Although much recent focus has been on US drug price policy and its ramifications for European markets, these must be understood in the evolving context for market access on the continent, including that driven by the European Union (EU). Several important EU legislative and regulatory changes were proposed, finalized, or implemented in 2025. Here we identify and review those which more directly impact market access and identify key themes for change. 

European Pharmaceutical Legislation  

This is broad reform of EU legislation, across regulatory processes, regulatory protection duration and incentives, and medicines supply. 

Status: A provisional agreement in December 2025 between the Council and European Parliament is awaiting formal endorsement, publication, and adoption. The transition period for adoption will extend to 2028. 

Implications for market access:  

• Drug launch obligation: Manufacturers are obliged to make a drug available in any EU market if requested, at risk of European Commission involvement and loss of market protection in that country. This is intended to ensure supply to smaller countries; but so far it is unclear what “available” means in practice, and hence if this could impact strategic selection and timing of launch markets.  

• “Bolar exemption:” Health technology assessment (HTA), and pricing and reimbursement decision-making, for generics and biosimilars may start during the period of patent protection, allowing immediate entry upon expiry of protection. This change may benefit generic/biosimilar manufacturers.  

Critical Medicines Act 

The Critical Medicines Act aims to improve the availability, supply, and production of medicines within the EU (complementing the EU Pharmaceutical Legislation). 

Status: Negotiations between the European Parliament, Council, and Commission started in February; the text is expected to be finalized in 2026.  

Implications for market access: 

• Provision for collaborative procurement: Procurement could be facilitated or conducted by the European Commission on request of several member states. From the perspective of drug developers, this could challenge usual launch planning considering achievable price, especially given the current proposal of lack of affordability as an eligibility criterion.  The final scope will be important: if focused on traditional critical medicines (usually generic products), or whether definition of “medicinal products of common interest” also applies to innovative medicines such as orphan drugs. 

HTA Regulation 

HTA regulation introduces EU-level assessment of clinical evidence for health technologies (Joint Clinical Assessment).  

Status: The platform, procedures, and methodologies have been implemented. The first twelve technologies entered assessment in 2025. Many more, including medical devices, are expected in 2026, which will build towards full introduction in 2030. Four Joint Scientific Consultations (with the European Medicines Agency [EMA]) have been completed, although remain confidential.  

Implications for market access:  

• Data readiness: The Joint Clinical Assessment (JCA) runs in parallel with the EMA regulatory process, requiring JCA dossier submission before receipt of Committee for Medicinal Products for Human Use opinion. Submission must include an analysis of comparative effects, including against non-trial comparators if requested. The shift from the usual sequential timeline (i.e., regulatory decision preceding HTA submission) brings manufacturer challenges for internal alignment and resources, together with the need for an evidence package aligned to the stipulated PICO (Patient, Intervention, Comparator, Outcomes) requirements which are not finalized until shortly before dossier submission.

• Impact on market-level appraisals and access outcomes: Market-level HTA template and process adaptations have been made in anticipation of JCA outputs. Industry will be keenly watching how the first JCA outcomes impact pricing and access decisions in European markets, plus any ex-European market impact. JCA may also stimulate further HTA environment change through future consolidation of market evidence expectations and wider use of HTA across the continent.

EU-backed Market Collaborations in Pricing and Reimbursement  

The EU provides funding support for collaborations between several European pricing and reimbursement authorities, including: 

• EURIPID: Sharing of price and reimbursement information 

• CAPRICORD: Project focused on pricing, reimbursement, and financing of orphan drugs 

Status: EURIPID and CAPRICORD are ongoing initiatives. 

Implications for market access: There is potential for wider use of more sophisticated and/or collaborative pricing and reimbursement arrangements in European markets.CAPRICORD considers pricing systems in the face of uncertainty and the role of clinical expert and patient involvement, with project involvement of Central and Eastern European countries with less established HTA. For manufacturers, this offers opportunities for both increased value recognition and novel access strategies, offering new market routes for the most innovative therapies by extending the experience of more mature markets. However, there may also be the challenge of higher-stakes, multi-market negotiation, building from experience of other cross-market collaborations incorporating drug procurement (such as BENELUXA-I and the Nordic Pharmaceutical Forum).  

Impact of these Changes 

Two key themes relevant to market access emerge from these European-level changes. Firstly, EU policies are leveraging European solidarity to drive for more equal access to health technologies across the continent. Strategic launch market selection and sequencing linked to affordability, willingness to pay, and international reference pricing (IRP) impact may be countered by incentives or mandates for launch across EU markets. The situation is made more challenging by emerging US drug price policy: European market drug prices—already linked through IRP— will have direct implications for US market price if Most-Favored Nation is fully implemented. Finalization and implementation of regulations will need to be monitored to understand their impact, particularly to what extent safeguards are incorporated that recognize commercial challenge.  

Secondly, current and emerging EU-level initiatives are driving an increased role and sophistication of HTA and reimbursement approaches across the continent. Although one stated aim of JCA was simplification of manufacturer evidence submission requirements, implementation is also associated with increasing HTA capacity and experience among many member states, and reference to methodological guidelines reflecting those of the most advanced, stringent HTA bodies. Initiatives such as CAPRICORD may further support greater innovation in approaches in more countries. For manufacturers, this may be an opportunity to shift the focus of access negotiations from budgets to value recognition, while also presenting a potential challenge for evidence provision.  

The EU is an increasingly important driver of change in the European market access environment. Recent policy and legislative change also have implications for the commercial opportunity and innovation investment in EU. The indirect impacts of such changes in the broader health technology environment are discussed in a recent article. Avalere Health is pleased to offer further insight and support in monitoring and interpreting these changes. Connect with us to learn more about how Avalere Health’s pricing, market access, and policy subject matter experts can support you.