UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices On account of Brexit, the UK is no longer subject to EU single market rules or the EU legislative framework. However, under the EU–UK With- drawal Agreement’s Protocol on Ireland and Northern Ireland, Northern Ireland continues to follow EU rules. However, this was somewhat narrowed by the entry into force of the EU-UK Windsor Framework on 1 January 2025, which allows for the UK-wide licensing of novel medi- cines, pursuant to domestic legislation, by the Medicines and Healthcare products Regulatory Agency (MHRA). Pre-existing domestic legisla- tion that implemented EU law continues to have effect in the UK. UK regulation of medicinal products derives from EU legislation, principally Directive 2001/83/ EC (EU Directive 2001/83) and Regulation (EC) 726/2004 (EU Regulation). The key UK legisla- tion is the Human Medicines Regulations 2012 (SI 2012/1916), as amended (HMRs). Similarly, UK regulation of medical devices derives from three EU Directives (the Medical Device Directives): • Council Directive 93/42/EEC on Medical Devices; • Council Directive 90/385/EEC on Active Implantable Medical Devices; and • Council Directive 98/79/EC on In Vitro Diag- nostic Medical Devices (IVDMD). These directives are implemented in UK domes- tic law through the Medical Devices Regulations 2002/618, as amended (UK Medical Devices Regulations). The more recent EU Regulations
on medical devices – Regulation (EU) 2017/745 on medical devices (EU MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR) – do not apply to Great Brit- ain, but do to Northern Ireland. The UK govern- ment intends to bring the UK Medical Devices Regulations up to date through a series of Stat- utory Instruments. The first of these regarding post-market surveillance requirements will come into force on 16 June 2025. The Medicines and Healthcare products Regu- latory Agency (MHRA) is an executive agency sponsored by the Department of Health and Social Care (DHSC). The MHRA has the statu- tory responsibility to apply and enforce laws governing pharmaceuticals and medical devices in the UK. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions of the MHRA can be challenged by way of judicial review in the Administrative Court, King’s Bench Division or through statu- tory review proceedings, although this is rarely used. For a judicial review, an application must be made promptly, and in any event within three months of the decision to be challenged, and the applicants must be able to show a sufficient interest in the matter to which the application relates. The court’s permission is required to proceed with a claim for judicial review. The grounds for judicial review can be summa- rised as: • illegality;
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