EU health chief faces pushback over fast-tracked Biotech proposal
A decision could be taken “within one to two weeks,” two sources close to the file told Euractiv
The long-awaited EU Biotech Act proposal, aimed at boosting Europe’s innovation capacity, will be submitted by the end of the year, EU Health Commissioner Olivér Várhelyi said on Thursday.
“I will propose this year a Biotech Act that will simplify clinical trials, speed up authorisation procedures for various health applications, and enable European industries to innovate and scale their activities up in Europe,” Várhelyi said at the European Health Forum Gastein.
However, Euractiv learned earlier this week that the proposal may not be ready by year-end as initially planned, due to extended internal consultations within the European Commission.
According to a well-informed source, the initial draft prepared by Várhelyi required adjustments. Commission President Ursula von der Leyen’s team has since stepped in to provide guidance, while Executive Vice-President Stéphane Séjourné is expected to play a more prominent role.
Séjourné, who oversees the internal market, industry and small and medium-sized enterprises, is seen as pivotal given the Biotech Act’s expected industrial dimension.
After several delays, the initiative had most recently been scheduled for the end of 2026, as the official EU consultation page suggests. However, in a surprise move in June, Várhelyi announced that the text would instead be presented before the end of the year.
A Commission spokesperson confirmed that Várhelyi and DG SANTE are leading the preparations for the upcoming Biotech Act but did not provide a date for publication.
“This involves input from other Commissioners and their services, and the Biotech Act will, of course, be a Commission proposal,” the spokesperson said, adding that a precise timeline will be communicated “in due course.”
Meanwhile, fears are mounting in the biotech industry and among some MEPs that the text could be rushed.
“If the text comes out before the end of the year, we fear it will be the same as with the CMA – an unfinished text,” a socialist parliamentary source told Euractiv.
Few details have emerged so far about the contents of the forthcoming Biotech Act. The legislation is expected to support the EU’s ambition to become a global biotech leader by improving access to funding and fostering innovation across member states.
(vic, bms, aw)
