Advertising

EU

  • The Advocate General (AG) Szuphar has delivered his opinion whether discount campaigns regarding prescription only medicines run by mail order pharmacies fall within the definition of advertising. The AG’s opinion is that the purpose of the discount campaign is not to encourage patients to purchase medicinal products, but rather to attract them to a specific pharmacy and thus it does not fall within the definition of advertising. It remains to be seen whether the Court will follow the AG’s opinion. See Opinion of the Advocate General Case C517/23 for further information.

Artificial Intelligence

EU

Brexit

UK

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a final reminder to marketing authorisation holders to comply with the Windsor Framework arrangements from January 2025. See MHRA press release for further information.
  • The MHRA has published an explainer document for the pharmaceutical industry which sets out the main changes that implementation of the Windsor Framework will introduce on 1 January 2025 and what companies need to do to prepare. See explainer document for further information. The MHRA has also introduced a video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland. See video series for further information.

Clinical Trials

EU

  • The European Medicines Agency (EMA) has launched a public consultation on the International Council for Harmonization (ICH) E6 (R3) Guideline for Good Clinical Practice – Annex 2. The consultation is open until 28 February 2025. For the draft Guideline and information on how to provide comments, see

UK

  • The Health Research Authority (HRA) is seeking feedback on simplifying the process of seeking and recording consent in low-risk clinical trials. The feedback will be used to help inform the future Clinical Trials Regulations in the UK and supporting HRA guidance. See here for further information and how to share feedback.

Codes of Practice

UK

  • The Prescription Medicines Code of Practice Authority (PMCPA) has published a Q&A document providing further guidance on Clause 10.4 of the Code of Practice. Clause 10.4 requires a written agreement to be put in place where a company provides support to an individual HCP or ORDM to attend an event/meeting. See Q&A document for further information – Q&A document

Competition Law

EU

  • The European Commission has published the findings of its evaluation of the EU competition rules on technology transfer agreements. The European Commission now intends to launch an impact assessment to examine policy options for a revision of the rules. See European Commission press release for further information.

UK

  • The Competition Appeals Tribunal (CAT) has re-made the decision of the Competition and Markets Authority (CMA) and imposed fines totalling £69 million on Pfizer and Flynn for abusing their dominant positions by charging excessive prices for an epilepsy drug, phenytoin sodium capsules, between 2012 and 2016. See CMA press release for further information.
  • The CMA has published a notice of a penalty imposed on Viatris Inc on 12 November 2024 under section 110 of the Enterprise Act 2002 (the ‘Act’). The CMA found that Viatris, without reasonable excuse, failed to comply with compulsory restrictions imposed during the CMA’s review of its deal with Theramex. See CMA press release for further information.

Collaborations

UK

  • The King’s Fund has published a report examining how the National Health Service (NHS) can better collaborate with life sciences industry partners. See here for further information.

Competitiveness

UK

  • The NHS has published its Innovation Ecosystem Programme report findings, detailing a package of recommendations to build an ecosystem to help transform health and care in the UK and support the growth of the economy. See here for further information. The Association of the British Pharmaceutical Industry (ABPI) has welcomed the review. See ABPI press release here

Data Privacy

EU

  • The European Data Protection Board (EDPB) has published its reply to the AI Office on the role of data protection authorities (DPAs) in the Artificial Intelligence Act Framework. See here for further information.
  • The Court of Justice of the European Union (CJEU) has published its judgement on the right to information in the case of indirect personal data collection. See Judgement Case C-169/23

UK

  • The Information Commissioner’s Office (ICO) has published guidance on data sharing for fraud prevention. See ICO guidance for further information.

Health and Clinical Data

EU

  • The European Medicines Agency (EMA) has opened a consultation on the Data Quality Framework for EU medicines regulation application to real-world data. The consultation is open until 31 January 2025. See here for further information and how to provide feedback.
  • The EMA has presented its plans in a webinar on the proposed expansion of activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications. See here for further information.

Intellectual Property

UK

  • The Court of Appeal of the Unified Patent Court (CoA) has ruled on the question of the requirements under which patent proprietors can effectively withdraw an earlier opt-out for their European patents during the transitional period of the Unified Patent Court (UPC). In its judgement the CoA ruled that any national proceedings brought prior to the transitional period, whether still pending or not, do not block an effective withdrawal of an opt-out made during the transitional period. See Order of the UPc CoA 489/2023, 500/2023 for further information.

Medicines Shortages

EU

  • The European Shortages Monitoring Platform has now gone live. Marketing Authorisation Holders can use the platform to report shortages of centrally authorised medicines. See EMA press release for further information.

Product Liability

EU

  • On 18th November 2024 the new EU Product Liability Directive was published in the Official Journal. Member States have 24 four months to transpose the new Directive into national laws and it is therefore expected that it will apply from the fourth quarter of 2026. See Directive (EU) 2024/2853 for further information.

Regulatory

EU

  • The EMA has published its Human Medicines Highlights for November 2024, including information on new medicines. See here for further information.

Research and Development

EU

  • The EMA has opened a consultation on ICH M15 Guideline on general principles for model informed drug development. The consultation is open until 28 February 2025. See here for draft Guideline and how to provide feedback.

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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