EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the development of the Single Market Strategy 2025. Biotechnologies play an essential and significant role in the delivery of EU goals for competitive, healthy, resilient and sustainable economies and societies. Applications are integrated throughout our industrial and social ecosystems, and it is a hallmark of success, demonstrating EU growth and benefit through innovation.

With a global biotech and biomanufacturing race underway, a truly integrated Single Market is key to secure European competitiveness, prosperity, resilience, and leadership. EuropaBio believes the Single Market Strategy 2025 must be translated into concrete actions, including an ambitious EU Biotech Act, that delivers on the needs of biotech innovators in the EU.

We highly welcome the Strategy’s aim to make the EU simpler and faster by reducing regulatory and administrative barriers, particularly for start-ups and SMEs, to accelerate time-to-market and economic growth. To address the needs of the biotech industries, EuropaBio recommends the following:

Simplify and harmonise regulatory frameworks across member states

Regulatory fragmentation across Member States hinders the development and deployment of biotech products across the EU. Today, biotech innovators have to navigate a complex and inconsistent framework between Member States which is slowing down or preventing products from reaching the European market. We urge the Commission and the Member States to simplify and harmonise regulatory requirements by accelerating product approval timelines and increasing support for innovators. There is also a need to boost the capacity of regulatory networks and accelerate the digital transition to streamline processes and reduce delays (see examples in the Annex).

Strengthen Intellectual Property (IP) Protections

Biotechnology innovation relies heavily on robust IP rights. IPR enable innovators to raise capital to support development and access to market. Even as European innovators face challenges with access to investments, ensuring the protection of biotech innovation in Europe and globally is essential. Ensuring strong and predictable IPR for biotech, including for proprietary data submitted to regulatory agencies and protection for certain products, as well as ensuring a level playing field on the global market are essential to a world-class biotech and life science ecosystem.

Tailored Support for Small and Mid-sized Companies

Within the ecosystem, smaller companies are the forefront of biotech discovery and innovation. Simplified access to funding, reduced bureaucratic burdens, fee reductions and targeted capacity-building initiatives will enable smaller biotech innovators to scale and innovate more effectively. While simplification measures will already bring significant benefits to smaller companies, tailored support should be explored to ensure those innovators can fully benefit from the Single Market, including by adopting sector-specific definitions of SMEs that reflect company maturation cycle within industries.

Building a Next Generation Ecosystem

The biotech ecosystem is highly productive with a labour productivity and job creation rates outperforming other industries such as the digital or financial sector.1 Building a next generation ecosystem with skilled and high-quality employment, globally resilient value chains, and integration and benefit within all Member States will require the full benefits of the Single Market.

Involve Stakeholders in Policymaking

The biotechnology sector welcomes deeper engagement in shaping policies that affect its operations. We urge the Commission to establish dedicated platforms for dialogue with biotech stakeholders, ensuring our insights inform future strategies and legislation.[1]

The downloadable PDF contains the Annex – Examples of Regulatory Burden on Biotech Innovators 

[1] Measuring the Economic Footprint of the Biotech Industry in Europe Data-Update 2021.pdf pp. 10 & 12.