Medical research and scientific innovations are evolving and progressing at an unprecedented rate. Scientific knowledge and technological innovations allow a better understanding of the human body, its mechanisms and how it responds to medical treatment. Research, development and production of medicines and vaccines continue to progress toward better adapted, safer and higher quality health solutions for patients. To support its solutions, a strong regulatory framework is required to oversee pharmaceutical companies, including on the use of animals in research, development, and production.
Animal research raises dilemmas not only for scientists that use animals as part of their research projects, but also for society as a whole. The current consensus is that the use of animals in research is justified only if there are clear benefits for human and animal health. As a key element of Corporate Social Responsibility, Sanofi commits to meet or exceed regulations and standards for the use of animals and to develop alternative approaches.
Our research, development and production activities are conducted across all continents. To promote a common vision of animal protection throughout the company, a Group-level Policy on Animal Protection has been implemented.
The most predictive scientific approaches must be chosen to ensure the safety and effectiveness of new and commercialized drugs and vaccines; thus, testing of vaccines prior to releasing batches is internationally required for public health reasons. Animal testing is mandated to ensure safety and effectiveness for the majority of the vaccines we develop.
In 2020, Sanofi has maintained its effort to replace and reduce the use of animals. Animals used on Sanofi sites globally is 303 507 animals, more than 99% being rodents and fish. Since 2013, the overall reduction is 45%.
Although diminishing, animal research continues to be an integral part of any research and testing strategy, alongside non-animal methods (such as computer models and in vitro studies), patient data and clinical research that, together, generate data sufficiently robust to ensure safe and appropriate health solutions for patients. None of those methods can alone be sufficient to predict the safety and efficacy in patients.
Sanofi has signed the French Transparency Charter on the use of animals for scientific and regulatory purposes. This engagement has followed the signature of the Belgian agreement. We are committed to making information on the use of animals for scientific or regulatory purposes accessible to the general public.
All professionals are committed to the "3Rs" and high animal ethics standards.
As it is imperative to use animals to ensure the safety or quality of medicines or vaccines, all procedures must comply with regulations and experiments are optimized to avoid suffering or distress to the animals. Any use of animals is overseen by ethics committees that monitor the care and use of animals, as well as the active implementation of the “3Rs” (replacement, reduction and refinement of animals in research and production), to which Sanofi has been committed for decades.
Our approach is to use animals only in the absence of adequate alternative methods to achieve an identical result (Replace), to use the smallest number necessary for quality science (Reduce), and to use state-of-the-art practices to protect animal welfare and prevent animal pain and distress in living and procedural conditions (Refine).
In the Factsheet on Animal Protection, examples of novel approaches include the replacement of animal use thanks to validated methods or scientific evidences supportive of regulatory waiving by the drug agencies, technology development to refine and reduce the use of animals.
Active collaboration with other pharmaceutical companies and competent authorities fosters the development of good practices and alternative approaches across biomedical research. Examples are reported in EFPIA brochure: "Putting animal welfare principles and 3Rs into action".
Partnership and collaborations strengthen and accelerate our long-standing commitment to the “3Rs” and applies to all animals used for research, development and manufacture of medical products, vaccines, medical devices, and pharmaceutical ingredients. It also applies to breeders, animal suppliers and transporters of animals for research, testing and production, as well as all to our partners, who use animals as part of their work with us.
Rehoming research animals has become a priority. A corporate program has been set up in Europe.
Efforts are continuing to offer a new home to animals who have contributed to research programs. The species include ferrets, dogs, pigs, sheep, horses, rabbits, poultry... A corporate policy has been approved by the Bioethics Committee.
A socialization program for dogs has been initiated by animal care takers and veterinarians to facilitate the new social life of beagles.
With the acquisition of Ablynx®, llamas and alpacas are now part of the long list of adoption with many great stories. For many years, Ablynx® has set up a robust adoption program to ensure the good quality of life of camelids after their stay in our facilities.
The fate of the animals at the end of the research projects is a concern for animal welfare bodies. When adoption options are limited, all efforts are made to find other projects or research institutions in respect with the strict regulatory obligations.
In France, Sanofi has contributed to the publication of guidance documents about the rehoming of research animals (GIRCOR, GRAAL). Those documents are available to the research communities and to the public.