ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of February 23, 2022 No. 105

About approval of the mechanism of negotiating on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance

Based on the part Item f 1) (2) article 12 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, DECIDES: the Government

1. Approve:

1) Regulations on the mechanism of negotiating on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance, according to appendix No. 1;

2) the Standard agreement of delivery of drugs and/or medical products to suppliers of pharmaceutical services, according to appendix No. 2;

3) the Guarantee of contract price, according to appendix No. 3.

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

Appendix No. 1

to the Order of the Government of the Republic of Moldova of February 23, 2022 No. 105

Regulations on the mechanism of negotiating on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance

I. General provisions

1. The regulations on the mechanism of negotiating on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance (further - the Provision) are developed for the purpose of establishment of procedure for negotiating on inclusion of drugs and medical products for compensation from funds of compulsory medical insurance.

2. Negotiations with the supplier of drugs and/or medical products (further - the supplier) in system of compulsory medical insurance are conducted apropos:

1) the drugs provided for assessment for the purpose of inclusion in system of compensation and/or compensated from the funds of compulsory medical insurance having in the pharmaceutical market only one trade name within the international general name;

2) the medical products provided for assessment for the purpose of inclusion in system of compensation from funds of compulsory medical insurance;

3) expensive, biological, innovative drugs, drugs with uncertain ratio "costs - efficiency", new drugs which will lead to increase in impact on the budget in comparison with the present standard of treatment, provided for assessment for the purpose of inclusion in system of compensation and/or compensated from funds of compulsory medical insurance;

4) the drugs of special purpose paid in addition to each treated case within stationary medical care or in addition to "the global budget" within out-patient specialized medical care, compensated from funds of compulsory medical insurance.

3. The procedure of negotiations on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance is initiated according to the decision of Council for the compensated drugs and/or Council for medical products (further - councils).

4. Councils are the interdepartmental bodies for decision making which do not have the status of the legal entity, created by the Ministry of Health, National medical insurance company, the Agency on drugs and medical products.

5. Councils bear responsibility for decision making about inclusion of drugs and/or medical products in system of compulsory medical insurance as a result of completion of the procedure of negotiations, the carried-out Commission on negotiating on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance (further - the Commission on negotiating).

6. The logistic expenses connected with the organization and functioning of the Commission on negotiating will become covered in the place of the main work of members of the commission on negotiating according to the legislation. Activities of members of the commission for negotiating are not paid.

II. Organization of activities of the Commission on negotiating

7. For the purpose of holding procedure of negotiations with suppliers in system of compulsory medical insurance the Commission on negotiating is created.

8. The commission on negotiating is the interdepartmental body for decision making which does not have the status of the legal entity independent in case of execution of the powers assigned to it created by the Ministry of Health, National medical insurance company, the Agency on drugs and medical products for the purpose of holding procedure of negotiations on inclusion of drugs and/or medical products for compensation from funds of compulsory medical insurance.

9. The commission on negotiating consists of five members:

1) two representatives of the Ministry of Health;

2) two representatives of National medical insurance company;

3) one representative of the Agency on drugs and medical products.

10. Appointment and response of members of the commission on negotiating is performed by the order of the Minister of Health and CEO of National medical insurance company.

11. In case of release of members of the commission on negotiating from posts of their obligation persons who are again appointed to the corresponding positions, according to Items 9 and 10 will carry out.

12. Members of the commission on negotiating shall observe legal regime of conflict of interest, incompatibility, prohibitions and restrictions, personal data and trade secret according to legislation provisions.

13. The structure of the Commission on negotiating can include also other representatives of the Ministry of Health, National medical insurance company, Agency on drugs and medical products, the Center for the public centralized procurements in health care, and also members of councils - without voting power, as observers and/or consultants.

14. The commission on negotiating performs the activities for the location of National medical insurance company.

15. The clerical work of the Commission on negotiating is provided with National medical insurance company, role of the secretary of the Commission on negotiating (further - the secretary) also carries out the representative of National medical insurance company.

16. Communication between the Commission on negotiating and suppliers is performed electronically (e-mail) and/or in writing, letters are sent in the location of National medical insurance company (e-mail of National medical insurance company) to the terms provided by this Provision.

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