Commission looks to AI to improve EU clinical trials

The European Commission has released plans intended to accelerate clinical trial approvals across the EU and cut costs by as much as 80–90% through the use of AI-enabled trials. The proposal is an attempt to catch up with EU competitors, where clinical trial approvals are faster. 

“If you look at [EU] average clinical trials, they take well over 100 days. In the UK, it’s roughly 60 days,” health Commissioner Olivér Várhelyi told Science|Business at a press conference in Strasbourg. “We are now looking at driving that down to 47–50 days on average.”

Another key objective, Várhelyi added, is to make Europe the first region to fully enable the use of artificial intelligence in clinical trials, cutting development timelines and reducing costs significantly, by around 80 to 90%. AI could also speed up patient selection, he said, alongside plans to streamline procedures for multi-country trials.

Várhelyi was in Strasbourg on November 16 to present the Commission’s health package to the final plenary session of the European Parliament. This included the first, health-focused part of the long-awaited EU Biotech Act. The second part, concentrating on industrial policy, is expected in the third quarter of 2026.

Europe excels in biotechnology, with leading institutions and research outputs, but continues to lag behind in translating innovation into market-ready products. As a result, European start-ups are often pushed abroad to scale up, creating jobs and value outside the EU and commercialising their products elsewhere.

This challenge comes at a time when recent US funding cuts have disrupted the global clinical trials landscape, while China’s share of trials continues to grow rapidly. Against this backdrop, the overarching goal of the proposed Biotech Act is to equip the EU’s biotech sector to compete globally.

Coordination and caution

From an industry perspective, however, faster approvals will depend not only on new rules, but on how they interact with the EU’s broader regulatory framework. Claire Skentelbery, director general of industry body EuropaBio, told Science|Business of the need for coherence and coordination across legislation, pointing to the interaction between the AI Act and related guidelines, the Clinical Trials Regulation and the Biotech Act. 

Skentelbery also highlighted the importance of effective central coordination at EU level, avoiding regulatory delays, and ensuring a “predictable and stable framework.”

The Biotech Act proposal follows a public consultation launched by the Commission in November to identify the most significant challenges and barriers facing the field. Two issues emerged as particularly pressing: time to market and access to risk-tolerant capital, given biotech’s high failure rates and long delays between development and commercialisation.

Renew group MEP Stine Bosse, who co-chairs a Parliamentary interest group on biotechnology and the life sciences, welcomed the Commission’s proposal, calling it “a very good starting point” in a tough global competition with the US and China. However, faster approvals must not come at the expense of patient safety or public trust. While she supports the Commission’s ambition to deploy AI more widely in clinical trials, she said safeguards and evidence would be critical. “We should not give up the level of safety for our citizens,” she told Science|Business.

The package

The proposal includes targeted support for high-impact projects that strengthen bio-manufacturing, fast-track the development of new therapies using AI and data, alongside measures to improve access to funding and help EU biotech companies grow and scale up. In particular, it outlines an EU health biotechnology investment pilot, to run in 2026 and 2027 in cooperation with the European Investment Bank, which would mobilise up to €10 billion in investment.

Another measure put forward under the Biotech Act is an extension of the supplementary protection certificate for biotech medicines by an additional year. This certificate is an intellectual property right that serves as an extension to a patent right.

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The proposal also includes initiatives to simplify and accelerate regulatory procedures, reducing costs for companies and shortening times to market through harmonised requirements and the use of regulatory sandboxes. In addition, it introduces measures to strengthen biosecurity safeguards and protect against the misuse of biotechnologies.

In food biotechnology, the Commission proposes enhancing the European Food Safety Authority’s capacity to provide scientific advice to companies and ensuring appropriate regulatory treatment of precision fermentation processes involving genetically modified microorganisms.

Brussels’ reaction

Associations such as EuropaBio, Eurordis and the Good Food Institute Europe, long critical of lengthy approval procedures and difficulties accessing finance, welcomed the strategy’s focus on simplification and investment de-risking. 

“Shortening authorisation timelines for multinational trials and removing additional procedural delays for advanced therapies can [. . .] help make Europe a more attractive place to develop innovative treatments,” said Virginie Hivert, acting chief executive officer of Eurordis.

However, some stakeholders see the EU Biotech Act as a missed opportunity for food innovation. The Commission proposal excludes novel foods from provisions to establish regulatory sandboxes, arguing that they may “trigger ethical or cultural concerns among various consumer segments regarding their acceptability.”

According to Seth Roberts, senior policy manager at alternative protein think-tank Good Food Institute Europe, expanding the regulatory guidance available to food innovators will help bring new products to market. 

“But the Commission’s decision to block novel foods from the sandbox rollout is a disappointing move that marks a missed opportunity to drive forward evidence-based regulation while providing a forum for open dialogue that can give consumers more confidence in new products,” he said in a statement.