Among the large number of organic compounds that may enter the environment, pharmaceuticals have been a focus of attention for many years due to their biological activity and evidence of their presence in the environment, although generally at low concentrations. Pharmaceutical substances may end up in the environment in various ways, and the use & excretion of pharmaceuticals by patients is considered the main source. After pharmaceuticals are administered or absorbed, a fraction may be excreted by patients unchanged, and another transformed by the body into metabolites. Excreted pharmaceuticals & metabolites are, then released into the environment through sewers and sewage treatment plants. Other, less prominent sources of pharamaceuticals in the environment include emissions from manufacturing plants and the inappropriate disposal of unused or expired medicines.
Our Ambition
Sanofi is committed to minimizing the potential environmental impacts of its medicines throughout their lifecycle from development to post-market.
- We have established a sound governance system for assessing the potential impacts of our products on the environment throughout their lifecycle from development to post-market.
- Pilot projects are being implemented to further promote the sustainable use and responsible disposal of unused medicines, devices and packaging.
Our Actions
Assessing the Environmental Risks Related to the Use of our Products
An Environmental Risk Assessment (ERA) is required for all pharmaceutical product marketing authorization applications in the European Union (since 2006), in the United States (since 1998) and in some other countries. As a result, all new Sanofi medicines are systematically assessed under these requirements. This assessment considers environmental fate and effects information as well as all other relevant information generated during drug development.
To complement this regulatory baseline, Sanofi has launched a voluntary Eco-Pharmaco-Vigilance (EPV) program to assess the environmental profile of legacy products. The program aims to strengthen our understanding of the environmental fate and effects of our marketed products and to evaluate their associated environmental risks. Assessments draw on all available data and may be complemented by additional testing where needed. Following a pilot phase on 5 APIs in 2024, we started extending the EPV program to cover more APIs and countries. We also developed a digital mapping tool for supporting our EPV risk monitoring. In 2025, a total of 25 APIs were managed under an EPV approach. By 2027, our top 100 selling products & any new medicine will be managed by an EPV approach. Where APIs are identified as potentially higher risk, we monitor environmental exposure (e.g. through comparison with measured environmental concentrations) and, where appropriate, develop targeted risk mitigation plans.
A growing proportion of Sanofi's portfolio (e.g. therapeutic proteins, monoclonal antibodies) is manufactured using biotechnology. Consistent with EMA guidelines, biologics are generally considered biodegradable — unless substantially modified — and are expected to present a significantly lower ecosystem risk than conventional (synthetic) molecules. We reinforce this through our EPV program by voluntarily testing biodegradability of our biologics and validating their low environmental risk profile.
Encouraging the Proper Use and Disposal of Medicines
Sanofi has been engaged in initiatives to encourage the proper use of medicines, by promoting information and education for healthcare professionals and patients. We also inform consumers about the safe disposal of unused medicines, and we support programs that collect and properly dispose of unused drugs from patients.
For many years, Sanofi has supported the development and implementation of local, regional or national programs to collect unused medicines in various countries including Belgium, Colombia, France, Greece, Japan, Mexico, Portugal, Spain, Australia or North America. Programs may differ depending on countriesthe country.
Our Performance
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Pursuant to European requirements, environmental fate and effects of new APIs are systematically analyzed.
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Beyond regulatory ERA requirements, in 2026, more than 60 of our top 100 selling medicines are managed under our voluntary Eco-Pharmaco-Vigilance (EPV) approach — going beyond fate and effect testing and the definition of 'safe' environmental thresholds for our APIs, to include, where appropriate, monitoring of environmental exposure and the development of targeted risk mitigation plans.