RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of April 3, 2019 No. 426

About reference pricing on some medicines which are bought for budgetary funds

According to articles 5 and 13 of the Law of Ukraine "About the prices and pricing" the Cabinet of Ministers of Ukraine decides:

1. Enter state regulation of the prices of medicines which in the procedure established by the law are registered in Ukraine or on which permission to parallel import of medicine is issued are bought for budgetary funds, and also:

are included in the National list of the main medicines approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2009 No. 333 "Some questions of state regulation of the prices of medicines and products of medical appointment" (The Official Bulletin of Ukraine, 2009, No. 27, Art. 906; 2022, No. 6, the Art. 343) (further - the National list);

concerning which by results of the state assessment of medical technologies which is carried out according to the Procedure for carrying out the state assessment of medical technologies approved by the resolution of the Cabinet of Ministers of Ukraine of December 23, 2020 No. 1300 (The Official Bulletin of Ukraine, 2021, No. 2, the Art. 94), prepares the conclusion of authorized body with recommendations of inclusion of medicine in the National list and/or the nomenclature (lists, lists, registers) which are bought for means of the government budget for accomplishment of programs and implementation of centralized actions for health care, except those medicines for which the conclusion or prolongation of effective period (prolongation) of agreements of the managed access is recommended.

State regulation of the prices of the specified medicines is performed by establishment of their extreme wholesale selling prices on the basis of the prices of medicines registered in the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia, Hungary (further - the reference countries) received from authorized state bodies of the reference countries, and in case of lack of the prices of medicine in four of five reference countries - on the basis of the prices of medicines in Ukraine received according to system of research of the market in Ukraine which is used on a contract basis by the Ministry of Health and/or the state company which belongs to the sphere of management of the Ministry of Health and is attracted for implementation of calculations. In case of lack of the prices of the specified medicines in the reference countries and limiting Ukraine wholesale selling prices on such medicines in connection therewith are not calculated by the resolution and provisions of the resolution of the Cabinet of Ministers of Ukraine of July 2, 2014 No. 240 "Questions of declaring of change of wholesale selling prices on medicines" are applied to them (The Official Bulletin of Ukraine, 2014, No. 56, Art. 1528; 2015, No. 54, Art. 1740; 2017, No. 13, Art. 361).

2. Determine that:

1) limiting Calculation of wholesale selling prices on medicines concerning which state regulation of the prices according to Item 1 of this resolution is entered is performed according to the procedure, determined by the Ministry of Health. the list of data on the extreme wholesale selling prices on some medicines which are purchased for budgetary funds and subject to reference pricing, and also form of the specified list affirm the Ministry of Health;

2) institution and healthcare institution which are fully or partially financed from state and local budgets, is bought by medicines concerning which state regulation of the prices according to Item 1 of this resolution, at the prices which are not exceeding the wholesale selling prices established by the limiting Ministry of Health taking into account taxes and fees, and also limiting supplying and sales and trade (retail) allowances determined by the resolution of the Cabinet of Ministers of Ukraine of October 17, 2008 No. 955 "About measures concerning price stabilization on medicines" (The Official Bulletin of Ukraine, 2008, No. 84, Art. 2825 is entered; 2019, No. 22, Art. 779);

3) operation of this resolution does not extend on:

medicines which are bought according to Item 19 parts five of article 3 of the Law of Ukraine "About public purchases";

the medicines included in the list of conditions and the international unlicensed names of medicines which reimbursation is provided by the program of the state guarantees of medical attendance of the population;

the paragraph the fourth is excluded according to the Resolution of the Cabinet of Ministers of Ukraine of 28.07.2021 No. 854

medicines which are bought according to agreements of the managed access;

4) procedures of purchases of the medicines included in the limiting state Register of wholesale selling prices on some medicines which are bought for budgetary funds as of the August 11, 2022 approved by the order of the Ministry of Health, begun by customers before approval by the Ministry of Health in October, 2022 of the register of data on extreme wholesale selling prices on some medicines which are bought for budgetary funds and are subject to reference pricing, come to the end at the prices which are not exceeding the extreme wholesale selling prices established by the specified register.

3. Make changes which are applied to resolutions of the Cabinet of Ministers of Ukraine.

4. To the Ministry of Health in two-month time to develop and approve the regulatory legal acts necessary for execution of this resolution.

5. This resolution becomes effective from the date of its publication, except the subitem 2 of Item 2 and Item 3 of this resolution which become effective since July 1, 2019.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of April 3, 2019 No. 426

Changes which are made to resolutions of the Cabinet of Ministers of Ukraine

1. Subitems 1 and 2 of Item 1 of the resolution of the Cabinet of Ministers of Ukraine of October 17, 2008 No. 955 "About measures concerning price stabilization on medicines" (The Official Bulletin of Ukraine, 2008, No. 84, Art. 2825; 2016, No. 3, Art. 166; 2017, No. 13, Art. 361; 2019, 22, 779) to state No. to the Art. in the following edition:

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info