On 10 April 2023 Presidential Edict No. 95 was announced, reintroducing registration of maximum sale prices for pharmaceuticals sold in the country. The government will determine the list of pharmaceuticals subject to price registration, and the procedure and timeframe for implementation.
The new act reactivates the approach in force under 2018 Presidential Edict No. 345 On the Registration of Pharmaceutical Prices, which was suspended in April 2020.
The method for calculating maximum sale prices will be determined by the Ministry of Antimonopoly Regulation with the agreement of the Ministry of Healthcare. According to the latter’s comments, the reference pricing method will be used to determine maximum sale prices by comparing the price of pharmaceuticals with the same trade name in other countries or pharmaceuticals with the same active ingredient on the Belarusian market. The maximum sale prices will be included in a state register maintained by the Ministry of Healthcare.
The following is an approximate overview of how the process of price registration for pharmaceuticals in Belarus could work in practice:
- Determination of the list of pharmaceuticals subject to regulation. Within three months of official publication of the Presidential Edict No. 95, the government will determine the list of pharmaceuticals subject to price registration. This list will likely include pharmaceuticals that are deemed vital for health, as well as high-cost pharmaceuticals and pharmaceuticals that have no analogues on the market.
- Selection of comparable pharmaceuticals. The registration process will involve selecting comparable pharmaceuticals for each pharmaceutical item on the list. Comparable pharmaceuticals will include products with the same trade name or the same international generic name (active ingredient).
- Comparison of prices. Once comparable pharmaceuticals have been selected, the government will compare the price of the pharmaceutical from the list to the prices of comparable pharmaceuticals. If the price of the pharmaceutical is higher than the reference price, the maximum sale price for that pharmaceutical will be adjusted to not exceed the reference price.
- Registration of maximum sale prices. After the comparison has been made, pharmaceutical companies shall register their maximum sale prices for the relevant pharmaceuticals. The registered maximum sale price will be the highest price that can be used for the sale of the pharmaceuticals in the Belarusian market.
- Monitoring and enforcement. The government will monitor the registered maximum sale prices to ensure compliance with the new regulation. Non-compliance with the regulation could result in penalties or other enforcement actions.
To sum up, the new regulation in Belarus requiring pharmaceutical companies to register their maximum sale prices with the Ministry of Healthcare could potentially impact foreign producers, including those operating in the country through local distributors. The registered maximum sale price may be adjusted to not exceed the reference price determined by the government, affecting the profits of foreign companies and their local distributors. This process may also add administrative burdens and costs. It is recommended that foreign companies and their local distributors monitor developments and seek advice to ensure compliance and minimise negative impacts on their business operations in Belarus.
Our Life Sciences & Healthcare sector group and Commercial & Regulatory practice group teams would be happy to assist with any pricing-related issues in the field of healthcare. You can address your questions and our experts will get in touch with you.
Kirill Laptev, Partner
+375 29 339 4590
Marina Golovnitskaya, Counsel
+375 29 188 4328
Olga Haiduk, Associate
+375 25 605 5455
Viktoria Shevyakova, Associate
+375 29 998 4184