Changes To The Regulation Of Pharmaceutical Business In Kazakhstan: Implications For Pharmaceutical Companies

A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the Republic of Kazakhstan on Healthcare Matters (Law on Amendments). Most of the amendments came into effect on 19 April 2015.

Also, the Rules on Advertisement of Medicines, Medical Items and Medical Equipment were adopted by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated 27 February 2015 No 105 (Advertisement Rules). The Advertisement Rules came into effect on 27 April 2015.

We outline below a brief overview of the major amendments to the Healthcare Code and the content of the Advertisement Rules.

Terminology

The list of defined terms contained in the Healthcare Code has been substantially extended and revised. For instance, the Healthcare Code now provides for such terms as "reproduced medicine (generic)", "authorized generic", "proper pharmaceutical practices", "certificate on pharmaceutical product", etc. Certain terms related to pharmaceutical activity including, inter alia, "medicine", "original medicine", "biosimilar", "forged medicine, medical item and medical equipment", "pharmaceutical substance", have been revised.

Advertisement

Advertisement content

The list of prohibitions/ limitations in relation to the advertising of medicines has been substantially extended. For instance, it is now prohibited to mention in an advertisement for population such diseases as sexually transmitted diseases, oncological, psychological, dangerous infectious diseases, HIV/AIDS, tuberculosis, and diabetes. It is also prohibited to refer to recommendations of scientists, healthcare specialists as well as officials of the state authorities who may encourage use of medicines, medical items and medical equipment. Giving the impression that the efficacy of treatment with a medicine is guaranteed or that the use of a medicine has no adverse effects is prohibited. Some other prohibitions have been introduced.

At the same time, the dissemination and placement of advertisements for medicines during medical, pharmaceutical conferences, congresses, symposiums, and other scientific events are now explicitly excluded from the list of prohibited advertisement activity.

In addition, an advertisement for medicines must now contain full (including limitations on the use of the medicine) and true information, the omission...