The conflict situation between domestic manufacturers of medical devices and the Single Distributor for the purchase of medicines and medical devices SK-Farmatsiya LLP was dismantled on the site of the Atameken National Chamber of Entrepreneurs of the Republic of Kazakhstan.

Due to the uncoordinated actions of government agencies, long-term contracts of domestic plants are in jeopardy.

Opening the meeting, Deputy Chairman of the Board of the "Atameken NCE RK Yuliya Yakupbayeva noted that the domestic market of medical devices is actively developing, more than 500 jobs have been created, the volume of tax payments to the budget from manufacturers amounted to more than 400 million tenge. From the moment of the first deliveries within the framework of long-term contracts since 2012, manufacturers have no claims.

"The time has come to conclude additional agreements to the long-term contracts for the purchase of medical devices, as from December 1 to December 15 of this year, manufacturers must carry out their delivery. However, in September of this year, the rules have changed dramatically," Yuliya Yakupbayeva explained the essence of the problem.

At the beginning of October, the single distributor sent letters to manufacturers saying that their quality certificates do not comply with the current legislation, and a new one is required.

But the procedure for obtaining a certificate is not a formality. It will take at least two months for the certification organization to make a valid quality assessment. That is, according to manufacturers, it is an impossible condition to get it in such short terms.

At the same time, to avoid losing volume and jobs, entrepreneurs are ready to undergo certification in Kazakhstan.

"Give us time to pass the certification, we do not refuse to do it. But 8 factories will not be able to pass the certification procedure within three weeks," Kairat Kaymoldaev, director of Super-Pharm LLP, told the government agency.

"I'm serious about the quality of my products and regularly participate in exhibitions. My certificate was recognized in Europe. They said, come to our markets. Now it turns out that in our country I hardly received a long-term contract, proving that my company will be able to cope with the delivery. At the same time, I am constantly investing in modernization, training my employees in Europe, Russia, and Ukraine. And in 2019 I supply products 12% lower than the cost of 2012. Now we are offered double certification, you understand that we have already certified our products at the stage of production before entering the market and have received an international certificate. Where will I get 1.5 million tenge to pass it now? I have 45 employees and their families," Baglan Bakkulova, Director of JULDYZ KENAN Co. LTD LLP, said. Baglan Bakkulova’s company was the first company that passed the international certification and entered the markets of neighboring countries.

She also noted that under such conditions she would have to close down the company and people would be left without work.

Gulmira Mukhamedzhanova, the Chairman of the Association, emphasized that the whole world market of medical devices is working through the online database of government agencies on accreditation. In each country, there is open access to these databases, by the number of the certificate it is possible to get its validity period, the body that issued it. All these data can be determined by a QR code via a mobile application.

The state authorities have not come to a consensus concerning the possibility of recognition of the international certificate.

According to the Acting Chairman of the Board of SK-Farmatsia LLP Berik Sharip, after several checks, the control body has revealed that the international companies that have issued the certificate are not accredited in the Register of Kazakhstan.

Deputy Chairman of the Committee of Technical Regulation and Metrology of the Ministry of Trade and Integration of the Republic of Kazakhstan Galiya-Banu Meyrbayeva explained that according to the Law of the Republic of Kazakhstan "On Technical Regulation", foreign organizations should be accredited in the Republic of Kazakhstan, and the register for such organizations that have opened activities in Kazakhstan, exists only for accounting.

As part of the discussion, Yuliya Yakupbayeva asked a question: "If manufacturers from other countries come to the domestic market to participate in the purchase of medicines and medical devices, what certificates will they provide?

Arnur Isabaev, Director General of the Republican state enterprise on the right of economic management “The National Center for Expertise of Medicines and Medical Devices”, replied that according to Regulation No. 1729, the requirements for the availability of ISO 13485 certificate are necessary only for the conclusion of long-term contracts. And there are no such requirements at the tender, in which distributors can participate.

While state authorities are discussing the condition of purchase, factories risk bankruptcy, and medical organizations do not receive in time the products necessary to provide medical care: from syringes and disposable gloves to heart implants and stents.

Kamalzhan Nadyrov, Vice-Minister of Healthcare, heard all the parties and expressed his readiness for more active participation of the Ministry of Health of the Republic of Kazakhstan in solving the existing problem.

As a result, the Atameken National Chamber of Entrepreneurs of the Republic of Kazakhstan and the Ministry of Health of the Republic of Kazakhstan decided to act promptly, to hold a meeting with the leadership of the Ministry of Trade and Integration of the Republic of Kazakhstan and discuss the decision to resolve the situation. If necessary, prepare changes to the legal acts.

The meeting is scheduled for the near future. We hope that the issue will be resolved positively.

Entrepreneurs themselves have officially sent an appeal to the President of Kazakhstan.