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European Access Hurdles Portal: Summary of the Third External Report

Overview

The European Access Hurdles Portal was launched in April 2022 by the EFPIA (European Federation of Pharmaceutical Industries and Associations) to increase transparency about the root causes of unavailability and delays of innovative medicines in Europe. The third report, published in May 2025, covers data on 94 products approved by the EMA between January 2021 and June 2024, all of which were submitted by 35 EFPIA member companies (100% participation). The report aims to analyze the speed of marketing authorisation, filing, reimbursement, and the root causes of delays.

Key Findings

1. Speed of Marketing Authorisation

• EMA approvals are slower than those in the US and Japan, with an average delay of 252 days compared to the US and 24 days compared to Japan.
• For oncology drugs, EMA approval is 69 days earlier than Japan but 303 days later than the US.
• For orphan products, EMA approval is 312 days later than the US and 95 days later than Japan.
• The delay in EMA approvals is partly due to companies taking longer to file with the EMA compared to the FDA, though data on submission dates are not publicly available.

2. Status of Filing, Availability and Accessibility

• 67% of products have been filed for P&R or made accessible via an AAS (Alternative Access Scheme) on average across European countries.
• 59% of products have been formally filed for P&R, with:
  • 55% of filed products being reimbursed.
  • 37% pending reimbursement decisions.
  • 7% receiving negative decisions or being withdrawn.
• The rate of filing and accessibility has increased over time, particularly in countries like Romania and Greece, where filing requirements and healthcare infrastructure are significant barriers.
• There is significant variation in filing rates across European countries, with some having high rates (e.g., France, Germany) and others low (e.g., Cyprus).

3. Speed of Filing and Reimbursement

• 31% of the total time between EMA approval and reimbursement is attributed to the time between MA and P&R filing.
• 69% of the time is due to the P&R decision-making process at the country level.
• The proportion of time taken for filing varies by region:
  • Nordic countries have the lowest proportion (26%).
  • Central and Eastern Europe (CEE) have the highest proportion (34%).

4. Root Causes of Delays in P&R Filing

• The root causes of non-filing are multi-factorial, involving:
  • Health system infrastructure (lack of required healthcare infrastructure and funding).
  • Economic viability (treatable population size, company presence, and launch cost recovery).
  • P&R process (country filing requirements, external reference pricing).
  • Value assessment process (evidence package not meeting country requirements, low value attributed to class competitors).
• These reasons are evenly distributed across all categories, indicating that improving P&R filing requires a shared effort among stakeholders.

5. Regional Differences in Non-Filing Reasons

• Western Europe delays are primarily due to the value assessment process.
• Central and Eastern Europe delays are mainly attributed to health system infrastructure and economic viability.
• Country-specific filing requirements and external reference pricing also play a role in delaying P&R filing.

6. Product Type and Non-Filing Barriers

• Oncology products face barriers related to evidence requirements and company presence.
• Orphan products are impacted by the size of the treatable population.
• ATMP (Advanced Therapy Medicinal Products) face challenges in the country’s P&R process.
• AASs can partially mitigate some barriers, but lack of company presence affects both filing and AAS accessibility.

7. Commitment to File (CTF)

• EFPIA members committed in 2022 to file for P&R in all EU countries within 2 years of central EU marketing authorization.
• 22 products received MA after the CTF and have been on the market for at least 2 years.
• Filing rates and AAS accessibility remain consistent at 71% for both pre- and post-CTF cohorts.
• The sample size is still small, and more data will be needed to assess the long-term impact of the CTF.

8. Trends in Filing Post-CTF

• Preliminary analysis shows an increase in filing speed over time since the CTF was introduced.
• This suggests that manufacturers are improving their systems to support earlier filing.
• Cohort 5 (Jul–Dec 2023) appears as an exception due to a higher proportion of oncology products.

9. Opportunities for Future Improvements

• The Portal should continue to refine data collection to reduce the use of 'other' responses.
• There is a need to differentiate the impact of multiple root causes on non-filing decisions.
• Including data from a broader range of companies, not just EFPIA members, would improve the dataset.
• Biosimilars could be included for differentiated analysis in future reports.

Conclusion

The European Access Hurdles Portal provides valuable insights into the factors affecting the availability of innovative medicines in Europe. While the EMA approval process is slower than in the US and Japan, the industry has shown a complete willingness to increase transparency. The CTF initiative has not yet significantly improved the overall filing rate, but early trends suggest progress. The report highlights the complexity of the P&R process, with delays stemming from multiple, region-specific, and product-specific factors. Future iterations of the Portal will benefit from expanded data collection and improved methodology to further enhance understanding and address access challenges.