We would like to present to your attention a publication from a series of analytical reviews of the SK-Pharmacy LLP Single Distributor within the framework of the National Health of the Nation project
The health of the nation and the availability of healthcare are the fundamental priorities of our state. Many countries are striving to improve the provision of health care services to the population through a wide range of ongoing reforms in this area, as well as activities aimed at improving the quality of health care provided. Kazakhstan is no exception.
A complete transformation of the health care system cannot be considered without a reboot of the system for providing medical institutions with modern diagnostic and treatment-and-prophylactic equipment.
To date, the development of technology has reached great heights, both in terms of treatment and in terms of early diseases’ diagnosis. Early diagnosis, in turn, contributes to the movement of the healthcare system towards the development of preventive medicine.
For high-quality treatment of patients it is necessary to create favorable conditions for equipping medical institutions with modern diagnostic and treatment-and-prophylactic equipment through the effective functioning of the medical equipment market and the availability of a list of bona fide suppliers.
The ultimate goal is the effect that patients will see, and this is the most important KPI of the entire industry.
During the speech of the Head of State at the enlarged meeting of the government, a separate block of speech was devoted to problems in the field of healthcare. In particular, he stressed the need to radically revise the system for medical equipment procuring.
“This is a big problem, since this area is highly corruptible. The regions systematically inflate estimates and prices for equipment, and spend huge amounts of money on its maintenance. Therefore, I instruct the government to switch to the centralized medical equipment procurement based on SK-Pharmacy LLP,” the President said.
PROBLEMS OF MEDICAL EQUIPMENT PROCUREMENT
STATE REGISTRATION AND PRICE REGULATION
MEDICAL EQUIPMENT SUPPLY SYSTEM:
HIGHLY CORRUPTIOGENIC
In accordance with the Rules, the procurement of medicines and medical devices is carried out in compliance with, among other things, the principles of optimal and efficient spending of money used for procurement, providing potential suppliers with equal opportunities to participate in the procurement procedure, and fair competition among potential suppliers. A formal attitude or non-compliance with these principles leads to a high level of corruption in the system for providing medical equipment.
Quite often, medical organizations want to procure specific medical equipment from a specific manufacturer and at the same time set all possible requirements (characteristics) that reduce the likelihood of obtaining medical equipment from another manufacturer. Such "sharpening" for the products of a particular manufacturer leads to high corruption risks of the medical equipment supply system.
In order to avoid restricting competition as a result of the description of the object of procurement corresponding to the goods of a single manufacturer, when preparing technical specifications, the Ministry of Health adopted the Rules for issuing an expert opinion on the compliance with the characteristics of the technical specification for the procurement of medical equipment, which should ensure that the characteristics of the technical specification for the medical equipment procurement correspond to at least two models from different manufacturers.
The problem of insecurity of doctors and medical personnel deserves special attention. The number of criminal cases initiated against the medical community for the medical equipment procurement at an inflated price has increased. Criminal cases initiated against the former leaders of the Mangistau Health Department with a sentence of 3.5 years for the procurement of a mobile X-ray machine at an inflated price, as well as for 8 years of the ex-head doctor of one of the hospitals in the Akmola region for the procurement of used ones, without a guarantee, discontinued Ventilators and anesthesia machines are a clear confirmation of this. Short-sightedness and insufficient knowledge of information on the part of the leadership of both local health authorities and chief doctors of regional hospitals create a favorable environment for the formation of an opinion among inspection bodies about a favorable corruption background in the healthcare sector.
SPECIALIST TRAINING SYSTEM:
INSUFFICIENT DEVELOPMENT OF DOMESTIC PRODUCTION
According to the data of the State Register of Medicines and Medical Devices, there are about 40 domestic manufacturers of medical equipment today.
It mainly produces non-complex medical equipment, such as medical and functional furniture, irradiators recirculating and other non-complex devices. Other words, domestic manufacturers of medical equipment in Kazakhstan, for the most part, are represented only by a skd-montage of equipment from components that are most often supplied from China. If we mark the manufacturers of complex and high-tech medical equipment, then there are only a few such manufacturers (Aktyubrentgen JSC, Qazmedpribor LLP, OralMedRegion LLP).
It is important to note that in society, in general, there is a distrust of domestic medical equipment. Medical workers, first of all, are afraid of the low quality of domestic medical equipment, even if the medical equipment did not give obvious reasons for this. This creates a biased attitude towards the domestic medical industry. Obviously, the preferences of medical workers are reduced to products of world brands, with which domestic medical equipment is compared. Changing the curve on the scale of negative values of the attitude of doctors to the quality of our medical equipment towards a positively directed graph is one of the challenges facing the healthcare system in Kazakhstan.
