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Alexey Tsoy: To support domestic pharmaceutical companies, procedures for examining medicines and assessing their quality accelerated

Tuesday, 06 October 2020, 12:37:26

At a government conference call chaired by Prime Minister Askar Mamin, the issue of the development of the country's pharmaceutical industry was considered. During the meeting, Minister of Healthcare Alexey Tsoy, as well as representatives of pharmaceutical enterprises, made reports on the current situation and future prospects of the industry.

According to the minister, the main stimulus for the growth of local production of pharmaceuticals is the program for concluding long-term contracts with domestic manufacturers for up to 10 years.

For the period of work of the Single Distributor from 2009 to 2019. 63 long-term contracts were concluded with 32 domestic producers for the supply of 3,600 items. Of these, in 2020, 586 items are supplied, the rest are in the process of launching production sites.

“It should be noted that 48% of drugs for COVID-19 disease are produced by domestic producers, which, taking into account the epidemiological situation, allows us to quickly cover the needs of the regions,” Tsoy said.

For 10 years, domestic products have been purchased for about 300 billion tenge, and their share in the guaranteed volume of medical care in kind has reached about 70% today.

Also, according to the minister, measures have been taken to support domestic producers:

  • accelerated examination of medicines during registration is ensured;
  • assessment of the quality of medicines and medical devices is carried out according to an accelerated procedure within 3 working days;
  • access to imported medicines and medical products in case of emergency simplified.

The task of pharmaceutical education is to provide the country's pharmaceutical industry with highly qualified and competitive personnel for modern pharmaceutical organizations and enterprises that meet the requirements of international quality standards. Specialists are being trained for the pharmaceutical industry of the country in Pharmacy, these are pharmacists studying in 41 colleges of the country, bachelors in 8 universities, masters and doctors of science (PhD).

In 2020 graduated: 277 bachelors of pharmacists, 16 masters and 5 PhD doctors in Pharmacy, 853 graduates in Pharmacy with secondary medical education.

A total of 17,150 specialists are employed in the pharmaceutical industry.

Tsoy also stressed that the approval of the Comprehensive Plan for the Development of the Pharmaceutical and Medical Industry for 2020-2025 is important for the development of the medical and pharmaceutical industry, especially the need to release new medicines, increase the capacity of existing industries during emergencies, emergencies and quarantine.

The Comprehensive Plan provides the main directions for the support and development of the pharmaceutical and medical industry. Among them are legislative and regulatory acts regulating pharmaceutical activities, circulation of medicines and medical devices within the EAEU, measures of state support, research and development work, attracting investments, staffing the industry, labeling, traceability of medicines and increasing the capacity of domestic manufacturers of medicines and medical devices.

As of today, the structure of the pharmaceutical market shows that the presence of domestic enterprises in the market in monetary terms in the first half of the year is 17%, in kind — 39%.

At the same time, the implementation of the planned measures of the Comprehensive Plan provides for an additional expansion of the range of manufactured medicines by 297 names of medicines and medical devices by 2,348, which will increase the share of domestic manufacturers in the market of medicines and medical devices of the Republic of Kazakhstan by 2025 in monetary terms from 17% to 30 %, and in kind from 39% to 50%.

“Achieving the share of domestic manufacturers in kind of 50% in the market of the Republic of Kazakhstan will ensure national drug safety, while WHO recommends ensuring the share of manufactured drugs and medical devices in each country by at least 30%,” Tsoy noted.

Representatives of pharmaceutical companies who spoke at the meeting also noted the measures taken by the Government to support domestic producers.

Director of Hospital Business at Khimpharm Aigul Isenova spoke about the development of one of the largest pharmaceutical manufacturers.

To date, the International Pharmaceutical Company Polpharma has invested more than $100 million in the development of Khimpharm JSC.

The production cycle of the company complies with international GMP standards, and the proper distribution practice GDP has been introduced.

In an epidemic, medicines are the most important resource, since the life of the country's citizens depends on its availability. According to Isenova, accepting the challenge of the pandemic, the company reorganized the work of production shifts to a non-stop mode, ensuring round-the-clock work of logistics for the supply of raw materials and shipment of finished products. At the same time, the emphasis was placed on finding and using all possible production reserves and capacities, on production discipline, on strict control over compliance with sanitary standards.

“Over the past 7 years, thanks to government support — the presence of long-term contracts for the supply of medicines — our share has increased from 4.7% to 6%, while over 5 years we note an increase in the amount of the contract with IC Pharmacia from 6.5 billion to 19 billion,” Isenova noted.

To date, the company's portfolio includes more than 120 names of medicines of 9 different forms, produced on 11 production lines. This is an indication that the company, as a domestic manufacturer, is represented in more than ten therapeutic groups.

“Our R&D potential allows us to bring ten new drug positions to the market by the end of this year. We are developing this area and by 2023 we will present about fifty drugs of Kazakhstani production for the treatment of patients,” Isenova also emphasized.

Today, Khimpharm's medicinal products are in wide demand in the markets of Central Asia and the EAEU, which made it possible to increase the volume of exports by 2.5 times only in the last 2 years.

Now the company's products are exported to countries such as Tajikistan, Turkmenistan, Mongolia, Russia and Kyrgyzstan. In general, exports have grown fivefold.

“Literally next year, we plan to double export, having mastered the Uzbek market. One of our biggest challenges is entering the drug market of the European Union, which we plan to ensure by 2023 with an increase in export volume by 4 times, that is, up to 16 billion tenge,’’ Isenova noted.

