In November 2010, following years of debate and intense negotiation, agreement was finally reached between the European Commission, the European Parliament and the Council of the European Union on the text of new legislation on animal experiments - European Directive 2010/63/EU.
Improvements for lab animals across Europe
Though less stringent in a number of areas than the UK Animals (Scientific Procedures) Act 1986, the new EU legislation represents a significant advance for many Member States and should lead to improvements for tens of thousands of animals.
For example, all scientific uses of animals will now be legally controlled and all Member States will have a basic system of licensing research establishments and projects. Very importantly, each project will have to undergo a harm-benefit assessment to assess whether the use of animals is necessary and justified, and there is a requirement to implement the 3Rs of replacement, reduction and refinement. Every establishment will also have to set up an Animal Welfare Body to advise on welfare issues locally and focus on the 3Rs throughout each project.
Unfortunately there are no real restrictions on the use of primates, and apparently stricter controls relating to which animals can be used and how much they may be permitted to suffer may be overcome by using a multitude of “get-out clauses” if an exceptional scientific benefit can be shown. There is also insufficient emphasis on replacing animals and the timeframe allowed for improving standards of housing and care (until 2017) is outrageously long.
How does this affect the UK?
The UK had until 1st January 2013 to ensure that it had implemented the requirements of the revised EU legislation. On the face of it, the UK appeared to have less to do than many other countries in order to ‘get ready’. However, with some people pushing simply for a straight transposition of the minimum requirements of the Directive into UK law, there was a real danger that controls and standards could have been weakened.
As a result, the RSPCA, along with many other organisations and individuals, made strong representations to the Government to emphasise the importance of at least maintaining the existing standards in national legislation (note: there are restrictions on whether one EU member state can unilaterally introduce new higher or more stringent measures). We argued that if standards were weakened, then animal welfare would suffer and consequently so would science and public confidence in the level of control.
In May 2012, the Home Office published the results of the public consultation it had run during 2011. This revealed overwhelming support for the UK to maintain its current standards. We welcomed the Home Office’s formal response that they would use the freedom permitted by Article 2 of the Directive to keep the vast majority of existing UK standards where they were higher than the minimum set out in the Directive.
In December 2012, the proposed amendments to the UK law were approved by Parliament. Most of our major concerns about the content of the revised legislation had been addressed but its impact in the future will very much depend upon how the Home Office and others choose to interpret and implement the new law.
2013 and beyond
The Home Office is currently producing Guidance to accompany the legislation and we are waiting to see how this accounts for our remaining concerns. We believe that clarification is needed on a number of important aspects such as how completed projects should be reviewed and how actual suffering experienced by animals should be assessed and reported. Guidance is also needed on the new role for a person in each establishment to ensure that people using animals are 'trained and competent', and it is also far from clear how the new Animals in Science Committee will operate in practice.
We will be monitoring the implementation of the newly amended law very closely, and will continue to meet regularly with Home Office officials to discuss our views and concerns.
- Around 1300 establishments (including universities, pharmaceutical and chemicals companies) use a total of 12 million animals in experiments each year across the EU.
- 181 establishments are based in the UK and they use around 3.7 million animals each year*.
* based on data for 2011.