Health ethics and the law / by Susan Scholle Connor and Hern'an L. Fuenzalida-Puelma

Health ethics and the law Why does WHO not deal more forthrightly with the searing issues of biotechnology and medicine that confront today's world? The authors argue that the Organization should play a much more positive role by Susan Scholle Connor and Herm)n L. Fuenzalida-Puelma A n international agenda for Health Ethics and Law must begin by defining the issues. What is health? What are health ethics? What is health law? How do they relate to each other? What are the international concerns? The questions are simple, answers are complex. First what is health? The Preamble to the WHO Constitution defines health as a "state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". It is an all-inclusive, positive state, a social index. Although not precise, this definition - by its breadth - encompasses virtually every sphere of social and personal activity. The WHO Constitution proclaims that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. This view is now virtually uni- versal. Health is everywhere seen as crucial to individual and societal well- being. Health ethics can be categorised into two headings: bioethics and medical ethics. Bioethics is a field which originated during the last four decades, and applies ethical principles to the new and unsettling questions presented by scientific and technologi- cal advances that probe into the deepest secrets of biology. In part, it resulted from the scientific self-doubt that accompanied the development of the atomic bomb in World War II, and was precipitated by the discovery of DNA (the genetic code) in 1959. One of its main concerns is to determine whether there are unacceptable risks in technological development and scienti- fic expertise. Bioethics also looks into such social aspects as the equitable distribution of 10 the fruits of scientific achievement and, in the health field, considers the principles for allocating scarce health resources, whether high-tech (organ transplants or in vitro fertilisation), medium-tech (kidney dialysis) or low- tech (primary health care). The issues are most dramatic at the beginning and end of life - in-vitro fertilisation, genetic manipulation, arti- ficial respiratory and feeding devices, artificial organs. Hallmarks of bioethics at this level are the belief that a human being has a certain autonomy over his or her own body, and that the doctor alone does not have the right to take decisions about whether life should be created or prolonged. Dr Susan Scholle Connor is Special Legal Counsel. and Dr Hernlm L. Fuenza/ida- Puelma is General Counsel and Chief. Office of ~~gal Affairs. WHO Regional Office for the Americas/Pan Amer- ican Sanitary Bureau. Washington D.C. Medical ethics traditionally ad- dressed issues related to the collegial practice of medicine (such as intra- professional relations) that are not covered within the field of bioethics. It was enshrined in such codes as the Greek Hippocratic Oath (sixth century B.C. to the first century AD.) or the Indian Oath of Initiation ( Carak Samhita, first century AD.) These codes deal with the conduct of physi- cians with patients, with the relation of physicians to each other, whether as peers, teachers or students. The codes of other health care professionals, for instance nurses and dentists, are similar. Not all of health ethics is translated into health law. Certain ethical stand- ards remain simply moral guidelines, without legal consequences. But increasingly, ethical standards are enforced by law. This is not a new development - the Protomedicata of the Middle Ages were a quasi-legal body, with authority over doctor- patient disputes, licensing, and allega- tions of unauthorised practice. Government licensing of health profes- sionals has been common for over 100 years. But as technology has advanced, so has its regulation and control - health law now encompasses over 22 subjects. The area of overlap between health ethics - both bioethics and medical ethics and health law - has grown and will continue to grow. International public health law can be seen to have begun in 1851, with the adoption by the First International Sanitary Conference (largely European) of the first international sanitary regulations dealing with cholera, plague and yellow fever. The International Sanitary Conferences, and their successor assemblies (the Office International d'Hygi(me Pub- lique, the Health Organization of the League of Nations, the World Health Organization and such regional health bodies as the Pan American Health Organization) were all governmental bodies. Health ethics - and particularly medical ethics - was left to the professional societies, which began meeting internationally with the Inter- national Medical Congress of 1867, or to the initiatives of other non- governmental organizations. Particu- larly notable is the work of the Interna- tional Red Cross, involved in drafting the first Geneva Convention of 1864 (revised in 1949) on the treatment of the sick and wounded, as well as prisoners, in time of war. It was World War II, however, that created the climate for the "interna- tionalisation" of human rights, in gen- eral, and for health ethics, in particular. The Universal Declaration of Human Rights, adopted in 1948, marks the first recognition that the manner in which a state treats its nationals is a subject of international concern. Since World War II, health ethics, like human rights in general, has increasingly become the subject of international activity - largely, however, conducted outside the auspices of WHO. In the field of medical ethics, the World Medical Association adopted an International Code of Medical Ethics in 1949, and CIOMS - the Council for International Organizations of Medical Sciences, proposed International WORLD HEALTH, April 1989 " E <i' ~ 0 ~--~ Posters and puppets: two ways of putting across family planning messages - in Costa Rica and Indonesia. Bioethics holds that all human beings have autonomy over their own bodies, and that the doctor alone may not take decisions about whether life should be created or prolonged. Guidelines for Biomedical Research Involving Human Subjects in 1982. The latter were drafted in conjunction with WHO, but have never been officially adopted by the World Health Assembly. The fate of those guidelines seems to illustrate the reluctance that WHO has shown in entering the field of health ethics. While the list of World Health Assembly resolutions includes a category of "medical law, ethics and humanitarian questions", the pattern has not been of a leadership role, but rather one of reaction to suggestions from particular governments, or initia- tives of other institutions. In 1962, the Assembly reiterated the WHO constitutional provision that health is a fundamental condition for peace and security. Some five years later, and for several years thereafter, the Assembly expressed its alarm over the problem of chemical and bacteriological weapons. And it was by invitation of another group - the United Nations- that Wi-IO's Executive Board responded to the issue of the need for a medical code of ethics for physicians concerning torture and other cruel, inhuman or degrading treatment or punishment in relation to detention