Post-Brexit and availability of medicines

Abstract

The United Kingdom (UK) officially left the European Union (EU) single market and customs union on December 2020. Since the UK is now considered a third country of the EU, unavailability of medicinal products from the UK across EU member states is expected. Small member states such as Malta have sourced their medicine supply from the UK. The unavailability of or insufficient supply of medicines represents a significant obstacle to patients' access to medicines. The aim of the study was to understand how Brexit has affected medicine availability in Malta. The objectives were: to identify which medicines are not available post-Brexit and to recognize experiences of different pharmaceutical sectors involved in the supply chain when it comes to medicine availability after Brexit. The study was divided into 2 phases. Phase 1 was a review of databases which includes the Government Formulary List (GFL) and the Malta Medicines Authority (MMA) Marketing Authorization database. The status of the marketing authorizations of medicines in the GFL, as well as, the status of medicines in the MA database from the MMA website were identified. Applications to make medicines with identified Withdrawn and Invalidated MA from the UK available were checked. Phase 2 consisted of individual semi-structured interviews to determine the stakeholders’ perspectives and experiences post-Brexit. A total of 542 Marketing Authorizations (MA) with the MA Holder based in the UK were withdrawn and a total of 544 MA were Invalidated MA from the UK since they no longer met EU legislation requirements. Twenty-nine stakeholders participated in the interviews. Challenges related to Brexit reported by the stakeholders (N = 29) were: Financial costs (n = 26); Brexit is an unprecedented event (n = 23); and Public’s attitude towards medicines (n = 21). The interviewees unanimously stated (n = 29) that although the unavailability of medicines is caused by different events happening concurrently such as the Covid-19 pandemic, escalating conflicts between nations and reports of Active Pharmaceutical Ingredient manufacturing concerns, Brexit had an impact on Malta’s medicine availability. Medicine unavailability has impacts on economic, clinical, and humanistic levels especially relevant to member states with small pharmaceutical markets such as Malta where unavailability of medicines is a problem. Sourcing out medicines from different EU countries would allow greater availability of medicines. Measures established, primarily regulatory measures, such the use of Article 20 of the Medicines Act; address the availability problems. Not only do the measures provide short-term solutions and help prevent medicines shortages, but also lay down the ground work in the long run.