Reform Of Pharmaceutical Regulation In Kazakhstan

As of the end of 2017, active work on legislation change and update is going on in Kazakhstan in the area of healthcare and pharmaceutical business.

Such legislative activity is aimed at harmonizing the laws of the Republic of Kazakhstan with the laws of the Eurasian Economic Union as well as implementing the States of the Nation Address by the President of the Republic of Kazakhstan, "Third Modernization of Kazakhstan: Global Competitiveness" dated January 31, 2017 and "New Opportunities under the Fourth Industrial Revolution" dated January 10, 2018. Today the draft law On Introduction of Amendments and Addendums to Certain Legal Acts on the Issues related to Circulation of Medicines and Medical Items as well as the draft concept and the draft of the new Code of the Republic of Kazakhstan On Health of the Population and the Healthcare System are being considered.

Introduction of regulation of prices for all medicines as well as ethical norms of promotion of medicines and medical items are among the major changes under consideration in the area of pharmaceutical business.

Regulation of prices for all medicines As it is known, currently prices for medicines procured within the framework of the guaranteed volume of free medical aid (GVFMA) and the system of mandatory social medical aid (SMSMA) are subject to regulation in Kazakhstan. Prices for medicines sold at retail market are not subject to regulation, and thus they may substantially vary in practice. It is planned to introduce regulation of prices for medicines sold in wholesale market in order to secure maximum economic availability of medicines for the population. At the basis of the new regulation lies the maximum price for a medicine above which it may not be sold.

The new regulation will, first of all, be contained in the Code of the Republic of Kazakhstan On Health of the Population and the Healthcare System. The respective amendments to this legislative act and many other legislative and subordinate acts will be made within the framework of the draft law of the Republic of Kazakhstan On Introduction of Amendments and Addendums to Certain Legal Acts on the Issues related to Circulation of Medicines and Medical Items. According to the publicly available information 1, this draft law was approved by the Majilis (lower chamber) of Parliament of the Republic of Kazakhstan on November 28, 2018 and was sent to the Senate (upper chamber). The introduction of the new regulation is...

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