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Biomedical research and animal welfare regulations in Switzerland
The present animal welfare legislation in Switzerland is based on a constitutional article introduced in 1973 declaring that Animal Welfare was of Federal concern. Based on this article a law was issued, creating the legal framework for animal protection in general and containing a chapter on animal experimentation. Animal protectionist groups obtained a referendum against this law, one of the arguments being that the law did not prohibit animal experimentation in principle. However, the referendum was rejected in December 1978 and the law was then introduced in 1981. The details of how it was implemented were provided by the Animal Protection Order of 1981.
Since then the Swiss population have had to vote three times on referenda concerning animal experimentation based on the initiatives of animal protectionist groups. Two of them were so extreme that they stood no chance and were rejected by more than 70% of the voters - which is an extremely clear vote in the history of Swiss referenda. However the referendum launched by the reasonable Swiss Animal Welfare Association, asking for a ban on painful experiments with declared exceptions, was only rejected with a majority of 56%. Since in the public and parliamentary discussions around this referendum it seemed possible that an initiative which had the potential of severely obstructing biomedical research stood a chance of being accepted, the parliament decided to amend the 1981 Order. The amendment introduced some of the demands of the Animal Welfare Association with the exception of the general ban on painful experiments and the right of animal welfare organisations to appeal against licensces issued by the authorities. This amendment, finding no opposition from the academic and industrial research community, came into force in 1991.
So the present regulation of animal experimentation in Switzerland is based on the Animal Welfare Act of 1978 and the Animal Protection Orders of 1981 and 1991. In addition, a number of guidelines with legal power regulate the details of licensing, caging requirements, recording, etc. The implementation of this Federal Legislation is delegated to cantonal (county) authorities, which may result in certain (minor) differences between the cantons. Any use of animals for experimental purposes has to be reported to the cantonal authority (usually the Cantonal Veterinary Office). Animal experiments are defined as every measure for which live animals are used with the aim of examining scientific assumption, of obtaining information or confirming the effect of a particular measure on an animal as well as the use of animals in experimental behaviour research. Experiments which could cause pain or severe anxiety or reduce the general condition of the animal considerably, require a licence. Such licences are also required for regulatory safety tests and have to be renewed every second year. Experiments in which an untreated animal is killed or bled immediately after general anaesthesia, in which body fluids can be taken from animals without pretreatment or general anaesthesia as well as simple observation and feeding tests have to be notified to the authorities. Licences may be issued for the following purposes only: basic scientific research, production of compounds, sera and vaccines, investigation of physiological and pathological functions and conditions, teaching at universities and professional training of certain specialists (eg laboratory technicians).
Licensed animal experiments may only be performed in institutes or laboratories which have the necessary personnel and facilities for housing the species used, and under the responsibility of persons having the necessary competence, training and practical experience. Licences are only issued to researchers with a university degree in biology, medicine, veterinary medicine and closely related scientific areas and three years of experience in animal experimentation. The researcher has to be acquainted with the particular types of laboratory animals, their needs and diseases as well as their use in experiments and has to be able to provide for their adequate care. This means that normally a curriculum vitae is required at the first application. A full report on the experiments has to be produced and kept for at least three years.
To obtain a licence the researcher has to fill in an application form giving the aim of the study, details of the procedure and a justification. The application is normally submitted to the Cantonal Veterinary Office, which makes its decision based on the recommendation of an independent committee of experts from science and animal welfare. The application is judged on the basis that the aim of the project is within the legally permitted purposes, that the method is suitable for obtaining the goal, that the species and the number of animals required are the lowest possible and that the other requirements for housing facilities, source of animals and competence of investigators are fulfilled. Licensces are not given if other valid methods exist, if no connection with life saving and health care of man and animals is conceivable or no new knowledge on basic biological processes will be gained, if in the testing of compounds the information is known or can be derived from previous investigations or if the degree of pain, suffering and damage inflicted does not justify the knowledge gained. The possibility of appealing against a decision of the cantonal authority exists, both for the applicant as well as for the Federal Veterinary Office. The latter possibility was introduced in 1991 as an alternative to the request that the animal welfare groups have this right for themselves. It has the advantage that a certain intercantonal harmonisation is achieved. Licences are given for two years maximum after which time they have to be renewed. They are valid for a number of single experiments not exceeding a total number of animals specified.
Looking back at the developments since the beginning of animal welfare legislation in Switzerland over the past 20 years, one can say that the activities of animal protection groups and the animal welfare legislation itself have neither hindered biomedical research at universities and industry greatly nor have there been any serious attacks against individuals working in the field of biomedical research. Only in a few cases have there been shifts of research work to foreign countries, chiefly due to the tedious and long application procedures in some cantons.
There has been a reduction in the number of animals used annually by more than 75% since 1977 or more than 60% since 1983, the year when the first overall survey became available. This is chiefly due to a reduction in the pharmaceutical industry (responsible for about 75% of the laboratory animals used in Switzerland) where animal tests have largely been replaced by in vitro methods in the screening and clarification of drug mechanisms.
Even the requirements for improved housing conditions for animals required by Swiss legislation were not considered a problem, because the time given to make the changes corresponded, in most cases, with the normal time in which caging material has to be renewed anyway. The fact that, in comparison with the situation 10 years ago, a greater portion of the experimental animals are kept for longer periods of time and with special requirements has led to the understanding that the investigator may have to go to the animal rather than taking the animal to the lab. Besides animal welfare, other factors, eg protection of personnel against hazards and protection of animals against disease, lead in the same direction.
There are, however, a few points of concern after the amendment to the legislation in 1991. The time required to obtain a licence can now be up to three months and the administrative load has grown tremendously. The applications for licences now have to contain far more detail than before (which is not in all cases bad) but as a next step a detailed record of how many animals have been acquired in one year, how many will be carried over to the following year (and counted again) and the degree of severity of pain, suffering or other damage they have undergone during the procedure now have to be kept. For a larger institution this can only be accomplished with a sophisticated software programme with questionable relevance to animal welfare.
Another point of concern is the continuous pressure from some of the animal protection groups who insist on having the right to appeal against licensces and to prohibit certain experiments, and have succeeded in obtaining these in some cantons. This results in uncertainty as to the future legal situation, which is definitely a negative factor in the plans of the pharmaceutical industry or for any new long-term projects in academia. There is also a pending referendum against gene technology which, if accepted, would stop all research on transgenic animals in Switzerland.
The biomedical research community is also worried by the trend within the Swiss Animal Welfare Association for the more emotional and abolitionist groups to gain the upper hand over the more moderate group. It is a sign of increasing intolerance and discrimination when in the latest documentation for school children on animal experimentation, objectivity is explicitly not aimed at, and the information is completely unbalanced. It shows the necessity for the biomedical research community to take up its public relations activities again, reduced after the last antivivisection campaign.
In conclusion: biomedical research at universities and in the chemical-pharmaceutical industry can live with the present situation although the number of hurdles have increased. The concerns for the future are the speed at which more hurdles are created and an increasing polarisation of animal welfare groups towards animal protectionism. The danger of militant attacks is considered of minor importance, because the possibility of expressing public opinion in referendum votes probably takes away a great deal of the pressure and violence is still considered a bad tactic. On the other hand, the repeated referenda demand a great deal of effort in educating the public about the need for animal experimentation.