The UK government has published its first major update to the NHS Intellectual Property (IP) guidance in over two decades. Developed by the Department of Health and Social Care (DHSC) and NHS England with support from the National Institute for
BioSlice Blog
The BioSlice Blog, published by Arnold & Porter Kaye Scholer LLP, focuses on regulatory, legal, and policy developments in the life sciences sector. It covers topics such as medical device regulations, pharmaceutical legislation reforms, intellectual property frameworks in healthcare, and digital health innovations. The blog provides analysis on EU and UK regulatory changes, compliance challenges, and industry impacts, including discussions on breakthrough and orphan device pathways, notified body regulations, NHS IP guidance updates, and antimicrobial resistance measures. It also addresses litigation, transactional, and public policy issues relevant to biotech, medtech, and pharmaceutical companies operating in regulated markets.
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European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products
On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.…
Virtual and Digital Health Digest – November 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2025 from the the United Kingdom, and European Union.…
US-UK Pharmaceutical Pricing Deal: UK agrees increase in amounts it can pay for innovative medicines and reduction of rebate rates
The UK and US governments have announced that they have reached an agreement on pharmaceutical pricing and tariffs. Under the arrangement, the tariffs charged by the US government on imports of pharmaceutical products from the UK will remain at zero…
New Medical Device and IVD Registration and Transparency Requirements to Apply in 2026
On 27 November 2025, the European Commission published a notice in the Official Journal confirming that the first four modules of the European database on medical devices (EUDAMED) are fully functional. The notice starts a 6 month transition period at…
Digital Omnibus: The European Commission published its proposal to amend the GDPR, AI Act, Data Act and other related frameworks
The EU Commission has published its proposal for the “Digital Omnibus” aimed to simplify and streamline the EU rules governing artificial intelligence, data protection, cybersecurity, and data use more broadly. The proposal seeks to amend several cornerstone EU regulations, including…
Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?
Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies
A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.
The intention is for a “bold new rulebook for rare therapies” to be published in 2026.…
Virtual and Digital Health Digest – October 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2025 from the the United Kingdom, and European Union.…
Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]
[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.
Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method…