Future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness

The European Parliament adopted by 494 votes to 83, with 71 abstentions, a resolution on the future of the EU biotechnology and biomanufacturing sector: leveraging research, boosting innovation and enhancing competitiveness.

Conditions for a comprehensive EU biotech act

Parliament pointed to the growth potential of the European biotechnology and biomanufacturing sector and the need for the EU to remain world-leading in this field.

Members called on the Commission, if it proposes new EU-wide regulation in the form of an EU Biotech Act, to address concrete gaps and shortcomings in the current legislation and its implementation, and to propose legislation that can be revised, simplified, streamlined and repealed and that reduces administrative burdens, paying particular attention to the specificities of the industry and respecting relevant safety and security standards. The legislation should be accompanied by an impact and cost assessment, and take into account the impact on SMEs and start-ups.

Parliament called on the Commission to:

- ensure that any future legislative initiative has a sufficiently broad scope to capture the width of the biotechnology and biomanufacturing industry and its full range of applications;

- present a report on the application of current legislation in the field of biotechnology which lists possible regulatory obstacles and gaps hindering the growth of industries employing these technologies and manufacturing processes;

- streamline, simplify and shorten the time required for authorisation procedures, particularly approval time frames, for biotechnology materials and products throughout their manufacturing- and life-cycles, and to facilitate the market uptake of bio-based solutions;

- consider the possibility of a simplified approvals procedure for biotechnological products already approved by trusted regulatory bodies in like-minded countries applying standards equivalent to those of the Union;

- consider simplifying labelling practices, such as the use of QR codes, and to ensure fair market conditions between biotechnology products and other products, for example in marketing and advertising.

The resolution underlined the strategic importance for the Union of having a strong biotechnology ecosystem to support research and development, the production of innovative medicines and patient access to them.

Need to promote the advantages and specificities of the biotechnology and biomanufacturing industries

Parliament called on the Commission to present an updated bioeconomy strategy, encouraging the development and production of sustainable and innovative bio-based materials, products and solutions with high added value, in order to contribute to the competitiveness and strategic autonomy of the Union.

The resolution highlighted the importance of adopting an open approach to different biomass technologies based on sound analysis, as well as the need to take into account the specificities of biogenic carbon. It highlighted the benefits of bioproducts and bioprocesses and their contribution to the Union's CO2 emission reduction targets.

Members believe that, in order to accelerate the substitution of fossil-based feedstocks, market demand and uptake of sustainable bio-based products should be further encouraged within the EU. Bio-based raw materials, such as sustainable biomass, recycled waste and CO2 captured from biogenic sources, could be used as alternative raw materials to manufacture various products.

Highlighting the potential of biotechnological applications when considering applications of biotechnology to food and feed, Parliament called on the Commission to identify pathways to market for safe applications of biotechnology in food products. Biosafety risks, including bioethical concerns, must also be addressed alongside innovation in biotechnology, ensuring responsible access to and use of synthetic biology tools, genetic editing technologies and biological materials.

Horizontal issues

Parliament underlined the importance for supply chain security of ensuring a sufficient, stable and competitive supply of feedstock, raw materials and essential components, such as sustainable biomass and enzymes for biotechnology and biomanufacturing companies. In an increasingly tense geopolitical context, biotechnology and biomanufacturing should be fully leveraged to strengthen the EU’s strategic autonomy, enhance food security and reduce dependence on non-EU countries.

Members pointed to the need to (i) improve the transfer of knowledge and technology between academia and industry to ensure that EU-funded biotechnology research leads to commercial applications and industrial deployment; (ii) have a skilled and diverse European workforce in the biotechnology and biomanufacturing sector; and (iii) urgently complete the Capital Markets Union to attract institutional investors to the biotechnology industry.

Deploring the fact that European private investment in research, development and innovation lags behind that of other major economies, Parliament called for an EU-wide approach to coordinating public investment in research and development for biotechnology and biologics. The Commission is invited to integrate innovation in biotechnology and biomanufacturing innovation into the EU's digital and artificial intelligence strategies.