Alterations to the practices of informing by representatives of pharmaceutical companies
Starting from 1 May 2023, in Belarus, the procedure and conditions for informing medical and pharmaceutical workers by representatives of manufacturers of medicinal products have been changed. New features are provided for by the Resolution of the Ministry of Healthcare No. 51 of 11 April 2023 and apply to medicinal products included in the State Register of Medicinal Products of the Republic of Belarus. In particular:
- there is no longer a requirement to keep a register about informing medical and pharmaceutical workers informed;
- an alleviation has been introduced in terms of information provision by enabling the dissemination of informational materials in both electronic and paper format within organisations: visitation to organisations has become a possibility, although without interaction with their staff;
- informing aimed at drawing attention to a specific medicinal product, shaping or maintaining interest in it, or promoting it on the market is prohibited.
As a reminder, oral presentations and distribution of informational materials are now only carried out at events included in the annual work plan/activities of the Ministry of Healthcare.
Furthermore, the scope of the rules on informing is specified, and they will not apply to:
- placement (distribution) of advertising;
- functioning of the pharmacovigilance system.
New procedure for dispensing of medicinal products by pharmacies
Starting from 1 June 2023, private fifth-category pharmacies will only be allowed to sell over-the-counter medicinal products. The exception includes pharmacies that provide free and preferential provision of medicines and dressing materials to certain categories of citizens. This feature is provided for by the Resolution of the Ministry of Healthcare No. 11 of 20 January 2023, which also amends the Good Pharmacy Practice and clarifies the concept of a fifth-category pharmacy:
- the pharmacy should retail drugs to the population, healthcare organisations and other organisations for medical use, as well as provide pharmaceutical counselling to the population;
- in order to open a pharmacy, a legal entity or an individual entrepreneur shall have a pharmacy of the first or second category located in the administrative centre of the administrative-territorial unit where the pharmacy is being established;
- the location of the pharmacy should be on premises isolated from premises used for other purposes, with designated areas for receiving, storing and serving the public;
- the actual area utilised should correspond to the volume of work conducted, but should not be less than 25 square metres.
The requirement for fifth-category pharmacies to be located in areas with the highest population concentration, such as shops, markets, train stations, hotels and the like, has been eliminated.
*Please note that certain provisions of Good Pharmacy Practice introduced by Resolution No. 11 have been found by the Ministry of Antimonopoly Regulation and Trade (MART) to be infringements of competition legislation: specifically, the limitations imposed on the sale of pharmaceutical products by fifth-category pharmacies, requiring the presence of pharmacies falling within the first and second categories, as well as the ban on the dispensation of prescription drugs by fifth-category pharmacies. In light of these findings, MART has issued a formal caution to the Ministry of Healthcare, urging the exclusion of these provisions byl 30 May 2023.
Discussion of the system of labelling and monitoring the movement of medicinal products
Belarus is setting its sights on, in the near future, introducing marking medicinal products with means of identification and monitoring their movement from the moment of import or production to their ultimate withdrawal from circulation – whether that be their release from pharmacies or their use at healthcare institutions for a specific patient.
In this regard, the Ministry of Healthcare is planning a pilot project, including pharmaceutical companies, to discuss the new system in order to refine the technology and identify problematic issues.
Detection of unfair competition in the actions of a pharmaceutical manufacturer
The Ministry of Antimonopoly Regulation and Trade (MART) has acknowledged a violation of competition legislation following a complaint by a Belarusian pharmaceutical manufacturer.
The basis of the infringement lies in dissemination of informational leaflets about a pharmacoeconomic comparison, including advantages on the part of the pharmaceutical manufacturer’s medicinal product’s form of release, with a medicinal product from another pharmaceutical company which has the same international non-proprietary name.
The regulatory authority has noted that, at present, there are no established rules from the Ministry of Healthcare defining the methodology for pharmacoeconomic comparisons between medicinal products. In order to compare generics, it is necessary to have the results of bioequivalence studies or comparative bioavailability studies.
Moreover, it was pointed out that comparing medicinal products with different forms of release, quantities (and dosages) was inappropriate. Any advantages of the medicinal product in the distributed informational leaflets should have been supported by information regarding specific experiments and objective evidence.
The regulatory authority has deemed it necessary to issue a proscription to the violator, without imposing any other sanctions, including administrative liability.
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