INSUFFICIENCY OF MEDICAL EQUIPMENT
Solving the problems of the imperfection of the regulatory framework for the medical equipment procurement is far from the only task that needs to be addressed in this area.
In accordance with the instructions of the Head of State, in 2021 the Ministry of Health carried out large-scale work to prepare for the modernization of the healthcare sector, as part of which an inventory of the existing fleet of medical equipment was carried out, as a result of which the level of equipment of healthcare organizations with medical equipment was 82%, and the wear rate was 49 %.
INEFFICIENT PLANNING AND PROCUREMENT ORGANIZATION
There are also many questions regarding the planning and organization of the medical equipment procurement, which is manifested on the ground by the procurement on paper, the procurement of identical medical equipment with a significant difference in price, the lack of averaging of technical specifications between similar models for the medical equipment procurement.
LACK OF APPROPRIATE METHODOLOGY AND SUSTAINABILITY OF TECHNICAL CHARACTERISTICS
As in any procurement in the system of providing medical equipment, preparing a description of the procurement object is one of the most difficult processes in its implementation. At the same time, it is not possible to thoroughly regulate this process, given the variety of procurement objects (from an electrocardiograph to a linear accelerator).
Thus, in order to implement the task of improving the system for providing medical equipment, it is necessary to develop an appropriate methodology (standards or GOSTs) for preparing technical specifications for procured medical equipment. These documents should be developed on the basis of the principles of the validity of the technical characteristics, as well as the possibility of their verification for the compliance of the goods with the requirements established in the technical specification at the stage of acceptance.
The principle of efficient spending of allocated funds for the medical equipment procurement is directly related to the validity of the requested technical characteristics, that is, medical equipment must be procured with such characteristics that are reasonably necessary to achieve the desired results and do not lead to the procurement of goods with excessive properties. Therefore, each requirement in the technical specification must be justified by the real need of the customer.
Also, when preparing technical specifications, one should avoid indicating characteristics that cannot be confirmed in practice at the stage of acceptance of goods in a medical organization, indications of which are also not available in the relevant documents, including from open sources, such as certificates, declarations, registration certificates or instructions for use.
INSUFFICIENCY OF FINANCIAL INVESTMENTS FROM THE BUDGET
In addition to the problem of insufficient medical equipment, it is also necessary to pay attention to other problems related to the lack of financial investments from the budget (infrastructure costs, training, maintaining the health of the medical equipment fleet), as well as the lack of affordable mechanisms for leasing medical equipment.
LOW SERVICE SYSTEM
Improving the system of medical equipment service maintenance remains one of the pressing issues of the healthcare sector, and its importance is increasing every year due to the increase in the equipment of medical organizations with more and more expensive high-tech medical equipment, new economic conditions, as well as increased responsibility for patient safety and the quality of medical care provided. services under health insurance.
Poor after-sales service can, on the contrary, lead to a malfunction of the device, equipment breakdowns, improper operation, deterioration of factory parameters, which in turn creates a risk of harm to the life and health of patients, misdiagnosis and a threat to the safety of patients and employees of a medical institution.
Until 1992, the Medtekhnika system of regional state-owned enterprises functioned, which carried out maintenance and repairs. However, later funding allocated for the medical equipment procurement and services for its maintenance decreased and the functioning of this system was disrupted. This led to the fact that the system of regional state-owned enterprises ceased to exist, and the maintenance of medical equipment in healthcare institutions in the post-warranty period is carried out on the basis of an agreement with service departments of medical equipment manufacturers, or with a service organization, as well as with the help of the medical organization's own technical service.
Insufficient funding of the service, as well as the absence of corresponding costs in the tariffs for the guaranteed volume of free medical care and compulsory medical insurance, leads to financing on a residual basis. If the medical equipment is idle, it causes losses.
LACK OF A SYSTEM FOR PROVIDING ACCESSORIES AND SPARE PARTS
The use of low-quality, non-original components and spare parts can lead to a loss of measurement and diagnostic accuracy, a reduction in the service life due to increased wear. For example, if the X-ray tube is not replaced in time, the X-ray machine generates stronger radiation, which leads to exposure of the patient and medical personnel. With an out of tune, unadjusted physiotherapy apparatus, the patient may receive a burn to the skin surface or an electric shock. If the analyzer is not calibrated and verified, the results of the study may be distorted and the doctor runs the risk of making an incorrect diagnosis and choosing the wrong treatment tactics.
