539-43. 120 David A. Asch and John Hansen-Flaschen, "Decisions to Limit or Continue Life-Sustaining Treatment by Critical Care Physicians in the United States: Conflicts between Physicians' Practices and Patients' Wishes", American Journal of Respiratory and Critical Care Medicine 151 (1995), pp. 288-92. 121 The SUPPORT Principal Investigators, "A Controlled Trial to Improve Care for Seriously 111 Hospitalized Patients: The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT)," Journal of the American Medical Association 274 (1995), pp. 1591-8.

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reflection of social and medical norms than a prospective instrument used to create a shift in behaviors. From this perspective, the U.S. experience suggests that the adoption of liberal informed consent andright-to-diepolicies in other countries, if they occur at all, must occur in an organic, evolutionary manner, reflecting an evolving consensus of what is right by the various constituencies - professional and lay - affected by such laws.

b) Usefulness of Advance Directive Legislation in the United States Having laws that facilitate advance planning may well be a necessary but not sufficient condition for such evolution. Physicians often must deal with uncertainty regarding the ethical and legal limits on their practices. Ethics are philosophical concepts of what is right and wrong, and by their very nature will be uncertain, open to debate, and fluctuating. Law, in contrast, provides rather clearly defined rules by which members of society are expected to behave. Thus, an alteration in ethical standards may slowly find its way into clinical practices. At some point, the law may be called upon to sanction such standards, providing credibility and some needed certainty (as well as a threat of monetary or even criminal penalties if not heeded). This suggests one reason why informed consent and various advance directive promoting laws have had little effect in the U.S. The law, the PSDA as well as individual state laws specifying the usefulness of advance planning documents, is simply too blunt an instrument to effectively change the way people approach difficult end-of-life issues. For example, failure to secure a patient's informed consent provides only a basis for civil liability, requiring that the patient suffer some poor consequence of medical care of which he was not apprised and which was substantial enough that it would have led the reasonable person to choose a different course of care. Civil claims against physicians are brought in only a small fraction of cases in which patients are injured, and cases based solely on lack of informed consent are rare. Thus, the likelihood of a physician being liable for failure to secure an informed consent is low. Other malpractice laws have similarly not been shown to have substantial effects on physicians' practices. Despite the considerable attention to medical malpractice litigation, there is little agreement regarding the response of physicians to the law. Some argue that defensive medicine is a pervasive response to the threat of malpractice litigation, while others argue that malpractice litigation actually has limited deterrent value. In a recent study, the U.S. Office of Technology Assessment (OTA) estimated that less than 8% of medical tests are ordered as a result of defensive medicine. But the O.T.A. placed numerous caveats on this finding, ultimately stating that defensive medicine can not be quantified with any precision but that claims of pervasive defensive practices are not supported by the available evidence.122 Sometimes, the defensive response is to simply overload the patient with

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information aboutrisksranging from the most insignificant to the most potentially lethal, a feature of some drug information leaflets or advertising. The evidence of the deterrent value of medical malpractice is equally unsettled. In the Harvard malpractice study using New York State data, researchers tentatively found little evidence that malpractice litigation deterred physicians from practicing substandard care. 123 In an earlier study, Danzon observed a drop in malpractice claims over time, consistent with a deterrence effect, but she was unable to discount alternative hypotheses.124 The methodological problems with detecting a behavioral response to malpractice litigation have not been resolved. In particular, there is an inevitable bias in qualitative (and perhaps even quantitative) responses to questions involving such a controversial topic. Regarding attitudes toward defensive medicine, the direction of the bias is unknown. Some physicians could simply refuse to admit that their decision making would be influenced by liability concerns, while others might take the opportunity to attack the legal system to justify actions they might take anyway. In contrast to malpractice laws, which hold physicians liable for injuries resulting from their departures from the standard of care, laws promoting advance directives have no sanctions built in to require physicians to help their patients prepare them, and the laws provide no direct motivation to citizens to complete documents. The PSD A requires only that information regarding patients'rightsunder state law be provided to patients. State laws determine the value advance directives will have in case they are needed at some future time. These laws are necessarily going to be less effective in generating physician interest and citizen preparation of advance planning documents than possible regulations directed specifically at requiring physicians to document their patients' advance plans, or perhaps laws requiring citizens to prepare such documents. Of course, such autocratic controls are strongly disfavored in the United States. Such distaste for a strong governmental role in such matters is part of the cultural canvas in which these laws must be viewed. If the law has not played a substantial role, can we say anything about what has led to the increased attention to advance directives? It is possible that the primary motivations for advance planning have arisen from public awareness of difficult

122 Peter A. Glassman, Melissa A. Bradley, Laura P. Petersen , and John E. Rolph, The Effects of Malpractice Experience on Physicians' Decision Making, Washington, DC: U.S. Congress, Office of Technology Assessment, 1993, pp. 67, 74. 123 A. Russell Localio, Ann G. Lawthers, Troyen A. Brennan, Nan M. Laird, Uesi E. Herbert, Lynn M. Peterson, Joseph P. Newhouse, Paul C. Weiler, Howard H. Hiatt, "Relationsh Between Malpractice Claims and Adverse Events Due to Negligence," New England Journal of Medicine 325 (1991), pp. 245-51. 124 Patricia M. Danzon, Medical Malpractice: Theory, Evidence, and Public Policy, Cambridge, MA: Harvard University Press, 1985, pp. 75, 83.

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cases such as that of Karen Ann Quinlan125 and Nancy Cruzan. Indeed, the PSDA itself was a reaction to the Cruzan case, in which the U.S. Supreme Court upheld the ability of Missouri to require clear and convincing evidence that a patient would want to be disconnected from life support systems before carrying out her family's wishes.126 Thus, the law aside, there has been a social trend toward taking the steps necessary to protect oneself from what many see as an undesirable use of technology - and one that can be imposed upon them if they do not act.

ΙΠ. Cross-Cultural Similarities and Differences An analysis of the clinical and legal features of the four countries surveyed reflects a remarkable core of four similarities amidst the diverse cultures, and health care and legal systems. First, despite different medical delivery and payment systems, educational resources to train physicians, technology employed, and access to services, all four countries share a roughly similar evolution of physician-patient relationships, marked by different degrees or speeds in which the absolute authority of the physician to make decisions for the patient is being challenged or diminished. Even in relatively stratified and hierarchical societies such as Germany and Japan, the physician is not immune from criticism, even though (particularly in Japan) there may be a cultural imperative to maintain smooth relationships and avoid conflict. Indeed, it may well be the case that patients in all four countries recognize the need to not antagonize or alienate physicians lest they go untreated or medically abandoned. Second, we note the development (perhaps most slowly in Chile) of national legal mechanisms to regulate physicians and control physician behavior, in part through the development of the "informed consent" doctrine, and the use of lawsuits and criminal proceedings to sanction physicians whose actions fail to meet the standards of acceptable behavior toward patients. Third, all four countries have scholars and academic centers in the field of bioethics, including medical and clinical ethics (with most in the USA), and these have made possible the discussion in four languages of the concept of advance directives and surrogate decision making, among other contemporary topics of bioethics. It is also not clear that physicians in all four countries perceive that they have benefited or changed their professional behavior as a result of these discussions and publications, although fewer have occurred in Japan and Chile. Fourth, advance directives (even in the United States) are rarely used, but surrogate decision making is often the clinical reality in all four countries to the extent 125 In re Quinlan, 70 N.J. 10, 355 A.2d 647, cert, denied sub. nom. Garger v. New Jersey, 429 U.S. 922 (1976), overruled in part, In re Conwy, 98 N.J. 321,486 A.2d 1209 (1985). 126 Cruzan v. Harmon, 760 S.W.2d 408 (Mo. 1989), aff'd sub. nom. Cruzan v. Director of Missouri Dept. of Health, 497 U.S. 261 (1990).

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that physicians choose to talk to families about treatment decisions involving the patient (even to the exclusion of the patient with decision-making capacity from the discussion), especially with regard to life-threatening situations or diagnoses. Such models are not the product of autonomous written directives from the patient, and non-relatives (such as friends or significant others) are not often welcomed into such discussions. The models do suggest, however, that the concept of consult-, ing others close to the patient when making treatment decisions is even more strongly held by physicians in all countries than the notion of asking the patient directly. It is important to note that patients who are ill or under great stress or anxiety may not retain and process verbal information given to them by physicians as they would under less stressful circumstances, and they also might choose to involve others in the decisions to be made rather than act as sole decision-makers. Thus, the role of families or significant others in making treatment decisions for patients may not only correspond to cultural norms or patients' preferences, but have additional validity in terms of the capacity of the patient at any given moment in time to make such informed decisions.

IV. Closing Discussion and Recommendations There has been little direct research studying the relationships between laws and individuals' behaviors, and specifically with regard to illness. The roles that rules, especially those that are poorly specified or highly uncertain, or merely deferential guidelines play in directing professional practices are largely unknown. Because of this dearth of social science research, it is unclear how important the law is to physicians' professional behaviors. Behavioral models provide a basis for future research of these issues. Consideration of cultural aspects influencing physicians' practices, such as the influence and pervasiveness of law and regulation, must be considered in such models.127 In the social psychology field, there has been an effort to conduct research and develop models "focused on determining specific factors that facilitate the prediction of behavior" with the predictive power of one's intentions being of special interest. 128 One general class of models, i.e., the so-called expectancy-value model, 1 2 9 may provide a particularly useful conceptual framework for understanding 127 George J. Annas and Frances H. Miller, "The Empire of Death: How Culture and Economics Affect Informed Consent in the U.S., the U.K., and Japan", American Journal of Law and Medicine 20 (1994), pp. 357-93. 128 Leah P. Dick, To Sign or Not to Sign a Living Will: An Application of the Theory of Planned Behavior with Older Adults, Ph.D. dissertation, St. Louis: Washington University, 1992, pp. 2-3. 129

Heinz Heckhausen, Motivation and Action, Berlin/New York: Springer-Verlag, 1991.

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physicians' behavior with respect to advance medical planning. Expectancy-value models regard behavior as jointly determined by the expectations that individuals hold about executing certain actions and the subjective value placed on the outcomes associated with those actions. The "theory of planned behavior" postulates, for example, that the intention to engage in a course of action is a function of three factors: personal attitudes toward the behavior, subjective norms associated with the behavior, and an individual's perceived capacity to execute the behavior. Attitudes toward the behavior refer to the degree to which an individual has a favorable or unfavorable evaluation of the required behavior. Subjective norms are determined by the views held by an individual's reference group and reflect the perceived social pressure to perform or abstain from performing the behavior in question. Finally, perceived behavioral control refers to the extent to which an individual regards him- or herself as possessing the capacity to engage in the target behavior. Perceptions of behavioral control reflect both past experience as well as anticipated impediments in performing the behavior. 130 The theory of planned behavior has been utilized and validated in a number of studies, many (if not all) of which have been focused on young people, including those predicting class attendance, grade expectations, and weight loss.131 Of particular relevance to the current study, it has also been used to evaluate the health attitudes and behavior of 40 college students, yielding the insight (at least as to these respondents) that females are more inclined toward performing health-related practices than males and that the desirability of performing health-related behaviors is closely linked to a perception of pleasure or displeasure in performing those behaviors as well as the degree to which one has performed those certain behaviors in the past. 132 Since few, if any, empirical studies had previously applied the theory of planned behavior to older adults and because she was aware of increased publicity about legal conflicts and court cases over medical treatment decisions, Dick decided to study older volunteers in St. Louis, Missouri, USA, and their "attitudes, subjective norms, and perceived controls towards the behaviors of the specific health care decision of writing a living will." 133 She first conducted a pilot study involving 32 participants (8 males, 24 females) between the ages of 60 and 83, and then a main study of 145 participants (54 males, 91 females) between the ages of 55 and 84.

130 leek Ajzen, "From Intentions to Actions: A Theory of Planned Behavior," in: Julius Kuhl and Jürgen Beckmann, eds.: Action-control: From Cognition to Behavior, Heidelberg: Springer, 1985, pp. 11-39. »31 Dick (op. cit. fn. 128), p. 4. 132 leek Ajzen and Christine Timko , "Correspondence Between Health Attitudes and Behavior", Basic and Applied Social Psychology 7 (1986), pp. 259-76. 133 Dick (op. CiL fn. 128), p. 34.

