Regulating the policies of medicines in small states with special reference to the Maltese islands

Abstract

When Malta acceded to the European Union, Malta had to adopt the European Union legislation including the legislation which covered medicinal products and pharmaceutical activities. The number of medicines which could be placed on the Maltese market went down from 8000 to 1760 (till end of July 2007). This study was carried out to explore the scenario of the Medicines Policy in Malta after the European Union accession, to analyse the benefits and constraints of European Union pharmaceutical legislation when implemented by a small state and to study the Medicines Policy of other European Union/European Economic Area small states .. A literature review was carried out to obtain an insight into the pharmaceutical sector and Medicines Policy, whilst portraying these specific areas to small states to identify the vulnerable characteristics of such states. The scope of Medicines Policy is to ensure that a given population has access to affordable and available medicines which are of safe, efficacious and of good quality, whilst promoting the rational use of medicines to the concerned parties (prescribers and patients).The most comprehensive and official framework identified to depict Medicines Policy was that of the World Health Organisation, and the literature review covered the components of the National Medicines Policy as presented by the World Health Organisation. Different methods were used to obtain a wide and deep coverage of the subject and results were presented as raw data and then analysed and triangulated to give a good insight of the situation in Malta following accession. The World Health Organisation's Level 1 Indicator Questionnaire (which is standardised and validated) and the Pharmaceutical Pricing and Reimbursement Information Report for Cyprus were used to obtain comparable information on the Medicines Policy in Malta, Iceland and Cyprus. The information was structured to compare the pharmaceutical framework of these three small states. The information of the focus group participants and questionnaire respondents was structured to build a picture of the benefits and constraints which stemmed upon the implementation of the European Union pharmaceutical legislation in Malta after accession and to portray the current scenario of the Medicines Policy in Malta. This study has shown that small states are dependent on larger countries, and sometimes find it difficult to compete with larger markets. This makes them susceptible to negative impacts if national policies are not adopted and implemented wisely. Participants were of the opinion that as a small state Malta could have adopted different measures and strategies, whilst emphasising that consultation is a key element to foretell and avoid certain negative impacts