Poor maintenance from dubious service companies that won the competition with a lower cost of service can lead to breakdowns that will require a huge amount of money to fix.
The lack of high-quality service maintenance of medical equipment, the lengthy process of supplying spare parts leads to idle time of procured expensive medical equipment, and as a result, to the failure to provide timely medical care to the population in full and to the country's losses.
VISION FOR SOLVING THE PROBLEM
To carry out the centralization of the medical equipment procurement on the basis of SK-Pharmacy LLP, following the example of the procurement of medicines and medical devices, which is planned to be implemented in two stages.
Development of the National Program for equipping medical organizations for a 5-year period, which is designed to achieve the following goals:
WHY IT WILL BE DONE ON THE BASIS OF THE SK-PHARMACY LLP SINGLE DISTRIBUTOR?
EXPERIENCE - The first and obvious argument is the experience in centralized procurement of medicines and medical devices, the possibility of concluding long-term supply contracts with suppliers who intend to create or modernize the production of medical devices, the mechanism for concluding contracts with contract manufacturing customers.
VOLUME CONSOLIDATION AND BUDGET SAVINGS
procurement centralization and consolidation of the volume of demand from all regions, which allows for savings in budgetary funds, unification of technical specifications for procurement, ensuring real competition between players in the procurement and negotiating price reductions with the winners.
Single distribution consolidates the volume for about 2,000 medical organizations in the country.
EFFICIENT MECHANISMS - The system of single distribution of medical products has effective mechanisms to reduce the price:
Tax-free medicines are procured without intermediaries directly from the manufacturers themselves, as well as through international organizations. The intermediary is excluded from the procurement chain. In 2022, savings only under contracts as part of the procurement directly from the manufacturer amounted to about 5.1 billion tenge.
Savings are also noted when procuring under long-term contracts with domestic producers, which suggests that the development of the domestic industry is not only ensuring the national security of the country, but also the possibility of saving budget funds. State support of domestic producers under the mechanism of long-term contracts for 10 years made it possible to increase the share of procurement in monetary terms from 15% in 2010 to 41% in 2021.
SAVINGS THROUGH THE AUCTION.
The greatest cost reduction is achieved through an auction to reduce the price, which is held on the electronic platform of a single operator. It is this stage, as a result of serious competition between suppliers, that provides the lion's share of budget savings through procurement procedures.
In total, over the years of the existence of a single system represented by SK-Pharmacy LLP, more than 185.9 billion tenge of budget funds have been saved.
STUDIES AND SUCCESSFUL CASES
DOMESTIC CASES AND EXPERIENCE OF SOME CIS COUNTRIES
EXPERIENCE OF KAZAKHSTAN - the experience of Karaganda and East Kazakhstan regions, as well as the KazMedTech JSC, was studied, from which useful cases in the field of medical equipment were extracted.
Karaganda region - a case was studied for the implementation of public-private partnership (PPP) projects, within which 13 medical organizations of the region were equipped with heavy medical equipment (CT, MRI), expert-class ultrasound machines, ophthalmological equipment and a hemodialysis machine. At the same time, the following procurement mechanisms were used: (1) Financial leasing with reimbursement of lease payments from various sources of financing (RB, LB, own funds); (2) Medical equipment in installments from the local budget; (3) PPP project - investment projects for expensive medical equipment.
East Kazakhstan region - a case was studied for the implementation of measures for the comprehensive modernization and equipping of the entire region.
As part of the project, the following units were upgraded: Reception ward (TRIAGE system); Operating block; Resuscitation (for adult and children); Maternity block (transfer to the II level of obstetric care); Oncology (Center of Oncology and Surgery); blood services; Simulation Center; Rehabilitation (Altai resort).
In total, the region was modernized and medical equipped for a total of 9,925.4 million tenge.
KazMedTech JSC - the current system for the examination and service of medical equipment was laid on the basis of KazMedTech JSC back in 2010, when Kazakhstan switched to a leasing system for the medical equipment procurement at 5% for 3 years.
Leasing was based on a long-term lease of medical equipment with the right to procurement, which made it possible to make flexible decisions when large financial investments are required.
At the same time, one hundred percent participation of the state in the activities of KazMedTech JSC was carried out the main task of the effective use of medical equipment acquired on lease by medical organizations by monitoring the use of medical equipment, as well as the provision of warranty service by suppliers for 37 months and then for the entire leasing period.
