Indian Journal of Medical Ethics

INTERNATIONAL ETHICS

Ethics and health at the World Health Organization
ALEXANDER MORGAN CAPRON, NIKOLA BILLER-ANDORNO

The use of genetic screening to detect potential diseases-as well as other characteristics-in embryos in a laboratory, in patients in a clinic, or in applicants for life insurance. The transplantation of human organs and tissues. The conduct of clinical trials in developing countries, including the special problems that arise in testing treatments or vaccines for HIV. Access to essential drugs in resource-poor settings. The procedures for deciding which treatments are made available in a country to treat which diseases-and which treatments will not be available and which diseases not treated. The implicit assumptions behind quantitative measures for the effectiveness of various uses of healthcare resources. The study of stored tissue samples to determine the genetic bases of diseases. The cloning of human embryos, to make babies or provide cells for research and therapy. The potential for stem cell therapy to change the treatment of many diseases and thereby either increase or greatly reduce the cost of treating chronic or degenerative conditions. Increases in long-term care, the burdens of which are often borne primarily by families (and within families, primarily by wives, daughters, and daughters-in-law).

Initiative by WHO

These are just a few of the topics that have become matters of concern to healthcare providers, government officials, and the general public in recent years. For many years, the World Health Organization (WHO) has contributed to the analysis of such bioethical issues as they have arisen in the context of its technical work on many topics. Recognizing that countries increasingly need advice and guidance on the ethical aspects of healthcare, public health, research with human beings and biotechnology, the Director-General launched an Ethics and Health Initiative by establishing a new unit within her office in October 2002.

The Ethics and Health Unit

The Ethics and Health Unit (DGO/ETH) facilitates the examination of a wide range of ethical issues raised by activities throughout the Organization-in the Regions as well as Geneva-and also initiates projects as needed. ETH works collaboratively with staff from all departments and the regional offices to identify, design and carry out studies addressing the ethics of healthcare, public health and biomedical science. This encompasses projects that originate in the unit and those on which it provides advice and assistance to activities located in other clusters and in regional offices.

The specific projects, many of which link different departments and involve experts from outside the organisation, will evolve in response to changes in the field as perceived by member states, regional offices, headquarters staff, and the academic world. The Unit's initial efforts are concentrated in four areas, beginning with WHO's central concern for the functioning of health systems. Health has been identified as a major precondition for economic development (1). Questions of access not only to essential healthcare, but also to the benefits of new technologies are in urgent need of further scrutiny from an ethical as well as technical viewpoint. Other issues, such as those that arise from the increasing reliance on long term care (2), need to be tackled by industrialised and developing countries alike, with special attention to the implications for individual, familial and societal responsibilities for care generally. Finding common-and just-standards will be a major theoretical as well as practical challenge (3). The topics already receiving attention are:

the value assumptions embedded in using clinical and outcomes data to rationalize and prioritise healthcare services;
the ethical consequences of increasing economic globalisation for health and healthcare; and
the intersections between ethics and human rights in the context of public health.

Second, many parts of WHO are involved with the practical, scientific and ethical issues in human genetics and genomics, as was apparent from the release of Genomics and World Health by WHO's Advisory Committee on Health Research (4). Among the topics on which the ETH team is working with other WHO and UN units are:

privacy and confidentiality issues raised by the development and use of genetic databases and of 'banks' of human biological specimens generally;
issues for drug companies, researchers and patients from the application of genetics to pharmaceutical testing and licensing;
the range of practical and theoretical issues in the patenting of human genes; and
the ethical aspects of genetic screening, testing, and counselling (a subject on which WHO has previously issued guidelines) (5,6).

