On approval of the Standard for the organization of medical care for patients with orphan (rare) diseases in the Republic of Kazakhstan

Order of the Minister of Health of the Republic of Kazakhstan dated July 16, 2026 No. 78. Registered with the Ministry of Justice of the Republic of Kazakhstan on July 20, 2026 No. 39349

In accordance with subparagraph 32) of Article 7 and paragraph 3 of Article 138 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 standard for the organization of medical care for patients with orphan (rare) diseases in the Republic of Kazakhstan.

     2. The Department of Maternal and Child Health 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

Appendix to the Decree of the Minister of Health of the Republic of Kazakhstan on July 16, 2026 No. 78

The standard of organization of medical care for patients with orphan (rare) diseases in the Republic of Kazakhstan

Chapter 1. General provisions

     1. This standard for the organization of medical care for patients with orphan (rare) diseases in the Republic of Kazakhstan (hereinafter referred to as the Standard) has been developed in accordance with subparagraph 32) of Article 7 and paragraph 3 of Article 138 of the Code of the Republic of Kazakhstan "On Public Health and the Healthcare System" (hereinafter referred to as the Code) and establishes requirements for the processes of organization of care medical care for patients with orphan (rare) diseases in the Republic of Kazakhstan.

     2. Terms and definitions used in this Standard:

     1) 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);

     2) clinical protocol (hereinafter referred to as KP) – scientifically proven recommendations for prevention, diagnosis, treatment, medical rehabilitation and palliative care for a particular disease or condition of the patient;

     3) primary health care is the place of first access to medical care focused on the needs of the population, including prevention, diagnosis, and treatment of diseases and conditions provided at the level of a person, family, and society;

     4) a multidisciplinary group (hereinafter referred to as MDG) is 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;

     5) the Register of orphan (rare) diseases (hereinafter referred to as the Register) is a digital system designed to register patients with orphan (rare) diseases, plan drug provision, monitor drug therapy and its effectiveness, as well as ensure transparency of financing and quality control of medical care for patients with orphan (rare) diseases.

     3. Medical care for patients with orphan (rare) diseases is provided by medical organizations in accordance with Resolution of the Government of the Republic of Kazakhstan dated October 16, 2020 No. 672 "On approval of the list of guaranteed free medical care and invalidation of certain decisions of the Government of the Republic of Kazakhstan."

     4. Medical organizations ensure the implementation of measures aimed at early diagnosis, the application of a multidisciplinary approach, treatment and dynamic monitoring of patients at all stages of medical care.

     5. Medical care for patients with orphan (rare) diseases is provided in accordance with the KP and the standards of organization of medical care for the relevant profile, in their absence in accordance with modern achievements of science and practice, taking into account the principles of evidence-based medicine.

     6. Provision of medicines to patients is carried out in accordance with the order of the Minister of Health of the Republic of Kazakhstan dated March 11, 2026 No. 29 "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 from other sources" (registered in the Register of State Registration of Regulatory Legal Acts under No. 38135).

     7. Medical organizations ensure the introduction of accounting documentation forms in the field of healthcare in accordance with the order of the Acting Minister of Health of the Republic of Kazakhstan dated October 30, 2020 No. KR DSM-175/2020 "On approval of accounting documentation forms 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).

Chapter 2. The structure of organizations providing medical care to patients with orphan (rare) diseases

     8. At the primary level, medical care for patients with orphan (rare) diseases is provided by medical organizations of primary health care and consultative and diagnostic care in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated August 24, 2021 No. KR DSM-90 "On approval of the Rules for the provision of primary health care" (registered in the Registry state registration of regulatory legal acts under No. 24094).

     9. At the secondary level, medical care for patients with orphan (rare) diseases is provided in specialized departments of multidisciplinary regional and (or) city hospitals.

     10. At the tertiary level, medical care for patients with orphan (rare) diseases is provided in specialized departments of medical organizations at the national level.

     11. Medical care in hospital-substituting conditions is provided by primary health care medical organizations, regional and city hospitals, and national-level medical organizations in accordance with Order No. 106 of the Minister of Health of the Republic of Kazakhstan dated June 7, 2023 "On Approval of the standard of medical care in hospital-substituting conditions in the Republic of Kazakhstan" (registered in the Register of State Registration of Regulatory Legal Acts acts under No. 32740).

