EU Commissioner Várhelyi revives Biotech Act for 2025

In a panel discussion at Medicines for Europe Annual Conference, EU Health Commissioner Olivér Várhelyi made a surprise announcement that the Commission will adopt the EU Biotech Act by the end of this year, citing growing “global challenges”. According to the EU Commission’s work programme, the legislation was initially scheduled for adoption in Q3 2025, together with the EU Bioeconomy Act. However, insiders report that internal issues pushed the timeline back to Q3 2026. The EU Bioeconomy Act is now set to be presented at a major EU conference in Copenhagen in late November.

The first von der Leyen Commission, which placed the Green Deal at the centre of its agenda, had already identified biotechnology as a key technology. The previous Parliament adopted a corresponding work programme. However, in its second term, the now pro-competitiveness Commission has largely deprioritised biotechnology – at least in its public statements – in favour of industrial competitiveness.

Now, however, Brussels appears to have realised that biotech powerhouses like the United States and China are investing additional billions to expand their leadership in this strategically vital sector. China’s President Xi Jinping has publicly stated the goal of overtaking the US in both medical and industrial biotechnology by 2035. In cancer research, China had already surpassed the US in 2023 in terms of deal volumes and the number of clinical trials.

In addition to the EU Biotech Act, Várhelyi also highlighted the EU Pharma package and the Critical Medicines Act. “The security of medicines has never been as critical as it is today. Without security of supply, there is no guarantee that our citizens will have access to the essential medicines,” he said. “We need to help our industry to remain and prosper in Europe, so that we have a robust European manufacturing base. With the Critical Medicines Act, we aim to bring manufacturing closer to home, through strategic projects, procurement and international partnerships.” Around 42% of all antibiotics are currently manufactured in China. By bringing the Biotech Act forward, the Commissioner said, the EU aims to “send a clear signal to everyone who wants to invest and manufacture in Europe,” according to an exclusive report by Euractiv.com.

While Várhelyi did not provide a specific date, a timeline has already been set for the EU Bioeconomy Act, which also is part of the EU’s broader Life Sciences Strategy.

According to Euractiv.com, the Brussels-based biotech industry federation EuropaBio had called on the Commission to introduce an accelerated “Biotech Omnibus” package to prevent the EU from falling further behind global competitors like China and the US. EuropaBio Director Claire Skentelbery told European Biotechnology: “We need to work very hard to get the Biotech Act right. It must be a thoughtful and impactful piece of legislation which serves Europe well for this technology recognised as a critical part of our security and resilience.” She did not disclose further details about the proposed omnibus package – but by now, a full package may no longer be necessary. What is needed, is a regulatory framework that makes EU investments more attractive, includes public funding for strategically critical areas like engineering biology, scaling infrastructures (see Biopilots4U) and enables clear, fast and unbureaucratic market access for new developments.

Under its current five-year plan, valid through the end of next year, China is investing a total of US$1.5tn into six future-defining strategic sectors. The US administration, meanwhile, has not only launched a US$500bn technology package, but also received a recommendation from the National Security Commission on Emerging Biotechnology in April to invest at least US$15bn in biotechnology by 2031 – with a strong push to begin within the next three years, in order to avoid irreversible long-term global leadership to China.

Already today, US biotech companies are heavily dependent on Chinese biotech service providers and drug developers. According to a prominent industry insider, over 70% of US biotech firms rely on supply chains, innovations or services from China. There are also growing concerns that investors for advanced cancer therapies – such as ADCs and bispecific antibodies – could increasingly turn their heads to China instead the US.

In the field of industrial biotechnology – expected firstly to play a vital role in future food production due to rising climate- and pandemic-related crop failures – China is also expanding its investment dramatically. In contrast, additional EU funds from the Multiannual Financial Framework (MFF) will not become available before 2028. The Important Projects of Common European Interest (IPCEI) on Biotechnology, led by Germany, Estonia and Finland, which is intended to channel billions from EU member states into areas such as raw material recovery, resilient chemical production, energy and transport, is also unlikely to be operational before 2028.

So far, the German government – the largest net contributor to the EU budget – has held back from biotech investment. Chancellor Firedrich Merz has so far refused to increase the MFF (which would underpin financing for the Clean Industrial Deal) and has also shown no national initiative to support biotechnology. Instead of investing in future technologies, his government has so far focused primarily on shoring up Germany’s traditional export sectors.

According to Euractiv.com, an European Biotech Alliance is now taking shape under the leadership of Danish MEP Stine Bosse (Renew). After the summer break, biotech professionals and Members of the European Parliament are expected to begin closer engagement through meetings and consultations.