A proposed restriction on the use of fluorinated substances and Polyfluoroalkyl Substances (PFAS), across the European Economic Area (EEA) is causing concern within the pharmaceutical industry. The restriction, under REACH (EU chemical legislation), is a joint effort by the Competent Authorities of Germany, the Netherlands, Sweden, Denmark, and Norway to mitigate environmental and human health risks associated with PFAS. Covering up to 10,000 substances, this proposal is one of the broadest ever put forward and could lead to a complete ban on all PFASs by 2027. The pharmaceutical industry acknowledges the environmental concerns but highlights that not all PFAS have the same level of risk, with those used in medicines having low identified risk.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has submitted a sector response to the European Chemicals Agency (ECHA) consultation, emphasizing the potential impact on medicine supply chains. They argue that if the proposal proceeds as is, it could affect over 47,000 global marketing authorizations and jeopardize access to critical medicines, including those on the WHO Essential Medicines List.
Furthermore, a socioeconomic assessment suggests that implementing such a broad restriction could have severe negative impacts on the European economy, society, and healthcare system. EFPIA calls for a more nuanced approach to ensure the continued availability of medicines while addressing environmental concerns.
The proposed PFAS restriction is a critical issue requiring careful consideration to balance environmental protection with maintaining essential medicine manufacturing in Europe.
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