Pinchuk D. The regulative policy in the sphere of trade of medicaments

The thesis is a complex research of theoretical, methodical and practical aspects of the regulatory policy in the sphere of trade of medicaments. The regulatory police in the sphere of trade of medicaments is a key element of social and humanitarian state policy, since it provides people with medicines and medical products, becomes an important element of effective heath care system establishment and functioning. The pharmaceutical sector is an object of high attention and regulation at the pharmaceutical market for the purpose of quality and efficiency provisioning of the medicines and pills that are produced and sold to the consumers. With this standpoint the state establishes the rules of access medicines to market as well as forms and procedures of quality maintenance in the course of its production and realization. The qualification criteria for subjects that exercise the production and selling of medicines are also established. The state regulation affects the availability of medicines, emerging the rules how they shall be bought for the funds of the state budget, rules of their realization within the ranks of commercial companies. The system of the state regulation of market highly affects the economic availability of medicines for the ultimate consumers by means of shifting the direct and indirect ways of price regulation and provides an access to the reimbursement of expenses on medicines. It is clearly settled that only that regulation system may be considered to be effective that provides the economic and physical availability of safe, qualitative and effective medicines for consumers with regulatory expenses of both state and business being minimized. The author’s treatment of the regulation system of the pharmaceutical market is witnessed as a complex and multilevel structure, which effective functioning depends on the existence of institutional, legal, economic and social determinants. The elements of the governmental regulation at different stages of the medicines turnover and its main directions and ways of fulfillment are detected. The functioning of the turnover regulation system in Ukraine is one of the main components of the national medicines quality securement system. The methodological aspects of the establishment of system of quality provisioning are proposed. The common scheme of the execution of the supervisory procedures over the medicines turnover is formed. Within the ranks of the state medicines regulation system the most important problem appears: how the cost of medicines shall be reimbursed – via the governmental solely means of repayments or by means of combined state and private reimbursement. The author’s treatment of term “reimbursement” is proposed – the reimbursement is a commonly applied in the international practice title for the process that affects the availability of medical services and medical products for people. The supervisory system on the turnover of medicines shall be appointed at the effectiveness of regulatory effects – by means of evaluation of their implementation outcomes; efficiency of expenses of the governmental institutions; the observance of validation procedures; the sell off according to the respective standards; the implementation of prices premiums; terms of preservation; the procedures of forestalling (especially for pharmacies); the activities of governmental bodies that are components of health protection system-buying procedures, the usage of medicines and medical products with appropriate packaging and admittance rules; mechanisms of market regulation by respective governmental bodies. The conceptual model of regulation of medicines is stated that includes the establishment of multilevel institutional provisioning with implementation application of measures, methods and regulation methods. Such approach is based on the EU – member states experience, which presupposes the evaluation of efficiency the regulatory policy in the sphere of medicines turnover on the basis of the all-around evaluation of health system and the improvement of the length of life. The methodological approach developed allows to increase the effectiveness of regulatory policy in the sphere of medicines trade in Ukraine.