Registration of Prices for Medicinal Products
Legal issues of state registration and re-registration of prices for medicinal products
Organizations that sell medicines included in the List of Vital and Essential Medicines are required to set maximum selling prices for them, which are registered by the Ministry of Health of the Russian Federation and should not exceed the specified maximum selling price, and the corresponding maximum wholesale mark-up and (or) the amount of retail allowances established in each subject of the Russian Federation. Also, the calculation of the initial maximum contract price during public procurement is carried out with the obligatory consideration of maximum selling prices.
Wholesale and retail surcharges are formed in accordance with the Rules for establishing the limits on wholesale and retail surcharges on actual selling prices set by manufacturers of medicinal products included in the List of Vital and Essential Medicinal Products in the constituent entities of the Russian Federation, approved by the Decree of the Government of the Russian Federation dated October 29 .2010 N 865. At the same time, these allowances are used based on the maximum selling price in accordance with the current legislation. Starting January 1, 2021, manufacturers are not allowed to sell medicinal products for which the maximum ex-works prices were not re-registered in 2019 – 2020 in accordance with the Rules for Mandatory Re-registration approved by Decree of the Government of the Russian Federation N 865 dated October 29, 2010.
Thus, it is necessary to re-register the maximum ex-works prices for medicinal products.
In particular, it establishes the need to reduce the maximum selling price for medicinal products included in the List of Vital and Essential Medicinal Products in the following cases:
- reduction of the price in foreign currency for the medicinal product in the country of the manufacturer and (or) in the countries in which the medicinal product is registered and (or) supplied by the manufacturer;
- price reductions for reference medicinal products (for corresponding generic, biosimilar (biosimilar) medicinal products);
- excess of the maximum selling price for the first reproduced, biosimilar drug of foreign production over the manufacturer's maximum selling price for the second reproduced, biosimilar medicinal product;
- excess of the maximum selling price for the first reproduced, biosimilar medicinal product of the manufacturer of the Member State of the Eurasian Economic Union over the maximum selling price of the manufacturer for the second reproduced, biosimilar medicinal product of the manufacturer of the EAEU Member State.
The current legislation establishes the Methodology for calculating the maximum selling prices for medicines included in the list of vital and essential medicines during their state registration and re-registration, approved by Decree of the Government of the Russian Federation dated September 15, 2015 N 979.
Taking into account the indicated documents, in order to re-register the maximum selling price for vital and necessary medicines, it is necessary to apply to the Ministry of Health of the Russian Federation with the following documents:
- application for re-registration;
- information about the price during the initial registration of the medicinal product (if the price was registered earlier);
- calculation of the maximum selling price of the drug;
- substantiation of the cost of a medicinal product manufactured in other countries;
- documents confirming the applicant's rights to the medicinal product.
The application can be sent in writing or through the service “Public services”.
The term for consideration of this appeal is 15 working days. Within the specified period, this price is agreed by the Ministry of Health of the Russian Federation with the Federal Antimonopoly Service of Russia. After the expiration of the specified period, a decision is made to re-register the price. At the same time, the Ministry of Health may request additional documents and clarifications from the applicant, which must be submitted within 10 (ten) working days from the date of sending the corresponding request. Otherwise, re-registration may be denied.
After a decision is made to re-register the maximum ex-works price for vital and essential medicinal products, the relevant information is placed in the State Register of Medicinal Products.
It is important to note that the issues of re-registration of the maximum selling price are related to the need to justify such recalculations for the registration authority. At the same time, there is a tendency that if it is impossible to justify a reasonable price, many manufacturers left the Russian market. In this regard, in order to prevent the defect of medicines, the Government of the Russian Federation takes appropriate measures. Thus, according to the letter of the Federal Antimonopoly Service of Russia dated 07.04.2022 N TN/33468/22 on the application of Decree of the Government of the Russian Federation dated 31.10.2020 N certificates of medicinal products should analyze the pricing of their medicinal products and divide them into medicinal products for which an annual re-registration of prices upwards is sufficient, and medicinal products for which economic conditions have changed significantly and in order to prevent a shortage of medicinal products, re-registration prices for them can be carried out only in the manner prescribed by the said Decree. In this case, it is necessary to bring economic and (or) social criteria that influenced pricing, leading to the risks of defects.
Thus, when registering and re-registering prices for vital and essential drugs, one cannot adhere to a formal approach and it is important to individually approach the justification of the price, respecting the interests of both patients and pharmaceutical manufacturers.
Legal services
- Analysis of registered marginal selling prices for the need for re-registration with a decrease / increase in price
- Advising on the possibility of re-registration of the maximum selling price on terms that will help to meet the interests of the owner (holder) of the registration dossier
- Legal support in the formation and submission of an application for re-registration of the maximum selling price and the set of documents required for such re-registration
- Analysis of the possibilities of re-registration of the maximum ex-works price, taking into account the risks of defective medicines
