Provision of population with affordable medicinal products in the full range at affordable prices is the basis of health, human potential development, and increased economy efficiency. Prices need to be regulated due to the high social value of these products. The availability of medicinal products is one of the key factors that determine the quality and standard of living, basic social security, and vital interests of all segments of the society. Creating a balanced and effective system of prices for medicinal products should stimulate development of the pharmaceutical market.
Among multiple methods of regulation of prices for medicinal products used in the various countries of the world, the most widely used method is price registration (Japan, France, Spain, Sweden, Belgium, Russia, Kazakhstan, Moldova, India, etc.).
On August 22, 2018 Decree No. 345 of the President of the Republic of Belarus “On Registration of Prices for Medicinal Products” was signed. The Decree has been developed to optimise functioning of the system of manufacture and distribution of medicinal products, as well as to regulate re-selling activity while marketing medicinal products in the domestic market. The Decree provides for implementation of the project on creation of the system of state registration (re-registration) of manufacturers’ maximum ex-works prices for medicinal products in the Republic of Belarus in 2018-2020. Activities for implementation of the project will be performed jointly by the Ministry of Health of the Republic of Belarus and the Ministry of Antimonopoly, Regulation and Trade of the Republic of Belarus within the competence of each of the government authorities.
State registration (re-registration) of prices for medicinal products will apply to medicinal products for treatment of cardiovascular diseases (involving 21 international non-proprietary names) and cancer (involving 16 international non-proprietary names).
One of the major purposes of this Decree is to provide a transparent price control mechanism clear to all market participants, including by determining the single algorithm of calculation by manufacturers of medicinal products of maximum ex-works prices and specific criteria based on which such calculation should be carried out. The maximum ex-works price proposed by the applicant will be subject to economic analysis, including for comparability with ex-works prices in the country of manufacture of the medicinal product, member states of the Eurasian Economic Union, as well as in other reference countries similar to the Republic of Belarus by the GDP per capita and territory (15 countries have been defined).
Keeping of the public register of the Republic of Belarus in relation to manufacturers’ maximum ex-works prices for medicinal products is provided for. The Ministry of Antimonopoly, Regulation and Trade in cooperation with the Ministry of Health developed the draft Resolution of the Council of Ministers of the Republic of Belarus “On Some Issues of Registration (Re-Registration) of Manufacturers’ Maximum Ex-Works Prices for Medicinal Products”, as well as a draft of the joint Resolution of the Ministry of Antimonopoly, Regulation and Trade of the Republic of Belarus and the Ministry of Health of the Republic of Belarus “On Approval of the Procedure for Calculating Manufacturers’ Maximum Ex-Works Prices for Medicinal Products”.
Creation of the system of state regulation of prices for medicinal products will allow to:
– establish prices for domestic and foreign medicinal products in the domestic market of the country, not exceeding the level of prices for the same medicinal products in the neighbouring countries;
– improve the pricing practices in relation to the wholesale prices of medicinal products;
– obtain reliable results of marketing researches of foreign markets of medicinal products that can be used in government procurements;
– minimise involvement of re-selling organisations in the process of marketing of the medicinal products in the market of the Republic of Belarus and exclude unreasonable (unfair) mediation in government procurements.
In order to improve implementation of the procedure for registration (re-registration) of manufacturers’ maximum ex-works prices for medicinal products, the department of registration of prices for medicinal products has been formed within the structure of the Department of Medicinal Products of Centre for Examinations and Tests in Health Service Unitary Enterprise. The main functions of this department will include primary examination of documents for registration of prices, record-keeping, and archiving under the procedure, study of international experience in the field of regulation of prices for medicinal products and introduction of best achievements in this field.
In case of positive results during the pilot project and ultimately reduction in prices for medicinal products, the list of medicinal products, the prices of which are subject to state registration (re-registration), will include medicinal products from the list of essential medicinal products (the list of medicinal products that satisfy the vital needs of the population of the Republic of Belarus in providing with medicinal products, as well as used for preferential, including free of charge providing with medicinal products during health care delivery on the outpatient basis).