Brussels, 09 October 2023

EuropaBio, the leading voice for the biotechnology industry in Europe, has released its position on the proposed revision of the EU General Pharmaceutical Legislation (GPL), underlining the vital role of biotech in shaping the future of healthcare.
EuropaBio firmly believes that a supportive and forward-looking GPL is essential to unlock the full potential of healthcare biotech innovations. Such legislation should be designed to address health challenges, unmet medical needs, and position the EU as a global leader in research and cutting-edge biotechnology.

Dr Claire Skentelbery, Director-General of EuropaBio said: “Healthcare Biotech is critical to Europe’s strategic agenda and this legislation will enable innovation to flow from Europe for the coming decades. It needs to support a thriving industry, from SMEs upwards, with benefits for patients, economic development and autonomy. It is essential that the legislation improves patient access to medicines across the EU without undermining the EU’s attractiveness for life science investments.”

While EuropaBio shares the European Commission's objectives for revising the GPL, it raises concerns about the approach being taken. A blunt, one-size-fits-all approach may have unintended consequences, potentially hampering Europe's ability to develop and identify therapies independently, ultimately relegating it to a tertiary market for therapies developed elsewhere.

EuropaBio is committed to collaborating with policymakers and stakeholders to ensure that the revised Pharmaceutical Legislation fosters innovation, supports rare disease patients, streamlines regulatory processes, and improves access to medicines across Europe.

Key recommendations from EuropaBio's include:

1. Regaining Leadership in Biotech Innovation: EuropaBio advocates for creating an investment-friendly environment that promotes competitiveness and enables rapid patient access to innovative therapies.
2. Patient-Centric Approach: The organisation emphasises the importance of addressing unmet medical needs for all patients, especially those with rare diseases.
3. Supporting Rare Disease Patients: EuropaBio believes in maintaining and expanding incentives to support research and development for rare diseases.
4. Preserving Regulatory Framework: The statement underscores the need for a stable and predictable regulatory environment to support small and growing biotech companies in Europe.
5. Balancing Regulatory Changes: EuropaBio welcomes positive changes in the proposed revision, such as faster assessment timelines and digitalisation, while also emphasising the importance of maintaining harmonised standards.

EuropaBio calls for a careful and balanced approach to the revision of the EU Pharmaceutical Legislation, ensuring that it fosters innovation, protects patients, and maintains Europe's competitive edge in the global biotech landscape.

Read our full position below.