EU Directive on Animal Experimentation

Nic Dakin Excerpts

Tuesday 27th March 2012 Westminster Hall

[Nic Dakin (Scunthorpe) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Walker.

The transposition of the European Union directive on animal experimentation into United Kingdom law provides an opportunity to celebrate and protect the UK’s proud record of pursuing the best standards of animal welfare. It was initially thought that the new directive would have little effect on the operation of the seminal Animals (Scientific Procedures) Act 1986. However, the process has turned out to be much more comprehensive and complicated than expected.

In response to a call for comments issued in 2011, the Home Office received more than 10,000 responses from individuals and almost 100 from organisations, illustrating the high level of interest in this issue.

In October 2011, the Home Office said that a report on the outcome of the consultation would be published early in 2012, as would a draft code of practice and draft guidance on the application of the revised UK legislation, and that these documents would be accompanied by an indication of the Government’s intentions in making the transposition of the requirements of the directive into UK law. It later became clear that Parliament would have to consider the Government’s proposals in yes/no votes, without the opportunity to make amendments, before the summer recess in July 2012. It is now expected that regulations to transpose the provisions of the directive will be published in May, giving little time for meaningful, effective consultation.

It must be recognised that there was a need to harmonise protection of laboratory animals within the EU member states. The new directive has a number of positive, welcome provisions. For example, it requires that upper limits of pain and distress should be laid down and should not be surpassed; that the weighing of likely benefit and likely suffering should be conducted before any project work begins; that there should be retrospective assessments to evaluate whether the stated objectives were achieved and what harm was inflicted on the animals used; that there should be personal records from birth for individual cats, dogs and non-human primates; and that all personnel involved should be adequately educated and trained.

The Government have attempted to reassure interested parties that high standards of laboratory animal protection, which have operated in the UK for many years, will not be relaxed. However, there is concern that the UK legislation might be watered down to harmonise with an EU minimum. This concern is not expressed only by animal welfare groups. Comments published in February’s edition of the British Medical Journal indicated that organisations representing some of the main users of laboratory animals, including the UK Bioscience Coalition, the Association of Medical Research Charities and the Institute of Animal Technology, are also apprehensive.

The fear expressed in the BMJ article was that the Government will not take advantage of article 2 of the directive, which permits member states to maintain higher standards than those required by the directive, but will merely copy out those standards word for word into UK law. Recent experience indicates these concerns may be justified.

The use of great apes as laboratory animals in the UK has been banned since 1997, but it is not in UK law. I wrote to the Minister earlier this year, on behalf of the all-party parliamentary group for the replacement of animals in medical experimentation, which I chair, suggesting that there were compelling ethical, scientific, logistical and economic reasons for making the ban a legal stipulation in the UK. Unfortunately, the reply was disappointing, saying the intention was indeed to copy out the paragraphs in the directive that allow member states to apply to permit the use of great apes in certain circumstances.

The case against using chimpanzees is unanswerable, since, even if their use were ethically acceptable, scientifically justifiable and affordable, where would animals be obtained from in the necessary numbers, if an unforeseen threat to humans arose that could not be dealt with in any other way? Surely the Government should seize the opportunity to put protections into this legislation.

The Fund for the Replacement of Animals in Medical Experiments, which provides the secretariat to the all-party group, and the British Union for the Abolition of Vivisection presented a joint submission to the Minister, which spelled out the case for making the ban on using great apes in the UK permanent and legally binding. The answer they received again repeated the Government’s view that they did not envisage any circumstances in which the UK would claim that there was a compelling need to use great apes. So why not make it clear in this legislation?

Unfortunately, the Government’s approach to great apes fuels concerns about their overall approach to the transposition, giving credence to concerns expressed by bodies such as FRAME, the BUAV, Animal Defenders International and the Royal Society for the Prevention of Cruelty to Animals, as well as those listed in the BMJ article, which I mentioned earlier.

The Minister knows that there is particular public concern about the use of any primates, highlighted by the recent Bateson report, showing that at least 9% of experiments, and probably more, have no discernible potential benefit for humans. In transposing article 8, will the Government clarify the meaning of “debilitating clinical condition” to make it clear that the use of primates can only be considered where a serious human disease is involved, not simply a mild or temporary deterioration, such as baldness or the common cold?

