Over the past decade Europe’s position in global clinical research steadily eroded. Europe’s share of global commercial1 clinical trials fell from 22% in 2013 to just 12% in 20232. Regulatory complexity and limited access to capital continue to push innovative companies elsewhere.
Against this backdrop, the Biotech Act matters—not because it promises a silver bullet, but because it signals what kind of investment environment Europe wants to offer. The Biotech Act presents the opportunity to reverse the decline by restoring confidence in Europe as a place to invest.
The Biotech Act is one of the few recent initiatives that genuinely signals a shift in how Europe approaches competitiveness. As the file now moves to the European Parliament, it offers MEPs a clear opportunity to strengthen an innovation ecosystem that has become increasingly fragile.
Recent EU policy developments in conjunction with the continued expansion of national level cost containment measures have collectively weakened confidence among innovators
This comes at an important moment. Recent EU policy developments3 in conjunction with the continued expansion of national level cost containment measures have collectively weakened confidence among innovators, rather than reinforced it.
First, the proposal to introduce a conditional extension of the supplementary protection certificate could be seen as a sign that intellectual property remains central to innovation‑driven growth in Europe. This is an improvement compared to what we saw during the EU Pharma Package. The bottom line is that without robust and attractive incentives, Europe will struggle to compete for high‑risk, long‑term investments.
Second, the proposal includes concrete measures to improve the EU’s clinical trials framework, notably by shortening and harmonising authorisation timelines for multinational trials. This is essential if Europe wants to regain attractiveness as a location for clinical research and benefit from its scientific and economic impact4.
Long‑term economic growth depends on continuous innovation—and innovation depends on credible incentives
For Pfizer, with over 130 EU‑approved clinical trials since the implementation of CTR5, and others under evaluation, regulatory predictability and speed shape future trial placement. While other regions still move faster, reducing fragmentation and unpredictability in the EU is essential to restoring Europe’s attractiveness for clinical research.
These choices are not abstract. Innovation does not happen by chance, nor does sustained economic growth. As recently recognised by the Nobel Prize in Economic Sciences, long‑term economic growth depends on continuous innovation6—and innovation depends on credible incentives. Weakening those incentives may reduce costs in the short term, but it risks deterring investment in ways that are far more costly to reverse.
The focus of the European Parliament should be to:
- Preserve and strengthen the Biotech Act’s core incentives,
- Safeguard meaningful regulatory streamlining, and
- Resist the temptation to offset ambition with short‑term political compromises.
Getting this right will not only shape the future of biotech in Europe; it will signal whether the EU’s competitiveness agenda is matched by legislative choices.
Sign up to The Parliament's weekly newsletter
Every Friday our editorial team goes behind the headlines to offer insight and analysis on the key stories driving the EU agenda. Subscribe for free here.