LAW OF UKRAINE

of March 17, 2020 No. 531-IX

About introduction of amendments to some laws of Ukraine, the medicines allocated for increase in availability, medical products and supportive applications to them which are bought by person authorized on implementation of purchases in the field of health care

The Verkhovna Rada of Ukraine decides:

I. Make changes to such laws of Ukraine:

1. In Bases of the legislation of Ukraine on health care (The sheet of the Verkhovna Rada of Ukraine, 1993, No. 4, Art. 19 with subsequent changes):

Part one of Article 3 to add 1) taking into account alphabetic procedure with the term of the following content:

"person authorized on implementation of purchases in the field of health care - the legal entity created by the central executive body which provides forming also realizes state policy in the field of health care, and authorized to conduct procurement of medicines, medical products and supportive applications to them and services for means of the government budget for accomplishment of programs and implementation of centralized actions for health protection, and also for means of grants (subgrants) for accomplishment of programs of Global fund for fight against AIDS, tuberculosis and malaria in Ukraine according to the law. Person authorized on implementation of purchases in the field of health care has the right to deliver gratuitously (to transfer) the medicines belonging to it, medical products and supportive applications to them and services to structural divisions concerning health care of the regional, Kiev and Sevastopol city public administrations or to subjects of managing which have the license for implementation of economic activity on medical practice";

2) in Article 44 part two:

in the first offer of the word "New Methods of Prevention, Diagnostics, Treatment, Rehabilitation and Medicines Which Are under Consideration in Accordance with the Established Procedure, but Yet Not Allowed to Application" shall be replaced with words "New methods of prevention, diagnostics, treatment, rehabilitation and medicines which are under consideration in accordance with the established procedure, but the unregistered medicines are not allowed to application yet, and";

in the third offer of the word "In case of Receipt of Consent to Application of New Methods of Prevention, Diagnostics, Treatment, Rehabilitation and Medicines Which Are under Consideration in Accordance with the Established Procedure, but Are Not Allowed to Application Yet" shall be replaced with words "In case of receipt of consent to application of new methods of prevention, diagnostics, treatment, rehabilitation and medicines which are under consideration in accordance with the established procedure, but are not allowed to application yet, and the unregistered medicines";

Article 54 after part two to add 3) with new part of such content:

"The list of the medicines, medical products and supportive applications to them which are purchased for means of the government budget for accomplishment of programs and implementation of centralized actions for health protection affirms the Cabinet of Ministers of Ukraine".

With respect thereto the third and fourth to consider parts respectively parts four and heel;

The Section XI to add 4) with Article 79-1 of the following content:

"Article 79-1. Agreements of the managed access

The central executive body which provides forming and realizes state policy in the field of health care on own initiative or according to its order person authorized on implementation of purchases in the field of health care and/or at the initiative of the applicant (the owner of the registration certificate / or the representative authorized by it) (further - the applicant) has the right to sign agreements of the managed access with the applicant in which delivery conditions of original (innovative) medicine (original biological medicine) on the territory of Ukraine for means of the government budget and/or local budgets for the purpose of ensuring availability of such medicines to patients are provided (further - the agreement of the managed access) to original (innovative) medicine (original biological medicine).

The agreement of the managed access shall provide following provisions:

amount of medicines which the applicant shall deliver on the territory of Ukraine during the term defined by the agreement of the managed access;

conditions concerning the price of medicines at which the applicant shall deliver medicines on the territory of Ukraine during the term defined by the agreement of the managed access;

sources of financing of acquisition of the medicines which are the subject of the agreement of the managed access;

procedure for agreement cancelation of the managed access.

The agreement of the managed access may contain other conditions and obligations of the parties which are not contradicting the legislation.

Procedure for negotiation concerning agreements of the managed access, types of such agreements and procedure for their conclusion, execution, change and termination, and also standard form of such agreement affirm the Cabinet of Ministers of Ukraine. In case of state registration in Ukraine of generic medicine (similar biological medicine) with the same international unlicensed name, form of release and dosage, as medicine concerning which the agreement of the managed access is signed the agreement of the managed access is subject to early termination on December 31 the current fiscal year if effective period of such agreement does not expire earlier specified date. The conclusion, execution, change and termination of the contract of the managed access are performed according to provisions of the legislation of Ukraine.

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