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Dick set out to explore three hypotheses based on the theory of planned behavior: 1) that "the act of writing a living will is predicted by the participants' intentions to perform these behaviors;" 2) that respondents "who exhibit scores reflecting high degrees of desired control over their health care [i.e., such as preparing a will or buying long-term-care insurance] are more likely to demonstrate perceptions of control consistent with behaviors related to making active health care decisions;" and 3) that "the performance of past behaviors significantly contributes to the prediction of target behaviors."134 Even though she discovered that a substantial number of the potential respondents initially contacted had already signed a living will (advance directive), she found that there was only limited support for the first hypothesis in that the actual rate of signing living wills following a discussion of them and respondents' intentions was only 30%. Because she found that signing a living will "is highly emotional and not well practiced behavior" and will not be done more than once, it is very difficult to predict by this model. 135 Dick also found that the model was successful in predicting the concrete intentions relating to document preparation, and even more strongly that those who had already taken action to exercise control of their future lives or health care were far more likely to actually sign living wills than those who had not taken such actions.136 In summary she found that "for the behavior of signing a living will, specific intentions do not predict equivalent, direct action; yet it does confirm a common belief that past behavior predicts future behavior." 137 Dick did not specifically test the effect of having a law in the State of Missouri providing for the legal recognition of living wills (advance directives), and thus, there is no clear indication that the presence or absence of a law proving for such documents and for their legal recognition will necessarily influence behavior, although one might speculate that it would. Moreover, Dick found that her study sample "was a group of older adults who expressed a strong interest in this behavior [signing a living will] but for some reason were hindered by their own obstacles."138 As Waitzkin has observed, "[t]he personal troubles that patients bring to doctors often have roots in social issues beyond medicine."139 There are obvious difficulties "in translating and transferring insights from one culture to another in bioethics,"140 and it would be extremely »34 ibid., p. 36. 135 Ibid., pp. 80-81. 136 Ibid., pp. 82-91. 137 Ibid., p. 93. 138 Ibid., p. 80. 139 Howard Waitzkin, "A Critical Theory of Medical Discourse: Ideology, Social Control, and the Processing of Social Context in Medical Encounters", Journal of Health and Social Behavior 30 ( 1989), pp. 220-39, at 220. 24*

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problematic to attempt to speculate on the personal obstacles that an individual in Valparaiso, Düsseldorf or Yokohama might face in considering the writing of an advance directive or even asserting his or her values in a conversation with a physician, based on studies of people in St. Louis. Legal anthropologists have debated the utility of studying law and culture as symbiotic, integrated processes that can allow for cross-cultural comparisons, but have noted that it also requires a focus on power relationships and historical transformations within individual cultures that may be ignored in the ahistorical cultural analysis favored by some.141 Each of the countries surveyed has undergone a specific historical development and cultural context of physician-patient relationships, and related issues of power and autonomy, and it would be simply naive to make generalizations that ignore such culture-specific realities. We conclude, however, that there is no evidence that law-based instruments of change such as those developed in the United States concerning advance directives and surrogate decision-making have been successful in changing behavior of either patients or physicians, and that there may be greater benefit in exploring educational initiatives that would target both groups in culturally-appropriate ways. Exporting U.S. models of legislation or even written instruments may not achieve as much as seeking to discuss publicly the issues involved, therisksand benefits of change, and the cost of maintaining the status quo regarding medical treatment decision making. To test this hypothesis, however, we conducted a pilot, scenario-based study among physicians practicing in academic medical centers in the four countries under review, and while there was a wide disparity in attitudes and responses, it offers perhaps a more hopeful role for the use of legislation with regard to advance directives. The survey and its results are summarized in the appendix to this article. 142 In closing, we would call attention to Meisel's observation for those seeking to enhance the autonomy of patients in health care systems dominated by physicians: The ultimate hope for assuring that individualistic concerns come into play in medical decision making may lie with assertive and well-educated consumers - that is, patients who are aware of the extent of their decisional authority and who do not hesitate to exercise it. 1 4 3 140

Patricia Marshall David C. Thomasma and Jurrit Bergsma , "Intercultural Reasoning: The Challenge for International Bioethics", Cambridge Quarterly of Healthcare Ethics 3 (1994), pp. 321-28, at 321. ι 4 * Sally E. Merry , "The Culture of Judging: Book Review", Columbia Law Review 90 (1990), pp. 2311-27. 142 A report of the Japanese data in this survey, plus additional Japanese survey data, can be found in Darryl R.J. Macer, Takashi Hosaka, Yuki Niimura, and Takayoshi Umeno, "A survey of university physicians' attitudes to advance directives in Japan," Eubios Journal of Asian and International Bioethics 6 (1996), pp. 63-69.

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The degree to which any such hesitancy may exist is directly related, in our view, to patients' perceived degree of understanding of their medical condition and in relation to the culture-specific contextual realities of support resources in their environment.

Appendix A Pilot Survey of Physician End-of-Life Medical Decision Making in Four Countries lntroduction

How to best make medical decisions at the end of life is a problern for physi­ cians and patients wherever medical technology has blossomed. The issue is handled differently in different nations for a variety of reasons including cultural differences in the approach toward illness and death, variation in physician atti­ tudes and the physician-patient relationship, and differences in the laws governing medical decision making. These international differences in end-of-life decision making are poignantly demonstrated by the nearly three-fold Variation in intensive care unit use across Western nations. Differences in the behavior of hospitals and physicians within individual nations could be measured in the future, however, and may well exceed these international differences. We performed a pilot, scenario-based study to evaluate end-of-life decision making among physicians in four nations. The purpose of the study was to com­ pare attitudes toward decision makers and appropriate decisions among physicians in different countries. Specifically, we were interested in the factors on which phy­ sicians based end-of-life medical decisions and whether physicians outside the United States would be receptive to a law which permitted patients to specify pref­ erences and an agent in an advance directive.

Methods

Convenience samples of physicians working in academic medical centers were surveyed in four countries: Japan, Germany, Chile and the United States. Survey instruments were translated for each country. Each physician was trained in the country in which he or she was surveyed and bad primary responsibility for adult patients in the academic medical center. Descriptors of the surveyed physicians are shown below:

143

Alan Meisel, "The 'Exceptions' to the Informed Consent Doctrine: Striking a Balance

between Competing Values in Medical Decision Making", Wisconsin Law Review (1979) pp. 413-88, at 488.

374

L.S. Rothenberg et al. Characteristics Japan N=86

of the Samples U.S. N=72

Germany N=28

Chüe N=26

Age (mean years)

44

41

34

51

% Male

86

57

64

92

Years since medical school grad (mean years)

19

16

9

27

61

100

50

77

0

0

17

0

39

0

33

23

Specialty (%) Medicine / subspecialty Surgery Other # of patients seen in last year (%) 500

20

36

39

58

% of patients over age 70

30

30

25

27

3

6

6

4

% of patients who died last year

The physicians surveyed in Japan and the United States tended to be older and there was variation by specialty among groups. Each physician considered a scenario and then answered simple questions concerning how they would handle the decision making and what clinical decision they would make. Physicians in the U.S. were queried concerning whether they were aware of laws enabling patients to complete advance directives. Physicians in Japan, Germany and Chile answered whether they would respect wishes and consult a surrogate decision maker prespecified in an advance directive if this were required by law. Raw data are presented; formal statistical testing is not performed on these pilot data.

Results

The scenario: A 68 year old gentleman with a rapidly progressive dementia is brought to your office with pneumonia. This dementia has been fully evaluated and is both progressive and unbeatable. He has worsened over the past year and now is able only to

375

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state his name, recognize family members and respond to simple commands. He is incontinent and bedridden and is unable to complete any activities of daily living; he must be fed, dressed, bathed. He appears to be in no pain. Now he has had cough and fever and shortness of breath for 3 days. Examination, laboratory findings and X-ray reveal pneumonia affecting both lungs. You have three options: (1) admit the patient to the hospital for intravenous antibiotics with an expected 80% chance of survival, (2) prescribe oral antibiotics for the patient to take at home with an expected 40% chance of survival, or (3) give no antibiotics and prescribe medications such as acetaminophen and cough suppressants to make the patient comfortable with an expected 5% chance of survival. The patient was a bank executive but has not worked in l l / 2 years. He lives with his wife who cares for him and has 2 grown children with whom he is close, a daughter, the elder, and a son, both of whom are married and live nearby. He had not told you in the past what type of care he would want in a clinical situation such as this. The patient's wife and children are all willing and able to communicate with you. Physicians' answers were as follows. Percentages are rounded off to the nearest whole number; responses may not sum to 100%.

Who makes the decision about how to treat the patient? Japan

U.S.

Germany

Chile

Physician alone

1%

0%

11%

4%

Physician with wife

2%

15%

18%

8%

Physician with daughter Physician with whole family

0%

0%

0%

4%

96%

85%

71%

85%

What decision would you make ? Japan

U.S.

Germany

Chile

Admit to hospital for IV antibiotics

96%

55%

67%

46%

Give oral antibiotics at home

4%

27%

26%

54%

No antibiotics/provide comfort care

0%

18%

7%

0%

376

L.S. Rothenberg et al. How important were the following factors in your decision ? Japan

U.S.

Germany

Chile

Very important

54%

31%

56%

58%

Somewhat important

35%

55%

30%

35%

Not important

11%

14%

15%

18%

Very important

42%

64%

48%

65%

Somewhat important

50%

32%

44%

35%

8%

4%

7%

0%

Very important

26%

41%

15%

58%

Somewhat important

56%

52%

52%

31%

Not important

19%

7%

33%

12%

Very important

19%

4%

14%

2%

Somewhat important

50%

46%

64%

38%

Not important

31%

50%

21%

50%

Patient's chance of surviving 6 months

Patient's functional status

Not important Patient's dementia diagnosis

Patient's age

Patient's gender Very important

0%

0%

5%

0%

Somewhat important

11%

1%

18%

0%

Not important

88%

99%

77%

100%

0%

0%

4%

8%

Patient's socio-economic status Very important Somewhat important

44%

3%

11%

46%

Not important

56%

97%

86%

46%

9%

6%

0%

15%

The cost of care Very important Somewhat important

60%

57%

21%

77%

Not important

30%

37%

79%

8%

377

Medical Treatment Decision-Making in Four Cultures Japan

U.S.

Germany

Chile

Very important

68%

90%

73%

81%

Somewhat important

28%

7%

19%

12%

4%

3%

8%

8%

Very important

84%

82%

39%

74%

Somewhat important

16%

18%

46%

18%

0%

0%

14%

8%

94%

89%

79%

96%

Somewhat important

6%

11%

14%

4%

Not important

0%

0%

7%

0%

Very important

61%

54%

14%

31%

Somewhat important

39%

39%

64%

62%

0%

7%

21%

8%

6%

9%

0%

8%

Somewhat important

49%

50%

14%

42%

Not important

44%

41%

86%

50%

What the patient wants

Not important What the family wants

Not important What's best for the patient Very important

What's best for the family

Not important What's best for society Very important

Advance Directive Attitudes

U.S. physicians only : Aware of advance directive law

99%

Would foUow patient's advance preferences

99%

Aware of law to appoint health care agent

99%

Would ask agent to make decision

100%

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L.S. Rothenberg et al.

Japanese, German and Chilean physicians: Japan

Germany

Chile

Would follow preferences in an advance directive if required by law, even if different from your own (percentage answering "yes")

89%

80%

65%

Would follow preferences of appointed decision maker if required by law

96%

92%

100%

Discussion This pilot study of physicians in four countries reveals that a clinical scenario can be used to compare the attitudes of physicians toward end-of-life care crossculturally. These data are limited by the nature of the convenience sample, small numbers, and differences among physician groups. The findings suggest, however, that the mechanism of decision making is similar among physicians in the four countries. On the contrary, physicians in the four countries differed in their preferred end-of-life medical decision, and there was substantial variation in the reasons underlying the physicians' decisions. Physicians responding from a single U.S. academic medical center were aware of advance directive law and physicians in Japan, Germany and Chile indicated that they would follow advance directives, should there be a law requiring them to do so. This pilot study suggests that a scenario survey of probability samples of physicians may elucidate across country differences in medical care utilization and that further exploration may portray a role for international use of advance directives in guiding medical care.

Zusammenfassung Der Beitrag untersucht, inwieweit die klinische Praxis in vier Ländern mit unterschiedlichen Rechtssystemen und Berufskulturen (Chile, Deutschland, Japan, USA) durch Rechtsnormen oder das Verständnis von Recht beeinflußt wird. Es wird gefragt, welche Funktion rechtliche Interventionen bei der Veränderung von Verhaltensnormen in unterschiedlichen Gesundheitssystemen haben können. Folgende Themenbereiche werden diskutiert: Entscheidungen über die medizinische Behandlung, die von Patienten und ihren Angehörigen oder Stellvertretern getroffen werden; die mögliche Rolle umfassender schriftlicher Verfügungen wie z. B. der Patiententestamente („advance directives"); die berufsübergreifenden Spannungen zwischen medizinischen und rechtlichen Belangen in sehr unterschiedli-

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chen Kulturen; der Einfluß, den gesetzgeberische Aktivitäten im Kontext der verschiedenen politischen und Gesundheitssysteme auf die medizinische Wirklichkeit haben. Bei ihrer Analyse der in diesem Zusammenhang bestehenden Beziehungen im Verhältnis von Recht und Verhalten haben die Autoren die Erkenntnisse vieler Disziplinen unter Einschluß der Sozialwissenschaften, soweit sie als relevant erscheinen, in ihren Beitrag eingearbeitet.

