MEPs' blueprint to strengthen EU biotech and biomanufacturing sectors
Calls to streamline biotech initiatives for efficient scaling and commercialisation
Simpler authorisation processes for quicker market access while ensuring safety
For a unified IP framework and flexible regulatory sandboxes for innovation
Calls to address barriers to funding and enhance capital access for bio-based projects
MEPs advocate for streamlined regulations and increased investment to foster innovation and growth in EU biotech, and their contribution to Europe's competitiveness and sustainability.
The report adopted on Wesdnesday in the Industry, Research and Energy committee stresses the strategic importance of the biotechnology and biomanufacturing sectors for Europe's future competitiveness and sustainability. The text highlights the critical role these sectors play in driving innovation and economic growth, calling for a robust policy framework to foster commercialisation and attract investments.
MEPs underscore the need to streamline and harmonise existing and upcoming initiatives related to biotechnology and biomanufacturing to strengthen the industry. They urge the Commission, in the reflexion towards a future EU Biotech Act, to ensure coherence across all legislative measures affecting these sectors, facilitating efficient scale-up and commercialisation of research and development results.
Simplify authorisation procedures
MEPs urge the Commission to simplify authorisation procedures for biotechnology products, ensuring faster market access while maintaining a risk and science-based approach. They call for the consideration of a simplified procedure for products already approved by trusted regulatory bodies in like-minded countries.
The report highlights the importance of a harmonised, predictable, future-proof and competitive intellectual property framework to foster innovation and support the strategic autonomy of the EU.
Addressing biosecurity risks
MEPs stress that innovation in biotechnology must be matched by strong biosecurity safeguards. The report calls for responsible access to synthetic biology tools and genetic engineering technologies, and urges the EU to close existing biosecurity gaps through better risk monitoring, international cooperation, and strategic oversight. It proposes an EU-level approach to improve transparency and protect critical biotech infrastructure, while ensuring Europe’s resilience against emerging biological risks.
Calls for a flexible regulatory environment
The report recommends using regulatory sandboxes to assess the impact of emerging biotechnology applications, ensuring that new technologies can be trialled in a controlled yet flexible regulatory environment. The report also calls for an updated bioeconomy strategy that incentivises the development of sustainable, innovative bio-based materials and solutions to enhance EU competitiveness and strategic autonomy.
Financing start-ups and scale-ups
MEPs voice concern regarding the European Investment Bank's interpretation of sustainability criteria, which may limit funding access for bio-based projects. They call for a review of relevant definitions and the proposal of de-risking instruments to raise capital for biotechnology and biomanufacturing initiatives. They stress the contribution of bio-based products to the EU's CO2 reduction objectives, and call to incentivise market demand and uptake of sustainable bio-based products. They also call for coherent and adequate sustainability criteria for biomass, to accelerate the substitution of fossil-based feedstocks.
The report calls for the urgent completion of the capital markets union to attract institutional investors to the biotechnology and biomanufacturing industry. It highlights the need to reduce cross-border investment barriers to facilitate investment in scale-ups.
Quote
"With the adoption of this initiative report in the ITRE committee, we are setting the stage for a European growth strategy on biotechnology and biomanufacturing. We call for a broad and ambitious approach – with coherent, lean, and internationally compatible regulation, shorter authorisation procedures, and a strong commitment to innovation and competitiveness. Europe must not just follow in biotech – we must lead" said rapporteur Hildegard Bentele (EPP, Germany).
Next steps
The non-binding report was adopted with 53 votes to 11, with 6 abstentions. It will be put to a vote by the full House during the 7-10 July plenary session in Strasbourg.
Background
The EU biotechnology and biomanufacturing sector is recognised as one of ten strategic technology sectors crucial for Europe's competitiveness, economic security, and sustainability. It is characterised by high productivity, growth, and employment, delivering globally competitive solutions in healthcare, life sciences, industrial production, and sustainable biomanufacturing.
Biotechnology and biomanufacturing are helping to enhance the EU's strategic autonomy and resilience by reducing dependency on fossil-based inputs and other external dependencies. Despite its potential, the sector faces regulatory and financial obstacles and an incomplete internal market.
The Commission is expected to present several strategic initiatives, including an EU Biotech Act, an updated Bioeconomy Strategy, a Life Sciences Strategy, an Innovation Act, and a Circular Economy Act to address these challenges.
