Written evidence submitted by the RSPCA (UKL0014)

The RSPCA recognises that the UK’s life science sector is widely viewed as a major global force, and delivers significant benefits to the country’s economy. However, the research involved can include the use of animals in experiments which cause pain, suffering and distress, and are of concern to the public. Those involved in conducting research in vivo frequently state that standards of animal welfare are ‘high’ in the UK, and that this results in better science and higher levels of public trust and acceptance. For example, the Concordat on Openness on Animal Research[1] includes a statement that ‘the life science sector in the UK has long been committed to striving to maintain and continue to improve high standards of animal welfare as well as undertaking world-leading research’. The RSPCA hopes that those who have signed up to this statement do not now seek to weaken appropriate controls and oversight on this contentious area of animal use in the guise of supporting the Government as it seeks to reduce the "burden of excessive EU regulation".

●      What are the key EU regulations and frameworks that govern/influence the conduct of research and innovation in the UK life sciences?

For the purposes of this consultation we will confine our comments to our experiences of the development, implementation and impact of European Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes[2]. This legislation establishes a common framework for the regulation of animal care and use in science across the EU and its requirements have been transposed into UK national law by amendment to the Animals (Scientific Procedures) Act 1986[3] and its Code of Practice for the Care and Accommodation of Animals.

There are also nine useful consensus documents[4] produced by the European Commission, that set out further guidance for Member States on articles within the Directive relating to: Animal Welfare Bodies and National Committees on the Protection of Animals Used for Scientific Purposes; Education and Training; Genetically Altered Animals; Inspections and Enforcement; Non-technical Project Summaries; Project Evaluation/Retrospective Assessment; Severity Assessment; Severity Assessment - Illustrative Examples; and Various Articles in the Directive.

●      In what ways do these EU regulations affect the UK life sciences? What are their benefits and the drawbacks?

Directive 2010/63/EU sought to reduce unfair competition and harmonise regulations on the use of animals in research, testing and education across the European Union. This means that those organisations using, breeding or supplying animals in each Member State are now (in theory at least) required to conform to similar controls, e.g. having designated establishments inspected by competent authorities, and having project proposals involving protected animals independently evaluated to assess the justification for the work and the extent to which the 3Rs[5] are being implemented. Standards of animal welfare should also be reasonably consistent. However, given the wide variation in expertise and resources (both within the scientific community and at regulator level) available within different Member States, it was always going to be unlikely that in practice all aspects of regulation in this area would be as consistent as was intended.

The RSPCA has always argued that a high standard of animal welfare is essential for achieving and maintaining scientific quality and efficiency in research in the UK, and in Europe. There were a number of areas where we and other animal protection groups were extremely disappointed with the final text of the Directive, such as the ‘safeguard clauses’ that could be used to overcome restrictions on primate use and potentially allow severe, long-lasting suffering that cannot be ameliorated.  However, most stakeholder and interest groups involved (e.g. scientists in academia, industry, patient groups, animal welfare organisations and the public) acknowledged that, if implemented robustly, the framework represented a fair degree of balance and proportionality.

We have not been presented with any evidence or compelling argument that implementation of Directive 2010/63/EU has had any detrimental effect to the competitiveness of the UK science base. In any case, the sorts of measures included (e.g. a project evaluation framework including a harm-benefit analysis and justification for animal use; regulatory oversight, including inspections of research establishments; openness and transparency; animal welfare provisions) are all factors that those using animals in research routinely argue are important for maintaining scientific quality, good animal welfare and public trust.

It would be surprising if EU regulations were regarded as a drawback for UK life sciences, as it is widely recognised that the standards for regulation and animal care in the Directive are the minimum required for good science and welfare. Throughout the Directive revision process, the UK scientific community and regulator participated fully and played an important role in ensuring that standards elsewhere in the EU were improved.  A further benefit of the Directive is the mutual recognition of training qualifications, which has now made it easier for life scientists to move between and work in different Member States.
 

●      How transparent, consultative and evidence-based are EU policy-making processes?

Stakeholders such as the European Science Foundation, the Federation of European Laboratory Science Associations, and the European Federation of Animal Technologists (which all have UK member organisations from whom they receive significant input) were provided with extensive opportunities to advise on and input into the legislative process during the revision of the Directive. This included in the development of the draft text by the European Commission, during its consideration by the European Parliament, during its review and transposition by the UK government, and in subsequent work of the EC to provide additional guidance for helping Member States understand and implement its requirements. The European Commission also held a public consultation early on in the revision process.
 

●      To what extent is the UK able to shape regulatory processes at the EU level that affect the life sciences?

As one of the major users of animals in research in the EU (and the world), and as a leader across numerous fields of science, the UK was a key driver of Directive 2010/63/EU. Indeed, much of what emerged as the agreed legislative text is largely modelled on and represents what the UK had been doing since the Animals (Scientific Procedures) Act of 1986. Furthermore, individuals and organisations from the scientific, regulatory and animal welfare communities in the UK provided much expertise with regards to the proposal and critical review of almost all aspects of the new legislation.

Whilst the new Directive required a significant number of Member States to implement a range of new measures and improved standards, the UK probably had the least work to do of any Member State to ready itself for the 1st January 2013 when then new agreed requirements were to be enacted.

●      Is the UK able to depart from the application, standards or timing of such EU regulation?

All Member States were required to implement the requirements of the new Directive by 1st January 2013. The UK met this target, though some other Member States took until 2015 to comply.

Article 2 of Directive 2010/63/EU set limits on the ability of any individual Member State to go beyond the requirements stipulated in the Directive. Member States were only allowed to maintain higher standards or stricter controls if these were already in place before 10 November 2010. Following the Home Office reviewing the results of a comprehensive public consultation it undertook during the process of transposition, the UK government chose to do this in a small number of areas (e.g. certain housing and care standards). Whilst the RSPCA argued for and welcomed the maintenance in the UK of most of the existing higher standards, we remain concerned that the wording of Article 2 could constrain the  ability of the UK to implement stronger controls or higher welfare standards where it considers these appropriate or necessary, other than on an agreed voluntary basis amongst those using animals in research.

As a result, it is possible that if the UK government deemed it important to introduce new provisions that would better protect animal welfare or improve the quality of science undertaken, it could be open to challenge from those subject to the regulation in the UK, or even another EU Member State. Having said that, there remains some degree of flexibility within the wording of the legislation that could enable the UK government to make a solid case that it is fulfilling an aspect of the Directive text (e.g. ensuring that the 3Rs are implemented wherever possible).

Any suggestion that the UK should depart from the Directive in a way that would relax controls on animal use, or reduce welfare standards, would be extremely disappointing, and to the detriment of UK science, animal welfare and public trust.

March 2016