Ethics and research

Both because of its obligations to member states to help them in building up their research capacity and because many WHO projects involve research with human beings which must be conducted according to the highest ethical standards, the Organization has been engaged for some time in a number of activities in this field. These have ranged from running workshops for committees that review the ethics of research to promulgating guidelines and standards. ETH is working not only to coordinate these activities, both within WHO and with other outside efforts such as those of the Council for International Organizations of Medical Sciences (CIOMS) (7), but also to make sure that the information provided is accurate and consistent. This process will have to involve a wide range of countries if it is to deal satisfactorily with many contentious disputes, such as those over research in developing countries especially regarding HIV AIDS (8-12). In addition, the Unit is working with others in WHO on developing an assessment tool to make research design and informed consent processes more culturally sensitive, and is analysing standards to see when special consideration is needed for research with populations in 'at risk' situations, including indigenous peoples, victims of disasters and recipients of humanitarian aid, children and pregnant women. This work should be helped by a study of universal Vs. culturally based approaches to bioethics.

Finally, a number of the ongoing projects involve biotechnologies, from human reproduction to the safety and ethical issues in increased international 'trade' in human organs and tissues. Another related field being studied is the implications for health systems of developments in human stem cell research; the emphasis here is not on the much discussed topic of the cells' derivation but rather their potential uses in drug and toxicology testing, in research and in treatment of a wide range of diseases, particularly chronic or degenerative conditions such as diabetes, Parkinson disease and Alzheimer disease.

Future directions

Besides forging linkages among activities in Geneva and the regional offices of WHO, ETH will work with other international and regional bodies on bioethics topics, in particular through interagency activities within the United Nations system and through its facilitation of the Global Summit of National Bioethics Commissions. ETH has already established a substantial web page (http://www.who.int/ethics/en/)to foster communication and information dissemination, especially through the Global Bioethics Calendar. It also provides education for WHO staff on the ethical aspects of their work, organises lectures, and provides an opportunity for junior and senior visiting fellows to join the unit temporarily. Staff at Headquarters whose programmatic responsibilities intersect with topics in bioethics meet monthly as the Ethics Council. This group addresses the full range of bioethics topics identified as relevant to the Organization's work; particular issues requiring greater inter-cluster attention or formal decisions are then addressed by ad hoc working groups. ETH hopes to develop working relationships with ethics centres around the world, as needed to carry out its responsibilities. Eventually, this should lead to the formation of a network of WHO collaborating centres in bioethics (units within academic or research institutions which cooperate with specified technical programmes according to mutually agreed terms of reference).

While still a new part of WHO, ETH has begun many challenging projects. It welcomes input on these-or other, related bioethics topics-from healthcare providers and policymakers, experts in academia, government and the private sector, and students of healthcare ethics generally.

References
1. Commission on Macroeconomics and Health. Macroeconomics and health: investing in health for economic de-velopment (Report). Geneva: WHO, 2001.
2. WHO Cross-Cluster Initiative on Long-term Care. Ethic- al choices in long-term care: what does justice require? Geneva: WHO, 2002.
3. Macklin R. Against relativism. Cultural diversity and the research for ethical universals in medicine. New York/Oxford: Oxford University Press,1999.
4. Advisory Committee on Health Research. Genomics and world health. Geneva: WHO, 2002.
5. UNESCO. Universal declaration on the human genome and human rights. Paris: UNESCO, 1997.
6. World Medical Association (WMA). Declaration of He- lsinki: ethical principles for medical research involv-ing human subjects.http://www.wma.net/e/policy/17-c_e.html, 2000.
7. Council for International Organizations of Medical Sci- ences (CIOMS). International ethical guidelines for bio-medical research involving human beings. Geneva: CIOMS, 2002.
8. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immuno-
deficiency virus in developing countries. N Engl J Med 1997; 337:853-856.
9. Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997;337:847-849.
10. Bhutta ZA. Ethics in international health research: a perspective from the developing world. Bull World Health Organ 2002;80:114-120.
11.Benatar SR. The HIV/AIDS pandemic: a sign of instability in a complex global system. J Med Phil 2002;27:163-177.
12. Feinberg J, Japour AJ. Scientific and ethical considerations in trial design for investigational agents for the treatment of human immunodeficiency virus infection. J Clin Infect Dis 2003;36:201-206.

ALEXANDER MORGAN CAPRON*, NIKOLA BILLER-ANDORNO**
*Director and **Ethicist in the Ethics and Helath Unit, WOrld Health Organization, 20, Av Appia, CH-1211 Geneve 27, Switzerland. e-mail:ethics@who.int