In line with Directive 2010/63 on the protection of laboratory animals, the pharmaceutical industry, which, together with other life science players, develops continuously new scientific paradigms that lead to replacing, reducing and refining animal studies (3Rs), calls for a balanced dialogue on the 3Rs process, driven by aspirations, but based on scientific reality.

Brussels, 6-7 December 2016 - Today’s European Commission conference “Non-Animal Approaches – the way forward?” is an opportunity for the scientific community to take stock of progress and identify gaps that need to be addressed on the replacement, reduction and refinement (3Rs) of research involving animals. The pharmaceutical industry is working continuously on improving its research tools to help it predict more precisely what might happen in people, rather than in animals, or in a cell culture. We support the start of a more structured dialogue with the civil society, initiated by the Commission.

“The paradigm shift in biomedical research is happening continuously with sometimes incremental, and sometimes significant breakthrough findings. Even if not specifically labelled “3Rs”, everyday research delivers tools, methods and approaches that replace and reduce the impact of R&D on live animals.  Only through joining forces across companies, life science sectors and stakeholders will we make significant progress. EFPIA is an active contributor to a number of platforms –including the Innovative Medicines Initiative (IMI) and the European Partnership for Alternatives to Animal Testing (EPAA) – and these are essential enablers of such collaborations,” says Magda Chlebus, EFPIA Director Science Policy.

Equally important is the full and correct implementation of Directive 2010/63, which sets rigourous standards for the protection of animals. Despite significant progress, alternative methods cannot always provide accurate information about the complex biology of a living organism, or predict the safety of candidate medicines. Directive 2010/63 mandates the use of available alternatives, and regulates strictly the conditions under which studies can involve animals, as well as how these studies are assessed, authorised and reviewed. “It is the joint responsibility of the scientific community and the competent authorities to make sure that the legislation is understood fully and complied with for the benefit of responsible and excellent research,” adds Chlebus.

EFPIA calls for resources to be made available at both national and European level to enable a more effective dissemination of guidance and good practice, to facilitate full and correct implementation of Directive 2010/63, and for continued support to public-private research collaborations within and across industry sectors. 

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The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 42 leading pharmaceutical companies, EFPIA is the voice in Brussels of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. More at www.efpia.eu

IMI, the Innovative Medicines Initiative is the largest public private-partnership for health research worldwide, co-funded by EFPIA and the European Commission. A significant number of its 75 ongoing or finished projects implemented by public-private consortia deliver results with 3Rs impact.

EPAA, the European Partnership for Alternative Approaches to Animal Testing, is a public private partnership between 7 industry sectors and the European Commission to progress 3Rs in regulatory testing.

The total number of animals used in research in 2011 in the EU decreased over half a million from the number reported in 2008 (just below 11.5 million)[i]. Since 2011, more than 70% of animal research has been conducted on rats and mice. Research involving a limited number of other species has led to important medical breakthroughs for cancer, diabetes, HIV, smallpox, Parkinson’s disease and many other conditions. It has also helped further our understanding of human and animal biology. Despite significant increase in research investments, the numbers remained stable, demonstrating significant efforts in 3Rs and scientific paradigm changes.