Draft World Health Organization (WHO) guidelines on bioethics
The guidelines below are a draft version, open to consultation before being presented at the World Health Assembly in May 1999.
The text has been prepared by Abdullah Daar, surgeon and bioethicist from Sultan Qaboos University in Oman, and, Jean-François Mattei, French physician and member of parliament (Démocracie Liberale, Bouches-du-Rhône). Comments should be sent to Abdullah Daar.
MEDICAL GENETICS AND BIOTECHNOLOGY: IMPLICATIONS FOR PUBLIC HEALTH
Executive Summary
Background
In May 1998, WHA51.10, 3 (1), called on WHO's Director-General "to establish a group, involving also government experts, with the aim of clarifying concepts and developing guidelines relating to the use of cloning procedures for non-reproductive purposes". The resolution further requested the Director-General "to continue to monitor, assess and clarify, in consultation with other international organizations, national governments and professional and scientific bodies, the ethical, scientific, social and legal implications of the use of cloning for human health".
Scope and mandate
Accordingly, the final mandate of the co-rapporteurs was to develop a strategy for WHO to monitor developments, provide advice and formulate guidelines in the area of gene manipulation in all actual and possible applications, where these could have implications for human health.
Consultation process
The following draft guiding principles and recommendations will be part of the formal report submitted by the Director-General to the Board and the Assembly. They are being submitted to the ACHR for its comments and suggestions. They will also be circulated to expert groups related to other WHO programmes dealing in particular with reproductive health, infectious diseases, tropical diseases, and genetics. As recommended by the Health Assembly, the consultation process, in the following months, will be extended to national governments, and relevant international organizations and professional and scientific bodies.
Based on this consultation and with the guidance of the Executive Board, a larger meeting should be held in Geneva in March 1999 to finalize the guidelines and recommendations in time for the World Health Assembly at its 52nd session, in May 1999.
Rapporteurs' Introduction
The Approaching Genetics Revolution
The genetics revolution will change the traditional boundaries between disciplines. It will force us to reassess the contribution to health of environmental factors, including chemical, infectious, physical, social, psychological, and nutritional factors. It will give us new tools to manipulate these environmental factors in relation to individual genetic endowment, thereby personalizing prevention and therapy in a way not possible previously. This will include the management not only of acute diseases but also of chronic diseases such as Alzheimer's disease, cancer and diseases of the cardiovascular system.
Completely new paradigms will result from the application of genetic knowledge, often in combination with other disciplines. For example, genetics and tissue engineering provide hope for patients with end-stage organ failure; genetics and cell culture techniques provide hope for replacement tissue for patients with Parkinson's disease and epilepsy.
The genetics revolution, fuelled by developments in information technology, will have far-reaching consequences for humanity in the next century. It will challenge our understanding of ourselves, of what it means to be human; of the etiology, manifestation, progression, and management of diseases, not only physical but perhaps also of behavioural and mental illness. The new era will witness a profound change in traditional health-care delivery and public health; and in the pharmaceutical and agricultural industries. It will challenge our ability to develop societal guidelines and to provide relevant, accurate, timely, and coordinated information only to the public and to politicians, policy-makers, and legislators.
The enormous changes that genetics promise require that we specifically prepare for them. We should develop strategies now, to be able to anticipate and manage the long-term public health implications of this revolution, coordinate our efforts, and harmonize standards and practices at international level.
Risk versus Benefits: the need for ethics
Draft report, guiding principles and recommendations
The draft Guiding Principles are meant to guide WHO as the field evolves. They attempt to encapsulate the essence of current scientific and ethical concerns arising from the genetics revolution and some of the main societal responses to these concerns. The proposed guiding principles are based on fundamental values such as dignity, human rights and freedom, as invoked by the UN Charter and other international instruments. They are also inspired by basic principles of medical ethics, including beneficence, non-maleficence, confidentiality, autonomy, and equity of access to care for all. The aim has been to ensure that these values can be faithfully incorporated in WHO's policies and cooperation work in areas of genetics related to human health.
The Guiding Principles refer to practical issues which are likely, directly or indirectly, to affect individual and public health as the genetics revolution begins to alter the way in which we conceive of, prevent, screen for, diagnose and manage diseases globally. They are followed by recommendations to WHO as a whole and to countries more specifically.
