Document 43pG4b5yMm4YLmp8NGN57v8N

From: Audun Heggelund[ @milj odir.no] Sent: 06.03.2024 09:13:04 To: Filip Godlewski[ @albergeiger.com] Subject: Exemption of Medical Devices from the PFAS Restriction Dear Mr Godlewski, Thank you for your email. We are currently going through all the comments from the consultation and amending the background document. Hence, we will also take input from West into consideration. Given the large number of comments received, it will not be possible for us to have meetings with individual stakeholders. However, in the case we have any questions on the information provided, we will contact the stakeholder who submitted the relevant comment. Best regards, Dr. Audun Heggelund (he/him) Senior Adviser, Section for Chemicals Mobile: (+47) 48 03 40 41 miljodir.no N Norwegian Environment Agency www.environmentagency.no I www.environment.no Front desk: (+47) 73 58 05 00 Fra: Filip Godlewski < @albergeiger.com> Sendt: torsdag 29. februar 2024 16:33 Til: Audun Heggelund < @miljodir.no> Emne: Exemption of Medical Devices from the PFAS Restriction Det er ikke ofte du mottar e-post fra-@albergeiger.com. Finn ut hvorfor dette er viktig. Dear Mr Heggelund, I am writing to you on behalf of Alber & Geiger, a EU government relations law firm. We are currently representing West, a US company that produces packaging for drugs. West is a world leader in containment and injectable medicines. Most West products are integral to the medicinal product and approved together (packaging and active substance) by EMA/FDA. West products were used in most Covid-19 vaccines and are used regularly in treatment of, among other conditions, allergic reactions, arthritis, diabetes and epilepsy, by approximately 11-15 million patients in the EU alone. West uses two fluoropolymers to make these essential products: PTFE and ETFE. Both are covered in the ongoing PFAS restriction. As West products are used in essential drugs, the proposed total ban could jeopardize the availability of critical medicines. Most West products will have to be withdrawn 18months after the entry into force of the ban. West is seeking an exemption from the proposal restriction for medical products like the ones it produces, while acknowledging the necessity of control over the use of fluoropolymers. It should be readily apparent the proposed restrictions on PFAS must be substantially modified to provide in any final restrictions a permanent derogation for the irreplaceable fluoropolymers used by West and other producers of drug containment and delivery devices. West believes the pharma laws currently in the pipeline, as well as the medical devices regulation would be best placed to deal with PFAS in medicinal products and medical devices. For more information, please see enclosed our 1-page summary of the issue and concrete ask. I would appreciate it if we could have a short meeting at your earliest convenience. Yours sincerely, Filip Godlewski Alber & Geiger Rue des Colonies 11 1000 Brussels Belgium Tel.: +32 (0)2 517 71 64 Fax: +32 (0)2 517 65 00 Pa riser Platz 4a 10117 Berlin Germany Tel.: 145 700 Fax: 145 500 @albergeiger.com www.albergeiger.com __________ Alber & Geiger is a specialized lobbying law firm. More information on www.advocacyinlegislation.com Alber & Geiger: Advocacy in Legislation