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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of February 23, 2022 No. 104

About approval of the Regulations on the mechanism of inclusion of medical products for compensation from funds of compulsory medical insurance

Based on part (2-1) articles 18 of the Law No. 1456/1993 on pharmaceutical activities (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes, parts (5) article 5 of the Law No. 1585/1998 on compulsory medical insurance (The official monitor of the Republic of Moldova, 1998, Art. No. 38-39, 280), with subsequent changes, and article 13-1 of the Law No. 102/2017 on medical products (The official monitor of the Republic of Moldova, 2017, Art. No. 244-251, 389), with subsequent changes, DECIDES: the Government

1. Approve Regulations on the mechanism of inclusion of medical products for compensation from funds of compulsory medical insurance it (is applied).

2. In departure from Item 25 of the Provision specified 1, the List of names of medical products on which document packages for compensation from funds of compulsory medical insurance for 2022 shall be given affirms the order of the Minister of Health and CEO of National medical insurance company till March 31 of the current year as Item and is published in the Official monitor of the Republic of Moldova.

3. This resolution becomes effective from the date of publication in the Official monitor of the Republic of Moldova.

Prime Minister

Natalya Gavrilitsa

Countersign:

Minister of Health

 

Nemerenko is scarlet

Minister of Finance

Dmitry Budiyanski

 

Approved by the Order of the Government of the Republic of Moldova of February 23, 2022 No. 104

Regulations on the mechanism of inclusion of medical products for compensation from funds of compulsory medical insurance

I. General provisions

1. The regulations on the mechanism of inclusion of medical products for compensation from funds of compulsory medical insurance (further - the Provision) regulate procedure for the organization and activities of Council for the medical products compensated from funds of compulsory medical insurance (further - Council), and the secretariat of Council, the procedure of creation and change of the List of the medical products compensated from funds of compulsory medical insurance (further - the List), methodology of calculation of the maximum retail prices and fixed amounts of compensation on medical products.

2. Council constitutes and changes the List, using the help of the secretariat of Council in the activities.

3. The list includes the name and model of medical product, registration number in the State register of medical products, compensation percent, the maximum retail price in drugstore, and also the maximum amount of surcharge by the patient, and affirms the order of the Minister of Health and CEO of National medical insurance company based on the decision of Council.

4. Delivery of the compensated medical products to the suppliers of pharmaceutical services included in system of compulsory medical insurance is performed by suppliers of medical products with whom the National medical insurance company signed the agreement based on decisions of Council.

II. Organization and functioning of council and secretariat of council

5. Council is the interdepartmental body for decision making without the status of the legal entity created by the Ministry of Health, National medical insurance company and the Agency on drugs and medical products for the purpose of creation, change and approval of the List.

6. Council consists of 13 members, including the chairman and the vice-chairman.

7. The chairman of the board is the state secretary of the Ministry of Health who coordinates the sphere of drugs and medical products. In the absence of the chairman of its function the vice-chairman of Council which the deputy director general of National medical insurance company responsible for the sphere of drugs and pharmaceutical activities is performs.

8. Are part of Council:

1) six representatives of the Ministry of Health (including the chairman of the board);

2) five representatives of the National company of medical insurance (including the vice-chairman of Council);

3) two representatives of the Agency on drugs and medical products.

9. Membership in Council stops:

1) in case of impossibility of implementation of activities as a part of Council;

2) on personal request of the member of council;

3) based on the requirement of the body or organization which proposed the corresponding candidate.

10. The secretariat of Council consists of the specialists having professional competences of the sphere of assessment of medical technologies and medical products.

11. Members of the secretariat of Council are:

1) the secretary of Council - the main consultant of management the politician in the field of drugs and medical products of the Ministry of Health;

2) the representative of the Agency on drugs and medical products;

3) representative of National medical insurance company;

4) representative of the National agency of public health.

12. The staff of Council and secretariat of Council affirms the order of the Minister of Health and CEO of National medical insurance company.

13. In case of release from posts of some members of council and the secretariat of Council, their obligation as a part of Council and the secretariat of Council are performed by the new faces appointed to the corresponding positions according to Items 11 and 12.

14. Members of council and the secretariat of Council shall observe legal regime of conflict of interest, incompatibility, prohibitions and restrictions according to the legislation.

15. The logistic expenses connected with the organization and functioning of Council and secretariat of Council are performed on principle place of employment of members according to the legislation. Activities as the member of council and the secretariat of Council are not paid.

16. For convocation of meeting of Council for the decision of the chairman the secretary informs members of council on date of meeting and distributes the draft of the agenda and required materials at least in 5 working days prior to its convocation by the letter and/or by e-mail.

17. Council is convoked at least two times a year, and in extreme cases - upon the demand of the chairman of the board or the CEO of National medical insurance company.

18. Meetings of Council will be organized in the building of the Ministry of Health and are considered competent if at least 2/3 members of council participate in them.

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