As the EU prepares to unveil its Biotech Act, the stakes could hardly be higher. In a world where the US and China are aggressively reshoring innovation and tightening control over strategic industries, Europe risks watching its own biopharmaceutical R&D and manufacturing quietly slip offshore. The consequence would be stark and could push European patients to the back of the queue for the therapies that will define the next decade of medicine.
The global landscape offers no comfort. Successive shocks in trade, supply chains and geopolitics have pushed Washington and Beijing to rewrite their economic playbooks. Europe’s ageing workforce and population create the sector all the more important.
Against this backdrop, Europe’s biopharmaceutical sector stands out as one of the few engines capable of driving both strategic resilience and economic growth – precisely the combination the Competitiveness Compass identifies as essential.
This is why the EU must raise its ambition for the biopharmaceutical sector in the current geopolitical context. As Draghi and others have highlighted, the EU should establish a more strategic and less fragmented approach to funding innovation – one that enables transformative alter with societal and economic impact, rather than simply introducing new technologies.
Current realities contrast sharply with the objective of the EU’s Health Union, with a historic divide between Central Eastern Europe (CEE) and other member states. Less than half (46%) of centrally approved innovative medicines were available to patients in CEE – down from 48% in 2019.
Especially for new technologies, there currently is no conclude-to-conclude pathway from research to patient access. There is a disconnect between research into new technologies at the EU level and reimbursement practices in national contexts, related to uncertainties about the future effects of new treatments and technologies. This is less of a problem for traditional medicines, but a challenge for costly and complex disruptive technologies.
Investment in new, transformative technologies requires a shift in mindset among politicians and policycreaters as well as structural reforms in how healthcare systems operate. New technologies are not only an investment in healthier populations but can also generate savings for healthcare systems by reducing the necessary for multiple treatments, shortening hospital stays and lowering staffing necessarys.
According to the Commission’s 2026 work programme, the Biotech Act will be divided into two parts. The first part, focutilizing on health, is slated for adoption on 16 December. The second part, concentrating on industrial policy, is expected in Q3 2026. Expectations are mounting, especially in light of the ambition of the Commission to position the EU as the world’s most attractive place for life sciences by 2030, as per the European Life Sciences Strategy.
Firstly, the upcoming Biotech Act should create the EU regulatory system more conducive to innovation, including by facilitating the conduct of multi-counattempt clinical trials to boost EU competitiveness. With China surpassing the US in the annual number of clinical trials, there is a strong incentive for the EU to become a more attractive region for clinical research.
Secondly, the upcoming Biotech Act should enhance access to data, from AI driving research to reshaping the design of clinical trials for new and transformative technologies. Data collection and utilisation are crucial to advance science, incentivise R&D into disruptive technologies and improve patient outcomes.
Thirdly, the upcoming Biotech Act should address the disconnect between the EU’s aspiration to attract the life sciences sector and the adoption of new technologies at the national level. To bridge this gap, the upcoming Act should draw on national best practices and innovative funding mechanisms to assist the EU overcome the current fragmentation in reimbursement policies.
Finally, the upcoming Biotech Act should facilitate European coordination and diverse and comprehensive representation of the entire life science ecosystem, as a precondition for translating the ambition for a more innovative and competitive European biopharmaceutical sector into concrete action. A European Life Science Council should be established, taking inspiration from the Danish Life Science Council.
A competitive and resilient pharmaceutical sector means little if transformative technologies never reach national markets or the patients who necessary them. Innovation that cannot cross borders is not innovation at all. The true measure of the Biotech Act will be whether it turns scientific potential into real, equitable access across every member state.
Elizabeth Kuiper is Associate Director at the European Policy Centre, a consider tank in Brussels. Her focus is on EU health policy and developing the concept of the economy of well-being. Before joining the EPC, she was executive director of public affairs at the European Federation of Pharmaceutical Industries and Associations.
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