COMMITTEE FOR TECHNICAL REGULATION AND METROLOGY AND SK-PHARMACEUTICALS INTEND TO INCREASE QUALITY STANDARDS AND LOCALIZATION OF MEDICAL PHARMACEUTICAL PRODUCTION

The Unified Distributor "SK-Pharmaceuticals" and the Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan agreed on cooperation to improve quality standards and localization of medical pharmaceutical production. The agreement was formalized in the form of a memorandum of understanding and cooperation.

The task and purpose of the memorandum is to develop cooperation to systematically increase the level of localization of domestic pharmaceutical production while receiving appropriate government support measures.

In his message, the Head of State instructed to intensify cooperation with global pharmaceutical corporations, attract investors, ensure the transfer of technology and the latest developments, expand the volume and range of offtake contracts with domestic manufacturers and increase the share of domestically produced medicines and medical devices to 50% already in 2025 year.

In accordance with the Code of the Republic of Kazakhstan Code of the Republic of Kazakhstan “On the health of the people and the healthcare system” one of the purchasing principles of the Unified Distributor is to support domestic producers in the form of concluding long-term contracts for the supply of medicines and medical devices.

After concluding a long-term contract, the manufacturer receives a ten-year government order, which guarantees the domestic producer a sales market for the period of formation and development of production for 10 years.

State support provided today within the framework of public procurement, including purchases under long-term contracts of the Unified Distributor, is subject to the provision of ST-KZ and industrial certificates by the business.

At the same time, production conditions are not aimed at increasing the localization of product production. Accordingly, it is enough for manufacturers to fulfill the minimum requirements for the production of goods, which does not contribute to the creation of jobs, payment of tax payments, and at the same time receive government support.

With this approach, it is impossible to formulate a unified policy to support Kazakhstani commodity producers, aimed at effectively ensuring increased localization and growth of production, as well as the export of products with high added value.

The Unified Distributor, being an operator for the purchase of medicines and medical devices, during purchases checks for the presence of a certificate of origin of goods for internal circulation ST-KZ and an industrial certificate. The data obtained do not make it possible to assess the real depth of localization of domestic pharmaceutical products.

In order to increase the level of localization of domestic pharmaceutical production, the Unified Distributor has developed a number of proposals to increase and increase the share of Kazakhstani content.

The proposals of the Unified Distributor were sent to the Ministry of Trade and Integration of the Republic of Kazakhstan. And to increase the level of localization of the domestic pharmaceutical industry, the Procurement Rules establish counter-requirements and criteria for Kazakh manufacturers.

Currently, the Ministry of Trade and Integration of the Republic of Kazakhstan is working to transition to a new approach to confirming the Kazakh origin of goods - the Register of goods of Kazakh origin instead of ST-KZ and industrial certificates.

The register of goods of Kazakhstan origin involves the inclusion of information about domestic producers if they fulfill the conditions for the production of goods established by authorized government agencies and aimed at ensuring the highest possible level of localization or its gradual growth over the years.

At the same time, it is proposed to provide state support measures only to those manufacturers whose information is included in the Register, as the only source of information about the Kazakhstani origin of the goods.

The conclusion of today’s memorandum was the result of comprehensive collaboration between the Unified Distributor and the Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan in order to methodologically and systematically develop the level of quality of medicines and the transition to a new system for determining the share of Kazakhstani content in the product.

Thus, by joining forces with the Committee for Technical Regulation and Metrology, it is planned to carry out systematic work to increase the level of localization of our own pharmaceutical production and timely monitor expected changes in the legislation of the Republic of Kazakhstan.

The result of bilateral cooperation will be a contribution to the implementation of Kazakhstan’s strategic programs aimed at developing the domestic pharmaceutical industry. The parties expressed their readiness for fruitful cooperation and confidence in achieving common goals.

For reference:

The state institution “Committee for Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan” is a department of the Ministry of Trade and Integration of the Republic of Kazakhstan, carrying out regulatory, implementation and control functions, as well as participating in the implementation of the strategic functions of the Ministry in the areas of technical regulation and metrology.