Home Office responds to consultation on updating animal research regulation

Posted on May 17, 2012 by

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Today the Home Office has responded to their consultation on the update of UK law governing animal research – held last year. A new EU Directive is coming into force in January 2013 and UK law must be brought into line. The government confirmed today how they are planning to update UK law, retaining the UK’s current welfare standards where they are higher than those proposed by the Directive. As they do this, they will be exploring ways to streamline bureaucracy where there is no benefit to the welfare of research animals. The Home Office are now drafting the regulations to put all this into practice. These will be discussed by both Houses of Parliament before they can be passed and UK law updated.

Background

Animal research is a small but important part of medical research to better understand disease and develop treatments that improve and save lives. It is strictly regulated in the UK and only conducted where the research is necessary and no alternative exists. The regulations demand high standards of animal welfare and include specific requirements for work to replace, reduce and refine of the use of animals.

The EU Directive governing animal research has recently been revised to raise and harmonise standards across the European Member States. This is intended to improve animal welfare and harmonise the rules across the EU which should make it easier for researchers and funders who work internationally. However, because this is a Directive and not a Regulation, Member States can choose how they implement the directive, so long as they meet the basic requirements. This means the UK has the flexibility to retain bits of our law where it is higher than the requirements in the Directive. Some UK standards are higher than those stipulated in the directive so the Home Office consulted last year on how they should update UK law. AMRC responded as part of a coalition of bioscience organisations.The process of updating UK law is called “transposition” and this must be in place by January 2013.

The APPG Medical Research held a briefing in the Commons earlier this year which included a very helpful guide to animal research and the Directive, you can download it here.

What has the Home Office said?

Lynne Featherstone, the Home Office minister responsible for the regulation of animal research, has said in a statement that they intend to “copy out” most of the Directive as it is but where the UK currently has stricter standards, maintain the UK’s priority for high animal welfare.

The Home Office has published a summary report of the consultation and their response – it’s really easy to follow going through issue by issue as they were outlined in the consultation, summarising the responses they have had and how they plan to act.

Of specific interest:

  • The special protection for non-human primates, cats, dogs and horses will be retained, meaning that research using these will continue to require a much more rigorous justification.
  • The ban on using great apes altogether will also be kept.
  • The UK will also maintain care and accommodation standards where they are currently stricter than those defined in Annex 3 of the Directive.
  • Personal licenses – The Directive does not require individuals carrying out experiments using animals to have personal licenses. The UK currently does and will continue to require this to ensure that only those who have had proper training are allowed to handle animals and conduct the experiments. The system of administering these licenses is currently complex and the Home Office does state that they plan to explore opportunities to simplify this process while maintaining the effectiveness of the licensing process.
  • Research facilities – Facilities where research using animals is conducted are inspected very regularly by trained vets or medical doctors. The Directive specifies a minimum frequency of inspections, lower than those we have currently. The Home Office plans to continue its risk-based approach of regular inspections and has committed to “maintaining a strong and properly resourced inspectorate”.
  • Section 24 of the current UK regulations prevent the Home Office from disclosing confidential information relating to animal research.  The Directive encourages greater transparency to promote the sharing of best practice and increase the refinement, reduction and replacement of animals in research. The Government recognises the difficulties with section 24 in its current form but balanced alongside the need to protect personal details, intellectual property and commercial information.  They plan to publish plans to revise Section 24 separate, in due course.

What does this mean for medical research?

The UK’s regulation of animal research is relatively strict among the European member states and the revised Directive’s main impact will be to bring the rest of the EU closer to the UK’s standards. The UK has chosen to maintain our standards where they are higher, so the UK’s regulatory framework will not change significantly.

We have welcomed the move to maintain the UK’s high animal welfare standards, which underpin high levels of public confidence and support for animal research for medical research where it is conducted to high ethical standards. We also welcome the continued focus on work to replace, refine and reduce the use of animals in research.

AMRC’s chief executive, Sharmila Nebhrajani said:

Today’s announcement outlining how the Home Office plans to update UK law means the public can continue to have the highest confidence in the conduct of animal research, which is a small but vital part of the world-leading research conducted here in the UK to improve and save lives. Independent polls time and time again show that over 85% of people support medical research using animals where it is conducted to high ethical standards and we welcome the government’s commitment to maintain these high standards whilst removing unnecessary bureaucracy.

The Home Office has developed their plans to update UK law in close consultation with all groups concerned, including the research community. They will continue working with them as they implement the updated regulations.

What next?

This is just the Government’s response to the consultation indicating how they plan to introduce legislation. They will now be in the process of drafting regulations to put this into practice and update UK law. They will be published as an affirmative Statutory Instrument (the affirmative bit means it must be debated by both Houses) and will go before Parliament to be agreed before they can become law. The deadline for the directive coming into force is January 2013 so, when you take into account summer recess from mid-July to September, time is tight for this process to be completed.

Posted in: Policy