Advance Directives and Surrogate Decision Making Ethical Questions, Legal Response and Clinical Summary A Critical View 1 Johannes Gobertus Meran

Introduction 1. Definition In 1969 Luis Kutner introduced the term "living will" for a written declaration issued by a patient to ensure that treatment would be stopped if he subsequently became terminally ill and incapacitated.2 It still remains a widespread concern that medical technology can keep patients alive in an undignified state. Prominent court cases brought the problem of decision making at the end of life into the public debate. 3 Subsequently these questions were discussed and analyzed by members of several academic and public institutions.4 Advance directives, which enable patients to declare their wishes and preferences for future situations when they are no longer able to communicate, appear to be very attractive. They seem to solve, at least theoretically, a lot of the difficult ι This paper has been supported, in part, by grantsfrom the Volkswagen Foundation to the Kennedy Institute of Ethics, Georgetown University, Washington, D.C. and to the Institute of Philosophy in Bochum, Germany within the Project: "Advance Directives and Surrogate Decision Making" directed by Prof. H. M. Sass and Prof. R. Veatch and by a personal grant "Habilitationsstipendium" from the Deutsche Forschungsgemeinschaft (DFG). I would like to acknowledge helpful comments and discussion on the topic with Hans-Martin Sass, Robert Veatch, Robert Olick, Jaro Kotalik, Anthony Kessel, Les Rothenberg, Ian Kennedy, Will Cartright, Andrew Grubb and Madison Powers. John D. Collahan and Kier Olsen helped to improve the English style and expression. 2 L. Kutner (1969). 3 See e.g.: In re Quinlan, 355 A.2d 647 (N.J.1976); In re Conwy, 486 A.2d 1209 (N.J.1985); Cruzan ν Director Missouri Department of Health 110 S Ct 2841 (1990); Airedale NHS Trust ν Bland [1993] 3 W.L.R. 316 and see J. C. Harvey (1993). 4

Inter alia: King's College Working Party Report by Age Concern Institute of Gerontolog and Centre of Medical Law and Ethics (1988); President's Commission for the Study of Et cal Pwblems in Medicine and Biomedical and Behavioral Research (1983); A. Eser and H. G. Koch (1991); House of Lords Select Committee on Medical Ethics (1994); The Law Commission (1995).

382

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questions arising in the care of incompetent patients by providing the answers these patients can no longer give: consent to, or refusal of, treatment.5 A further suggestion was to name a health care proxy, who is familiar with the patient's wishes and can decide on behalf of the patient. In the USA the "1990 Patient Self-Determination Act" introduced by federal statute both "Advance Directives" and surrogate decision making through a "Durable Power of Attorney", combined with an ambitious educational effort. 6 To date, no statutory regulations have been issued in England and Germany, but proposals have been made and living wills are being distributed by private organizations.7

2. Important Distinctions Before discussing the ethical issues in detail, it is important to note that (unlike earlier forms) most advance directives nowadays are supposed to work in the following ways: a) to refuse treatment in advance, and b) to authorize treatment in advance. Furthermore, they are used to declare concrete decisions, like "no blood transfusion under any circumstances" or to express rather inspecific attitudes, general wishes, and preferences. These distinctions can have moral and legal significance.

3. Goal The aim of this paper is to provide a very critical view of advance directives.8 As legislation is in preparation, it seems to be important to put the onus of proof on the concept of advance directives. Before a statute imposes legal power, all questions as to the moral authority of advance directives should be addressed, and if possible answered. Therefore, the various criticisms will be emphasized without attempting to equally balance them with possible benefits.

5 President's Commission for the Study of Ethical Problems in Medicine and Biomedic and Behavioral Research (1983); L L Emanuel/E. J. Emanuel (1993); E. J. Emanuel/ L L Emanuel (1990).

β The PSDA is contained in sections 4206 and 4751 of the Omnibus Budget Reconciliation Act 1990, P.L. 101-508, 42 USCA §§ 1395cc & 1396a. Specific legislation is provided by almost every single American State; see: P. M. McCarrick (1991) revised April 1992. 7 See for living will forms: OMEGA Mit dem Sterben leben e.V. (1992); J. G. Meran/H. Poliwoda (1996); The Terrence Higgins Trust and Centre of Medical Law and Ethics (1994). β If not otherwise indicated, I include both devices, written advance directives and durable (enduring) powers of attorney.

Advance Directives and Surrogate Decision Making

383

4. Structure In the first part, ethical questions will be raised, starting with conceptual presuppositions. In the second part, I try to sketch and compare the legal responses , of England and Germany. The conclusion aims to include the clinical point of view as a third perspective. Although the ethical and legal perspectives are interwoven, they are separated in this paper for analytical purposes. The basic structure stretches from theory to practice and indicates in a logical, progressive manner how to issue and implement an advance directive (see Figure 1).

PART A: Ethical Problems and critical points

1. Conceptual presuppositions Physician 2. Problem of information

3. Problem of normative assessment

Patient ι

4. Moral authority

Advance Directive

5. Practical shortcomings Physician 6. Normative interpretation

7. Further practical shortcomings Patient Figure 1 : ADVANCES DIRECTIVES and SURROGATE DECISION MAKING

384

Johannes Gobertus Meran

A. Philosophical Questions 1. Conceptual Presuppositions The concept of advance directives is based on two important presuppositions. First, at the root of any directive or expression of self-determination is the recognition of autonomy. Second, it is assumed that a person cannot only direct and determine medical care hie et nunc, but can advance autonomy into future incompetent states. It is the second presupposition that causes most of the ethical concerns and practical problems. a) Autonomy Autonomy is assumed to be a basic principle of morality.9 Respect for autonomy can be invoked from deontological views, like Immanuel Kant's categorical imperative 10, as well as from utilitarian philosophies.11 The concept of autonomy is not part of a homogeneous theory, but seems to have various aspects and interpretations. Freedom from interference and the right to choose appear to be part of a broad consensus. There is, however, a difference between the (negative) freedom to be left alone and the (positive) freedom to have certain options.12 Refusal of and demand for a particular form of treatment thus can find different moral justifications. Some philosophers have suggested that there can be obstacles to autonomy within oneself, such as conflicting desires.13 Although the right to self-determination is almost unanimously recognised, not everybody is held to be autonomous or entitled to determine what happens to himself. There are certain conditions to be met. The famous statement of Justice Cardozo restricted the right of self-determination to adults of sound mind.14 Further 9

TL· Beauchamp/J. F. Childress (1989). Immanuel Kant , Grundlegung zur Metaphysik der Sitten, 2. Abs. in Band 6 der Werke in 10 Bänden, hrsg. von W. Weischedel, Darmstadt: Wissenschaftliche Buchgesellschaft (1956): "Autonomie ist also der Grund der Würde der menschlichen und jeder vernünftigen Natur", p. 69 (BA 79, 80); "Moralität ist also das Verhältnis der Handlungen zur Autonomie des Willens, das ist, zur möglichen allgemeinen Gesetzgebung durch die Maximen desselben ", p. 74 (BA 87); "Die Autonomie des Willens als oberstes Prinzip der Sittlichkeit: Autonomie des Willens ist die Beschaffenheit des Willens, dadurch derselbe ihm selbst (unabhängig von aller Beschaffenheit der Gegenstände des Wollens) ein Gesetz ist. Das Prinzip der Autonomie ist also: nicht anders zu wählen, als so, daß die Maximen seiner Wahl in demselben WoUen zugleich als allgemeines Gesetz mit begriffen seien.", p. 74 (BA 87). See further R. Eisler (1989) 54ff. 10

" J. S. Mill (1962). 12 /. Berlin (1969). 13 See infra: Problem of self-binding and H. G. Frankfurt (1982); C. McKnight (1993); R. Gillon (1993) 14 Schloendorff ν Society of New York Hospital (1914) 211 NY 125 at 126 Cardozo J: "Eveiy human being of adult years and sound mind has a right to determine what shall be done with his own body;".

Advance Directives and Surrogate Decision Making

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(legal) restrictions on autonomous choice in health care are rules of hygiene, quarantine and obligatory vaccinations. Generally, when other people are put at considerable risk, then self-determination may be constrained. There have been cases where even the patient's decision to refuse treatment was overruled by the state's interest in protecting dependent children.15

b) Advance Directives and Autonomy Advance directives try to extend the exercise of self-determination into the special situation of incompetence, where at least one crucial component of autonomy is lacking: active, contemporaneous personal choice.16 It has been suggested that "it is a deceptive fiction" to speak of an incompetent person's right to self-determination. "The responsibility for what becomes of him rests squarely on others." The implementation of advance directives is thus limited by normative constraints to respect the dignity of that person.17 To find out the limits of advance directives the underlying purpose of this entire paper.

is

Regarding the second presupposition, that autonomy can be advanced to future incompetent states, there is a fundamental challenge to the moral authority of future-oriented directions:

c) Different Views on Personal Identity18 "She is no longer the same person we used to know" is sometimes said after a disease or an accident has made a relative incompetent. This common-language expression emphasises the perception of a profound change. But what has changed in such a case and what do we mean by "no longer the same person"? Presumably we had a certain image of our relative, of the character, the reactions, and emotions that we were able to grasp. She may have been a happy and lively student, helpful and amusing. We have memories of her "body language", and her facial and verbal expressions. Perhaps we even had some insight into her thoughts and ideals. All these impressions and experiences constitute our subjective image of the person, which is inseparably connected with a certain name. As a result of changes

15 Application of President & Directors of Georgetown College , Ine, 331 F 2d 1000 (1964). 16 President's Commission for the Study of Ethical Problems in Medicine and Biomed and Behavioral Research (1983) p. 136. π L Gormally (1992) p. 60. is The discussion about personhood is one of the most complicated in philosophy and can only be touched in this paper. I am particularly interested in the views that challenge the authority of advance directives.

25 Jahrtwch für Recht und Ethik, Bd. 4 (1996)

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in that person effected by the accident, parts of our impression of her have been altered. The new image no longer seems congruent with the person and the name that we had previously correlated. But if assured that she is our relative, we perhaps would consider that the accident had changed her and initiated a new phase in her life. Thus, we would assume that the change has taken place within a person's life. Even if she has lost her memory and cannot recognize her relatives or decide for herself, we would accept that she still remains the same individual. To the extent that we are able to ascertain her "spatio-temporal continuity" she is in a way the same, despite all the changes.19 competent

* A incompetent

However, there are philosophical arguments that challenge this view. Derek Parfit pointed out the implied contradiction, implicit in the statement that a person is no longer the same and suggested an alternative explanation: "If certain things happen to me ... the truth might be that the resulting person is someone else."20 He explains this astonishing suggestion by distinguishing two views of personal identity. One is the traditional "all-or-nothing " view, where a person is determinate. (In his earlier essay "Later Selves and Moral Principles " he called it the "simple view".) Parfit, however, is in favor of another view, where identity is seen as changing proportionally to "psychological connectedness and psychological continuity".21 He claims, expanding on ideas of John Locke,22 that our personal identity is a matter of the continuity of our memories, intentions, desires and beliefs. If a certain minimum of connected psychological features is lacking, he would question the persistence of personal identity. A competent

* A incompetent

(standard view)

A competent

* Β incompetent

(complex view)

time 1

time

2

According to this view, personal identity over time would simply consist in the maintenance of psychological continuity, defined by overlapping chains of strong w Derek Parfit called this the "standard view", D. Parfit 20 D. Parfit ( 1984) p. 202.

(1984) p. 203.

21 D. Parfit (1984) p. 204fF. 22 The claim that "experience-memory" provides the criterion of personal identity was suggested by John Locke: "personal identity consists, not in the identity of substance, but... in the identity of consciousness" § 14, 342 and "For whatever substance there is, however framed, without consciousness there is no person" § 23, in: An' essay concerning human understanding, reprinted in: P. H. Nidditsch, ed., Oxford 1975.

