Introduction

While EU medicine access challenges are a widely acknowledged reality, the 2024 EFPIA Patients W.A.I.T. Indicator study and Charles River Associates report quantify these hurdles, revealing a shared burden for industry and patients across Europe. With only 46% of centrally approved medicines (2020–2023) available in 2024, down from 48% in 2019, and public reimbursement rates dropping to 29% from 42%, these reports highlight systemic inequities. This summary distills the foremost EU medicine access challenges to guide strategic planning and advocate for policy reforms that enhance market entry and patient outcomes.

Main Findings

EU Medicine Access Challenges: Growing Delays

• 578 days: Average time to market availability in 2024, up from 531 days in 2023, a 47-day increase.

• Country disparities: Germany achieves access in 128 days, while Portugal requires 840 days.

• Two-thirds of delays stem from regulatory bottlenecks, health technology assessments, and reimbursement negotiations. Executives must prioritize early payer engagement to mitigate these delays.

Limited Availability and Restricted Access

• 46% availability: Only 46% of innovative medicines approved centrally (2020–2023) were available in 2024, with disparities favoring Northern/Western Europe.

• 17% restricted access: Medicines with reimbursement restrictions rose from 6% in 2019 to 17% in 2024; reimbursement rates fell to 29%.

• Smaller markets face structural barriers, limiting access to advanced therapies. Tailored evidence packages are critical to navigate restrictive reimbursement systems.

EU Medicine Access Challenges: Infrastructure and Policy

• Key barriers: Insufficient diagnostic capacity, staff specialization, duplicate evidence requests, and non-harmonized pricing frameworks hinder access.

• Policy risks: Proposed EU legislation weakening IP protections and external reference pricing could divert R&D to the U.S./China. Executives should advocate for policy reforms and invest in market-specific solutions.

Strategic Priorities for Market Access

• EU HTA Regulation (Jan 2025): Mandates joint clinical assessments, requiring early HTA engagement.

• EFPIA proposals: Equity-based tiered pricing and outcomes-based payment models can accelerate access, alongside the EU Critical Medicines Act.

• WHO/Europe Platform: Partnerships with smaller markets can reduce disparities. Executives must allocate resources for robust HTA submissions to overcome EU medicine access challenges.

Conclusion

The EFPIA report underscores access challenges in Europe, with 578-day delays, 46% availability, and 17% restricted access signaling systemic issues harming outcomes, especially for cancer treatments. Executives should focus on early HTA engagement, tailored reimbursement strategies, equity-based pricing, and policy advocacy, including tailored approaches for smaller markets, to ensure timely launches and equitable access, strengthening their EU market position.