PFAS is a broad non-specific term relating to thousands of molecules. Not all PFAS present the same risks to the environment or health. The industry relies on certain PFAS for safe manufacturing, distribution and use of medicinal products. Packaging, drug application devices and processing machinery, or items to extend a medicine’s shelf life or protect sterility, are just a few examples of what would fall under a blanket ban.
For example, high-performance fluoropolymers — especially polychlorotrifluoroethylene and ethylene tetrafluoroethylene — are vital to the containment, storage and delivery of injectable medicinal products. They help to form protective barriers, ensuring quality and safety and preventing degradation and deterioration. They also facilitate sterilization according to required Good Manufacturing Practices standards of fully coated stoppers due to the smooth hard surface. The unique properties of fluoropolymers provide resistance to biological, chemical and physical degradation.
The impact on medicines and vaccines development
It is with this in mind that the industry is urging caution on a blanket ban on PFAS. Without a derogation for medicines, 98% of the market authorizations of new medicines would need to be amended, which in turn could see around 70% of critical medicines in EU member states at risk of short supply.
An EFPIA survey of 40 pharmaceutical companies found that at least 93% of APIs manufacturing relies on PFAS.
If the ban applies as proposed, a wide range of medicines will become in short supply or unavailable, with impact on patient health anticipated both within and outside of the European Economic Area (EEA). Manufacturing and product development will have to be relocated outside of the EEA, impacting the economy and strategic autonomy of Europe. Additionally, banning PFAS within the EU while importing PFAS-containing products from elsewhere would be inconsistent and undermine the policy’s credibility.
