In recent years, the use of animals in research has become one of the most important questions in research ethics. On the one hand, experiments using animals are important when, for example, testing medicine to ensure that it will not harm people. On the other hand, many feel that we have an obligation to these animals and that we cannot let them suffer for our sake. Already in the Declaration of Helsinki of 1964 it is stated that medical research is to respect the well-being of laboratory animals. How this is to be achieved is regulated by laws, rules and voluntary declarations from various sources. It is not only the experiment itself that can be morally uncertain: the animals are sometimes raised under hard conditions, and are then transported to research institutions to be kept under varying conditions. They are often finally destroyed, which naturally can be done in different ways. It is thus important to safeguard many aspects of laboratory animals' situations.
What is an animal experiment? It is what the animal is used for that determines whether an activity is an animal experiment. The Animal Welfare Act's §1 describes what is considered to be an experiment: when an animal is used for scientific research or in instruction (given certain prerequisites), disease diagnosis, development of medicine or chemical products or for other comparable purposes. To create genetically modified animals with the help of gene technology or comparable methods also counts as animal experimenting. The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes also defines what is to be considered animal research. Note that these definitions do not always coincide: That which is considered an animal experiment in one case is not necessarily considered so in the other. For this reason, one-to-one comparisons between Sweden and the rest of Europe can easily be misleading.
Which animals may be used? 'Animals used for research' refers to animals used in experimentation or animals intended to be used, or animals alraedy used or having been intended for such use (§1 of the Animal Welfare Act). The types of animals that occasion ethical consideration are mammals, birds, reptiles, Anura, fish, cyclostomes and octopuses.
Permission to experiment
In Sweden, it is above all the Animal Welfare Ordinance and the Animal Welfare Act that rule on questions regarding animal research (and Statens Jordbruksverks föreskrifter och allmänna råd om försöksdjur - SJVFS 2012:26). There is also an ordinance from the Medical Products Agency: "Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på djur - HSLF-FS 2016:78".
According to §19 of the Animal Welfare Act (SFS 1988:534), it is an absolute necessity that animal research only be carried out if the work's objective cannot be attained through another satisfactory method not involving the use of animals.
How is research involving animal experimentation scrutinized? The Board of Agriculture (earlier the Animal Welfare Authority) is responsible for issuing regulations and general advice. Ethical review of animal experimentation has been obligatory in Sweden since 1979; there are seven ethical committees across the country. Each committee is chaired by a member of the legal profession, and of its twelve members half are scientiests or staff who work with laboratory animals and half are laymen, some representing animal welfare oganizations. As a rule, members are appointed for a period of four years. The examination is to be carried out only from an ethical perspective, thus rendering things such as economic aspects irrelevant. The committees' decisions are binding but may be appealed. (From January 1 2013, a central animal ethics committee has been established, that also can examine already performed animal experiments.)
According to the Animal Welfare Act the ethical committee shall weigh the importance of the experiment against the suffering inflicted to the animal. The committee can only approve of an experiment if it is important for the public and if three demands in 19 § 1-3 are met, i.e. if the aim of the experiment cannot be satisfied by use of another method not involving animal experimentation ('replacement'), if as few animals as is possible are used ('reduction'), and if the animals are not exposed for more suffering than absolutely neccessary ('refinement'). These demands are known as the three Rs. An animal experiment cannot be approved if it means great and extended suffering that is not possible to relieve (says the ordinance).
Researchers need in their projects indicate clear, predictable, and irreversible criteria for determining the humane endpoints for experiment animals. Humane endpoints indicate the limit of suffering or distress to which the animals may be subjected. If animals give signs of having reached that point, and no remedy is possible, they should be immediately removed from the experiment and euthanized (see here DFS 2004:4 from Djurskyddsmyndigheten and the Guidance document from OECD).
A change with the new EU directive is a demand for those who do animal testing to be trained. Earlier a researcher could take a course before two years had passed, but now animal research cannot be initiated before a course in animal testing procedures has been completed. Every facility with animals for research must now also have an animal welfare body, that promotes animal welfare and the three Rs.
The Natonal Board of Occupational Safety and Health (now the Swedish Work Environment Authority) regulations concerning work with laboratory animals (AFS 1990:11) address above all premises, fixtures and equipment, waste management, personal protection equipment and hygiene, as well as vaccination and medical checkups. The Board of Agriculture has enacted a number of regulations regarding the handling of laboratory animals; you can find an introduction to Board of Agriculture activities as well as a list of regulations here.
Sweden is obliged to follow two European provisions regarding animal research. In 1988 we ratified the European Convention with addenda for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, which, among other things, regulates when animal experiments are allowed and when they are to be reported to the appropriate authority. The European Union has several regulations regarding animal research, primarily Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Further recommendations are given in the commissions guidelines for the accommodation and care of animals used for experimental and other scientific purposes, with instructions on the physical facilities, the environment and its control, education and training, animal care, humane killing, and various species-specific guidelines. See also the Note for Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use from EMA.
The new EU Animal Protection Directive states that it will be compulsory to carry out ethical evaluations and contains a ban on the use of great apes (chimpanzees, bonobos, gorillas and orangutans) in scientific procedures. The European Science Foundation has issued a Position on the Directive on the Protection of Animals used for Scientiﬁc Purposes.
Some other issues and documents
Researchers from Europe has created a Basel Declaration in which is stressed that research should adhere to the 3 R's and is called for more trust, transparency and communication on animal research.
In a report on xenotransplants, WHO has taken up the issue of the prevention of cruelty to animals. The Good Clinical Practice guideline discusses when and how animal research is to be conducted. The European Science Foundation has published a policy briefing document on the use of animals in research (no 9). CIOMS has International Guiding Principles for Biomedical Research Involving Animals. The International Association for the Study of Pain has published Ethical Guidelines and in an article Guidelines for the welfare and use of animals in cancer research has been proposed by researchers. Ethicists and scientists have offered advice for testing human brain cells in primates ("Moral Issues of Human-Non-Human Primate Neural Grafting")
How far can we go in genetically modifying animals? The EU Commission's Group of Advisers on the Ethical Implications of Biotechnology has issued a statement on Ethical Aspects of Genetic Modification of Animals. Research in the area of veterinary medicine has its own rules, and The European Medicines Agency provides a large number of guidelines for this area. The Federation of European Laboratory Animal Science Associations (FELASA) provides various policies and recommendations.
Last updated: 2017-02-25