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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

Drug shortages have complex causes and important clinical and economic consequences

Abstract There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.

Background In accordance the WHO framework of health system functions and by using the indicators collected within the EURO-HEALTHY project, this work aims to contribute to the discussion on the classification of EU health systems. Methods Three methods were used in this article: factor analysis, cluster analysis and descriptive analysis; data were mainly collected from the WHO and Eurostat databases. Results The most relevant result is the proposed classification of health systems into the following clusters: Austria-Germany, Central and Northern Countries, Southern Countries, Eastern Countries ‘A’ and Eastern Countries ‘B’. Conclusions The proposed typology contributes to the discussion about how to classify health systems; the typology of EU health systems allows comparisons of characteristics and health system performance across clusters and policy assessment and policy recommendation within each cluster.

IN 'Canary Wharf (Bp4) T1 Ltd. v European Medicines Agency' [2019] EWHC 335 (Ch), the European Medicines Agency (EMA) unsuccessfully sought to escape a 25-year lease on a London skyscraper by arguing that the lease would be frustrated when UK ceased to be a Member State of the EU.