UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
may be performed under a WDA that authorises import. No authorisation is required to import medical devic- es, but importers should notify the UK Responsible Person or the Northern Ireland-based Authorised Rep- resentative (as described in 3.4 Procedure for Obtain- ing a Marketing Authorisation ), as they are required to provide the MHRA with a list of device importers. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Details of specific tariff duties and measures that apply to particular goods in the UK are contained in the Integrated Tariff of the UK. An importer or export- er is responsible for the correct tariff classification of goods. HMRC has developed an online trade tariff tool to assist in product classification. 7.5 Trade Blocs and Free Trade Agreements Under the EU–UK Trade and Co-operation Agreement, and the UK’s free trade deal with Norway, Iceland and Liechtenstein, there are no tariffs or quotas on trade in medicinal products and medical devices between the UK and the EU and EEA countries, and mutual recognition of GMP inspections and certificates. The UK has also entered into an economic partnership agreement with Japan, which provides for mutual rec- ognition of conformity assessments for GMP. The UK has entered into free trade agreements and mutual recognition agreements (MRAs) with Australia and New Zealand which provide for no tariffs or quo- tas on trade in most medicinal products and medical devices as well as mutual recognition of conformity assessment of medical devices and GMP. The UK- USA MRA provides for mutual recognition of conform- ity assessments for GMP of pharmaceuticals. In December 2025 the USA and the UK agreed a pharmaceutical pricing deal under which the US gov- ernment imposes a zero percent tariff on imports of pharmaceutical products into the USA until at least the end of 2028. However, following a ruling by the US Supreme Court that tariffs imposed by the US govern- ment were unlawful, the status of existing trade deals is uncertain.
The UK-Switzerland Trade Agreement provides for mutual recognition of GMP inspections and certifica- tions. The UK-Canada Trade Continuity Agreement includes a protocol relating to mutual recognition of conformity assessments for GMP of pharmaceuticals. The UK-Israel Trade and Partnership Agreement pro- vides for mutual recognition of GMP inspections and certifications. The UK-Singapore Free Trade Agree- ment provides preferential tariffs and a reduction of non-tariff barriers for medicinal products and medical devices. The UK-India Free Trade Agreement, which will elimi- nate import duties on most Indian pharmaceuticals and reduce import duties on UK medical devices, is expected to come into force in the first half of 2026. The UK remains a member of the World Trade Organi- zation. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Statutory controls on pharmaceutical pricing are set out in the National Health Service Act 2006 and subor- dinate legislation. There are currently two schemes for controlling prices of branded medicines purchased by the national health services in the UK: (i) the Voluntary Scheme; and (ii) the Statutory Scheme. Voluntary Scheme The Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) is an agreement, which is non-binding under the laws of contract, negotiated between DHSC, NHS England and the ABPI. It con- Medical Devices Medicinal Products trols the prices of branded health medicines by: • controlling the maximum prices which may be charged for medicines within VPAG; • establishing a budget cap on the total expenditure by the NHS on branded health service medicines, with member companies making scheme pay- ments to the DHSC as quarterly rebates (calcu-
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