1. Background
Gene and cell therapies are on the rise. On June 12, 2024, the German Federal Government was handed the strategy paper for a National Strategy for Gene and Cell Therapies. The paper is intended to serve as a basis for policymaking to give Germany a leading role in the field of gene
In this episode of Covington’s Life Sciences Audiocast, Seán Finan and Rosa Oyarzabal discuss some important recent developments in the regulation of sustainability and green claims and labelling schemes, and the ever-increasing enforcement risk that comes with greenwashing.
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
Tune into this episode of Covington’s Life Sciences Audiocast, where Winsome Cheung and George Jenkins discuss the key trends in Life Sciences Transactions for 2024. The speakers discuss the outlook for deal-making in Life Sciences and predictions for deal trends, including in relation to nuclear medicine, GLP-1, antibody-drug conjugates and other modalities. The speakers also
On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”). The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the
A UK judge has decided that Odysea Ltd, an artisan food company, can use the word “raw” to describe its small-batch, minimally‑processed honey. Judge Neville, of the First‑tier Tribunal (General Regulatory Chamber), gave the decision on 26 February 2024. The judgement is available here and opens with a classic reference to Winnie the Pooh:
In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in January 2024, the German government plans to
