The European Commission is pushing to boost biotechnology and biomanufacturing in the EU with a series of actions represented in a new Communication.
Biotechnology and biomanufacturing are one of the most promising technological areas of this century to advance life sciences and to help the modernisation of agriculture, forestry, energy, food and feed sectors and industry, contributing to competitiveness and to strategic autonomy. According to figures from 2021, the market was dominated by the US, contributing 60% of the global value, followed by the EU (12%) and China (11%).
In this context, biotechnology is among the technologies identified by the Commission Recommendation on critical technology areas for the EU’s economic security presented in October 2023. It is also one of the technology priorities in the proposal for the Strategic Technologies for Europe Platform (STEP) regulation. Moreover, the Communication on Advanced Materials for Leaderships highlights the need to substitute critical raw materials with alternative advanced materials, for which materials from biotechnology are included as one of the potential solutions.
Consequently, on 20 March 2024, the European Commission (EC) presented a Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU. It highlights current challenges and barriers for biotechnology and biomanufacturing, including the transfer to market of high-quality research results, the regulatory complexity, access to finance, skills, value chains obstacles, intellectual property, public acceptance, and economic security. In line with the EC Communication on the long-term competitiveness of the EU, it also proposes a series of actions to address these challenges, for example the review of the EU Bioeconomy Strategy by the end of 2025. Besides, it includes among other, the following actions:
First, it proposes to simplify regulatory frameworks and to improve access to the market. A study, that should be published by mid-2025, will assess how legislation for biotech and biomanufacturing can be further streamlined across EU policies to reduce fragmentation and to explore possible simplifications, including faster approval and market integration. This study could provide the foundations for a possible EU Biotech Act. Moreover, the EC aims to establish by the end of 2024 an EU Biotech Hub, an operational tool for biotech companies to navigate through the regulatory framework and identify support to scale up, and at the same time, it pushes further for the establishment of regulatory sandboxes to test novel solutions as a way of bringing more of them quickly to the market.
Second, the EC will support stakeholders’ exchanges to accelerate the uptake of AI, especially, generative AI, in biotech and biomanufacturing (in the context of GenAI4EU), including in 2024, raising awareness of the facilitated access to the EuroHPC supercomputers for AI startups and the science and innovation community.
Third, it encourages to foster public and private investments, via Horizon Europe [including the Circular Bio-based Europe Joint Undertaking (CBE JU), the Innovative Health Initiative Joint Undertaking (IHI JU)], EU4Health, the Innovation Fund, and STEP. Likewise, the Communication aims to develop and scale up innovations, for which the EC wants to include specific challenges on biotech and biomanufacturing in the European Innovation Council (EIC) Accelerator in its Work Programme 2025. The EC also plans to complete a study to identify barriers and ways to support the consolidation of investment funds, stock exchanges and post-trading infrastructure by mid-2025.
Fourth, the EC plans to develop methodologies to ensure a fair comparison between fossil-based and bio-based products in 2025, including the Product Environmental Footprint (PEF) to assess the environmental impact of products.
Fifth, international cooperation with partners, such as the US, India, Japan and, South Korea should be deepened to enhance research and technology transfer and explore possibilities for strategic cooperation on regulatory and market access-related topics. Besides, through the Global Gateway, and in line with the EU Global Health Strategy, the EC aims to enhance existing partnerships with Africa, Latin America and the Caribbean in terms of manufacturing health products to diversify global supply chains.
Sixth, the EC aims to commission a study to assess the EU’s position compared to other global leaders in emerging biotechnology generation transfer to the biomanufacturing industry, as well as to facilitate a more productive use of research infrastructures via the use of the Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU IBISBA).
Seventh, the EC plans to strengthen biotech-related skills, for example, via the Blueprint Alliances activity of the Erasmus+ programme, or the increasing number of European Universities alliances and relevant Erasmus+ partnerships.