The effect of Covid-19 and Brexit on compliance of the Falsified Medicines Directive

Abstract

The Falsified Medicines Directive (FMD) was ratified in July 2011. The motivation behind the FMD is to stop falsified drugs from reaching patients. The aim of this study was to evaluate the impact of Brexit and Covid-19 on compliance with the FMD. Three questionnaires were disseminated to pharmacists, two in Malta pre and postunique identifier (UI) implementation and one in Bonn post-UI implementation. A focus group discussing the consequences of Brexit and Covid-19 with respect to the FMD was conducted and the results were analysed. Eighty-five participants answered the pre-implementation questionnaire in Malta. Participants never encountered a case of falsified drugs (n=78), agree that the UI will increase their workload (n=56), cause drug prices to increase (n=46), will decrease entry of falsified medicines in the legal supply chain (n=69), and is worth its financial impact (n=34). Seventeen participants answered the post-implementation questionnaire in Bonn and eighty-six participants answered the post-implementation questionnaire in Malta. Participants never encountered a case of falsified drugs (Bonn: n=15; Malta: n=72), agree that that the UI caused an increase in their workload (Bonn: n=12; Malta: n=56), caused drug prices to increase (Bonn: n=0; Malta: n=23), has decreased entry of falsified drugs in the legal supply chain (Bonn: n=9; Malta: n= 48) and is worth its financial impact (Bonn: n=3; Malta: n=29). Brexit related challenges identified during the focus group included Malta’s historical dependence on the UK market, its small market, and the current lack of Maltese importers able to affix the safety features to medicinal packs. With respect to Covid19, strengths identified included the temporary exemption granted by the EU to v manufacturers of the Covid-19 vaccines from having to bear the safety features. Weaknesses identified included the high demand for Covid-19 vaccines and other medications being used for Covid-19. The UI is seen as effectively preventing falsified drugs, but most participants did not agree that it is worth its financial impact. Increase in workload was envisaged and experienced by pharmacists surveyed. Brexit and Covid-19 present a challenge to pharmaceutical stakeholders, which is further complicated by the implementation of FMD.