and imprisonment. Instead of taking the lead on the issue, the Executive Board and the Assembly referred the topic to CIOMS and the World Medical Association (both non- governmental organizations of profes- sional societies, and both accredited to the WHO as such) . Medical code of ethics On humanitarian law, the only issue on which the World Health Assembly has shown consistent concern through the years is based on the WHO Consti- tution's preambulatory statement that the health of all peoples is fundamen- tal to the attainment of peace and security. That principle was reaffirmed by a World Health Assembly resolution in 1962, and again in 1979, 1981 and 1983 (the latter in connection with the report on the effects of nuclear war) . Activities on health legislation have generally been confined to publishing summaries of national health laws, especially in the International Digest of Health Legislation, an outstanding contribution to the field, but far less active than the legislative activities of other international bodies such as the International Labour Organisation and the Food and Agriculture Organi- zation. The authors have puzzled over the reasons for this. Certainly the WHO Constitution contains no prohibition of active involvement in the field of health and ethics and the law. In areas of an ethical nature, as 11 Another concern for bioethics. A man lies dying after a road accident. Would doctors be justified in taking organs from his body to save other lives? discussed above, even guidelines have been relatively few, although this trend may be changing. The 41st World Health Assembly adopted last May a resolution entitled "Ethical criteria for medicinal drug promotion." A much more assertive role on ethical/legal issues has been taken by the Global Programme on AIDS, which has adopted consensus statements and issued guidelines on such policies as informed consent for testing , avoidance of mass screening, need for confidentiality, respect for human rights, and condemnation of discrimi- nation. A controversial arena Should the Assembly follow the lead of the Global Programme on AJDS, and deal more forthrightly with the searing issues of biotechnology and medicine facing the world today? The authors can only guess at the reasons for WHO's traditional reluctance to enter into such an arena, which is inevitably controversial. First, the belief that the 12 Organization should not become involved in the internal affairs of its member states is very strong, dates back virtually to the First International Sanitary Conference, and is generally the rule for public international bodies. Secondly, there is a common institu- tional antipathy to and concern about politicising the Organization. While any public international organization, whose members are sovereign states, is inevitably a political body, WHO has walked an uneasy line between politics and science. Executive Board Members are selected, accord- ing to the WHO Constitution, not only with regard to equitable geographic distribution, but as persons "technically qualified in the field of health", and they are required to vote on behalf of the whole, and not as representatives of governments. Moreover, at WHO the typical international concern for achieving consensus is exceptionally strong. These factors, plus the generally technical or scientific training of the secretariat, militate for a "hands off" attitude towards matters not subject to scientific proof, or towards controversy, where national political views or cultu- ral diversity could lead to deep-seated differences of opinion. Health law is WHO/ T Urban largely ignored because of concerns over meddling in national politics; health ethics are avoided due to their relationship to morality which, barring certain general principles (do not kill) , can cause emotional and heated debate (is abortion a killing?) . Debate at a high level The authors do not suggest that WHO should adopt an international agenda for conventions, agreements or regulations on health law and health ethics. But they do believe that the Organization has a duty to foster exchanges of information, and pro- mote debate at a high level on such issues. To ignore them is to neglect reality: the concerns of regulation of biotechnology and regulation of health ethics exist, and there is now no international forum that deals with these concerns in a truly global way. International consensus may not be achievable, but international debate is. Genetics, genetic engineering, clinical medicine, cancer and AJDS research, human reproduction techno- logies, control of death - all these are not only scientific and technical mat- ters; they have deep ethical, legal, social, cultural and political conse- quences. Hence, participation should WORLD HEALTH , April 1989 be made available to a broad represen- tation of interests and disciplines. There is also a growing need to discuss, to evaluate and to regulate clinical research conducted in less developed countries. Important issues on the ethics of biomedical research have been raised concerning the appli- cation of ethical standards of developed countries to developing nations. The rights of the subjects of biomedical research, the doctrine and practice of informed consent, the shar- ing and disclosure of research results - these are matters in need of an open forum and of regulation, both institu- tional and governmental. The eager- ness to find cures to a particular disease and the availability of resources towards this end should not lead, in spite of good intentions, to double ethical standards. The issue of social ethics, of equity in the access to health care services, universalisation of health care, the dichotomy of health as a right versus health as a commodity, the diverse models in the search for a fair health system compatible with scarce resources, privatisation versus public or mixed economy schemes, social security/ ministry of health/ private medicine - these are among the issues in which the rhetoric and the reality of health care appear in stark opposition. Discussion, exchange of information and evaluation of improvements in the health and well-being of the people should be encouraged. The issues of health are national, in that they belong to everyone - as individuals and as members of society. There is no official ethics, there is no official health; there are ethical prin- ciples, values and standards; there is health as a state of decent, just well-being, with access to care and to the enjoyment of healthy living con- ditions. WHO can and must play a leading role in the discussions to come. One of the main justifications for the existence of international organizations is that they constitute the specialised forum, the institutional umbrella under which studies, research and discussion can take place on a basis of sound data and with respect for all. Health ethics and law provide WHO with a comprehensive, intelligent and rich opening from which to work humanis- tically for the health for all mankind. • A young bride in Indonesia receives advice on the contraceptive pill. Last year's World Health Assembly adopted a resolution on "ethical criteria for medicinal drug promotion., WOR LD HEALTH , April 1989 Health ethics and the law World Council of Churches/ J . Taylor 13