Order of the Minister of Health of the Republic of Kazakhstan dated December 25, 2019 No. KR of DCM-151 approved the Rules of use of medicines and medical products not registered in the Republic of Kazakhstan for the provision of medical care based on indications for a particular patient or for the provision of medical care to a limited number of patients with rare and/or very serious pathology.
Under the regulation, in order to use medicines and medical devices not registered in the RK, the health care organization shall send a letter to a local health care department to coordinate the need for such products with indication of a rare and/or very serious pathology, number of patients and calculations for the required number of medicines or medical products. At the same time, the health departments should additionally coordinate the need for imunobiological medicines not registered in the RK with a state body in the sphere of sanitary-epidemiological care for the population.
After obtaining approval for the need, the import of medicines or medical devices not registered in Kazakhstan for provision of medical care for a particular patient or to a limited number of patients with a rare and (or) very serious pathology is carried out in accordance with the Rules of import and export of medicines or medical products, approved by Order of the Ministry of Health Care of RK of August 17, 2015 No. 668.
Before using an unregistered medicine or medical product, the attending physician informs the patient or the patient’s legal representatives (if any) about the expected efficacy and safety of the medicine or medical product, possible risk for the patient as well as about actions in case of undesirable reactions to its use, and obtains the informed consent of the patient or the patient’s legal representatives (if any).
Consent to use the unregistered medicines or medical products for minors and adults recognized by a court as legally incompetent should be given by their legal representatives. In case of absence of legal representatives, the decision on the use of an unregistered medicine or a medical product shall be made by a board of doctors, and when it is impossible to convoke such board, directly by a health care worker with subsequent notification of the officials of the medical organization.
The use of an unregistered medicine or a medical product without the consent is based on medical indications regarding the persons:
- who are in depressed, comatose state, and unable to express their will;
- who suffer from diseases that are dangerous to others;
- who suffer from severe mental disorders (illnesses);
- who suffer from mental disorders (illnesses) and have committed a socially dangerous act.
The health care organization provides monitoring of side effects and analysis of efficiency and safety of an unregistered medicine and medical product in accordance with the Order of the Minister of Health of the Republic of Kazakhstan dated May 6, 2019 No. KR DCM- 67 “On Approval of the Rules for Evaluation of Rational Use of Medicines”.