Introduction

The Communication¹ issued today by the European Commission (the “Commission”) focuses, as its name suggests, on two important areas: “biotechnology” and “biomanufacturing”.

“Biomanufacturing” is the manufacturing component of the biotechnology industry, understood as the use of biological mechanisms to synthesize products, act as tools or undertake processes. An example can be found in the forest sector, which can offer sustainably produced, renewable and recyclable raw materials that can be used for products such as batteries or healthcare applications (e.g., nanocellulose-based wound dressings).

According to the OECD, “biotechnology” is understood as the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services. Advanced biotechnologies are geared towards various application areas, the main ones being:

• Medical and pharmaceutical (referred to as “red biotechnology”) which can help to address challenges linked to, among others, ageing (such as disease prevention, personalised medicine, regenerative medicine and chronic illness) and antimicrobial resistance. Examples include mRNA therapeutics such as mRNA-based vaccines for COVID-19.
• Agri-food (referred to as “green biotechnology”) which can allow for feed and foodstuffs with improved environmental and health traits (e.g., with reduced saturated fats or allergens or with increased disease-fighting nutrients), reduce crop and food losses, and enable a more efficient use of natural resources and input materials such as, for example, chemical synthetic pesticides or mineral fertilisers.
• Industrial and environmental (referred to as “white biotechnology”) which can enable new processes that use less resources and energy, and produce less waste and polluting emissions, as well as provide effective solutions to depollute waste streams, reduce microplastic pollution and remediate contaminated soils. Innovative examples include microbiomes which can contribute to the fight against climate change by improving the detection and monitoring of chemical pollutants.
• Marine biotechnology (referred to as “blue biotechnology”) which is also gaining increased attention in several market segments, with the discovery of hundreds of new marine compounds every year. Examples include engineered marine algae or bio-hybrid artificial photosynthesis systems that provide alternative energy sources and innovative carbon-capture solutions.

Current challenges

Among the challenges currently faced by the EU biotechnology and biomanufacturing sectors, the Commission identifies the following:

• Lab-to-market technology transfer. There remain difficulties in transferring R&D results from academia and research centres to the market. Notwithstanding the EU research efforts and high-quality scientific publications, the U.S. and China continue to be more successful in converting many biotech innovations into products, technical solutions and treatments that reach the market.
• Regulatory obstacles. Developers of innovative biotechnologies are faced with difficulties in navigating a complex regulatory landscape at both EU and national levels which often fail to take into account the specific features of biotechnology solutions. For example, some biorefineries (converting biomass to energy and other beneficial by-products, such as chemicals) are faced with lengthy permitting and authorisation procedures before they can become operational.
• Sustainable feedstock. Companies struggle with sourcing enough sustainable feedstock and biomass to transition from fossil fuels to renewable raw materials on a large scale. In this area, the EU relies mostly on imports (e.g., oilseeds, pulp, textile fibres) and some potential domestic alternatives have not been fully explored (such as organic waste).
• Public awareness. The Commission also highlights the challenges in terms of public awareness of biotechnology and biomanufactured products and the need to assure the public about responsible use, safety and sustainability. For many consumers, societal and sustainability benefits are not necessarily apparent and perceived as justified for the typically higher prices of these products.

Some of the other spotted challenges relate to access to financing and an appropriately skilled workforce, intellectual property rights and economic security (in view of the potential risks of biotechnology misuse).

Proposed actions to be taken at the EU level

From the many proposed measures listed by the Commission in this Communication, we highlight the following:

• Regulatory simplification and faster access to the market

The Commission will launch a study aimed at assessing the current EU regulatory framework and related obstacles to developers, identifying possibilities for simplification and thereby allowing faster access of innovations to the market. The Commission expects this study to be finalised by mid-2025 and the results may lay the foundations for a potential “EU Biotech Act”.

Potential simplification measures could include the setting out of harmonized requirements for low-risk biotechnologies, simplification of approval processes for certain product categories, and mechanisms to support developers with borderline technologies when there is a lack of clarity about the applicable regulatory framework. This is a concern also felt in other adjacent areas such as the blood, tissues and cells legislation, with the new SoHO Regulation establishing a coordination board to provide opinions on the regulatory status of substances, products or activities.

In parallel, the Commission is also proposing to promote the establishment of so-called “regulatory sandboxes”, allowing the testing of novel biotechnology and biomanufacturing solutions in a time-limited and controlled environment, under the supervision of competent authorities (similar to what is provided as part of the EU pharma package for medicinal products).

The Commission will also promote the development and updating of relevant European standards. In its 2024 work programme for European standardisation, the Commission has already identified the development and/or update of standards on bio-materials, bio-based, and wood-derived products.

Lastly, the Communication provides that the Commission will work towards the establishment, by the end of 2024, of an “EU Biotech Hub”, an operational tool intended to support companies in navigating the regulatory landscape and identifying support for scale-up.

• Use of AI and generative AI

To stimulate the use of big data and AI by biotechnology and biomanufacturing companies, the Commission intends, among other measures, to support stakeholders’ exchanges to accelerate the uptake of AI (and in particular Generative AI) and raise awareness of facilitated access to the EuroHPC supercomputers for AI start-ups and the science and innovation community in the context of the GenAI4EU initiative.

• Stimulating market demand

Demonstration of sustainability and lower environmental impact, when compared, for instance, to petrochemical products, is key for the market success of bio-based products. For this purpose, the Commission announced that it will review the assessment of fossil-based and bio-based products to ensure equivalence of treatment in the next periodical revision of the Product Environmental Footprint (PEF) method (a methodology for assessing the environmental impacts of products recommended by the Commission).

The Commission will also examine the feasibility of introducing bio-based content requirements in specific product categories and in public procurement to accelerate the substitution of fossil feedstock and to stimulate the demand and adoption of bio-manufactured products. Other proposals include the adoption of a voluntary ‘bio-labelling’ solution to inform consumers and build their trust regarding the bio-based content and sustainability of bio-manufactured non-food products, as well as the development of sustainability criteria for bio-based feedstock beyond energy.

Next steps

Although the Commission’s Communication offers exciting prospects for developers, the proposed measures will need concrete and timely implementation to translate into tangible benefits for the industry. The results of the Commission’s study expected by mid-2025 will be instrumental in determining the future shape of the EU’s biotechnology and biomanufacturing sectors and help pave the way for a potential “EU Biotech Act”. We would advise interested stakeholders to keep a close eye on developments regarding this new initiative and to provide input, where possible, early on in the process.

Please get in touch with a member of our team should you wish to discuss how these proposed actions may affect your business activities in the EU.

Authored by Grégoire Paquet and Cláudia Mendes Pinto.

References

1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU, Brussels, 20 March 2024, COM(2024) 137 final, available here.