Key diary dates

• Tuesday 19 March: European Parliament’s committee vote on the reform of EU pharmaceutical rules.

• Wednesday 20 March: Presentation of the European Commission‘s first ‘EU Biotech and Biomanufacturing Initiative’.

• Tuesday 19-Friday 22 March: European Commission organises Digital Markets Act workshops with gatekeepers.

In spotlight

This Wednesday (20 March) the European Commission is expected to unveil a new ‘EU Biotech and Biomanufacturing Initiative’ .

Despite half-hearted attempts at regulatory simplification in the sector in the past, life science technologies are increasingly drawing attention from policymakers.

Last month Euronews first reported on the health component of this initiative based on a leaked draft document that highlighted a focus on the vibrant biopharmaceutical sector – responsible for providing breakthrough messenger RNA (mRNA) molecules playing an essential role in COVID-19 vaccines.

But biotech applications are not limited to the health sector, ranging from sustainable sourcing of advanced materials to climate-smart production and other components essential to a fossil-free and circular economy.

A ‘blue’ biotech is also emerging, with new research on aquatic organisms and microalgae fermentation ready for commercial exploitation – not to mention the potential of new genomic techniques (NGTs) for food production, already under discussion by EU lawmakers.

The main goals of this initiative will be to survey the status quo and track future challenges facing the biotech sector to orientate policy efforts in readiness for the next legislative mandate.

Some policy ideas are likely to be proffered, such as a one-stop shop to permit and authorise biotech manufacturing – while a controversial proposal for an R&I tax credit for biotech companies is rumoured to have been shelved for the moment.

This first dedicated attempt to address the sector won’t be the last, with economic security and strategic autonomy likely to be key buzzwords for the next commission.

Biotech is expected to be a new beat to keep a close eye on and it has already been listed as a critical technology for the continent, together with semiconductors and artificial intelligence.

The defence imperative dominating current commission thinking involves European independence from military aircraft to sourcing these critical new technologies.

Policy newsmakers

@Hahn                                                                                                                   @Wiewiórowski

Commission under data notice

The European Commission was ordered last week to bring its use of Microsoft 365 office programs in line with its own rulebook, after European Data Protection Supervisor (EDPS) Wojciech Wiewiórowski found following an investigation that the commission breached EU rules on transfers of personal data outside the EU. The commission now needs to suspend all data flows resulting from its use of Microsoft 365 to Microsoft and to its affiliates and sub-processors located in countries outside the EU/EEA that are not covered by a data transfer agreement. The commissioner responsible for admin, Johannes Hahn, will have to demonstrate compliance with the orders by 9 December 2024.

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