The European Federation of Pharmaceutical Industries and Associations (EFPIA) recently warned that more than 600 essential medicines could be at risk if suggested limitations on the use of fluorinated substances, especially per- and polyfluoroalkyl substances- PFAS, in pharmaceutical manufacturing within the European Economic Area are put into operation.
According to EFPIA, the European Union’s chemical legislation, which is known as the Regulation on the registration, evaluation, authorization, and restriction of chemicals (REACH), carried out by the Competent Authorities (CAs) of Germany, Sweden, the Netherlands, Denmark, and Norway, will be the largest to date. This legislation looks to restrict the production, sale, as well as utilisation of roughly 10,000 substances referred to as PFAS.
Nathalie Moll, Director General of EFPIA, said that they acknowledge the importance of regulating specific PFAS substances, but it is also crucial to adopt an equitable strategy that guarantees the ongoing production and access of medications throughout Europe. Putting in a complete ban would result in a pause in medicine production in the EU within a span of less than three years. She added that this action would not only endanger the manufacturing of all pharmaceutical substances in Europe but at the same time oppose the EU’s strategy of reducing its reliance on countries out of the EEA during shortages or pandemic scenarios.
Restriction of PFAS in Pharmaceutical Manufacturing
EFPIA acknowledged that the ongoing process, if it continues the way it is, might end in a complete ban on all PFASs by 2027, with only a few exemptions.
The pharmaceutical industry has concerns about the environmental impact of certain harmful PFAS. Nonetheless, it is important to note that not all PFAS have the same level of dangerous properties. The Organisation for Economic Co-operation and Development has gone on to classify some PFAS as of low concern, as highlighted by EFPIA.
PFAS happens to be commonly utilised in various stages of pharmaceutical production. EFPIA emphasised that the legislation would specifically target packaging materials that employ fluoropolymers, in addition to combination products like pre-filled syringes. The organisation declared that the presence of PFAS in a final drug poses no or low identified risk in the context of both the risk-benefit evaluation of the medicine as well as the environmental risk assessments.
EFPIA’s response:
In its sector response to the open consultation by the European Chemicals Agency (ECHA), EFPIA updated both ECHA and the Commission about the possible impact of the PFAS restriction on the supply chains of medicinal products.
The organisation’s response included the results of a patient impact analysis. According to EFPIA, if the suggestions are executed as they currently stand, several consequences may arise.
– A minimum of 47,677 global marketing authorizations could be affected, potentially resulting in the absence of numerous critical medicines.
– More than 600 medicines listed on the World Health Organisation’s Essential Medicines List could be at risk.
– The “Critical Medicines Lists” of European Member States would be notably impacted. For example, the proposed restriction could potentially affect a significant portion of the essential medicines list in various countries. In Norway, approximately 78% of the list could be impacted, followed by Finland with 74%, Sweden with 73%, France with 72%, as well as Germany with 60%.
Further socio-economic assessment
- If deviations are not granted, the pharmaceutical industry will no longer have the capacity to produce active pharmaceutical ingredients or related medicinal products in the European Economic Area.
- The restriction on PFAS would have an effect on European competitiveness if it led to shortages of medicines due to limited production ability.
- The replacement of PFAS is currently limited by the accessibility, technical applicability, as well as environmental trade-offs of substitutes that are not readily available at this time.
