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EFPIA statement on the Commission response to the European Parliament non-legislative resolution on plans and actions to accelerate a transition to innovation without the use of animals in research, regulatory testing and education


The European Commission has published its response to the European Parliament non-legislative resolution on plans and actions to accelerate a transition to innovation without the use of animals in research, regulatory testing and education. The response identifies an existing robust program with cross-sectorial coordination, a multiplicity of initiatives and commitments from many stakeholders. We support the statement from the Commission that it is not possible to predict when scientifically valid methods will become available that can replace particular animal procedures.
 
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.
 
Advances in science are leading to fewer tests and experiments on animals, and to new ways to reduce the impact on animals. Medicines developers continue to be involved in a number of initiatives, which affirm the key principles of the 3Rs (Replacing animal experiments wherever possible with substitutive methods, Reducing the number of animals used and Refining experiments to minimise the impact on animals) or change the current research and development paradigm.
 
Research involving the use of animals can provide much important information – for instance they can help to advance basic scientific knowledge, understand the basis of diseases, and to investigate and develop new medicines as they allow for to evaluate effects on a whole organise. However, we also recognise the ethical and animal welfare issues involved. 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 improved biological knowledge, technological advances, computer simulations and innovative (Microphysiological systems, Complex 3D models) methods may lead to a significant reduction of the number of animals actually used. To date, most of these methods are not yet able to fully replicate or extrapolate the conclusion of simple models to 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 the ones to the others, address the scientific questions for the progress of medicine.
 
Europe must remain a world leader in medical research and innovation to address the unmet medical needs of its citizens and to preserve its capacity to shape its health strategies as well as the unmet medical needs of world regions that do not have the resources or expertise to address their healthcare issues, e.g. addressing Malaria and Ebola to name a few. The global health pandemic also highlights this importance. Those conducting biomedical research should have access to the most appropriate technologies to achieve this imperative objective.
 
EFPIA publishes regular reports on the many 3Rs and animal welfare initiatives of the pharmaceutical sector (Podcast of the pharmaceutical sector).  The next report is foreseen to be published in Q2 2022. In 2020, the innovative pharmaceutical industry invested an estimated € 39,000 million in R&D in Europe. There has been a steady increase for the past 30 years. However, with clear increase in R&D investment we are seeing a consistent decrease in the number of animals used across the innovative pharmaceutical industry during this period (information justifying this is available on dedicated company webpages or their CSR reports).  EFPIA are founding members of the European Partnership for Alternative Approaches to Animal Testing - a cross-sectorial and multidisciplinary partnership between five European Commission services, 37 companies (9 of which are pharma companies) and eight industry sector associations – which for 15 years have been promoting 3Rs in regulatory testing, and facilitating the development and implementation/ regulatory acceptance of replacement testing strategies.  Furthermore, specific to medicine and vaccine development, the Innovative Medicines Initiative projects have contributed enormously to animal welfare and to the 3Rs. Many projects from the 170 in the portfolio with a budget of 5.3 billion have contributed towards improved animal welfare and take up of the 3Rs.
 
Although no timelines could be determined, EFPIA will maintain its effort to reducing the number of animals and will continue being an active contributor to the development of New Approach Methodologies (NAMs).
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