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 of pharmaceuticals by patients is considered as the main source. After pharmaceuticals are absorbed or administered, they are excreted by patients in the same form or they are transformed by the body into metabolites, which may be released into the environment through sewers and sewage treatment plants. Other sources of discharge 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.
- the environmental impact of Sanofi’s 100 best-selling medicines are being evaluated, as well as all new medicines on the market, regardless of regulatory requirements; and
- 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 Impacts 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, the United States and some other countries. This assessment considers environmental fate and effects information as well as all other relevant information generated during drug development.
While new drugs today are fully assessed for environmental risks, older drugs that are already on the market may have been studied less thoroughly, since regulatory requirements were not as stringent at the time they were launched, and new studies are often not needed unless marketed quantities will increase significantly.
Sanofi has implemented a voluntary program to evaluate its legacy products, that were brought to market prior to enactment of the ERA requirement. This program aims at increasing knowledge about the environmental fate and effects of our marketed products, and at evaluating the related environmental risks. These assessments consider all available data and may lead to additional testing.
To strengthen the management of potential environmental risks related to the use of our medicines by patients, Sanofi has voluntary launched an EcoPharmacoVigilance (EPV) pilot on 5 APIs. The aim of this pilot was to develop and test a process to identify and monitor potential environmental risks related to the use of medicines by patients in various countries around the world. Following this pilot phase, in 2024, we started extending this process to cover more products and countries. Today, an increasing number of Sanofi products are, biopharmaceuticals, such as therapeutic proteins. These products are considered to have no significant environmental effects and are potentially less harmful to the environment after use by patients.
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 countries.
Our Performance in 2024:
- 85% of our top 100 selling medicines have been evaluated for their impact on ecosystems.
- Support of local, regional of national programs to collect unused medicines in many countries.
- We continued to define science-based environmental thresholds for APIs. Assessing the environmental impacts related to the use of our products.
- We continued to voluntarily expand our knowledge on the environmental fate and effects of our new and legacy active pharmaceutical ingredients.