The EU biotechnology and biomanufacturing sector is facing a number of challenges: research and transfer of technology to the market, regulatory complexity, access to finance, skills, value chain barriers, intellectual property rights, public acceptance and economic security, which has led the European Commission to propose a series of actions dedicated to benefiting from the biotechnology and biomanufacturing industry.
On March 28, the European Commission announced the proposal of a series of targeted actions to be taken to promote biotechnology and biomanufacturing in the EU. This Communication with Nature for a Common Future identifies challenges and barriers and is based on a communication on the long-term competitiveness of the EU.
Utilizing research and promoting innovation
To help identify the drivers and bottlenecks of innovation and technology adoption, the European Commission has launched a study to investigate the EU's position vis-à-vis other global leaders in the generation of emerging biotechnologies and their transfer to bio-manufacturing. In order to promote more efficient use of research infrastructure, the European Commission will explore ways to accelerate the development and use of the Industrial Biotechnology Innovation and Synthetic Biology Accelerator (EU IBISBA) as a trusted network of digital repositories and services in the field.
Stimulate market demand
In order to be successful in the marketplace, biobased products need to demonstrate that they have a lower environmental impact compared to petrochemical products. The European Commission will review the assessment of fossil and biobased products to ensure equal treatment and the inclusion of carbon storage methods in building materials. Accelerated substitution of fossil feedstocks.
Stimulating demand and market uptake of biologics, the Commission will conduct in-depth feasibility impact assessments, biobased content requirements for specific product categories and public procurement. In addition, the Commission will explore how biomanufactured non-food products can better present themselves through bioproduct labeling.
Streamlining regulatory pathways
The European Commission will assess how to further simplify EU legislation and its implementation in order to reduce any fragmentation, explore possibilities for simplification and reduce time to market. Biotechnology innovation: and regulatory barriers to an effective single market that arise at national or other governance levels. The study will lay the groundwork for a possible EU biotechnology bill. The Commission will also work towards the establishment of an EU Biotech Hub, an operational vehicle for biotech companies to navigate the regulatory framework and identify scale-up support by the end of 2024. The Commission will further promote the establishment of regulatory sandboxes, which allow new solutions to be tested in controlled environments for a limited period of time under the supervision of regulators, as a way to bring more solutions to market quickly.
Promoting public and private investment
The EU has a wide range of financing instruments to support biotechnology and biomanufacturing, such as Horizon Europe, including the Bio-based Circulation Europe Joint Undertaking (CBE JU) and the Innovative Health Initiative Joint Undertaking (IHI JU); the EU4Health Innovation Fund; and now the European Strategic Technology Platform (STEP). Developing and scaling up innovation: with the potential to create new markets, the European Commission will advocate for the inclusion of biotechnology and biomanufacturing-specific challenges in the European Innovation Council's (EIC) Accelerator 2025 work program. In line with the recent Eurogroup statement on the Capital Markets Union, the European Commission will launch a study by the end of 2024 to identify barriers and ways to support the consolidation of investment funds, stock exchanges and post-trading infrastructures in order to be able to develop the necessary scale, enhance the knowledge base, create deeper pools of liquidity and help to reduce the cost of financing for high-growth companies.
Enhancement of biotechnology-related skills
Large-scale and regional skills partnerships can play an important role in providing opportunities for skills upgrading and re-skilling in biotechnology and biomanufacturing. Specific large-scale partnerships in biotechnology and biomanufacturing could be explored, which could be co-funded through the Blueprint Alliance activities of the Erasmus+ program. The growing number of dynamic European university consortia and Erasmus+ partnerships, as well as innovation alliances, could also enhance the development of skills needed in the biotechnology sector.
Developing and updating standards
The European Commission will continue to encourage the development and updating of European biotechnology and biomanufacturing standards to facilitate market access and innovation.
Support for collaboration and synergies
The European Commission will encourage the deployment of technologies related to biotechnological processes and biomanufacturing in all regions of the EU through the relevant Regional Innovation Valleys.
Promoting participation and international cooperation
The European Commission will explore the possibility of establishing an international biotechnology and biomanufacturing partnership with key international partners, such as the United States, India, Japan and the Republic of Korea, in order to collaborate on research and technology transfer, as well as to explore the possibility of strategic cooperation on topics related to regulation and market access. Through the Global Gateway and in line with its global health strategy, ECLAC will build on existing partnerships with Africa, Latin America and the Caribbean in the manufacture of health products, with the aim of diversifying the global supply chain, overcoming shortages of key health products and reducing the global burden of disease.
Using Artificial Intelligence and Generative AI
The European Commission will support structured exchanges with stakeholders to accelerate the application of AI, in particular reproductive AI in biotechnology and biomanufacturing (in the context of GenAI4EU). The Commission will also raise awareness of the ease of access to the EuroHPC supercomputer for AI startups and the science and innovation community in 2024.
Review of the Bioeconomy Strategy
The European Commission will review the EU Bioeconomy Strategy by the end of 2025. The review will take into account current social, demographic and environmental challenges and strengthen the industrial dimension of the bioeconomy and its linkages with biotechnology and biomanufacturing for a stronger EU economy.
Advances in life sciences supported by digitization and artificial intelligence (AI) and the potential for biology-based solutions to solve societal problems make biotechnology and biomanufacturing one of the most important fields one of the most promising technological areas of this century. They can help the EU modernize its agriculture, forestry, energy, food and feed sectors and industries. In addition, these technologies can help build a more competitive and resilient EU, provide better health care for its citizens, and enable a successful green and digital transformation.
