The increasing importance of Genetic Engineering in the last 25 years and the questions about the impact of genetically changed organisms on health and environment induced the Swiss authorities to create a legal background which should provide a secure and controlled use of such organisms.

Based on Article 24novies of the Swiss constitution the Environmental Act (USG) has been amended. In its form of 21st December 1995, it covers Genetic Engineering . The most important modifications are the introduction of grant- and notification procedures for commercialization, the experimental release and the use in closed facilities of genetically changed and pathogen organisms, a duty of declaration for products containing genetically changed organisms a duty to inform the public as well as the regulation of liability.

The Federal Expert Commission for Biological Safety (EFBS) which is governed by article 29h of the USG is of major importance as well. The new commission started its activities on 1st January 1997. Its 16 members are appointed by the Federal Council and have been proposed by a variety of different organizations (universities; industry; agricultural, environmental and consumer organizations). One of the main functions of EFBS is to advise the Federal Council in preparing the detailed implementing provisions related to Genetic Engineering and to advise the authorities (federal and cantonal) in grant-procedures. The new provisions of the USG are (together with those of the Epidemic disease Act) concretized in an ordinance by the Federal Council. Whilst taking the objectives of the constitution and the USG into consideration , Switzerland is heading towards a body of law comparable with those of EU countries.

The modifications of the Environmental Act, the Epidemic Disease Act as well as the new provisions of the new Food Act, dated 9th October 1992, are the first concrete acts worked out by the Interdepartemental Commission for Genetic Engineering (IDAGEN) for an extensive legal regulation of Genetic Engineering in Switzerland.

On 8th June 1998 the Swiss public had to take its part in regulating Genetic Engineering. The initiative ("Volksinitiative") that had to be voted on aimed at prohibiting the production and the dealing with genetically changed animals. Furthermore, it intended to prohibit the release of and the issuance of patents for such organisms. The Swiss Federal Council recommended to reject the initiative due to its adverse impact on Swiss economy and the insufficient co-ordination with the current regulations. But concurrently the Federal Council was willing to present its own proposal: the so called Gen-lex package.

After the rejection of the initiative on June 8th, 1998, the Federal Council - aware of the lack of regulation - had a set of rules worked out limiting the release of altered organisms to the following: Experiments and production are subject to a grant-procedure, need to be scientifically supervised and may not have negative impacts on the environment. In addition, respective liability of companies involved in genetic engineering was aggravated (the statute of limitation was expanded to 30 years) and products containing genetically changed ingredients were made subject to a duty of declaration. The adjustments of the various acts will, due to the ongoing legislation process, enter into effect in spring 2000 at the earliest.

The content of this article is intended to provide general information on the subject matter and is not a legal advice. An individual matter requires legal advice according to the specific circumstances.

For further information please contact Dr. Rolf P. Jetzer or Dr. Gaudenz G. Zindel