Archived: WMA Statement on Fetal Tissue Transplantation

Adopted by the 41st World Medical Assembly Hong Kong, September 1989
and rescinded at the WMA General Assembly, Pilanesberg, South Africa, 2006

PREAMBLE

The prospect of therapeutically effective fetal tissue transplants for disorders such as diabetes and Parkinson’s disease has raised new questions in the ethical discussion on fetal research. These questions are distinct from those addressed in the 1970s that focused on invasive procedures performed by some researchers on living, viable fetuses. They are also separate from the questions that were raised by the development of new techniques for prenatal diagnosis such as fetoscopy and chorionic villus sampling. Although the use of transplanted tissue from a fetus after spontaneous or induced abortion would appear to be analogous to the use of cadaver tissue and organs, the moral issue for many is the possibility that the decision to have an abortion will become coupled with the decision to donate fetal tissue for the transplantation procedure itself.

The utilization of human fetal tissue for transplantations is, for the most part, based upon a large body of research data derived from experimental animal models. At this time, the number of such transplants performed has been relatively small but the various applications are promising avenues of clinical investigation for certain disorders. The demand for fetal tissue transplantation for neural or pancreatic cell engrafments may be expected to increase if further clinical studies conclusively show that this procedure provides long-term reversal of neural or endrocrine deficits.

Prominent among the currently identified ethical concerns is the potential for fetal transplants to influence a woman’s decision to have an abortion. These concerns are based, at least in part, on the possibility that some women may wish to become pregnant for the sole purpose of aborting the fetus and either donating the tissue to a relative or selling the tissue for financial gain. Others suggest that a woman who is ambivalent about a decision to have an abortion might be swayed by arguments about the good that could be achieved if she opts to terminate the pregnancy. These concerns demand the prohibition of:

1. the donation of fetal tissue to designated recipients;
2. the sale of such tissue; and
3. the request for consent to use the tissue for transplantation before a final decision regarding abortion has been made.

The abortion process may also be influenced inappropriately by the physician. Consequently, measures must be taken to assure that decisions to donate fetal tissue for transplantation do not affect either the techniques used to induce the abortion or the timing of the procedure itself with respect to the gestational age of the fetus. Also to avoid conflict of interest, physicians and other health care personnel involved in performing abortions should not receive any direct or indirect benefit from the research or transplantation use of tissues derived from the aborted fetus. The retrieval and preservation of usable tissue cannot become the primary focus of abortion. Therefore, members of the transplant team should not influence or participate in the abortion process.

There is a potential commercial gain for those involved in the retrieval, storage, testing, preparation, and delivery of fetal tissues. Providing fetal tissue by nonprofit mechanisms designated to cover costs only would reduce the possibility of direct or indirect influence on a woman to acquire her consent for donation of the aborted fetal remains.

RECOMMENDATIONS

The World Medical Association affirms that the use of fetal tissue for transplantation purposes is still in an experimental stage and should only be ethically permissible when:

1. The World Medical Association Declaration of Helsinki and the Declaration on Human Organ Transplantation are followed, as they pertain to the donor and the recipient of the fetal tissue transplant.
2. Fetal tissue is provided in a manner consistent with the World Medical Association Statement on Live Organ Trade and that such tissue not be provided in exchange for financial remuneration above that which is necessary to cover reasonable expenses.
3. The recipient of the tissue is not designated by the donor.
4. A final decision regarding abortion is made before initiating discussion of the transplantation use of fetal tissue. Absolute independence is established and guaranteed between the medical team performing the abortion and the team using the fetus for therapeutic purposes.
5. Decision concerning the timing of the abortion is based on the state of health of the mother, and of the fetus. Decisions regarding the technique used to induce abortion, as well as the timing of the abortion in relation to the gestational age of the fetus, are based on concern for the safety of the pregnant woman.
6. Health care personnel involved in the termination of a particular pregnancy do not participate in or receive any benefit from the transplantation of tissue from the abortus of the same pregnancy.
7. Informed consent on behalf of both the donor and the recipient is obtained in accordance with applicable law.