Document pezj1mw0gav9n9Brwby2pwd

BioPhorum meeting with the DG for Internal Market, Ref.Ares(2024)2545030-08/04/2024 Industry, Entrepreneurship and SMEs Agenda 1. Welcome and introductions (5 minutes) 2. PFAS and the Pharmaceutical industry - (graphic presentation) (20 minutes) 3. Specific issues and implications (20 minutes) 4. Industry position (5 minutes) 5. Questions (40 minutes) Development, Manufacture & Supply of Medicinal Products - PFAS Use* Pharmaceutical Manufacturing PFAS containing materials handled in an industrial setting Fluorinated Drug Substance PFAS containing Raw Materials, Starting materials, Intermediates Fluoropolymer containing plant, equipment, consumables Substitution is Challenging because of unique substance properties and manufacturing process validation Paxlovid Substitution Impossible (API = molecule) Packaging & Drug Delivery Devices A time unlimited derogation proposed for manufacture, import & use of APIs - but reporting obligation applies All other parts of supply chain are in scope unless derogations are granted PFAS research & development + Quality control analysis Challenge: Post Approval changes to Marketing Authorisation of Medicinal Product *NB - this is not an exhaustive list, additional use scenarios may come to light during the ECHA public consultation BioPharma product development process PFAS is used in numerous applications across BioPharma drug lifecycle from discovery/development through to commercial production/supply. A ban will place existing product and those in development at risk. Discovery Preclincal Development Clinical Development Phase I,II,III Commercial/ Marketed Product Life time of equipment will be shortened - maintenance at risk Production License of marketed products at risk Common Unit Operations in the Manufacture of Biological Active Substances Budzinski et. al. New Biotechnology Volume 49, 25 March 2019, Pages 37-42 Equipment & process aids using PFAS PFAS used in the sample preparation for analytical instruments Raw materials & intermediates Storage Analytics Product contacting PFAS Sterile filtration (PVDF); potential alternatives exist Airfilters (PVDF/PTFE) for sterile processing; no alternatives Drug packaging & delivery PFAS - REACH Restriction Timeline Disruption of medicinal product supply chains begins 2027 ECHA Opinion Making Process: Committees RAC & SEAC decide if derogations are justified 2024 Comitology Procedure: Commission Amendment & Scrutiny by European Parliament and Council 2026 18 month transition period 2023 Public consultation 22 March to 25 September 2023 6-month consultation period Industry stakeholders must provide supporting information to justify derogations 2025 Entry into Force (EIF) Earliest estimate - a later EIF will move the timeline accordingly 2027 Q1/Q2 2027 All PFAS use is banned unless derogation in place *REACH Registration, Evaluation, Authorisation and Restriction of Chemicals Specific issues and implications Fluoropolymers: Fluoropolymers are used so extensively in biopharma that if the proposals are enforced there could be a real threat to the global availability of critical vaccines and biotherapeutics. Impact on supply chain and patient access: PFAS compounds are a critical and unavoidable part of drug manufacturing and packaging requirements - in many cases no short to mid-term alternatives are commercially available. Impact on regulators/regulatory approvals: Changes to registered drug manufacturing must be approved by Regulatory Authorities which can take 3-5 years. This risks significant increases in change approval submissions causing increased risk of supply chain disruptions of drugs. Impact on European Businesses/SMEs: The proposals would impact operations in the pharmaceutical sector and clash with previously stated ambitions to strengthen the European Pharmaceutical industry, including European industrial manufacturing and shifting investments away from the EU. Industry position Request for complete exemption for direct Fluoropolymers materials used in BioPharma BioPharma industry and the required supply chain should be considered a missing use category and be exempt from all proposed restrictions where alternatives are not available Questions/discussion a. What information can we provide to the EC/ECHA to justify an exemption for direct Fluoropolymers materials and maximum derogation for other PFAS materials used in BioPharma manufacturing processes? b. What information can we provide to justify further consideration of the impact of the proposals on the Biopharmaceutical industry? c. REACH policy: the general approach moving forwards seems to be group restrictions. With that in mind, is a 6-month public consutlation period sufficient for this type of consideration? i. For future proposals, how can we ensure our industry is as engaged and represented as possible?