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Europe’s Quest for Health Sovereignty: Building the Next Generation of Biotechnology

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      Editorial — Europe’s Quest for Health Sovereignty: Building the Next Generation of Biotechnology

      Europe is entering a decisive decade. Health has become far more than a public policy: it is now a strategic asset at the crossroads of competitiveness, industrial resilience, technological leadership and geopolitical security.

      The race for biotechnology is no longer simply a race for medical innovation. It is increasingly a race for industrial leadership, economic sovereignty and global influence. The countries that succeed in mastering biotechnology will not only shape the future of healthcare but also secure leadership in advanced manufacturing, artificial intelligence, data-driven medicine and the wider bioeconomy.

      As global competition accelerates, the United States and China are investing massively across the entire biotechnology value chain—from fundamental research and clinical development to industrial manufacturing and commercial deployment. Europe, meanwhile, continues to produce world-class science, yet too often fails to transform scientific excellence into industrial leadership. Bridging this gap has become one of the European Union’s defining economic and strategic challenges.

      This new reality is reshaping the European agenda.

      Across the European institutions, a broad consensus is emerging that biotechnology will become one of the key drivers of Europe’s future prosperity. It will not only determine the evolution of healthcare but will also strengthen Europe’s competitiveness across strategic sectors, reinforce supply-chain resilience and contribute to Europe’s long-term technological sovereignty.

      It is within this context that the forthcoming Biotech Act II takes on its full significance.

      More than another legislative initiative, it offers a unique opportunity to rethink Europe’s entire biotechnology ecosystem. Its ambition must go beyond supporting research and innovation. It must create the conditions for innovative companies to grow, manufacture, scale and remain in Europe. Too often, discoveries made in European laboratories generate investment, production and high-value jobs elsewhere. Reversing this trend will be essential if Europe is to compete successfully in the decades ahead.

      The contributions gathered in this special edition illustrate both the scale of this opportunity and the complexity of the challenge. They demonstrate that Europe already possesses exceptional scientific talent, leading universities, innovative companies and world-class healthcare systems. What remains fragmented are the connections between research, investment, regulation, manufacturing and market deployment.

      Building these bridges will require more than a single legislative proposal.

      Alongside the Critical Medicines Act, the Pharmaceutical Package and the European Life Sciences Strategy, the Biotech Act II should become one of the foundations of a genuine European biotechnology strategy—one capable of accelerating clinical research, mobilising investment, simplifying regulatory pathways, strengthening manufacturing capacity and enabling European companies to scale successfully within the Single Market.

      Competitiveness, however, cannot become an objective in itself. Europe’s strength has always been its ability to combine innovation with solidarity, scientific excellence with public trust, and industrial ambition with equitable access to healthcare. Strengthening Europe’s biotechnology sector must therefore go hand in hand with faster patient access to innovation, resilient supply chains and sustainable healthcare systems.

      The challenge facing Europe is therefore not whether it can innovate. It already does.

      The real question is whether Europe can become the world’s most attractive place to discover, develop, manufacture and deploy biotechnology—and whether it can transform its scientific leadership into lasting industrial leadership.

      The decisions taken during this legislative cycle may well determine Europe’s position in the global biotechnology landscape for decades to come. This is a window of opportunity that Europe cannot afford to miss.

      This special edition of The European Files brings together European Commissioners, Members of the European Parliament, ministers, researchers, healthcare professionals, industry leaders and innovators to contribute to this essential debate. Together, they explore how Europe can seize the momentum created by the Biotech Act II to strengthen not only its health sovereignty, but also its competitiveness, strategic autonomy and global leadership.

      Europe has the knowledge. Europe has the talent. Europe has the scientific excellence.

      The next biotechnology revolution will not wait for Europe. The challenge now is to create the conditions for biotechnology to flourish—and remain—in Europe.

