Following the initiative of the Ministry of Health, Kazakhstan engaged in activities to reform its healthcare legislation. The concept of the updated Kazakhstan Code “On People’s Health and Healthcare System” is expected to be proposed for consideration by the countries Government in December 2018 and by their Parliament in the first half of 2019. Certain amendments (in particular, those relating to the market promotion of medicines and medical products) are currently considered by the Mazhilis of the Kazakhstan Parliament, and it is expected that they will be signed until the end of 2018.
Drafting of the respective laws is conditioned by the necessity to implement steps 81 and 82 of the Plan of the Nation (100 Concrete Steps to Implement Five Institutional Reforms), fulfill the tasks stipulated by “Densaulyk” State Healthcare Development Program for the years 2016-2019, and to follow the instructions of the President provided in the President’s address to the people of Kazakhstan – “Third Modernization of Kazakhstan: Global Competitiveness.”
When presenting the upcoming changes, Mr. Yelzhan Birtanov, Minister of Health of Kazakhstan, mentioned that in order to fulfill high-priority tasks outlined by the President and the Government the draft laws also amend, together with the Code on People’s Health and Healthcare System, more than 10 legislative acts (including, but not limited to, the Criminal Code, Criminal Procedure Code, Administrative Code) and numerous subordinate regulatory legal acts.
Key directions of the contemplated changes:
Eradication of corruption in the sphere of circulation of medicines, ensuring market promotion of medicines and medical products in complying with ethical norms, and establishment of liability for violation thereof
To this end, specific ethical rules were developed, which prohibit representatives of pharmaceutical companies visiting outpatient hospitals and inpatient facilities during working hours to advertise and promote medicines and medical products. In addition to the currently existing prohibition for medical workers to advertise medicines and medical products, the new requirements exclude the possibility of rendering sponsor support, providing bonuses and compensating for conference-related expenses to medical workers by pharmaceutical companies.
Regulation of prices for medicines
The expected amendments relating to the formation of prices for medicines and medical products imply four levels of price regulation: at the level of a manufacturer, wholesale selling, retail sales, and procurement in the framework of the guaranteed volume of free medical aid (GVFMA) and mandatory social medical insurance system (MSMIS).
Given the available price formation experience, the list of reference countries was reconsidered subject to their comparability with Kazakhstan in terms of macroeconomic performance indices, since the previous list included the countries Kazakhstan can hardly be compared with, such as the USA, UK, etc. The manufacturer’s prices will be registered based on the prices of reference countries for a consumer pack.
Margin in the wholesale and retail sale of medicines will also be regulated using the regressive markup scale. Respective plans cover the strengthening of economic expert examination of prices for medicines and medical products as to whether they are reasonable or not. The register of registered and limit prices for medicines and medical products is being drafted now. Such register will allow all parties concerned to get information on prices for pharmaceutical products.
Introduction of joint and several liability of citizens
For example, in the event of total agreement among healthcare professionals, community, Government and the Parliament, Kazakhstan may introduce administrative sanctions, including fines for irresponsible attitude toward own health and health of own children. So far, the issue of introduction, spheres of application and forms of sanctions are at the stage of discussion.
Introduction of a new model of GVFMA and MSMIS package in complying with the WHO principles
Medical care under the GVFMA will be provided to all citizens, oralmans (an official term used by Kazakh authorities to describe ethnic Kazakhs who have immigrated to Kazakhstan since its independence in 1991), foreigners and stateless persons permanently residing in Kazakhstan, including outpatient and inpatient care. Medical care provided based on the MSMIS will include medical services beyond the GVFMA, and the MSMIS package will be greater for KZT 42.4 thousand as compared with the GVFMA package.
Improvement of the system of corporate management in medical organizations
This is to ensure efficient management and development of competition in the healthcare sphere by extending the authority of supervisory councils in state medical institutions, the introduction of collective executive bodies and an internal audit service.
Improvement of public health protection
The improvement of public health is according to amendments introduced by the World Health Assembly in May 2005 concerning the implementation of International Health Regulations (IHR). For the purpose of regulating the authorities and status of the National Coordinator for IHR, the draft law provides for statutory definition of the Ministry of Health (MoH) of Kazakhstan as the authorized agency for the implementation of IHR. This will allow, adherence to the law-maker’s expectations and will ensure the increased operational efficiency and quality of interaction between the MoH of Kazakhstan and the WTO concerning critical situations in the sphere of public health.
Improvement of the medical education system and science and enhanced training of medical staff
This includes introducing; the Institute of strategic partnership in the sphere of medical education and science, a system for the evaluation of competence of academic staff, ensuring conditions for the trinity of science, practice and education through the mechanism of organizing integrated academic medical centers and academic teaching hospitals in a manner similar to Nazarbayev University.
- Improvement of the Institute of donation and provision of medical aid to tuberculosis patients
- Introduction of the system of national healthcare accounts
- Reconsideration of the sets of elements of certain administrative and criminal violations
- Filling the gaps in the current healthcare legislation.
In light of the fact that the contemplated changes in general and, specifically, the norms relating to price formation and regulation will affect the entire pharmaceutical community, they are actively discussed in the course of “round tables” with all parties concerned including; representatives of the Ministry of Industry and Development of Kazakhstan, Pharmacy Committee of the Ministry of Health of Kazakhstan, National Center for Expert Examination of Medicines, Republican Center for Healthcare Development, SK-Pharmacy LLP, National Chamber of Entrepreneurs “Atameken” and field-oriented associations, national and foreign pharmaceutical manufacturers, distributors of pharmaceutical products and other community leaders.