Advance Directives and Surrogate Decision Making

387

psychological connectedness.23 A person at a certain time (tl) is only then the same person at a later time (t2) if there are enough direct psychological connections from one day to the next, thus providing the required continuity. Parfit called this the "psychological criterion " of personal identity and contrasted it to the "physical criterion. " Personal identity on the latter view consists in the continued existence of the body, or at least "enough of the brain to be the brain of a living person". The qualification of a functioning brain relates to the suggestion that one could imagine losing parts of the body, such as a limb, without losing identity.24 Both, the physical and the psychological views of personal identity are reductionist, because they claim that identity consists exclusively in physical and/or psychological continuity. Other views, which Parfit calls non-reductionist , claim that persons are, or require, separately existing entities distinct from the brain and body or continuing experiences. "Cogito ergo sum" was the famous statement by Rene Descartes, claiming a spiritual substance as the "Pure Ego". In Decartes's dualism the concept of substance and the subject are united in the reflecting Ego, which covers all mental functions. Other philosophers argue for teleological entities that are supposed to constitute personal identity, for instance the abstract self or the soul. Again, other views claim that the unity of a mental life cannot be separated from the person who has the experiences. The person is the necessary presupposition of such experiences.25 Parfit, however, argues that we have no evidence to believe that a person is any kind of separately existing entity. On the other hand, he states, much evidence supports the belief that the brain is the carrier of our psychological continuity and the idea that psychological connectedness could hold to a reduced degree.26 Therefore, our identity is not always determinate; otherwise, it would have to be an all-or-nothing matter and not a matter of degree. A —• (A) —• ? —• ? —> ? —• ? —• Β —• (Β)

His view is criticized by Bernard Williams27, who claims that, as long as a person's brain continues to exist and supports consciousness, this person will continue 23 D. Parfit (1984) p. 204. 2* A similar thought-experiment of reducing the human body part by part until one ends up with the brain cortex is used in the discussion of brain-death. A. Tardiff (1992). 25 For further discussion see H. Noonan (1991). 26 D. Parfit (1984) p. 228. 27 B. Williams (1973) p. 64ff. and D. Parfit (1984) p. 229. 25*

388

Johannes Gobertus Meran

to exist however great the breaks in psychological continuity of this person's mental life may be. This view of physical continuity provides a more traditional and common view of personal identity. A —> Ai — • Aii —> Aiii —• Aiiii

But Parfit argued that there could be a (nowadays fictional) gradual supplementation of the body and even brain structures without altering psychological continuity. In this thought experiment the body and the brain would always function normally without interruptions, despite the fact that the final result is a complete exchange of parts. He compared it with a wooden boat that, after ongoing repairs, becomes entirely composed of new bits of wood. If the brain structure that is exchanged or transplanted would provide exactly the same or at least similar opportunities for our memories, intentions and desires, the purely physical criterion would no longer be relevant in his view. He added another fictional example in which a neurosurgeon alters the brain in a way such that small gradual changes in our psychological features take place. This "psychological spectrum" would start with some minor changes of character and lost bits of memories and, over time, finish by leaving the person with a completely different character as well as different desires, wishes and intentions. Analogous to this is the well-known example of the "paradox of the heap", where taking away grain after grain leaves a heap until only a few grains are left. Finding the answer to the question of whether three, two or even one grain is still a heap is difficult. 28 The same problem, Parfit argues, occurs with personal identity, where it is impossible in some borderline cases to determine whether a particular person is still the same, or has already become another person. (On both ends of the spectrum he assumes that the stability or alteration of identity is clear, but in the middle we can only assess the degree of psychological connectedness.) Therefore, the question of whether an identity is mine or someone else's, cannot always be answered. He calls this question an "empty question"29 and claims that personal identity is not what matters. What really matters is the degree of psychological connectedness. d) Changing Identity and Advance Directives Rebecca Dresser has applied Parfit's view on personal identity to the problem of advance directives.30 She questions whether the person who executed the advance 28 B. Williams (1986) p. 130. 29 D. Parfit (1984) p. 233.

Advance Directives and Surrogate Decision Making

389

directive is still the same person as the now incompetent patient. It could be that the disease has altered the identity (and the desires and values) in a Parfitian sense, so that now a directive would be applied to a different person.31 This, however, would considerably limit the moral authority of advance directives. Future-oriented directives would be valuable indicators of patients' preferences only if strong psychological connectedness holds between the former competent and now incompetent patient. Especially in the case of a conflict between contemporaneous needs of the incompetent with the advance directive of the former competent, Dresser would favor a decision based on the patient's current needs. She refers to Tom Regan's concept of "preference autonomy". In this view, all individuals with preferences and the capacity to initiate efforts to satisfy them possess a minimum level of autonomy that ought to be considered in decision making.32 Dresser does not complete!^ reject advance directives, but remains sceptical about future-oriented decision making, as the "hierarchy of interests" is difficult to assess. She leaves it open as to whether treatment decisions should be made purely on the basis of an assessment of contemporaneous interests, an approach that includes the potential problems of mistake and abuse, or whether one should rely on past expressed preferences "on grounds that a former self's wishes are more likely to represent the present self's interests, than the decision of a surrogate."33 This latter reason she gives, however, seems to be a pragmatic concession that still favors current needs over previously expressed preferences. Allan Buchanan and Dan Brock, both former Staff-Philosophers for the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in Washington D.C. and therefore proponents of advance directives and surrogate decision making, respond to questions about advance directives that Parfit's and Dresser's views have raised.34 They seem to follow Parfit's basic assumption of a reductionist view and admit that personal identity depends on a set of necessary and sufficient conditions, psychological continuity being at least one of them.35 Furthermore, they follow Parfit by admitting that psy30 Dresser contrasts the "Simple view" as an all-or-nothing issue to Parfit's "Complex view" of personal identity, citing Parfit's article "Later selves and moral principles" published in 1973. Later, in his 1984 book "Reasons and Persons" the "Complex view" is redefined as the "Reductionist view", whereas the "Simple view" is assumed to be "Non-Reductionist". D. Parfit (1984). 31 R. S. Dresser (1989). 32 T. Regan (1983) p. 85: as cited by R. S. Dresser (1989): Any creature with things it "prefers having, or ... prefers not having" has preference interests. 33 R.S. Dresser ( 1989) p. 163. 34 A. E. Buchanan/D. W. Brock (1989). 35 A. E. Buchanan/D . W. Brock (1989) p. 155; Personhood in their view is thus confined to a group of individuals who meet certain requirements like mental abilities, self-consciousness, reasoning, and the ability to engage in purposive sequences of actions, p. 160.

390

Johannes Gobertus Meran

chological continuity is "inherently vague, since the temporal continuity provided by mental states admits of degrees". However, they would not agree with Parfit's conclusion that, since personal identity is a matter of degrees of psychological connectedness, it cannot (always) be determinate. Buchanan and Brock escape this conclusion by simply narrowing the scope in which personhood is not determinate, until almost no cases are left. At one end of the psychological spectrum the argument is the following: a patient with complete neurological destruction, as in a persistent vegetative state or deep irreversible coma, clearly has no psychological continuity and thus no personal identity (Tab. lc). Particularly problematic cases are those that involve advanced Alzheimer patients who have totally lost their memories, have impaired cognitive abilities and changed characters, but still are capable of experiencing pain and physical pleasure. Rebecca Dresser had such patients in mind when she argued that the moral authority of advance directives executed by one person, should be questioned if they determine what happens to a by then different person. Buchanan and Brock call this the "slavery argument", but emphasise that it is applicable and valid only if the resulting individual qualifies as a person, i.e. meets the necessary conditions of personhood, because, if there is no person left, the argument of enslaving is less strong. Whereas on Parfit's view personal identity is a matter of degree, Buchanan and Brock argue pragmatically for a threshold policy. They compare this policy with the threshold for competence that is conceived of as an all-or-nothing matter, despite the fact that decision-making capacities are a matter of degree.36 However, setting a threshold is a matter of choice 3 7 , a fact they are not only willing to admit, but also to use. Based on this threshold-model, the way to handle difficult cases is, for them, to choose a rather low degree of psychological continuity necessary to preserve personal identity. If such a low threshold is utilized, "then there will be very few, if any real-world cases in which we would be justified in concluding that neurological damage has destroyed one person, but left a living, different person." 3 8 This low threshold will lead to a disruption of personal identity almost exclusively in those cases where "neurological damage is so catastrophic that the living being who remains is not a person at all and hence, a fortiori, not a different person."39 Characteristically, they compare the moral status of the remaining human being, who can still experience pain and pleasure (e.g. the Alzheimer patient) to 36 A. E. Buchanan/D. W. Brock (1989) p. 158. 37 I would emphasise that this choice is a normative and prescriptive one, relying on subjective judgment, seeA. E. Buchanan/D. W. Brock (1989) p. 158. 38 A. E. Buchanan/D . W. Brock (1989) p. 159. 39 A. E. Buchanan/D . W. Brock (1989) p. 159.

Advance Directives and Surrogate Decision Making

391

that of animals, who "are uncontroversially not persons" but in whom it is widely held to be wrong to cause gratuitous pain. 40 The following question remains: Does Buchanan's and Brock's strategy allow for the continued moral authority of advance directives? What they claim is in contrast to Dresser in that 1) the preferences or needs of the surviving individual significantly lose their moral weight as soon as his or her mental abilities fall short of the standard required for a person; 2) the interests implemented by the advance directive of the former competent person should count more than "whatever obligations we have" to the current needs of the surviving individual.41 Their suggestions establish a hierarchy of moral weight : a) preference expressed by a competent person (Ac) b) preference expressed by the same, but incompetent person (Ai) c) preference expressed by the successor person (Bi) d) preference expressed by the surviving non-person (bi)

They justify this claim by arguing that some interests are "surviving" and, without explicitly mentioning it, imply that the surviving interests are more important than those of the surviving human being (bi). 42 Examples of interests that are assumed to survive not only a state of incompetence and the loss of personhood (in their sense) but even death are for instance the interests to be remembered as a certain person or to be buried in a specified way. "If interests can survive death, then a fortiori they can survive permanent unconsciousness and loss of personal identity."43 Buchanan and Brock argue that we have to consider both sets of interests: those surviving from former competent states and those existing in the present disabled condition. This inclusion of both sets, however, makes sense only if we believe that the competent and the incompetent are the same person. A competent

* A incompetent

On the assumption that, due to neurological damage, the person is no longer the same, the situation is much more complicated. Tab: A —• Β ehaubaren Diskussion um dieses Thema sind vor allem zwei Aspekte für die Frage, ob die empirische Psychologie einen Beitrag zum Problem der Willensfreiheit leisten kann, von besonderer Bedeutung. Dies ist zum einen die Frage, ob die Behauptung: ,,Er hätte anders handeln kön­ nen" überhaupt im Widerspruch zu einer kausal-nomologischen Erklärung des fraglichen Verhaltens steht. Ware dies nicht der Fall, gäbe es eigentlich gar kein Problem der Willensfreiheit mehr, denn dann spräche ja gar nichts mehr gegen

un­

sere vertraute Intuition, wir würden entscheiden, ob und welche unserer Handlun­ gen wir ausführen. Und die Frage nach einem Beitrag der empirischen Psychologie wird erst dann zu einem brisanten Diskussionspunkt, wenn ihr Beitrag einer theo­ retischen Modeliierung der Willensfreiheit sozusagen das Wasser abgraben würde. Wenn aber der Widerspruch zwischen Freiheit und Determinismus aufrechterhal­ ten werden kann, dann stellt sich zweitens die Frage, was überhaupt außer unserer subjektiven Intuition für die Freiheit spricht, oder anders gesagt, ob wir sie als überholte lllusion (deren Funktionalität ja durchaus ernst zu nehmen sein könnte) nicht wenigstens im Kreise Eingeweihter über Bord gehen lassen können. Der erste Punkt betrifft die sogenannte Kompatibilismus-Debatte. 24 Auf den er­ sten Blick scheint das Problem geradezu absurd. Jeder, der anfangt, über Willens­ freiheit nachzudenken, tut dies doch auch gerade deshalb, weil der unglaubliche Erfolg der empirischen Wissenschaften - nicht zuletzt der vom Menschen - einem Phänomen wie der Willensfreiheit keine Lebensluft mehr zu lassen scheint. Wenn alles durch Naturgesetze determiniert ist, wie sollte es dann noch freie Entschei­ dungen und freie Handlungen geben können? Man muß eine Position etwa im Sinne Kants, die sowohl der Freiheit als auch dem Prinzip der Kausalität ihr jewei­ liges Recht zugesteht, nicht unbedingt überzeugend finden, um

zu

sehen, daß die

wissenschaftliche Erklärbarkeil menschlichen Verhaltens mit seiner Freiheit nur unter bestimmten Voraussetzungen im Widerspruch steht. Insbesondere die De­ batte dieses Jahrhunderts hat aber an diesen Voraussetzungen erheblich gerüttelt. Im Kern lassen sich dabei drei Argumentationslinien für die Vereinbarkeil unter­

scheiden:

24

Ich folge hie r über weite Strecken der klaren und fairen

Argu mentation

lnwagen, 1983; vgl. zu verschiedenen Punkten auch Patzig, 1990.

von Peter

van

Schiedsrichter der Schuld?

