BUSINESS OPINION ON AMENDMENTS TO THE DRUG COMMERCE LAW
"Atameken" held a round table to discuss the draft law "On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan Concerning the Drug Commerce"
On April 25, 2018, a round table was held on the Atameken platform to discuss the draft law "On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan Concerning the Drug Commerce" with the participation of the deputies of the RK Majilis, representatives of the Ministry of Health of the RK, "Social Health Insurance Fund" NJSC, "National Center for Drug Expertise" RSE on the Right of Economic Use,"SC Pharmacy" LLP, public associations of pharmaceutical entities, "Damu Center for Information Technologies" LLP and the pharmaceutical community of the regions.
"The bill, the provisions of which were repeatedly discussed last year on the site of the NCE with the participation of representatives of the Ministry of Health, industry associations, large employers and business community, continues to be discussed in the Majilis. Within the framework of the Working Group, many business proposals have been adopted, the main ones are the introduction of a transitional period for the introduction of standards for proper pharmacy practice, the exclusion of the standard for the introduction of a pharmaceutical traceability system, the possibility of budgetary purchasing of drugs manufactured in pharmacies and others. Today, the issues of price regulation and the implementation of GxP standards remain relevant," - Yulia Yakupbaeva, Deputy Chairman of the Board of the "Atameken" NCE RK, noted at the beginning of the meeting.
Yermek Yasylov, President of the "Eurasian Medical Association" Association of Legal Entities, also stressed that the main norms advocated by the members of the pharmaceutical sector associations concern the issues of one-step introduction of the GMP, GDP, GPP standards since 2021, the definition of the Kazakhstan national Registry as a reference document for specialists industry without the need to indicate the prices of medicines and without the inclusion of medications in it due to the specificity.
"I wanted to dwell on the inexpediency of setting limit prices for medical products because of the variety and complexity of characteristics that can not be objectively compared in assessing the cost and the lack of such a mechanism, even from the authorized body," - Yermek Yasylov noted.
The country's pharmaceutical market is experiencing an era of great change, but not all of the participants have the same desire for it's implementation.
We need a Roadmap for the transition from the current quality control system to the Quality Assurance System, containing measures to motivate participants in the pharmaceutical market and changes in legislation, regulating licensing and issuance of GMP, GDP and GPP certificates, as well as optimizing the quality control system and drug safety with the declaration of compliance and analysis of medicines presented on the market to itroduce the standarts successfully" - the executive director of the "Association of Pharmaceuticals Distributors" Natalia Gunko voiced.
In addition, according to the member of the Majilis Ivan Klimenko, the issue of the GxP practices implementation is very complicated and its rough implementation without adaptation to existing realities might pose a threat to the country.
"It is necessary to take into account that the introduction of GxP leads to serious financial costs and the subsequent rise in the medicines prices. The transition to GxP standards should be voluntary and and therefore it is necessary to develop a system of reputational incentives for the participants of the pharmaceutical market" - Klimenko said.
The regional participants of the meeting actively discussed the information of the speakers; in particular, a lot of proposals were voiced concerning the need for training specialists in the regions by representatives of the state body and subordinate organizations that received training.
Another issue of discussion was the introduction of co-payment (reimbursement) under the system of medical insurance. Natalia Gunko spoke about the experience of introducing reimbursement in Poland, all its advantages and risks.
"Since 2015, "Atameken" has repeatedly voiced a proposal to work out the issue of introducing a co-payment mechanism for the patient together with the CSHI fund as part of the development of approaches to the introduction of compulsory social health insurance. To date, this issue has not been resolved. In this regard, we would like to draw attention to the need to consider this issue and propose a creation of a Working Group for a comprehensive study and elaboration of proposals for the introduction of a co-payment mechanism," - Yulia Yakupbaeva commented
Further, the Head of the development and quality control service of the "Damu Center for Information Technologies" LLP, S. Berezin acquainted the participants with the work of the DMED complex medical information system as one of the mechanisms for solving the problems of patients' self-treatment and over-the-counter delivery of all drugs in order to improve the safety and quality of treatment.
As a result, Yulia Yakupbaeva invited all the participants of the meeting to submit their proposals to the bill to the "Atameken" NCE RK. All of them will be examined within the working group of the Majilis.
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