Forever Chemicals In Medical Devices

Challenge

Alber & Geiger assisted West Pharmaceutical, a US corporation and world market leader in medical devices, paving the way for PFAS ban exemptions for their products. The intention was to prevent disruptions in the supply of certain medical devices, where the medicinal products are inseparably connected with the devices, like it is the case with the diabetes pen or with vaccines prefilled in containers and syringes.

Strategy

Our team engaged in a multifaceted approach to safeguard the interests of the medicinal and medical devices. We provided strategic input during the consultation period with the European Chemicals Agency (ECHA), highlighting the unique needs and safety considerations of specific medical devices. This was followed by an extensive outreach to stakeholders within the European Parliament, the European Commission, and the EU member states. Our efforts focused on educating decision-makers about the indispensable role of PFAS in medicinal products and medical devices and the potential supply chain risks posed by a PFAS ban.

Results

Our advocacy efforts led to a pivotal development in the regulatory landscape on medical devices. Our targeted approach opened the door to potential derogations of several years for specific medical applications where there is substantial evidence that viable alternatives to PFAS do not exist. This ensures that essential medical devices remain available and effective, safeguarding patient care and industry stability.