     12. Medical care for patients with orphan (rare) diseases at the level of regions, cities of republican significance and the capital is coordinated by a medical organization determined by a decision of the local public health management body of the region, the city of republican significance and the capital.

     13. The coordination of medical care for patients with orphan (rare) diseases is carried out by a national–level medical organization determined by an authorized body (hereinafter referred to as the Coordination Center).

     14. The Coordination Center provides organizational and methodological support for patients with orphan (rare) diseases, coordinates the conclusions of the MDG regions in the Registry, monitors the effectiveness and safety of therapy for patients with orphan (rare) diseases, and generates an annual analytical report with subsequent referral to the authorized body.

Chapter 3. Main tasks and activities of organizations providing medical care to patients with orphan (rare) diseases

     15. The basic principles of providing medical care to patients with orphan (rare) diseases are:

     1) timely implementation of measures aimed at prevention, diagnosis, treatment, palliative care and medical rehabilitation of patients with orphan (rare) diseases;

     2) conducting molecular genetic research and medical genetic counseling to assess hereditary risk;

     3) provision of medicines, medical products, and specialized medical nutrition products in accordance with the KP in the relevant profile;

     4) providing palliative care to patients with orphan (rare) diseases for medical reasons;

     5) ensuring interaction with educational, social protection organizations and other interested agencies on issues of comprehensive care for patients with orphan (rare) diseases;

     6) participation in scientific research and international projects aimed at the introduction of new technologies in the field of diagnosis and treatment of orphan (rare) diseases.

Chapter 4. The procedure for providing medical care to patients with orphan (rare) diseases

Paragraph 1. Procedure for providing medical care to patients with orphan (rare) diseases on an outpatient basis

     16. Outpatient medical care for patients with orphan (rare) diseases includes the provision of primary health care and specialized medical care.

17. At the primary health care level, medical care is provided, including:

     1) conducting a clinical examination by a doctor;

     2) conducting laboratory and instrumental examinations;

     3) dynamic monitoring, management and treatment of the patient, taking into account the conclusion of the MDG;

     4) monitoring of laboratory parameters against the background of ongoing therapy;

     5) conducting an examination of temporary disability in accordance with the order of the Minister of Health of the Republic of Kazakhstan dated November 18, 2020 No. KR DSM-198/2020 "On approval of the rules for conducting an examination of temporary disability, as well as issuing a sheet or certificate of temporary disability" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21660);

     6) drawing up conclusions for referral to a medical and social examination in accordance with the order of the Deputy Prime Minister - Minister of Labor and Social Protection of the Population of the Republic of Kazakhstan dated June 29, 2023 No. 260 "On Approval of the Rules for conducting a medical and social examination" (registered in the Register of State Registration of Regulatory Legal Acts under No. 32922);

     7) carrying out information and explanatory work among the population;

     8) providing psychological and medical-social assistance to patients with orphan (rare) diseases;

     9) provision of palliative care and medical rehabilitation in accordance with the CP;

     10) referral for hospitalization to receive specialized medical care, including high-tech medical services.

Paragraph 2. Procedure for providing medical care to patients with orphan (rare) diseases in inpatient and inpatient-substituting conditions

     18. Medical care for patients with orphan (rare) diseases in inpatient settings is carried out in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated March 24, 2022 No. KR DSM-27 "On approval of the Standard of medical care in inpatient settings in the Republic of Kazakhstan" (registered in the Register of State Registration of Regulatory Legal Acts under No. 27218).

     19. Hospitalization of patients with orphan (rare) diseases is carried out as planned through the portal "Bureau of Hospitalization" or for emergency indications.

     20. Medical organizations that provide care to patients with orphan (rare) diseases in inpatient and inpatient-replacement settings provide a multidisciplinary approach, specialized and high-tech medical care, as well as comprehensive support aimed at improving the quality and life expectancy of patients.

     21. Provision of inpatient care at the secondary and tertiary levels includes:

     1) provision of specialized and high-tech medical care;

     2) confirmation of the clinical diagnosis based on the results of laboratory and instrumental studies, including molecular genetic studies, if indicated;

     3) the organization of remote medical services with the participation of national-level medical organizations in complex diagnostic cases.

     22. Pathogenetic therapy and tactics are determined based on the results of laboratory tests conducted in accredited (certified) state medical organizations.

