As global competition for life science investment intensifies, the health package published today by the European Commission is a positive step toward making Europe a more attractive location for cutting-edge science, clinical research and biotech innovation. 

Fragmentation in the administration of clinical trials has presented a long-standing challenge for research-driven life sciences companies. The Biotech Act’s ambition to reduce clinical trial approval timelines to 75 days would make Europe considerably more attractive for innovative or time-critical trials. Considering Europe has seen its global share of clinical trials halved, over the last decade, leaving 60,000 Europeans without access to potentially life-saving trials, this is essential to improving EU’s competitiveness and reducing delays for patients.  

In addition, the coordinated assessment for combined studies and EMA support for competent authorities in the context of multi-country clinical studies, introduced by the targeted revision of the Medical Device Regulation and the In Vitro Diagnostic Regulation, are welcomed measures to enhance the consistency, efficiency, and predictability of clinical trial processes. This, together with new criteria for breakthrough and orphan devices, the creation of a dispute resolution mechanism, increased flexibility for in-house devices and an enhanced role of expert panels should make innovating in Europe easier. The revision however falls short of centralisation processes which should be the long-term goal.  

Strengthening IP protection, through a targeted extension of the SPC regime, will be an important lever to enhance Europe’s attractiveness for pharmaceutical R&D. At the same time, we note with concern that the proposed incentive would apply only to a limited subset of products. This approach risks unintentionally excluding major biotech-driven breakthroughs and could skew investment away from areas where innovation is most urgently needed. Similarly, establishing “manufactured in the EU” as a criterion for IP protection does not reflect how innovation happens. For Europe to take a leadership role in global innovation, it requires the adoption of non-discriminatory policies that attract and retain investment, and support innovation, without distinguishing between EU-manufactured and imported products.   

Finally, establishing an EU health biotechnology investment pilot with the European Investment Bank is a positive step to help retain and develop European SMEs, helping turn the region’s academic excellence into new treatments for patients and economic growth. 

Nathalie Moll, EFPIA Director General, said: 

 “The publication of the health package today is an important moment for Europe’s life sciences sector. Improving access to growth capital, reducing approval timelines and strengthening coordination across authorities to biotech innovation make Europe a more attractive location for research and development. Strengthening Europe’s IP provisions is particularly important, however its effectiveness may be limited by restricting it to an overly small subset of products or geographical conditions on manufacturing. The Biotech Act and revision of the MDR/IVDR represent positive signals that Europe has the ambition to be a location where breakthrough science is developed, tested, and scaled to the benefit of patients today and in the future.”