IN OTHER INDUSTRIES - Positive trends in the application of centralization processes in other areas - the agricultural industry, the construction industry, national companies (examples of Samruk Kazyna and Kazakhstan Engineering) were noted.
For example, a system of centralization of certain functions has been introduced in national companies, incl. and procurement/supply management, through the establishment of a Shared Service Center (SSC). Thus, the SSC makes it possible to centralize such processes as accounting, tax and management accounting, treasury, personnel management, while at the same time allowing to reduce administrative costs without harming the activities of individual enterprises.
EXPERIENCE OF UZBEKISTAN - The experience of Uzbekistan in the field of centralized procurement is also interesting. In accordance with the Law of the Republic of Uzbekistan, which regulates this area, budgetary customers are obliged to procure goods, works and services through an electronic store, an auction to lower the starting price (in electronic form), a competition, a tender, public procurement from a single supplier.
Examination of procurement documentation is carried out by the State Unitary Enterprise Center for Comprehensive Expertise of Projects and Import Contracts under the National Agency for Project Management under the President. O’zmedimpeks LLC is a structural subdivision of the Ministry of Health of the Republic of Uzbekistan, which carries out centralized procurement.
EXPERIENCE OF BELARUS - It is also worth noting the experience of the Republic of Belarus. In the course of organizing and conducting public procurement procedures, the organizer may involve experts for consultations, including when combining applications for the procurement of medical devices during the centralization of public procurement.
The procurement is carried out by a single organizer of the procurement of medical equipment and medical devices (medical products) for healthcare institutions of the Republic of Belarus - the Belmedtekhnika Production and Trade Republican Unitary Enterprise. The structure of Belmedtekhnika UE includes five subsidiaries located in the cities: Baranovichi, Vitebsk, Gomel, Grodno, Mogilev. It has its own network of specialized retail stores with more than 120 facilities located in more than 70 locations across the country. The total number of employees is more than 900 people.
FOREIGN PRACTICE
Foreign experience in import substitution mainly consists in comprehensive support for domestic producers (preferential rates on loans, financial assistance to innovative enterprises), as well as in the establishment of a strict system for obtaining certificates that allow foreign manufacturers to enter the domestic market.
The experience of advanced countries, in particular the USA, Malaysia, the United Arab Emirates, Korea, Russia, Australia, the countries of the European Union, and Japan, has been studied.
An analysis of global procurement practices shows that centralized procurement, as an important social function in the world, is usually carried out by organizations that are part of or associated with authorized bodies in the healthcare sector. In Argentina, India, New Zealand, Estonia, centralized procurement at the state level is carried out by the Ministry of Health.
In the reference models, which are similar to the RoK in a number of important criteria, centralized procurement is carried out by government entities or procurement agencies reporting to government entities.
In AUSTRALIA, the central procurement of medicines and medical devices is carried out by the Purchasing Agency, which is subordinate to the Australian Health Authority.
In DENMARK, by the Procuring Agency, subordinate to the regional authorities, as in Norway.
In SERBIA - the National Compulsory Health Insurance Fund, subordinate to the state.
In Saudi Arabia, by the Procuring Agency, financed from the state budget and the profit generated by the agency through a markup.
In the USA, pharmaceutical and medical distributors, which are world wholesale leaders, McKesson, AmerisourceBergen and Cardinal Health consolidated more than 90% of sales in the US market and about 45% of sales of all medical products in the world.
McKesson - the main activities of pharmaceutical distribution (supply of pharmaceuticals to more than 40,000 customers), as well as the supply of medical and surgical supplies and medical equipment. The company's catalog includes more than 150,00 items of goods, including its own line of medical products.
AmerisourceBergen - carry out wholesale and specialized distribution of medicines and medical devices. In addition to the United States, it operates in 10 other countries, mainly in Europe (Great Britain, Spain, Turkey, Czech Republic, Lithuania, France, the Netherlands, Norway, Romania and Egypt).
In BULGARIA, public procurement is carried out by one agency, the Public Procurement Agency, which is responsible for procurement functions at the national, regional and municipal levels.
In the UK, central procurement and framework agreements are handled by the National Health Service Procurement and Supply Agency. Its field of activity is exclusively related to the National Health Service (about 500 client organizations). In the UK, the National Health Service (NHS) is the largest purchaser of medical equipment, the publicly funded, provides approximately 85% of the country's health care.
The POLISH model of centralization provides that one agency - the Public Procurement Office - is authorized to work at the national level.
