The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe and other organisations representing the cosmetics and pharmaceutical sectors have urged EU Ministers of Economy to ask the European Commission to ‘stop the clock’ on  implementing the extended producer responsibility (EPR) scheme under Directive (EU) 2024/3019 (Urban Wastewater Treatment Directive, UWWTD). They state that the cost of upgrading wastewater treatment to remove micropollutants may be significantly higher than the Commission’s estimate of up to up to €1.4bn annually until 2045. They also raise concerns that the methodology used to allocate toxic load to sectors overstated the contribution of pharmaceuticals and cosmetics to urban wastewater pollution. They argue that limiting EPR obligations to those sectors is inconsistent with the polluter pays principle. In addition, they indicate that the directive could result in increased financial and administrative burdens, particularly for small and medium-sized enterprises, and note that fixed pricing mechanisms in the pharmaceutical sector may limit the ability to pass on additional compliance costs, with potential implications for medicine supply. They call for a pause in the EPR-related provisions and for a further science-based reassessment of the directive’s impact.

EFPIA and Vaccines Europe (VE) have urged the European Commission to ensure that the forthcoming EU Biotech Act delivers clear, predictable and supportive legislation to strengthen Europe’s competitiveness, attract global investment, and reverse the decline in research, innovation and clinical trials.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has announced it and its member companies will participate in the Critical Medicines Alliance to improve medicines supply chain security. The EFPIA will work towards a number of recommendations including boosting EU leadership in technologies such as advanced therapies and MRNA, accelerating digitalisation and promoting sustainable procurement conditions.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and 34 other stakeholders in the European healthcare ecosystem, including MedTech Europe of the medical devices industry, have expressed concerns regarding the draft text of the European Health Data Space (EHDS) currently in EU trilogue negotiations. While the EFPIA acknowledges that the EHDS is intended to make the functioning of European health systems more efficient, contribute to better health outcomes, and support public health and health research and innovation activities in the EU, it worries that fundamental issues have not been addressed satisfactorily in the trilogues negotiations. As it stands, the draft lacks the necessary degree of legal certainty and consistency with the existing regulatory frameworks and recently incorporated or amended key provisions should be carefully considered to avoid unintended negative consequences.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded to a report it commissioned by Evidera that assessed the simulation of a joint clinical assessment (JCA) by applying the EUnetHTA21 proposed methods guidelines to three cancer medicines that were approved in recent years. JCAs are a new system proposed by the new Regulation (EU) 2021/228 on Health Technology Assessment (HTA) that will assess clinical effectiveness of new technologies versus current treatments. JCA reports will be intended to support access and reimbursement decisions at national level. The new HTA Regulation is due to apply in under a year and developers of oncology medicines and advanced therapy medicinal products (ATMPs) need to be prepared and guidance is needed. It aims to improve and accelerate the availability of innovative therapies for patients, ensure efficient use of resources, and strengthen the quality of HTA by harmonising HTA approach across the EU and reducing multiplicative efforts by EU HTA bodies, however, industry has expressed concerns. The Evidera report's findings were detailed but generally concluded JCAs can support getting new innovative cancer medicines to patients faster provided it can balance the need for evidence generation with facilitating assessment by national decisions on access to these treatments. In response, the EFPIA Oncology Platform has proposed concrete measures to address the shortcomings identified in the Evidera report.

About 110 European associations of the European Federation of Pharmaceutical Industries and Associations (EFPIA) representing key European research, development, and innovation (RD&I) stakeholders have issued a statement urging the EU to significantly increase the budget for the next European Framework Programme for Research and Innovation (FP10). They argue that the EU lags behind global competitors in RD&I investments, especially from the private sector, hampering its ability to capitalise on its scientific and technological potential. FP10 plays a crucial role in stimulating private RD&I investments by lowering risks and pooling resources across Member States, industry, research organisations, and academia to tackle complex challenges collectively. Evaluations show the highest financial leverage was achieved through European partnerships in Horizon 2020, where private contributions more than doubled or tripled EU investments. The associations call for reinforcing collective EU RD&I investments in the next EU budget, complemented by national investments meeting the 3% of GDP target to leverage more private RD&I spending. They argue that FP10 should focus on excellent cross-border collaborative RD&I with strong industrial participation, reinforcing competitiveness in Pillar II while making it a key driver for Pillars I and III. Pillar II is crucial for building long-term public-private partnerships, reducing risk to stimulate private investment in the EU, and supporting the green and digital transitions while preserving technology neutrality. They deem themselves ready to further discuss the design of FP10 with the EU Institutions

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe filed separate legal challenges with the EU General Court on 10 March 2025 against Directive 91/271/EEC (Urban Wastewater Treatment Directive (UWWTD)). The cases contest the directive's Extended Producer Responsibility system, which requires pharmaceutical manufacturers to fund wastewater treatment costs. The industry bodies argue the directive violates EU Treaty principles of polluter-pays, proportionality and non-discrimination. The Commission estimates annual costs of €1.18bn, while industry and member state projections range from €5bn-€11bn per year.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a blog welcoming the revision of the EU’s General Pharmaceutical Legislation (GPL), while cautioning that some provisions—such as limited flexibility in using Real-World Evidence and the exclusion of marketing authorisation holders from labelling decisions when data is generated by regulators or third parties—could unintentionally undermine the framework’s effectiveness if not refined.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a blog supporting the multi-stakeholder initiative led by EURORDIS–Rare Diseases Europe to develop a European Blueprint for Rare Diseases, which would provide the foundation for a future EU Action Plan on Rare Diseases. The blog argues that fragmented policies, limited access to diagnosis and care, and barriers to research and development continue to hinder progress for the 30 million people living with rare diseases in Europe. It identifies four priority areas for action: strengthening rare disease data infrastructure through improved access to standardised, high-quality data; reducing research and development risks for ultra-rare and paediatric conditions through public-private partnerships and indication-based pricing; creating sustainable long-term funding and support mechanisms to maintain successful EU-funded research platforms; and improving alignment between regulatory, health technology assessment (HTA) and payer requirements to accelerate patient access to new treatments. The blog concludes that progress in these areas would support innovation, enhance Europe’s competitiveness in rare disease research, and help address unmet patient needs, and states that industry is committed to working with EURORDIS and other stakeholders to develop the proposed Blueprint.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called for the EU co-legislators to seize the opportunity provided by the European Health Data Space (EHDS) draft regulation to thoroughly examine certain aspects of the EHDS to provide greater legal certainty and keep the momentum for harmonisation.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published an article which emphasises that the narrow definition of unmet medical needs in the General Pharmaceutical Legislation may hinder the development of new treatments, particularly for chronic conditions. This has led to EU Member States calling for clear criteria to be established in the legislation for unmet medical needs, however, the EFPIA states this is a nearly impossible task. Instead, the EFPIA calls for a science-based definition that includes patient insights, ensuring equitable consideration across all disease areas to foster innovation.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has urged the EU to accelerate reforms to EU Regulation No 536/2014 (Clinical Trials Regulation (CTR)) to strengthen Europe’s global competitiveness in medical research. EFPIA supports greater centralisation and harmonisation of trial assessments to replace fragmented national systems and cut approval times from over 100 days to 30–60 days. It welcomes the European Commission’s review of the CTR and the proposed EU Biotech Act, expected from 2025, as key opportunities to modernise regulation, enhance digital integration and reduce delays. Swift action, EFPIA says, could make 2026 a turning point for clinical research and faster patient access to innovation.