This is the first issue of the newsletter in 1999, after a pause of over a year. This does not mean that 1998 has been a year without activities which is evident below. This newsletter will also be sent to most of you by email, in order to save postage costs and the time it takes to stuff envelopes. ETHICA is a network with very little infrastructure in Bergen, although we are working on improving this. The newsletter is being sent to those who have contacted us and to others we think might be interested in receiving it. If you are not interested in receiving future issues, please let us know.

Issues of medical ethics have received increasing attention during the past few years. Most of the attention has, however, been on issues related to concerns of Western, industrialized nations. There has been comparatively little emphasis on ethical issues related to health in developing and non-Western countries. The main aim of ETHICA is to facilitate research on ethical issues of special relevance to developing countries, by establishing a network of researchers and by proposing and seeking funding for collaborative research proposals. ETHICA has thus far concentrated on three major areas, and has been successful in initiating or participating in several collaborative research projects. The three areas are research ethics, ethics of health policy, and cross-cultural ethics.

RESEARCH ETHICS

Collaborative clinical research raise special ethical problems, such as how to deal with different economic conditions and different cultural traditions in partner countries. The controversy surrounding the HIV perinatal transmission studies have highlighted the inadequacy of currently accepted research ethics guidelines to deal with these issues. There is therefore an urgent need to develop new, more appropriate guidelines. A background paper has been prepared which examines these issues. It is available at the address below.

EU-project on ethical, social and legal issues of vaccines

Bergen is a partner in a recently funded EU project on ethics of vaccine developmen, EURO-ELSAV. Bergen is responsible for a sub-part of this project dealing with ethical issue in international collaborative vaccine trials. An international workshop was organized in Bergen in November 1998 on this topic. A WEB site as well as background reports will be produced during this three year project.

Report on Community Advisory Boards

A number of international research ethics guidelines have recommended that Community Advisory Boards should be part of the research protocol evaluation process. There has been relatively little experience with such boards in Europe. An international workshop on Community Advisory Boards for HIV clinical trials was organized in Bergen in 1997. The report from the workshop is now available. Some of the key recommendations include:

• One should strengthen the operating procedures of such Boards
• There should be less dependence of pharmaceutical company support
• Training programs should be introduced

The report is available at the address below. It is available free if sent via email.

Training workshops for ethics committees in developing countries

Bergen has been asked by UNAIDS to develop training material as well as to organize training workshops on research ethics in a number of countries during 1999. Workshops are planned for countries in Asia, Africa and Latin-America. The background material should be available in March 1999.

HEALTH POLICY AND ETHICS.

Recently, a number of initiatives for health sector reform have been proposed, such as increased reliance on the private sector, introduction of basic packages, or the use of Disability Adjusted Life Years (DALYs) for identifying cost-effective interventions. There is an urgent need to examine the ethical issues associated with these proposals, but they have received little, sustained attention.

Human Rights, Equity and Health Sector Reform

This is a two-year (1998-1999) TDR/WHO funded project, involving Bangladesh, Sri Lanka and Thailand. The major aim of this project is to explore the relevance of human rights instruments for health sector reform. The first project meeting was organized in Bangkok in October 1998. An annotated bibliography on equity and health policy has been developed. It is available at the address below. Several background documents as well as Ph.D. projects are in the process of being implemented under this project.

Course in ethics and health policy

A course in ethics and health policy will be offered by the Department of Philosophy during February 1999. The first class meeting is Wednesday, February 3, at 12:15 in Auditorium E, Sydneshaugen Skole. Topics covered will be:

• Ethical issues in the QALY and DALY methodologies
• Key concepts of economic theory: efficiency, Pareto optimality, competition
• Ethical presuppositions of these economic concepts
• Concepts of equity
• Theories of justice, human rights, liberalism
• Economic and social rights. The debate over Asian values

It has often been claimed that contemporary medical ethics shows a bias towards prominent Western values, such as autonomy. There exists, however, very little evidence in the form of empirical studies to back up this claim. There is also an increasing interest in introducing medical ethics into the medical school curriculum in a number of countries. It would be important to develop locally relevant teaching material based on the types of issues that are important in non-Western countries.

