The European Commission plans to present the first biotech legislation by the end of 2025, with the intention of making the regulatory framework more favourable to innovation, accelerating clinical trial procedures and attracting researchers and investors. This is what European Commissioner for Health and Animal Welfare Olivér Várhelyi said on Wednesday 2 July when presenting the life sciences strategy (see EUROPE 13672/3).
“Biotechnology legislation was originally scheduled for 2026, but we clearly need to move faster, because the times we live in demand bolder and quicker action”, he said.
He did not wish to go into details of the project, which is still “under development”, but pointed out that the legislative act will have to be negotiated and adopted by the EU Council and the European Parliament, a process that generally takes two years. However, Mr Várhelyi warned: “We don’t have two years to lose”, calling on the co-legislators to speed up the procedures (see EUROPE 13640/28).
“Our aim is to facilitate innovation. When you have an innovative idea that connects several sectors, it should be possible to move forward much more quickly and create new products more easily in Europe”, explained the commissioner.
He cited clinical trials, believing that the EU is losing ground in the life sciences sector, where authorisation times are much longer than in competitors such as the United States or China.
“In some cases where we remain competitive, the gap is more than 200 days compared with China and the United States. We must act: it’s clear that we’re losing a large number of clinical trials conducted in Europe”, he insisted, pointing out that less than 20% of the world’s clinical trials are carried out in Europe.
According to Mr Várhelyi, there is a need to simplify procedures, for example by facilitating clinical trials conducted in several countries, and to take advantage of artificial intelligence (AI) for chemical modelling of trials, in order to save time.
“I hope to be able to present a major health package towards the end of the year”, he said. This package would include the biotech regulation and “should include a revision of the regulation on clinical trials”. It also provides for “a complete overhaul of the medical devices sector”. (Original version in French by Lionel Changeur)