New data reveals how systemic fragmentation delays treatment—and why training future professionals is key to solving it.

Just imagine if patients across Europe could access a newly authorized medicine the day it receives European Commission approval. It’s not a fantasy—it’s an aspiration shared by policymakers, healthcare professionals, industry leaders, and patients. Yet in 2024, the reality is far from that ideal.

New EFPIA data shows the average time from EU marketing authorization to national patient access is 578 days. In Germany, patients typically wait 128 days. In Portugal, it can be over 840. The same medicine, the same science—seven times longer to reach those in need depending on where they live.

This isn’t just a regulatory inefficiency—it’s a public health challenge.

The Persistent Patchwork of Access

Under the European Medicines Agency (EMA), medicine approvals are centralized. But pricing, reimbursement, and access are left to national and sometimes regional systems. This fragmentation results in a complex mix of health technology assessments, divergent evidence requirements, and inconsistent decision timelines.

The EFPIA’s root cause analysis identifies 10 key barriers—from slow health technology assessments and duplication of clinical evidence, to local budget limitations and delayed company filings. In Western Europe, the bottlenecks stem mainly from value assessment complexities. In Eastern Europe, health system capacity and commercial viability play a larger role.

The outcome? Millions of Europeans face unequal—and often prolonged—access to scientific breakthroughs that could dramatically improve or save their lives.

From Data to Action: Rethinking the Ecosystem

EFPIA argues that tackling these delays requires far more than technical tweaks. The revision of Europe’s Pharmaceutical Legislation must lay the groundwork for a more cohesive, flexible, and forward-thinking access system. This includes supporting novel pricing models, evidence-based assessments, and cross-border collaboration.

Industry has put forward solutions: Equity-Based Tiered Pricing (EBTP), outcomes-based payment systems, and subscription models aimed at reducing upfront financial barriers for high-cost, high-impact therapies. But such models require reform of external reference pricing and more adaptive legislative frameworks to avoid parallel trade or market distortion.

The call is clear: stakeholders—from payers and HTA bodies to patient groups, regulators, and industry—must be at the same table.

Educating the Professionals Who Will Lead the Change

This isn’t just a policy problem; it’s an education challenge. That’s where the GMDP Academy steps in. Through our Certification in Medicines Development and modular training in regulatory strategy, market access, health economics, and medical affairs, we are preparing professionals to engage with precisely these challenges.

Whether it’s understanding how real-world evidence can accelerate HTA approval, or exploring the ethical and strategic implications of value-based pricing, our curriculum connects scientific advancement to access outcomes. It ensures our graduates don’t just know how medicines are developed—but how they reach patients.

Our module on Medical Affairs and Health Economics equips learners to analyze data generation, affordability models, and commercialization pathways. In Regulatory Affairs, participants explore how EU-level harmonization initiatives can support quicker and fairer access to innovation across diverse healthcare systems.

Why the Wait Must End

When a patient in Germany starts treatment for leukemia within four months of approval, while another in Romania waits over two years, the implications go beyond numbers. They strike at the heart of Europe’s promise of universal health access.

As the EFPIA rightly notes, no single actor can fix this alone. The solution lies in collaboration, courage, and competence.

At the GMDP Academy, we are committed to building the latter—ensuring tomorrow’s leaders are ready to shape systems where innovation doesn’t wait, and neither do patients.

References

GMDP Academy. (2024). GMDP Academy Offerings 2024–2025.  https://info.gmdpacademy.org/course-catalog

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred