Biotechnology: boosting innovation to improve public health

Position Europe as the leading destination for investment in biotechnology R&D, manufacturing and clinical trials

Increase public and private investment in biotechnology

Ensure policy coherence of new EU Biotech Act with existing and ongoing legislation

Public Health Committee MEPs adopted their contribution to the upcoming EU Biotech Act, calling on the EU to streamline the potential of biotechnology and life sciences in healthcare.

MEPs want the EU Biotech Act to review, simplify, and optimise the regulatory framework of biotechnology in healthcare to foster innovation, including off-patent-led developments, while maintaining high standards of safety, quality, efficacy, and ethical compliance, as well as public health and environmental protection. They underline that the new act must ensure policy coherence by aligning with the ongoing revision of the pharmaceutical legislation and the proposed Critical Medicines Act and ensuring consistent implementation of other relevant legislation.

The text insists on the need to create a harmonised, streamlined, and science-based clinical trials framework to increase efficiency, transparency, and cross-border collaboration. Clinical approval processes should be simplified and better coordinated across the EU, they add.

Supporting innovation and digital transformation

MEPs call on the Commission and EU countries to support the development of regional biotechnology innovation hubs integrating good manufacturing practice, regulatory expertise, clinical infrastructure and workforce training. They highlight the need for the EU Life Sciences Strategy and the Biotech Act to position Europe as the leading destination for investment in biotechnology R&D, manufacturing, and clinical trials.

The report underlines the growing role of artificial intelligence (AI) and its potential to contribute to bioprocess design, optimisation of metabolic pathways for biopharmaceuticals, and the development of more efficient and humane research methods.

Ensuring adequate funding and specific support to start-ups, scale-ups and SMEs

MEPs highlight the to increase public and private investment in biotechnology across the value chain, with particular focus on early-stage development. These investments should be directed towards biotechnologies that address unmet medical needs, such as rare diseases, antimicrobial resistance, and chronic conditions where traditional treatments have proven inadequate. The text calls on the Commission to explore the creation of an EU Biotech Innovation Fund to support researchers, academia, start-ups and SMEs conducting R&D and innovation in healthcare biotechnologies.

Next steps

The own initiative report was adopted with 25 votes in favour, eight against and three abstentions and will be put to a vote by Parliament during a future plenary session.

Background

OECD defines biotechnology as “the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services”. In healthcare and pharmaceutical applications, biotechnology has led to the discovery and development of Advanced Therapy Medicinal Products (ATMPs) including cancer treatments (CAR-T), mRNA vaccines and gene-editing technologies (CRISPR).