Submitted by: The Ethics Unit of the World Medical Association, an international non-governmental professional organization.
Contact: Prof. John R. Williams, Ph.D., Director of Ethics, World Medical Association

The World Medical Association (WMA) is an international non-governmental federation of National Medical Associations representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the WMA endeavours to achieve the highest possible standards of medical care, ethics and education and health-related human rights for all people. The Ethics Unit was established in 2003 to coordinate policy development and review on ethical issues, to liase with other international organizations dealing with these issues and to produce ethics resource materials.

The Ethics Unit of the WMA is pleased to have this opportunity to address the UNESCO International Bioethics Committee (IBC) on the subject of its proposed Declaration on Universal Norms of Bioethics. Since its formation in 1947, the WMA has never ceased to be a major force in medical ethics and bioethics (cf. its Declaration of Geneva, adopted in 1948, International Code of Medical Ethics, 1949, Declaration of Helsinki, 1964, and more than 50 other statements on ethical issues). The formation and staffing of the Ethics Unit is further evidence that the WMA is continuing to play a major role in international bioethics.

This submission will follow the order set out in the outline provided by the IBC Secretariat. It will reference, where appropriate, the 13 June 2003 Report of the IBC on the Possibility of Elaborating a Universal Instrument on Bioethics (SHS/EST/02/CIB-9/5 [Rev.3]) and the 22 September 2003 Report by the Director-General on the Possibility of Elaborating Universal Norms on Bioethics (32 C/59).

1. Aims and Scope of a Declaration on Universal Norms on Bioethics

   Perhaps the biggest challenge that this project faces is the one described in para. 47 of the Director-General's Report: "If the framework is too general, it may be less useful in terms of its application to specific practices. Conversely, if it is very detailed, it may be rendered obsolete by rapid advances in practices and techniques." Bioethics is a very large field and covers many specific topics, as can be seen in the list at the end of the Secretariat outline. It would not be feasible to deal with all of the topics in one declaration.

   Bioethics has three major divisions: clinical ethics (dealing with the relationship of health care professionals and the individuals they care for), research ethics (dealing with issues in scientific experimentation), and public ethics (dealing with laws, regulations and policies on issues in biology, medicine and health care). The IBC would be wise to focus the declaration on public ethics, since many other organizations are dealing with clinical ethics and research ethics. Nevertheless, any declaration on public ethics needs to take account of both the resolved and the unresolved issues in the other fields so that it is supportive where appropriate and does not interfere where that would be inappropriate.

   In formulating a declaration dealing with issues in public bioethics, the IBC must be clear about the relation of law and ethics. While it may be appropriate to have legislation and regulations on some bioethical issues, ethics and law must never be conflated. Ethics often calls for higher standards of behaviour than the law requires and in some cases ethics requires disobedience to (unjust) laws. As the IBC Report states (para. 40), "At any level, laws accompanied by effective control should be adopted in order to facilitate personal choices, and only a few substantial issues should be regulated through international rules. In other words, the aim should be to maximize moral evolution and to minimize the need for legislation." On the other hand, the Director-General reported (para. 27) that the IBC sees the declaration "as a tool to help States wishing to enact laws in that field." The IBC will have to decide whether to produce a declaration on bioethics or on biolaw. If the latter is chosen, the document should not include the word 'bioethics' in its title.

   Another challenge for the project is to find consensus among different cultural, religious and philosophical traditions on a wide range of bioethical issues. On each of the topics listed, there is considerable diversity about how humans should behave and the role of the state in regulating their behaviour. The Director-General might have been overly optimistic when he stated (para. 36): "…an instrument on bioethics can provide unity, while recognizing the special challenges posed by the unique histories, cultures, politics, judicial systems and economic situations of the countries involved worldwide."

   One way of achieving unity in the face of diversity that is not recommended is to leave key words undefined. 'Dignity' is a prime example. It is cited by both opponents and proponents of abortion, euthanasia, and therapeutic cloning, but obviously to support entirely different positions. Another example is 'norms'. The declaration should define its key terms, even if this makes it more difficult to achieve consensus.

   For all these reasons, the IBC needs to determine very carefully the aims and scope of the declaration. The aim should be either an ethical, primarily educational, document or a legal one, but not both. The scope should be the public policy dimension of bioethics, not clinical or research bioethics.

   It should be noted that two of the aims of the declaration, as stated by the Director-General (para. 44), namely, "to encourage Member States to set up national and regional bodies designed to encourage the population to take part in informed debate in various fields, including those related to the most recent developments in biotechnology," and "to encourage States to strengthen the dialogue with their scientific community, universities and other academic centres, the media and non-governmental organizations and to promote the active participation of all interested parties," can be accomplished whether or not there is a declaration.

   For practical reasons, the declaration should probably be limited to human beings. It will be difficult enough to achieve consensus at this level without involving the relationship of humans to animals, the environment, etc. A subsequent declaration could deal with these broader issues.

2. Structure and Content of a Declaration on Universal Norms on Bioethics

   Discussion of the structure of the declaration is premature. The nature and scope of the document must be decided before any determination of the appropriate structure ("form follows function").

   It will be especially important to establish the basic principles for judging whether particular scientific or health-related activities should be obligatory, encouraged, merely tolerated, or forbidden. The declaration should not simply state conclusions without providing the reasons for them. In a pluralistic world where the meanings of autonomy, dignity, benefit sharing, justice, etc. are all contested, the surest foundation for international bioethics are the major human rights principles. The declaration should use these principles to ground and support whatever norms on bioethics it sets forth.

   Whatever topics it treats, the declaration should distinguish carefully between those on which a general consensus has been achieved (e.g., on informed consent) and those where there is no such consensus. For the latter, the role of the declaration should be to identify relevant ethical considerations and present the arguments for the different positions on the issue. It should not attempt to foreclose debate prematurely.

   The list of topics in the Director-General's report and the Secretariat outline is clearly far too extensive for adequate treatment in a declaration. Moreover, if the aim of the declaration is to identify universal norms on bioethics, there is no need to discuss all the specific issues in bioethics. Some of them can be cited as examples of how the norms apply.

3. Conclusion

   Given the importance and complexity of the task undertaken by the IBC, it is essential that sufficient time be allotted for both crafting the document and for meaningful consultation with the major stakeholders. It seems quite unrealistic to expect that the task can be completed by the end of 2005 and in any case there is no urgency that would require a document by then. Indeed, it may well be that the discussion process is more important than the outcome, i.e., the declaration.

   We hope that these remarks will help to focus the aims and scope of the IBC project. The WMA, with its long experience in developing and reviewing policies on bioethical issues, is very willing to work with the IBC to bring the project to a fruitful conclusion.