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Pricing and reimbursement
Ukrainian legislation does not impose an obligation on marketing authorization holders to obtain approval for the price or reimbursement status of medicines before they are placed on the market. If a marketing authorization holder intends to sell medicinal products for public funds, he is required to declare the wholesale price in advance. Requirements for the declaration of wholesale prices are not imposed on medicines, which are purchased at the expense of the Ukrainian state budget by specialized international organizations and funds (UNDP, UNICEF, Crown Agents) and the company of State “Medical Procurement of Ukraine” (these). In case the marketing authorization holder is willing to participate in reimbursement, he must submit the price of the medicine subject to reimbursement to the Ministry of Health, who will include it in the register of medicines subject to reimbursement. provided that the price meets the requirements set by legislation.
The procurement of medicines for public funds in Ukraine is organized on the basis of various positive lists (for example, the national list of essential medicines, the list of international nonproprietary names subject to centralized procurement, etc.) and on the obligation to declare the wholesale price (import price (for imported products) or manufacturer’s price (for locally produced products)) of drugs purchased with public funds or reimbursed.
An important aspect of the Ukrainian public procurement system in the pharmaceutical field is the application of “centralized purchases” (purchases made for the funds of the Ministry of Health for the treatment of the most socially important diseases (oncology childhood, hepatitis, orphan diseases, HIV, etc.)). These purchases are made by the ES, which is an entity specially created in 2019 to ensure the transfer of the centralized purchasing function of specialized funds and organizations (UNDP, UNICEF, Crown Agents) which purchase drugs on behalf of the Ministry of Health since 2015, and whose role is diminishing as SE gains hands-on experience and reputation in procurement. It is expected that from spring 2022, all centralized purchases will be made exclusively by the SE, with the exception of certain covid-related purchases. From November 2021, a pilot project on the centralization of localized purchases is implemented allowing local healthcare establishments to voluntarily group their requests and ask the SE to conduct tenders on their behalf to ensure a smooth process. more professional bidding procedures and more savings as a result of aggregated quantities of drugs and medical devices procured.
For drugs purchased with public funds or listed on the national list of essential drugs (with the exception of narcotics, psychotropic drugs, precursors and medical gases), wholesale and retail margins are set at 10% and 10 to 25 percent depending on the wholesale price, respectively. For insulin products, the wholesale and retail margins are set at 10% each. For products subject to reimbursement (except insulin products), wholesaler margins are 10% and retailer margins are 15%.
In March 2020, legislative amendments drafted by Arzinger’s lawyers and supported by the Ukrainian parliament provided for the possibility of concluding managed entry agreements (MEAs) between the Ministry of Health (or SE on behalf of the ministry) and the marketing authorization holders for innovative products. . MEAs are intended to enable the purchase of innovative drugs at the expense of the state budget while ensuring price confidentiality, while information about the existence of the contract itself will be publicly available.
The list of drugs that can be purchased under the MEA is determined exclusively by the Cabinet of Ministers of Ukraine.
The conclusion of an MEA will be preceded by the health technology assessment (HTA), and the first conclusions of the HTA have already been published. Negotiations on the conclusion of the first MEAs are ongoing between the Ministry of Health and the innovative pharmaceutical manufacturers to date.
Supervision of compliance with the requirements of the price laws is entrusted to the Ukrainian State Service for Food Safety and Protection of Consumer Rights, but the Antimonopoly Committee of Ukraine (an authority responsible for antitrust and competition – the AMCU) in the context of competition and antitrust investigations ongoing violations in the pharmaceutical market tend to control the “fairness” of the profit margin received by commercial entities operating in the market. Multi-million hryvna fines have already been imposed on a number of global pharmaceutical companies and their local distributors for “excessive pricing” on drugs supplied to the public market.
Health technology assessments are introduced in a limited scope only for medicines that are planned to be included in the national essential medicines list, medicines subject to managed entry agreements and medicines procured for funds from the state budget (centralized purchasing). As the HTA procedure was only introduced at the end of 2020, there is not much practice in this regard, and the companies and authorities concerned have yet to determine how the HTA will work in Ukraine. Currently, Ukraine is establishing the legal framework for the conclusion of MEAs, which should be concluded based on the results of HTA, including information on clinical efficacy and cost-effectiveness.
As for medical devices, they are currently not subject to price regulation and reimbursement; however, some legislative initiatives are actively discussed to also introduce reimbursement for medical devices.