With regulatory reforms, the EU can lead in global medicine innovation
(This image was generated using AI.)
Europe’s current challenges in medicine approvals
The European Medicines Agency (EMA) has played a vital role in advancing public health across the EU. Yet, the study reveals that pharmaceutical companies are increasingly prioritizing other regions, especially the U.S., for submitting their innovative medicines.
On average, the EU takes 453 days to approve a new medicine—over 120 days longer than the U.S. (333 days) and Japan (322 days). In addition to slower timelines, fragmented pricing and reimbursement systems across the EU, from 133 days in Germany to over 899 days in Romania create a complex environment for companies seeking market access which can range.
This delay does not only impact patients needing life-saving treatments but also signals a regulatory system that is struggling to compete with more dynamic frameworks elsewhere, deterring pharmaceutical investments and driving innovation to markets with simpler, more streamlined processes.
A call to reclaim leadership
The study sought to uncover why Europe has fallen behind in attracting pharmaceutical companies and how it can regain its position as a global leader in medicine innovation.
By interviewing 47 pharmaceutical industry professionals, the researchers identified key obstacles:
- A complex and fragmented regulatory system across EU member states.
- Lower medicine prices, which diminish the financial appeal of launching in Europe.
- Fewer incentives and slower approval timelines compared to other major markets like the U.S.
Despite these challenges, the researchers see a clear path forward for the EU to lead in global healthcare innovation.
"Our interviews revealed that the European system's complexity discourages pharmaceutical companies from prioritizing the EU for new submissions. Simplifying processes and providing stronger incentives can turn this around," notes HOI researcher Stefan Haefliger.
A roadmap for reform
That is why the study recommends several reforms to strengthen the EU’s regulatory framework:
- Boost regulator autonomy: Give European regulators more control over budgets and hiring to improve expertise and drive innovation by establishing more competitive expedited pathways.
- Streamline regulatory systems: Simplify processes, shorten timelines, and offer faster approval pathways with better support for early drug development across member states to create a unified, predictable system.
- Strengthen global collaboration: Partner with international regulators like the FDA, establish competitive work-sharing models, and lead global initiatives in AI and digital innovation like Project Orbis.
With its reputation for scientific excellence and a strong public health ethos, Europe has the potential to lead in pharmaceutical innovation. Implementing these reforms would not only accelerate access to medicines for European patients but also strengthen the EU’s position within global healthcare.
Meet the researchers
- Pedro Franco: Merck Serono Limited, UK
- Stefan Haefliger: House of Innovation, Stockholm School of Economics, Sweden; Bayes Business School, City St. George’s University of London, UK
