BioPhorum acknowledges the concerns raised regarding the potential adverse effects of various per- and polyfluoroalkyl substances (PFAS) materials on human health and the environment, and fully support efforts
to minimize and mitigate the presence of these, and other potential substances of concern in our manufacturing processes and products.
Our industry sector shares a responsibility to work with all relevant stakeholders to manage the transition away from materials of concern while maintaining our ability to ensure the safety and well-being of patients and the communities in which we operate. Any efforts to restrict usage and production of materials of concern by our industry must be pragmatically considered; the risk of drug shortages and therefore failure to supply medicines to patients must be evaluated against the risk the materials pose to the environment and that very same population.
While the Annex XV report includes consideration of the use of various PFAS in medical devices and some limited pharmaceutical applications, the biopharma industry has not been specifically considered as a sector in the framework of the current proposal and needs to be appropriately evaluated due to the considerable impact the proposal will have on our ability to supply safe and effective therapies to patients suffering from life-threatening/debilitating illnesses.
One hundred per cent of the biopharmaceutical products currently being developed or already licensed for sale in the EU utilize PFAS somewhere in their development, manufacture, testing, storage of intermediates or in their drug delivery systems. If the ban is enforced, all those drugs would be removed from the market until PFAS alternatives could be developed, sourced, validated and approved for use, thus preventing access to lifesaving therapies.
While this specific response is focused on the biopharma sector, BioPhorum and its member companies recognize that the scope of PFAS use and resulting impact of the proposed restrictions on other industries is far wider across the pharmaceutical and healthcare industries and beyond.