Many Member States are still struggling to achieve appropriate transposition of the EU Directive on the protection of animals used for scientific purposes.
A key intention of the Directive (2010/63/EU) was to harmonise the way animals are used in science within the EU. Some flexibility does exist in the way Member States may implement the Directive, but, for example, it does not allow them to implement higher standards unilaterally. This means that if a Member State wants in the future to improve housing and care standards, or prohibit the use of animals for certain purposes, it cannot do this without the agreement of all other Member States.
The first review of the Directive in 2017 concluded that it provided a solid basis for the regulation of the use of animals in research, but found, amongst other things, that the implementation of non-animal methods is slow. The reasons identified for such delays include:
Cost: implementing non-animal methods implies additional investment, especially when the costs associated with the use of animals are not dropped
Lack of knowledge: researchers do not tend to receive continuous training throughout their careers, which in turn means that curricula in life sciences are often out-of-date too
Insufficient communication: dissemination actions and sources on non-animal methods and on the limitations of the animal-based methods are not enough, and they don’t reach students, educators, and researchers
In addition, the quality, transparency and impact of oversight bodies and project evaluation mechanisms vary significantly throughout the EU. Different structures for project evaluation in MS raise many challenges on the impartiality, proportionality and consistency of evaluations. The fact that almost all project applications are authorised in every country, linked with significant concerns around the standards to which much scientific research is carried out, and the poor translatability of many animal studies, also indicates a general lack of critical challenge regarding the ‘need’ to use animals.
Under the Directive, the Commission is responsible for conducting periodic Thematic Reviews on the principles and practices of the “3Rs”: the replacement, reduction and refinement of the use of animals in research, education and testing.
However, ten years after the adoption of the Directive, no such reviews have yet been conducted, despite a number of proposals from animal protection organisations. Thematic Reviews can be an opportunity to investigate the reasons, contexts, situations and purpose of the use of animals in research, and potential ways to decrease our reliance on animals in research by learning from best practices and addressing the poor ones.
WHAT DOES THE PUBLIC THINK?
The latest EU survey found that seven in ten (70%) adults in EU Member States agree that enabling the full replacement of all forms of animal testing with non-animal testing methods should be a priority for the EU; and that two thirds (66%) of adults agree that the EU should immediately end all animal testing.
Earlier public opinion polls revealed a high degree of sympathy with animals used for testing, although attitudes may diverge significantly between countries in the EU. Overall, the majority of the public is opposed to animal testing that causes pain or which is conducted for reasons which have no connection with life-threatening diseases. A British survey in 2018 demonstrated that the majority of people can accept animal research as long as it is for medical research, there is no unnecessary suffering, and there is no alternative. However, the public also complains about the lack of transparency, including details of experiments, harms to animals, and alternatives to the use of animals.
POLICY - CURRENT STATE OF PLAY
The transposition of the Directive 2010/63/EU into Members States’ national legislation was supposed to happen by 1 January 2013, but in fact the last transposition only happened in 2015. From 2017 to 2019 the Commission, in accordance with Article 258 of the Treaty on the Functioning of the European Union, gave formal notice to 15 Member States and a reasoned opinion to three, to ensure that they transposed the Directive correctly. Until now, only three infringement cases have been closed.
Even though the Commission’s transposition checks will continue, it is clear that many Member States are lagging behind what is required from this Directive in terms of inspections of laboratories, penalties, record-keeping, training of personnel, and obligations to comply with one or more of the principles of the 3Rs.
The results of the first review of the Directive in 2017 found a suboptimal uptake of the 3Rs. The project evaluation and authorisation processes, that are carried out before animals are used, raised concerns related to poor efficiency, effectiveness, impartiality and consistency of the evaluations. Progress towards the Directive’s ultimate goal of the full replacement of animals has been disappointingly slow, and where non-animal methods have been available, the review identified that they aren’t always being used.