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UK

Artificial Intelligence

UK

  • On 13th December the Information Commissioner’s Office published its response to the generative artificial intelligence (AI) consultation series. See ICO response for further information.

Clinical Trials

UK

  • New legislation setting out the updated regulatory framework for clinical trials was laid before parliament on 12th December. The updated regulations will be debated in the new year and will come into force in 2026 after a twelve-month implementation period. See MHRA press release for further information.
  • The Association of the British Pharmaceutical Industry (ABPI) has published its annual report on UK clinical trial performance. See report and press release for further information. The Health Research Authority (HRA) has commented on the ABPI report. See here for their response.

Competition Law

EU

  • The European Commission has approved the proposed acquisition of Catalent by Novo Holdings. See European Commission press release for further information.

UK

  • The Competition and Markets Authority (CMA) is investigating whether Vifor Pharma may have abused its dominant position through its conduct in relation to intravenous iron treatments. It has opened a consultation on commitments proposed by Vifor Pharma. See CMA press release and consultation information for further information. The consultation is open until 17 January 2025.
  • The CMA has opened a consultation on draft guidance on the protection from unfair trading provisions in the Digital Markets, Competition and Consumers Act 2024. The consultation is open until 22 January 2025. For further information, including how to respond to the consultation see here

Data Privacy

EU

  • The European Data Protection Board (EDPB) has requested comments on new guidelines to clarify Article 48 of GDPR on data transfers to third country authorities. The guidelines are subject to public consultation until 27 January 2025. See EDPB press release for further information including how to provide feedback to the consultation.

France

  • The French data protection authority, CNIL has issued formal notice on misleading cookie banners. See here for further information.

Intellectual Property

UK

  • The UK Intellectual Property Office (IPO) has updated its guidance on changes to supplementary protection certifications from 1 January 2025. In particular, it has provided additional guidance to the ‘Existing SPCs and applications’ section for SPCs filed before Brexit. See here for further information.

Market Access

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed concern that insufficient advice meetings are being offered to discuss clinical plans at a critical stage of planning, which could delay market access decisions. See EFPIA press release for further information.
  • The EU HTA Coordination Group has published its work programme for 2025. See here for further information.
  • EFPIA has published a blog article with its response to ‘Guidance on outcomes for joint clinical assessments’. See blog for further information.

Medical Devices

EU

  • The European Commission has launched a consultation and call for evidence on EU Medical devices evaluation. The consultation is open until 21 March 2025. For further information and how to respond to the consultation see here
  • The European Commission has updated a Q&A document on the obligation to notify in the case of interruption or discontinuation of certain medical devices and in vitro diagnostic medical devices. See here for further information.

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published a revised roadmap for implementation of the medical devices future regime. See here for further information.
  • The MHRA has published an overview of the five technologies selected for the AI Airlock pilot. The AI Airlock pilot is the regulatory sandbox for AI as a medical device products. See here for further information.

Packaging

Denmark

  • The Danish Medicines Agency (DMA) has announced a pilot project for English only packaging for human medicines. The pilot will run for five years and will test the usability of packages in English across the Nordic countries. See DMA press release for further information.

Research and Development

EU

  • EFPIA has published nine recommendations to maximise the impact of the future EU Framework Programme for Research and Innovation (FP10). See EFPIA article for further information.
  • EFPIA has published its 2024 Pipeline Review. The report highlights areas of innovation set to transform patient care. See EFPIA press release for further information.

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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