Seahen study completed

The data gathering of the South East Asian Health Ethics Network has now been completed. 20 physicians in each of six countries have been interviewed. The countries participating in this study are: Bangladesh, India, Indonesia, Myanmar, Nepal and Sri Lanka. The physicians were asked to identify the ethical problems which they encountered in their clinical practice, and to explain why they were perceived as ethical problems, and how they dealt with these issues. The interviews have been transcribed and are now being analyzed. This is probably the first, major empirical study of this type in the region, and will provide material which will document how ethical issues are dealt with in this region. In addition questionnaires were distributed to 50 physicians in each of the countries, containing questions about ethics in clinical medicine as well as ethics of resource allocations. The questions have been used in Western countries previously, and will provide comparative material when analyzed. It is expected that the first report of the questionnaire study will be available in May 1999. Country reports have also been prepared which will be available in February 1999. A searchable database on literature about health ethics in the region is now available on the net.

The material will be used to develop regionally relevant course material. This will be done at the workshop in Thailand in August 1999, but preliminary outlines are already available.

UPDATE: Ethical issues in health policy in Sri Lanka

This is a five year (1996-2000) NUFU funded collaborative project between the University of Colombo, Sri Lanka and the University of Bergen, Norway. The main aim of the project has been to establish a Research Group in Medical Ethics in Colombo which will be a resource group and a focal point for the examination of ethical issues in health care in Sri Lanka. During the past year there has been direct involvement in the health policy process in Sri Lanka. The President of Sri Lanka appointed a Task Force on Health Policy Implementation in January 1997. Dr. Saroj Jayasinghe, who is part of the NUFU collaboration, was appointed as the coordinator of the Task Force, as well as a member of two sub-committees. Professor Nalaka Mendis, co-coordinator of the NUFU collaboration, was appointed a Task Force member, a member of one of the sub-committees, and chair of the Committee on Legislative Framework for Health Services.

FOCUS: HEALTH AS A HUMAN RIGHT

The International Covenant on Economic, Social and Cultural Rights, article 12, states that "the States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health". In the Constitutions of a number of countries, a similar "right to health" is recognized. The South African constitution, article 27 (1) states that everyone has the right to have access to health care services, including reproductive health care and in article 27 (2) it says that the state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of these rights. In November 1997, the Constitutional Court of South Africa decided on a case involving the scope of such a "right to health". The case involved a diabetic man with ischaemic heart disease and cerebro-vascular disease with chronic kidney failure. He was rejected for the dialysis program on the grounds that there was a shortage of dialysis machines and dialysis had to be reserved for people with acute renal failure or for patients who are candidates for kidney transplantation. He appealed this decision on the grounds that the South African Constitution gives every person a right to life and that nobody may be denied emergency medical treatment. The Court rejected the appeal on the grounds that this was not an emergency treatment, and that a right to life should be interpreted as a right to non-interference, but not necessarily a duty to sustain life. In the words of the Court

"It [article 27(3)] provides reassurance to all members of society that accident and emergency departments will be available to deal with unforeseeable catastrophes which could befall any person, anywhere and at any time" (section 51)

and

"The applicant suffers from chronic renal failure. To be kept alive by dialysis he would require such treatment two to three times a week. This is not an emergency which calls for immediate remedial treatment. It is an ongoing state of affairs resulting from a deterioration of the applicant's renal function which is incurable" (section 21)

Although the appellant did not appeal the decision on the basis of the South African Constitution's article 27 (1) giving everyone a right to have access to health services, the Court did discuss this matter. The Court pointed out that it is not disputed that the Department of Health

"does not have sufficient funds to cover the cost of the services which are being provided to the public ... This is a nation-wide problem and resources are stretched in all renal clinics throughout the land. Guidelines have therefore been established to assist the persons working in these clinics to make the agonising choices which have to be made in deciding who should receive treatment and who not" (section 24).

The Court further maintained that the current guidelines are justified by the fact that more patients would benefit from the limited resources available than by any alternative use of resources, and that "it has not been suggested that these guidelines are unreasonable or that they were not applied fairly and rationally when the decision was taken by the Addington Hospital that the appellant did not qualify for dialysis" (section 25).

