Artificial Intelligence 

EU 

  • The European Data Protection Board (EDPB) has adopted a statement on the Data Protection Authorities’ (DPAs) role in the Artificial Intelligence Act (AI Act) framework. See statement 3/2024 for further information. 

France 

  • The French data protection authority, CNIL has published a series of frequently asked questions (FAQs) on the deployment of generative artificial intelligence. See CNIL press release and FAQs for further information. 

Netherlands 

  • The Dutch data protection authority has published its spring 2024 report on the risks and effects of the use of artificial intelligence (AI) and algorithms in the Netherlands. See press release and report for further information. 

UK 

  • The University of Cambridge has developed an artificial intelligence tool which outperforms clinical tests in predicting the progress of Alzheimer’s disease. The Cambridge team say the new approach could reduce the need for invasive and costly tests while improving treatment outcomes. See here for further information. 

Clinical Trials 

EU 

  • The European Medicines Agency (EMA) has endorsed a new method for evaluating severity of Alzheimer’s disease. The method received biomarker qualification opinion from the EMA on 25 June 2024. The endorsement means that the method can be confidently used in clinical trials by researchers who are seeking new treatments for Alzheimer’s disease. See the Innovative Health Initiative press release for further information. 

UK 

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an Infringement Notice on Celixir under Regulation 48 of the Medicines for Human Use (Clinical Trials) Regulations 2004. It is the view of the MHRA that Celixir, the trial sponsor, failed to ensure the conduct of the trial in accordance with the conditions and principles of good clinical practice and therefore risked seriously jeopardising the rights, safety and well-being of trial participants. See Infringement Notice for further information. See the MHRA Good Clinical Practice for Clinical Trials, as updated following the Celixir Infringement Notice here 

Competition Law 

EU 

  • The European Commission has accepted commitments made by Vifor and made them legally binding under EU antitrust rules. The commitments address the Commission’s competition concerns relating to Vifor’s potential disparagement of Monofer, a close competitor of Vifor’s intravenous iron medicine in Europe, Ferinject. See European Commission press release for further information. 

EU/UK and US 

  • The EU, UK and US competition authorities have issued a joint statement supporting competition in AI. The statement recognises the transformational opportunity AI presents but also the risks posed to competition and consumers by the technology, which need to be addressed before causing irreversible harms. See the joint statement here 

Competitiveness Strategy 

EU 

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded to the publication of Political Guidelines for the next European Commission 2024-2029 and recognised the ambition to support European life sciences through a dedicated life sciences strategy included in the new Political Guidelines. See EFPIA statement for further information. 

Data Privacy 

EU 

  • The EDPB has adopted two FAQ documents concerning the EU-US Data Privacy Framework (DPF) to provide further clarification on the functioning of the DPF. The documents include an FAQ for individuals and an FAQ for business 

UK  

  • The Information Commissioner’s Office (ICO) has concluded its investigation into Snap’s approach to assessing the data protection risks of its “My AI “chatbot. The investigation led to the ICO issuing a Preliminary Enforcement Notice in October 2023 for alleged breaches of Articles 35 and 36 of UK GDPR. The ICO is now satisfied that the revised data protection impact assessment carried out by Snap complies with the requirements of Article 35 GDPR. No breach of Article 36 was found. See here for the ICO Decision. 

 

  • The ICO has published its annual report for the period 2023-2024, which includes the ICO’s key activities and operational performance for the period. See ICO Annual Report for further information. 

Health Data 

EU 

  • EFPIA has issued a position statement on the regulation of the European Health Data Space. See EFPIA press release and position statement for further information. 

Intellectual Property 

EU 

  • The United Patent Court (UPC) has issued its first revocation order in Sanofi v Amgen UPC_CFI_1/2023 . The decision takes a strong stance on the patentability of therapeutic antibody inventions in Europe and is in stark contrast to the US Supreme Court decision on Amgen’s corresponding US patents. The decision of the UPC confirms that the US and European approaches to antibody inventions are diametrically opposed. In Europe, broad antibody inventions are found to lack inventive step because it is considered too routine to make antibodies. 

Medicines Shortages 

EU 

  • A European Commission assessment shows a need to reinforce resilience of critical medicine supply chains. The assessment report is part of the Commission’s ongoing work to address shortages of medicines and will inform further actions to reinforce security of supply of a first tranche of 11 critical medicines from the Union list of critical medicines. For further information see here  

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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