Animal use and welfare in pharmaceutical research and developmentMedical 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 – both in experimental research, and in ensuring maximum safety of treatments before their use in humans, which is legally required. Research involving animals poses dilemmas, not only for the researchers and scientists who use animals for medical research, but also for society as a whole. The current consensus is that research with animals is justified where there are clear benefits for our health and when the 3Rs are applied. Advances in science are leading to fewer tests and experiments on animals, and to new ways to reduce the impact on animals. This is why dialogue and transparency about the use of animals for medical research and developments in science need to be debated by everyone involved. 

Why use animals?

Only when it is necessary and unavoidable, animals are used for research to help scientists bridge the gap between the theories developed and the reality of introducing a new treatment to the patient. It is legally required that new medicines ensure maximum safety to humans, making the use of animals an essential step in the medical development process. So, in short, without animal testing, there would be no new medicines.

The regulatory framework

Use of animals in testing and research is highly regulated at both EU and Member State levels. The latest legislation regulating use of animals in research passed at EU level in September 2010 came into force on 1 January 2013 and makes the 3R principles a legal requirement (Directive 2010/63). The Directive sets full replacement as a long-term vision and sets the most stringent protection framework worldwide to protect animals that would still need to be used after application of alternative research methods. 

Pharmaceutical industry and 3Rs

Animal research raises dilemmas not only for scientists and organisations that use animals as part of their research projects, but also for society as a whole. Applying alternative methods may lead to significant reduction in animals used, however, most of these methods are not yet able to fully replicate the complexity and reactions of a living organism especially for systemic and chronic conditions. However, they are already widely used by scientists to inform their research programs and, being complementary with others, address the scientific questions for the progress of medicine.
EFPIA members are committed to the science-based phase-in of methods to replace the use of animals for scientific purposes and the deletion of animal tests which are obsolete or redundant. EFPIA members aim to lead progress on this by engaging in a wide range of practical activities to help drive the development, uptake and promotion of non-animal technologies (NATs) and new approach methodologies (NAMs) so that these can be phased-in as soon as it is scientifically possible to do so.

Animal welfare and 3Rs principles in action
The pharmaceutical industry strive to go beyond what is legally required and work to implement 3Rs to ensure high animal welfare and high quality science and ultimately improve the lives of the people and animals that stand to benefit from the research. Since the adoption of the EU legislation governing animal use, EFPIA and its member’s have been publishing reports giving an extensive overview of their actions on putting animal welfare principles and the 3Rs into action. Our 6th report includes the industry commitment to the science-based phase-in of methods to replace the use of animals for scientific purposes and the deletion of animal tests which are obsolete or redundant and a non-exhaustive list of activities and successes of the pharmaceutical industry which indicates the passion and commitment of individuals and their companies to responsible animal use, with tangible outcomes leading to improved animal welfare and high-quality science.
Click here to discover more on EFPIA’s commitment to the scientific phase in.
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The pharmaceutical industry members of EFPIA:
  • Are fully committed to the principles of 3Rs;
  • Continue to support the objectives of the Directive 2010/63/EU on the protection of animals used for scientific purposes which has enhanced animal welfare standards and mandated the application of replacement, reduction and refinement across the EU while ensuring Europe remains a world leader in biomedical research;
  • Will continue to strive to go beyond what is legally required and work to develop and validate systems leading to improved 3Rs, animal welfare and high-quality science and technologies in every day practice and ultimately improve the lives of the people and animals that stand to benefit from the research. Training of staff will remain an essential element of good science and good welfare;
  • Are committed to continue invest in collaborative research initiatives and projects to improve animal welfare and 3Rs, and support start-ups with expertise in new approaches as we transition from the Innovative Medicines Initiative (IMI – the largest health public private partnership) to the new Innovative Health Partnership;
  • Will continue to work with regulators, the scientific community and civil society to improve implementation of the science and speed up regulatory acceptance of alternative methods in the EU and at a global level;
  • Will strive to lead by example by disseminating beyond own department and own establishment to drive improvements in welfare and general quality of science;
  • Will improve the systems in place working with academia, CROs, animal breeding and testing facilities to share good practices, new methodologies and lead by example by uptake of high 3Rs and animal welfare standards in the daily activities;
  • Will be transparent in telling what we do and how we do it, to explain and justify where live animals are required and used and also inform on the work and commitment of companies to reduce the sectors reliance on animals;
  • Will continue to identify, develop and implement their phase-in strategies and communicate on animal use through either dedicated webpages or CSR reports. Open communication and dialogue with the public are key to highlight our contribution to phasing-in replacement methods.

Culture of Care

Directive 2010/63/EU aims to improve the welfare of animals still needed in scientific research by, amongst other things, enhancing the Culture of Carereferred to as the “climate of care” in Recital 31. Establishing, promoting and maintaining a good culture of care is a fundamental component if ethical, scientific and animal welfare obligations, along with wider responsibilities towards employees and the public, are to be met.

EFPIA members have been reflecting on the concept of a Culture of Care and how it is understood and applied across research institutions and companies in Europe - a “checklist” to help engage in or enhance discussions on a Culture of Care within your establishments.

A Framework has been developed with the aim to help organisations identify gaps or potential areas for improvement in support of a positive Culture of Care. The framework is intended as an aid for continuous improvement, highlighting where indicators of good practice are present within companies with the objective to be used as a starting point for consideration and discussion.

Effective experimental design and statistical analysis are critical means of minimising the use of animals and achieving study outcomes.

EFPIA organised a workshop with the pharma user community to enable an open discussion across industry on the concepts and importance of effective experimental design. A report was prepared following the workshop and now industry is working on implementing the recommendations.
Good Transportation practice of live animals for research
European legislation and good research practice require animals used in research to be purpose bred, however those animals cannot always be bred in or close to research sites, and therefore transportation in good conditions greatly contributes to the overall welfare of laboratory animals.

The primary objective while ensuring that legislative requirements are met, should be that animals are transported in a manner that does not jeopardise their well-being and ensures their safe arrival at their destination in good health, with minimal distress or fear which is important to ensure good animal welfare and the validity of scientific procedures.
Therefore, the Research and Animal Welfare Group recommends that EFPIA members, breeders, Contract Research Organizations and transporters consider the LASA guideline as a reference document when planning and carrying out transportation of laboratory animals. The document “Laboratory Animals – Good transportation practice” provides reference and links and highlights specific points to consider for the transportation of non-human primates, dogs and (mini-)pigs.
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Supporting R&D for better science and more welfare

For more information, contact:

Kirsty Reid, Director Science Policy