EU aims to enhance biotech sector with faster approvals and simplified regulations

Daniela Castillo Monagas

The European Commission plans to speed up biotechnology approvals and launch an EU Biotech Act in the next mandate, as announced by Executive Vice President Margrethe Vestager. This move aims to make Europe more attractive to businesses worldwide. To address key obstacles to European competitiveness, the Commission will review its Bioeconomy Strategy by the end of 2025, advocate for the inclusion of specific challenges on biotech and biomanufacturing in the European Innovation Council (EIC) accelerator work programme for 2025, and support the uptake of bio-manufactured products. Additionally, the EU is betting on the potential of artificial intelligence to help companies scale up their operations. The biotech industry has welcomed these announcements, but emphasizes the need for concrete actions such as funding, support for scaling-up production, and clear regulatory frameworks.

As Vestager presented the Commission’s biotechnology and biomanufacturing initiative on 20 March, she said, “Europe will not be attractive to businesses worldwide if permitting and other administrative procedures take much longer than in other parts of the world.” She also mentioned that the sector is set to benefit from streamlined permitting procedures under the Net-Zero industry Act, and that the Commission will conduct an impact assessment for bio-based requirements in public procurement.

Regarding the potential risks of biotechnology, Vestager acknowledged that biomanufacturing can be used to synthetically manufacture new molecules, which can have both civilian and military uses. She added that the Commission is working with member states to assess the risk of technology leakage.

The biotech industry’s positive response to these announcements includes calls for further action, such as a sustainable supply of biomass and more stimulating measures for market uptake. Rob Beekers, chair of the Bio-based Industries Consortium, stated, “The new EU Parliament and EU Commission should make the bioeconomy and bio-based industries a political priority. Implementing the actions proposed in this communication would be a good start.”

Claire Skentelbery, Director General of EuropaBio, said, “If you’ve got investors within the EU, they are going to push you to launch in the US first.” She added that more standardized guidance for manufacturing using industrial biotechnology and additional resources

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