Pricing regulation in healthcare in Belarus: drugs
To date, the basis for regulation of prices for drugs in Belarus is represented by an extensive list of regulatory legal acts and explanations of state bodies.
The main legal acts in this sphere are:
1. Edict of the President of the Republic of Belarus of August 11, 2005 No. 366 “On Formation of prices of drugs, medical devices and medical equipment”, hereinafter – Edict No. 366.
2. Edict of the President of the Republic of Belarus of August 22, 2018 No. 345 “On registration of prices of drugs”.
3. Resolution of the Council of Ministers of the Republic of Belarus of October 31, 2018 No. 776 “On registration of manufacturers' maximum selling prices of drugs”.
4. Instruction on the methodology of calculation of manufacturers' maximum selling prices of drugs approved by Resolution of the Ministry of Antimonopoly Regulation and Trade of the Republic of Belarus of July 11, 2023 No. 45 “On approval of the Instruction on the methodology of calculation of manufacturers' maximum selling prices of drugs”, hereinafter – the Instruction.
The basis for control of the price growth of drugs sold in Belarus by the retailers and wholesalers is the establishment of maximum wholesale and retail markups for drugs.
Amounts of maximum wholesale and retail markups for drugs:
There is a different regulation for the manufacturers of drugs from the List of drugs, the maximum selling prices for which are subject to registration (hereinafter referred to as the List). Example of drugs from the List: amoxicillin + clavulanic acid; valsartan; ibuprofen; nimesulide; lactulose; omeprazole; rivaroxaban etc.
The Instruction determines the methodology of calculating manufacturers' maximum selling prices for drugs, defining it as an average value calculated from the weighted average of the actual selling (contract) price adjusted for the forecasted consumer price index and the average arithmetic value calculated based on manufacturers' minimum selling prices in referent countries and the country of the dosage form.
Note: the list of reference countries includes Belgium, Bulgaria, Hungary, Greece, Kazakhstan, Latvia, Lithuania, Poland, Russian Federation, Romania, Slovakia, France, and the Czech Republic.
The possibility to determine independently the maximum selling price of a drug is provided for new drugs in the absence of sales on the domestic and foreign market, absence of information on the manufacturer's price of a drug on the Internet, including the manufacturer's price of a drug having the nearest adjacent amounts and (or) dosages.
There is a requirement to register manufacturers' maximum selling prices for drugs. The registration of the maximum selling price is based on the fact that the drug is included in the List.
Registration is carried out by the Ministry of Health. The body authorized to receive and review documents is the Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare” and the Ministry of Antimonopoly Regulation and Trade is authorized to conduct economic analysis of the maximum selling price.
The state register of manufacturers' maximum selling prices for drugs is available on the website of the Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare” at the following link: https://www.rceth.by/Refbank/reestr_drugregpricenew/results.
The maximum selling prices are registered in Belarusian rubles.
Note that the holder of the registration certificate (or authorized person) may specify the currency of the contract when applying, if the drug is sold in the territory of Belarus based on a contract in which the amount of payment is expressed in foreign currency.
Some price registration issues:
The registered maximum selling price may be changed. Economic inexpediency could be a reason to change the already registered maximum selling price. Among the cases considered while calculating the new maximum selling price: changes in commodity prices, materials, overhead expenses.
Authors: Dmitry Viltovsky, Aliaksandra Vasilyeva.
