Medical Devices And The PFAS Ban

Challenge

Alber & Geiger assisted West Pharmaceutical Services (“West”), the world market leader in medical devices and medicinal products. The products that West manufactures are vital to providing critical medications to patients suffering from serious and challengeing illnesses. West turned to Alber & Geiger for support on the PFAS Restriction and EU legislations on pharmaceuticals and medical devices. The primary aim of our advocacy was to request a derogation for fluoropolymers used in drug containment and delivery devices. Be it from the PFAS Restriction and the horizontal regulations on pharmaceuticals and medical devices.

Strategy

Our team engaged in a multifaceted approach to safeguard the interest of West in the EU. We started our advocacy by emphasing that the use of fluoropolymers is key to the manufacture of containment and delivery devices for medications. Furthermore, we informed politicians and regulators on the lack of suitable alternatives with the properties necessary for the safe and efficient containment and delivery of medicines. Finally, we put the spotlight on the socio-economic arguments. Especially how any policy that would hamper the use of PFAS in the containment and delivery of medicines would put at risk patient access to life-saving medicines. Focus was also put to the resulting unemployment and negative economic consequences.

Results

Alber & Geiger helped raise the awareness on the possible ramifications of a PFAS ban on medical devices and medicinal products. Thanks to our outreach in the European Commission, Permanent Representations of the Member States and the European Parliament we helped keep the PFAS debate out of the review of the legislations on pharmaceuticals and medical devices. We also were able to create visibility of our concerns by helping raise parliamentary questions in the European Parliament, and creating doubts about the suitability of the PFAS ban on medicinal products and medical devices.