The EU executive is to announce new measures, including establishing a Biotech Hub, paving the way for a legislative initiative designed to ease biomanufacturing approvals across the bloc, according to a leaked document seen by Euronews.
ADVERTISEMENTThe unveiling of a ‘Biotech and Biomanufacturing Initiative’, a first of its kind, is tabled for this Wednesday (20 March) after a formal go-ahead in the weekly College of Commissioners.
The biotech sector is considered “one of the most promising technological areas of this century” according to the latest draft of the communication – seen exclusively by Euronews – set for approval by commissioners later this week.
The initiative “summarises the current challenges and barriers for biotechnologies and biomanufacturing” and proposes actions "to address these challenges in a timely manner”.
The leaked document focuses the commission’s work into eight key actions ranging from obtaining faster entry into the market for biotech products to setting the course for future initiatives including a review of the EU Bioeconomy strategy by the end of 2025.
A key feature is the proposed establishment by the end of the year of an EU Biotech Hub, described as “an operational tool for biotech companies to navigate through the regulatory framework and identify support to scale up".
This is intended to be a one-stop shop for biomanufacturing authorisations and permits designed to streamline regulatory processes and foster a clean path from “lab to fab”.
While the communication flags capital access and investment scaling among hindrances faced by the sector, the commission states it can achieve the most impact through regulatory actions.
To this end, the EU executive will shortly launch a study exploring “targeted simplifications to the regulatory framework, including for faster approval and bringing to the market”.
“The study will be finalised by mid-2025 and could lay the foundations for a possible EU Biotech Act,” according to the leaked document, adding that it will also map “key current industrial bio-based value chains”.
Meanwhile, the EU executive will further promote so-called regulatory sandboxes to accelerate the market introduction of novel solutions tested under regulatory supervision – a system recently proposed in the revision of the EU’s pharmaceutical framework for the development of breakthrough therapies.
Generative AI for health
The commission appears to be doubling down on artificial intelligence (AI) as the main technology to complement the life science sector, armed with its recently rubber-stamped legislation on the matter.
“Artificial intelligence (AI) applied to bio-based industry allows companies to automate a wide range of processes helping them to streamline and scale up their operations,” the document states.
In particular, “generative AI holds a particular promise”, it continues, pointing out its contribution to creating or examining gene sequences, aiding comprehension of intricate genetic disorders, expediting drug development, and enhancing protein and peptide engineering for medical applications.
The commission will support use of generative AI in biotech and biomanufacturing through financial stimuli in the GenAI4EU, a recent initiative that has earmarked €500m for the uptake of generative AI in different industrial sectors.
The text also touts advanced generative AI models for healthcare to be privileged under this new impetus, as well as personalized healthcare solutions and the development of customised treatments and diagnostics.
Easier approval for biopharma and AMTPs
In the draft, the EU executive acknowledges how the existing regulatory framework for the development and use of biotech-based medicinal products – the so-called biopharmaceuticals – is cumbersome.
“The commission will launch a study to identify how best to leverage existing assets and infrastructures for health biotechnology, including those developed under Joint Undertakings, with the aim to boost biomanufacturing capacity within the EU,” according to the leaked document.
Obtaining authorisations involving multiple legislations covering medicinal products represents a key obstacle for biopharmaceuticals. The commission is therefore planning to provide “clarifications on the interface and interaction with other legislative frameworks to help developers navigate the regulatory requirements, especially for combination products.”
ADVERTISEMENTBiopharmaceuticals and advanced therapy medicinal products (ATMPs) are particularly affected by differences in national requirements for clinical trial assessments required before formal authorisations are granted.
By the end of 2024, the commission will launch a study on the implementation of the clinical trial regulation – originally designed to rationalise collected evidence from across the bloc – to assess its impact on European clinical research and consider necessary steps such as the potential for clinical trial hubs.
As regards ATMPs, the commission will explore proposing clearer rules on the use of the hospital exemption which allows the use of such therapies without a central marketing authorisation.
