Today’s announcement of a Life Science Strategy from the European Commission, includes action to address long-standing issues that have been hampering the region’s competitiveness and preventing European patients from accessing the latest advances in treatment. The Strategy represents a very welcome step forward for life science companies operating in Europe. 

The focus on making it easier to conduct clinical trials across Europe is pivotal to increasing the number of trial places available to European citizens. Plans to bring forward and publish a Biotech Act in 2025, as well as better support for SMEs and improvements to the regulatory framework are all positive signals. The creation of the Life Sciences Coordination Board is particularly welcome and we hope can be instrumental in translating the strategy into rapid, tangible action.  

If combined with increased investment in innovative medicines and a globally competitive intellectual property framework, the strategy can help restore Europe to its place as a world leader in life sciences. 

Nathalie Moll, Director General EFPIA, said: “That EU policy makers recognise the need to reverse declining trends and actively seek new investments is extremely encouraging. The sector in Europe has been on the ropes for two decades and the Strategy delivers some good news at a time when it is most needed. For Europe to truly lead it needs to invest in medicines, attract investment, accelerate turning that investment into new treatments and economic growth as well as ensuring that patients across the EU get access to them at the same pace as other regions.” 

EFPIA view on key areas:  

Clinical trials and research 

Acting as a unified region, creating a functioning single market for clinical trials and developing a strategy for multi-country trials are vital. This work should start immediately, and we look forward to seeing the timelines and how the necessary funding will be mobilised.  

We believe the ambition shown today on clinical trials is an immensely positive step for European patients and the life science community. 

The Commission’s plans to create a network of European Centres of Excellence in advanced therapy medicinal products (ATMPs) to coordinate their further development together with Member States is another move in the right direction.  

EFPIA also supports the proposed pilot which will bring phased funding of collaborative research, leveraging results from past EU projects to secure the faster development of promising health technologies. 

Biotech Act and supporting SMEs 

EFPIA also welcomes the desire to speed up the Biotech Act. While the industry continues to seek improvements in the revision of the Pharmaceutical Legislation, eyes are now turning to the Biotech Act as the next opportunity to strengthen European competitiveness and reinforce internationally competitive Intellectual Property (IP) protection rules.   

We must unlock public and private investment to catch up with other regions of the world, as this is crucial for growing and scaling up European life science start-ups and to ensure that their innovation stays in Europe. Recognising that increasing the participation of institutional investors and pension funds is crucial, as Europe needs this substantial additional capital to attract and support innovation. Therefore, we are pleased to see the reference to the recently published European Startup and Scaleup Strategy and would welcome further dialogue on how to improve the mechanisms supporting European biotechs and SMEs.  

Regulatory  

We welcome the references to the COMBINE programme which is doing great work in improving the interface between the regulatory frameworks for clinical trials of medicines and for medical devices when these are studied in combination, as this is crucial to improve the environment for clinical trials in Europe for precision medicine.  We look forward to the proposed legislative intervention from the Commission based on their current assessment of the medical devices and IVD regulations to streamline the regulatory framework and improve Europe's competitiveness. 

We also support the European Commission’s proposals to simplify EU regulations related to medical devices to speed up access for patients, recognising the need to strike a balance between faster access and patient safety. 

Procurement  

Finally, the proposed funding of EUR 300 million via Horizon Europe and EU4Health, to stimulate the procurement of life science innovation through dedicated calls in areas such as climate change, next-generation vaccines and oncology treatments is also a welcome development.