627

(1) Das Bedingungssatz-Analyse-Argument. Auf George Edward Moore25 geht

die erste Argumentationslinie zurück, und sie funktioniert wie folgt. Was beißt ei­

gentlich "er hätte anders handeln können"? Heißt es nicht einfach: "er hätte anders gehandelt, wenn er anders entschieden hätte"? (Natürlich begründet Moore diese Äquivalenz etwas ausführlicher, aber tatsächlich nur etwas.) Diese Formulierung aber ist natürlich mit dem Determinismus - und a fortiori mit jeder schwächeren Erklärungsversion - nicht weniger vereinbar als die Behauptung, daß dieses Stück

Zucker sich im Kaffee gelöst hätte, wenn ich es hineingelegt hätte.

Unglücklicherweise jedoch hat dieses Argument, das kürzlich in der Zeitschrift

für Philosophische Forschung wieder aufgegriffen wurde,26 gleich eine ganze Rei­

he von Schwierigkeiten. Der Punkt, an dem es im Kern scheitert, kann mit Chis­

holm ganz kurz dargelegt werden?7 Die Formulierungen (i) "er hätte anders han­

deln können" und (ü) "er hätte anders gehandelt, wenn er sich anders entschieden

hätte" sind schlicht nicht äquivalent, weil es Fälle gibt, in denen zwar (ü) wahr ist,

aber nicht (i). Und zwar sind dies eben die Fälle, in denen der Handelnde sich nicht anders hätte entscheiden können. Wenn ich zum Beispiel aufgrund eines hypnoti­ schen Befehls jetzt das Zimmer verlasse, dann ist es zwar wahr, daß ich anders ge­

handelt hätte, wenn ich anders entschieden hätte, aber nicht, daß ich anders hätte handeln können, weil ich - eben wegen der Hypnose - nicht anders hätte entschei­ den können.

(2) Das Zufalls-Argument. Das zweite Argument weist zunächst darauf hin, daß eine freie Handlung, wenn die Unvereinbarkeitsthese richtig wäre, das Resultat ei­ ner undeterminierten Entscheidung sein muß. Eine freie Handlung wäre dann aber, so folgert das Argument, einfach Zufall, und der vermeintliche Handelnde wäre also auch nicht für sie verantwortlich zu machen. Schuld für einen Zufall gibt es (rechtmäßigerweise) nicht. Eine zufällige Handlung wäre gar nicht seine Handlung gewesen, und wahrscheinlich überhaupt keine. Also muß die Determiniertheil der Handlung mit ihrer Freiheit vereinbar sein, wenn es überhaupt freie Handlungen gibt. Dieses Argument trifft zum Teil einen richtigen Punkt. Es zeigt, daß Freiheit auch mit Indeterminismus unvereinbar ist, wenn Indeterminismus einfach Zufall 28 ist. In der Tat ist ,,Indeterminismus nicht genug", wie Popper es formuliert bat. Natürlich ist eine freie Handlung verursacht, verursacht nämlich (u. a.) durch die

freie Entscheidung des Handelnden29. Aber "verursacht" beißt nicht "determi­

niert", und insbesondere ist über die Art dieser Verursachung noch nichts gesagt. Freiheit ist nach der berühmten Definition von Kant eben das "Vermögen ... , eine

25

Moore, 1912.

26

Rheinwald, 1990,

21

Chisholm. 1977.

zur

Kritik Greve, 1994b.

28 Popper. 1982. 29

Vgl. dazu auch Patzig, 1990, S. 153.

628

Werner Greve

30 Reihe von successiven Dingen oder Zuständen von selbst anzufangen". Von Chisholm stammt ganz in diesem Sinne der Vorschlag, von der "transeunten" Ver­ ursachung (wie etwa das Anstoßen eines Billardballes durch einen anderen) eine ,,immanente" Verursachung zu unterscheiden, nämlich die Verursachung einer Handlung, die ihrerseits nicht verursacht wurde.31 Der Einwand, daß diese Form einer ,,immanenten" Verursachung kaum verständlich zu machen sei, ist deshalb nicht stichhaltig, weil wir den Begriff der - transennten - Ursache möglicherweise überhaupt nur durch unser eigenes immanent-kausales Wrrken als Handelnde erler­ nen und begreifen können. Eine so verstandene Freiheit wäre also weder mit einem Determinismus noch mit Zufall vereinbar, sondern etwas Drittes. Diese Antwort macht die Sache leider nicht viel klarer, aber sie zeigt, daß die Unterstellung einer metaphysischen Willensfreiheit jedenfalls nicht absurd oder selbstwidersprüchlich ist. Das Problem, wie man sich eine ,,immanente" Verursa­ chung nun eigentlich vorzustellen habe, ist vermutlich ungefähr so groß wie die Bitte nach einer Veranschaulichung des ,,Dinges an sich", aber Schwierigkeiten sind keine Einwände. Daß es derartiges nicht gibt oder daß eine solche immanente Verursachung mit dem Determinismus vereinbar ist, muß jedenfalls eigens gezeigt werden. (3) Das paradigmatische-Fälle-Argument. Aber wir lernen doch einen abstrak­ ten Begriff wie ,,Freiheit", so lautet das dritte Argument, an Beispielen, an paradig­ matischen Fällen. Mindestens für sie ist er also zutreffend. Nun ist aber schwer vorstellbar, daß es ausgerechnet für diese Fälle keine naturgesetzliche oder wissen­ schaftliche Erklärung geben können sollte. Also ist die Möglichkeit dazu mit Frei­ heit vereinbar.

Dieses Argument macht jedoch zwei Voraussetzungen, die man beide - und un­ abhängig voneinander - bezweifeln kann . Zunächst können wir uns offenbar über den Gebrauch eines Begriffs wie ,,Determinismus" hinreichend einig sein, ohne dabei darin übereinstimmen zu müssen, ob die Welt determiniert ist oder nicht. Und offenbar gibt es Begriffe, die wir einerseits verstehen, d. h. mit denen und über die wir uns verständigen können, für die es aber andererseits zweifellos in unserem Leben keinen paradigmatischen Fall gegeben hat, beispielsweise ,,Ewigkeit". An­ ders gesagt scheint das paradigmatische-Fälle-Argument den Unterschied zwisehen der Intension eines Begriffe s und seiner Extension nicht genügend zu beach­ ten. Mit van Inwagen zu sprechen: ,,Es ist möglich, Propositionen zu konstruieren, die mit allen unseren Beobachtungen vereinbar sind, aber nicht mit der These, wir hätten einen freien Willen."32 Nun kann man gegen diese Antwort noch einiges einwenden. Laßt uns doch se­ hen, so könnte man sagen, ob ein Freiheitsbegriff, der auch unter der Bedingung 30

KrV, B 476.

31

Chisholm, 1977.

32 Van /nwagen, 1983, S. 111.

·

Schiedsrichter der Schuld?

629

der Wahrheit einer Form des Materialismus noch anwendbar ist, nicht für alle ernsthaften Zwecke ausreicht, zu denen wir den Freiheitsbegriff tatsächlich brau­ 33 Dagegen zu argumentieren hieße zu zeigen, daß wir Freiheit in einem um­

chen.

fassenderen Sinne, als derartige Positionen es noch zulassen, tatsächlich brauchen, beispielsweise für unseren Begriff von moralischer Verantwortlichkeit und perso­ naler Zurechnung. Ein solcher Nachweis wird, auch wenn man vielleicht nicht allzu pessimistisch 34 Jedoch läßt sich auch die zweite Vorausset­

sein muß, jedenfalls nicht leicht sein.

zung des paradigmatische-Fälle-Argumentes angreifen, die unausgesprochene An­ nahme nämlich, daß eine naturgesetzliche oder wissenschaftliche Erklärung jedes Ereignisses wegen der kausalen Geschlossenheit der physischen Welt grundsätz­ lich möglich sein müsse. Nun spricht für die kausale Geschlossenheit der Welt si­ cher manches, z. B. die Überlegung, daß sie in bewährten, akzeptierten und prakti­ kablen Theorien der Naturwissenschaft anscheinend implizit enthalten ist (etwa im ,,Energieerhaltungssatz", auf den materialistisch gesonnene Autoren in diesem Zu­ sammenhang dann gerne verweisen35), oder auch die Intuition, daß sie als metho­ disches bzw. heuristisches Prinzip dem Unternehmen ,,Naturwissenschaft" über­ haupt zugrunde liegt. Jedoch ist es einfach zirkulär, eine "absolute" Willensfreiheit mit Hinweis auf diesen Punkt zu verwerfen, denn aus ihrer Annahme folgt ja ge­ rade, daß der wissenschaftlichen Erforschbarkeil der Welt Grenzen gesetzt sind. In­ sofern ist die Tatsache der Willensfreiheit, wenn sie denn eine ist, sozusagen mit Recht ein Hindernis für die Naturwissenschaft. Das aber ist zunächst noch kein Ar­ gument gegen ihre Existenz. Daraus folgt aber umgekehrt auch, daß eine naturgesetzliche Erklärung mensch­ licher Handlungen, wenn sie denn möglich ist, tatsächlich der Freiheit keinen Platz mehr läßt, jedenfalls nicht der Freiheit, die wir meinen, wenn wir von unseren Ent­ scheidungen sprechen, von personaler Zurechenbarkeit, von Verantwortung und eben auch von Schuld. Nun klingt dies ein wenig nach der Position, daß nicht sein könne, was nicht sein dürfe. Schade, könnte man einwenden, aber: "amicus Plato, magis amica veritas". Tatsächlich jedoch ist sogar etwas richtiges daran, daß es doch wohl nicht wahr sein darf, daß es keine Freiheit gibt. Immerhin gibt es die Praxis der Zuschreibung von Schuld und Verantwortung, und es darf bezweifelt werden, ob wir uns auch jenseits juristischer Konventionen im alltäglichen Handeln und Reagieren ernstlich und

zur

Gänze von ihr freimachen könnten.

Hinter diesem Problem aber verbirgt sich die interessante, in der Diskussion aber nur selten aufgeworfene Frage, wer eigentlich angesichts der gelegentlich so

33

Dies ist etwa die Linie, die Dennett, 1984, verfolgt.

34

Im letzten Kapitel seines Buches führt

van

Inwagen, 1983, Argumente in dieser Rich­

tung. 33

Vgl. in diesem Sinne

z.

B. Bunge, 1984, oder Vollmer, 1993.

630

WemerGreve

starken subjektiven Erfahrung und so naheliegenden Unterstellung von Willens­ und Entscheidungsfreiheit die Beweislast in dieser Debatte trägt. Vermutlich könnte man die Position ziemlich gut und lange verteidigen, daß die Naturwissen­ schaftler die Beweislast für die universelle Reichweite ihres Ansatzes zu tragen hätten, und daß sie daran ziemlich schwer zu tragen hätten. Nun sind Psychologen mittlerweile lange genug zum habituellen Selbstzweifel sozialisiert worden. Fragen wir uns also, ob denn außer unserer Hoffnung oder vielleicht auch nur Denkgewohnheit, daß es sie gebe, irgendetwas für die Realität der Willensfreiheit spricht. Nun, immerhin dies, daß die Alternative noch unplau­ sihier ist. Es ist nämlich aus einer materialistischen Perspektive grundsätzlich schwierig, für den Materialismus überhaupt zu argumentieren, denn Sprechen und insbesondere Argumentieren ist absichtliches Handeln. Dieses Argument der "Selbst-Stultifizierung" 36 zeigt zwar nicht, daß der Materialismus als Theorie in­ kohärent oder selbstwidersprüchlich ist, aber er demonstriert die Inkohärenz der

Behauptung jeder Position, die die Möglichkeit und Berechtigung des ,,mentalen Idioms", d. h. von Begriffen wie ,,Absicht", "Wunsch" oder ,,Person" bezweifelte. Daraus ergibt sich mindestens eine gewaltige Herausforderung für jede Form des Materialismus. Das Programm des Materialismus (in welcher Form auch immer) kann überhaupt nur Erfolg haben, wenn es ihm gelingt, unsere Redeweise von uns als Personen, von unseren Absichten, Meinungen, Entscheidungen und Handlun­ gen nicht zu bedeutungslosen Lautäußerungen werden zu lassen. Denn in diesem Falle würden wir allen seinen Argumenten keinen Glauben schenken können, weil sie erstens unsicherer wären als unser Wissen von uns als Person, und weil sie zweitens dann ja ihrerseits nur bedeutungslose Lautäußerungen wären. Philoso­ phen, die nun fordern, man müsse dann eben den ganzen intentionalen Begriffsap­ parat revidieren, haben daher, wie Norman Maleolm ironisch bemerkt, "den Ernst 37 der Lage nicht ganz begriffen" • Wir können nicht anders als unter der Vorausset­ zung der Freiheit denken und handeln; wir können uns nicht gegen sie entscheiden, weil "entscheiden" bereits Freiheit voraussetzt. In diesem Sinne sind wir tatsäch­ lich ,,zur Freiheit verurteilt", d. h. dazu, vorauszusetzen, daß wir frei sind. Was immer die Psychologie (und ihre Verbündeten) in Zukunft noch herausfin­ den mag: Es wird entweder menschliche Handlungen nicht betreffen (sofern es nicht überhaupt begrifflich inkohärent ist) oder jedenfalls unsere Voraussetzung, daß wir- manchmal- selbst handeln und nicht von den Naturgesetzen behandelt werden, nicht wirklich erschüttern können. Mag sein, daß der Materialismus oder der Determinimus wahr ist; wir werden es nicht nur niemals herausfinden, sondern auch niemals glauben können, weil dies zugleich hieße, daß es uns nicht eigentlich gebe, und kein Argument, kein Befund, keine Einsicht wird je gewisser sein als das Bewußtsein, daß es mich im vollen Sinne des Wortes gibt.

