Safer Medicines - putting patient safety first

Putting patient safety first

Regulatory Affairs Journal (RAJ) Pharma 19/05/09

International regulators sign deal on validating alternatives to animal testing

International regulators have signed a co-operation agreement that is intended to give new impetus to the worldwide availability of scientifically proven alternatives to animal test methods1.

The agreement, signed by regulatory organisations that deal with validating alternatives to animal tests in the European Union, the US, Japan and Canada, is expected to see that testing methods that undergo scientific validation are more credible and more rapidly applied by the biomedical research and safety testing community.

The collaboration is designed to enhance international co-operation and co-ordination on the scientific validation and evaluation of in vitro toxicity testing methods. It formalises the way the bodies already work together in test method evaluation, validation studies, independent scientific peer review and recommendations from regulatory authorities. The collaborating organisations are: the European Centre for the Validation of Alternative Methods (ECVAM); the Interagency Coordinating Committee on the Validation of Alternative Methods in the US; the Japanese Center for the Validation of Alternative Methods; and Canada's Environmental Health Science and Research Bureau.

"Reducing animal testing, both out of concern for animal welfare and ethical issues, and protecting consumer safety are two major objectives of this international agreement," said European commissioner for Science and Research Janez Potocnik. In addition, EU Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes requires that the commission and the member states actively support the development, validation and acceptance of methods that could reduce, refine or replace the use of laboratory animals. Directive 86/609/EEC is currently in the process of being revised.

The commission believes that strengthened collaboration among the signatories should facilitate test methods that are widely accepted by regulatory bodies in the EU, US, Japan, Canada and internationally by the Organisation for Economic Co-operation and Development, for example.

Validation bottlenecks

Commenting on the agreement, the UK-basedSafer Medicines Campaign - which is lobbying for an evaluation to be conducted into whether advances in human-biology-based tests outperform animal tests in assessing drug safety2 - hopes that it will lead to the removal of the current barriers that slow down the validation of non-animal tests3.

"The validation process currently represents a bottleneck in the acceptance of non-animal methods because limited resources are available to steer them through a process which may take years," Margaret Clotworthy, science consultant for the Safer Medicines Campaign, told RAJ Pharma. "Presently, even after one body has accepted the test as valid, many years may pass before international agreement is obtained and the test incorporated into OECD guidelines." Dr Clotworthy noted that the OECD had now fully accepted one of the available reconstituted human skin models. However, in vitro tests for eye irritation and teratogenicity, amongst others, whilst validated by ECVAM, "still languish awaiting full international approval", she continued. "Hopefully this new agreement will address this problem."

Dr Clotworthy added that, "whilst no one doubts that new tests should be rigorously assessed. such standards have never been demanded of animal tests". She hoped that the agreement might also lead to "recognition of the need for a parallel process, whereby current [animal] tests that would not stand up to the rigours of validation may be reviewed and invalidated".

UK consultation on revised directive proposals

In other developments concerning the use of animals in scientific experiments, the UK Home Office has launched a public consultation on the commission's proposal to revise Directive 86/609/EEC to strengthen the regulation in this area; the consultation closes on 3 July4.

The commission published its proposal last November5. The draft directive is intended to harmonise the regulation of animal experiments across the EU, in order to create a level playing field for both researchers and industry. In March 2009, the European Parliament's agriculture committee watered down the proposals, saying that there was a need to make the draft directive "better balanced and enable medical research to go ahead"6. The European Parliament on 4 May voted in favour of the agriculture committee's revisions to the proposals7.

The UK Home Office, commenting on its consultation, said that its key priority in negotiating the revised directive was to develop practical, proportionate and enforceable legislation that made proper provision for the welfare of experimental animals, facilitated their responsible use, and could adapt to further technical progress. It added that the government would also work hard to ensure that the new directive did not undermine the success of UK and European research by developing and adopting inflexible measures which would add disproportionate or unjustified regulatory burdens.

Next steps for directive

A statement from the European Parliament notes that it has not been possible to conduct talks with the council of ministers with a view to reaching a first-reading agreement before the European elections in June. "It will therefore be up to the newly elected Parliament to confirm or amend the outgoing Parliament's position and negotiate with Member State representatives in order to conclude work on this directive," it notes.

References

1. European Commission, press release, 27 April 2009, http://europa.eu/rapid/pressReleasesAction.do?reference=IP/09/643&format=HTML&aged=0&language=EN&guiLanguage=en

2. The Regulatory Affairs Journal - Pharma, 2009, 20(2), 87-90

3. Personal communication, the Safer Medicines Campaign, 30 April 2009

4. UK Home Office, Consultation on protecting animals used in scientific research, 7 May 2009, www.homeoffice.gov.uk/documents/cons-2009-animals-research/cons-2009-animals-research?view=Binary

5. The Regulatory Affairs Journal - Pharma, 2008, 19(12), 830-831

6. The Regulatory Affairs Journal - Pharma, 2008, 20(5), 315

7. European Parliament press release, 4 May 2009, www.europarl.europa.eu/pdfs/news/expert/infopress/20090504IPR54954/20090504IPR54954_en.pdf

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