On approval of the rules for the provision of medicines for the treatment of orphan diseases within the guaranteed volume of free medical care and at the expense of other sources

Order of the Minister of Health of the Republic of Kazakhstan dated March 11, 2026 No. 29. Registered with the Ministry of Justice of the Republic of Kazakhstan on March 12, 2026 No. 38135

  In accordance with paragraph 2 of Article 177 of the Code of the Republic of Kazakhstan "On the Health of the people and the healthcare system", I ORDER:

     1. To approve the attached rules for the provision of medicines for the treatment of orphan diseases within the guaranteed volume of free medical care and at the expense of other sources.

     2. The Department of Drug Policy of the Ministry of Health of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, shall ensure:

     1) the state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

     2) posting of this order on the Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

     3) within ten working days after the state registration of this order with the Ministry of Justice of the Republic of Kazakhstan, submit to the Legal Department of the Ministry of Health of the Republic of Kazakhstan information on the implementation of measures provided for in subparagraphs 1) and 2) of this paragraph.

     3. Control over the execution of this order is entrusted to the supervising Vice Minister of Health of the Republic of Kazakhstan.

     4. This order shall enter into force upon the expiration of ten calendar days after the date of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Alnazarova

Approved by the Order of Kazakhstan Republicsindensaulyk Aktau ministery2026 zhylgy 11 nauryzdagi No. 29

Rules for the provision of medicines for the treatment of orphan diseases within the guaranteed volume of free medical care and at the expense of other sources

Chapter 1. General provisions

     1. These Rules for the Provision of medicines for the treatment of orphan diseases within the guaranteed volume of free medical care and from other sources (hereinafter referred to as the Rules) have been developed in accordance with paragraph 2 of Article 177 of the Code of the Republic of Kazakhstan "On Public Health and the Healthcare System" (hereinafter referred to as the Code) and determine the procedure for providing patients with medicines for treatment of orphan diseases within the framework of the guaranteed volume of free medical care (hereinafter – GOBMP) and at the expense of other sources.

     2. Terms and definitions used in these Rules:

     1) the outpatient drug accounting information system (hereinafter referred to as the ILS) is an information system defined by the authorized body in the field of healthcare to automate the accounting of prescriptions, the release of goods to suppliers of pharmaceutical services or services for the accounting and sale of medicines and medical devices within the framework of the GOBMP and (or) in the system of compulsory social health insurance (hereinafter referred to as the – OSMS);

     2) the social health insurance fund (hereinafter referred to as the fund) is a non–profit organization that accumulates deductions and contributions, as well as purchases and pays for services of healthcare entities providing medical care in the amounts and on the terms stipulated in the contract for the purchase of medical services, and other functions defined by the laws of the Republic of Kazakhstan;

     3) a single distributor is a legal entity operating within the framework of the GOBMP and (or) in the CSHI system in accordance with Article 247 of the Code.;

     4) scientific organization in the field of healthcare – a national center, scientific center or scientific research institute engaged in scientific, scientific, technical and innovative activities in the field of healthcare, as well as medical, pharmaceutical and (or) educational activities;

     5) the authorized body in the field of healthcare (hereinafter referred to as the authorized body) is the central executive body responsible for the management and intersectoral coordination in the field of health protection of citizens of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological welfare of the population, circulation of medicines and medical devices, quality of medical services (assistance);

     6) multidisciplinary group (hereinafter referred to as MDG) – a group of various specialists, formed depending on the nature of the violation of the functions and structures of the patient's body, the severity of his clinical condition;

     7) orphan (rare) diseases are rare serious diseases that threaten a person's life or lead to disability, the frequency of which does not exceed an officially defined level.;

     8) the "electronic government" mobile application is a software product installed and launched on a cellular subscriber device and providing access to government services and services provided in electronic form via cellular communications and the Internet.

Chapter 2. The procedure for providing medicines for the treatment of orphan diseases within the framework of the GOBMP and at the expense of other sources

     3. Providing patients with medicines for the treatment of orphan diseases within the framework of the GOBMP and from other sources on an outpatient basis is carried out in accordance with the list of orphan diseases and medicines for their treatment (orphan), approved by Order of the Minister of Health of the Republic of Kazakhstan dated October 20, 2020 No. KR DSM - 142/2020 "On approval of the list of orphan diseases and medicines means for their treatment (orphan)" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21479) (hereinafter referred to as the List).

