Human organ and tissue transplantation
Report by the Secretariat
The way forward
Access: improving the supply of organs and tissues for transplantation
12. Further improvements in both policy and ethical guidance could aid progress in transplantation at the global level.
13. Successful experiences in countries with varied cultural, religious and economic backgrounds may prove useful for Member States in establishing national transplantation programmes and improving procurement practices. Although the need for communities to be better educated about transplantation is widely recognized, efficient and transparent regulatory mechanisms are also essential if popular support for procurement activities is to be generated. Donations are motivated not only by altruism and generosity but by the individual's realization that a well-run transplant programme, the existence of which depends on everyone's willingness to donate, is a resource of potential importance for his or her own health.
Quality and safety
Global safety standards
14. Global safety standards for human organ and tissue transplantation are not yet fully in place, despite the recent formulation of specialized and regional guidelines. In 2002, the International Atomic Energy Agency, which supports the development of tissue banks in 30 countries that use radiation to sterilize bone and other tissues, issued a set of International Standards on Tissue Banks. The Council of Europe published a Guide to Safety and Quality Assurance for Organs, Tissues and Cells in February 2002. In June 2002, the European Commission proposed a Directive of the European Parliament and of the Council of Ministers setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells. Essential safety and quality principles applicable from procurement to follow up of recipients and living donors are urgently needed.
Strengthening national legislative and regulatory environments
15. Health authorities are expected to back procurement organizations and enforce ethical and public health requirements. To do so needs a well-defined chain of responsibility that allows full accountability for the proper collection and use of human tissues and organs in transplantation as well as transparency in all related activities. Yet the enforcement of existing legislation has not necessarily been consistent, and continuing violations, particularly concerning traffic in human tissues and exploitation of kidney donors, have been reported. In the past decade several Member States have reinforced their oversight of transplantation activities. Support for the establishment and effective implementation of an improved legal framework could help to optimize safety, quality and effectiveness in human organ and tissue transplantation as well as full respect for ethical principles. Moreover, the movement to classify various human tissues as medical products has allowed better control of international transactions through cooperation among national regulatory authorities.
Ethical issues
Updating of the 1991 Guiding Principles
16. Without any change in their ethical premises, the Guiding Principles and their commentaries may benefit from re-examination in the light of medical and legal developments during the past decade, and from various ethical and practical perspectives identified in the regions. Protection of the person, whether recipient or donor, should remain a priority and needs reinforcement, and additional matters, such as confidentiality and anonymity of both parties, need to be tackled. Although good reasons exist for continuing to favour cadaveric donors, improvements in immunosuppression reduce the need for living donors to be genetically related to the recipient. The increasing use of genetically unrelated donors means that even greater attention must be paid to ensuring that consent is informed and voluntary. Likewise, proposals to offer incentives in various contexts need careful scrutiny to prevent commercialization or exploitation.
Action by the executive board
17. The Executive Board is invited to take note of the report.