How will the government update UK law regulating research using animals?

Posted on October 25, 2011 by

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The Lords were looking at animal research again yesterday evening, in particular the process of updating UK law to bring us into line with the EU Directive governing animal research which was updated recently.

The Home Office minister responding made a very clear statement of the value of research using animals and stressed the government’s commitment to ensuring this update of UK law is used as an opportunity to improve and streamline UK legislation and not reduce the UK’s standards in any way.

Background

Animal research in the UK is strictly regulated, 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. The UK needs to bring our regulations in line with the revised directive by January 2013. In a debate in the Lords a couple of weeks back, the government minister Lord Henley confirmed:

I can give an absolute and categorical assurance that we will not be dropping our standards in any way whatever.

However the Home Office are still working on the detail of the how to update the UK regulations – the Home Office recently consulted on this  – AMRC responded as part of a coalition of bioscience organisations. It’s likely that new legislation will be brought before parliament for MPs and peers to scrutinise early next year.

What was discussed yesterday?

Lord Wills had called for the debate with the question:

To ask Her Majesty’s Government what plans they have to change the regulations governing experiments on animals.

He kicked off by discussing attitudes towards medical research and conditional acceptance of some research using animals – stressing the government’s role in this, balancing concerns and regulating research sensitively, prioritising animal welfare:

..it is now widely accepted that scientific and medical research should be carried out only if there is a clear potential benefit and if there is no other means of achieving it.

…This remains a deeply contentious area of public policy, with a wide range of ethical and philosophical considerations in play, passionately held beliefs on all sides, and in a scientific field which is developing at an extraordinary rate.

 

In these circumstances, it is the Government who hold the ring, balancing these competing views, and it is important that they do so. If the public believe that animals are being cruelly treated or that there is no measurable benefit from the experiments being carried out on them, then public consent is likely to be withdrawn from the scientific and medical research being conducted using animals, and potentially valuable research will be lost.

He then outlined his concerns that the requirements in the revised EU Directive are in some cases weaker than the current UK ones and pushed the government for reassurance that they would not be reducing UK standards when they update UK law.

In particular he raised concerns over possible changes to:

  • Home office inspectors and the number of inspections they carry out each year
  • the ethical review process
  • increasing transparency
  • the use of non-human primates in research
  • cumulative severity of suffering

He also asked the government whether they were planning to ban the sale of cosmetics that had been tested on animals (the testing of cosmetics on animals is not allowed in the UK). And asked for a report of government progress on their pledge to work to reduce the use of animals in research (this was a pledge made by the coalition government – see my previous blog for details)

Lord Willis, AMRC’s chair, was also at the debate. The UK Home Office recently consulted on how to update UK law to bring it in line with the EU Directive. AMRC responded to this consultation as part of a coalition of bioscience organisations. Lord Willis outlined the thinking behind this response:

…our priorities are: to promote high-quality science and patient benefits; to ensure high standards of animal welfare; to apply the principles of the three Rs; to harmonise EU regulatory requirements so that we do not have different levels in different countries; and to promote public confidence in humane animal research, which can be done only through openness and transparency.

He went on to clarify what the coalition is and isn’t calling for – you can read a Q&A here which explains the coalition position and the reasoning behind this on some of the more contentious issues such as the ban on the use of great-apes in research (the coalition supports the continuance of this ban).

He also touched on the increasing numbers of animals use in procedures. (Confusingly, the number of procedures is not directly equivalent to the number of animals used in experiments. For many experiments, mice are genetically modified to display characteristics of the disease being studied. The act of breeding a genetically modified animal counts as a procedure. Also, some animals are involved in more than one experiment. As a result, one animal may undergo several procedures.):

there has been an increase in the number of animals used in procedures, particularly in the past couple of years, with some 3.7 million being used in 2010. However, 47 per cent of those include animals that are bred to be used in laboratories, particularly transgenic mice. It also includes the production of zebrafish on which to experiment. When you look at the figures more closely, you see that the use of dogs has gone down by 2 per cent, rabbits by 10 per cent, cats by 32 per cent and guinea pigs by 29 per cent.

