Several European Union (EU) legislative and policy changes over the past year have directly impacted the market access landscape. Below we analyze other recent EU-driven change through the lens of market access: the context of evidence development and market launch, support and rewards for investment in innovation, and health policy that influences health system readiness and priorities.

Innovation in Regulatory Approaches

The recently finalized European Pharmaceutical Legislation includes a provision for more adaptive regulatory frameworks from the European Medicines Agency (EMA), including the regulatory sandbox approach for technologies unsuited to usual requirements, and approaches for platform technologies. This brings the EMA in line with progressive approaches seen recently from other global regulators. Regulatory simplification is further included in the Biotech Act proposed in December 2025. The ongoing EMA workplan further reflects openness to new approaches to evidence, including the current draft guideline on patient preference studies, and work to examine uses of artificial intelligence in regulation.

Change is also emerging in regulation ensuring safety in research and development and of licensed products, aiming to alleviate development and launch barriers. The European Pharmaceutical Legislation includes provision for decentralized manufacturing of innovative medicines (again in line with other regulators) and streamlines EMA assessments from 210 to 180 days.

Further, policymakers are proposing to simplify the Medical Devices and In Vitro Diagnostic Medical Devices regulations as an element of the Strategy for European Life Sciences. The goal is to accelerate and address barriers to authorization of research and marketing, through mechanisms such as prioritizing breakthrough or orphan devices and enabling single submissions for drug/device combination trials. The Biotech Act also aims to reduce timelines for multinational clinical trial approvals.

Manufacturers welcome these changes, as they address concerns about regulatory burdens hindering development and launch, especially when those regulations do not align to disease and product profiles. From a market access perspective, however, the challenge will be to ensure payer expectations similarly recognize the need for adaptability in evidence requirements and efficient decision making to ensure innovation reaches patients. Provision for Joint Scientific Consultation between the EMA and the HTA Coordination Group is limited despite being a key potential forum for alignment on evidence expectations. In a European payer landscape of increasing use of HTA, and limited healthcare budgets driving need for certainty, manufacturers must ensure that discrepancies are recognized and bridges built between regulatory and payer expectations.

Incentives for Investment in Biotechnology

The European Strategy for Life Sciences was launched by the European Commission in July 2025, with the stated aim “to make Europe the most attractive place in the world for life sciences by 2030.” This strategy encompasses planned investment in research and development initiatives, infrastructure and coordination, and, through the Biotech Act, measures to encourage biotechnology company investment. The European Pharmaceutical Legislation has attempted to balance countries’ desire to lower medication costs through competition, countered by the need to maintain attractiveness for research investment, through changes to market exclusivity period in Europe. In the final version of the legislation, the baseline regulatory period was shortened by one year, to nine years (including also orphan drugs), but new exclusivity period incentives are included for unmet medical need, EU trials and launch priority, and antimicrobials. EU measures have also sought to support tools for biomedical research, for example as a stated benefit of European Health Data Space regulation introduced in 2025.

The next years will tell if the stated aim can be fulfilled, especially as many countries worldwide have ambitions for life sciences investment and domestic pharmaceutical manufacturing. From a market access perspective however, manufacturers have characterized a gap between the stated desire to encourage innovation and willingness of public health systems to provide access to innovative technologies, noting wide disparity across the EU. The collaborative Innovative Health Initiative, which is supported partially by the EU, may encourage change. However, given that pricing and reimbursement decisions sit with individual countries, national policy change is likely more important. Despite this situation, the EU strategy could encourage recognition of the need for favorable investment conditions when determining financing of innovative technologies.

EU-level Health Plans in Key Therapeutic Areas

The first EU plan for cardiovascular health, the Safe Hearts Plan, was launched in 2025, following several years of alliance-building and lobbying through the European Alliance for Cardiovascular Health. Recognizing the humanistic and economic burden of cardiovascular diseases, actions in the plan focus on health promotion, disease prevention, better screening and early detection, and improving and addressing inequalities in treatment. The plan is delivered through national disease plans, and at EU-level, through legislation (such as regulation of tobacco and junk food advertising), target-setting, and research funding. A cited motivation for stakeholders behind this plan was the example of investment driven by the EU Beating Cancer Plan (published in 2021 and associated with €4 billion funding). Beyond these, ongoing EU health initiatives within the EU4Health program address therapeutic areas such as mental health, vaccination, and rare diseases.

Many actions and targets within these plans focus on public health rather than health technologies. Additionally, much focus within disease management is on advancing care in less mature health systems by improving care pathways and use of low-cost diagnostics and interventions. This does offer opportunities for manufacturers of the latter, but the direct impact for innovative therapies is perhaps more limited. However, as EU plans are incorporated into national plans, manufacturers may wish to highlight the focus and targets of these plans and the role that more innovative technologies can play. Additionally, EU investment in areas such as diagnostics, digital healthcare technologies, and clinical research networks may support access more widely, especially recognizing barriers, beyond national pricing and reimbursement, associated with health system readiness. If these plans are able to drive real change, this should encourage stakeholder engagement and support for European-level plans and action in other disease areas.

Beyond the direct impact of EU legislation, regulations, and funding, recent broader changes and initiatives are impacting the market access environment, bringing opportunities and challenges to manufacturers. 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.