Human organ and tissue transplantation
Transplantation of human organs and tissues, which saves many lives and restores essential functions for many otherwise untreatable patients, both in developing and developed countries, has been a topic for ethical scrutiny and health care policy-making for more than thirty years. In 1991, the World Health Assembly approved a set of Guiding Principles (see link below) which emphasize voluntary donation, non-commercialization and a preference for cadavers over living donors and for genetically related over non-related donors. While they have had a great influence on professional codes and legislation, these Principles do not directly address safety concerns and they face challenges from leaders in the field who urge that policies be changed to allow the use of "incentives" to increase the numbers of organs for transplantation, from the involvement of organ donation programs in commercialized tissue operations, and from "organ trafficking" (such as that described in the 10 May 2003 Lancet) which apparently occurs in a number of countries where payment for organs is supposedly outlawed.
In response to a request from the Government of Colombia, the Ethics department (ETH), along with what is now the Department of Essential Health Technologies (EHT/HTP), undertook a study of the current issues in organ and tissue transplantation. On 28 May 2003, the WHO Executive Board, having considered the resulting report from the Secretariat, requested that the subject be reexamined and a preliminary report submitted at its next meeting in January 2004. ETH/SDE and EHT/HPT, with advice from a wide range of experts and special support from transplant officials in Spain, the United States, and France, jointly carried out a consultation process which culminated in a meeting in Madrid from 6-9 Oct. 2003, at which 37 clinicians, ethicists, social scientists, and government officials from 23 countries, representing all WHO regions and all levels of economic development, closely analysed issues of global concern regarding the ethics, access and safety of tissue and organ transplantation. The report by the Secretariat produced by EHT and ETH was accepted by the Executive Board, which on 22 January 2004 adopted a resolution recommending action by the World Health Assembly in May 2004.
On 22 May 2004, the 57th World Health Assembly adopted a slightly amended version of the resolution. The WHO Secretariat is now at work on the tasks set forth in that resolution and will report back at a later date to the Assembly.
Bibliography on ethics and and organ transplantation, collected by the Department of Ethics, Trade, Human Rights and Health Law, Geneva, August 2004
Official WHO documents
- Report by the Secretariat, May 2003
Report by the Secretariat, January 2004, including Draft Resolution
Resolution adopted by the Executive Board, 22 January 2004
Resolution adopted by the 57th World Health Assembly, 22 May 2004
- Resolution of the World Health Assembly, 1989
European legislation and resources
Directive of the European Parliament and of the Council of 31 March 2004 (Directive 2004/23/EC) on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Opinion of the European group on ethics in science and new technologies to the European commission on the ethical aspects of tissue banking
Additional protocol to the convention on human rights biomedicine concerning trnaplantation of organs and tissues of human origin, Council of Europe, 2003
Replies to the questionnaire for member states on organ traffickking, Steering Committee on Bioethics (CDBI) and European Health Committee of the Council of Europe (CDSP)
Report of the Nuffield Council on Bioethics on Human tissue: ethical and legal issues, 1995
Report of the Nuffield Council on Bioethics on Animal to human transplantation: the ethics of xenostransplantation, 1996
- World Medical Association statement on human organ and tissue donation and transplantation, 2000
- Organ trafficking and transplantation pose new challenges