EFPIA welcomes today’s focus on Europe’s biotech sector, given the importance of the sector to the region’s competitiveness, open strategic autonomy and overall health security.

The Communication published today can provide a much needed springboard for a more coherent vision on how to boost an industry which is a key driver of Europe’s health, economic growth and security, and which is critical in tackling Europe’s biggest health challenges, including an ageing population, increased chronic disease and the threat of antimicrobial resistance (AMR).

EFPIA agrees with the premise of the Communication, that a thriving EU biotech ecosystem is of strategic importance for the effectiveness of healthcare and resilience of health systems in times of strain such as public health emergencies’.

The Communication rightly references the importance of addressing the numerous challenges that face the health biotech sector; these include simplifying existing regulatory frameworks, developing a supportive investment landscape, improving the European intellectual property structure, and enhancing the translation of research and development (R&D) into treatments for EU patients.

EFPIA agrees that a renewed focus on the consolidation of European life science venture capital is vital if we are to retain and support innovative start-ups and SMEs in Europe – a market which is seen as challenging and uncompetitive.

Closing the gap in R&D and manufacturing investments between Europe and other parts of the world - in both biotech and the wider pharmaceuticals and life science sector – is a matter of urgency. Europe has already seen a 25% decline in its global share of R&D investment over the past two decades. Bold and broad policies are needed to ensure Europe’s regulatory system is fit for purpose and the region remains competitive to global companies for scientific R&D clinical trials and advanced manufacturing.

To meet these ambitions, EFPIA is today asking the European Commission to put a comprehensive health and life science strategy at the heart of its next mandate.

This should include coordinated and strategic governance to ensure policy coherence and to bridge existing silos between research, health, industry, and internal market policies. The aim should be to reclaim Europe’s position as the hub for health R&D and to put European patients to the front of the queue for innovative new treatments and technologies.

The strategy will need to address the full health R&D eco-system; from skills and excellence in basic research to the translational research gap, access to finance and a more favorable venture capital environment, clinical research environment, robust and enforceable IP frameworks. It should also ensure agile and future-proof regulation for new types of innovation and modern manufacturing, open trade and supply chains and a market access environment that rewards innovation that brings value to patients, health systems and societies.

Regular competitiveness checks on policy and legislation should be carried out to ensure that the cumulative impact of new proposals are fully understood.

EFPIA looks forward to further dialogue with policy makers and partners on a strategy that would deliver improved healthcare and economic benefit to all Europeans.

Notes to editors

The European Biotechnology and Biomanufacturing sector contributes EUR 35 Billion to the EU economy[1] with 224,600 direct jobs and EUR 48.8 Billion in exports,[2] and its healthcare application is deeply integrated with the pharmaceutical sector which brought over EUR 100 Billion and 859,607 jobs to the EU economy in 2021.[3]

[1] Including the UK

[2] WiFor/EuropaBio (2022), Economic Footprint of Biotechnology Industry, pp. 6-7 and 11. Available here.

[3] EFPIA (2023), The Pharmaceutical Industry in Figures, p. 3. Available here.