An important part of the rapporteurs' mandate has been to identify issues specifically relevant to developing countries. Some argue that high-technology methods are not applicable in developing countries. However, this is not the case. Vaccines, for example, are "high-tech" products, but developing countries have always been major users of them. The same may well be true for genetics in the future. In the report, we have highlighted areas where the developing world may be able to leverage its genetic resources, and suggested methods through which the technological gap between industrialized and developing countries could be narrowed. It must also be stressed that, irrespective of their current stage of technological development, developing countries have an intrinsic right and fundamental interest in participating in the global debate on policies and practices relating to genetics and human health.
DRAFT GUIDING PRINCIPLES
GENERAL ISSUES
2. Genetics research and development must be accompanied by public education and debate involving all relevant sectors of society. Negative perceptions of science can detract from the beneficial application of genetics to human health. Ethical concerns in this area should be given serious consideration and be dealt with carefully.
3. The Human Genome Project is contributing greatly to understanding the genetic basis of disease and development of diagnostic tests. This and related research has the potential to promote health and prevent disability and premature death. The research must continue as a common global enterprise for the benefit of humankind. The knowledge it generates should be in the public domain and its fruits be distributed equitably.
4. As UNESCO's Universal Declaration on the Human Genome and Human Rights points out, the human genome is the common heritage of humankind. To protect the interests of public health, the genome's basic elements should not be granted patent protection.
5. While much of human ill-health has a genetic component, environmental, behavioural and other factors may also play a significant role. Care must be exercised not to overemphasize the genetic aspect of diseases. The importance of acting on lifestyles and environmental factors to help prevent diseases such as cancer and reduce their severity must continue to be stressed.
6. Hurried and premature legislation in the rapidly-evolving field of genetics can be counterproductive. Legislation and guidelines should be based on a full and sound scientific and ethical assessment of the techniques concerned. They should be general enough to accommodate new developments, and they should be reviewed periodically.
GENETIC MATERIALS AND INFORMATION - RIGHTS AND RESPONSIBILITIES
7. Individuals have the right to retain control over their genetic material and the information derived from it. Access and use must be defined through consent, contract or law. Genetic information should not be used as the basis for refusing employment or insurance. Exceptions would have to be legally defined.
8. When conducting genetic research among defined populations, recognized ethical principles governing research on human subjects must be extended to include group consent, confidentiality, and the protection of the group's identity, culture, reputation and traditional beliefs. The fruits of research must be shared equitably with the populations according to prior agreement.
9. The use of traditional knowledge for genetic research and development of new products must be acknowledged and, where appropriate, justly compensated.
10. The Biodiversity Convention acknowledges that governments have specific rights over their non-human genetic resources. The same should be acknowledged for their human genetic resources, subject to the rights and interests of the individuals and populations studied.
11. Patents are designed to protect intellectual property and stimulate innovation and they are part of the product development process. The private sector, however, also has public responsibilities. A balance must be sought between the need for patent protection and the obligation to ensure society's access to the health benefits of new knowledge and technology.
12. The proper conduct of biomedical researchers, including medical practitioners, demands publication at an early opportunity of medical research findings with significant implications for public health. The withholding of such findings for financial or other personal gain is contrary to professional ethical behaviour.
13. International collaborative research with developing countries should be encouraged. It should be carried out with the explicit agreement of the authorities of the countries in which the research is done, with the full and informed consent of the individuals concerned, and with due respect for their cultures, traditions and beliefs.
14. The ownership and intended uses of specimens must be clearly defined and explained to the donor before their collection. Donors must be able to specify or limit the uses - present or future - to which specimens are put. Privacy and confidentiality must be maintained, through coding or other such mechanisms.
15. The collection of genetic data in databanks, coupled with ease of communication and analysis, presents the danger of misuse. Clear and enforceable regulations must be developed to protect the public against misuse of genetic databanks.
16. There is a great need for guidelines on the use for genetics research of the large numbers of previously collected and stored specimens. The guidelines should seek to reconcile concern for the rights of individual specimen donors with concern for the potential benefits of research to society. The issues are complex, and patience and caution must be exercised while guidelines are being developed.
GENETIC INTERVENTIONS
General
Non-Human Uses
19. If animals are to be used in genetics research which might involve genetic manipulation or cloning, this should be done in full compliance with internationally recognized principles to ensure their welfare. Such use should also be accompanied by a careful assessment of any potential harm to human and animal health and to the environment.
Human Uses
21. Sex is not a disease. Except for severe sex-linked genetic disorders, the use of genetic services for the purpose of sex-selection is not acceptable.
