News of the legislation of Kazakhstan - January 2022
Amendments to the Health Code
On 3.01.2022, the President signed a law aimed at enhancing competition in the Republic of Kazakhstan (hereinafter – “RK”). The Law of the RK No. 101-7 ZRK dated 3.01.2022 “On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan on the Development of Competition” (hereinafter – the “Law”), among other things, introduces amendments to the Code of the RK No. 360-VI ZRK dated 7.07.2020 "On Public Health and Healthcare System" (hereinafter – "Health Code").
- The main amendments introduced by the Law affect the state’s price regulation of medicines and medical products. Pursuant to the amendments, only the listed medicines will be subject to price regulation within the wholesale and retail sales. The said list of medicines will be approved by the Ministry of Healthcare in coordination with the Agency for Protection and Development of Competition no more than once in a half-year no later than the 10th (tenth) day of the 3rd (third) month of the half a year period. According to the presently discussed draft amendment to the rules regulating prices to medicines, the criteria for inclusion into the list will be availability of several trade names or manufacturers of medicines within 1 (one) international non-proprietary name.
- The ban on purchase and co-payment of medicines and medical products registered in the RK without a maximum price for a trade name within the guaranteed volume of free medical care and (or) in the system of obligatory social medical insurance remains in force.
Thus, it can be noted that a gradual process of the medicine price deregulation has been launched in Kazakhstan in order to maintain competition in the market and increase the choice of medicines for wholesale and retail sales.
These changes will come into effect as of 7.03.2022.
Amendments to the procedure on formation of the lists of rare diseases and medicines for their treatment
On 22.01.2022, Order of the acting Minister of Healthcare of the RK No. KR DSM-142 dated 31.12.2021 "On Amendments to Some Orders of the Ministry of Healthcare of the Republic of Kazakhstan" introduced amendments to some acts of the Ministry of Healthcare of the RK.
In particular, the amendments affected rules for the formation of a list of orphan diseases.
- Orphan diseases are rare severe diseases that threaten a person's life or lead to disability, the frequency of which does not exceed an officially defined level[1]. Treatment of such diseases is carried out within the guaranteed volume of free medical care[2].
- According to the amendments, Ministry of Healthcare proposes inclusion of a disease in the list of orphan diseases within 3 (three) working days from the moment of its receipt to scientific organizations in the field of healthcare according to the profile of the disease, and (or) to the "Working Body", which is a scientific organization that through research, implementation of scientific, technical, informational and educational programs promotes the development of healthcare[3].
The Order also introduces the following amendments:
Amendments in relation to orphan diseases:
- The list of orphan diseases and medicines for their treatment was adopted in a new edition and increased by 4 (four) items
- Now, the Ministry of Healthcare of the RK can submit the following proposals for consideration by the Formulary Commission at its own initiative:
- on the inclusion of medicines used to treat orphan diseases in the Kazakhstan National Medicinal Formulary (hereinafter – “KNF”);
- on the inclusion of medicines or a medical device used to treat orphan diseases in the list of outpatient medicine provision;
- on the inclusion of medicines or medical device used for the treatment of orphan diseases in the list of purchases under the guaranteed volume of free medical care and (or) obligatory social medical insurance system.
Amendments in relation to the formation of KNF:
- KNF was adopted in a new edition;
- Information about the medicines included in KNF should be displayed in clinical protocols on the website of the Ministry of Healthcare of the RK;
Amendments in relation to the rules for the formation of the list of medicines and medical devices for outpatient medicine provision:
- The list of the diseases that can be included in the list of outpatient medicine provision was expanded. Now, the diseases contained in the lists approved by the Order of the Minister of Healthcare of the RK No. ҚР ДСМ-149/2020 dated 23.10.2020 "On Approval of the Rules for Organizing the Provision of Medical Care to Persons with Chronic Diseases, the Frequency and Timing of Observation, the Mandatory Minimum and Frequency of Diagnostic Studies" can also be included in the abovementioned list of outpatient medicine provision.
[1] part 1 of the Article 177 of the Health Code
[2] part 2 of the Article 177 of the Health Code
[3]Clause 4, of the Rules for the Formation of the List of Orphan Diseases and Medicines for Their Treatment