     4. The basis for providing patients with medicines included in the List is the conclusion of the MDG indicating nosologies, names of medicines, dosages, single dose, frequency of administration per day, duration of one course of treatment (number of days of admission per month), duration of admission per year (number of courses per year), method of administration.

     5. The procedure for providing medicines to patients includes determining the need, purchasing, supplying, prescribing and disposing, storing and accounting, monitoring and controlling the use of medicines, regardless of the source of funding.

     6. Financing of medicines included in the List is carried out from the following sources:

     1) at the expense of the national budget in accordance with the List of medicines and medical products for free and (or) preferential outpatient care for certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions), approved by the Order of the Minister of Health of the Republic of Kazakhstan dated August 5, 2021 No. KR DSM-75 "On approval of the List of medicines and medical devices for free and (or) preferential outpatient care for certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions)" (registered in the Register of State Registration of Regulatory Legal Acts under No. 23885);

     2) at the expense of local executive bodies of regions, cities of republican significance and the capital, it is carried out on the basis of decisions of local representative bodies on the recommendation of local public health management bodies in accordance with subparagraph 5) of paragraph 1 of Article 12 of the Code.;

     3) at the expense of other sources not prohibited by the legislation of the Republic of Kazakhstan, including funds from charitable foundations and non-profit organizations, sponsorship, funds from legal entities and individuals, free of charge by manufacturers of medicines is carried out on the basis of a decision of the authorized body.

     7. Manufacturers of medicines submit proposals to the authorized body on cost-sharing of the cost of drug therapy in compliance with the requirements of the ethics of drug promotion in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated December 21, 2020 No. KR DSM-294/2020 "On approval of the Rules of Ethics for the promotion of medicines and medical devices" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21870).

     8. The Formulary Commission of the authorized body (hereinafter referred to as the Formulary Commission) considers proposals from manufacturers to share the cost of medicines by reimbursing part of the cost of drug therapy.

     9. A single distributor, based on the recommendation of the Formulary Commission, concludes contracts with manufacturers of medicines providing for reimbursement by manufacturers of part of the cost of medicines.

     10. Local public health authorities of oblasts, cities of republican significance and the capital send to a single distributor a personalized need for medicines provided by medical organizations providing specialized medical care according to the conclusions of the MDG.

11. The purchase of medicines is carried out by a single distributor based on a personalized need in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated June 7, 2023 No. 110 "On approval of the rules for organizing and conducting the purchase of medicines, medical devices and specialized medical products within the guaranteed volume of free medical care, additional volume of medical care for persons held in pre-trial detention isolation wards and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance, pharmaceutical services" (registered in the Register of State Registration of Regulatory Legal Acts under No. 32733).

     12. Payment of the cost of medicines upon provision of patients on the basis of secured prescriptions is carried out in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated November 27, 2020 No. KR DSM-210/2020 "On approval of the Rules for payment of the cost of pharmaceutical services within the guaranteed volume of free medical care and (or) medical care in the system of compulsory social health insurance for subjects in in the sphere of circulation of medicines and medical devices" (registered in the Register of State Registration of Regulatory Legal Acts). acts under No. 21715).

Paragraph 1. Determination of the need for medicines for the treatment of orphan diseases at the outpatient level

     13. The calculation of the need for medicines for the next financial year by medical organizations providing specialized medical care is carried out personified automatically in the ISLO based on the conclusions of the MDG.

     14. The collection of the need for medicines is carried out by March 15 of the current financial year in the ISO, indicating nosologies, names of medicines, single dose, frequency of intake per day, duration of one course (number of days of admission per month), duration of admission per year (number of courses per year), annual need per patient, the issued and secured volume for the previous year (hereinafter referred to as the Personalized Need).

     15. By March 25 of the current financial year, the Personalized need of the region, formed in the ISLO, is signed with an electronic digital signature of an authorized official of the medical organization or a person replacing him.

     16. By April 1 of the current fiscal year, local public health authorities of the regions, cities of republican significance and the capital coordinate the Personalized needs of the region by reconciling calculations taking into account the conclusions of the MDG, the actual consumption volumes for the previous year.

