Analysis of public procurement of combination inhalation medications for 2024–2025:  regulatory framework, practice, and interchangeability

The article analyzes the practice of state procurement of combined inhaled medicinal products (CIMPs) in the Russian Federation for the period 2024-2025.

Objective. The aim of the study was to verify the application in procurement activities of the provision of subparagraph "b" of paragraph 3 of the Specifics for the Description of Medicinal Products (Government Decree No. 1380), which allows for the possibility of replacing a multicomponent drug with a set of single-component ones.

Materials and methods. Based on the analysis of 202 procurement notices and 167 contracts concluded in the Unified Information System, a complete absence of cases of using this norm in relation to the studied CIMPs was established.

Results. The results demonstrate that none of the analyzed combined drugs is recognized as interchangeable with a set of single-component drugs either in the State Register of Medicinal Products or in the Unified Structured Directory-Catalogue of Medicinal Products.

Conclusions. It is concluded that the non-application of this opportunity in practice is due both to the lack of officially established interchangeability and the existence of a special position of the Russian Ministry of Health, set out in an explanatory letter, regarding the impossibility of achieving a similar therapeutic effect when replacing CIMPs with separate single-component drugs.

1. Federal Law of 05.04.2013 No. 44-FZ "On the contract system in the sphere of procurement of goods, works, and services to meet state and municipal needs." (In Russ.).

2. Resolution of the Government of the Russian Federation of November 15, 2017 No. 1380 "On the specifics of the description of medicinal products for medical use that are the object of procurement to meet state and municipal needs" (In Russ.).

3. State Register of Medicines (In Russ.). https://grls.rosminzdrav.ru/Default.aspx

4. Unified structured reference book and catalog of medicinal products of the Russian Ministry of Health (In Russ.). https://esklp.egisz.rosminzdrav.ru/

5. <Letter> of the Ministry of Health of the Russian Federation dated 14.02.2018 No. 418/25-5 “On sending answers to frequently asked questions about medicinal products for medical use that are the object of procurement to meet state and municipal needs.” (In Russ.)].

6. Official website of the unified information system in the field of procurement (In Russ.). https://zakupki.gov.ru/

7. Federal Law of 12.04.2010 No. 61-FZ "On the Circulation of Medicines". (In Russ.).

8. Resolution of the Government of the Russian Federation of September 5, 2020 No. 1360 "On the procedure for determining the interchangeability of medicinal products for medical use." (In Russ.).

9. Resolution of the Government of the Russian Federation No. 1357 of September 4, 2020, "On Approval of the Rules for the Use of Information on Interchangeable Medicinal Products for Medical Use and the Provision of Clarifications on the Interchangeability of Medicinal Products for Medical Use, as well as on Amending the Description of Medicinal Products for Medical Use Purchasing for State and Municipal Needs." (In Russ.).

10. Resolution of the Government of the Russian Federation of 08.02.2017 No. 145 "On approval of the Rules for the formation and maintenance in the unified information system in the sphere of procurement of a catalog of goods, works, services for meeting state and municipal needs and the Rules for the use of the catalog of goods, works, services for meeting state and municipal needs." (In Russ.).