Primates & Science
2011 Issue #3 Primates & Science The Use of Primates in the EU
Irmela Ruhdel and Ulrike Gross
The welfare of animals used for scientific purposes in the European Union (EU) is protected by a mutually agreed upon Directive, the latest of which was adopted in September 2010. Transposing the new Directive into individual Member State laws needs to be completed by the 27 EU Member States by November 2012 and be applied starting January 2013. During negotiations between the EU Commission, European Parliament, and Council of Ministers, the original EU Commission Directive proposal regrettably became considerably weakened, and the new Directive has not met the expectations of the animal protection community. However, we acknowledge the overall improvement of the protection of laboratory animals within the EU, especially in EU Member States that previously had no or incomplete regulations.
One special concern of animal welfare people is the use of nonhuman primates due to their closeness to humans, their highly developed social skills, and their ability to suffer, which is very similar to that of humans. European animal welfare organizations lobbied hard to implement a ban on their use but failed; however the use of primates has been restricted.
The 'recitals' (similar to a preamble) to the Directive contain some strong statements of intent with regard to the use of primates. It is recognized that the use of primates raises specific ethical and practical issues in terms of meeting their behavioral, environmental, and social needs in a laboratory environment. The additional suffering caused by the capture of wild animals is also recognized, and strong public concern is acknowledged. It is stated that their use should be restricted to the study of potentially life threatening or debilitating conditions in humans.
Use of great apes
The Directive states that "great apes shall not be used in procedures." However, if a Member State has justifiable grounds, it may adopt a provisional measure for their use that has to be agreed upon by a committee of the European Commission.
From our point of view, experimenting on great apes cannot be ethically justified. It is for this reason that some EU Member States, including Great Britain, the Netherlands, Sweden, Belgium, and Austria, have already prohibited experiments on great apes. Within the EU, statistics show that the last great ape experiments were performed in 1999. For the transposition into national law, we are asking for a ban on their use without exceptions.
Although the Directive stipulates that "[nonhuman] primates shall not be used in procedures" with the exception of those meeting certain criteria, the allowance is quite broad. Drug testing and basic research are permitted, as is translational or applied research investigating "the avoidance, prevention, diagnosis, or treatment of debilitating or potentially life-threatening clinical conditions in human beings."
...the use of primates raises specific ethical and practical issues in terms of meeting their behavioral, environmental, and social needs in a laboratory environment. From the point of view of animal protection, experiments on monkeys other than great apes are also ethically unjustifiable. The initial half-clause, "primates shall not be used in procedures," acknowledges this. However, exceptions mentioned in the Directive essentially nullify any prohibition. For example, clinically speaking, "debilitating" generally refers to serious, long-lasting, often incurable diseases like multiple sclerosis or late stage cancer. But the provision meant to restrict clinical research in primates to "debilitating" conditions is reduced to pointlessness, since the term is far too often defined as "a reduction in a person's normal physical or psychological ability to function." This means that even research into the common cold can be considered licit.
Further restrictions with regard to primates include use of only purpose-bred primates from self-sustaining colonies (dependent on a feasibility study that will take at least 11 years); retrospective assessments of all projects using primates; and annual inspections of all breeders, suppliers, and users of primates. The Directive also specifically allows Member States to ban the use of primates in procedures involving severe pain, suffering, or distress that are likely to be long-lasting and cannot be ameliorated.
The future use of primates in Europe will depend not only on the transposition of the Directive. Court cases will also influence the application of the law, and already have to some extent in Germany and Switzerland, where invasive brain research using primates was challenged on ethical grounds.
Both cases involved similar research in which electrodes were surgically inserted into the brains of monkeys, who were strapped in chairs and had bolts cemented to their skulls to keep their heads still. Each animal spent hours concentrating on a screen and performing visual tasks for the experiments, and cooperation of the monkeys was forced by restricting drinking water. Brain activity was recorded, and at the conclusion of the experiments, the monkeys were killed.
In each country, new legal concepts deriving from constitutional amendments re-evaluating animal rights are being tested.
In Germany, for example, the Constitution guarantees freedom of research. In 2002, the German Constitution was amended to include animal protection as a target provision. This meant an upgrade of animal welfare against freedom of research. Consequently, in 2008, when a researcher applied to continue invasive brain research in monkeys, the Health Authority ruled that the suffering of the primates outweighed the possible benefit for the community, and denied a new license. The researcher filed suit against the Authority's decision at the local Administrative Court and applied successfully for a preliminary injunction to continue his experiments until the decision. In May 2010, the Court overturned the denial of the license by the Authority. It did not issue a blanket license, however, but ruled that the Authority had to re-evaluate the case. The Authority appealed, and the case is pending. Probably the argument will have to be decided by the German Constitutional Court or even the European Court of Justice.
In Switzerland, the Constitution has explicitly protected the dignity of animals since 1992. Also, the Canton of Zurich permits appeals against animal experimentation licenses. Based on this unique legal situation, the Cantonal Advisory Committee on animal experimentation filed appeals against two licenses for invasive brain research in macaques to the Cantonal Council in 2006. Both appeals were approved and the experiments banned. The researchers appealed, first to the Cantonal Council, and when it upheld the ban, to the Canton's Administrative Court. It, too, upheld the ban and the researchers appealed to the Swiss Supreme Court, which confirmed the ruling in both cases. This is the first successful appeal against a license for animal experimentation, and the first time that dignity of animals and the violation thereof has been acknowledged to be legally significant.A general prohibition of primate use in experiments may not be realizable when transposing the new Directive into national law. Animal protection organizations, therefore, are advocating that authorization policies should at least aim at approving primate experiments only in quite exceptional circumstances and only after thorough scrutiny of each individual case. AV
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