ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of July 24, 2015 No. 600/320-A

About the mechanism of inclusion of medicines in system of compensation from funds of compulsory medical insurance

Based on Art. 2 of the Law on health protection No. 411 of March 28 1995, the item (3) Art. 5 and the item. (6) to Art. 6 of the Law on drugs No. 1409 for December 17 1997, of the Order of the Government "About Procedure for Compensation of Medicines according to Conditions of Compulsory Medical Insurance" No. 1372 of December 23, 2005 for the purpose of enhancement of the mechanism of inclusion of medicines in system of compensation from funds of compulsory medical insurance, for ensuring transparency of decision making process, increase in availability of the population to the medicines compensated from funds of compulsory medical insurance, the Ministry of Health, work and social protection according to Art. 9 of the Provision "About the Organization and Functioning of the Ministry of Health, Work and Social Protection" approved by the Order of the Government No. 397 of May 31 2011, and National medical insurance company according to the item 29 to lit.a) the Charter approved by the Order of the Government No. 156 of February 11 2002, we ORDER:

1. Approve:

1) Regulations on the mechanism of inclusion/exception of medicines of system of compensation from funds of compulsory medical insurance, according to appendix No. 1 to this Order;

2) Methodology of calculation of fixed amounts for compensation of the medicines included in the List of international non-proprietary names of the compensated medicines from funds of compulsory medical insurance according to appendix No. 4 to this order.

2. Expenses are logistic, connected with the organization and operational work of Council for the compensated medicines and its secretariat, will be covered on principle place of employment of participants of data of structures according to provisions of the current legislation.

3. Claim that in case of dismissal of members of council or the secretariat of Council of their power persons who are again appointed to the corresponding positions without publication of the new order will perform.

4. This order becomes effective from the date of publication in the Official monitor of the Republic of Moldova.

5. To impose control over execution of this order on the state secretary, Mr. Ion Prisekara and the deputy director general, Mrs. Doynu-Mariyu Rotara.

Appendix No. 1

to the Order of the Ministry of Health and National company of medical insurance of the Republic of Moldova of July 27, 2015 No. 600/320-A

Regulations on the mechanism of inclusion/exception of medicines of system of compensation from funds of compulsory medical insurance

Section 1. General provisions

1. The regulations on the mechanism of inclusion/exception of medicines of system of compensation from funds of compulsory medical insurance (further – the Provision), are developed according to the Law on health protection No. 411 of March 28 1995, the Law on compulsory medical insurance No. 1585-XII of February 27 1998, the Order of the Government "About Procedure for Compensation of Medicines according to Conditions of Compulsory Medical Insurance" No. 1372 of December 23 2005, the Order of the Government "About Approval of the Single Program of Compulsory Medical Insurance" No. 1387 of December 10, 2007.

2. The provision establishes the basic principles of compensation of medicines from funds of compulsory medical insurance, procedure for creation and inclusion of changes in the List of international non-proprietary names of the compensated medicines of funds of compulsory medical insurance (further - the MNN List) and the List of commercial names of the compensated medicines from funds of compulsory medical insurance (further - the KN List), criteria of inclusion and exception of the list, procedure for the organization of work of Council and secretariat for the medicines compensated from funds of compulsory medical insurance.

3. The provision is directed to enhancement of the mechanism on selection of medicines for compensation from funds of compulsory medical insurance and ensuring transparency of decision making process on inclusion of medicines in the MNN List.

4. Selection of medicines for compensation from funds of compulsory medical insurance is continuous process, multi-profile, shall be based on efficiency, safety, quality, cost of medicines and is aimed at providing their rational use.

5. It is allowed to include in the MNN List only the international names of medicines which are introduced in the state nomenclature of medicines, national price catalog on medicamentous (medicinal) products and made according to rules of the Proper production practice (Good Manufacturing Practices - GMP).

5-1. Based on the MNN List approved by Council on compensated to medicines, the National medical insurance company develops and updates the KN List in information system of the compensated medicines.

5-2. The KN list contains:

1) group of the compensated diseases;

2) code of the international non-proprietary name of medicines;

3) international non-proprietary name;

4) dose of the international non-proprietary name in information system;

5) ceased to be valid;

6) code of the commercial name;

7) extent of compensation;

8) fixed amount of compensation, including the VAT and excluding VAT;

9) commercial name;

10) dose, pharmaceutical uniform, distribution, country of the producer, owner of the registration certificate medicine/producer;

11) number of registration, the ATC code (Anatomic, Terapeutic, Chimic), price approval number the Agency on medicines and the medical equipment, inclusive with subsequent changes, comments.

Section 2. Bases of compensation of medicines from funds of compulsory medical insurance

6. Compensation of medicines is performed on the basis of the following principles:

a) The principle of human value which emphasizes respect for equality of all people and immunity of each person. Discrimination of persons on bases of sex, races, age, etc. in decision making process about compensation of medicines is inadmissible.

b) The principle of need and solidarity which provides recognition of the priority status for persons having serious illness in comparison with patients with uncomplicated diseases.

c) The principle of cost efficiency which assumes that costs on use of medicines shall be reasonable and justified from the medical point of view, from line item of the patient and in the context of social and economic development.

d) The principle of transparency which provides that selection process of medicines shall be absolutely transparent, thereby being the unconditional ethical requirement during decision making.

7. Compensation of cost from funds of compulsory medical insurance is performed for medicines which are applied in out-patient treatment of the priority diseases approved in the main program documents of the Ministry of Health and also to medicines which show positive dynamics in case of treatment of chronic diseases, cause decrease in the mortality rate and primary disability.

Section 3. Procedure for the organization of process of inclusion of medicines in system of compensation of funds of compulsory medical insurance

8. For inclusion of new medicine in the KN List, it is necessary to submit the application on behalf of the producer or his official representative, or the companies importing and/or extending medicines or any physical person or legal entity (further - the applicant). The sample of the application blank is provided in appendix No. 1 to this Provision.

9. About inclusion of medicine in the KN List, Council for inclusion/exception of medicines for compensation from funds of compulsory medical insurance which structure affirms the joint order of the Ministry of Health and National company of medical insurance is responsible for decision making (by a majority vote).

10. The secretariat on the medicines compensated from funds of compulsory medical insurance created by the joint order of the Ministry of Health and National medical insurance company gives to council help in its work.

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