36 So hat es Lewis W. Beck, 1976, genannt. 37

Malcolm, 1977, S. 361.

Schiedsrichter der Schuld?

631

V. Was bleibt?

Was bleibt der Psychologie, und was kann sie insbesondere zum Thema „Fr heit" beitragen? Nicht jeder Psychologe (und gewiß auch nicht jeder Philosoph) wird diesem Fazit zustimmen wollen. Gerade innerhalb der Psychologie ist die Debatte, ob eine empirische Antwort auf die Frage nach der Willensfreiheit möglich ist, aktuell wieder in Bewegung gekommen.38 Kühl hat kürzlich erneut für die Chancen eines empirischen Forschungsprogramms über den (freien) Willen plädiert.39 Ein solches Programm aber kann nur dann überzeugen, wenn es auf die genannten Bedenken eine Antwort gibt. Es mag sein, daß ihm das gelingen kann. Was aber bleibt der Psychologie, wenn es nicht gelänge, und was bleibt ihr insbesondere in bezug auf das Thema „Freiheit" und damit auf das Thema Schuld und Schuldfahigkeit? Zunächst bleibt, wie schon eingangs gesagt, der unabsehbar weite Bereich der subjektiv empfundenen Freiheit. Unter welchen Umständen fühlen wir uns mehr oder weniger frei? Welche subjektiven oder objektiven Restriktionen nehmen wir wahr, welche ernst? Wieviel und wie wenig „Wahl" können wir aushalten? Ist die Uneindeutigkeit der Situation des Buridanischen Esels Freiheit? Fühlen wir uns manchmal auch frei, wenn wir tun, was wir für unsere Pflicht halten? Welche Konsequenzen hat es für unser Erleben, auch unser Verhalten, wenn wir uns in unserer Freiheit eingeengt fühlen? Hierzu gibt es empirische Forschung, aber es kann noch sehr viel mehr geben. Vielleicht wiegt es vor diesem Hintergrund dann gar nicht mehr so schwer, daß die empirische Psychologie, wenn diese Untersuchung nicht fehlgegangen ist, zur Erklärung freier menschlicher Handlungen und also auch zur Erklärung des Phänomens Willensfreiheit selbst aus prinzipiellen Gründen nichts beizutragen hat, jedenfalls nichts negatives. Eine gravierende Konsequenz freilich hätte es doch, wenn dem so sein sollte. Die Entscheidung über die grundsätzliche Schuldfahigkeit wäre, aus dieser Perspektive jedenfalls, keine psychologische Frage, und erst recht keine medizinischpsychiatrische. Sie wäre überhaupt keine empirisch-wissenschaftliche Frage. Damit muß für die Frage, ob wir - als soziale Gemeinschaft - daraus juristische Konsequenzen ziehen sollten, noch nichts entschieden sein. Wir können bei der gegenwärtigen pragmatischen „Lösung" bleiben, und auf das Augenmaß der forensischen Gutachter vertrauen, hier sinnvolle Grenzen zu ziehen. Eine solche Haltung wird insbesondere solchen Positionen sympathisch sein, die in „Strafe" vor allem eine generalpräventive und individualpräventive und -korrektive Sozialtechnik sehen, die einfach bei einer bestimmten Klientel kaum mehr Wirkung zeigen kann. Vertreter solcher Positionen plädieren dafür, ,jede Zufügung von Leid zu vermeiden, die nur gerechtfertigt werden könnte, wenn es solches freies Handeln

38 Vgl. ζ. B. von Cranach, 1991; von Cranach/Foppa, 39 Kühl, 1996.

1995; Greve, 1992.

632

Werner Greve

gibt". 40 Der Sprachgebrauch der „Schuldunfähigkeit" ist dann aber, genau genommen, unangemessen und irreführend. Gemeint ist der Sache nach offenbar eher, daß sich die Beschuldigung nicht „lohnt", daß sie im intendierten Sinne keinen Zweck hat. Die Gefahr dabei liegt nicht zuletzt darin, daß diese „Grenzen der Unverantwortlichkeit" allzu leicht zu weit hinausgeschoben werden. Vor allem die schwerlich klar definierbare Kategorie der „Abartigkeiten"41 öffnet einer Psychologisierung devianten oder delinquenten Verhaltens (das dann - eben deshalb kein Handeln mehr gewesen sein kann) vielleicht mehr als nur eine Hintertür. Ubiquitäre journalistische Schilderungen besonders schwerer Lebensumstände eines Täters oder einer Täterin oder besonders auffälliger Begleitumstände einer Tat zeigen gerade dann, wenn sie sehr einfühlsam und human gelingen, wohin die Entwicklung hier gehen könnte. Diese Überlegung führt damit über das Thema „Willensfreiheit" hinaus und zu der Frage, was die Konsequenz einer Beschuldigung zu sein hat. Anders gefragt: Hat Strafe überhaupt noch einen verteidigbaren Sinn, wenn wir nicht an eine Freiheit menschlicher Handlungen mehr glauben können? Oder sollte eine staatliche Reaktion gar in jedem Falle nur den Zielen der Vorbeugung (und, eventuell, der Befriedigung bestimmter Bedürfnisse, etwa der Opfer) dienen (dürfen)? Strafe in einem engeren Verständnis setzt „Verdienst" voraus; sie ist der „Preis", der für die Tat zu entrichten ist, auch wenn kein Opfer ihn fordert oder eine Wiederholung (oder Nachahmung) nicht zu befürchten ist. Die Voraussetzung dafür aber ist mindestens die Schuld des Beschuldigten, und dies meint nicht nur, daß er die ihm zur Last gelegte Handlung auch tatsächlich begangen hat, sondern auch, daß sie seine Handlung war, daß er wußte, was er tat, daß er sich absichtlich so verhalten hat und dies auch hätte lassen können, kurz: daß er sich wirklich schuldig gemacht hat. Man muß, wenn man an die grundsätzliche Möglichkeit einer solchen Schuld glaubt, nicht unbedingt strafen, aber man kann strafen nur dann, wenn man davon ausgeht, daß es diese Schuld gibt. Schiedsrichter dieser Schuld aber kann die Psychologie niemals werden. Summary Guilt presupposes as a necessary condition the possibility of doing otherwise, i.e. free will. The article investigates whether empirical psychology can answer, or at least contribute to answering, the question of whether there is a human capability of free will. The discussion is divided into four sections. It begins with an attempt to distinguish the object of investigation from other issues and in particular to more precisely explain the term "free action". The next section examines to what extent human action can be understood in terms of empirical explanation. 40 Patzig, 1990, S. 161; aus psychologischer Perspektive argumentiert etwa Montada, 1988,1989, mit ähnlicher Stoßrichtung. Vgl. zur Diskussion auch Wegener, 1992, S. 100 ff.

Schiedsrichter der Schuld?

633

The problern that arises in this context is determining whether the relationship be­ tween intentions (decisions) and action is an ernpirical or rather a purely concep­ tual, logical one. If the Jatter were the case, the question whether free will is to be conceived of as a necessary cornponent of action explanation would be useless. It is argued, however, that even if there is a logical connection between actions and intentions to act, there are still several aspects of human action that do require ern­ pirical explanation. One of these - the explanation of the intention itself - is claimed to be the core of the free-will problern. The third section of the article ar­ gues that the free-will problern is a serious problern for ernpirical psychology since an ernpirical explanation referring to general natural laws excludes free will

as

a

necessary condition of the action under concem. However, in a fourth step the the­ sis is defended that there is no conceivable alternative to the supposition of the hu­ man capability of acting and deciding freely. The final section deals with the ques­ tion of what these results imply for psychology

as

cular, of what is left for psychology with respect to

empirical science, and, in parti­ an

investigation of "freedom".

Literatur

Anscombe, G. E. M., Intention, Oxford: Basil Blackwell (1957), (dt. 1986, übersetzt, heraus­ gegeben und eingeführt von J. M. Connolly /T. Keutner, Freiburg: Alber). Beclc, I.. W., Akteur und Betrachter, Freiburg: Alber (1976). Bieri, P., .,Generelle Einführung", in: P. Bieri (Hrsg.), Analytische Philosophie des Geistes, Königstein: Hain (1981) S. 1-28. Brandtstädter; J., ,,Entwicklung im Lebensablauf. Ansätze und Probleme der Lebensspannen­ Entwicklungspsychologie", in: K.-U. Meyer (Hrsg.), Lebensläufe und sozialer Wandel. Kölner Zeitschrift für Soziologie und Sozialpsychologie 31 (Sonderheft) (1990) 35 1 373 . -

- .,Strukturelle Implikationen und empirische Hypothesen in handlungs-, emotions- und mo­ ralpsychologischen Forschungsprogramrnen: Wechselbeziehungen und Verwechslungen", in: L. Eckensberger/U. Gähde (Hrsg.), Ethische Norm und empirische Hypothese, Frank­ furt a.M.: Suhrkamp (1993) S. 244-267.

Bunge, M., Das Leib-Seele Problem, Mohr: Tübingen (1984). Burkhardt, B., ,,Der Wille als konstruktives Prinzip in der Strafrechtsdogmatik", in: H . Heck­ hausen/P. M. Gollwitzer/F. E. Weinen (Hrsg.), Jenseits des Rubikon: Der Wille in den Humanwissenschaften, Berlin: Springer (1987) S. 319-339. Chisholm, R., ,,Freiheit und Handeln", in: G. Meggle (Hrsg.), Handlungsbeschreibungen (Analytische Handlungstheorie, Bd. 1), Frankfurt a.M.: Suhrkamp (1966/1977) S. 354-

387.

Dennett, D. C., Elbow Room, Oxford: Clarendon (1984). - The Intentional Stance, Cambridge, Mass.: MIT Press (1987).

Drewniak, R., Strafrichterinnen als Hoffnungsträgerinnen? Eine vergleichende Analyse straf­ rechtlicher Orientierungen von Richterinnen und Richtern, Stuttgart: Enke (1994).

634

WemerGreve

Frankfurt, H., "Willensfreiheit und der Begriff der Person", in: P. Bieri (Hrsg.), Analytische Philosophie des Geistes, Köni gstein: Hain ( 1971/1981) S. 287-302. Greve, W., ,,Möglichkeiten und Grenzen einer psychologischen Theorie der Freiheit. Kriti­ sche Anmerkungen zu von Cran ach (1991 ) ", Zeitschrift für Sozialpsychologie 23 (1992)

277-286. -

H andlungskläru ng, Bem: Hu ber (1994a).

- ,,Freiheit und Determinismus. Zur Kritik an der Argumentation von Rheinwald", Zeitschrift für philosophische Forsc h ung 48 - ,,Die Grenzen empirischer

(1994b) 117-127.

Wissenschaft. Philosophische Schwierigkeiten einer psycholo­ M. von Cranach I K. Foppa (Hrsg.), Freiheit des

gischen Theorie der Willensfreiheit", in:

Entscheidens und Handelns. Ein Problem der nomologischen Psychologie, Heidelberg: Asanger

(1995), (im Druck).

Hermum.n, T., "Über begriffliche Schwächen kognitivistischer Kognitionstheorien: Begriffs­ " inflation und Akteur- System-Kontami nation , Sprache und Kognition

1 (1982) 3-14.

Kant, I., Kritik der reinen Vernunft (Unveränderter photomechanischer Abdruck der von der

preußischen Akademie der Wissenschaften 1902 begonnenen Ausgabe von Kants gesam­ melten Schriften, Bd. ill), Berlin: de Gruyter (1968/1787[B) /1781 [A]). Krampen,

G.,

Handlungstheoretische

Persöolichkeitspsychologie,

Göttingen:

Hogrefe

(1987). Kuhl, J., ,,Motivation und Handlungskontrolle: Ohne guten Willen geht es nicht", in: H.

