Prospects of introducing reference pricing for medicines

On February 22^nd, 2019 the Ministry of Health of Ukraine published draft resolution of the Cabinet of Ministers of Ukraine “On Reference Pricing for Medicines Procured for Budget Funds” for public discussion.

The draft has been developed pursuant to Recommendation of the AMCU of Ukraine “On Measures Aimed at Development of Competition and Prevention of Violations of Legislation on Economic Competition Protection” No. 43-рк as of December 13^th, 2018 and to increase affordability of medicines included to the National List of Essential Medicines (the National List) approved by Resolution of the Cabinet of Ministers of Ukraine “Some Matters of State Regulation of Prices for Medicines and Medical Devices” No. 333 as of March 25^th, 2009.

In order to increase affordability of medicines included to the National List of Essential Medicines and procured for budget funds, the AMCU, among other things, recommends taking effective measures to include to the list of medicines for which reference pricing mechanism has been introduced all medicines included to the National List.

Thus, from July 1st, 2019 the draft resolution offers:

• to introduce reference pricing for medicines included to the National List and procured for budget funds;
• to cancel mechanism of declaring changes in ex-factory prices for medicines procured for budget funds;
• to switch to state regulation of maximum trade (retail) mark-ups by establishing regression scale.

In order to introduce reference pricing mechanism, application of internal and external reference pricing mechanism is provided, and the procedure for calculating maximum ex-factory price should be approved by order of the Ministry of Health.

The draft resolution will not apply to:

• medicines procured under Article 2(3)(16) of the Law of Ukraine “On Public Procurement”, namely goods and services subject to procurement under procurement agreements concluded by central executive authority of Ukraine ensuring making and implementation of state policy in the healthcare sector with specialized procurement organizations;
  
  
• by January 1^st, 2020 – insulin drugs prices for which are regulated in accordance with Resolution of Ukraine “Issues of Implementation of Pilot Project on Introduction of State Regulation of prices for Insulin Drugs” No. 73 as of March 5^th, 2014.

There calculation of maximum ex-factory prices for active substance included to the reimbursement program will continue based on the current mechanism of external reference pricing provided by Order of the Ministry of Health of Ukraine No. 1423 as of December 29^th, 2016.