Reference pricing for some medicines on the national list of essential medicines start to work soon

Two important orders of the Ministry of Health of Ukraine were published in the Official Bulletin of Ukraine on the introduction of a reference pricing for medicinal products, which approved:

• The procedure for forming the list of medicines included in the National List of Essential Medicines and for which the maximum wholesale prices are set;
• The procedure for calculating maximum wholesale prices for Medicines which are specified in the list of medicines included in the National List of Essential Medicines and for which maximum wholesale prices are set;
• The list of medicines that are included in the National List of Essential Medicines and for which maximum wholesale prices are set (hereinafter – “the List”).

Thus, the List includes 23 INNs (international nonproprietary names) of medicinal products that were selected on the basis of the following criteria:

1. INN, drug dosage form and dosing are included in the National List of Essential Medicines;
2. expenditures of budgetary funds for the purchase of a medicinal product (INN, which includes all forms of release) by institutions of health care, wholly or partially financed from the state and local budgets, throughout the territory of Ukraine over the last 12 months and amount over 5 million UAH;
3. the price of a medicinal product in Ukraine exceeds the prices for such a medicinal product established in the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia, and Hungary.

The orders of the Ministry of Health of Ukraine dated July 11, 2019 No.1600 and July 29, 2019 No.1713 entered into force on the day of their official publication.

It should be reminded that these instruments were introduced to implement the CMU Resolution of April 3rd, 2019 No. 426 “On Reference Pricing for Some Medicinal Products Procured for Budget Funds,” which provides for the introduction of a reference pricing for some medicines from the National List.

In accordance with the provisions of the aforementioned resolution, the Ministry of Health of Ukraine also approves the Register of Maximum Wholesale Prices for Medicinal Products Included in the List, the approval of which is expected in the near future.

As soon as such a Register enters into force, health care institutions fully or partially financed from the state and local budgets will be able to procure medicines from the List at prices that do not exceed maximum wholesale prices established by the MHU including taxes and duties, as well as maximum supply and sales (retail) margins determined by CMU Resolution No. 955 of October 17th, 2008 “On Measures to Stabilize Medicinal Products Prices”.

Thus, the new regulation will only deal with cases of procurement of medicines for budgetary funds. If such medicines are sold only through pharmacies to end consumers, the established price restrictions will not apply.

Contact the author: Natalia Spivak, Senior Associate, Legal Alliance Company, spivak@l-a.com.ua.