Heckhausen/P. M. Gollwitzer/F. E. Weinert (Hrsg.), Jenseits des Rubikon: Der Wille in den Humanwissenschaften, Berlin: Springer (1987) S. 101-120. - "Wille und Freiheitserleben: Formen der Selbstste uerun g" , in:

J. Kuhl/H. Heckhausen (Enzyklopädie der Psychologie, Serie ,,Moti­ vation und Emotion", Bd. 4), Göttingen: Hogrefe (1996) S. 665-765.

(Hrsg.), Motivation, Volition und H andlung

Malcolm, N., ,,Ist der Mechanismus vorstellbar?", in: A. Beckennano (Hrsg.), Handlungser­ klärungen (Analytische Handlungstheorie, Bd.

2), Frankfurt a.M.: Suhrkamp (1968/1977)

s. 332-363.

Montada, L, Vore in genomro enh eite n im Urteilen über Sch uld und Verantwortlichkeit", in: L. Montada/K.. Reusser/G. Steiner (Hrsg.), Kognition und Handeln, Stuttgart: Klett-Cotta (1983) s. 165-168. "

- Schuld und Sühne in strafrec htli cher und psychologischer Beurteilung. Berichte aus der

Arbeitsgruppe "Verantwortung, Gerechtigkeit, Moral", 45, Trier: Universität Trier (1988). - "Strafzwecküberlegungen aus psychologischer Sicht", in: C. Pfeiffer/M. Oswald (Hrsg.), Strafzumessung. Empiri sche Forschung und Strafrechtsdogmatik im Dialog, Stuttgart: En­ ke

(1989) S. 137-141.

Moore, G. E., Ethi cs (1912; 21966), (dt.: Übersetzung von A. Pieper, München: Beck 1975). Norrie, A., ,,Freewill, detenninism and criminal justice", Legal Studies 3 (1983) 60-73. Oswald. M. E., Psychologie des richterlichen Strafens, Stuttgart: Enke (1994).

Schiedsrichter der Schuld?

635

Patzig, G., „Philosophische Bemerkungen zu: Willensfreiheit, Verantwortung, Schuld", in: K. Thomas (Hrsg.), Schuld: Zusammenhänge und Hintergründe, Frankfurt a.M.: Lang (1990) S. 147-164. Popper, K. R., The Open Universe. An Argument for Indeterminism, Totowa, New Yersey: Rowman & Littlefield (1982). Rheinwald, R., „Zur Frage der Vereinbarkeit von Freiheit und Determinismus", Zeitschrift für Philosophische Forschung 44 (1990) 194-219. van Inwagen, Ρ, An Essay on Free Will, Oxford: Clarendon (1983). Vollmer,

G , Wissenschaftstheorie im Einsatz, Stuttgart: Hirzel (1993).

von Crcmach, M., „Handlungsfreiheit und Determination als Prozeß und Erlebnis", Zeitschrift für Sozialpsychologie 22 (1991) 4-21. von Cranach, hi. /Foppa, K. (Hrsg.), Freiheit des Entscheiden und Handelns. Ein Problem der nomologischen Psychologie, Heidelberg: Asanger (1995) (im Druck). Wegener, Η., Einführung in die forensische Psychologie, Darmstadt: Wissenschaftliche Buchgesellschaft (19922). Winch, P., Die Idee der Sozialwissenschaft und ihr Verhältnis zur Philosophie, Frankfurt a.M.: Suhrkamp (1966; orig. 1958).

Recension

Gerhard Werle/Thomas V/andres, Auschwitz vor Gericht. Völkermord und bundesdeutsche Strafjustiz. Mit einer Dokumentation des Auschwitzurteils. - München: Verlag C. H. Beck, 1995, 241 S. mit 3 Plänen. ,3s ist Teil der bundesdeutschen Geschichte, daß man über lange Jahre hinweg kein Interesse daran hatte, die NS-Verbrechen zu verfolgen." (S. 27). Mit Recht zeichnen die Autoren auf den ersten Seiten des hier anzuzeigenden Buches zunächst die Linie,unterlassener Strafverfolgung" (S. 27) von NS-Taten in den ersten Jahren der Bundesrepublik Deutschland nach (S. 16 ff.). Symptomatisch ist die Bitte eines Bundestagsabgeordneten der damaligen Regierungskoalition im Bundestag (1. Wahlperiode), „das Wort »Kriegsverbrecher 4 allgemein zu vermeiden", da es sich bei diesem Personenkreis nicht um Verbrecher, sondern im wesentlichen um unschuldig Verurteilte handele (vgl. S. 21 mit Fußnote 11). Die Autoren stellen die lange Reihe von Amnestiediskussion, Amnestiegesetzen und faktischer Amnestie durch den (zum Teil vom Gesetzgeber „übersehenen") Ablauf von Verjährungsfristen dar und machen als Wendepunkt der Befassung mit der mörderischen NS-Vergangenheit durch die bundesdeutsche Justiz den Ulmer Einsatzgruppenprozeß von 1958 aus (S. 23, 27), in dem einem Einsatzkommando von Polizeibeamten die Tötung von über 500 jüdischen Opfern in Litauen nachgewiesen wurde (S. 16, 23). Der Prozeß war eher zufallig in Gang gekommen, weil einer der Angeklagten (1941 Polizeidirektor in Memel), nachdem er zunächst untergetaucht war, Mitte der fünfziger Jahre dreist auf Wiedereinstellung in den Polizeidienst geklagt hatte und dabei durch einen Zeitungsbericht über den Prozeß ein Leser dieses Berichts sich an die Beteiligung des Klägers an Massentötungen erinnerte. Der Kläger wurde zum Angeklagten (vgl. S. 17). Aus dem Urteil in diesem Verfahren teilen die Autoren mit: „Die Beamten treiben die Opfer mit Schlägen und Gebrüll zum Tatort. Sie rufen: »Schnell, schnell, desto früher haben wir Feierabend!4 Die Opfer... werden in Zehnergruppen erschossen. Die nächsten müssen vor ihrer eigenen Erschießung die zuvor Getöteten in das Massengrab werfen. Am Tatort sieht es aus ,wie in einem Schlachthaus4. Manchen Tätern wird übel, andere lassen sich bei den Erschießungen ,in Pose4 fotografieren. Nach den Exekutionen gibt es Essen und Schnaps.44 (S. 23 mit Fußnote 18). Seit diesem Prozeß werden Verfahren u. a. gegen das Lagerpersonal der Vernichtungslager Chelmno, Auschwitz, Treblinka, Sobibór, Belzec und Majdanek durchgeführt Totungsaktionen von SS- und Polizeikommandos in Polen und der Sowjetunion sind mehrfach Gegenstand von Verfahren (vgl. S. 27). Allerdings stehen vor Gericht regelmäßig nur Mitglieder der Einsatzgruppen und der Lagerwachmannschaften.,»Insgesamt werden von 1958 bis heute nur einige hundert Personen.- und zwar deutlich weniger als 500 - wegen der Beteiligung am Holocaust verurteilt. Zehntausende bleiben unbehelligt.44 (S. 27). Mit Recht heben die Autoren kritisch hervor, daß die Angehörigen des ausgedehnten Verwaltungsapparates, der die Zulieferung der Opfer in die Totungsfabriken besorgte, im wesentlichen ausgespart blieben (S. 27 /

28). Im Hauptteil ihres Buches geben die Autoren am Beispiel des „wohl größten und bedeutendsten Verfahrens 44 (S. 28) gegen NS-Täter, dem Auschwitz-Prozeß, einen Einblick i» die Grundprinzipien der nach 1958 durchgeführten NS-Verfahren. Dabei geht es ihnen zum einen um die Frage der Erfassung der Wirklichkeit in den Gerichtsverfahren und zum anderen um

640

Recension

die rechtliche Bewertung dieser festgestellten Fakten (vgl. S. 28). Die Beantwortung beider Fragen hat nach wie vor hohe Aktualität. Die der ersten Frage deshalb, weil es immer wieder Versuche gibt, das Geschehen in den Vernichtungslagern schlicht in Abrede zu stellen (sog. Auschwitz-Lüge; vgl. dazu auch S. 212 ff.). Die Beantwortung der zweiten Frage deshalb, weil sich die Probleme der juristischen Auseinandersetzung mit „staatsverstärkter Kriminalität" (so eine treffende Bezeichnung des Phänomens von Naucke, Die strafjuristische Privilegierung staatsverstärkter Kriminalität, 1996) immer wieder neu stellen. Die Autoren dokumentieren „die Feststellung des Geschehens" als „ein Zeugnis gegen das Leugnen von Völkermord" (S. 28), indem sie die wichtigsten äußeren Daten wiedergeben (S. 41 f.), das öffentliche Interesse am Prozeß (S. 42 ff.), die Prozeßatmosphäre (S. 45 f.), Einleitung und Beginn des Verfahrens (S. 46 ff.) und die einzelnen Verfahrensabschnitte (Vernehmung der Angeklagten, Anhörung der Sachverständigen, Zeugenvernehmung, „Ortsbesichtigung" in Auschwitz, Plädoyers, letzte Worte der Angeklagten, mündliche Urteilsbegründung; S. 55 ff.) schildern. Dabei wird auch deutlich, wie die Verteidigungslinien der Angeklagten im Prozeß nach und nach, insbesondere unter dem Eindruck von Zeugenaussagen, in sich zusammenbrechen. Es ist hier nicht der Ort, die Einzelheiten zu wiederholen; dazu sei auf die Lektüre des Buches verwiesen. Aus dieser Lektüre wird deutlich, was der Senatspräsident des Schwurgerichts in Frankfurt/M. in seiner mündlichen Urteilsbegründung so zusammenfaßt: „ Wie aber sah Auschwitz tatsächlich aus? Über dem Lagertor waren die Worte zu lesen: »Arbeit macht frei 4. Unsichtbar aber stand geschrieben: ,Ihr, die Ihr hier eingeht, laßt alle Hoffnung fahren. 4 Denn hinter diesem Tor begann eine Hölle, die für das normale menschliche Gehirn nicht auszudenken ist..." (S. 90). Bei der Wiedergabe des schriftlichen Urteils und seiner Gründe (S. 92 ff.) mußten sich die Autoren auf Auszüge aus dem Text beschränken. Diese Auszüge werden durch entsprechende Zwischenüberschriften gegliedert und gehen zunächst auf die Entstehung von Konzentrationslagern in Deutschland (S. 94 ff.), dann den Bau des Lagers Auschwitz mit den Einzelheiten der »Organisation4 des Lagers (S. 98 ff.), die Massentötungen und die ,Endlösung der Judenfrage 4 ein. Als Grundlagen der Beweisführung dienten dem Gericht einerseits die Zeugenaussagen, andererseits aber auch die Aussagen der Angeklagten. Zwar haben die meisten Angeklagten bestritten, selbst etwas mit dem Geschehen im Einzelnen zu tun gehabt zu haben, doch wurden die allgemeinen Feststellungen über Auschwitz von ihnen nicht in Frage gestellt (vgl. S. 123, 216). Weiterhin konnte sich das Gericht auf umfangreiche Sachverständigengutachten, den autobiographischen Bericht des ehemaligen Lagerkommandanten Höß und den schriftlichen Bericht eines Angeklagten stützen (vgl. S. 123). Bei der Darstellung des ,Alltags in Auschwitz44 (S. 124 ff.) stehen in der Dokumentation des vorliegenden Buches die Lebensläufe und Taten von fünf Angeklagten (übrigens alles Familienväter!) exemplarisch im Vordergrund, die in Auschwitz als Adjutant des Lagerkommandanten, als Mitglied der politischen Abteilung, als Rapportführer, als Apotheker, als Sanitäter und Desinfektor und als Blockältester waren. Wegen der grauenhaften Einzelheiten der festgestellten Taten muß wieder auf die Lektüre des Buches verwiesen werden. Es bedarf wohl keiner besonderen Hervorhebung, daß die für den naiven Blick harmlos erscheinenden Zwischenüberschriften, wie ,3unkerentleerung", „Schwarze Wand44, Mützenwerfen 44,„Kra- * watte-Legen44, „Sportmachen44 in Auschwitz tödliche Bedeutung hatten. Zu jedem der Angeklagten werden ausfuhrlich Beweisführung und rechtliche Würdigung dargestellt und kommentiert Beeindruckend ist dabei, wie akribisch das Gericht die Beweise gewürdigt hat und geringsten Zweifel stets zugunsten der Angeklagten wirken ließ. Gerade deshalb sind die verbliebenen Tatsachenfeststellungen so überzeugend. Auch die juristische Würdigung zeigt,

