Draft guiding principles on human organ transplantation
Guiding principles on human organ transplantation
1. As the Director-General's report to the seventy-ninth session of the Executive Board pointed out, human organ transplantation began with a series of experimental studies at the beginning of this century. That report drew attention to some of the major clinical and scientific advances in the field since Alexis Carrel was awarded the Nobel Prize in 1912 for his pioneering work. Surgical transplantation of human organs from deceased, as well as living, donors to sick and dying patients began after the Second World War. Over the past 30 years, organ transplantation has become a worldwide practice and has saved many thousands of lives. It has also improved the quality of life of countless other persons. Continuous improvements in medical technology, particularly in relation to tissue "rejection", have brought about expansion of the practice and an increase in the demand for organs. A feature of organ transplantation since its commencement has been the shortage of available organs. Supply has never satisfied demand, and this has led to the continuous development in many countries of procedures and systems to increase supply. Rational argument can be made to the effect that shortage has led to the rise of commercial traffic in human organs, particularly from living donors who are unrelated to recipients. There is clear evidence of such traffic in recent years, and fears have arisen of the possibility of related traffic in human beings. Health Assembly resolutions WHA40.13 and WHA42.5 are an expression of international concern over these developments.
2. These Guiding Principles are intended to provide an orderly, ethical, and acceptable framework for regulating the acquisition and transplantation of human organs for therapeutic purposes. The term "human organ" is understood to include organs and tissues but does not relate to human reproduction, and accordingly does not extend to reproductive tissues, namely ova, sperm, ovaries, testicles or embryos, nor is it intended to deal with blood or blood constituents for transfusion purposes. The Guiding Principles prohibit giving and receiving money, as well as any other commercial dealing in this field, but do not affect payment of expenditures incurred in organ recovery, preservation and supply. Of particular concern to WHO is the protection of minors and other vulnerable persons from coercion and improper inducement to donate organs.
Organs and tissues (referred to in this text as "organs") may be removed from the bodies of deceased and living persons for the purpose of transplantation only in accordance with the following Guiding Principles.
Guiding principle 1
Organs may be removed from the bodies of deceased persons for the purpose of transplantation if:
(a)any consents required by law are obtained; and
(b)there is no reason to believe that the deceased person objected to such removal, in the absence of any formal consent given during the person's lifetime.
Guiding principle 2
Physicians determining that the death of a potential donor has occurred should not be directly involved in organ removal from the donor and subsequent transplantation procedures, or be responsible for the care of potential recipients of such organs.
Guiding principle 3
Organs for transplantation should be removed preferably from the bodies of deceased persons. However, adult living persons may donate organs, but in general such donors should be genetically related to the recipients. Exceptions may be made in the case of transplantation of bone marrow and other acceptable regenerative tissues.
An organ may be removed from the body of an adult living donor for the purpose of transplantation if the donor gives free consent. The donor should be free of any undue influence and pressure and sufficiently informed to be able to understand and weigh the risks, benefits and consequences of consent.
Guiding principle 4
No organ should be removed from the body of a living minor for the purpose of transplantation. Exceptions may be made under national law in the case of regenerative tissues.
Guiding principle 5
The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment (including any other compensation or reward) for organs should be prohibited.
Guiding principle 6
Advertising the need for or availability of organs, with a view to offering or seeking payment, should be prohibited.
Guiding principle 7
It should be prohibited for physicians and other health professionals to engage in organ transplantation procedures if they have reason to believe that the organs concerned have been the subject of commercial transactions.
Guiding principle 8
It should be prohibited for any person or facility involved in organ transplantation procedures to receive any payment that exceeds a justifiable fee for the services rendered.
Guiding principle 9
In the light of the principles of distributive justice and equity, donated organs should be made available to patients on the basis of medical need and not on the basis of financial or other considerations.