Development of new medicines especially required evaluations of their efficacy and safety, with various steps before the 1rst use in Human then the market authorization.
Up to now, animals remain essential and legally required to allow to discover and develop new medicines. This allows to fight diseases for which medical needs are not satisfied yet.
Animal use is a major responsibility for the scientists but also for the society. This is why we are strongly committed to the 3Rs principles (Replacement, Reduction and Refinement) in animal research:
- Replacement. Replacing the use of animals with non-animal methods where possible.
= Applied every time when a proper other choice is possible.
- Reduction. Reducing the number of animals used to a minimum while still obtaining scientifically valid results.
= Complex evaluation of the number of animals strictly required to reach the scientific/legal objective
- Refinement. Refining practices to minimise the stress and improve the welfare of study animals used for regulatory purposes.
= Continuous improvement of the methods used to enhance animal welfare.
As long as animals are needed for the benefit of patients, ethical principles for the use of animals will be at the heart of our research.
The first principle is to use animals only when there is a scientific and/or legal reason and if there is no other option. For example, at the beginning of the development, we select candidate medicines using in silico or in vitro methods. For this reason, only the best candidates will go to the steps where we need animal studies to continue development.
In addition, the regulatory requirements change thanks to the application of 3Rs “Replacement, Reduction, Refinement” (see above and EMA website).
These Research and Development activities are covered by different national and international regulations and standards taking into account the 3Rs Principles. We comply with (or sometimes exceed) these regulations including: