Inquiry into the Revision of the Directive on the Protection of Animals used for Scientific Purposes

Embargo: Immediate Monday 20 July 2009
Contact: Owen Williams 020 7219 8659

LORDS EU COMMMITTEE WRITES TO HOME OFFICE WITH EMERGING CONCLUSIONS ON PROPOSALS TO REVISE PROTECTION FOR ANIMALS USED IN SCIENTIFIC EXPERIMENTS

The House of Lords EU Committee has written to Home Office Minister Lord West of Spithead with emerging conclusions from its inquiry into the proposed revision of the EU Directive on the Protection of Animals used for Scientific Purposes.

The Committee intends to produce the final report on the inquiry in November, but has written to the Government with emerging conclusions at this stage because the Swedish Presidency of the EU are keen to make early progress with the proposal. It is expected that there will be significant discussions on it in September.

Some of the Committee’s emerging conclusions include:

  • Revision of the Directive is needed: the Committee particularly welcomes the proposal that a requirement for prior authorisation of animal procedures, including an ethical review process, should apply across the EU.  This is already a feature of arrangements in the UK.
  • The Committee does not support reducing the maximum term for authorisation of research projects to 4 years. It is currently 5 years in the UK.
  • The Committee calls for the proposal to be unambiguous in specifying the necessary limitations on the use of non-human primates in research.  Subject to keeping the feasibility of the timetable under review, it supports the proposed dates after which only the off-spring of non-human primates kept in captivity may be used for research, in order to phase out the use of animals taken from the wild.
  • The Committee recognises that the proposed care and accommodation standards for animals have been anticipated for some time and are unlikely to affect the competitiveness of the pharmaceutical industry in the EU.  But the impact on academic research establishments may need to be re-considered.
  • The Committee is clear that current efforts being made to provide clear definitions of “severity classifications” in the text of the Directive must be brought to a successful conclusion if the Directive is to be agreed.
  • Taking account of all the evidence received, the Committee does not believe that implementation of the Directive will contribute significantly to any diversion of animal-based research out of the EU.

Notes to Editors

  1. The text of the letter from the Committee is reproduced below.
  2. For more information on the Committee and its inquiry please visit www.parliament.uk/hleud

[ENDS]


Letter of 17 July 2009 from Lord Roper, Chairman of the Select Committee on the European Union of the House of Lords, to Admiral Lord West of Spithead, Parliamentary Under-Secretary of State, Home Office

Proposed Revision of the Directive on the Protection of Animals used for Scientific Purposes

Over the past three months, we have been conducting an inquiry into the proposed revision of this Directive.  We have taken evidence from a number of key interested parties, including the pharmaceutical industry, academic and research funding bodies, the National Centre for the 3Rs (NC3Rs), and organisations advocating animal welfare, the use of alternatives to animals in research, and an end to vivisection.  Our intention is to conclude our inquiry and publish our report after the summer recess.

However, we know that the Swedish Presidency aims to make early progress with this dossier, and that there may well be important discussions related to the proposal during September.  While we have not yet finalised our inquiry, we think that we should indicate our emerging conclusions at this stage, so that these are in the public domain before discussions under the Presidency move ahead significantly.

Our first finding, which reflects a firm consensus among our witnesses, is that a revision of the Directive is clearly needed; and that, of the changes contained in the proposal, the introduction across all Member States of a requirement for prior authorisation of animal procedures, including an ethical review process, is particularly to be welcomed.  Much of our evidence has borne out the importance of the operation of this process in the UK.

There was, however, a clear divergence of views among our witnesses about the possibility that the requirement for authorisation of “mild” procedures might be modified (as a result of amendments proposed by the European Parliament) to become one of notification.  We note the argument that this would significantly lower current levels of animal protection in this country.  We agree that a revised Directive should not lead to this outcome, and we therefore support the authorisation requirements set out in the Commission’s proposal and reject a move to require notification (rather than authorisation) for “mild” procedures.  However, we would urge that those concerned should seek to ensure that the authorisation process is completed quickly.