22. Somatic gene therapy holds promise for improving human health, but possible risks for health must be balanced against possible benefits. In delivering such therapy, care must be exercised that vector/gene components do not contaminate germ lines. At present, germ-line therapy is not acceptable, but this should be reviewed with advancing knowledge.
23. The term "cloning" can be applied not only to whole mature organisms, but to DNA, genes, cells, tissues, organs, embryos and fetuses. Statements about cloning must differentiate between these levels.
24. The cloning of DNA, genes and cells has been used in the manufacture of vaccines, pharmaceuticals and diagnostic products over a long period of time, without negative ethical or medical consequences, but safeguards should be put in place as new techniques and applications develop.
25. Major potential benefits may come from the development of cloning techniques for the production of human tissues and organs from non-embryonic cells. Care should be taken that such applications of cloning are developed in conformity with ethical and legal requirements.
26. As stated by resolutions WHA 51.10 and EB101.R25, "loning for the replication of human individuals is ethically unacceptable and contrary to human dignity and integrity". Elaboration of the ethical, scientific, social and legal considerations that are the basis of this call for the prohibition of reproductive cloning should continue.
27. Deliberate reproductive cloning by embryo splitting is also unacceptable. However, the use of embryo splitting for non-reproductive purposes in the form of biopsies, for pre-implantation genetic diagnosis of serious clinical disorders, is seen as acceptable in some countries.
28. As recognized by the World Health Organization, non-reproductive, in vitro cloning research, with the clinical objective of repairing damaged tissues and organs has important potential benefits. Relevant animal research would be acceptable provided it was carried out in accordance with the CIOMS ethical guidelines on the use of animals in biomedical research. Guidelines addressing the possible involvement of human gametes or embryos must be developed.
DRAFT RECOMMENDATIONS TO THE WORLD HEALTH ORGANIZATION
It is recommended that the World Health Organization should do the following:
1. Establish an integrated genetics resource centre within WHO. In coordination with relevant bodies and organizations, this resource centre would help countries:
2. Carry out a survey of genetics research institutions and genetics services; identify areas of need and support capacity-building where there is a deficiency.
3. Encourage non-profit organizations to focus on capacity-building for genetics research and applications, especially in developing countries.
4. Inform members of parliament about developments in genetics; enlist the support of medical MPs to introduce appropriate legislation related to public health and economic aspects of genetics; and cooperate with the International Medical Parliamentarians Organization (IMPO) to organize a conference on the public health aspects of genetics.
5. Request that the Council for International Organizations of Medical Sciences (CIOMS) hold a conference on the ethical, legal, social and economic aspects of genetics applied to human health. In its revision of the International Guidelines on Biomedical Research involving Human Subjects, CIOMS should also be requested to cover genetics.
6. Monitor developments and assist countries in establishing the necessary legal and regulatory measures to prohibit human cloning for reproductive purposes.
7. Ensure that cloning research has clear ethical guidelines, distinguishing between the levels of concern relating to each of the different techniques involved, and between research and application.
8. Assign to the Special Programme of Research, Development and Research Training in Human Reproduction (HRP) the task of reviewing and assessing recent technical developments in medically-assisted procreation and their ethical and social implications.
9. Implement the recommendations of the WHO Task Force on Organ Transplantation and the WHO Consultation on Xenotransplantation.
10. Ensure that ethical concerns are given due consideration and visibility in all WHO technical activities and programmes with whatever coordination is required for consistency.
11. Play a leading role in the international harmonization of guidelines on genetics research and its applications; and collaborate with the relevant bodies in defining and harmonizing fair intellectual property laws that relate to human health.
12. Develop, as a matter of urgency, a WHO Declaration on the medical and public health aspects of genetics, using as a starting point the Guiding Principles and Recommendations contained herein, the Preliminary Statement on Ethical Issues in Medical Genetics, the Proposed Guidelines on Genetic Counselling, and other relevant documents.
DRAFT RECOMMENDATIONS TO COUNTRIES
Countries, if they have not yet done so, should consider taking the following steps:
1. To encourage genetics research and development for the promotion of human health.
2. To regulate patenting of genetic materials and life-forms and the release of genetically modified organisms and plants.
3. To regulate genetic testing and screening in order to protect individuals with regard in particular to:
4. To establish a mechanism to monitor practices and ensure that regulations are implemented.
5. To raise public awareness of the importance of genetics in human health by including it in school curricula, and by giving the necessary prominence to the relevant aspects of genetics in education, training and continuing education in the fields of medicine, public health, law, business and government services related to public health and international trade.
