12th December 2025 Update

Advertising

UK

• The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Angelini Pharma has breached the ABPI Code of Practice and brought discredit upon the pharmaceutical industry in relation to an in-person presentation by a contracted speaker at a company-organised promotional meeting, and its recording, which criticised the European Medicines Agency’s licensing decisions. See Angelini Pharma UK-I Limited – Case AUTH/3916/5/24 for further information.

Artificial Intelligence (AI)

EU

• The European Commission has launched a whistleblower tool for the AI Act, which will provide a confidential channel to report suspected breaches. See European Commission press release for further information.

Clinical Trials

UK

• The Association of the British Pharmaceutical Industry (ABPI) has published its annual report on clinical trials and says the number of patients being recruited into UK industry clinical trials has fallen considerably with participation now at its lowest level since 2017/2018. See ABPI press release for further information. The Heath Research Authority has also commented on the report- see here for further information.

Competition Law

Belgium

• Belgium has updated its rules for parallel distribution and imports of human medicines with a new Royal Decree published on 1 December 2025 and effective 11^th December 2025, aiming to streamline procedures and align with EU regulations. See here for further information.

UK

• The Competition and Markets Authority (CMA) has published responses following its consultation on renewed merger remedies guidance. See here for further information.

Critical Medicines

EU

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its response to the Council General approach on the Critical Medicines Act. EFPIA is generally supportive of the proposed approach. See here for further information.

Data Privacy

EU

• Several European data protection authorities have issued statements on the Digital Omnibus Regulation proposal urging the need for clarity, including Sweden, Netherlands and Denmark. The European Data Protection Board (EDPB) has also had a preliminary discussion on the proposal and will issue a joint statement with the European Data Protection Supervisor (EDPS). See here for further information.

UK

• The Information Commissioner’s Office (ICO) has issued a statement on increased cookie compliance including actions it has taken. See here for further information.

Enforcement

UK

• The MHRA’s Criminal Enforcement Unit has uncovered an organised crime network operating a series of websites to illegally supply unlicensed medicines. Three individuals have been convicted for their role in the network. See MHRA press release for further information.

Freedom of Information

UK

• The ICO has issued a series of enforcement notices and recommendations to public authorities after identifying their failures to comply with the Freedom of Information Act 2000. See here for further information.

Health Data

UK

• The UK government has appointed a new chair for the Health Data Research Service. See Department for Science, Innovation and Technology (DSIT) press release for further information.

Intellectual Property

EU

• On 25^th November 2025 the Unified Patent Court (UPC) Court of Appeal handed down its decision in Amgen v Sanofi and Regeneron UPC_CoA_529/24 and UPC_CoA_528/24 and clarified it approach to questions of the patentability standard for broad functional antibody inventions. In summary it has followed an approach broadly similar to that of the European Patent Office on both sufficiency and inventive step.

UK

• The Intellectual property Office (IPO) has confirmed that fees will increase from April 2026. See IPO press release for further information.

Market Access

UK

• The UK government will invest around 25% more in new treatments, the first increase in over two decades as increases to the National Institute for Health and Care Excellence (NICE) cost-effectiveness thresholds are confirmed. See NICE press release for further information.

Medical Devices

EU

• The European Commission has published a notice in the Official Journal confirming that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use from May 2026. The publication triggers a six-month transition period. See here for further information.

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) and NICE have received funding to improve safety and effectiveness of digital mental health technology. See MHRA press release for further information.
• The MHRA has published guidance on how to apply for a regulatory advice meeting on medical devices and in vitro diagnostics. See here for further information.

Rare Diseases

UK

• The BioIndustry Association (BIA) has released its report calling for a new pathway to give patients access to innovative rare disease medicines. See BIA press release for further information.

Research and Development

UK

• The MHRA has published general guidance on the seven funded Centres of Excellence for Regulatory Science and Innovation (CERSIs), including objectives, focus areas and funding. See here for further information.

Safety

UK

• The MHRA has published its Safety Roundup for November. See here for further information.
• An Expert Working Group of the Commission on Human Medicines, advising the MHRA, has completed a review of how the potential risks associated with the use of antidepressant medicines is communicated to patients within the patient information leaflet. See MHRA news story for further information.

Strategy Policy and Trade

UK

• A landmark trade deal has been reached between the US and the UK, which sees the UK secure a zero percent tariff on pharmaceuticals to the US, protecting UK-based manufacturing and renewing confidence of the pharmaceutical industry in the UK. See DSIT press release for further information. See also ABPI press release here.