REPUBLIC OF KOREA - a specialized department has been created and is functioning in the country - the Central Agency for Public Procurement (hereinafter referred to as the Agency). Its powers include the procurement of goods, works and services at the expense of the budget for the needs of the public sector of government. The Agency maintains and manages The Korea ON-line E-Procurement System (hereinafter referred to as KONEPS), which provides electronic access to public procurement to all interested suppliers (procurement participants) in real time.
Pure Health is one of the leading companies in the UAE that operates a network of hospitals, medical laboratories and carries out group procurement of medicines and medical devices for its own clinics (GPO - Group Purchasing Organization). This mechanism allows suppliers to use multiple procuring channels to provide process flexibility, as well as Pure Health's full control over the ordering and payment processes.
Philips, GE Healthcare - work was carried out in terms of studying and exchanging experience on the localization of the production of medical equipment, including the issues of procuring medical equipment directly from manufacturers using the life cycle contracts mechanism, as well as visits to localized production of medical equipment by Philips companies, GE Healthcare in the CIS.
INTERNATIONAL ORGANIZATIONS
UN - Procurement from the United Nations (UN) and, accordingly, organizations operating under the auspices of the UN (including WHO - World Health Organization) is carried out through the electronic resource UNGM (The United Nations Global Marketplace) - UNGM (United Nations Global Marketplace). Nations). Suppliers can register on the portal by filling in the relevant data and participate in competitive procedures.
UNGM is the electronic procurement portal of the UN system. It brings together UN procurement staff and the vendor community interested in doing business with the UN. Procurement under UNGM is a global market with over US$14 billion in annual turnover for all types of goods and services.
The main functions of UNGM are as follows:
- to provide providers with a centralized and unique portal registration process for 29 UN organizations (including WHO);
- to provide suppliers and the public with access to UN procurement and contracting opportunities;
- to disseminate relevant UN procurement information and UN market information.
UNGM also supports government trade promotion organizations in promoting UN procurement opportunities in their business community.
Also hosted by the UN is the Doing Business with UN platform, through which UN organizations host virtual business seminars, where suppliers can get useful information on how to start business with the UN. The platform aims to make it easier to reach a wider audience than traditional business seminars.
International Procurement Seminars (IPS), also known as Interagency Business Seminars, provide an opportunity for UN buyers and suppliers to meet in person and have one-on-one meetings between UN buyers and suppliers.
WHO PROCURING PRINCIPLES:
- Environmental factors: climate change mitigation and adaptation; pollution prevention; sustainable resources; protection of the environment and biodiversity.
- Social factors: human rights; labor rights; gender equality; variety of suppliers; inclusiveness and accessibility for people with disabilities; sustainable consumption; social health and well-being. WHO encourages a variety of vendors to participate in its tendering opportunities, including Women on Board (WOB), disability-friendly vendors, and a variety of other vendors such as Youth on Board (YOB) belonging to indigenous peoples or LGBTQI+ groups.
- Economic factors: calculation of the cost of the entire life cycle; local communities and micro, small and medium enterprises; supply chain sustainability.
PRODUCTION LOCALIZATION AND OPTIMAL BRANDS SELECTION - Further development of the centralized medical equipment procurement should be gradually transformed into a system of integrated equipment in priority areas, with the development of mechanisms for concluding long-term contracts on the terms of localization of contract manufacturing, contracts for the life cycle of medical equipment.
LOCALIZATION BENEFITS – localization of production in the country has the following advantages: (1) a more sensitive understanding of the needs in whole and needs of medical organizations in the necessary medical equipment; (2) creation of new jobs in the country; (3) creation of products that meet the demand and specifics of the domestic market (clear interface, understandable language, etc.); (4) construction of modern production sites; (5) the possibility of training in-house medical engineers at localized production bases.
Major players in the aviation, transport and logistics, and agricultural industries also welcome the focus on optimal brands when localizing production / operation.
In the product line of each brand, there is always the best option that combines the optimally necessary equipment and a set of functions that meets the required conditions and tasks. Conventionally, they can be called "workhorses". Such "horses" are able to perform the functionality, maintaining the quality not below the required level.
BRANDS - The application of the approach of the optimal choice of brands of the world's leading manufacturers should also be applied to the large-scale medical equipment in the Republic of Kazakhstan, including taking into account localization / contract manufacturing and the introduction of the pre-qualification stage.
The concentration of efforts on a certain list of manufacturers of medical equipment will allow, taking into account the nationwide need to update the fleet of medical equipment, to put forward conditions for manufacturers to localize production, open a network of service centers and spare parts warehouses (not only in Nur-Sultan and Almaty), will reduce the price for the account for the consolidation of procurement of the medical equipment itself, as well as for maintenance, repairs, and training.
