Commission takes a two step approach to Biotech Act

When European Commission President Ursula von der Leyen unveiled her political guidelines for 2024–2029, she promised “new European legislation on biotechnology in 2025.” Some raised doubt at the ambitious timetable, given the continuing negotiations on the General Pharmaceutical Legislation and the launch of the Critical Medicines Act earlier in the year.

The Biotech Act seemed even more unlikely to be delivered on schedule when member states said its scope should be broadened beyond health to other sectors, such as agriculture, forestry, energy, food and feed sectors.

Nevertheless, Health Commissioner Olivér Várhelyi has always remained steadfast, boldly asserting that the Biotech Act would be published before the end of the year. His confidence now appears justified - at least in part.

The Biotech Act that von der Leyen envisaged in her mission letter to Várhelyi is still on track. It will focus on what she described as “a regulatory environment conducive to innovation in areas of health technology assessment, clinical trials and others.”

The Commission says it has acknowledged that different sectors within biotech need different approaches, which is why they are taking a two-staged approach.

Confusingly, the Commission Work Programme for 2026, published on Wednesday (22 October), simply referred to a Biotech Act in the third quarter of next year. The Commission has now clarified that this refers to a second strand that will address the wider biotech ecosystem "to create a consistent and forward-looking framework for building a competitive internal market for biotechnology".

Both Biotech Acts - or whatever they end up being called - will address the need for a predictable framework for the sector, the reduction of the regulatory burden, encourage investment, foster innovation, and have the aim of bringing solutions to patients and industry more quickly.

The Commission says that it has already widely engaged with health-related biotech stakeholders, and there is a clear need for urgent action in this area. Just today (23 October), Várhelyi met with the Life Sciences Manufacturers Association, to discuss the act.

The Biotech Act to be presented before the end of this year will include simplification elements linked to clinical trials and will be presented along with a targeted revision to streamline the rules and procedures for medical devices and in-vitro diagnostic medical devices.

The Biotech and Life Sciences Alliance welcomes the move: “The decision to split the Biotech Act signals the Commission's commitment to addressing both the health and industrial dimensions of biotech - a welcome recognition of the breadth of the biotech sector, which calls for a comprehensive regulatory framework.” However, they warn that rushing the process could undermine the potential of a “truly ambitious” and “integrated” Act.

“It is crucial that both parts act as a unified whole, coherent and aligned with each other.”