I am particularly concerned that we take the opportunity to put animal experiments on a more transparent footing. I welcome the Government’s acknowledgement that section 24 of the Animals (Scientific Procedures) Act needs to be reconsidered to meet the transparency requirement of the directive. The simplest way to do that would be just to remove it, while leaving in place the protection of personal data, safety and commercial confidentiality provided for in the Freedom of Information Act 2000. In fact, if the Government published anonymised project licences centrally, together with the findings, whether positive or negative, that would remove any remaining risk of individual researchers being harassed, while allowing a mature public discussion of the costs and societal and scientific benefits of experiments, as well as enabling researchers to check that they are not duplicating previous research. Will the Minister confirm that university research will still be open to freedom of information requests, within the existing FOIA safeguards?

Of grave concern is the possibility that the current financial situation could be used to reduce the effort put into the administration of the UK legislation, including the licensing system and the work of the Home Office inspectorate. The system of licensing, consultation between licensees and inspectors, unannounced visits and regional administration has worked well for many years and is strongly supported by the scientific community. However, there are fears the number of inspectors will be allowed to dwindle, that inspectors will interact less with licensees, as advisers and unannounced visitors, and that the whole system will be run electronically from one site, probably at the Home Office in London.

Such changes could undoubtedly be made to fit with the requirements of the directive, but they would have a serious, deleterious effect on the standard of protection of laboratory animals in the UK, which, we are regularly informed, is currently the highest in the world and is something that we in the UK can rightly be proud of.

Given the high regard in which it is held and the key function it plays in ensuring compliance with the law, the implementation of the three R’s—replacement, reduction, refinement—and the maintenance of best possible practice, the Home Office inspectorate should be maintained at its current capacity and its advisory role should be kept intact.

Furthermore, there are concerns that UK housing and husbandry standards might be reduced to the lower EU standards, including for the floor area of cages for dogs or the height of cages for rats, which are greater in the UK than would be required under the directive. Many in the scientific community would find that undesirable. In order to maintain good public relations and perceptions of research and to ensure the continuation of the UK’s established reputation for high standards of animal welfare, lower standards should be avoided, by recourse to article 2 if necessary.

In addition to possibly lowering technical standards, the transposition could weaken the current, successful ethical review process, by substituting it with the “animal-welfare body” stipulated in the directive. Although the Home Office indicated in the consultation that the two were similar, there are important differences in function and emphasis. For instance, it is important to retain the “ethical” aspect of the name, as that more accurately reflects what the role of the body should be. A great deal of effort has been invested in improving the effectiveness of the process, and the general consensus is that it is useful and desirable, and that, where there are problems, they are about effective implementation, rather than with the process per se. There are strong arguments, therefore, for retaining function 2 of the process, namely project evaluation, which would be lost in purely animal welfare considerations. That is particularly important in considering local factors that impact on projects, and in facilitating communication and dissemination of information to the various people involved.

In summary, the recent media coverage concerning the unwillingness of internal transport companies to carry laboratory animals shows that animal experimentation remains high on the public and scientific agenda. Therefore, very great care should be taken to ensure the transposition of the directive does not in any way weaken the UK’s hard-fought reputation for maintaining the highest standards in preserving the essential fine balance between science and animal welfare. In a joint response, the British Veterinary Association and the Laboratory Animals Veterinary Association emphasised that the responsible use of animals in research has improved human and animal welfare through the advancement of scientific knowledge and the development of safer and more effective medicines. They went on to say:

“animals should only be used in research when no alternative is available and the work is justified through independent ethical scrutiny, and we continue to support the traditional principles of the ‘Three Rs’. We strongly believe that higher standards should be retained under Article 2 of the Directive even without clear evidence of benefit to animal welfare, unless there is evidence to show that no reduction in welfare will result.”

That is a clear message from the professional bodies. They conclude:

“The high level of public confidence in the robust regulation of scientific procedures using animals in the UK should not be compromised by the reduction of requirements without this evidence.”

I will be grateful if the Minister could clarify a number of issues in his response. How will he ensure sufficient parliamentary time to scrutinise the proposals when they are brought forward? Will he take the opportunity to put the protection of great apes in legislation? Will he clarify the meaning of “debilitating clinical condition”? Will he clarify how the transparency of access to information will work, so that researchers do not duplicate their research? Will he give reassurances that the current successful approach to licensing and inspection will not be weakened? Finally, will he commit to retaining a robust ethical review process?