We consider that the concerns about authorisation voiced by industry and academia may in some instances result from a lack of clarity in drafting. We therefore urge the Council to ensure that the Directive provides clearly for a smooth and timely authorisation procedure, while maintaining a high level of animal welfare.  It will be important to ensure that the ethical review process is effectively dovetailed into the procedure, including specifying time-limits for that process which are consistent with the 30-day time-limit for authorisation.

We have looked at the issue of whether implementation of the proposal might drive animal-based research work out of the UK and EU to other parts of the world, but we have not found evidence that this is likely to be the case.  As witnesses recognised, a good deal of activity linked to the pharmaceutical sector has been built up in recent years in China and other non-EU countries  for commercial and economic reasons, and it is these factors that will continue to dominate key locational decisions.  And in the case of academic research, transfer of activity abroad is also mostly driven by other reasons, notably the availability of research funding.

We accept, however, that the imposition of bureaucratic burdens that are not justified by any gain in animal welfare is undesirable in itself, and may influence the climate of opinion among those deciding on future investments.  To that extent, we lend our support to calls for the procedures contained in the proposal to be fine-tuned to the scientifically demonstrated needs of animal welfare, without unnecessary elaboration.  Authorisation processes must be efficient, so that scientists in both industry and academia can take on new lines of inquiry and amend current approaches without undue delay.

The proposal envisages that the maximum term of authorisation for projects should be four years; in the UK it is five years.  We have not seen evidence that shortening the term in this way would be justified by significant animal welfare benefits.  We are also not persuaded of the case for the provision in the proposal that all projects lasting 12 months or more should be subject to annual review (by the ethical review body).  This also contrasts with the current position in the UK, where, while retrospective review is required, ethical review processes (ERPs) are allowed more flexibility in the degree of on-going scrutiny they give to projects, allowing efforts to be focused where and when the ERP feels that review is really needed.

Some of our witnesses  raised the issue of the transparency of the authorisation process.  The proposal requires (in Article 40) that non-technical summaries of authorised projects be made publicly available and that these be updated with the results of retrospective assessment.  In addition, it also requires (in Article 49) the annual collection and publication of statistical information on the use of animals in procedures, including information on the actual severity of the procedures.  Of these provisions, reporting data on actual severity and the results of retrospective assessments would increase the information on animal procedures made publicly available in the UK.  We consider that such greater transparency may well be justified, although publication of additional information should not extend to the disclosure of the identities of individuals or establishments.

It seems clear to us that the care and accommodation standards in the proposal (which are the result of extensive and lengthy discussion among stakeholders) are not likely to impact unduly on the competitiveness of the pharmaceutical industry. We note that those standards have been anticipated for some time and are already being applied or worked towards in this country and elsewhere in the EU.

None the less, we understand that the standards proposed may prove more difficult for academic research establishments to meet on the timescale envisaged, and we think that there may be a need to re-consider the timescale for implementation in the light of experience.  We welcome the fact that the proposal provides for this possibility, since Annex IV can be amended through Article 48 (adaptation of annexes to technical progress).  Moreover, we draw particular attention to concerns that have been expressed over the practicalities of the stocking densities proposed for rodents and rabbits at breeding establishments.

Importantly, we also heard from several witnesses that key explanatory text which accompanied the standards as first elaborated by the Council of Europe guidelines has been lost in the proposal, and we agree that it should be restored.

We understand the importance of research work undertaken using non-human primates.  While we acknowledge the arguments put to us about the special case of these animals, we consider it important that the Directive allows such work to continue as at present. We are mindful of concern voiced by some of our witnesses that the Directive as drafted is insufficiently clear in establishing the circumstances in which research work using non-human primates may be permitted. Some witnesses considered that the wording of Articles 5 and 8 would allow an increase in this type of research, while others considered that it would lead to an unacceptable decrease. We therefore stress the importance of ensuring that the text of the Directive is clear in setting out the circumstances in which research work using non-human primates may continue.

We fully endorse the aspiration that supply of non-human primates should be restricted to F2 non-human primates , the offspring of such animals bred in captivity. We have sympathy with the arguments by some of our witnesses that the Directive should include specified time-limits after which only F2 animal should be used. It may be that the time-limits suggested in Annex III are appropriate. However, given the degree of uncertainty related to the practicality of this suggestion, we consider it crucial that this aspect of the Directive be monitored closely, and that the feasibility of the time-limits should be investigated on a species-by-species basis. The Commission's review of the Directive must include information on progress in phasing out the use of F1 primates. On this issue as well, it is relevant that there is flexibility under Article 48 to amend the time limits.