Lord Winston also spoke, talking about his own license to carry out animal research and some of the work studying reproduction and transplantation this has enabled him to do. He also explained why for this research, there was currently no alternative to using animals. And he stressed the importance of public engagement about why and how we use animals in research.

Lord Taverne, who is Chair of Sense About Science, stressed the need to update UK law with an eye to ensuring we do not introduce any unnecessary bureaucracy which does not enhance animal welfare. Lord Taverne also pushed for steps to increase public awareness of the role animal research plays in the development of new drugs and treatments.

Baroness Warwick, Chair of the Human Tissue Authority and formerly chief executive of Universities UK, stressed the amount this research taking place in universities and stressed the importance of ensuring they are supported to conduct this research.

Lord Henley was the Home Office minister responding to the debate.

He made a clear statement on the value of research using animals

…animal experimentation continues to be absolutely vital both in developing the improvements in healthcare that we have seen over the past hundred or however many years it is and in ensuring that all our health services continue to function effectively with the gains that have been provided to us over the years.

and went on to explain the Home Office’s need to balance the need for research against the need to ensure high standards of animal welfare and address moral concerns about research..

“but”-we have a moral obligation to ensure that effective arrangements are made for the protection of animals used in that work

On the updating of UK law to bring us into line with the EU Directive (transposition) he said:

We believe that getting the transposition of the directive is absolutely vital. It provides a valuable and timely opportunity for the United Kingdom to review all its legislation governing experiments on animals. It also provides an opportunity to confirm the best aspects of current regulation and to make improvements where we can do better. We believe that the new directive will help us to promote the further development of alternatives to the use of animals. It will also allow us further to reduce unnecessary bureaucracy-referred to by the noble Lord, Lord Winston, and the noble Baroness, Lady Warwick-where it exists and to streamline our existing processes where this will not adversely affect animal welfare, building on the significant improvements that we have already made in the day-to-day implementation of current regulations.

And in response to concerns that the update may lead to a reduction in the requirements in UK law,

I give an assurance that we will certainly not be looking to reduce our standards in any way whatever.

He attempted to address some of the specific concerns raised in the debate including:

Possible change to the Home Office inspectorate who monitor those holding licences to do research using animals:

we will maintain a strong and properly resourced inspectorate. The relationship among inspectors, establishments and licence holders is crucial to the effective implementation of the regulatory framework and we will not jeopardise that. The inspectorate will continue to carry out a comprehensive programme of inspections.

He confirmed ethical review processes will continue in their present form

On the need to maintain and improve transparency:

..we will aim to publish non-technical summaries for all licensed projects. We will also consider how we might adapt Section 24 of the 1986 Act-the statutory bar to disclosure-to enable more information to be disclosed, again ensuring that proper safeguards are included.

on the use of non-human primates in research:

Research using non-human primates is a small but currently vital part of work to protect and improve human lives. I assure the House that the Government will continue to be supportive of all work directed at developing alternatives to non-human primates in scientific research.

And on the proposed ban on the marketing of cosmetics which have been tested on animals:

The marketing ban is being phased in and took effect in 2009 for all cosmetics and ingredients except for those used in tests for the most complex human health effects. The full marketing ban was always conditional on there being full and validated replacement tests in place.

The ban is due to come into force in 2013. In the absence of full replacement tests, the UK is still considering its position.

And on questions over progress with the coalition government’s work to reduce the use of animals in research, Lord Henley reaffirmed that NC3Rs are taking forward this work at the moment and will respond to some of the input they have had from organisations into this.

What next?

The consultation on how to  update UK law in line with the revised EU Directive only closed in September so we’re now waiting for the government to respond to that consultation and develop a legislative proposal that can then be brought before parliament for discussion – probably early in 2012.

Posted in: Policy