“We have no time to lose.”
Europe's Health Commissioner Olivér Várhelyi is in a hurry. In fact, he seems intent on finishing nearly every file on his desk within a few months.
By the end of 2025, Várhelyi aims to complete negotiations on the pharma package, deliver a proposal for a new Biotech Act, finish the Critical Medicines Act, amend the Medical Devices and In-vitro Diagnostics regulations, as well as update the Clinical Trials Regulation.
These targets are bundled within the EU Life Sciences Strategy, unveiled by Várhelyi and Research Commissioner Ekaterina Zaharieva in Brussels on Wednesday, and are aimed at boosting research and innovation in the bloc in areas such as biotech drugs and novel foods using fermentation, increasing clinical development and manufacturing of new medicines, and clawing back investment lost to the U.S. and China.
To Várhelyi, the need to make changes is urgent. Presenting the strategy to reporters, he spoke of the need to go “faster” and to “accelerate” the various files.
Medical devices is one sector Várhelyi says is in need of assistance. The European Commission began an evaluation last year of whether it needed to revise the rules on medical devices and in-vitro diagnostics, after regulations led to higher assessment costs, long certification delays, an unpredictable market and products being withdrawn. A “major overhaul” of this sector is needed and long overdue, he told reporters, and should come “this year.”
The strategy also calls for an assessment of the Clinical Trials Regulation with the “aim to make Europe more competitive for clinical trials and medical research investments.” But Várhelyi has already concluded the regulation needs to be revised — to make it "less complex," to allow more multi-country studies and to enable artificial intelligence to do "the chemical part," he told reporters.
He explained Europe was at the forefront of basic life science research and clinical trials 10 years ago but is now losing ground, "so we need to really change our mindset.”
How will clinical trials rules change? "I have a rough idea on what needs to be done, but it's something we still need to develop," he said.
Why the rush?
According to Várhelyi, the competitive quagmire facing the European life sciences industries — which he says are overburdened with confusing regulation — requires urgent intervention. New legislation, such as the Biotech Act, typically takes around two years to get through, Várhelyi said, warning: “We don’t have two years to waste.”
But while the Hungarian commissioner seems eager to prove he is no ditherer, some experts in the industry he is trying to save are wondering whether he should slow down.
Out of all the files slated for 2025, the timeline for the Biotech Act seems to have the most leeway. A schedule accompanying the Life Sciences Strategy says it will be ready in 2026 “at the latest.” But Várhelyi was happy to make his preference known: “If it is up to me, I still want to deliver this this year because, again, we have no time to lose.”
For industry lobby EuropaBio, 2026 is the sweet spot. Director General Claire Skentelbery said the priority should be delivering a “thoughtful” piece of legislation that will “stand the test of time.”
“The EU has one shot at getting the Biotech Act right and it will set the tone for investment into innovation for the next generation,” she said.
The pressure on Várhelyi to move quickly has always seemed to be self-imposed. Commission President Ursula von der Leyen’s mission letter stressed the importance of hitting “the ground running on day one.” But it said nothing, for example, about proposing a Critical Medicines Act within 100 days of Várhelyi taking the job. That deadline left no time for a standard impact assessment, alarming industry lobbyists and civil society experts alike, who feared the legislation was being rushed.
The frenetic pace of work the commissioner has set at the health directorate DG SANTE likely makes for a challenging few months ahead for its staff. It may well be the busiest office in all of Brussels this August, as the rest of the city empties out for the summer break.