The WMA Declaration on the Rights of the Patient states, "In circumstances where a choice must be made between potential patients for a particular treatment which is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination."
The World Health Organization (WHO) has launched its "Three by Five Initiative" http://www.who.int/3by5/en/ to provide three million people living with HIV/AIDS in developing and middle income countries with life-prolonging antiretroviral treatment (ART) by the end of 2005. Because there are at least six million people who could benefit from such treatment, life-and-death choices must be made among the potential recipients.
Recognizing that access to limited supplies of ART involves ethical considerations of equity and equality, WHO and UNAIDS undertook the development of an ethics guidance document for those responsible for access policies and programs. In January 2004 the two organizations convened an international consultation on Ethics and Equitable Access to Treatment and Care for HIV/AIDS to identify the issues and determine how best to address them. The report of the consultation, and the three background papers, can be viewed at www.who.int/ethics/resource_allocation/en/#gotohere.
Following the consultation, WHO and UNAIDS produced their Guidance on Ethics and Equitable Access to HIV Treatment and Care www.who.int/ethics/en/ethics_equity_HIV_e.pdf. The document's recommendations focus more on process issues in the development of fair policies for access to treatment than the content of these policies. For example, it identifies some of the groups (healthcare workers, heads of families, etc.) that should be considered in any priority-setting exercise but does not say which groups should be given priority).
As major participants in HIV/AIDS policy development and treatment programs, physicians and their National Medical Associations will profit from considering the WHO/UNAIDS work on this issue. The WMA is about to review the numerous policy statements on HIV/AIDS that it has adopted over the years, both on its own and in connection with other health provider organizations (e.g., the World Health Professions Alliance's 2004 Resolution on HIV/AIDS www.whpa.org/pr06_04.htm, and undoubtedly it will incorporate considerations of equitable access to treatment in any revised policy.

January 2005 - UNESCO Declaration on Universal Norms on Bioethics

In 1993 the United Nations Educational, Scientific and Cultural Organisation (UNESCO) established an International Bioethics Committee (IBC). Although the functions listed in its statutes are primarily educational (e.g., promoting reflection on the ethical and legal issues raised by research in the life sciences and their applications and encouraging the exchange of ideas and information, particularly through education), a major part of its work has been the elaboration of documents such as the Universal Declaration on the Human Genome and Human Rights, which was adopted by UNESCO's General Conference in November 1997.

Following a meeting of Ministers of Science on "Bioethics: International Implications" in October 2001, UNESCO began a process to determine the feasibility of elaborating universal norms on bioethics. The IBC produced a report on this subject in June 2003 and the General Conference of UNESCO in October 2003 authorized the work to continue. A Drafting Group of the IBC was appointed and began its work on 30 April 2004, following a 2-½ day consultation with interested parties, including the WMA Ethics Unit. Simultaneously, the UNESCO Executive Board approved a timetable for the project that will terminate in the adoption of a final declaration by the General Conference in October 2005. (Cf. the UNESCO Ethics website for a detailed description of the different stages of the process.)

In December 2004 the Drafting Group completed its fourth outline of the draft text of the Declaration, which it proposes to entitle, Universal Declaration on Bioethics and Human Rights. This draft will be vetted by the UNESCO Intergovernmental Bioethics Committee, composed of government representatives, following which the IBC will adopt its final version on 28 January 2005. The draft Declaration will then go to government representatives who will review and finalize it for the UNESCO Executive Board and General Conference meetings in October 2005.

Although a preliminary consultation with governments had revealed a widespread desire that the Declaration deal with specific bioethical issues, the current draft does not do this. It consists rather of a preamble, general provisions (scope, aims, etc.), general principles, implementation principles, procedures, and promotion and implementation.

One of the most controversial features of the proposed Declaration is its scope, in particular whether it should deal with medical and public health issues (which fall under the mandate of WHO, not UNESCO) as well as scientific and educational ones. The current draft of the document explicitly defines bioethics as "the systematic, pluralistic and interdisciplinary field of study involving the theoretical and practical moral issues raised by medicine and the life sciences as applied to human beings and humanity's relationship with the biosphere". However, several articles of the draft Declaration seem quite unclear or inappropriate when applied to clinical medical practice, for example:

• Article 8 states, "Any decision or practice shall seek to maximize the benefits to the person concerned and minimize the possible harm resulting from that decision or practice." In medical practice there is more than one person concerned and the benefits for one (e.g., the physician) may be quite different than for another (e.g., the patient).
• Article 9 requires that, "Any decision or practice shall take into account the cultural backgrounds, schools of thought, value systems, traditions, religious and spiritual beliefs present in society." This is clearly impractical, if not impossible, in most physician-patient encounters in medical practice.
• Article 12 deals with informed consent in research and clinical practice. Its provisions for research on persons who do not have the capacity to consent are perhaps more restrictive than the current state of the debate on this issue warrants. Moreover, although the first aim of the Declaration is "to provide a universal framework of fundamental principles and basic procedures designed to guide States in the formulation of their legislation and their policies in the field of bioethics," the principle for consent to medical diagnosis and treatment for incompetent patients in this article is that domestic law should be followed.
• Article 13 on privacy and confidentiality is also very restrictive and so broad in its scope that it is likely unworkable.
• Article 14, "Any decision or practice shall pay due regard to solidarity among human beings and encourage international cooperation to that end," is inappropriate in the individual physician-patient relationship.
• Article 16 requires that, "Benefits resulting from scientific research and its applications shall be shared with the society as a whole and the international community, in particular with developing countries". Every patient, and every physician, benefits from the applications of scientific research but it is not at all clear how such benefits can be shared with others.
• Article 17 is equally impractical for clinical medical practice: "Any decision or practice shall have regard for its impact on all forms of life and their interconnection and the special responsibility of human beings for the protection of biodiversity and the biosphere within which human beings exist."
• Article 18 states that, "Any decision or practice shall … avoid conflict of interest." Conflicts of interest, e.g., in relation to allocation of scarce health resources, cannot always be avoided, although they need to be managed.
• Article 19 constitutes a serious challenge to medical ethics where it states: "Any decision or practice shall …be available for appropriate scrutiny by the persons concerned and by civil society" and "be susceptible to informed, wide and pluralistic public debate."
• Article 29 calls on States to "take all appropriate measures, whether of a legislative, administrative or other character, to give effect to the principles set out in this Declaration…."

Concerns about the proposed Declaration can be addressed to members of the committee of government experts who are expected to carry out consultations on the document in their own countries between March and June 2005. Watch for an announcement of the committee membership on the IBC website.