09-09-2020 | 09:46

The state of competition in the field of medicine sales was a part of the Report on competition development for 2019

The change in the pricing system and the transition from an inefficient "cost-based" method to indicative parameters allowed the FAS Russia to reduce 242 prices for medicines from the list of vital and essential ones in 2019.

According to the Report on the state of competition for 2019, since 2016, the FAS Russia has reduced more than 1 thousand maximum selling prices of manufacturers for vital medicine. The average reduction was 40%.

By the end of 2020, the FAS Russia will complete a large-scale review of all registered maximum selling prices of manufacturers for vital and essential medicine [1], prices for which were registered in 2010-2019. This work has already led to lower prices for medicine in real terms.

Substitutability of medicine

The Report also notes the importance of adopting a law developed by the Russian Ministry of Health on the initiative and jointly with the FAS Russia, which provides for the definition of substitutability for most medicines by the end of 2021.

The need for amendments was caused by the following. In accordance with the procedure approved in 2014, medicines registered as reproduced in relation to the corresponding reference products were not recognized as substitutes and could form different items of purchase.

Some medicines were registered as reproducible, and their registration dossiers did not contain the results of relevant clinical studies. Certain reproduced medicinal products were registered in fundamentally different dosage forms and dosages from the reference medicinal products - more than 900 registration certificates of medicinal products show that the dosage forms of the reference and corresponding reproduced medicinal products differ from each other. It also allows to create different items of purchases and mislead consumers in pharmacies.

Besides, the facts of registration of several reference medicines corresponding to one international generic name were revealed, which contradicts the world practice of registration of medicines and creates conditions for artificial monopolization of medicine markets.

Therefore, only 16% of all medicines sold in Russia were considered substitutable by the Russian Ministry of Health as part of the procedure for determining the substitutability of medicines.

The key change in the procedure for determining the substitutability of medicinal products, introduced by Federal Law No. 475-FZ of December 27, 2019, is the recognition of the substitutability of registered medicinal products in the registration dossiers for which there are results of relevant clinical studies in relation to the reference medicine.

The new procedure also created a clear and precise algorithm for determining substitutability, extend the list of medicines for which substitutability is determined, significantly reduced the time frame for determining substitutability, approved a mechanism for suspending the circulation of medicines and elimination of state registration if the registration dossier does not meet modern requirements.

Measures to promote competition in the healthcare sector

In the Report on the development of competition, the FAS Russia proposed a number of measures aimed at developing competition in the healthcare sector. In particular, there are such steps as:

-       creating a list of reference medicines;

-       work on measures to inform the medical community and patients about substitutable medicines;

-       creating a register of standard prescribing instructions for substitutable medicines;

-       identifying equivalence of dosage forms of medicine prior to approval of the list of pharmaceutical forms of medicinal products for medical use by the order of Ministry of Health of Russia No. 538н of July 27, 2016;

-       introduction of requirements for pharmacy organizations about the offer to buyers at first the cheapest substitutable medicinal product, the requirement to inform buyers on the availability of cheaper analogues of purchased medicines and its prices;

-       establishing criteria for the state of markets for medicines that can be purchased from a single supplier, establishing a procedure for selecting contracts holders for the supply of medicines in order to prepare drafts of relevant acts of the President of the Russian Federation and the Government of the Russian Federation on determining the sole suppliers of medicines;

-       prohibition of  combining services for the supply, storage and distribution of medicines into one lot;

-       work on the issue of fixing in the applicable regulations the possibility of participation of owners of commodity aggregators in the remote sale of medicines, given that it will increase the level of competition in the relevant commodity market and ensure access to the commodity market of owners of commodity aggregators;

-       development of administrative regulations for monitoring remote trade of medicines, etc.



[1] Federal Law No. 134-FZ of June 6, 2019 and Decree of the Government of the Russian Federation No. 1683 of December 16, 2019 on mandatory re-registration under the current rules of all manufacturers' maximum selling prices registered in 2010-2019 for medicines included in the list of vital and essential ones.

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