In turn, Commercial Director of Dolce LLP Bayan Demeuova also noted the increase in production capacity during the pandemic and the expansion of exports.

Dolce LLP is the largest domestic manufacturer of disposable medical products — surgical operating kits, disposable clothing and underwear, medical masks, shoe covers and others.

The company fully covers the requests of medical institutions in the country, fulfills a government order for the supply of medical devices and medicines under a long-term contract with SK-Pharmacy LLP, and is also export-oriented for the countries of Central Asia and the CIS.

If the company began its activity in the 2000s as a wholesale and retail trade with 15 employees, today it is a full-fledged domestic manufacturer with 430 employees.

Since 2011, the company has been closely cooperating on a long-term basis with a single distributor, SK Pharmacy LLP. Since 2012, there has been an active increase in production volumes and sales of finished products to the medical sector of the economy.

Today the company produces more than 250 types of medical devices.

As part of the fight against the pandemic, the enterprise has increased the capacity of medical masks from 60 thousand to 360 thousand masks per day. 15 types of medical masks are produced.

The company sells 75% of its products to a single distributor SK Pharmacy LLP, the remaining 20% ​​are sold on the commercial market and 5% are exported.

In the future, there are great opportunities to increase the share of the commercial market and export direction.

At the end of October this year, it is planned to launch a new production site, built according to international standards. This site will produce modernly modeled kits for cardiac surgery and other complex kits for operating procedures. The product is export oriented.

In addition, the company's portfolio includes 4 strategic projects.

The first project is the production of nonwoven fabric, with an investment volume of $7 million, which is scheduled to start in 2022. Building area 6,000 m², capacity 3,000 tons per year. This project is aimed at import substitution of raw materials for the production of personal protective equipment.

The second project is the production of disposable medical gloves, which will create 120 new jobs. The project cost is $5 million, the implementation period is 2022-2023, the capacity is 120 million pairs per year.

The third project is the production of medical syringes. The number of jobs is 160, the volume of investments is $7 million, the implementation period is 2022-2024. The fourth project is the production of sterile consumables with an investment of $7 million. 160 jobs will be created here, the implementation period is 2022-2024, 300 million units per year.

The company also plans to build its own logistics center according to GDP standards.

These projects will be implemented as part of the Comprehensive Plan for the Development of the Pharmaceutical and Medical Industry for 2020-2025, in the development of which the company took an active part.

“As part of the implementation of our projects, we are counting on the use of new measures of state support, the elaboration of which is provided for by the Comprehensive Plan,” Demeuova noted.

Executive Director of the PharmMedIndustry of Kazakhstan, Association of Manufacturers of Pharmaceutical and Medical Products of Kazakhstan, Guldariya Manakpaeva, also expressed gratitude to the government on behalf of domestic manufacturers of pharmaceutical and medical products for the attention and support of the domestic pharmaceutical industry of the country.

“It is obvious that now our industry plays a key role in the fight against a global disease and, of course, the adoption of proactive measures in the developed Comprehensive Plan is to ensure national security, which implies the physical and economic accessibility of all segments of the population to safe and effective drug care,” noted Manakpaeva.

The Association of the Pharmaceutical Industry of Kazakhstan, uniting one third of all enterprises, took an active part in the development of the Comprehensive Plan and all the main directions and proposals of domestic manufacturers were reflected in it.

Among the most important events of the Association, the executive director noted the procurement and supply chain management system.

“First, one of the key areas in the development of our own pharmaceutical production is procurement and supply chain management, for which a clear forecast of needs is provided. Processes of procurement, warehousing and distribution, inventory management and service will be as transparent as possible,” said Manakpaeva.

For this, it is envisaged to improve and use a more efficient procurement and supply procedure aimed at the rational use of medicines and allowing to increase the share of domestic producers in the procurement of the Single Distributor and at regional levels.

Second, it proposed fair pricing for medicines and medical devices aimed at balancing the interests of all market participants, the solvency of the healthcare system and patients, as well as sufficient market incentives for investment in innovative research and production of medicines.

Third, using world experience and within the framework of the EAEU, it is planned to separate the process of regulating medicines and medical devices.

Fourth, in order to support the domestic producers and for national security, the issue of maintaining national procedures within the EAEU was considered, by analogy with the countries of the European Union.

Fifth, support from the state is envisaged in the formation and development of human resources corresponding to their mission. This is in key areas such as development, manufacturing and regulation, where special competencies are required to ensure the quality, safety and effectiveness of medical devices.

Sixth, it was proposed to provide for the introduction of new support measures in the form of subsidizing new developments and clinical trials of drugs and medical devices.

In this regard, it was proposed to initiate amendments to the Code of the Republic of Kazakhstan "On people's health and the health care system" and other regulatory legal acts of the Republic of Kazakhstan aimed at separate regulation of medicines and medical devices, establishing an unlimited registration of medicines and medical devices manufactured by domestic producers by analogy with by the EAEU countries, revising approaches to the procedure for assessing the quality of medicines and medical devices in the post-registration period, as well as using the possibility of localizing production by applying compulsory licensing procedures, technology transfer and contract manufacturing.

“The main task for the pharmaceutical industry today is to create conditions for import substitution of pharmaceutical and medical products by increasing production capacities, introducing modern technologies in accordance with international standards of good manufacturing practices GMP and ISO 13485. Let me once again express my gratitude to the Government for the attention given to the development of pharmaceutical industry of the country and the development of a Comprehensive Plan for the Development of the Pharmaceutical Industry for 2020-2025," Manakpaeva concluded her speech.

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