On Tuesday 19 March, the European Parliament’s committee will vote on the reform of EU pharmaceutical rules, followed by the European Commission unveiling the ‘EU Biotech and Biomanufacturing Initiative’ on Wednesday 20 March. The Commission also plans to hold workshops on the Digital Markets Act with gatekeepers from Tuesday to Friday. The focus is on regulatory simplification in the life science technologies sector, which is increasingly drawing attention from policymakers.
The ‘EU Biotech and Biomanufacturing Initiative’ will highlight the biopharmaceutical sector, including breakthrough messenger RNA (mRNA) molecules used in COVID-19 vaccines. Beyond healthcare, biotech applications range from sustainable sourcing of advanced materials to climate-smart production for a fossil-free and circular economy. ‘Blue’ biotech involving aquatic organisms, microalgae fermentation, and new genomic techniques for food production is also emerging. The initiative aims to survey the current status and future challenges of the biotech sector to inform policy efforts for the next legislative mandate.
Policy ideas expected to be proposed include a one-stop shop for permitting and authorizing biotech manufacturing. However, a controversial proposal for an R&I tax credit for biotech companies has been put on hold for now. Economic security and strategic autonomy are likely to be key themes for the next commission, with biotech being identified as a critical technology alongside semiconductors and artificial intelligence. The focus on European independence from critical technologies aligns with the commission’s defense imperative.
The European Commission was instructed by the European Data Protection Supervisor to align its use of Microsoft 365 office programs with EU rules on transfers of personal data outside the EU. The commission must suspend data flows resulting from its use of Microsoft 365 to countries outside the EU/EEA that do not have a data transfer agreement. Commissioner Johannes Hahn is tasked with ensuring compliance with these orders by 9 December 2024. A policy poll question asks what should be done with profits generated by Russian state assets frozen in Europe.
The ‘EU Biotech and Biomanufacturing Initiative’ aims to address the challenges facing the biotech sector and pave the way for policy efforts in the future. The focus on regulatory simplification and advancing biotech applications beyond healthcare will be key areas of exploration. The commission’s compliance with data protection rules regarding the use of Microsoft 365 will also be closely monitored. As key policy dates and developments unfold, it is essential to stay informed on the latest EU policy updates through platforms like “The Policy Briefing” newsletter.
