Document 9JN62Mg160Eze5dLkr96d9N6p

Aktdetaljer Akttitel: VS: Exemption of Medical Devices from the PFAS Restriction Aktnummer: 362 Sagsnummer: 2023 - 11008 Akt-ID: 9580075 Dato: 04-03-2024 13:05:43 Type: Indgende Dokumenter: [1] VS Exemption of Medical Devices from the PFAS Restriction.eml [2] Exemption of West Pharmaceutical's Medical Devices from the PFAS Restriction.pdf Den 12. juli 2024 Til: Cc: Fra: Titel: Sendt: Bilag: P1 P2 ( El ), DE ( E2 ( E2 ( E3 ), Ida Svostrup Petersen (M@nnst.dk), Peter Juhl Nielsen restrictiePFAS ( E4 ) P4 ( E4 ) VS: Exemption of Medical Devices from the PFAS Restriction 04-03-2024 13:04 Exemption of West Pharmaceutical's Medical Devices from the PFAS Restriction.pdf; ), ' P3 (=@nnst.dk) Dear all, Meeting invitation from Alber & Geiger on behalf of a medical firm below. Anyone else received the same? Unless anyone is of another opinion, we will decline the invitation as usual. Kind regards, P4 Fra: P5 < E5 Sendt: torsdag 29. februar 2024 16:33 Til: P4 < E4 Emne: Exemption of Medical Devices from the PEAS Restriction Det er ikke ofte du mottar e-post fra ES Dear Mr Heggelund, Finn nt hvorfor dette er viktig 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 PEAS 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 Most West products will have to be withdrawn 18-months after the entry into force of the ban.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 PEAS 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 PEAS 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, P5 Alber & Geiger Rue des Colonies 11 1000 Brussels Belgium Tel.: +32 (0) T1 Fax: +32 (0) T2 Pariser Platz 4a 10117 Berlin Germany Tel.: +49 T3 Fax: +49 T4 M.Palbergeiger.com www.albergeiger.com Alber & Geiger is a specialized lobbying law firm. More information on www.advocacyinlegislation.com Alber & Geiger: Advocacy in Legislation == AKT 9580075 == [ VS: Exemption of Medical Devices from the PFAS Restriction ] == Dokument 2 == [ Exemptio... == Exemption of West Pharmaceutical's Medical Devices from the PFAS Restriction 1. West Pharmaceutical ("West") is a world leader in providing primary containment and delivery components, solutions and systems for injectable drugs. West produces stoppers and seals for vial packaging systems, plungers for syringe and cartridge systems, and self-injectable systems for medicinal delivery. 2. West products are utilised with over 100 medications, including to treat chronic illness, prevent infections and treating allergic reactions. Most producers of COVID-19 vaccines and other vaccines use West's components of stopper and seals for vial containment. 3. All these drugs and vaccines are approved by EMA/FDA not just as a substance but together with their containers and injection systems as a package. 4. Any changes to West's products due to a PFAS ban would require readmission or withdrawal of all vaccines and drugs by EMA/FDA. 5. For the containers and injections systems, West uses two different fluoropolymers, polytetrafluoroethylene ("PTFE") and ethylene tetrafluoroethylene ("ETFE"). 6. West uses fluoropolymer lamination as a barrier film to prevent chemical migration of extractables and leachable from the container elastomer into the drug and to ensure medical quality. Moreover, fluoropolymer films have a long-track record of safety, quality and reliability as they are used in over 1,900 SKUs made by West to contain numerous injectable drugs. We conservatively estimate 14-15 million patients per year in the EU use injectable drugs packaged with a West fluoropolymer-coated component. 7. There are currently no alternatives for the fluoropolymer films used in West's products that can offer similar benefits supporting medicinal products. 8. West's products don't create PFAS concerns with waste. End of life is handled by users such as hospitals, medical centres and pharmacies who comply with specific rules concerning disposal of medical waste and recycling. 9. West employs over 4,100 individuals at 14 facilities in Germany, France, Denmark, Italy, Ireland and Serbia which depend on a respective PFAS restriction exemption. 10. The PFAS restriction proposal foresees three options: a) full ban, b) time-limited derogations of five and twelve years, and c) time-unlimited derogations for active substances in plant protection, biocidal and medical products. 11. West's products use fluoropolymers which are PFAS of low concern. West's products should be exempted from the scope of any PFAS restriction. 12. In any case, West's products need a time-unlimited derogation as foreseen in option 3 of the PFAS restriction proposal to avoid vaccine and drug shortages in the EU.