EFPIA’s goals are to accelerate the development of and access to integrated healthcare solutions for unmet medical needs in the interests of patients and society at large. This often requires a paradigm shift in research, regulatory and medical practice. The paradigm change also encompasses furthering the welfare of animals used in research and testing, which in turn contributes to high quality science. Having recently joined EFPIA, I have seen already that these goals of accelerating innovation and protecting laboratory animals are interconnected and reflected in EFPIA policies and scientific activities.

Part of this paradigm shift is grounded in the 3Rs Principles. The Rs stand for: reduction (using fewer animals); refinement (modifying procedures or husbandry and care practices so as to minimise the suffering of animals); and replacement, whereby methods, strategies or approaches that do not use live animals are employed). Established in 1959 by William Russell and Rex Burch in their book “The Principles of Humane Experimental Technique”, the Principles remain relevant and continue to drive progress.

Europe is known as a leader in the 3Rs and the welfare of laboratory animals. Directive 2010/63/EU on the protection of animals used for scientific purposes, which replaced the legislation of 1986, integrates fully these principles in all stages of research processes. Thanks to the Directive (and trust me it’s happening), questions, tools and regulations are evolving, driven by scientific progress and collaboration. The legislation challenges scientists to change their perspectives and way of thinking, to drive for change.

The inclusion of the 3Rs is clearly extensive and very impressive, however, nothing is effective if the Directive is not implemented and enforced fully. A mere two years since the deadline for national transposition passed, it is at this point too early to measure the impact of all its provisions. A preliminary Commission report is expected in November this year and a full evaluation of the legislation has been promised for 2019. In the meantime, our energy should go into appropriate and effective implementation.

How?

• Certainly through engagement, dialogue, transparency, and the sharing of good practices. EFPIA is already involved in or champions several related initiatives.
• Then there is the use of guidance. Following the adoption of the Directive, guidance was produced on specific provisions of the Directive, and endorsed by all the Member States. The guidance is readily-available on the Commission website, in all the major languages of the EU. It is our joint responsibility to make sure that all those involved in planning and running research know about it and apply it.
• Finally, by challenging continually research paradigms in order to improve and accelerate translation from discovery to clinical research. The EU invests extensively – sometimes jointly with the industry, as is the case in the Innovative Medicines Initiative (IMI).

Pharmaceutical companies and their research partners take measures proactively to minimise the impact on animals, in cases where animals remain important for specific purposes in medical research and testing.

This stands out in our recent report on “Putting animal welfare principles and 3Rs into action”. The health and welfare of animals remain important, as do the personnel involved and the pharmaceutical industry engage strongly in the Culture of Care. They also contribute by providing resources and workmanship to the Innovative Medicines Initiative which has injected millions of euros into successful projects, many of which offer direct and indirect benefits for the 3Rs, leading to refined animal models, computer-modelling, non-invasive imaging, safety biomarkers, stem cells and real world evidence, which help to generate a better understanding of numerous chronic diseases as well as to produce more effective medicines.

But it goes still further. Medical research continues apace. It needs to, as many health challenges still remain unmet. Animal studies continue to play an invaluable role in meeting these challenges and they remain a legal requirement. However, the change in mindset is ongoing and science continues to evolve. In fact, scientific advances are leading to fewer tests and experiments on animals, as well as to new ways of reducing the impact on animals. This is why dialogue and transparency about the use of animals for medical research and developments in science must remain at the forefront of debate and scrutiny for all those involved.