On October 18, 2018 new wording of the Rules of state registration and re-registration of maximum sale prices established by drug manufacturers for those drugs, that are included in the vital and essential drugs list (the Rules and the Drugs correspondingly) has been enacted1 with the amendments introduced by the Russian Government Decree of 08.10.2018 No. 1207 On amendments to the Russian Government Decree of October, 29 2010 No. 865 and of September, 15 2015 No. 979 (the Decree).
Specifically, the main changes introduced by the Decree are as follows:
1. New templates of applications for state registration and re-registration of the manufacturer’s maximum sale price for the Drug are approved
Application templates for registration2 and re-registration3 of the manufacturer’s maximum sale price for the Drug (&the Templates) are mostly similar to the former application template4. At the same time there are some changes:
- Applicant must provide additional information in the Templates regarding tax registration of the Drug’s market authorization holder or owner;
- There is a new table in the Templates, where information on each production stage of the Drug, manufacturer’s name, address and country must be provided;
- There is a renewed information in table with Drug’s information.
2. Additional requirements as to the state registration of manufacturer’s maximum sale price for the Drug are established
List of additional documents required for Russian Federal antimonopoly service (FAS) to carry out an economic analysis of the proposed Drug’s price is established by clause 22 of the Rules for the purpose of state registration of manufacturer’s maximum sale price for the Drug. Namely, the following documents are additionally required from the Drug’s manufacturer being incorporated in the EEU member state:
- Information on production, shipment and prices of medicines according to form No. 2-LEK (prom);
- Copies of consignment notes for the particular Drug.
3. Changes to procedure for re-registration of manufacturer’s maximum sale price for the Drug are introduced
Registered manufacturer’s maximum sale price for the Drug can be re-registered in order to be increased no more than once in a calendar year. In this case additional set of documents is required for FAS to carry out an economic analysis of the new estimated price. The set of documents5 is stipulated by clause 35 of the Rules.
Meanwhile, time limits for re-registration of manufacturer’s maximum sale price for the Drug in order to be reduced are canceled.
4. Requirement for price of the generic Drugs to be not higher than the registered price of the original Drug is stipulated
5. The limit of profitability in amount of 30% is applied for price establishing upon the re-registration of prices for Drugs manufactured within the EEU member states
Under the official comment to the Decree published6 on the website of the Russian Government, inclusion of the economic analysis and its methodology in the Rules will allow to determine the manufacturer’s maximum sale price of the Drug objectively and prevent an unreasonable increase in prices for the Drugs. Thus, the amendments introduced by the Decree to the procedure of registration and re-registration of manufacturers’ maximum sale prices for the Drugs are aimed at improving and optimizing the state regulation of establishing reasonable price for the Drugs and reflect the latest FAS approaches in the sphere of Drugs’ prices regulation.
1Official publication link: http://publication.pravo.gov.ru/Document/View/0001201810180006
2Schedule No. 1 to the Rules
3Schedule No. 2 to the Rules
4Approved by the Order of the Ministry of health and social development of the Russian Federation of 02.11.2010 No. 958n «On approval of the application form for registration of the manufacturer’s maximum sale price for drugs included in the vital and essential drugs list»
5Apart from clause 5 of the Rules