The associations representing human medicines, veterinary medicines, self-care products, life sciences manufacturing, including biomanufacturing and pharmaceutical manufacturing, supply chain and delivery systems support the objective of reducing PFAS emissions and ensuring high standards of environmental protection.

At the same time, any PFAS restriction must remain proportionate, evidence-based and compatible with patient and animal health, continuity of supply, innovation and Europe’s strategic resilience.

Across the pharmaceutical lifecycle, PFAS are used in highly regulated and low-volume applications that are essential to the discovery, development, manufacture, packaging, delivery and safe use of medicines and healthcare products.

These uses include but are not limited to:

• Active pharmaceutical ingredients (APIs), intermediates, solvents and reagents;
• Manufacturing equipment and infrastructure, including seals, valves, gaskets, tubing, membranes, single-use technologies, fluid management systems, filters and coatings;
• Drug delivery systems and combination products;
• Packaging and container closure systems;
• Medical propellants and fluoropolymer coatings used in inhalation therapies;
• Research, development, analytical and quality control applications.

Changes to any part of this lifecycle are subject to medicines-specific regulatory requirements designed to ensure patient safety, and may therefore require extensive testing, validation and potential regulatory approval before patients can continue to receive medicines safely.

The associations jointly underline the following key points:

1. Essential healthcare and life sciences use require a differentiated and proportionate approach
   Human and veterinary medicinal products are governed by comprehensive sectoral legislation and stringent
   regulatory oversight. Restricting PFAS used in these applications without a complete sector-specific
   assessment risks unintended consequences for patient care, animal and public health, food supply, safety and
   healthcare system resilience. Any measures proposed must be assessed for their feasibility within a medicines’
   lifecycle, recognising that maintaining medicine quality, safety, efficacy and availability may place constraints
   upon substitution.
   
2. Suitable alternatives are frequently unavailable or not yet validated
   For many applications, no alternatives to PFAS currently exist. Where alternatives are technically feasible,
   implementation requires extensive development, qualification, stability testing, manufacturing revalidation
   and regulatory approval processes that may extend over a decade or even longer.
   
3. Broad restrictions risk shortages and reduced access to medicines
   A broad PFAS restriction without appropriate derogations could disrupt pharmaceutical manufacturing and
   supply chains, delay innovation and reduce the availability of essential human and veterinary medicines.
   Critically, any derogation should extend across the entire pharmaceutical value chain, including but not limited
   to inputs, materials, and equipment necessary to manufacture these end products.
   
4. Risk management should focus on emissions and controlled use
   Many pharmaceutical and life science uses are highly controlled and already subject to strict GMP,
   environmental and product safety requirements from production through to end-of-life. The signatory associations would
   support targeted, risk-based approaches focused on emissions reduction, that fully take into account existing
   lifecycle management and existing sectoral controls as well as technological and scientific capabilities rather
   than broad prohibitions disconnected from actual exposure pathways.
   
5. Regulatory coherence and legal certainty are essential
   The pharmaceutical ecosystem requires alignment between REACH and existing human and veterinary
   medicines legislation. Regulatory uncertainty and fragmented derogation frameworks undermine investment,
   supply security and Europe’s strategic autonomy. A siloed, application-by-application approach risks
   addressing individual products while overlooking suppliers, manufacturers and inputs that underpin
   pharmaceutical production, biomanufacturing and the wider life sciences sector. Long-term, reviewable and
   value-chain coherent derogations are therefore necessary where substitution is not feasible.
   Decisions concerning therapeutic alternatives, product withdrawal and medicine availability fall within
   established medicines regulatory frameworks. Any PFAS restriction should therefore be designed and
   implemented in a manner that remains fully compatible with existing pharmaceutical and veterinary
   legislation.
   
6. Europe must preserve innovation and industrial resilience
   The EU is a global centre for pharmaceutical, biotech, life sciences innovation and manufacturing across the
   full value chain. In line with the objectives of the EU industrial strategy and Competitiveness Compass, any
   measures aimed at addressing PFAS emissions and pollution should be proportionate and internationally
   aligned to ensure healthcare, life science innovation and manufacturing remain anchored into Europe.

JOINT RECOMMENDATIONS

The associations call for:

• Recognition of human medicines, veterinary medicines, life sciences manufacturing and biomanufacturing as a distinct healthcare ecosystem requiring consideration of the sectors’ specificities;
• Assessment of actual emissions and exposure pathways and practical feasibility across healthcare applications before applying generic restrictions;
• Maintenance of an appropriate derogation framework extending across the entire pharmaceutical value chain;
• A risk- and emissions-based and proportionate regulatory approach that takes into account existing sectoral requirements;
• Realistic transition timelines reflecting regulatory and validation requirements supported in coordination with involved industries;
• Strong alignment with existing sectoral legislation and global regulatory frameworks;
• Continued dialogue with medicines regulators, stakeholders and industry experts to ensure environmental objectives are achieved without compromising health, innovation or supply security.

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Signatories

• Access VetMed
• AnimalhealthEurope
• AESGP – Association of the European Self-Care Industries
• EuropaBio
• European Confederation of Pharmaceutical Entrepreneurs
• EFPIA – European Federation of Pharmaceutical Industries and Associations
• International Pharmaceutical Aerosol Consortium
• Life Science Manufacturers Association
• Medicines For Europe
• Vaccines Europe