When physicians have responsibilities both to their patients and to a third party and when these responsibilities are incompatible, they find themselves in a situation of 'dual loyalty'. Third parties that demand physician loyalty include governments, employers (e.g., hospitals and managed care organizations), insurers, military officials, police, prison officials and family members. Although the WMA International Code of Medical Ethics states that "A physician shall owe his patients complete loyalty," it is generally accepted that physicians may in exceptional situations have to place the interests of others above those of the patient. The ethical challenge is to decide when and how to protect the patient in the face of pressures from third parties.

Dual loyalty situations comprise a spectrum ranging from those where society's interests should take precedence to those where the patient's interests are clearly paramount. In between is a large grey area where the right course of action requires considerable discernment.

At one end of the spectrum are requirements for mandatory reporting of patients who suffer from designated diseases, those deemed not fit to drive or those suspected of child abuse. Physicians can fulfil these requirements without hesitation, although patients should be informed that such reporting will take place.

At the other end of the spectrum are requests or orders by the policy or military to take part in practices that violate fundamental human rights, such as torture. In its 2003 Resolution on the Responsibility of Physicians in the Denunciation of Acts of Torture or Cruel or Inhuman or Degrading Treatment of which They are Aware, the WMA provides specific guidance to physicians who are in this situation. In particular, physicians should guard their professional independence to determine the best interests of the patient and should observe, as far as possible, the normal ethical requirements of informed consent and confidentiality. Any breach of these requirements must be justified and must be disclosed to the patient. Physicians should report to the appropriate authorities any unjustified interference in the care of their patients, especially if fundamental human rights are being denied.

Closer to the middle of the spectrum are the practices of some managed health care programmes that limit the clinical autonomy of physicians to determine how their patients should be treated. Although such practices are not necessarily contrary to the best interests of patients, they can be, and physicians need to consider carefully whether they should participate in such programmes. If they have no choice in the matter, for example, where there are no alternative programmes, they should advocate vigorously for their own patients and, through their medical associations, for the needs of all the patients affected by such restrictive policies.

A particular form of a dual loyalty issue is the potential or actual conflict of interest between a physician and a commercial entity on the one hand and patients and/or society on the other. Pharmaceutical companies, medical device manufacturers and other commercial organizations frequently offer physicians gifts and other benefits that range from free samples to travel and accommodation at educational events to excessive remuneration for research activities. A common underlying motive for such company largesse is to convince the physician to prescribe or use the company's products, which may not be the best ones for the physician's patients. The WMA is developing guidelines for physicians in such situations and many national medical associations already have their own guidelines. The primary ethical principle underlying these guidelines is that physicians should resolve any conflict between their own interests and those of their patients in their patients' favour.

An important resource for physicians and other health professionals involved in dual loyalty situations is the report of the International Dual Loyalty Working Group, a collaborative initiative of Physicians for Human Rights and the School of Public Health and Primary Health Care, University of Cape Town, South Africa: Dual Loyalty & Human Rights in Health Professional Practice: Proposed Guidelines & Institutional Mechanisms. It contains chapters on the dimension of the problem, proposed general guidelines for health professional practice, proposed guidelines for practice in difficult settings, and institutional mechanisms to protect human rights in health practice.

Physicians working in prisons face many dual loyalty conflicts. To help them identify and deal with these issues, the Norwegian Medical Association, in collaboration with the WMA, is offering a web-based course on human rights and ethics directed specifically towards prison doctors. It can be accessed at www.wma.net/e/webcourse_2004.htm.

August 2004 - Patents and Human Health

Until recently the patenting of health products was relatively unproblematic. The main point of contention was the length of patent protection, which determined when generic versions of patented drugs could be made available.

During the past decade, however, patenting has become a major source of controversy in relation to health. Two issues in particular have engaged the attention of health organizations, ethicists and other interested parties: the patenting of life forms, including human genes, genetic sequences and embryonic stem cells, and the use of patents to restrict the production of more affordable generic drugs for conditions such as HIV/AIDS, especially in developing countries.

Despite strong opposition from religious, environmental and other interested groups, genetically modified organisms have been patentable in Europe, the U.S.A. and many other jurisdictions since the 1980s. However, there is at present considerable controversy regarding the extent to which human beings, or their parts, should be exempt from patenting. The Human Genome Project of the 1990s identified almost all of the approximately 30,000 human genes and their constituent sequences, and patents have been granted for many of these sequences. However, there has been considerable opposition to the patenting of human DNA, even when it isolated from its natural environment, and European and American patent authorities are now reassessing their criteria for patents of gene sequences.

One National Medical Association that has addressed this issue is the American Medical Association in the 2000 and 2001 reports of its Council on Scientific Affairs: Patenting of Genes and Their Mutations and Gene Patenting: Utility Examination Guidelines.

Another controversy over the application of patent protection has arisen with regard to human embryonic stem cells and even whole embryos that have been created in vitro.

The WMA has not yet dealt with the ethics of patenting life forms, including DNA and stem cells. Its only policy on patenting is the1999 Statement on Medical Process Patents. This Statement opposes the patenting of medical processes on the grounds that this would pose serious risks to the effective practice of medicine by potentially limiting the availability of new procedures to patients and is therefore unethical and contrary to the values of medical professionalism. However, the statement approves of the patenting of medical devices.

The second major patenting issue in regard to health is the availability of low-cost generic drugs in developing countries. This was the subject of difficult negotiations at World Trade Organization meetings, and was partially resolved in 2003 through the Doha Declaration on the TRIPS Agreement and Public Health. However, there are still many related questions about the appropriateness of patent protection in matters of public health. To address these issues, the World Health Organization has established a Commission on Intellectual Property Rights, Innovation and Public Health.
A related issue is the negative effect of patent protection on medical research. Patents have been granted on both products and processes, and researchers often need to use multiple products and processes in their work. In order to avoid patent infringement, even despite the 'research exception' that provides a limited right for researchers to experiment on a patented invention, they spend considerable effort in identifying patent owners and, when necessary, obtaining licenses for use of the patented product or process. This leads to increased costs of both research and the resulting products.
Because of the enormous impact of patenting policies on human health, National Medical Associations, other health organizations and ethicists need to study the issues carefully and participate in both national and international efforts to find optimal solutions to the problems described above.