Artificial Intelligence

EU 

  • EFPIA has issued a statement on the use of artificial intelligence (AI) in the medicinal product lifecycle in the context of the AI Act and has stated that it considers the exemption (under Recital 25, Articles 2.6 and 2.8 of the AI Act) applies to AI-based drug development tools used in the research and development of medicines because the sole use of these tools is in the R&D of medicines development.  See full statement here. 

UK 

Clinical Trials 

EU 

  • The European Medicines Agency (EMA) has issued its latest news on the Clinical Trial Information System (CTIS) transparency rules, which will become effective on 18 June 2024. See ctis newsflash for further information. 

Competition Law 

EU 

  • The European Commission is seeking feedback on commitments offered by Vifor Pharma over possible anticompetitive disparagement of competing iron medicine treatments.  For further information see European Commission press release.  

UK 

  • The Competition Appeal Tribunal (CAT) has unanimously upheld the level of penalty imposed by the Competition and Markets Authority (CMA) for a market sharing agreement relating to 20mg hydrocortisone tablets. See CMA press release for further information. 

Confidential Information 

EU 

  • EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a working arrangement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for the exchange of confidential information on medical and medicinal products. For further information on the arrangement see here. 

 

  • The Heads of Medicines Agencies/EMA draft guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier, has been published. The draft guidance document is published for public consultation and is available here . The consultation is open until 28 June 2024.  

Data Privacy 

EU 

  • The European Data Protection Board (EDPB) has published its annual report for 2023 on safeguarding individuals’ digital rights. See here 

 

  • The Council of the European Union has adopted a data transfer framework with Japan, allowing for free data flows between the EU and Japan. See press release for further information. 

France 

  • The French data protection authority, the Commission nationale de l’informatique et des libertés, will begin a consultation toward “updating and creating new standards” for health data processing. The consultation will begin on 16 May 2024. See press release  for further information. 

UK 

  • The U.K. Information Commissioner’s Office (ICO) has urged health care organizations to improve data protection efforts after individuals’ HIV statuses were targeted in data breaches. See ICO statement for further information. 

Health Data 

EU 

  • On 24th April, the European Parliament approved the provisional agreement to create the European Health Data Space. See press release for further information. 
  • The European Commission has released a Q&A on the European Health Data Space proposal to advance digital health care, while allowing patients to access their health data. For further information see Q&A document 

Marketing Authorisations 

EU 

  • EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting. For further information see here.

UK 

  • For information published by the MHRA on UK marketing authorisations granted in 2024 see here. 

Medical Devices 

EU 

  • The European Commission has launched an investigation into Chinese public procurement of medical devices. See European Commission press release for further information. 

UK 

  • The MHRA has updated its Guidance on Software and Artificial Intelligence (AI) as a Medical Device to include updates to the digital mental health technology section. The update follows funding by the Wellcome Trust into a project focusing on effective regulation and evaluation of digital mental health technology. See here and here for further information. 

Pricing 

UK 

  • The Association of the British Pharmaceutical Industry (ABPI) has responded to UK government proposals to change the statutory pricing scheme for branded medicines and has published an executive summary of its consultation response. For further information see here 

Supply Chain 

EU 

  • The European Medicines Agency (EMA) has published several recommendations to strengthen the supply chain of medicines included in the list of critical medicines. See EMA press release and recommendations for further information. 

Sustainability 

EU 

  • EFPIA has published its view on the circular economy. See EFPIA comment and White Paper on the Circular Economy 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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