Although there has been little criticism of this particular decision, and the reasons the Court gave for its decision, there has been criticism of a more principled type. The Court seems to have rejected any involvement by the courts in appeals of this type, when it stated the provincial administrations should make decisions as to how funds for health care should be spent and that courts should be "slow to interfere with rational decisions taken in good faith by the political organs and medical authorities whose responsibility it is to deal with these matters" (section 29).

And

"courts are not the proper place to resolve the agonising personal and medical problems that underlie these choices. Important though our review functions are, there are areas where institutional incapacity and appropriate constitutional modesty require us to be especially cautious. Our country's legal system simply cannot replace the more intimate struggle that must be borne by the patient, those caring for the patient, and those who care about the patient. The provisions of the bill of rights should furthermore not be interpreted in a way which results in courts feeling themselves unduly pressurized by the fear of gambling with the lives of claimants into ordering hospitals to furnish the most expensive and improbable procedures, thereby diverting scarce medical resources and prejudicing the claims of others" (section 58).

This view of the role of the courts has been criticized by Darrel Moellendorf in a recent article in the South African Journal of Human Rights (vol 14, part 2, pp. 327-333). Moellendorf argues that the courts should rule on what is meant by "within available resources" and that the Constitutional Court previously has recognized that rulings on soci-economic rights do have budgetary implications: "the Court's role in upholding socio-economic rights is not foreseen as limited to the framework of existing national or provincial budgetary allocations. Rather the court may pass judgments on these rights, as with other rights, that require a change in fiscal priorities" (p. 331).

The South African case raises a number of interesting issues. The first is the general one of the role of human rights instruments in health policy and the role of the courts in enforcing such rights. In the literature on social and economic rights it has been recognized that some type of monitoring mechanism is necessary, similar to what is found with regard to political and civil rights. Some mechanism needs to be in place to hold states accountable for providing appropriate health care. However, most commentators have been reluctant to suggest that the most appropriate monitoring should be through the existing court system as courts tend to focus on the individual circumstances of a particular person rather on the wider policy implications of the decision. There is therefore an urgent need to suggest novel, legal and other approaches to this matter. The second issue raised by the South African case is connected with the recent controversy over the perinatal HIV transmission studies. The controversial placebo controlled studies were initiated in a number of developing countries with the justification that this would be the only way to obtain knowledge useful for these countries. There was an urgent need to ascertain whether a short course AZT treatment, which would be much cheaper than the long course, unaffordable treatment, was more effective than placebo in reducing transmission of HIV from mother to child. Last year it was found that such short course treatment was indeed effective in reducing transmission. However, the Minister of Health in South Africa decided in October, 1998 not to provide funding for such short course treatment, arguing that it was not justified given the limited resources of the State. Naturally, this decision has outraged those who defended the trials as well as HIV patient advocates worldwide. Initiatives are underway to challenge this decision legally, using the provision in the South African Constitution guaranteeing access to health services as well as a much stronger right to health care for children. This is going to be an important case to follow.

PERSONS ASSOCIATED WITH ETHICA IN BERGEN

Faculty:

Professor Reidar K. Lie, Department of Philosophy

Professor Tore Nordenstam, Department of Philosophy

Associate Professor Ole Frithjof Norheim, Department of Community Medicine

Ph. D. Students:

Banson Barugahare, M.Phil, from Uganda

Olandim Fonseca, M.D. from Brazil

Sanga Intajak, R.N., M.A. from Thailand

Rafiqul Islam, M.D. from Bangladesh

Kjetil Karlsen, M.D. from Norway

AVAILABLE REPORTS:

• Report on Community Advisory Boards
• Annotated bibliography on Equity and Health Policy
• Background document on ethical issues in international collaborative research
• Course outlines for one week courses in General medical ethics, ethics and health policy and research ethics.
• Country reports from the SEAHEN study (February 1999)
• Training material for research ethics workshops (March 1999)
• Results of the SEAHEN questionnaire study (May 1999)

All of these reports are free if sent by email. If sent by ordinary mail we have to charge NOK 100 for each report to cover photocopying and postage.