by The unveiling of the ‘Biotechnology and Biomanufacturing Initiative’, the first of its kind, is set for this Wednesday (March 20) after it formally went ahead in the weekly College of Commissioners.
The biotech sector is considered to be “one of the most promising technology areas of this century” according to the latest draft of the communication – seen exclusively by Euronews – which is set to be approved by commissioners later this week.
The initiative “summarizes the current challenges and barriers in biotechnologies and biomanufacturing” and recommends actions “to address these challenges in a timely manner”.
The leaked document focuses the Commission’s work on eight key actions from faster market entry for biotech products to setting the course for future initiatives including a review of the EU’s Bioeconomy strategy by the end of 2025.
A key feature is the establishment of an EU Biotechnology Hub by the end of the year, described as “an operational tool for biotech companies to navigate the regulatory framework and identify support to scale up”.
This is intended to be a one-stop shop for biomanufacturing authorizations and permits designed to streamline regulatory processes and foster a clean path from “lab to fab”.
Although the communication shows access to capital and investment scaling among the obstacles facing the sector, the Commission states that it can achieve the greatest impact through regulatory actions.
To that end, the EU executive will soon launch a study investigating “targeted simplifications of the regulatory framework, including faster approval and take-to-market”.
“The study will be completed by mid-2025 and could lay the groundwork for a possible EU Biotechnology Act,” according to the leaked document, adding that it will “identify key current industrial bio-based value chains map too”.
Meanwhile, the EU executive will promote so-called regulatory sandboxes to speed up the introduction of novel solutions tested under regulatory oversight – a system recently proposed in the review of the EU’s pharmaceutical framework for breakthrough therapies to develop.
AI generation for health
Armed with its recently rubber-stamped legislation on the subject, the Commission appears to be doubling down on artificial intelligence (AI) as the key technology to complement the life science sector.
“Artificial intelligence (AI) applied to bio-based industry allows companies to automate a wide range of processes helping them streamline and scale up their operations,” the document says.
In particular, “generative AI holds particular promise”, he continues, pointing out its contribution to creating or examining gene sequences, helping to understand complex genetic disorders, speeding up drug development, and protein engineering and peptide enhancement for medical applications.
The Commission will support the use of generative AI in biotechnology and biomanufacturing through financial incentives in the GenAI4EU, a recent initiative that has earmarked €500m for the adoption of generative AI in various industrial sectors.
The text also refers to high-level AI generation models for healthcare that will be privileged under this new stimulus, as well as personalized healthcare solutions and the development of customized treatments and diagnostics.
Easier approval for biopharmaceuticals and AMTP
In the draft, the EU executive admits that the existing regulatory framework for the development and use of medicinal products based on biotechnology – the so-called biopharmaceuticals – is very difficult.
“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, in order to increase biomanufacturing capacity within the EU,” of according to the document released.
Obtaining authorizations related to multiple legislations covering medicinal products is a major obstacle for biopharmaceuticals. The Commission, therefore, intends to “provide clarification on the interface and interaction with other legislative frameworks to help developers navigate the regulatory requirements, particularly in relation to combination products”.
Biopharmaceuticals and advanced therapeutic medicinal products (ATMPs) are particularly affected by differences in national requirements for clinical trial assessments required before formal authorizations are granted.
By the end of 2024, the Commission will launch a study on the implementation of the clinical trials regulation – originally designed to rationalize evidence collected from all over the bloc – to assess its impact on European clinical research and to take the necessary steps to consider, such as the potential for clinical. trial hubs.
With regard to ATMPs, the Commission will examine proposing clearer rules for the use of the hospital exemption that allows the use of such therapies without a central marketing authorization.
