The European Federation of Pharmaceutical Industries and Associations (EFPIA) is challenging Directive 91/271/EEC (Urban Wastewater Treatment Directive (UWWTD)) in the EU General Court. EFPIA seeks clarity on the directive's alignment with the EU's polluter pays principle, arguing that it unfairly targets the pharmaceutical and cosmetics sectors for wastewater treatment costs.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released an article on data anonymisation which highlights the importance of data anonymisation in balancing privacy and progress in healthcare research and innovation. It also discusses the challenges of protecting individuals' privacy while enabling the use of valuable data for scientific advancements and notes the need for robust anonymisation techniques and clearer governance frameworks to ensure data privacy while creating responsible data sharing and utilisation. The article further highlights the role of public trust in data handling practices and the importance of transparency in fostering confidence in the use of anonymised data for research purposes. The EFPIA has also developed a visual aide called the Anonymisation Gradient which will help individuals outside of clinical trial disclosure understand the balance of retaining data utility and protecting patient privacy. The Gradient outlines a non-exhaustive spectrum of controls and levels of redaction and transformation for different purposes.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has endorsed PAS 2090:2025, published on 30 November 2025, as the most robust approach for harmonised Product Carbon Footprint (PCF) frameworks for pharmaceuticals. The specification, sponsored by NHS England, the Office for Life Sciences (OLS) and the Pharmaceutical LCA Consortium, represents the first publicly available standard establishing harmonised, internationally applicable Product Category Rules for Life Cycle Assessments (LCAs) and PCFs of pharmaceutical products. PAS 2090 sets requirements for data quality, methodological consistency and transparent reporting to address the previous absence of pharmaceutical-specific standards that had led to divergent methodologies and inconsistent results across the sector. EFPIA member companies have committed to collaborate with stakeholders and global authorities to implement the framework, with the organisation acknowledging stakeholder interest in product environmental data to support climate goals.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an overview outlining how projects funded under the Innovative Medicines Initiative (IMI) and the Innovative Health Initiative (IHI) are advancing rare disease research. The article explains how these public–private partnerships are addressing structural research barriers across five priority areas: (1) transforming clinical trial design for rare and ultra-rare diseases; (2) accelerating diagnosis and enabling earlier detection through genetic screening and digital technologies; (3) developing interoperable, patient-centred data ecosystems; (4) incorporating patient preferences into research and decision-making processes and (5) strengthening Europe’s rare disease research capacity. Highlighted projects include RealiseD (ultra-rare disease trial development), EU-PEARL (platform trial infrastructure), Screen4Care (genetic newborn screening and digital diagnostic tools) and CONNECT4Children (paediatric clinical trial networks).

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and 38 other EU health community representatives have issued comprehensive recommendations following the publication of the European Health Data Space (EHDS) in the Official Journal of the EU. They urge policymakers to ensure effective stakeholder engagement and capacity building during implementation, stressing the need to avoid excessive bureaucracy and maintain a coherent interpretation of the law.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a joint statement with the Association of the European Self-Care Industry acknowledging the Council of the EU's approval of the Urban Waste Water Treatment Directive but expressing concerns over its impact on medicine access and industry competitiveness. The associations argue that the Directive’s Extended Producer Responsibility imposes a disproportionate financial burden solely on human pharmaceuticals and cosmetics, overlooking the polluter-pays principle. They call for fair implementation involving all polluting sectors and urge the EU to conduct an impact assessment to address cost implications for medicine availability.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a position paper responding to the EU Critical Medicines Act. The paper outlines recommendations for implementing the Act while avoiding duplicative administrative requirements. EFPIA emphasises the need to align the legislation with existing EU and national frameworks to maintain Europe's pharmaceutical innovation leadership. The position paper addresses concerns about Europe's declining share of global biopharmaceutical R&D investment and advocates for flexible, coordinated regulatory approaches to strengthen supply chain resilience.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a position paper on the topic of drug repurposing regarding the review of the EU General Pharmaceutical Legislation, which include Directive 2001/83 and Regulation 726/2004. The EFPIA proposes principles for the effective use of repurposing in exceptional situations like public health crises, or conditions for which no or few medicines are currently authorised. Drug repurposing aims to provide avenues to explore new uses of older, off-patent medicines, for instance in areas where no treatments are available, or research gaps exist, thus benefitting patients affected by conditions for which limited, or no therapeutic options are approved or development is economically challenging.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued recommendations on 12 June 2025 on phasing out animal testing for chemical safety assessments. Its latest proposals, based on the '3Rs' principles of Replacement, Reduction, and Refinement, introduce a three-tiered approach that categorises tests according to their current applicability and future potential, thereby outlining a clear pathway for implementation. This roadmap illustrates a broader evolution in scientific strategy, embracing advances in organ-on-chip technology and AI-driven toxicology, as well as encouraging global collaborative efforts to align with emerging regulatory and ethical standards. While recognising challenges such as regulatory fragmentation, data silos, and intellectual property concerns, the strategy relies on transparent engagement and a commitment to harmonising international efforts, striving for a future of safety science that is both innovative and ethical.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement following the conclusion of the EU-Mercosur Free Trade Agreement. The Director General of EFPIA, Nathalie Moll, welcomed the agreement as a step towards strengthening trade relations and noted that it includes some progress for the innovative pharmaceutical sector, particularly through partial tariff reductions. However, EFPIA stated that the agreement falls short of the level of ambition needed to fully support innovation. It specified that EU free trade agreements should seek to include key provisions on intellectual property protection, including Regulatory Data Protection and Supplementary Protection Certificates, as well as meaningful access to public procurement.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement in support of the European Medicines Regulatory Network’s (EMRN) considered approach to AI, which builds on existing methods, good research practices, and requirements applied to other drug development tools, such as traditional statistical methods and approaches including model informed drug development. The EFPIA will be collaborating with the EMRN on upcoming guidance for the use of AI in medicines development.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and eight other healthcare associations have raised concerns that the European Chemicals Agency (ECHA) will not conduct individual sector assessments for medicines as part of its proposed universal restriction on PFAS chemicals. While the healthcare sector remains within the restriction's scope, ECHA indicated that 'other medical applications' covering medicinal products and manufacturing will not be individually assessed during preparation of final opinions by the Risk Assessment Committee and Socio-Economic Analysis Committee. The associations argue this approach prevents the European Commission from understanding public and animal health impacts and urge ECHA to ensure dedicated assessment of the healthcare sector within the PFAS restriction process.