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Laboratory animal research legislation in Sweden
The Swedish system of regulating animal research comes under a general law controlling animal welfare, the Animal Protection Act and the Animal Protection Ordinance, both of 1988. To appreciate the way in which these regulate animal research, it is necessary to explain the way in which much of the legislation in Sweden operates.
Each Ministry in the Government has a number of National Boards operating under it. The legislation passed by the Parliament deals with the general principles and then delegates the power to create specific regulations to certain National Boards.
Under the Swedish Ministry for Agriculture, there is a National Board for Laboratory Animals which is responsible for setting up seven regional ethical committees. Scientific and medical experts make up half of the membership of each committee with the other half being lay members. Animal welfare representatives can only make up one third of the committee. The Chairman of each committee is a senior lawyer, usually a judge. Detailed rules for the operation of the committees are provided by the National Board for Laboratory Animals. All animal research and testing proposals are considered by these committees which are required to weigh up the importance of the experiments against the animal suffering involved. Projects can be approved for a maximum of three years. Although these committees only have advisory power, their recommendations are always followed. Animal experimentation conducted without ethical committee approval is illegal under the basic animal welfare provisions of the Animal Protection Act. There is no appeal against the decision of an ethical committee.
All animal research projects require ethical committee approval, including feeding studies, experiments under terminal anaesthesia and the killing of animals to remove tissues for use in vitro biomedical research.
It is worth noting that the Swedish legislation covers all animals, not just vertebrates. There is a general requirement that laboratory animals must be specially bred, but exceptions are granted for most types of animals apart from the normal laboratory species. Wild mammals are included in the exceptions. The re-use of animals in not banned under the Swedish system, but it is taken into account by the ethics committee when they assess the project proposal.
Veterinary inspectors from the local or regional authorities check research establishments to ensure compliance with the committee decisions. Where problems are found, they have the power to force researchers to comply with the committee recommendations or to impose a fine. However, the experimenter can appeal against this to the regional authorities of higher if necessary. In 1990, the law was amended to ensure that the ethical committee decision took precedence over the opinion of the inspector. The amendment ensured that when an animal research project was approved by an ethical committee and performed in accordance with the protocol approved by that committee, the inspector had no legal power to halt the project.
The Laboratory Animal Board is also responsible for the keeping of records and collection of statistical data about the numbers and type of animals used. They are also responsible for the regulation of education and training requirements for experimenters and technicians and funding the development of alternatives methods to the use of laboratory animals.
In the National Board for Agriculture, there is a Department of Veterinary Affairs which has to approve the design of animal research facilities before they are built or before any significant modifications to the buildings are made. It licences the facility when it meets the guidelines for temperature control, humidity, cage sizes,etc. Each facility is required to appoint a supervisor, a person in charge of animal research for the facility who must be approved by the National Board of Agriculture. This Board also registers and approves laboratory animal breeders and suppliers.
All animal researchers, technicians and animal carers are required to undergo training within two years of starting working with animals. Until they have completed this training and passed a test on it, they are required to work under supervision. The National Board for Laboratory Animals has set out a number of subjects which must be covered by the training, although no formal curriculum or duration of training is stipulated.
The National Board for Laboratory Animals also creates regulations about the recording of animal experiments and the reporting of statistical data. Regulations also cover the way that certain procedures must be conducted. These include immunisations, the production of monoclonal antibodies and acute toxicity testing.