The European Medicines Agency (EMA) and the European Chemicals Agency (ECHA) warned that restrictions under chemical and environmental legislation could significantly impact pharmaceutical and medical device supply chains, during a joint meeting with industry stakeholders on 9 June 2026. Chaired by Melanie Carr, Head of EMA's Stakeholders and Communication Division, the meeting brought together the two agencies, the European Commission, and industry representatives to discuss regulatory challenges and the need to balance environmental protection with patient access to medicines.
EMA and ECHA Executive Directors opened the meeting by highlighting their commitment to stakeholder dialogue and the increasing fragility of pharmaceutical supply chains, with a continued focus on public and animal health. EMA presented its role in medicines lifecycle management, including monitoring supply chain impacts on medicine availability. It emphasised that chemical restrictions can affect not only active pharmaceutical ingredients and excipients but also substances used in manufacturing processes, machinery, containers, and packaging. EMA stressed the need for decision-makers to strike a balance between environmental protection and safeguarding patient health, especially in an uncertain geopolitical environment.
ECHA outlined its mandate to implement EU chemicals legislation, noting that the right of initiative for action on specific substances lies with EU Member States or the European Commission. The agency highlighted stakeholder involvement through calls for evidence and consultations, urging early engagement with national competent authorities.
The European Commission underlined its commitment to the One Health approach and the 'One Substance, One Assessment' initiative, which aims to enhance chemical safety and regulatory efficiency. The Commission stressed the importance of proportionate risk management measures and innovation in sustainable alternatives, particularly regarding the phasing out of per- and polyfluoroalkyl substances (PFAS) in pharmaceuticals and medical technologies. It pointed to the public-private partnership under the Innovative Health Initiative Joint Undertaking as a key enabler for finding non-PFAS alternatives. The Commission also expressed support for developing non-animal testing methods in collaboration with ECHA, EFSA, and EMA.
Industry participants welcomed the joint meeting and expressed support for the EU Roadmap towards phasing out animal testing in chemical safety assessments. EMA and ECHA reaffirmed their commitment to the 3Rs principles (replacement, reduction, and refinement) and minimising environmental impact, with EMA highlighting that medicinal products should be considered a special case justifying a risk-proportionate approach due to potential patient impact.
Industry representatives from human and veterinary pharmaceutical, medical device, and manufacturing sectors highlighted challenges from overlapping and evolving regulatory frameworks. They called for greater coherence, early engagement, and sector-specific considerations to prevent unintended impacts on medicine and device availability. The increasing complexity of the legislative landscape and its cumulative effects were identified as key concerns, with industry recalling the importance of systematic cross-legislative impact assessments.
The meeting underscored a tension between environmental protection goals and the need to maintain resilient pharmaceutical supply chains. For patients, overly restrictive chemical regulations could lead to medicine shortages, while for industry, compliance costs and regulatory uncertainty may increase. For regulators, the challenge lies in balancing these competing priorities without compromising public health or environmental objectives. The European Commission's support for innovation in alternatives and non-animal testing methods may help mitigate some impacts, but industry stressed that early engagement and impact assessments are critical to avoid unintended consequences.