Europe’s share of global clinical trials has declined sharply in recent years, despite the growth of the global market. In its proposal, the Commission points to the need for a more predictable, efficient and innovation-friendly framework to reverse this trend, it states.

“It is positive that the Commission clearly puts competitiveness and innovation at the center. Europe remains strong in life science, but we have long lost ground in clinical trials and investments. The Biotechnology Act is an important step in strengthening Europe’s attractiveness in an increasingly tough global competition,” says Sara Lowemark, international director at Lif – the research-based pharmaceutical companies.

Key elements of the Biotech Act

  • Increased access to capital for biotech companies, including through a new European Health Biotech Pilot Project together with the European Investment Bank.
  • Strengthened industrial capacity and biomanufacturing, with targeted support for production within the EU.
  • Simplified and faster regulatory processes, including harmonised requirements, regulatory sandboxes and common authorisation processes for complex products.
  • Measures to strengthen clinical trials in Europe, including shorter deadlines for multinational studies and reduced administrative burden.
  • Incentives for innovation, where certain biotech therapies may receive an extra year of market exclusivity, provided that production takes place wholly or partly in the EU.
  • Increased use of data, AI and digital solutions, linked to the European Health Data Protection Regulation (EHDS).

“Particularly important is the ambition to strengthen Europe’s role as a location for clinical trials. If new treatments are not developed, tested and actually used here, Europe also risks losing investments, production and, in the long run, patient benefit,” says Lowemark.

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The EU’s new pharmaceutical legislation has been presented

There are welcome improvements but in the major issues around data protection and market exclusivity, the basic conditions for investments in new medicines, the new legislation will unfortunately not strengthen the EU’s competitiveness, states SwedenBIO.


The outcome now depends on how the bill is formulated in the continuing legislative process

Lif welcomes the Commission’s taking a holistic approach to Europe’s biotechnology competitiveness, but emphasizes that the outcome now depends on how the bill is formulated in the continuing legislative process.

“For the Biotech Act to truly make a difference, a stable and predictable framework is needed that strengthens investment, intellectual property rights and clinical research in Europe. This is an opportunity to reverse a long-standing negative trend – but the focus must be on strengthening Europe’s competitiveness and making the EU the obvious place for the next generation of medicines and biotech innovations,” says Lowemark.

The bill will now be considered by the European Parliament and the Council of Ministers.

Source: Lif