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In Brief The long-awaited EU AI Act was published in the Official Journal of the European Union today, 12 July 2024. The Act regulates activities across the AI lifecycle, as covered in more detail in our previous post, and the countdown for implementation has now started for companies developing or deploying AI technologies, with the Act entering into force 20 days after its publication on 1 August 2024. The Act as a whole is generally applicable two…

Alongside its allies, the EU has implemented a vast volume of sanctions on Russia and Belarus following Russia’s invasion of Ukraine in February 2022. The EU sanctions against both Russia and Belarus are at the core of the EU’s response to Russia’s military aggression and aim to diminish Russian resources and curb Russia’s capacity to continue the war. On 24 June 2024, the EU introduced its awaited 14th sanctions package on Russia and not long…

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commission’s proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…

In brief The Commission’s Implementing Act on Joint Clinical Assessments for medicines for human use was finally adopted on 23 May 2024. This is the first out of six Implementing Acts for the EU HTA Regulation. With only seven months to go before the HTA Regulation becomes applicable, developers of medicines within the first wave of products subject to the HTA Regulation will need to consider their strategy for EU assessment and its interplay with…

On 10 April 2024 the European Parliament approved the text of the recast Urban Wastewater Treatment Directive. Of particular relevance to pharmaceutical and cosmetic companies, the recast Directive will introduce new extended producer responsibility (“EPR”)[1] obligations in respect of micropollutants from their products that end up in the urban wastewater stream. Background The EU’s Urban Wastewater Treatment Directive (the “Directive”) has been in place since 1991 and aims to protect human health and the environment…

How does the EU AI Act impact upon medicines R&D? The answer is not much at all. This position stems from an exemption for scientific R&D in the AI Act, as explained by a recent statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA). This will be welcome news for the pharmaceutical industry, but questions remain for the medical device industry, where the position is far murkier at the research and development stages.…

EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The next step is Council’s adoption, expected next month. Following the Council’s sign off, the final text will be prepared for publication in the Official Journal and will enter into force 20 days afterwards. Once adopted, the Act will become applicable in a gradual manner. For products that are already required to…

The Corporate Sustainability Due Diligence Directive (“CS3D”), provisionally agreed in December 2023, will create significant behavioural and reporting obligations for many EU and non-EU healthcare and life sciences companies active in the EU, adding an additional layer of compliance and complexity to their already highly intricateglobal value chains. In this first instalment of our new “CS3D Explainer Series”, we provide an overview of scope, key obligations and relevant timeline under the CS3D.

On 14 December 2023, Council and the European Parliament reached a major political agreement on the Substances of Human Origin (SoHO) Regulation. This Regulation will replace the Blood Directive and the Tissues and Cells Directive, combining both legal texts into one. In addition, the Regulation will extend its protection to any SoHO regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’ to avoid that certain groups of donors or recipients are left…

On 24 October 2023, the European Commission issued a communication setting out short-term and medium/longer-term actions to prevent or mitigate critical shortages at EU level, with a particular focus on the most critical medicines for which supply needs to always be assured in the EU. Actions to be taken in the short term include the following: The immediate deployment of a voluntary solidarity mechanism to support member states experiencing shortages. This scheme will allow member…