An example of choosing the optimal set of operated brands in the aviation industry, for example, is Air Astana JSC, which has aircraft manufactured by Airbus, Boeing, Embraer. That provides the possibility of forming stocks of spare parts and components, training of specialists operating and servicing equipment.
LOCOMOTIVES - An example of the successful implementation of the localization of production in the Republic of Kazakhstan and the choice of a strategic partner is the opening of a locomotive assembly plant in Nur-Sultan together with the leading manufacturer of railway equipment General Electric Transportation (GETS). On the basis of the established joint venture Lokomotiv kurastyru zauyty JSC, two types of diesel locomotives (freight and passenger) are produced.
Another example of localization of production in the field of railway transport is the opening in Nur-Sultan of Electric Locomotive Assembly Plant LLP, which produces electric locomotives KZ8A and KZ4AT developed by the French company ALSTOM TRANSPORT in accordance with the terms of reference of National Company Kazakhstan Temir Zholy JSC.
CASES ON THE IMPLEMENTATION OF LIFE CYCLE CONTRACTS (LCC)
EXPERIENCE OF MOSCOW - On the territory of the CIS, there is a positive experience in the capital of the Russian Federation, where life cycle contracts in the healthcare sector have been concluded since the end of 2019. The mechanism turned out to be in great demand among manufacturers of medical equipment, and in less than two years more than 100 contracts worth more than 80 billion rubles were signed with them. Last year alone, based on the results of tenders, 45 contracts were concluded for a total of 23.1 billion rubles. According to them, more than 600 units of the latest models of medical equipment will be delivered to Moscow medical institutions.
In turn, suppliers have not only the technical capabilities to produce the equipment the city needs, but also relevant service experience. This is important when entering into life cycle contracts, since they assume that companies will ensure the performance of the equipment during the entire service life - in this case it’s about 10-12 years.
Such a public procurement mechanism allows medical institutions to use the devices more efficiently, and the city to optimize the cost of repair and maintenance of the procured equipment. Manufacturers, thanks to life cycle contracts, ensure the loading of their production capacities, and also receive stable income throughout the entire contract period, subject to the conscientious fulfillment of its conditions. In addition, suppliers can improve their technology, as it is often necessary to upgrade equipment to customer requirements.
STAGES OF THE CENTRALIZATION PROJECT IMPLEMENTATION
STAGE I : In 2022
INTRODUCTION OF CENTRALIZED MEDICAL EQUIPMENT PROCUREMENT WORTH MORE THAN 20 MILLION. TG. PER UNIT, AS WELL AS DEVELOPMENT AND APPROVAL OF THE PROGRAM OF EQUIPMENT OF MEDICAL ORGANIZATIONS FOR A 5-YEAR PERIOD.
To date, changes have been made to the Rules for the organization and conduct of the procurement of medicines, medical devices and specialized medical products within the framework of the State Compulsory Health Insurance and (or) in the compulsory medical insurance system, pharmaceutical services, approved by the Decree of the Government of the Republic of Kazakhstan dated 04.06.2021 No. 375. The procedure for the medical equipment procurement is regulated by Chapter 12 of these Rules.
Customers procure medical equipment worth over 20 million tenge per unit by submitting to the Single Distributor through the information system of the Single Distributor (https://portal.efis.kz/) an application in the form approved by the authorized body in the field of healthcare, which must contain:
1) a list of procured medical equipment in the form approved by the authorized body in the field of healthcare;
2) technical specification in the form approved by the authorized body in the field of healthcare (when preparing the technical specification, the customer includes parameters that affect the functional purpose of medical equipment, the absence of which leads to the impossibility of using it for its intended purpose);
3) an expert opinion on the compliance of the characteristics of the technical specification for the medical equipment procurement with at least two models from different manufacturers or the absence of analogues registered in the Republic of Kazakhstan, issued by an expert organization.
On June 9, 2022, by order of the Minister of Health of the Republic of Kazakhstan No. ҚR DSM-50, the Rules for issuing an expert opinion on compliance with the characteristics of the technical specification for the medical equipment procurement were approved. According to these rules, in order to issue an opinion, the applicant submits to the expert organization:
1) an application for issuing an opinion on the compliance of the characteristics of the technical specification for the medical equipment procurement for at least two models from different manufacturers of medical equipment in the prescribed form;
2) documents and materials containing information on the technical characteristics of similar medical equipment in full compliance with the data of the state register of medicines and medical devices.
