Gene Therapy in Germany: The Regulation and the Debate on Regulation

- Jan Vesting,
Research Centre Biotechnology & Law,
University of Luneburg, D-21332 Luneburg, Germany

Eubios Journal of Asian and International Bioethics 6 (1996), 30-1.
Since 1987, when the final report of the German federal parliament's enquete-commission on "chances and risks of gene-technology" was published, there has been a lively discussion on the question of whether gene-therapy needs regulation or not.

As far as germ-line-manipulation is concerned, the answer was "yes": Germ-line-modifications are now forbidden under the Embryo-Protection-Act of 1990 (exceptions are possible, if the germ-line-alteration is not the aim, but only a side-effect of medical treatment). This restrictive regulation which can only be found in few other European countries, has to be seen on the background of the horrible experiences with "eugenics" between 1933 and 1945. The goal of the regulation is to protect human dignity. As a result of this development of an informed opinion, Germany is trying to push trough it's position on germ-line-alteration wherever bioethics are discussed, e.g. the UNESCO draft Declaration on the Protection of the Human Genome or the so-called Bioethics Convention of the Council of Europe.

Meanwhile the public attitude to germ-line-therapy is indecisive: about 50% of the German citizens can imagine to approve germ-line-alteration for therapeutic reasons, and indeed there is an interesting inconsistency in German regulation: Under the criminal law, abortion is not punished within the first 12 weeks of pregnancy if the pregnant woman is having a consultation before it (so called "law allowing the termination of a pregnancy within the first three month"). The woman's reason for her decision to terminate the pregnancy is not relevant. Therefore, the woman could decide to terminate her pregnancy, e.g., after having heard on the occasion of a prenatal diagnosis that her embryo has got a genetic defects. This legal position leads to the question, why one should not allow a preimplantation-diagnosis (PID) (which is actually prohibited under the EPA, too): The trouble for the women would be less, if the embryo would not have to be implanted before getting the option to terminate it's life, and the result for the embryo would be the same as in being a victim of an abortion. If, for this reason, PID becomes permissible in the future, the next question would be, if it is more ethical to terminate the embryo's life than to heal it's genetic disease by germ-line-therapy. The described consideration could be summarized as follows: The embryo is protected until it is allowed to carry out it's abortion.

Even having in mind that this question raises, of course, only in those cases where a somatic gene therapy would not lead to curing the disease, and still the problem of eugenics is not solved sufficiently, I dare to predict that the prohibition of germ-line-alteration in Germany is not made for ever. Somatic gene therapy is very much accepted in the public; the approval to it is some 85%. From an ethical point of view, it is not considered to be a new kind of treatment, but as comparable to organ transplantation. Actually, there is no special law on somatic gene therapy (it is supposed to be covered by the federal Act on the manufacture and prescriptions of drugs), but there does exist a special guideline on carrying out gene-therapy which is binding for physicians (to understand this, one has to keep in mind that there is a system of professional self-regulation for physicians in Germany).

The debate on the regulation of somatic gene therapy in Germany is concentrated on 3 issues: social control; risks to the patient and risks to the environment; and third, the German federal parliament, the federal ministry of health, an intergovernmental working-party on gene-therapy, a commission of the federal physicians chamber and other protagonists are discussing the question whether the existing regulation is sufficient or not. Scientists have funded the "German working group on gene therapy", which has about 160 members and which is trying to coordinate research and to influence the debate on the regulation. Social control is actually ensured by a local ethics committee which, according to the physicians professional self regulation, has to be consulted before carrying out a clinical trial. According to the Act on drugs, an ethics committee must even give it's approval. The ethics committees are also responsible for the safety of the patient. Before starting a clinical trial, the biological safety is checked in accordance with the Act on Gene Technology by the Central Commission for Biological Safety, but the range of the Act on Gene Technology does not cover the application of GMO on human beings. Therefore, the only control concerning the risks for the environment and the third issue is carried out by the ethics committee when looking after the patient's safety. This is not an expressed duty of the committee, but a kind of side effect. Therefore it is supposed to be not so clear if the biological safety is really supervised sufficiently. In addition, ethics committees are only responsible for clinical trials (treating patients with a scientific approach), but are not competent for the single attempt to heal (where the main target of the trial is not a scientific one). Another problem might be, that the competent putting together of the committees is not regulated by law (as, e.g., in France), but only more or less guaranteed by a potential liability of the members and the authority which is responsible for setting up the committee (this is also considered to be a problem concerning the social control of gene therapy). Finally, there is practically no chance for the drug-administration to control the clinical trial if the ethics committee has given its approval.

After all, it seems like there are some loopholes concerning the biological safety, which might become relevant when a trial is carried out with viral vectors. But if this will lead to new regulation in Germany or on the European level seems to be uncertain because of the fear to loose contact to those countries that are leading in science.

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