Ukraine Changes Regulatory Framework for Pharmaceutical and Medical Services Business

On 17 March 2017, the Cabinet of Ministers of Ukraine ("CMU") adopted its Resolution No. 152 "On Ensuring Availability of Medicinal Products" (the "Resolution") approving the Procedure for Reimbursement of Medicinal Products and the Procedure for Determining Coverage Amount for Medicinal Products Subject to Reimbursement.

The Resolution introduces legal mechanism of full or partial reimbursement of medicinal products provided to the ambulatory patients suffering from cardiovascular disease, type II diabetes, and asthma (the "Reimbursement"). The Reimbursement shall be carried out for the benefit of pharmaceutical entities, provided that such entities (i) hold the license on retail of medicinal products, and (ii) have their pharmacy institutions within the territory of respective administrative-territorial unit (the "Pharmaceutical Entities").

According to the Resolution, the Reimbursement applies to finished medicinal products, which have been  registered in Ukraine with including them into (i) the List of International Non-proprietary Names (CMU Resolution No. 863 dated 9 November 2016), and (ii) the Register of Reimbursable Medicinal Products approved by the Ministry of Health of Ukraine (the "Medicinal Products").

The Medicinal Products can be dispensed to patients based on prescriptions issued by the servicing medical institutions of any type of ownership and formalized on standard blank No. 1 (the "Prescriptions"). Upon distributing the Medicinal Products to end customers, the Pharmaceutical Entities are obliged to keep the Prescriptions on file for a period of three years after such a distribution.

Notably, shortly before adopting the above Reimbursement regulations, CMU has also initiated an important legislative package in the sphere of health care, which, inter alia, includes the draft laws "On State Financial Guarantees for Providing Medical Services and Medicinal Products", "On Additional State Guarantees for Providing Medical Services and Medicinal Products to Persons who Defend the Independence, Sovereignty and Territorial Integrity of Ukraine during the Anti-Terrorist Operation and Ensure its Implementation", "On Amending Article 17 of the Law of Ukraine "On Medicinal Products" (Regarding Shelf-Life Term of Medicinal Products Purchased through Specialized Organizations", and "On Amendments to the Budget Code of Ukraine Regarding Expenditure on Primary Medical Care".

It is expected that the adoption of these legislative amendments will help implement the wide-scale medical reform and build the modern health care system of Ukraine capable of responding to current needs of both patients and market operators.

For further information please contact Asters' partner Vadym Samoilenko,
and associate Maryana Sayenko.

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