Advertising

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance for promotional material within the context of the Windsor Framework. See Guidance for further information. The Medicines and Healthcare products Regulatory Agency (MHRA) has also published its own MHRA guidance providing information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
  • The MHRA has published decisions made by the MHRA following investigations into complaints about advertising for licensed medicines. See July , August and September decisions for further information.

Artificial Intelligence

EU

  • JRC has published harmonized standards for the EU AI Act. See here for further information.
  • The European Commission’s AI Office has launched a consultation on the AI Act prohibitions and AI system definition. The consultation is open until 11 December 2024. For further information on the consultation and how to submit a response please see press release and here
  • The European Commission has published a Q & A document on general purpose AI. See here for further information.

Brexit

UK

  • The MHRA has issued a second webinar in a two-part series on preparation for the Windsor Framework implementation. See Windsor Framework Webinar Recordings here for further information.

Clinical Trials

UK

  • In a webinar on 15 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) stated that it expects the new UK clinical trial regulation to be implemented by January 2026. A recording of the webinar on plans to implement the new Clinical Trials Regulations is now available. See here for further information.
  • The NHS Health Research Authority (HRA) has published a new draft model Commercial Chief Investigator Agreement and is seeking feedback on the draft model agreement. For further information, including a copy of the draft agreement and how to provide feedback, see here
  • The HRA has published a new toolkit for supporting research carried out across borders in the UK. The aim of the toolkit is to make it easier to set up research across the UK. See here for further information.
  • The MHRA has announced a consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2. The consultation is open until 14 February 2025. See here for further information.

Switzerland

  • On 1 November 2024 a new Swiss clinical trials framework takes effect. See here for further information.

Competition Law

EU

  • The European Commission has fined Teva EUR 462.6 million for abusing its dominant position to delay competition to its blockbuster medicine for the treatment of multiple sclerosis. The Commission found that Teva had misused the patent system and disparaged a rival’s product to hinder market entry. See European Commission press release for further information.

EU/UK

  • The EU and UK have agreed a new competition cooperation agreement. The agreement will allow the Commission, the national competition authorities of the EU Member States (‘NCAs’) enforcing EU competition law, and the UK Competition and Markets Authority (CMA) to cooperate directly in competition investigations. See EU press release and CMA press release for further information. 

Competitiveness

EU

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has just published a report it commissioned showing the EU R & D pharmaceutical spending across member states and a comparison of spending in other regions across the globe, such as the US and China. For further information see here

Data Privacy

EU

  • The European Data Protection Board (EDPB) has adopted a report on a first review of the European Commission Implementing Decision on the adequate protection of personal data under the EU-US Data Privacy Framework. See Report for further information.

UK

  • The Information Commissioner’s Office (ICO) has issued key data protection considerations to be taken into account when using AI to assist with recruitment. See ICO  data protection considerations document for further information.

Health Data

EU

  • The European Medicines Agency (EMA) has opened a consultation on the draft European Medicines Agencies Network Data Strategy – Increasing the value of data for the benefit of public and animal health. The consultation is open until 31 December 2024. See here and here for further information.

UK

  • The Sudlow Review, an independent review of the UK health data landscape, titled ‘Uniting the UK’s Health Data: A Huge Opportunity for Society’, was published on Friday 8 November 2024. The Review is available The Association of the British Pharmaceutical Industry (ABPI) and the HRA have both commented on the review and their responses are available here and here

Innovative Medicines

UK

  • The MHRA has published a statement of policy intent, setting out plans for the relaunch of the Innovative Licensing and Access Pathway (ILAP). The ILAP focuses on getting new transformative medicines to patients more quickly. See here for further information and the statement of policy intent.

Intellectual Property

UK

  • The Supreme Court has ruled in the Sky v Skykick case, overturning the Court of Appeal on key aspects of bad faith, which will have implications for trade mark filing and enforcement. See judgement for further information.
  • The Intellectual Property Office (IPO) has published statutory guidance on changes to supplementary protection certificates (SPCs) from 1 January 2025, when new legislation on SPCs comes into force. See statutory guidance for further information.

Market Access

EU

  • The European Commission has published the third of six Regulations implementing the Health Technology Assessment Regulation (EU) 2021/2282. The third Implementing Regulation sets out rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations. See Implementing Regulation for further information.
  • EFPIA has published two blog articles on joint clinical assessments under the Health Technology Assessment Regulation. See blog article and blog article for further information.

Medical Devices

UK

  • The MHRA has announced a consultation on the Medical Device Regulations: routes to market and in vitro diagnostic devices (IVDs). The consultation is open until 5 January 2025. For further information on the consultation and how to provide feedback see here
  • The MHRA has launched a consultation on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will focus on four key policy areas, including UKCA marking, international reliance, IVDs and assimilated EU law. The findings from this consultation will inform the new law. The consultation is open until 5 January 2025. See here for further information.

Orphan Medicines

EU

  • The European Court of Justice (CJEU) has issued a judgement relating to orphan market exclusivity. The judgement considers the scope of the ‘clinical superiority’ criteria which can provide for a derogation to orphan market exclusivity. See judgement in Case C – 237/22 P for further information.

Urban Wastewater Treatment Directive

EU

  • EFPIA has issued a joint statement from the human pharmaceutical industry on the Urban Wastewater Treatment Directive. See 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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