On March 20th, 2019 the Ministry of Health put the revised draft resolution of the Cabinet of Ministers of Ukraine “On Reference Pricing for Some Medicines Procured for Budget Funds” (hereinafter – the draft resolution) on public discussion.
The mentioned draft resolution has been developed given that in the first six months of 2018 budget expenditures on medicines from the National List of Essential Medicines (hereinafter – the National List) at tenders increased, in particular, since from the most procured 60 INN prices for 30 have increase by 24%.
According to analysis of prices in the hospital sector of 60 most consumed medicines included to the National List, prices for 36.8 % INN in Ukraine are higher than in the reference countries, and for 63.2% - lower.
Taking this into account, the draft resolution offers to introduce state regulation of prices for some INN included to the National List and procured for budget funds from July 1st, 2019 by setting maximum ex-factory price. This List will comprise INN whose price in Ukraine is higher than in the reference counties. According to the Ministry of Health, prices for approximately 30 INN require government regulation.
Maximum allowed price for such medicine will depend on prices on such medicines in the reference countries. They are Poland, Slovakia, Czech Republic, Latvia and Hungary.
In connection with the abovementioned, in order to ensure effective regulation of prices for such medicines, the Ministry of Health will be obliged to set the mechanism of formation of the List of Medicines included to the National List of Essential Medicines and for which maximum ex-factory prices are set (hereinafter – the List), as well as the mechanism of calculating maximum ex-factory price; the draft resolution grants 2 months to develop and approve the above.
It should be noted that medicines can be sold on the free market without complying with the corresponding levels of maximum ex-factory prices.
However, trade (retail) mark-ups can be used based on the regression scale. Thus, maximum mark-up will be 25% for procurement price of up to UAH 100 (inclusive), and in case the procurement price is more than UAH 1000, it cannot be more than 10%.
The mechanism of ex-factory price declaration will remain effective for medicines procured for budget funds but not included to the abovementioned List.
The resolution will not apply to medicines procured through international organizations which take part in the program “Affordable Medicines” or included to the pilot project for introduction of state regulation of price for insulin drugs.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.