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The Swiss genetic engineering initiative
The impact of genetic engineering and biotechnology has increased in the past 20 years and both are now considered to be key technologies for the 21st century. As these technologies have gained importance, questioning of the risks associated with them has also increased. A broad debate with access to all the relevant information is necessary, since Switzerland will be facing political decisions on this subject in the near future. These decisions will set the guidelines for the future development of these technologies.
This article will explain the existing Swiss legislation on reproduction and genetic engineering, the overall picture of the position of the genetic engineering initiative, including the attitudes of the advocates of the initiative, the Council of Ministers, the parliament and biomedical research industry; and the effect it would have on the economic position of Switzerland if the initiative were to be accepted.
In spite of the existing constitutional article and resulting regulations, biotechnology and genetic engineering have caused concern and fear in some parts of the population who are concerned, on one hand, with the biological safety of these technologies and, on the other hand, with the middle and long term effects of genetic engineering on the individual and environment. Fundamental questions about ethics and the existence of human beings were also raised. It goes without saying that all these aspects need to be discussed in depth and - if necessary - further regulations need to be created or amended through legislation.
The legal position in Switzerland with respect to genetic engineering is remarkable. All aspects of reproductive medicine and genetic engineering have been covered by Federal Law since 1992. The origins of this law started several years before, when the Council of Ministers requested the interdepartmental office for legal proceedings on the application of DNA organisms (KOBAGO) to clarify how the new constitutional article could be implemented in legislation. According to the KOBAGO report of 1992, we could do without separate legislation on genetic engineering. Currently, genetic engineering is used in many different fields of economic activity which are mostly covered by legislation already in force. Thus, while it should not be necessary to create new legislation for genetic engineering, existing regulations should be refined and amended.
Based on this report, the Federal Government decided in May 1992, to legislate without producing a special law for genetic engineering, but to revise existing legislation. The parliament accepted this decision and rejected different attempts from within its own ranks to create a genetic engineering law. This decision was confirmed again, in the framework of a conference on the revised environmental protection law, in June 1995.
With the approval of the new constitutional article on reproductive medicine and genetic engineering in May 1992, regulations on genetic engineering have entered the constitution. The field of human reproductive medicine is regulated in some detail, but there is less detail in the regulations outside the human field. From a historical perspective, this is because the main emphasis of the 'Beobachter initiative' was directed at human reproduction medicine. However, it is also due to the fact that constitution already regulates the genetic engineering of plants and animals in several different ways. However, these constitutional regulations are only supplementary in nature.
In January 1993, the 'Swiss Genetic Engineering Task Force' produced a report on the legislation covering genetic engineering and reproductive medicine. This report included a programme of nine concrete proposals for legislation, eight of them about genetic engineering. According to the 'Swiss Genetic Engineering Task Force' there are still some gaps in both the constitutional article and the resulting legislation. The Task Force launched their 'Gen Schutz' (gene protection) initiative even before the constitutional article had been accepted by referendum. The goal of this initiative is to restrict or ban the use of genetic engineering on plants and animals.
Early in 1998 the people of Switzerland will vote on an initiative called 'Initiative for the protection of life and environment against gene manipulation' which will call for a complete ban on:
In addition, the initiative would require all research projects using genetic engineering to demonstrate the necessity of the research before they could obtain approval to proceed. If the population votes in favour of this initiative it will become legally binding in Switzerland.
The promoters of this initiative argue that biomedical research would not be hindered if the initiative was introduced. They are supported by a number of important organisations including the Swiss Animal Protection Association, the World-Wide Fund for Nature, Greenpeace and the Swiss Nature Protection Organisation.
The organisations opposing the initiative aim to convince the population of the necessity of using transgenic animals in biomedical research and to inform the public about the measures taken to safeguard against animal suffering and 'loss of genetic integrity'. It is important that the potential risks as well as the potential benefits of gene technology are discussed.
According to the opinion polls, the Swiss public is in favour of many aspects of the initiative - although different polls record different majorities in favour. Only the use of gene technology for medical progress is well accepted by the public. Evidently, it does not seem to have been realised that the ban on producing and maintaining transgenic animals would completely hinder much medical progress.
The Federal Government has warned that the initiative could have very serious results for biomedical research. The restriction on genetic engineering would put considerable technical obstacles in the path of research. The ban on the creation and purchase of transgenic animals would make it impossible for biological laboratories to do research in many essential areas of medical research. In the opinion of the Federal Government, the demand in the initiative for evidence of benefit, safety, lack of alternatives and ethical responsibility would seriously effect basic medical research in Switzerland. For basic research it is often very difficult to provide evidence of benefit before the research is conducted.
The pharmaceutical industry in particular would suffer from the restrictions contained in the initiative and would have to compete with other national industries operating without such legal restraints. The government considers that this fact could produce a strong incentive for the Swiss pharmaceutical industry to move their research, development and manufacturing facilities out of the country. Apart for the manufacturing ban, the inability to achieve patent protection for this type of biotechnological invention could have a very negative impact on industry. On one hand, it would remove the incentive for research and investment in an industry where very high levels of funding are required to remain competitive when faced with international competition. On the other hand it would weaken an industry that has achieved a significant international position. The ban would inhibit the publishing of research results and promote the secrecy of such information.
In summary, the Federal Government is convinced that the negative impact on biomedical research would be enormous should the authors of this initiative be successful. In their opinion, the existing legislation is sufficient and could be amended without the need for a further article in the Constitution.