Brexit: does the Windsor Framework help resolve challenges for health?

Solving old problems The EU already acted last year to remove one major immediate source of worry for suppliers and users of medicine in NI—the threat that medicines tested for compliance in GB would not be valid for use.4 Article 3 of the proposed new Regulation will eliminate another: the threat t...

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Bibliographic Details
Published in:BMJ (Online) 2023-04, Vol.381, p.825-825
Main Authors: Dayan, Mark, Hervey, Tamara, Fleur, Mark
Format: Article
Language:English
Subjects:
Councils
Diffusion Magnetic Resonance Imaging
EU membership
European Union
Food
Humans
Labeling
Opinion
Parliaments
Politics
Regulation
Regulatory agencies
Suppliers
United Kingdom
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Summary:Solving old problems The EU already acted last year to remove one major immediate source of worry for suppliers and users of medicine in NI—the threat that medicines tested for compliance in GB would not be valid for use.4 Article 3 of the proposed new Regulation will eliminate another: the threat that after a grace period ended, suppliers would need to start removing EU security tags and identifiers when a product entered GB, only to reapply new ones when it crossed the Irish Sea.5 A House of Lords Committee recently described this as “the single biggest factor causing difficulties under the Protocol.” Driven by growing divergence in authorisations, which our recent report showed had slowly started to emerge, this was a source of concern among healthcare and medical officials we spoke to, both for cutting-edge drugs and for more inexpensive products where a wide range of suppliers helps guard against price rises and shortages.16 This was the result of NI remaining subject to the approvals system for medicines within the EU’s single market. PE/6/2022/REV/1. https://data.europa.eu/eli/dir/2022/642/oj 5 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland. https://commission.europa.eu/system/files/2023-02/COM_2023_122_1_EN_ACT_part1_v2.pdf 6 Nuffield Trust. (EU) No 609/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission
ISSN:1756-1833
1756-1833
DOI:10.1136/bmj.p825