Responsible Use of Animals in Research and Production

Medical research and scientific innovations are evolving and advancing at an unprecedented rate. Scientific knowledge and technological innovations allow a better understanding of the human organism, its biology and how it responds to medical treatment. Research, development and production of medicines and vaccines continue to progress toward even more appropriate, safe and quality health solutions for patients. To support these solutions, a strict but necessary regulatory framework accompanies players in the pharmaceutical sector. The protection of animals used in the research, development and production process is one of them.

The use of animals in research raises dilemmas not only for scientists who use these animals as part of their research projects, but also for society as a whole. For Sanofi, the current consensus is that the use of animals in research and production is justified only if there are clear benefits for human health. As a key element of Corporate Social Responsibility, Sanofi is committed to complying with regulations and standards on animal use, and even going beyond, and developing alternative approaches. 

A global animal protection policy

Our research, development and production activities are spread across all continents. To promote a common vision of animal protection throughout the company, a Group-level Policy on Animal Protection applies to all animal uses by Sanofi. The essential principles of this Policy are included in the Sanofi Code of Conduct.

The most predictive scientific approaches must be chosen to ensure the safety and efficacy of new drugs and vaccines and those already on the market. For example, vaccine batch testing remains internationally mandatory before batch release for public health reasons, and for the majority of vaccines we develop, the use of animals for these tests is a legal obligation to ensure the safety and efficacy of marketed vaccines. However, as soon as science makes it possible to do things differently, everything is done to develop an alternative method and have its validity officially recognized.

In this perspective and in accordance with our “Integrated Research and Testing Strategy”, Sanofi’s objective is to reduce the total number of animals used in research and testing by 50% between 2020 and 2030.

This total covers the number of animals used at Sanofi sites as well as that of animals used on behalf of Sanofi (in contract research organizations and through collaborations where Sanofi is a sponsor). Since 2020, this large total shows a significant reduction in line with our policy, as indicated in our animal protection factsheet (see below).

Although decreasing, animal use continues to be an integral part of any research and testing strategy that typically relies on a combination of models that together generate data that are robust enough to ensure safe and appropriate health solutions for patients. These can be in silico (computer modeling, artificial intelligence...), in vitro (cells and tissues, including human tissues, biochemistry, microbiology, -omic...), and in vivo (animal models), with additional information from patient data and clinical research. None of these methods alone can be sufficient to predict safety and efficacy in patients.

Sanofi has signed the Transparency Charter on the Use of Animals for Scientific and Regulatory Purposes in France (in French), as well as in Belgium (in English), Germany (in German) and the United Kingdom and supports the US initiative, committing to making information on the use of animals for scientific or regulatory purposes available to the general public.

More details on the animal protection program at Sanofi, as well as examples of new approaches to reducing animal use, are provided in the Factsheet on Animal Protection. Any question could be asked to the Chief Veterinary Officer, please use the contact form.

All professionals committed to the "3Rs" and demanding ethics principles

As long as it is imperative to use animals to ensure the safety or quality of drugs or vaccines, the procedures applied comply with the regulations and the experiments are optimized to avoid any suffering or distress to animals. Any use of an animal is supervised by animal ethics and welfare committees that monitor animal care and use, as well as the active implementation of the “3R” principle to which Sanofi has been committed for several decades.

Our approach is to use animals only when a non-animal method is unsuited for the required use or not accepted by the authorities (replacement), with the smallest number necessary for quality science (reduction) and to implement state-of-the-art practices to improve animal welfare and prevent animal pain and distress in housing and procedure conditions (refinement).

Collaboration with other pharmaceutical companies and competent authorities accelerates the development of good practices and alternative methods in biomedical research. For instance, by signing the "Marseille Declaration” in 2022, Sanofi has committed, alongside other pharmaceutical companies, to promoting high standards of animal welfare worldwide. Examples are reported in EFPIA brochure: "Putting animal welfare principles and 3Rs into action" (2022).

These international collaborations aim to strengthen and accelerate our long-standing commitment to the “3Rs” principles that apply to all animals used for research, development and manufacture of medical products, vaccines, medical devices, and pharmaceutical ingredients. By extension, per our global animal protection policy, these principles are also applicable to animal breeders and suppliers, as well as to external partners and subcontractors who use animals under the sponsorship of Sanofi and in collaboration with Sanofi

A strong commitment to the rehoming of animals after their use in research and production

Providing new life to animals who have contributed to research projects is one of the aspirations that Sanofi firmly believes in. This willingness is affirmed through a specific position approved by the Sanofi Bioethics Committee.

The species concerned are ferrets, dogs, pigs, sheep, horses, poultry, rabbits, but also lamas and alpacas...

For many years, a robust and systematic adoption plan has been in place for lamas and alpacas to ensure the good quality of life of all animals at their rehoming place after their stay at our facilities. Similarly, for dogs, a socialization program has been set up by animal and veterinarians to educate dogs in preparation for their new life in a home.

The future of animals at the end of the research project is a concern for the structures in charge of animal welfare, present at all European sites. Where adoption options are limited, we seek to identify other research projects or institutions that can accommodate and use animals in strict compliance with regulatory obligations and an ethical approach to each animal.

In France, Sanofi has contributed to the publication of guidance documents (in French) about the rehoming of research animals (GIRCOR, GRAAL).Those documents are available to the research communities and to the public.