EFPIA’s annual W.A.I.T. report indicates growing pharmaceutical disparity across Europe

At ISPOR Europe 2024, Lightning Health presented a poster titled ‘Reducing Inequity: Does the Reform of the EU Pharmaceutical Legislation Address Challenges to Pharmaceutical Access in Central and Eastern Europe?’. Primary research was conducted with HTA/payer representatives across markets with either a lower-than-average rate of pharmaceutical availability or longer-than-average delays from EMA approval to access, as identified through the EFPIA W.A.I.T 2023 report.

Across the final scope markets (Hungary, Croatia, Slovakia, Portugal, Romania, Poland and Greece), a consistent theme emerged. Although the proposed reform of the EU pharmaceutical legislation was recognised as an important step towards improving equity in patient access to new medicines in Europe, stakeholders anticipated its real-world impact would be constrained by underlying disparities in affordability between Member States.

Two years later, the EFPIA Patients W.A.I.T. Indicator 2025 Survey (published May 2026) reinforces concerns of widening pharmaceutical inequity across Europe. Key findings for the 168 innovative medicines that received central marketing authorisation between 2021 and 2024 include:

• Median time to availability of 532 days, ranging from 56 days in Germany to 1,201 days in Romania
• A widening gap compared to the previous report (47 days in Germany and 775 days in Romania in 2023)
• An 88% access disparity between the highest- and lowest-access European country (compared to 84% in 2023)

The report also highlights that restrictions have become increasingly commonplace for innovative medicines:

• 49% are not available to patients in Europe (up from 46% in 2019)
• 17% are  available only under restricted conditions (up from 6% in 2019)
• The proportion of medicines fully available on public reimbursement lists has declined to 28% (from 42% in 2019)

While some markets have shown improvements in time to availability - including Turkey, Hungary, Spain, Bulgaria, Slovakia, Serbia, and England  - these have not been sufficient to offset the overall trend of widening disparities across Europe.

Taken together, these finds demonstrate not only persistent delays, but increasing divergence in access between European markets, with differences in affordability and national access pathways continuing to drive variation.

As predicted by Lightning Health, analysis of the root causes confirmed multifactorial issues that will not simply be solved through implementation of the EU pharmaceutical legislation alone. Access remains strongly shaped by structural differences in affordability, pricing frameworks, and national HTA processes. Marketing Authorisation Holders and Member States alike will require greater clarity and predictability moving forward to ensure pharmaceutical inequity can be addressed in Europe. Addressing these challenges will require a combination of system-level, operational, and pricing innovation, potentially including:

• Acceleration of the European Medicine’s Agency regulatory processes (in line with international best practice)
• Ensuring efficient implementation of EU HTAR so that engagement with the JCA does not become an additional barrier
• Development of a pan-European portal to improve visibility across pricing and reimbursement submissions in EU27+Iceland, Norway, and Switzerland
• Development of a conceptual framework for equity-based tiered pricing
• Adoption of novel payment and pricing models, particularly in lower-affordability markets

With increasing attention on the Most Favoured Nations (MFN) Policy, it may be tempting to assume this is contributing to observed trends. However, EFPIA clearly state that it is too early to capture any impact from the changing global policy environment caused by MFN, especially as data reflects trends only up to the end of 2025. Future W.A.I.T. reports will be assessing the anticipated impact of MFN through close monitoring of disparities between FDA and EMA regulatory approvals.

What does this mean?

For global pharmaceutical manufacturers, these findings reinforce that European launch strategy can no longer be approached as a uniform process and there are additional factors that need to be taken into consideration. Companies must not only prepare for the JCA (if applicable to their product) but also for the broader implications of EU pharmaceutical legislation and evolving pricing dynamics. This includes:

• Accounting for pricing risks – including external reference pricing and potential MFN implications – within launch sequence decisions
• Aligning evidence generation strategies with diverse HTA requirements and JCA expectations
• Earlier planning for pricing and access strategies to account for varying levels of affordability e.g., managed entry agreements, alternative pricing models, differentiated approaches across markets

The trajectory of pharmaceutical inequity may only be clearer following publication of the next annual W.A.I.T. report. In the meantime, manufacturers may need to consider greater strategic focus on non-EU and emerging markets, particularly where policy constraints are less restrictive or those outside the scope of MFN.

Article by Nick Stringfellow

‍