     17. Based on a Personalized Need in the Republic of Kazakhstan, the Fund forms a budget request from the republican budget for a three-year period by region, indicating nosologies, names of medicines, and the number of patients, and sends it to the authorized body, a Single distributor, no later than April 15 of the current fiscal year.

     18. A single distributor, based on a Personalized need for outpatient medicines, conducts an analysis to determine the volume of purchase of medicines, taking into account the volume of the undiminished stock, the actual needs of the previous year and the projected balances at the end of the current financial year.

     19. A single distributor shall submit a report on the results of the purchase of medicines to the authorized body within 5 (five) business days from the date of summing up the purchase results.

Paragraph 2. Release of medicines for the treatment of orphan diseases

     20. Prescribing medicines for the treatment of orphan diseases on an outpatient basis is carried out at the reception (consultation) by medical professionals of medical organizations providing primary health care and (or) specialized medical care based on the conclusion of the MDG.

     21. A record of prescribing medicines for the treatment of orphan diseases is entered electronically into medical information systems and ISOs in accordance with the List.

     22. To obtain medicines for the treatment of orphan diseases, prescriptions are prescribed electronically on forms according to form No. 078/u, approved by Order of the Acting Minister of Health of the Republic of Kazakhstan dated October 30, 2020 No. KR DSM-175/2020 "On approval of forms of accounting documentation in the field of healthcare, as well as instructions for completing them" (registered in The Register of State Registration of Regulatory Legal Acts under No. 21579).

     23. The procedure for prescribing, accounting and storing prescriptions for medicines is carried out in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated October 2, 2020 No. KR DSM-112/2020 "On Approval of the Rules for Prescribing, Accounting and storing Prescriptions" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21493).

     24. The prescription is written out in the ISLO with an indication of the single dose, the method and frequency of administration, and the duration of the course of treatment.

     25. Provision of a patient or his legal representative with a medicinal product for the treatment of orphan diseases is carried out according to an international nonproprietary name, taking into account the dosage form and dosage, by scanning an electronic prescription (QR code) presented through the Social Wallet service in the e-government mobile application.

     26. The release of medicines is carried out for a course of treatment for up to one month, and the actual amount of the dispensed medicine is included in the invoice.

     27. The provision of medicines in infusion dosage form, including immunological (immunobiological) medicines, is carried out under the supervision of a medical professional in medical organizations providing primary health care and (or) specialized medical care in inpatient conditions.

Paragraph 3. Storage and accounting of medicines for the treatment of orphan diseases

     28. When providing medicines, a Single distributor carries out shipments to medical organizations providing specialized medical care, taking into account the actual consumption and remaining medicines.

     29. A single distributor sends monthly information to the authorized body on the quantitative and cost indicators of contracts, the results of the fulfillment of contractual obligations by the parties.

     30. In medical organizations providing specialized medical care, medicines are subject to accounting in paper and (or) electronic form in total and quantitative terms by arrival, expenditure (invoices, invoices, powers of attorney) in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated February 16, 2021 No. KR DSM-19 "On Approval rules of storage and transportation of medicines and medical devices" (registered in the Register of State Registration of Regulatory Legal Acts under No. 22230).

     31. In medical organizations providing specialized medical care, the supply of medicines does not exceed the needs of 90 (ninety) calendar days.

     32. On the first day of each month, medical organizations providing specialized medical care draw up an act of reconciliation of medicines for the treatment of orphan diseases within the framework of the GOBMP and at the expense of other sources in accordance with Annex 1 to these Rules.

     33. During the inventory, the actual remaining medicines are reflected in a separate inventory statement.

     34. For the purpose of rational use of medicines, as well as to analyze data on the provision of citizens, local public health authorities of regions, cities of republican significance and the capital conduct quarterly monitoring of the provision of medicines to patients for the treatment of orphan diseases within the framework of the GOBMP and from other sources using the ISLO in accordance with Appendix 2 to these Rules.

Акт сверки лекарственных средств для лечения орфанных заболеваний в рамкахгарантированного объема бесплатной медицинской помощи и за счет иных источников

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Мониторинг лекарственных средств для лечения орфанных заболеваний в рамках гарантированного объема бесплатной медицинской помощи и за счет иных источников

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