The expert organization conducts a comparative analysis of the functional parameters of the technical specification with the technical characteristics of at least two models of different manufacturers of medical equipment submitted by the applicant and, based on the results, a conclusion is issued. It should be noted that when issuing a conclusion, the materials of the state register of medicines and medical devices and the documents of the corresponding registration dossier are taken into account.
Conducting this analysis at the stage of preparation for the procurement will ensure real competition between different manufacturers of medical equipment at the auction stage and will lead to the equipment procurement at a fair price.
On the platform of the Unified Pharmaceutical Information System (EFIS) of the Single Distributor, the Application for centralized procurement of ME section has been developed, through which applications are collected from the country's Health Departments. Several times, trainings were conducted for employees of the Health Departments regarding the submission of applications through this platform. After the collection and consideration by the Single Distributor, these applications will be uploaded to the web-based procurement portal of the Electronic Finance Center JSC of the Ministry of Finance of the Republic of Kazakhstan (EFC), which is integrated with the EFIS portal of the Single Distributor, for tender procedures. Automation of the collection of applications on the EFIS platform of the Single Distributor and the conduct of tender procedures based on the procurement web portal of EFC JSC of the Ministry of Finance of the Republic of Kazakhstan will ensure complete transparency of the procurement procedure, which will contribute to the prevention of corruption factors.
Single Distributor analyzed the experience of using such systems in a number of countries (Turkey, Russia, Korea) and formulated the following requirements for the system of accounting and control of the existing medical equipment fleet (ME):
- export of data on medical equipment to IS for ME from accounting programs (to eliminate errors in manual data entry by medical personnel);
- automated calculation of the need for ME;
- calculation of the efficiency of the use of ME;
- ME service control;
- module of interaction between the medical organization and the service center;
- creation of a situational center for ME;
- integration into the system of the possibility of transferring and exchanging medical diagnostic information (metadata of regional PACS servers for monitoring the performance of the ME and idle time).
To date, the Single Distributor collects information from the regional health departments on the need for medical equipment for 5 years. Needs analysis and subsequent approval of the republican program for medical equipping will contribute to the further industrialization of Kazakhstan through the localization / contract manufacturing of medical equipment by the world's leading manufacturers in cooperation with domestic manufacturers of medical equipment.
STAGE II: From 2023
CENTRALIZED PROCUREMENT OF MEDICAL EQUIPMENT FOR COMPREHENSIVE EQUIPMENT IN PRIORITY AREAS, DEVELOPMENT OF MECHANISMS FOR CONCLUDING LONG-TERM AGREEMENTS ON THE TERMS OF LOCALIZATION / CONTRACT PRODUCTION, LIFE CYCLE CONTRACTS OF MEDICAL EQUIPMENT IN REPUBLIC OF KAZAKHSTAN:
Cooperation with global pharmaceutical corporations should be intensified. It is important to attract investors, to ensure the transfer of technologies and the latest developments. It is necessary to expand the scope and range of off-take contracts with domestic producers. The share of medicines and medical products of domestic production must be increased from the existing 17% to 50% as early as 2025,”
the President instructed.
FROM PLAN TO ACTION
AS PART OF THE WORK TO CENTRALIZE THE MEDICAL EQUIPMENT PROCUREMENT, A NUMBER OF ACTIONS WERE IMPLEMENTED:
the collection and analysis of the need for medical equipment for 2022 from local executive bodies was carried out and the threshold for centralization of the medical equipment procurement was determined.
normative legal acts regulating the centralized procurement of medical equipment were developed and adopted.
a module for collecting applications for the centralized procurement of medical equipment based on the Unified Pharmaceutical Information System (UPIS/EFIS) was developed.
work was carried out to integrate the procurement web portal of CEF JSC of the Ministry of Finance of the Republic of Kazakhstan and the module for collecting applications from the EFIS and trained specialists from the regional health departments to submit applications to the EFIS for the centralized procurement of medical equipment.
the foreign experience of centralized procurement, procurement on the terms of the LCC and the experience of localizing the production of medical equipment were studied in detail on the example of General Electric, Philips in the Russian Federation, and as part of the work on the centralization of the medical equipment procurement, the production sites of domestic medical equipment manufacturers were visited: Kazmedpribor, KazMedAspap, Aktyubrentgen, Aselsan. Their potential for localization has been studied.
the requirements for the development of regional programs for the provision of medical equipment for 5 years were prepared, and the collection and analysis of the need for medical equipment is being carried out.
