EU Biotech and Biomanufacturing Initiative

EU Biotech and Biomanufacturing Initiative 

Eight actions to unleash the full potential of biotech in the EU 

The EU Biotech and Biomanufacturing Initiative is a non-legislative proposal falling under the “an economy that works for people” workstream of the European Commission. This initiative aims to unleash the full potential of biotech and biomanufacturing in the EU, recognizing their pivotal role in bolstering EU competitiveness and fostering industrial modernization.

According to the communication, the EU accounted for 12% of the global value share of the biotech sector in 2021. Additionally, the healthcare biotech industry contributed 29% of the overall GDP of the EU in 2018 (EUR 31 billion). By tapping into the significant growth prospects and labor productivity these sectors offer, the initiative seeks to tackle issues such as regulatory fragmentation and differing interpretations of biotechnologies among EU Member States. The communication was published on March 20.

The EU Biotech Initiative proposes eight actions:

1. Launching a study to analyze biotech legislation for a simplified regulatory framework and faster market access, aiming to finalize by mid-2025 and potentially laying the groundwork for an EU Biotech Act.
2. Establishing an EU Biotech Hub, an operational tool for biotech companies to navigate the regulatory framework and identify scale-up support, by the end of 2024. This will be possible with the help of existing structures such as the European Enterprise Network.
3. Supporting structured exchanges with stakeholders to accelerate the adoption of AI, particularly generative AI in biotech, while promoting facilitated access to EuroHPC supercomputers for AI startups and the science community throughout 2024. 
4. Conducting a study to identify barriers to investment and propose measures to support investment funding consolidation (including venture capital, stock exchanges, and post-trading infrastructure), creating deeper pools of liquidity, and helping lower the cost of financing for companies. This should be completed by mid-2025.
5. Proposing the inclusion of biotech and biomanufacturing in the European Innovation Council Accelerator Work Programme 2025 to foster innovation development and scalability, thereby using public investments to encourage private investments in the biotech sector.
6. Developing methodologies to ensure fair comparison between fossil-based and bio-based products by 2025, including reviewing the Product Environmental Footprint (PEF). 
7. Enhancing cooperation with international partners, such as the US, under Science and Technology Agreements to expand the market for biotech and biomanufacturing, by the end of 2024.
8. Reviewing the EU Bioeconomy Strategy by the end of 2025 to ensure alignment with evolving needs and priorities. As the strategy was last updated in 2018, there is a need to ensure that EU policy on bioeconomy takes into account the current societal and environmental challenges, reinforcing its industrial dimension and its links to biotechnology and biomanufacturing. 

What is the EU Bioeconomy Strategy?

The strategy aims to accelerate the deployment of a sustainable European bioeconomy, including ensuring food and nutrition security, managing natural resources sustainably, reducing dependence on non-renewable, unsustainable resources, limiting and adapting to climate change, and strengthening European competitiveness and job creation—this strategy contributes to the European Green Deal. In January 2018, a review of the strategy refocused the actions to better support the 2030 Sustainable Development Goals (SDGs), Paris Agreement climate objectives, and new EU policy priorities.

What could this mean for the EU life sciences ecosystem? 

The initiative goes beyond healthcare biotech alone, but given the significance of the EU healthcare biotech market and the proposed actions of this initiative, there are major policy implications for the sector. It signifies a proactive stance by the European Commission to harmonize regulations and foster an environment conducive to innovation and investment in the healthcare biotech sector. This is intended to lead to streamlined processes for market entry, facilitating growth opportunities for companies operating within, or intending to enter, the healthcare biotech market.

A broad range of stakeholders within the EU life sciences ecosystem stand to benefit from these proposals, including (in no particular order):

• academic spin-offs, start-ups, small and medium enterprises (SMEs), and larger biotech and pharmaceutical enterprises
• private investors, venture capitalists, and public investors
• academia and higher education institutions, supportive manufacturing and distribution industries, as well as supply- and value-chain partners
• patients, consumers, and healthcare professionals
• regulators, HTA bodies, and payers, among others.

This initiative could be viewed as the Commission’s response to “rebalance” the recent Pharma Package proposals—led by the Commission’s Directorate-General for Health and Food Safety (DG SANTE)—which are heavily polarised in terms of “access versus innovation.” (Read EGA’s analysis on the EU’s Pharma Package proposals here). In contrast, this Biotech Initiative—led by the Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW)—is focused on competitiveness, innovation, investment, resilience, and industrial and strategic autonomy in Europe. It is situated within the broader global context of ensuring the EU remains an attractive region for investment in innovative biotech and biomanufacturing.

While the actions included within this initiative could lead to an improved and supportive system, a number of important questions will need to be addressed. For instance, there appears to be a degree of overlap with some elements of the current EU General Pharmaceutical Legislation (and ongoing proposals of the EU Pharma Package), the Clinical Trials Regulation, and the Regulation of Substances of Human Origin (SoHO). It remains to be seen how much of these would be complemented, consolidated, or replaced by a potential future EU Biotech Act. In relation to the fifth action of the initiative—using public investments to encourage private investments in the biotech sector—some have raised concerns that Europeans “pay twice for their medications”—where products have been developed and launched by the private sector with the partial support of public funding in early-stage R&D. 

What’s the bigger picture?

Globally, there’s a growing recognition of the importance of biotech and biomanufacturing in addressing societal, environmental, and economic challenges. Trends indicate a shift towards bio-based solutions, driven by concerns over climate change, resource scarcity, and health issues. Countries are investing in biotech research, innovation, and infrastructure to capitalize on these trends and gain a competitive edge in the global market. This is especially relevant in a context in which, as the Communication highlights: “Worldwide growth in health biotech R&D (which concentrates most of the investments in biotech) since 2021 can largely be attributed to the entry and activity of US firms.” That is to say, not EU-based firms.

At the same time, uptake and societal acceptance of biotechnology will be as important in establishing this competitive advantage. Latest research from the 2024 Edelman Trust Barometer paints a picture of a world in which citizens’ trust in technological advancements, including healthcare biotech such as gene-based medicines, is strongly linked to how these technologies are managed. When there is confidence that regulation is effective, there is a significant increase in how willing people are to embrace such innovations. This further emphasizes the importance of this initiative, and particularly one of its key objectives: ensuring a comprehensive but simplified regulatory framework for biotech.

Overall, the launch of this initiative holds direct relevance for the EU life sciences ecosystem and beyond. It provides an opportunity to engage with EU institutions and relevant stakeholders at a critical juncture in the EU’s political calendar—in close proximity to elections and institutional changeover—in order to secure the EU as a hub for biotech and biomanufacturing innovation in an increasingly competitive global landscape. 

Edelman and its boutique government affairs and business advisory firm, Edelman Global Advisory, help clients navigate the complex policy environment and develop integrated policy-communications strategies designed to maximize business results in the short and longer term.

Materials presented by EGA Brussels. For more information, please contact Jamie Wilkinson, Managing Director, Health: Jamie.Wilkinson@EdelmanEGA.com