On November 9 the Government has adopted the Resolution of the Cabinet of Ministers of Ukraine № 862 “On state regulation of prices for medicines” and № 863 “On the introduction of reimbursement of the cost of medicines”. Official texts of the documents have been published only at the end of November and came into force on December 1, 2016.
The Resolution of the Cabinet of Ministers of Ukraine № 863 provides that since April 1, 2017 patients with cardiovascular disease, type II diabetes or asthma (21 international nonproprietary names in general), which have the appropriate prescription, will have an opportunity to purchase medicines for their treatment at pharmacies cheaper than now. Such medicines should be included into the National List of Essential Medicines, approved by the Resolution of the Cabinet of Ministers of Ukraine dated March 25, 2009, № 333.
To date the work on introduction of the reimbursement has just begun. Thus, the Ministry of Healthcare together with the Ministry of Economic Development and Trade of Ukraine within one month shall approve the procedure for determining the amount of compensation of cost of medicines and make public the information about the amount of compensation for the cost of medicines.
Regulatory legal act establishes that supply and sales markups for such medicines are limited at the level of 5 %, the retail markups should not exceed 15% including taxes and charges.
Inextricably linked to reimbursement is the Resolution of the Cabinet of Ministers of Ukraine № 862, that since January 1, 2017 introduces state regulation of marginal prices for medicines by comparing the prices in reference countries (Poland, Latvia, Slovakia, Hungary, the Czech Republic). The Ministry of Healthcare will independently set marginal prices for medicines, within which the wholesale prices shall be determined. Thus, while disposing medicines of certain category, market actors should be guided by the marginal price set by the Ministry of Healthcare.
Probably the speed of drafting and the adoption of the Regulation of the Cabinet of Ministers of Ukraine № 862 has affected its quality, so the document has provoked the appearance of some inaccuracies in the regulation.
Thus, hardly unambiguously can be interpreted the provision concerning medicines subject to abovementioned regulation. Most likely, provision implied the medicines included into the National List of Essential Medicines (except those produced in pharmacies), which are referred to the program of state reimbursement of the cost of medicines (i.e. 21 abovementioned international nonproprietary names).
Provided that, such state regulation will not relate to the medicines purchased through international procurement.
The procedure for the calculation of marginal prices for medicines is now being developed by Ministry of Healthcare and soon will be published for public comment.
On November 22 the meeting in the Cabinet of Ministers of Ukraine between Prime Minister of Ukraine and the representatives of pharmaceutical companies, central government authorities and nongovernmental organizations took place. Vladimir Groisman mentioned that the amount of necessary expenses for reimbursement have already been included into the draft of the State budget of Ukraine.
In order to help the pharmaceutical market players to understand the latest amendments in legislation in the area of state price regulation, on December 13, 2016 Legal Alliance Company arranges workshop "On anticipation of change of the system of state regulation of prices for medicines", where participants will have opportunity to acquaint themselves with the latest updates in the sphere of state regulation of prices.
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.
