Abstract
Support impactful implementation of Directive 2010/63/EU and get ready for the forthcoming review
Directive 2010/63/EU on the protection of animals used for scientific purposes is an essential piece of legislation that anybody who carries out fundamental biological research and preclinical development potential involving live animals, from octopus and fish, to birds, rodents and other mammals, must know.
The Directive provides for one of the most progressive and stringent mandatory lab animal protection framework worldwide. It harmonises standards across the EU so as to promote both animal welfare and high quality scientific research.
Its full and correct implementation is not only a legal obligation, but more importantly it is an investment in societal acceptance and continuity of research, and in the quality and robustness of scientific results.
To make it simple, Directive 2010/63/EU is doing what good research practice requires anyway: think twice about the question you want to address and the methods that you need to address it. And when this involves the use of animals, there is an added responsibility to challenge yourself and be challenged by others before you start. This is enshrined in the legislation, which requires explicit justification around the selection of methods, scientific rationale, ethical review, authorisation process and retrospective review and inspections. But this goes beyond legal compliance; these provisions are all part of the culture of challenge that must be inherent to high quality research. Transparency measures, such as non-technical summaries and statistical reports, are tools to support the communities strive for excellence and support openness with society.
As is the case for any political compromise, not every provision of the Directive is unambiguous: certain terms do not translate well, for others there is no aligned interpretation or practice. Recognising the challenge, the European Commission together with scientists, animal welfare groups and competent authorities, produced guidance on these grey areas. This guidance clarifies unclear terms and provides examples and is posted on a dedicated Commission portal at the following link: http://ec.europa.eu/environment/chemicals/lab_animals/interpretation_en.htm.
Full and correct implementation of Directive 2010/63/EU as a contract on continuity of research in Europe is even more important today.
Over the next twelve months, the European Commission will evaluate the impact and effectiveness of the Directive. The scientific community has a responsibility to articulate the influence that this Directive has had, taking into account that the impact builds over time. The European Commission will soon solicit users’ views –