an analysis of the Information System for Management of Medical Equipment of the Republic of Kazakhstan was carried out and requirements for its improvement were formulated. The production of medical equipment and consumables is open for investment, and such projects will receive full support from the state.
measures were initiated to localize the production of medical equipment in the Republic of Kazakhstan using the mechanisms of long-term contracts, off-take contracts, leasing mechanisms, and life cycle contracts. The development of production is one of the key tasks, however, it is impossible to create an increase in the production of medical equipment in the short term. In this regard, the localization of the production of medical equipment will be an effective tool for expanding production capacity, modernization, as well as the effective use of financial resources.
a substantive study of the issues of localization of production is being carried out with major world manufacturers in Korea, Japan, Europe and domestic manufacturers of medical equipment. The Single Distributor takes an active position in the development of cooperation in the field of medical and pharmaceuticals with the world majors of the industry. Thus, as part of the activities carried out to support the development of domestic production of pharmaceutical and medical products, the Single Distributor takes the initiative to provide a platform for major brands to enter the country from packaging to the full production cycle. Establishing close cooperation with the global medical and pharmaceutical business is of great importance for Kazakhstan.
negotiations were held with foreign manufacturers of medical equipment on the issues of localization of production, LCC: Philips, Canon, negotiations were held with foreign manufacturers of medical equipment on the issues of localization of production, LCC: Philips, Canon, General Electric, DRTech, Mindray, Lowenstein, Roche Diagnostic. Also, through the Ministry of Foreign Affairs of the Republic of Kazakhstan, requests were sent to the headquarters of about 50 foreign manufacturers of medical equipment with a request to take part in the negotiations.
cooperation with the Swiss company Roche was worked out, and within the framework of the signed agreement, cooperation is planned to introduce international experience and innovative diagnostic methods for early detection of diseases, their prevention and, accordingly, more effective treatment. Roche expressed its readiness to provide methodological and logistical support to Kazakhstan for the introduction of new diagnostic methods, namely, to provide the necessary laboratory equipment for research projects and as grants. The company's experience can help strengthen Kazakhstan's laboratory infrastructure and ensure that it meets international standards.
a comprehensive service and training of medical staff is being worked out. This will significantly increase the volume and quality of medical services provided to the population and reduce the cost of their provision through the effective use of medical equipment by healthcare organizations.
The most optimal service model is a three-level strategy for the maintenance of medical equipment:
The first level of service should include monitoring the state of medical equipment before each use and after completion of work and be carried out by the user of medical equipment of a healthcare organization.
The second level of service maintenance should include planned monitoring of the technical condition and prompt response to incoming requests to eliminate emerging faults and be carried out by a staff engineer for medical equipment of a healthcare organization.
The third level of service should include scheduled preventive maintenance and be carried out by a service engineer of a specialized organization.
The implementation of such a three-level maintenance will keep medical equipment in good condition and ensure its efficient use and can also lead to a greater optimization of the use of human and technological resources.
* DOMESTIC MANUFACTURERS OF MEDICAL EQUIPMENT
FOREIGN MEDICAL EQUIPMENT MANUFACTURERS INTERESTED IN LOCALIZATION
EFFECTS FROM IMPLEMENTATION
corruption risks will be eliminated and the transparency of the procedure for planning and procuring medical equipment will be ensured.
it will be possible to equip healthcare organizations with the necessary medical equipment, reduce the availability of medical equipment with an operation period of more than 10 years.
annual budget expenditures on capital expenditures of medical organizations will be reduced by reducing the cost of medical equipment. Reducing the cost of medical equipment is planned through the introduction of mechanisms for direct contracts, procurement on the terms of the LCC, consolidation of procurement, averaging of technical specifications for centralized procurement, and the development of standard technical specifications for the medical equipment procurement.
the quality of after-sales service will improve, which, among other things, will lead to savings in the funds of medical organizations for after-sales service, and ensuring the efficiency of the use of medical equipment. As the analysis showed, more than 100% of its initial cost can be spent on maintenance and repair of heavy medical equipment over 10 years of operation.
will increase the country's human resources potential in the field of technical professions and increase the share of domestic producers in the medical equipment market. This will allow the successful development of after-sales service and will give a good impetus to enter the international market.
The new Kazakhstan is a qualitatively different benchmark set before us in the foreseeable future, which is fundamentally different from the traditional approaches that have been established over the years in the implementation of measures to improve the country's welfare. This benchmark requires a change in philosophy in approaches in the field of medical technology.
The new format of work involves the provision of the following components in the updated system:
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