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Embryonic Research Act [Switzerland]

One of the main principles of the Swiss Constitution is the protection of human dignity and personality as well as a person’s “genetic heritage.” The ban on any manipulation of germ cells of human gametes and embryos in the constitution (Article 2(a)) is consistent with this principle. In addition, Article 119(1) states that human beings must be protected against any abuses connected with genetic engineering research.

The Embryonic Research Act provides protection against any abuse relating to embryonic research. In particular, Article 3 considers the modification of germ cells, the production of stem cells from any embryo whose germline has been modified, or the use of such cells to be “forbidden practices” sanctioned by penal clauses.

Concerning gene therapy specifically, the Swiss government enacted the Law on therapeutic products 2000 and the Ordinance on clinical trials of therapeutic products 2001 to provide quality assurance and protection for patients who participate in gene therapy clinical trials.

The scope of the Law on Therapeutic Products 2000 covers all clinical trials or therapeutic treatments, including gene therapy to the extent that the treatment directly relates to therapeutic products (Article 2). The law established the Swiss Agency for Therapeutic Products (Chapter 5) to authorize gene therapy protocols and ensure that all clinical trials are carried out in accordance with recognized principles of good clinical practice (Article 53).

In view of the provision pertaining specifically to clinical trials relating to therapeutic treatment in the Law on Therapeutic Products 2000, and in accordance with Article 2(1)c) of the law, the Swiss Federal Council enacted the Ordinance on clinical trials of therapeutic products 2001. The ordinance covers clinical trials of somatic gene therapy but excludes from its scope clinical trials that involve live human organs, tissues or cells, or “ex vivo gene therapy” (Article 2). The regulatory process for gene therapy is outlined in detail in the ordinance. Before commencing a clinical trial, the medical institute must obtain approval from the institutional ethics committee. The ethics committee must verify that the clinical trial respects ethical and quality standards. According to Article 4 of the ordinance, all clinical trials must conform to the Guidelines for Good Clinical Practice (GCP) adopted by the International Conference on Harmonization. For clinical trials of somatic gene therapy and of medicines containing genetically modified microorganisms, the ordinance requires authorization from the Swiss Agency for Therapeutic Products. The agency evaluates the following:
a. the risks relating to the therapeutic product tested;
b. the risks relating to the clinical trial from the point of view of protecting humans and the environment, in particular concerning the possible dissemination of genetically modified organisms into the environment and their capacity to survive, to reproduce or to transfer genetic material; and,
c. the security measures necessary for the protection of humans and the environment, in particular against any dissemination of genetically modified organisms into the environment during the clinical trial and during their transport, storage, and elimination (Article 16).

Before authorizing a clinical trial, the Swiss Agency must obtain a favorable decision from the Swiss Federal Office of Public Health, the Swiss Agency for the Environment, Forests and Landscape, and the Swiss Expert Committee for Biosafety (Article 17 of the ordinance).

Other normative measures

The Swiss Academy of Medical Sciences (SAMS) published guidelines for somatic gene therapy in humans in 1998. The academy encourages somatic gene therapy but states that any modification of germline cells should be prohibited.

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