Today's positive vote creates a full-fledged legal basis for the application of the mechanism of managed entry agreements (MEAs) in Ukraine.
The Verkhovna Rada of Ukraine, by 309 votes in favor, passed in the second reading Bill 4662 amending Section X “Final and Transitional Provisions” of the Law of Ukraine “On Public Procurement” to ensure the possibility of procurement of medicines under managed access agreements.
Managed entry agreements (MEAs) are a mechanism used to provide innovative drugs to patients with complex and rare diseases.
The mechanism of procurement using managed entry agreements is used in many countries around the world: Italy, France, the Netherlands, Belgium, Sweden, Denmark, Finland, Australia, the Republic of Lithuania, the United States, Great Britain, Poland and others. As of 2019, they were used in 28 of the 41 member states of the Organization for Economic Cooperation and Development and/or the European Union.
MEA creates the following opportunities:
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for patients - expanding access to innovative treatment;
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for the state - the possibility of effective use of budget funds, improving patients' access to medicines, increasing the effectiveness of treatment;
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for producers/applicants - receipt of guarantees and orders from the state for the supply of goods in certain quantities.
The list of drugs that can be purchased under the MEA will be approved by the Cabinet of Ministers of Ukraine after their analysis and evaluation by the Department of Medical Technology Evaluation of the State Expert Center of the Ministry of Health.
In the future, on behalf of the Ministry of Health, the negotiating team will hold talks with manufacturers. During the negotiations, the parties agree on special conditions: purchase volumes, terms of the agreement, terms of delivery/monitoring, discounts, etc.
The State Enterprise "Medical Procurement of Ukraine" may be involved in the work of the negotiating group on the relevant instructions. Based on the results of negotiations on behalf of the Ministry of Health of Ukraine, SE "Medical Procurement of Ukraine" will enter into MEAs, within which the implementation of agreements will take place.