EFPIA reaction to the publication of ECHA scientific committees’ opinions on PFAS Restriction.

The pharmaceutical sector is deeply concerned by the opinions published today by ECHA’s scientific committees on the proposed Per- and Polyfluoroalkyl Substances (PFAS) restriction, which do not support derogations for PFAS for pharmaceutical uses.

EFPIA and its member companies share the ambition of protecting public health and the environment. Unfortunately, the opinions published today fail to reflect the reality of how medicines are developed, and the current availability of PFAS alternatives. The absence of clear and durable derogations for medicines would compromise patient access to critical treatments and drive manufacturing out of Europe.

PFAS materials are essential for manufacturing processes, medicinal products, APIs, delivery devices and packaging used by millions of Europeans. Medicines and their components cannot be substituted on a one-to-one basis without going through R&D, legal and regulatory approval processes.

At a time when EU leaders are calling for greater competitiveness and strategic autonomy, policy decisions should fully consider that restricting PFAS would cause significant disruption for patients, healthcare systems and companies operating in Europe.

Nathalie Moll, Director General EFPIA, said: “The opinions expressed today by the ECHA are alarming given what's at stake for patients and the sector. The industry is working hard to find solutions to replacing and reducing PFAS, however, this will take time. A proper derogation for pharmaceuticals is the only way to achieve this, while also mitigating the risk for patients and our industry."

Notes to editors

APIs

• Without a time-unlimited derogation for pharmaceutical active pharmaceutical ingredients (APIs) containing fluorine could see many withdrawn from the market as early as 18 months after entry into force.
•  Data indicates that at least 139 APIs containing PFAS moieties are currently used in medicines across 44 therapeutic classes

Medical application uses

• Without derogations we could see the loss of more than 650 medicines on the WHO Essential Medicines List. Over 90% of 1922 APIs involve EU manufacturing could fall under the scope of the restriction, with over 47,000 global marketing authorisations concerned. [here].
• The pharmaceutical industry is committed to finding PFAS alternatives and reducing their use and emissions. This includes a 50million Euro IHI public private partnership launched this year.

For more about Industry work on sustainability see here