2nd June 2025 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Sanofi is in breach of clauses 2, 3.5 and 5.1 of the Code of Practice for the Pharmaceutical Industry (the “Code”) by providing gifts to patients via a patient organisation. See Case/0284/09/24 for further information.

• The PMCPA has ruled that Pfizer has breached clauses 2, 3.1, 3.3, 7.2 and 9.1 of the Code for promoting an unlicensed vaccine including to members of the public on Twitter. See Case AUTH/3888/4/24 for further information.

Artificial Intelligence (AI)

EU

• The European Commission is seeking views on the use of data in AI. The consultation is open until 18th July 2025. See here for further information on the consultation and how to provide feedback.

Biotech Act (EU)

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the EU Biotech Act, which it says offers “an opportunity for serious improvements to European competitiveness in clinical research”. See EFPIA commentary here

Clinical Trials

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) Chief Executive, Lawrence Tallon reflects on the reforms to the regulatory framework for clinical trials. See MHRA press release here

Competition Law

EU

• The European Commission has adopted proposals to sign and conclude the EU-UK Competition Cooperation Agreement, a framework for cooperation between competition authorities when enforcing competition law rules. See European Commission press release for further information.

• The Court of Justice of the EU (CJEU) has ruled on when an exclusive distributor can benefit from restrictions on active sales into its territory under the 2010 Vertical Block Exemption Regulation (VBER). Although the VBER was replaced in 2022, it is considered that the current VBER should be interpreted in the same manner. See CJEU decision for further information.

UK

• The Competition and Markets Authority (CMA) has published its decision to accept commitments from Vifor Pharma in relation to intravenous iron treatments and has closed its investigation. See here for further information.

Cybersecurity

UK

• The Information Commissioner’s Office (ICO) has updated its cybersecurity guidance for organisations. See here for further information.

Data Privacy

EU

• The European Commission has published its proposal for a Regulation amending several existing regulations including GDPR to simplify obligations on small and medium sized enterprises (SMEs) and to extend certain mitigating measures to mid-cap enterprises. See Proposal for further information.

Intellectual Property

EU

• The European Commission has welcomed political agreement on new rules for compulsory licensing to improve the EU’s crisis resilience. See European Commission press release for further information.

• The European Commission has published its biennial Report on Protection and Enforcement of Intellectual Property Rights (IPR) in Third Countries, identifying IPR deficiencies in Third Countries which cause the most harm to EU interests. See European Commission press release for further information.

• The Unified Patent Court (UPC) has issued its first decision on second medical use claims in a long-running dispute between Sanofi and Amgem, providing useful guidelines on assessment and infringement of second medical use claims. See decision for further information.

Market Access

US

• President Donald Trump has signed an Executive Order aimed at bringing U.S. drug prices in line with prices paid in “comparably developed nations”. The Order aims to implement “most-favored-nation” pricing targets in 30 days. See here for further information.

Medical Devices

UK

• The MHRA has announced that it will hold a webinar on 19th June 2025 to present an update on the MHRA AI Airlock regulatory sandbox pilot for AI as a medical device products. Early insights from the pilot will be presented at the webinar. See here for further information, including how to obtain tickets.

Policy, Strategy and Trade

UK

• The Department for Science, Innovation and Technology (DSIT) has announced new plans to support ten-year funding for certain research and development activities. See DSIT press release for further information. The announcement was also welcomed by The Association of the British Pharmaceutical Industry (ABPI). See ABPI press release here

Regulatory

UK

• The MHRA has updated its Guidance on the national assessment procedure for medicines and included a link to a webinar, which took place on 6th May 2025. See here for further information, including link to the webinar.

• The MHRA has opened a consultation on a draft guideline on the use of external control arms based on real world data to support regulatory decisions. For further details on the draft guideline and consultation see 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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