Analysis of the legislation of the Republic of Moldova in terms of pharmaceutical security

Abstract

Background: The pharmaceutical security can only be ensured taking into account its multidimensional and systemic character; the partial or one-sided approach will not ensure the feasibility and the sustainability of such security. A major condition to ensure pharmaceutical safety is the existence of a legislative base. The purpose of the paper is to highlight regulatory gaps affecting the pharmaceutical security of the Republic of Moldova. Material and methods: Based on a logical analysis, all conditions, the compliance with which would ensure the pharmaceutical security of the state and of each citizen were determined. The existence or absence of legal provisions legalizing the application of various ways, methods, processes, procedures, regulations and other measures that would impose compliance with pharmaceutical security conditions was highlighted. The level of legislative coverage of the requirements for the provision of pharmaceutical security was determined. The quantification scale regarding the level of legislative coverage for the provision of pharmaceutical security was developed. Results: The research resulted in the development of the methodical toolbox by means of which the legislative coverage level of the pharmaceutical security was identified. The calculations demonstrated that the legislation of the Republic of Moldova does not sufficiently cover the pharmaceutical security. This fact refers mostly to the insufficient regulation of the good quality of pharmaceutical services, of the proper functioning of the entire pharmaceutical system and of ensuring physical and economic availability of drugs. Conclusions: The impact of the governmental factor in the Republic of Moldova concerning certain aspects of the pharmaceutical security was highlighted. The toolbox of methods for the analysis of the level of legislative coverage of pharmaceutical security was drawn up.