The proposal extends the scope of the Directive to include several invertebrates. We would argue that the scope should be linked as closely as possible to broadly accepted evidence of sentience. It is apparent, however, that the scientific evidence on the sentience of certain species is unclear. Against this background, we are minded to agree that, while cyclostomes and cephalopods should be included, decapods should be excluded. We also take the view that independently feeding larval forms of invertebrates should be excluded.

At the same time, we are concerned that there is no provision in the Directive to amend the list of invertebrates in Annex I. We therefore consider that Article 48 should be amended to include Annex I. This would allow the Commission to take account of the new scientific evidence pertaining to sentience, either by expanding the list in Annex 1 or reducing it.

Independently feeding larval forms and embryonic or foetal forms (as from the last third of their normal development) of live non-human vertebrate animals would also be included. We are concerned that this may in some cases lead to a substantial increase in the administrative burden with no benefit. While the proposal would in fact mean a reduction in the extent to which controls applied to eggs used in vaccine production in the UK (from half-way through development to the last third), the impact on production procedures elsewhere in the EU may well be greater. This may again beg the question of whether a potentially very significant increase in administrative burden would be matched by a corresponding benefit to animal welfare.

More generally, we consider that the provisions of the Directive should be amended to ensure that the breeding and humane killing of animals for their tissues and organs should not be regarded as a "project" within the terms of the Directive. While it is of course necessary that the care and welfare of these animals should be ensured, work involving them should not be subject to the authorisation processes required of projects.

We fully endorse the near-unanimous view among our witnesses that the severity classifications need to be clearly defined in the text of the Directive. We welcome the efforts made by the Commission towards building a consensus among stakeholders on the content of the definitions. We note that clarity on the definition of severity classifications is particularly important for implementing the proposal's provisions on re-use of animals. We also consider that the re-use provisions must be amended in order to avoid unintended consequences for animal welfare. Left in their current form, the provisions would be likely, in certain specific circumstances, to increase the number of animals (and degree of suffering) that would need to be used.

There is widespread support for the principle (Article 44(1)) that there should be mutual acceptance between Member States of data from tests required under Community legislation, so that, for example, vaccine batch-testing done in one EU country should not have to be repeated in another. Key to this, we consider, is that Member States implement legislation to ensure that, at the least, the use of animals for ratification of such data will be sanctioned only in exceptional circumstances and for strictly scientific reasons.

The provisions in Article 44(2) give rise to some of the more substantive concerns relating to the proposal. We are aware of the strong concerns expressed by the research community about the loss of intellectual property rights if researchers were obliged to share commercially sensitive data. We consider that obligations on data-sharing should apply only where there is evidence of duplication of procedures making use of animals, and we have seen little, if any, such evidence. We reject the European Parliament amendments on this issue.

We fully support the principle of the 3Rs, including the explicit reference to it in the proposal, but we consider that the specific proposal that national reference laboratories be set up must be re-considered. We are persuaded, on the other hand, that a system of national centres along the lines of the UK's NC3Rs might well be developed. Some witnesses have suggested that the role of the European Centre for the Validation of Alternative Methods (ECVAM) be expanded. We consider that ECVAM plays a valuable role and it may be able to assist in the important task of sharing best practice and information on the 3Rs between EU countries.

Finally, we have been struck by what we have heard from our witnesses about the inconsistency with which the 1986 Directive has been implemented; this is indeed one of the reasons why there is widespread agreement on the need for a revised Directive.  We put particular stress on the need for due attention to be paid to the implementation of the revised Directive, once it has been adopted.  Such are the uncertainties around the implementation of this Directive that Member States must send information on implementation of the Directive sooner than six years after the transposition date. The Commission should review the Directive no later than five years after it has come into force (and not ten, as proposed).

We support the European Parliament amendment which would oblige, rather than permit, the Commission to undertake controls of the infrastructure and operation of national inspections in Member States; we see this as of particular importance.