On September 21, 2021, the Verkhovna Rada of Ukraine passed at second reading bill No.4662 "On amendments to the Law of Ukraine 'On Public Procurement' and other Ukraine's laws on medicine procurement under managed entry agreements" (hereinafter referred to as the Law).
It should be reminded that the legal grounds for the medicine procurement under managed entry agreements (hereinafter referred to as MEAs) were established as early as 2020 by the law of Ukraine "On amending some laws of Ukraine aimed at increasing the availability of medicines, medical devices and auxiliaries to them, procured by an organization authorized to make purchases in the health sector." The specifics of such purchases, the negotiation process, the MEA model form, as well as the procedure for concluding, executing, modifying and terminating MEAs were determined by Cabinet of Ministers of Ukraine Resolution No.61 "Some issues on managed entry agreements and suspension of the first paragraph of clause 12 of Cabinet of Ministers of Ukraine Resolution No.333 dated March 25, 2009," dated January 27, 2021. Furthermore, the issues of the state health technology assessment (HTA) were regulated.
Meanwhile, procurement under MEAs in accordance with the requirements of the Law of Ukraine "On Public Procurement" and in the electronic procurement system was impossible due to the specifics of such a procurement mechanism, including in terms of ensuring confidentiality and protecting information at all stages of procurement.
Thus, the law adoption was conditioned, foremost, upon the need to exclude the procurement procedure under MEAs from the scope of the Law of Ukraine "On Public Procurement."
According to the Law in the revision prepared for second reading, the Law of Ukraine "On Public Procurement" does not apply to cases when the subject of procurement is original (innovative) medicines to be purchased under MEAs until December 31, 2023. The law shall come into force on the day following the day of its promulgation. We expect the necessary procedures will be conducted in the near future and the first MEAs will be concluded, which will help to provide patients with the necessary original (innovative) medicines.
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