6. To develop training and a career structure in the field of medical genetics for counsellors, laboratory technicians, physicians and related professions.
7. To establish a broadly based national body to advise the government in such areas as:
8. To monitor developments in the clinical use of genetic modification so as to optimize the safety and ethical acceptability of the procedures involved. Issues such as xenotransplantation require international coordination to harmonize guidelines and regulatory instruments (see WHO document, Xenotransplantation: guidance on infectious disease prevention and management).
To comment on the draft WHO guidelines, all correspondence should be addressed to:
The World Health Assembly and the Executive Board have declared human cloning for reproductive purposes ethically unacceptable and condemned its potential use as contrary to human dignity and integrity (WHA50.37, WHA51.10 and EB101R.25).
To coordinate work and facilitate consultation on these issues, the Director-General designated Professor A.S. Daar, from Oman, and Professor J.-F. Mattei, from France, to prepare a report on the current and potential applications of cloning and the various issues they raise. It soon became clear that to deal adequately with cloning it was necessary to put it in perspective, and consider the specific areas of science and human activity within which cloning may be applied. Only then can one begin to understand the potential uses and consequences of this technique, and the related risks and benefits for society and for human health.
From 12 to 14 October 1998, a small working group of independent and government experts met in WHO to consider a first draft of the report, including a narrative and proposals for recommendations to WHO and its Member States. Further work on the narrative part of the report is now being done by the members of the working group, each in their specific areas of interest and expertise. The report will be available as a background document to WHO Executive Board at its January 1999 session.
Genetics is promising a revolution in health care. We are beginning to make major inroads, particularly in the use of genetics to understand disease mechanisms. The picture that is emerging is that while our genes may have "loaded the gun", it is environmental factors that "pull the trigger". Thus new opportunities are opening up for the promotion of individual and public health, and for the prevention of disease, disability, premature death and economic waste.
There are obvious potential risks and benefits in the genetics revolution and it is impossible as yet to quantify the ratio. The impression is one of islands of danger in a sea of possibilities. But the field is moving too rapidly and there are too many stakeholders to be able, objectively, to determine either the value of specific scientific endeavours or the risks attached to them. More than anything, the outcome of the first reading of this new map should be to encourage the engagement of every informed individual in continuous analysis and probing of the science and the values it enhances or challenges. Perhaps at no other time in modern medical history have we been faced with stakes that were so high in terms of risk and benefit to our health. This presents an urgent need for ethics education, sensitivity and application. To cope with this revolution, one of the most important requirements is to increase the flow of information and the level of public education and discussion.
The draft report builds upon and extends work done by WHO's Governing Bodies and Technical Programmes. The report is in two parts: the first is a narrative that summarizes current science and its attendant ethical, social and legal implications (ELSI). The second includes draft WHO Guiding Principles and recommendations to WHO and its Member States.
1. The genetics revolution holds promise for the betterment of human health. The new biotechnology also has potential to cause major harm if misapplied or misused. Developments in genetics must not overtake our ability to develop ethical guidelines calmly, giving careful consideration to all their implications.
17. Although genetic interventions hold great promise for the betterment of human health, vigilance should be exercised lest they contribute to racism, stereotyping, stigmatization, discrimination or the development of ruthless social policy. State-sponsored eugenics and discriminatory policies based on genetic inheritance are unacceptable. Such policies violate human dignity and freedom and contravene the Universal Declaration of Human Rights and other international instruments, and should be condemned.
18. The genetic engineering of plants can contribute significantly to the improvement of human health and well-being. More data, however, are required to be able to reach objective conclusions on risks and benefits. Research and development must continue, but vigilance and ongoing review of potential harm are also needed. The release of genetically modified organisms and crops must fully take into account possible risks for human health and the environment, and also conform with the need to maintain and protect biodiversity in the long term.
20. With regard to genetic testing and screening, the principles of voluntariness, consent, information and comprehension, privacy and confidentiality must always be upheld. Counselling, before and after testing, should avoid coercion and be as non-directive as possible. Results of gene tests must not be released to those who do not wish to know them. Decisions resulting from testing must be made autonomously by the individuals being tested.
Abdullah Daar
Professor of Surgery
College of Medicine
Sultan Qaboos University
Oman
Fax 1-815-364 0816
Email: asdoc@gto.net.om
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