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The rest of the proposals
There are several other measures proposed for the revised Directive, but we consider that most of them will not cause significant problems for biomedical researchers in the EU
In total, there are about 20 specific proposals described in the expert consultation about the revision of the Directive and the majority of them would either have no real effect on biomedical research or result in only limited additional costs in certain countries, administrative burden. In this article we present a quick overview of these proposals.
Technically, the use of animal in fundamental research is not controlled by the existing Directive. However, all the Member States (with the exception of a few of the new ones) have national legislation the regulates all types of animal experimentation, both fundamental and commercial. Accordingly, the proposal that the revised Directive should regulate fundamental research will have little or no effect in reality.
It is proposed that animals bred to provide fresh tissue for use in research (ie where no scientific procedure is carried out on the living animal) should be regulated by the Directive, unless they are killed by a recognised humane method. Once again, this is likely to have little or no impact because almost all killing is carried out by recognised humane methods.
It is also proposed that the use of decapod, cephalopod and cyclostome species should be regulated by the new Directive. There appears to be hardly any research on these species in the EU, so this proposal is unlikely to have any significant impact.
Another proposal is that the foetal and embryonic forms of mammalian species should be regulated after two thirds of the way through gestation. The vast majority of foetal and embryonic forms used in research are either non-mammalian or in circumstances where they are in utero, so that the mother animal is involved and the experiment has to be regulated anyway. Once again, this proposal is unlikely to have any real impact.
The proposal that the new Directive should cover the use of animals in education and training will have some impact. There is a limited amount of student education involving experimental procedures on animals and some training of scientists and technicians. This will require ethical review and authorisation, resulting a limited additional level of administrative burden. Medical device training courses (eg laproscopic surgery) use a greater number of animals and they will experience a more significant additional burden of costs and administration.
The consultation includes the ides of retrospective reviews of projects to assess the harms to the animals and scientific or other benefits that came out of the project. A harm-benefit assessment would be part of the initial ethical review of each project, so the retrospective review would act as a double-check on this. However, the consultation takes the view that the time and effort required for retrospective review would not justify the benefits. We agree with this.
In addition to ethical review bodies in each establishment, it is proposed that there shoald be a national body to set standards for ethical review. Most Member States already have such a body, or something very similar.
With one small exception, the use of great apes in research has now finished in the EU, so the proposal for a ban on their use, with only very limited exceptions, simply reflects the current situation.
The proposal that all establishments should be inspected twice each year, with one of the inspections unannounced will cause a significant additional cost and administrative burden in the majority of Member States, where inspection is less frequent. However, inspection is a good way of ensuring compliance with the regulations and will increase public confidence that laboratory animals are properly treated. Moreover, it is politically impossible to argue against such a proposal without looking as if one wants to get away with poor compliance.
A requirement for initial and on-going training for all the types of people working with laboratory animals is proposed, using the FELASA system as a basis. Whilst this would have cost and administrative implications, the benefits that come from better training are likely to outweigh the costs.
A confidential EU database of information about project authorisations and ethical review that can be used by applicants, reviewers and regulators is proposed. The aim is to encourage best practice and exchange ideas. This sounds like a very good idea to us.
Finally, it is proposed that each year Member States should collect statistical information about the numbers, types, species, etc, of animal experiments and communicate this to the European commission, who would publish annual EU statistics. This would include information on the severity levels of procedures. Whilst this would involve extra work and administrative burden for the majority of Member States, publishing reliable statistical data is important for transparency and highly-valued by European politicians and regulators.