EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS ban
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on the availability of medicines, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).EFPIA raised these concerns in a 28 September position paper that was produced in response to a February 2023 proposal by the European Chemicals Agency (ECHA) to limit the manufacture and use of a wide range PFAS. The proposal -- put forth by Germany, the Netherlands, Sweden, Denmark and Norway -- would restrict up to 10,000 substances used in medicines.
The controversial proposal generated 5,600 parties comments; the deadline to respond was 25 September 2023.
“While we support the need to restrict certain PFAS, we need to find the right approach to ensure the continued manufacturing and availability of medicines in Europe,” Nathalie Moll, EFPIA’s Director General said in a statement. “A total ban would see medicines’ manufacturing in the EU grind to a halt in under three years. It would also jeopardise the production of all pharmaceutical substances in Europe and would be in conflict with the EU’s strategy of reducing dependency on nations outside of the EEA in the event of shortages or pandemics.”
PFAs can cover active pharmaceutical ingredients (APIs), raw materials used for chemical synthesis, as well as reagents and equipment, according to EFPIA. The restrictions can also apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes.
EFPIA said 47,677 global marketing authorizations could be affected by the ban, and a “significant number” of critical medicines would no longer be available. The ban would also affect more than 600 medicines from the World Health Organization’s (WHO) Essential Medicines List. Additionally, the ban would impact 78% of the medicines on Norway’s critical medicine list, 74% of these medicines in Finland, 73% in Sweden, and 72% in France, the group estimated.
In a statement, EFPIA said the pharmaceutical industry “is concerned about the impact of PFAS on the environment and does not oppose the close consideration of certain harmful PFAS. However, not all PFAS have the same hazardous properties with some considered of low concern by the OECD [Organization for Economic Cooperation and Development].”
EFPIA added that PFAS used in medicines pose “no or low identified risk.”
The group urged the use of derogations, or a carve out, to prevent medicines shortages in a response to the ECHA open consultation. “Without additional derogations, the entire pharmaceutical industry would no longer be able to manufacture active pharmaceutical ingredients (APIs) (whether classified as PFAS or non-PFAS APIs) or associated medicinal products in the [European Economic Area],” EFPIA wrote.
In a related development, ECHA proposed to limit the amount of microplastics in pharmaceuticals in 2022. That proposal is now pending before the European Commission (RELATED: Excipient group releases guidance on reporting microplastic use in pharmaceuticals, Regulatory Focus 24 March 2022).
EFPIA announcement
