Updated EC legislation on the protection of animals used in research raises questions

The European Science Foundation (ESF) has urged European institutions to reconsider key points in the proposed revision of the directive on the use of animals in research. The revised directive, which was put forward by the Commission at the end of 2008, is scheduled for discussion in the European Parliament in the coming weeks.

In 1986, in an effort to standardise the treatment of animals used in scientific research throughout the EU, the European Council adopted a Directive (86/609/EEC) regarding the protection of animals used for experimental and other scientific purposes. Among the many issues considered, the directive set minimum standards for housing and care, and required that researchers use alternatives to animal testing when possible. Part of the directive promoted the development of alternative methods to using animals, resulting in the creation of the European Centre for the Validation of Alternative Methods (ECVAM) in 1991.

Because the provisions contained in the directive were left open to interpretation, and because ethical review processes and the compulsory authorisation of experiments were not outlined, a revision of the directive was necessary. In 2002, the European Commission initiated the process and contracted a preliminary impact assessment. Subsequently, a technical expert working group produced a review, the Animal Health and Animal Welfare Panel provided a scientific opinion, and a public stakeholder consultation was held in 2006.

The results were incorporated into the proposed revision, which sets out stringent guidelines - particularly regarding the use of non-human primates in experimental research. The revision also attempts to incorporate principles valued by the scientific community, called 'the three Rs': reduction, refinement and replacement. Specifically, the legislation urges scientists to use existing data were possible to reduce duplication of effort.

An expert group (EG) of the ESF's European Medical Research Councils has now issued a position paper on the proposed revision, in which it urges legislators to reconsider several points. They emphasise their considerable concern in three areas: basic research involving non-human primates, sharing data to prevent unnecessary duplication and the promotion of the three Rs.

The proposal states that non-human primates shall not be used in procedures, with the exception of those undertaken with a view to the avoidance, prevention, diagnosis or treatment of life-threatening or debilitating clinical conditions in human beings. It further stipulates that there must be a scientific justification, i.e. that the purpose of the procedure cannot be achieved by the use of species other than non-human primates.

"Whether or not a species needs special protection should not be based solely on its [...] relations to humans, but on its potential for suffering," according to the EG. The same characteristics that make other primates similar to humans also make them particularly important for research that translates basic findings into clinical research. For example, chimpanzees are particularly important for the development of a hepatitis C vaccine because they are the only other primates who are susceptible to the disease.

The total ban on basic research in great apes, the EG says, "will terminate all prospects of such research in the EU in the future, with a potentially disastrous outcome for the ability to tackle diseases that might be particularly targeted at humans and other advanced primates.

"Critically, the EG is firmly of the opinion that Article 8, Paragraph 1 must be revised to continue to allow basic research in non-human primates," the statement reads.

The EG agreed that the overall concept of data sharing is important in avoiding the unnecessary duplication of animal experiments. However, this can be problematic in basic research, where data have not been validated. In the very early phases of research, it is important to back up initial findings by repeating certain experiments. Some improvement in the legislation was recommended in this context.

In terms of implementing the new rules, the group emphasised the importance of setting clear and well-defined timelines. They suggested that a review of proposed research be set to an upper limit of 90 days' duration to avoid being unduly held back by the bureaucratic process.

Regarding the three Rs, the EG was of the opinion that the new legislation should underline their importance more strongly. "The scientific community takes seriously its responsibility to progress and implement up-to-date knowledge on the three Rs," the EG says. At present, there are not enough alternative methods to the use of primates in the lab; there should be more impetus to develop such new methods, according to the EG.

"We hope the consensus reached within the medical research community at the pan-European level [...] will contribute to protecting animals used for scientific purposes while at the same time allow the continuous advancement of medical research with the aim of improving [the] health and [...] well-being of European citizens," the statement concludes.

According to the European Commission, the main objectives of the proposal are to minimise the number of animals used in scientific procedures and to significantly improve the treatment of the animals still needed for safety testing and biomedical research throughout the European Union. It also hopes that the revised legislation will 'enhance the quality of research conducted in the EU and ensure high standards of human and animal health and environmental protection'.

The proposal is currently awaiting review by the European Parliament and the European Council.

To read the Directive on the Protection of Animals Used for Scientific Purposes, click here

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