The implementation of the falsified medicines directive in Malta

Abstract

The aim of this dissertation is to assess how the Falsified Medicines Directive will affect the small island state of Malta. The Delegated Act will come into force on 9 February 2019. The implications of implementing this directive are wide-ranging, affecting all stakeholders in the pharmaceutical supply chain. MaMVO, the Maltese Medicines Verification Organisation was set up in late 2017, being composed of the main local stakeholders. This non-governmental organisation has been progressing fairly speedily in setting up the necessary framework and is aiming to make the deadline. In formulating this legislation, the EU policy-maker is claimed not to have taken into consideration small state needs, and that their difficulties and challenges are perceived to be just that, ‘small’. The research is a Case study, evaluating the particular case of how Malta is being affected by a European pharmaceutical policy. The theoretical framework chosen is that of Europeanisation, based on Radaelli’s definition. The literature on small states and how their characteristics impose limitations on their capacities is also included. This enabled the researcher to theorise the Europeanisation process in the context of small states. It is postulated that this policy is being implemented in a top-down approach, and therefore states, including Malta need to adopt the policy as prescribed by European institutions. The way domestic policies and polities are affected by Europeanisation was thus pursued. A qualitative approach was considered appropriate since this type of social research aims at obtaining in-depth findings about an event. In order to guide the researcher through the study, a set of three research questions were compiled, aimed at evaluating policy processes, how actors interact with European institutions and subsequent effects of pharmaceutical policy on small states. Since the implementation of the delegated regulation is occurring during the compilation of the study, the researcher opted for semi-structured interviews to capture stakeholders’ perceptions and obtain the latest information from primary sources. Nine face-to-face interviews were conducted with the main stakeholders, with the average duration of 34 minutes. Analysis of the verbatim interview transcripts was performed by means of QSR NVivo 11. The process of thematic coding was performed to extract key concepts from the text. These codes, together with key categories elicited from the literature review helped to inform the creation of the conceptual framework for this research study, based on Azzopardi Muscat’s (2016) work on health systems in small states. The study’s findings correlate well with the literature and provide a clear picture of the implications of the FMD on Malta. Stakeholders are still willing to implement the policy, despite their cynicism of the reasons behind the legislation. They will face several challenges related to maintaining supply of medicines locally and cost of medicines. Small states have limited powers on their own to affect European policies. This research speculates about possible ways of how small states may best improve their chances of having their health interests represented. It also advocates for empowerment of stakeholders and the creation of stronger networks on health policies.