In the latest installment of what promises to be a long political drama, scientists and officials representing major U.K. biomedical organizations today released a joint declaration expressing concern that a proposed revamping of European regulations on the use of animals in research will cause more harm to science than good for animals.
The European Union (EU) directive 86/609/EEC was set up in 1986 to standardize animal welfare in research labs across Europe. Fifteen years and 12 new members states later, the European Commission decided to update the law and initiated a lengthy review procedure. This was back in 2001. Seven years on, the first amendments to the directive are up for a vote next Tuesday (31 March) at the agriculture committee of the European Parliament.
Some of the proposed changes, such as expanding restrictions on research with invertebrates, have already sparked concern among scientists.
And as animal-rights groups rally support and intensify their lobbying efforts for tighter restrictions, a panel of scientists today held a media briefing in London to release the new declaration and make their case. Mark Walport, director of the Wellcome Trust, said that scientists across Europe welcome the revision to the law and embrace the 3R recommendations—to refine the techniques, reduce the numbers, and replace animals in research—but he stressed that "medical research still requires the responsible use of animals."
The main changes to the old regulation included in the proposal are:
- compulsory ethical reviews and approval for every experiment involving animals (already in place in many EU countries, such as the U.K.)
- widen the scope of protection to include invertebrate species, animal fetuses in their last trimester of development, and larvae used in basic research, education, and training
- use of animals born and bred in labs to avoid taking animals from the wild and exhausting wild populations
- minimum housing and care requirements
- ban on the use of great apes (chimpanzees, gorillas, and orangutans) in scientific procedures—none has been used in the E.U. since 2002
- phasing out of tests on nonhuman primates (monkeys)
Panelists at the briefing included representatives from the U.K. government, industry, academia, and medical charities. To them, some of these proposals, namely the changes to the animal-accommodation requirement, are likely to end up in increases in cost without visible benefits to the animals. Tim Hammond, speaking for the European Federation of Pharmaceutical Industries and Associations, noted that his organization is "particularly concerned with the amount of bureaucracy associated with the directive" and the added "multiple levels of approval, review, and authorization" that do not translate to an increase in animal welfare. He also pointed out that some of the new rules aimed at minimizing the experimental reuse of animals may end up increasing the overall number of animals used.
Tony Peatfield, on the behalf of the Research Councils UK, protested against the added protection given by the directive to fish and amphibian larvae and decapode crustaceans (lobsters or shrimps). “There is no evidence that these animals are sentient at all," he says. Giving these animals a sentient status comparable to mammals will endanger basic research on the nervous system with no other gains apart from satisfying an ill-placed precautionary principle, Peatfield adds.
Arguably the most contested proposal is the aim to phase out medical research on nonhuman primates, such as monkeys, except in the case of fatal human diseases. Monkeys account for less than 0.1% of animals in research but have produced several success stories, the scientists said. One example is the development of deep-brain stimulation therapy for patients with Parkinson's disease, which requires electrodes to be implanted in the brain. To develop this technique, "30 monkeys have been used over the past 20 years, and it’s estimated that about 40,000 people worldwide have benefited from that," says Sophie Petit-Zeman of the Association of Medical Research Charities.
Roger Lemon, a neurophysiologist at University College London, argues that nonhuman primates are important for more than medical research of life-threatening conditions. They are also the key for basic research into autism or how the brain controls delicate finger movements, he says. Lemon is also concerned that "research in very severe pain will not be possible," because to study arthritis or migraines, it's necessary to inflict these conditions—and pain—on animals.
Following the 31 March votes on the 800 individual amendments to the proposal, the first reading will then be submitted for discussion at the European Parliament, which may then propose further changes to the document. The series of consultations, votes, amendments, and discussions that follows is intricate and may take anywhere from 1 to 3 years to be completed. Peatfield is confident that many proposals feared as too restrictive by researchers won’t pass. For example, he says, "the inclusion of larval forms is so impractical that it almost certainly won't be accepted."
Still, any measures that add costs or increase the bureaucracy of animal experimentation could have an impact on European research. The medical and pharmaceutical industry is highly competitive worldwide, says Walport, warning that research organizations and people "vote with their feet" and might move to the Americas or Asia, where regulations on animal research are not so strict.
To be continued ...
UPDATE: The European Science Foundation also spoke out yesterday on the new animal use directive, releasing a report detailing its concerns and recommending changes to the current language of the directive.