Ethics and the regulation of preimplantation diagnosis in Germany

- Stefan Mueller, Ph.D.
Research Centre Biotechnology & Law, University of Lueneburg, D-21332 Lueneburg, GERMANY

Eubios Journal of Asian and International Bioethics 7 (1997), 5-6.
Research towards preimplantation diagnosis (PID) of genetic diseases is done considering the aim of helping those couples who would prefer selection to occur at this stage rather than during pregnancy. Following in-vitro-fertilization (IVF), biopsy and removal of one or two cells from the early "pre-embryo" provides the material for molecular genetic diagnosis without interfering the development of the embryo. If the diagnosis is positive for a hereditary disease the embryo will be rejected, otherwise the embryo will be transferred to the uterus of the mother. After the embryo is preimplanted, the pregnancy of the mother will start with a similar success rate to usual embryo transfer. PID has been already successful for hereditary diseases like cystic fibrosis, Tay Sachs disease and Lesch-Nyhan syndrome.

In Germany a local ethics committee did not approve the first German PID trial (1). The reasons for this were not explicitly of ethical nature but questions concerning the legal situation. PID is affected in Germany by different laws. At first there is the Embryo Protection Law (2). This law is intended to protect embryos from "improper use" and to protect against improper use of modern reproductive technologies. Therefore it is forbidden to make any investigations on totipotent cells. In humans, the cells seem to be totipotent up to the eight-cell stage. So it is forbidden to make DNA analysis on one or two cells of those totipotent "pre-embryos", but an investigation on cells of an later stage is not forbidden by the Embryo Protection Law. Also the guidelines for the use of the IVF and similar methods of the Federal Physicians Chamber (3) are relevant. These guidelines cover the conditions for the use of IVF. The only permitted use of IVF is for treatment of the infertility of a couple, but not selection of a genetically normal embryo by a PID. The professional regulations for physicians (4) also do not allow the use of PID.

However on the other hand abortion is allowed in Germany when the conditions for a medical indication are fulfilled (5). Those persons who obtain abortion under those conditions are not liable to prosecution. Medical indications for an abortion include a variety of hereditary diseases which can be genetically tested by chromosome or DNA analysis. Medical indications also could be if pregnancy would be a physical or psychological burden for the mother. The only requirement for the mother is that a counseling must be performed before an abortion could be done. In Germany over one hundred institutes offer genetic counseling. Genetic counseling and prenatal diagnosis procedures are regulated by guidelines (6), but not by a law.

In summary, there is ethical disagreement seen in the regulation of the PID in Germany. The selection of healthy embryos before the beginning of a pregnancy is forbidden, however, an abortion some weeks later, with the same indications, is allowed. There should be a public debate on the question: Will the German society use the possibilities raised by PID for early genetic counseling of hereditary diseases? And if we want to use it the regulations have to be changed to allow families to use it, and to prevent the abuse of this new technology.


1. Votum der Ethikkommission der Medizinischen Hochschule zu LŸbeck vom 19.08.1996.

2. Gesetz zum Scvhutz von Embryonen vom 13. Dezember 1990 (BGBl. I S. 2746).

3. BundesŠrztekammer, 1994: Die Richtlinien zur DurchfŸhrung des intratubaren Gametentransfers, der In-vitro Fertilisation mit Embryonentransfer und anderer verwandter Methoden erhalten folgende Fassung. Deutsches €rzteblatt 91, Heft 1/2, 10. Januar 1995, A58-62.

4. For example: Berufsordnung der Hamburger €rzte/€rztinnen vom 12. September 1994.

5. Schwangeren- und FamilienhilfeŠnderungsgesetz (SFH€ndG) vom 21. 08. 1995 (BGBl. I S. 1050ff).

6. fachaerztliche Berufsordnung

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