The availability of medicines post-Brexit in Malta

Abstract

Following the EU Referendum decision in June 2016, the United Kingdom (UK) officially leftthe European Union (EU), and its single market and customs union on 31 January 2020.Since the UK now has third country status with regard to dealings with the EU, restrictedavailability of medicinal products from the UK across EU member states (MS) is expected.Smaller MS, such as Malta, have historically sourced medicinal supplies from the UK. Thelack of availability or insufficient supply of medicines represents a significant obstacle topatients’ access to medicines. Within this article, we investigated how Brexit has affected medicines availability in Malta,namely, to identify which medicines are not available post-Brexit and to recogniseexperiences of different pharmaceutical sectors involved in the supply chain when it comesto medicine availability post-Brexit. A total of 542 marketing authorisations (MA) with theMA holder based in the UK were withdrawn, and a total of 544 MA became invalidated as MAfrom the UK since they no longer met EU legislative requirements. Poor medicines availability has a clear negative downside on economic, clinical and humanlevels which are especially relevant to MS, such as Malta with smaller pharmaceuticalmarkets, where lack of availability of medicines is a problem. Ultimately, sourcingmedicines from other EU MS would allow greater availability of medicines.