Artificial Intelligence (AI) 

EU 

  • With effect from 2 February 2025 the first provisions under the Artificial Intelligence Act started to apply, including the AI system definition and a number of prohibited AI use cases outlined in the AI Act. See European Commission press release for further information. 
  • The European Commission has published guidelines on the AI system definition under the AI Act. See European Commission publication for further information.
  • The European Commission has published guidelines on prohibited practices under the AI Act. See publication for further information. 

UK 

  • The Department for Science, Innovation and Technology (DSIT) has published a Code of Practice for the cybersecurity of AI. This includes the development of a voluntary Code of Practice to be used to help create a global standard in the European Telecommunication Standards Institute (ETSI). See DSIT policy paper for further information. 

Brexit 

UK 

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has published supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. See guidance for further information. 

Clinical Trials 

EU 

  • The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a blog article on removing barriers to clinical trials to benefit patients and improve competitiveness. See blog article for further information.
  • The Clinical Trials Regulation is now fully applicable and all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation. See European Medicines Agency (EMA) press release for further information. 

Competitiveness 

EU 

  • The European Commission has presented a Compass to regain competitiveness. See press release for further information. EFPIA has also responded to the publication of the Competitiveness Compass stating that it “strongly supports the objective of simplification and coordination of the EU regulatory environment as a key component of the region’s competitiveness.” 

Data Privacy 

EU 

  • The European Court of Justice (CJEU) has published the Advocate General’s Opinion on pseudonymized data and data transfers in EDPS v SRB Case C-413/23. See opinion for further information.  

UK 

  • The Information Commissioner’s Office (ICO) has published a free online tool to help organisations ensure their direct marketing activities are compliant. See ICO press release for further information.
  • The ICO has published a blog article debunking data protection myths about AI. See blog article here 

Health Data 

EU 

  • EFPIA has responded to the adoption of the European Health Data Space by the Council of the European Union. See EFPIA response for further information. 

Innovative Medicines 

EU 

  • The European Commission has launched a new biotech and biomanufacturing hub to support companies bringing innovative products to the European market. See European Commission press release for further information. 

UK 

  • NICE has approved an innovative gene therapy for severe sickle cell disease. The treatment uses CRISPR gene editing technology. See NICE press release and Vertex (marketing authorisation holder) press release for further information.
  • The MHRA has announced a consultation on draft guidance on individualised mRNA cancer immunotherapies, a new type of cancer treatment being tested in clinical trials. The consultation is open until 31 March 2025. See MHRA press release and here for further information. 
  • The MHRA has refreshed and updated the Innovative Licensing and Access Pathway (ILAP) that offers an integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible. See MHRA press release and guidance for further information. 

Intellectual Property 

EU 

  • The United Patent Court (UPC) has confirmed that it has jurisdiction to consider infringement of European patents in every country in which those patents apply – which can include countries like the UK which does not participate in the UPC system. See UPC decision in UPC-CF7-355/2023 for further information. 

UK 

  • The Intellectual Property Office (IPO) has updated its guidelines on examining patent applications relating to AI. See updated guidance here

Market Access 

EU 

  • The European Commission has opened the first request submission period for joint scientific consultations. See European Commission press release for further information.
  • The European Commission has adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation.  See European Commission press release for further information.
  • The European Commission has published a video setting out the new rules on Health Technology Assessment. See here for further information.
  • It has been announced that the Belgium health technology assessment body (National Institute of Healthcare and Disability Insurance (NIHDI)) will lead the consortium of EU member states HTA agencies. The consortium will jointly assess new medicines coming on the market. See NIHDI press release for further information. 

UK 

  • NICE has launched a consultation on proposed changes on how health tecnologies are evaluated, aiming to transform its HealthTech programme and drive more technology into the National Health Service (NHS). See NICE press release for further information. The consultation is open until 6 March 2025.
  • The Association of the British Pharmaceutical Industry (ABPI) has commented that the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) payment rate for newer medicines is well above the expected rate, putting growth and investment at risk. The rate has been set at 22.9% in 2025. See ABPI press release for further information. 

Medical Devices 

UK 

  • The MHRA has published new guidance to help manufacturers meet UK medical devices regulations and ensure digital mental health technologies are effective, reliable and acceptably safe. See press release and guidance for further information. 

Medicines Shortages 

EU 

  • The European Commission has announced a call for evidence on the proposed Critical Medicines Act, which is intended to address supply chain vulnerabilities of critical medicines and reduce Europe’s dependencies to strengthen the supply of critical medicines. The call for evidence is open until 27 February 2025. See here for further information.
  • EFPIA has published a proposal for action to tackle medicines shortages. See EFPIA proposal for action here
  • The European Shortages Monitoring Platform is now fully operational, allowing marketing authorisation holders to directly report information on supply, demand and availability of nationally and centrally authorised medicines. See EMA press release for further information.  

Pharmacovigilance 

UK 

  • The MHRA has updated its guidance clarifying the expectations on the application of the EU guidance on good pharmacovigilance practices.  See here for further information. 

Regulatory 

UK 

  • The MHRA has published a document outlining guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. See guidance for further information. 

Unlicensed Medicines 

UK 

  • The MHRA has updated its guidance on importing, distributing and supplying specially manufactured or ordered products (specials) – see updated guidance here. The guidance on notification of intent to import an unlicensed medicine has also been updated and is available 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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