      Editor-in-Chief 

      Laurent ULMANN

      TABLE OF CONTENTS
      • Building the future of health in Europe
        Olivér Várhelyi, European Commissioner for Health and Animal Welfare
      • Strengthening Health Innovation and Biotechnology in the EU
        Neophytos Charalambides, Minister of Health of Cyprus
      • Towards a Sovereign Health Union
        Frank Vandenbroucke, Deputy Prime Minister and Minister of Social Affairs and Public Health – Belgium
      • Regional biotech ecosystems as engines of Europe’s health sovereignty: from clusters to global competitiveness
        Montserrat Daban Marín, PhD, Strategy and Global Partnerships Director, Biocat, Past President of CEBR
      • The Biotech Act: A blueprint for a strong, resilient, and fair Health Union
        Vytenis Andriukaitis, MEP (S&D, Lithuania), Rapporteur in the SANT Committee on the European Biotech Act, member of the Committee on Public Health, and former European Commissioner for Health and Food Safety
      • Scaling Europe’s biotech industry: from research excellence to industrial leadership
        Wouter Beke, Member of the European Parliament (EPP/cd&v – Belgium) – ITRE Rapporteur on the European Biotech Act
      • Building a competitive and sustainable biotech ecosystem in Europe
        Claire Skentelbery, Director General, EuropaBio
      • The Biotech Act can help Europe compete again in life sciences but on its own cannot deliver the change that Europe urgently requires
        Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA)
      • From breakthrough to manufacturing: Europe’s biotech sector must build what it invents
        Jeannette Baljeu, Member of European Parliament for VVD, Renew Europe – Netherlands
      • Biotechnology, medical countermeasures and preparedness: DG HERA’s role in Europe’s health sovereignty
        Florika Fink-Hooijer, Director-General – DG HERA – Directorate-General for Health Emergency Preparedness and Response Authority, European Commission
      • Innovation and Access to Medicines in Europe’s Biotech Framework
        Nicolás González Casares, Member of the European Parliament (S&D -Spain), Member of the SANT and ITRE Committees
      • Securing Europe’s Health Sovereignty: From Innovation to Outcomes
        Stefan Woxström, SVP Europe and Canada at AstraZeneca
      • Europe’s Quest for Health Sovereignty
        Tilly Metz, Member of the European Parliament (Group of the Greens- Luxembourg), Vice-Chair – Committee Public Health
      • Europe’s Unused Power
        Isabelle Deschamps, Head of Public Affairs France, Sanofi
      • Scaling Cell Therapy in Europe: Why the Biotech Act Must Keep Pace with Innovation
        Lynelle Hoch, President, Cell Therapy Organization, Bristol Myers Squibb
      • Strengthening Europe’s pharmaceutical sovereignty
        Tomislav Sokol, Member of the European Parliament (EPP Group – Croatia), ENVI Committee
      • The role of vaccines innovation in Europe’s biotech strategy
        Sibilia Quilici, Executive Director Vaccines Europe
      • Rare diseases as a strategic driver of Europe’s biotech leadership
        Avril Daly, President, EURORDIS — Rare Diseases Europe
      • Clinical Trials at the Heart of EU’s Competitiveness: Delivering on the Promise of the EU Biotech Act
        Kimberly Bollache, Vice-President, International Regulatory Sciences, Pfizer
      • From Research Excellence to Industrial Scale-Up: enabling Europe’s biotech competitiveness – the Lovaltech experience
        Patrick Barillot, Ceo Lovaltech
      • Bridging the gap between advanced therapy development and patient access in Europe: regulatory, clinical and translational challenges
        Ana Hidalgo-Simon MD, PhD, Associate Professor LUMC and reNEW Consortium – Leiden University Medical Center
      • Europe’s preparedness will only be as strong as its vaccine and biotech base
        Juan Carlos Jaramillo, Chief Medical Officer of Valneva SE
      • EU pharmaceutical policy at a crossroads: A call to EU Institutions and Member States to concretely act now
        Dr Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
        Stefano Romanelli, Government Affairs Associate Director, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
      • How the Biotech Act should reinforce the public trust in Europe’s health systems
        Stine Bosse, Member of the European Parliament (Renew Europe – Denmark) – Vice-Chair SANT Committee