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Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German Parliament has now accepted a modified version of

On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”).  The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an

In this episode of Covington’s Life Sciences Audiocast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.

Parliament’s position comes less than a year since the Commission published its proposal, and

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12

On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here).  In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process. 

Today, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027.  Some studies suggest that the costs that producers would have to collectively pay could be around €1 billion per

Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners.  The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.

Tune into this episode of Covington’s Life Sciences Audiocast, where Sibel Yilmaz, Majken Lagerbielke, and Leire Garagorri Eguidazu discuss the new market definition notice published by DG COMP, specifically the latest on the new guidance concerning pharmaceutical innovation markets and possible implications for analysing M&A and licensing deals.