21st March 2025 Update

Artificial Intelligence (AI)

EU

• The European Medicines Agency (EMA) has qualified the first artificial intelligence tool to diagnose inflammatory liver disease. See EMA press release for further information.

• The European Commission has published the 3^rd draft of the General-Purpose AI Code of Practice. See here for further information and link to the third draft of the Code.

• The European Commission has published updated model contract clauses for AI procurement. See here for further information.

Competition Law

Belgium

• The Roche group has been accused by the Belgium Competition Authority of having implemented a strategy between 2017 and 2020 designed to delay the market entry of biosimilar rivals of its oncology medicines. See Belgium Competition Authority press release here

UK

• The Competition and Markets Authority has opened a consultation on a proposed recommendation that the Secretary of State replace the Assimilated Technology Transfer Block Exemption with a UK block exemption order, when it expires on 30 April 2026. The consultation is open until 11 April 2025. For further information on the consultation, see here

Critical Medicines

EU

• The European Commission has proposed new rules to secure the supply of critical medicines. See European Commission press release , European Commission news article, Q&A of the Critical Medicines Act for further information. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has also published its response on the Critical Medicines Act. See EFPIA response here

Data Privacy

UK

• The European Commission has proposed to adopt an extension of the UK adequacy decision. See European Commission announcement here

• The Information Commissioner’s Office (ICO) has announced plans for a new set of regulatory measures to help drive growth. See ICO press release here

Health Data

EU

• EFPIA has published an article setting out an overview of cancer outcomes data across Europe. See EFPIA article for further information.

• EFPIA has published a report on harnessing real-world evidence to transform healthcare decision making in Europe. To access the report see here

Manufacturing

UK

• The Medicines and Healthcare products Regulatory Agency (MHRA) has published information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025. For further information see here

Market Access

UK

• National Institute for Health and Care Excellence (NICE) has approved changes to the routing criteria for highly specialised technologies. See NICE press release for further information.

Pricing

UK

• The government is proposing to raise the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies’ NHS sales in the second half of 2025. A consultation has been opened which closes on 25 April 2025. For further information on the proposal and how to respond to the consultation see The Association of the British Pharmaceutical Industry (ABPI) has published two articles in response to the government’s proposal. See here and here for further information.

Regulatory and Regulatory Bodies

EU

• EMA has published its March 2025 Human Medicines Highlights with information on CHMP opinions and new medicines approvals. See here for further information.

• EMA and the Heads of Medicines Agencies have published their joint network strategy to 2028. The strategy, called ‘Seizing opportunities in a changing medicines landscape’, is a comprehensive update of the five-year strategy. See EMA press release for further information.

UK

• The government has announced that NHS England is to be abolished and brought back into the Department of Health and Social Care. See parliamentary statement and press release for further information.

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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