Recension

641

daß hier um juristische Neutralität bemühte Richter und keinesfalls Racheengel am Werke waren. Wenn dies kein fairer Prozeß war, dann gibt es überhaupt keinen fairen Prozeß. Dies gilt auch dann, wenn man heute die Grundlagen der jurisüschen Würdigung der Sachverhalte, etwa zur Differenzierung zwischen Täterschaft und Teilnahme und zur Legitimierung der Strafen aus dem Recht des Dritten Reiches, kritisieren mag (vgl. S. 30 ff.). Viel spricht dafür, wenn die Autoren ζ. B. in Bezug auf den letzteren Aspekt bemängeln, daß die bundesdeutsche Justiz an die Stelle einer offen ausgewiesenen rückwirkenden Bestrafung eine versteckte gesetzt habe, indem sie das NS-Recht nachträglich uminterpretierte (S. 40). Trotzdem bleibt die Feststellung der Autoren nachdrücklich zu unterstreichen, daß „das herausragende Verdienst dieser Prozesse ... die unanfechtbare Feststellung des Geschehenen" ist (S. 215). Die vorliegende Schrift von Werle und Wandres bringt keine neuen historischen Erkenntnisse; das ist aber auch erklärtermaßen nicht ihre Aufgabe. Sie stützt sich vielmehr auf die einschlägige Forschung, zu der die Autoren selbst entscheidend beigetragen haben (vgl. insbesondere Werle, Justiz-Strafrecht und polizeiliche Verbrechensbekämpfung im Dritten Reich, Berlin 1989), und bringt diese auf den Punkt: „Die tätige Bereitschaft des Rechtsstaats, die Freiheit und Würde eines jeden Menschen ... uneingeschränkt zu wahren, ist Grundvoraussetzung dafür, daß sich Auschwitz nie wiederhole." (S. 218). Jan C. Joerden

41 Jahrbuch für Recht und Ethik, Bd. 4 (1996)

Contributors Akabayashi, Akira, Professor, M.D., Department of Ethics and Anthropology, School of International Health, The University of Tokyo, 7-3-1 Hongo, Bukyo-ku, Tokyo 113, Japan Bernau Erwin, Universitäts-Dozent Dr. iur., Karl-Franzens-Universität Graz, Rechts wissenschaftliche Fakultät, Institut für Bürgerliches Recht, Heinrichstraße 22, A-8010 Graz Bonkovsky, Frederick O., Professor, Ph.D., Acting Director, Bioethics Program, National Institute of Health, Warren G. Magnuson Clinical Center, Bathesda, Maryland 20892-1154, USA Byrd, B. Sharon, Professor, J.D., LL.M., J.S.D., Friedrich-Schiller-Universität Jena, Rechtswissenschaftliche Fakultät, Carl-Zeiss-Straße 3, D-07740 Jena Clayton, Ellen Wright, Professor, M.D., J.D., Division of General Pediatrics, Vanderbüt University School of Medicine, Suite 5028, Medical Center East, Nashville, Tennessee 372328555, USA Cohen, Lloyd R., Professor, J.D., Ph.D. (Economics), School of Law, George Mason University, 3401 North Fairfax Drive, Arlington, Virginia 22201-4498, USA Cohen-Almagor, Raphael, D. phil., Department of Communication, Haifa University, Mount Carmel, Haifa 31905, Israel Dworkin, Roger B., Professor, J.D., School of Law, Indiana University, Bloomington, Third Street and Indiana Avenue, Bloomington, Indiana 47405-1001, USA Figueroa, Patricio, M.D., Research Associate, Kennedy Institute of Ethics, Georgetown University, Washington, D.C. 20057, USA Fuenzalida-Puelma, Hernan L., J.D., LL.M., Visiting Scholar, Human Development Department, The World Bank, 1818 H Street, NW, Room S9-070, Washington, D.C. 20433, USA Fukuhara, Shunichi, Professor, M.D., M.Sc., Clinical Epidemiology Division, The University of Tokyo, Faculty of Medicine, Igaku-Toshokan 204, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113,Japan Giesen, Dieter, Dr. iur. (Bonn), M.A.status (Oxon), Professor of Private and Comparative Law; Head, Working Centre for Studies in German and International Medical Malpractice Law, Free University of Berlin, Sometime Visiting Fellow Pembroke College, Oxford (England); address: Boltzmannstr. 3, D-14195 Berlin, Tel: +49-30-838 4713, Fax: +49-30838 4709 Greve, Werner, Dr. iur., Kriminologisches Forschungsinstitut Niedersachsen e.V., Lützerodestraße 9, D-30161 Hannover 41*

644

Contributors

Gruter, Maigaret, Dr., J.S.M., Gruter Institute for Law and Behavioral Research, 158 Goya Road, Portola Valley, California 94028, USA Hayashi, Hideaki, Dr., M.D., Tokyo Metropolitan Koraagome Hospital, Komagome, 18-22, Honkomagome 3 chôme, Bunkyo-ku, Tokyo 113, Japan Hayashi, Motoko, Professor, MSW, AIDS Co-Ordinator, Miyazaki 605-11-303, Miyamae Ku, Kawasaki City, 216, Kanagawa, Japan Herbert, Gary B., Professor, Ph.D., Department of Philosophy, Loyola University, Box 138, 6363 St. Charles Avenue, New Orleans, Louisiana 70118-6143, USA Herranz, Gonzalo, Professor Dr., Departamento de Bioética, Facultad de Medicina, Universidad de Navarra, Apartado 273, E-31080 Pamplona Heyd, David, Professor Dr. phil., The Faculty of Humanities, Institute of Arts & Letters, The Hebrew University of Jerusalem, Mount Scopus, Jerusalem 91905, Israel Hosaka, Takashi, Professor, M.D., Department of Psychiatry and Behavioral Science, Tokai University School of Medicine, Bohseidai, Isehara, Kanagawa 259-11, Japan Hruschka , Joachim, Professor Dr. iur., Friedrich-Alexander-Universität Erlangen, Institut für Strafrecht und Rechtsphilosophie, Schillerstraße 1, 91054 Erlangen Hylton, Keith Ν., Professor, J.D., Law School, Boston University, 765 Commonwealth Avenue, Boston, Massachusetts 02215, USA Joerden, Jan C., Professor Dr. iur., Europa-Universität Viadrina Frankfurt (Oder), Lehrstuhl für Strafrecht, insbesondere Internationales Strafrecht und Strafrechtsvergleichung, Rechtsphilosophie, Große Scharrnstraße 59, D-15230 Frankfurt (Oder) Kagawa-Singer, Maijorie, Professor, Ph.D., R.N., M.N., School of Public Health and Asian American Studies Center, University of California, Los Angeles, Box 951772, Los Angeles, California 90095-1772, USA Kaminsky, Carmen, M.A., Ruhr-Universität, Zentrum für Medizinische Ethik, Institut für Philosophie, Fakultät für Philosophie, Pädagogik und Publizistik, D-44780 Bochum Kamm, Frances Myrna, Professor, Ph.D., Department of Philosophy, Main Building, Room 503, 100 Washington Square East, New York University, New York, New York 100036688, USA Kaufmann, Matthias, Professor Dr. phil., Martin-Luther-Universität, Halle-Wittenberg, Fachbereich Geschichte, Philosophie und Sozialwissenschaften, Institut für Philosophie, D06099 Halle (Saale) Kettner, Matthias, Dr. phil., Kulturwissenschaftliches Institut im Wissenschaftszentrum Nordrhein-Westfalen, Hagmanngarten 5, D-45259 Essen Kielstein, Jan T., Medizinische Klinik der medizinischen Hochschule Hannover, Abteilung Hämatologie und Onkologie, Konstanty-Gutschow-Straße 8, D-30625 Hannover

Contributors

645

Kielstein, Rita, Professor Dr. med., Klinik für Nephrologie, Medizinische Fakultät, Otto-von­

Guericke-Universität, Leipziger Straße 44, D-39120Magdeburg Kimura, Rihito, Professor Dr., Director, Asian/lnternational Bioethics Program, Kennedy In­

stitute of Ethics, Room 222-D, Georgetown University, Washington, D.C. 20057, USA; or: School of Human Seiences, WASEDA University, Tokyo, Japan Kliemt, Hartmut, Professor Dr. phil., Gerhard-Mercator-Universität, Gesamthochschule Duis­

burg, Fachbereich 1, Philosophie- Religionswissenschaft- Gesellschaftswissenschaften, Fach: Philosophie, Lotbarstraße 63, D-47057 Duisburg Koch, Hans-Georg, Dr. iur., Max-Planck-Institut für ausländisches und internationales Straf­

recht, Günterstalstraße 73, D-79100 Freiburg i. Brsg. Kurokawa, Kiyoshi, Professor, M.D., Dr. med. sei., Chairman, First Department of Interna!

Medicine, T he University ofTokyo, Faculty ofMedicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113, Japan Macer, Darryl, Ph.D., Institute of Biological Sciences, University of Tsukuba, Tsukuba Sei­

ence City, lbaraki 305, Japan Marshall, Grant N., Ph.D., Health Seiences Program, RAND Corporation, 1700 Main Street,

SantaMonica, California 90407-2138, USA Masters, Roger D., Professor Dr., Department of Government, Silsby Hall, Dartmouth Col­

lege, Hanover, New Hampshire 03755, USA Meisel, Alan, J.D., Dickie, McCamey & Chilcote Professor ofBioethics, and Law & Psychia­

try, School of Law, Center of Medical Ethics, University of Pittsburgh, 3900 Förbes Ave­ nue, Pittsburgh, Pennsylvania 15260, USA Meran, Johannes Gobertus, Dr. med., Medizinische Hochschule Hannover, Abteilung Häma­

tologie und Onkologie, Konstanty-Gutschow-Straße 8, D-30625 Hannover Merz, Ion F., J.D., Ph.D., Research Assistant, Professor of Bioethics, Department of Cellular

and Molecular Engineering and Center for Bioethics, University of Pennsylvania, 3401 Market Street, Suite 320, Philadelphia, Pennsylania 19104-3308, USA Michelsen, Melisa, School of Law, George Mason University, 3401 North Fairfax Drive, Ar­

lington, VIrginia 22201-4498, USA Olick, Robert S., M.A., J.D., Ph.D. (Can.), Department of Philosophy, Georgetown Universi­

ty, Wasbington, D.C. 20057, USA Powers, Madison, Professor, J.D., D. phil., Kennedy Institute of Ethics, Department of Phi­

losophy, Georgetown University, Washington, D.C. 20057, USA Ried� Mare, Professor,M.D., Director, Center for ClinicalMedical Ethics, University of Chi­

cago, Department ofMedicine, MC-6098, 5481 South Maryland Avenue, Chicago, Illinois 60637·1470, USA Rothenberg, L.S., Division ofMedical Genetics, Department of Medicine, University of Cali­

fornia, Los Angeles, Box 951736, Los Angeles, California 90095-1736, USA

646

Sass,

Contributors Hans-Martin, Professor Dr.

phil.,

Institut für Philosophie, Ruhr Universität, D-44780

Bochum; Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University,

Washington, D.C. 20057,USA

Sieg/er,

Mark, Dr., Director, Center for Clinical Medical Ethics, University of Chicago, De­

partment of Medicine, MC-6098, 5481 South Maryland Avenue, Chicago, ßlinois 606371470,USA

Sippel, Albrecht

E., Professor Dr.

rer.

nat., Albert-Ludwigs-Universität, Institut für Biologie

ill, Schänzlestraße 1,D 79104 Freiburg i. Br. -

Spitz.

Deborah, Professor, M.D., Director of Residency Training, Department of Psychiatry,

New England Medical Center, 750 Washington Street, Box 1007, Bost on Massachusetts ,

02lll,USA Tanabe, Noburu, M.D., Dr. med. sei., LL.M., Faculty of Law, Kyoto University, Hiyoshidai

3-3-23, Takatsuki City, Osaka 569, Japan

Wenger,

Neil S., Professor, M.D., Division of General Interna! Medicine & Health Services

Research, Department of Medicine, University of California, Los A ngeles, Box 951736, Los A ngeles, California 90095-1736, USA

Wiesing,

Urban, Privatdozent Dr. med. Dr. phil., Westfälische Wilhelms-Universität, Institut

für Theorie und Geschichte der Medizin, Waldeyer Straße 27, D-48149 Münster

Wolfslast, Gabriele, Professor Dr. iur.,Universität Rostock,

Juristische Fakultät, Lehrstuhl für

Strafrecht, Strafprozeßrecht und strafrechtliche Nebengebiete, Möllner Straße 10, D18109 Rostock

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