EFPIA report highlights widening disparities in access to innovative medicines across Europe

A new report from EFPIA suggests that access to innovative medicines across Europe remains highly uneven, with widening disparities in availability and reimbursement timelines. Industry stakeholders also raised concerns that global pricing pressures could further influence future launch strategies and patient access.

The Baseline

• EFPIA’s latest Patients W.A.I.T. Indicator found that patients in Europe wait a median of 532 days to access new medicines, with nearly half of therapies unavailable across European markets.
• The report identified substantial variation between countries, with access disparities reaching 88% across Europe.
• Industry stakeholders suggested that US pricing reforms and ongoing European policy changes could affect future launch decisions and access timelines.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its latest annual Patients Waiting to Access Innovative Therapies (W.A.I.T.) Indicator, outlining persistent disparities in the availability and timing of access to innovative medicines across Europe. The annual analysis, carried out by IQVIA, is one of the most comprehensive datasets examining publicly funded access to new medicines in Europe, assessing 168 therapies that received centralized approval from the European Medicines Agency (EMA) between 2021 and 2024 across 36 countries.

The report tracks two core measures: the proportion of medicines available to patients through national reimbursement systems and the time required for those medicines to become accessible following EMA approval. According to the latest findings, patients in Europe wait an average of 597 days and a median of 532 days to access new medicines, although timelines vary substantially between countries. EFPIA also reported an 88% disparity in access rates between the highest- and lowest-performing European countries.

The analysis suggests that availability has continued to decline in recent years. In 2025, 49% of innovative medicines included in the cohort were unavailable to patients across Europe, compared with 46% in 2019. At the same time, the proportion of medicines fully available on public reimbursement lists fell from 42% in 2019 to 28% in 2025, while the use of restricted reimbursement arrangements increased from 6% to 17%.

Alongside the W.A.I.T. Indicator, EFPIA published new regulatory tracking data examining whether medicines approved by the US FDA subsequently receive authorization from other regulatory agencies, including the EMA and China’s National Medical Products Administration. According to the analysis, approval trends over the past 18 months suggest a decline in the proportion of FDA-approved medicines later authorized in Europe, with the steepest drop occurring since October 2025.

The organization suggested that broader, global pricing dynamics may increasingly shape launch strategies, particularly following the introduction of the Most-Favored-Nation (MFN) pricing policy. EFPIA noted that the US currently accounts for 74.1% of global pharmaceutical sales of new active substances, compared with 15.6% in Europe, arguing that continued uncertainty around pricing and market conditions could influence where companies prioritize launches.

Nathalie Moll, Director General of EFPIA, argued that Europe’s longstanding access challenges risk worsening under evolving global pricing reforms. She stated that Europe needs to “make a choice,” warning that continued pressure on medicine pricing and government clawback mechanisms could undermine investment attractiveness, delay launches, and further affect patient access to innovative therapies.

EFPIA described delays and limited availability as multifactorial, pointing to regulatory timelines, differing evidence requirements, and budget constraints across Member States. The organization stated that “the industry shares concern about these delays and recognize that delays and the unavailability of medicines harm patients,” adding that the findings provide important context for ongoing debates surrounding the EU General Pharmaceutical Legislation revision and the proposed Biotech Act.

As part of the report package, EFPIA also outlined proposals intended to accelerate access, including a “Day 1 access” approach that would allow patients to receive medicines immediately following regulatory approval while national health technology assessment (HTA) and reimbursement processes continue within a proposed 180-day timeframe.

Expert reactions and policy concerns

Industry analysts and stakeholders echoed concerns about growing launch hesitancy across Europe. Speaking at the recent ISPOR 2026 conference, Jens Grueger (Boston Consulting Group) described current reimbursement timelines and declining rates of unrestricted access as “a disaster for patients,” arguing that MFN-style reference pricing could further discourage launches in Europe as companies prioritize the US market.

Neil Grubert (Independent Global Market Access Consultant) similarly highlighted uncertainty surrounding both US and European policy reforms. He noted that proposed changes to EU General Pharmaceutical Legislation, including revisions to regulatory data protection, orphan exclusivity periods, and launch obligations, alongside broader cost-containment pressures in some Member States, may further reduce willingness to launch medicines in Europe. Grubert added that the coming months may clarify whether current launch hesitancy represents a “temporary phenomenon – pending clarification of MFN – or a more enduring shift” in global launch strategy.

In commentary published by the Association of the British Pharmaceutical Industry (ABPI), Sophie Caseby (Value and Access Policy Manager, ABPI) highlighted continued access challenges in the UK, noting that England ranked seventh overall in Europe for access to newly approved medicines but lower for oncology therapies. She also referenced concerns that around one-third of medicines licensed in the US are not licensed in Europe or the UK, stating that “the UK needs to better reflect the value of medicines for patients with few or no alternatives,” while pointing to recent efforts to improve alignment between regulatory and HTA processes.

Meanwhile, Pablo A Panella (Senior Vice President, Head of Oncology for Europe and Canada at AstraZeneca) stated that the combination of widening access disparities, evolving pricing reforms, and broader geopolitical shifts “necessitate a strategic European response”. Panella argued that the current environment represents a critical moment for European policymakers, adding that coordinated action from national governments will be needed to strengthen recognition of innovation, support investment attractiveness, and help secure long-term patient access to new therapies.