     23. After completing the course of treatment, the patient is referred to a medical organization providing primary health care at the patient's place of attachment for dynamic monitoring based on the MDG conclusion.

     24. The medical organization submits to the MDG meeting the discharge epicrisis from the patient's medical record and the results of laboratory and instrumental studies.

     25. MDG determines the method and tactics of treatment, taking into account a personalized approach, assessing the patient's condition, monitoring the effectiveness of therapy and developing recommendations for the use of treatment methods 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 for their treatment (orphan)" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21479) (hereinafter referred to as the List).

     26. The MDG consists of freelance specialists of the relevant profile of the region, in palliative care, medical rehabilitation and medical genetics, determined by the decision of the local state health authorities of the regions, cities of republican significance and the capital.

     27. The conclusion of the MDG is drawn up in the Register in accordance with the annex to this Standard.

     28. In the absence of a response to therapy conducted in accordance with the KP, the development of complications that prevent the continuation of treatment, as well as in the presence of complex clinical cases requiring an integrated approach, the Coordination Center is considering the possibility of using therapy not provided for by KP, taking into account international experience.

     29. The Coordination Center attracts specialized specialists of relevant specialties at all levels of medical care using telemedicine technologies, including remote consultations of specialists from medical organizations at the national level, with mandatory registration of results.

     30. Based on the results, the Coordination Center submits to the expert council the opinion of the MDGs not represented in the List.

     31. The Expert Council is an advisory body under the authorized body, which includes freelance specialists in palliative care, medical rehabilitation, medical genetics, clinical pharmacology and specialized specialists, determined by the decision of the authorized body.

     32. The purpose of the expert council is to provide an integrated and individual approach to providing medical care to patients with orphan (rare) diseases.

Paragraph 3. The procedure for providing emergency medical care, including involving medical aircraft, to patients with orphan (rare) diseases

     33. Emergency medical care, including with the involvement of medical aviation, is provided to patients with orphan (rare) diseases in accordance with the order of the Minister of Health of the Republic of Kazakhstan dated November 30, 2020 No. KR DSM-225/2020 "On approval of the rules for the provision of emergency medical care, including with the involvement of medical aviation" (registered in the Register of the state registration of regulatory legal acts under No. 21713).

     34. Transportation of patients with orphan (rare) diseases, if necessary, to provide them with emergency medical care, including with the involvement of medical aviation, to medical organizations at the national level is carried out:

     1) paramedic field ambulance teams that have received appropriate training;

     2) medical field ambulance teams;

     3) specialized field ambulance teams trained in the field of "ambulance and emergency medical care";

     4) mobile medical aviation teams.

     35. Emergency medical care for patients with orphan (rare) diseases is provided when:

     1) the presence of an immediate threat to life, in which the lack of timely medical care can lead to deterioration or death.;

     2) there is a high risk of an immediate threat to life at any time.

     36. The provision of emergency medical care is carried out by field teams equipped with the necessary medical and diagnostic equipment and medicines, staffed by qualified medical personnel.

     37. When transporting children with orphan (rare) diseases using medical aviation, therapy correction is carried out aimed at preventing complications during transportation.

Chapter 5. Recommended staff of healthcare organizations providing medical care to patients with orphan (rare) diseases

     38. Recommended staffing standards are determined in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated June 30, 2025 No. KR DSM-419 "On approval of standard staffing and staffing standards for healthcare organizations and (or) their structural divisions."

     39. The minimum staffing standards of departments providing outpatient and inpatient care are established based on the volume of medical and diagnostic work and the number of patients in accordance with the standards of organization of medical care in the relevant profile.

Chapter 6. Recommended equipping of healthcare organizations providing medical care to patients with orphan (rare) diseases with medical devices

     40. The minimum equipment of the department providing outpatient and inpatient care is determined in accordance with the standards of organization of medical care in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated October 29, 2020 No. KR DSM-167/2020 "On approval of minimum standards for equipping healthcare organizations with medical products" (registered in the Register of State Registration of Regulatory Legal Acts under No. 21560).

Appendix to the Standard for the Organization of Medical Care for Patients with Orphan (Rare) Diseases in the Republic of Kazakhstan

Form

Conclusion

multidisciplinary group on Orphan (rare) diseases

     Protocol no._____ from "_" "________" 202_ year

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