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.
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.
- NEW - recording of the EFPIA/RSPCA webinar on Animal Welfare Body - A catalyst for progress 18 June 2021
- Evaluating opportunities to enhance the implementation of selected welfare and 3Rs provisions of Directive 2010/63
- Blog: EU legislation and science further the protection of laboratory animals
- Directive 2010/63/EU: facilitating full and correct implementation
- Animal Welfare: Your questions answered
- Report from the Commission to the European Parliament and the Council on the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in the Member States of the European Union
- Report from the Commission to the European Parliament and the Council 2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017
- NEW - Q&A explaining the EU report on the use of animal statistics
- European Union Reference Laboratory for alternatives to animal testing
- European Commission DG ENVIRONMENT
- FEAM Forum round table on animals in science
- NEW: EFPIA/EARA response to EURL ECVAM Recommendation on Non-Animal-Derived antibodies
Pharmaceutical industry and 3Rs
The pharmaceutical sector continue to be involved in a number of initiatives, which affirm the key principles of the 3Rs (Reducing the number of animals used, Refining experiments to minimize the impact on animals, and Replacing animal experiments wherever possible with alternatives) or change the current research paradigm (such as the Innovative Medicines Initiative).
Science, technology and research practice evolve every day and bring new tools to address scientific questions differently. This paradigm shift is operating seamlessly every day without necessarily being labelled 3Rs.
Animal welfare and 3Rs principles in action
- Putting animal welfare principles and 3Rs into action get_app
- Report 2019: Putting animal welfare principles and 3Rs into action get_app
- Report 2016: Putting animal welfare principles and 3Rs into action get_app
- Report 2015 Update: Putting animal welfare principles and 3 Rs into action get_app
- Report 2012 Update: Putting animal welfare principles and 3 Rs into action get_app
- Report 2011: Putting animal welfare principles and 3Rs into action get_app
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 Care, referred 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.
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.
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.
Accelerating Global Deletion of the Abnormal Toxicity Test. Planning common next steps.
Organised by AFSA/HSI and EFPIA in collaboration with IABS, the workshop aimed to assess the lingering barriers, to reach a shared agreement on further concrete actions to make the deletion of the test a global concrete achievement.View Event
NEW - Fitting vaccine research into one year - Were animals used?
European Partnership for Alternative Approaches to Animal Testing
On the Innovative Medicines Initiative: here and here
A Review of the Contributions of Cross-discipline Collaborative European IMI/EFPIA Research Projects to the Development of Replacement, Reduction and Refinement Strategies
For more information, contact:
Kirsty Reid, Director Science Policy