News in the Medicines Price Regulations and Medicines Advertising Rules

As outlined in our earlier Overview of main developments in pharmaceuticals regulations of Kazakhstan in 2019, as a result of steady dynamic of medicines prices, we observe the same dynamic in continuous changes of legislative framework governing the pricing of medicines.

In June 2020, new edition of the Rules for Medicines Price Regulation was adopted by the Order of Acting Minister of Healthcare of the Republic of Kazakhstan dated 17 June 2020 ("Price Regulation Rules 2020").

The Price Regulation Rules 2020 mainly introduce clarifying and editorial changes. However, there are some provisions that change certain processes of the medicines price regulation. Following the essence of changes introduced, we understand that the legislator took a step towards improving the processes of the medicines price regulation, as well as rationalizing the practical application of legislation in this area.

Specifically, the medicine pricing algorithm, according to the Price Regulation Rules 2020^[1], consists of: (i) registration (re-registration) of the estimated base price; (ii) markup setting; (iii) calculating the ceiling price; (iv) ceiling price approval; (v) price monitoring and analysis. The last mentioned stage of the medicines pricing is a new and significant addition to the pricing process.

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^[1] paragraph 5 of the Price Regulation Rules 2020

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Authors:

Aliya Zhumekenova, Counsel

Darya Zhanysbayeva, Senior Lawyer