EU Launches Consultation on Biotech Law to Boost Innovation and Competitiveness

The European Commission has launched the call for data for an impact assessment, which in Spanish practice is called the prior public consultation period of the Biotechnology Law for the European Union.

This is one of the pillars on which the European Executive wants to build the new research and competitiveness environment of the biosanitary sector and which is part of the Political Guidelines of the European Commission for 2024-2029, announced at the beginning of the new period by the President of the EC, Ursula von Der Leyen.

Public input sought on regulation, financing, AI, and talent to shape EU biotech strategy for 2024–2029

The consultation period will remain open until June 11th. This assessment will be incorporated into the Commission’s proposal for a biotech law expected to be published in the third quarter of 2026.

The overall objective of the initiative is to improve the size and competitiveness of the EU biotech sector while maintaining high levels of safety. With the impact assessment just launched, the Commission hopes to obtain feedback from the biotech sector on five pillars.

First, the EC is expected to make contributions regarding the speed and access to innovation, as well as procedures for simplifying the regulatory framework, including risk assessment procedures.

On this issue, Europe aims to address a demand from the sector to accelerate the development and approval of biotech products and their commercialization. In this regard, Europe notes that “several activities have been initiated to address this objective through proposals already adopted by the Commission, such as the reform of pharmaceutical legislation (e.g., proportionate risk assessment and reduced timeframes for market access, testing environment) and the proposed legislation on plants obtained through certain new genomic techniques.”

On the other hand, the consultation seeks proposals regarding financing. In this area, it emphasizes that risk-tolerant capital “is essential for the development of the biotechnology industry,” although it also opens the door to “improving existing public activities, incentives, and financing schemes offered within the framework of Commission programs.”

Likewise, a call is made for ideas regarding anything that can help “businesses, particularly spin-offs, start-ups, and other SMEs, thrive in Europe.”

In addition, the initiative addresses training and talent attraction and finally calls for proposals related to the use of data and AI in the biotechnology sector.

The European Parliament calls for ambition

The consultation period launched by the Commission practically coincides with the debate already underway in the European Parliament’s Public Health Committee, which has already submitted its first report, whose rapporteur is MEP Margarita de la Pisa Carrión (Vox).

This report presents the Commission with “an ambitious roadmap ,” while warning of the ethical and security risks associated with new technologies and calling for robust oversight to prevent genetic discrimination and guarantee human dignity.

It also advocates for simplifying the regulatory framework, accelerating innovation, and ensuring the ethical development of health technologies.

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(Featured image by Alexandre Lallemand via Unsplash)

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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