22nd August 2025 Update

Advertising

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published its decisions for July 2025 following investigations into complaints about advertising for licensed medicines. See here for further information.

Artificial Intelligence (AI)

EU

• The European Commission has published a Question and Answers (Q&A) on the call for the establishment of an AI scientific panel. See Q&A for further information.

UK

• The Law Commission has published a discussion paper on AI and the Law, which aims to raise awareness of the legal issues regarding AI. See here for further information including link to the discussion paper.

Clinical Trials

UK

• The MHRA has published Guidance on the Route B substantial modification pilot, which starts on 1 October 2025. Route B refers to a specific category of changes made to a clinical trial approval under the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. See Guidance here for further information.

Competition Law

UK

• The Competition and Markets Authority (CMA) has reported that the Subsidy Advice Unit (SAU) has accepted a referral of the proposed Life Sciences Large Investment Portfolio scheme by the Office of Life Sciences. The Life Sciences Large Investment Portfolio (LSLIP) scheme provides subsidies to companies investing over £250 million in UK-based manufacturing and/or R&D. The SAU will evaluate whether the scheme complies with the subsidy control requirements. See here for further information.

Data Privacy

UK

• The Information Commissioner’s Office has launched a consultation on the Data (Use and Access) Act 2025 to help shape its proposed guidance. The consultation on ‘recognised legitimate interest’ as a new lawful basis is open until 30 October 2025. The consultation on handling data protection complaints is open until 19 October 2025. For further information on the consultations see here
• The first provisions of the Data (Use and Access) Act 2025 have come into force on 20th August. See further information from the ICO on the Act here and government guidance here.
• The ICO has issued a statement on how data protection law applies to facial recognition technology. See here for further information.

Intellectual Property

Global

• The World Intellectual Property Organisation (WIPO) has published a primer on technology transfer in the field of biotechnology. The primer includes templates and examples of language that have been utilised in successful biotechnology agreements. See here for further information.

Market Access

UK

• The accelerated review of the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) has ended without agreement after Wes Streeting issued an ultimatum to the pharmaceutical industry to accept the government’s terms on drug pricing or he would end the talks. See Association of the British Pharmaceutical Industry (ABPI) press release for further information.

Policy, Strategy and Trade

EU

• The EU and US have published a Joint Statement on transatlantic trade and investment. The Joint Statement builds on the political agreement reached at the end of July. See European Commission press release and the European Federation of Pharmaceutical Industries and Associations (EFPIA) EFPIA response for further information.

Regulatory

EU

• The European Medicines Agency (EMA) has published its Human Medicines Highlights for August 2025 including details of new medicines recommended for approval and information on approved medicines. See here for further information.

UK

• The MHRA has opened a consultation on the revised ICH Guidance M4Q (R2), a guideline to capture quality information for the registration and lifecycle management of pharmaceuticals for human use. The consultation is open until 26 October 2025. For further information on the consultation see here.