Institute Of 'Data Exclusivity' In Kazakhstan And Its Influence On Activity Of Pharmaceutical Companies

For the Republic of Kazakhstan (hereinafter - "the RK") the notion and institute of "data exclusivity" is a novelty. The legislation on healthcare of the RK envisages conditions on "data exclusivity". However, the legislation does not define of this particular notion.

This circumstance plays a prominent role and has significant consequences both for developers and manufacturers of original drugs and for companies manufacturing generic drugs.

Implementation of a regulation on term of "data exclusivity" was caused by entry of Kazakhstan into the World Trade Organization ("WTO"). Within the frames of entry of the RK into the WTO the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") that is one of fundamental documents, which terms should meet the legislation of all member-countries of the WTO. Therefore, the legislation of Kazakhstan has been amended in accordance to the requirements for memberships of the WTO.

Currently, conditions, which regulate "data exclusivity", are present in Art. 71 (19) of the Code of the Republic of Kazakhstan "On People Health and Healthcare System" No. 193-IV ЗРК as of 18.09.2009 (hereinafter - "The RK Code on Health") and are stated as follows:

"State expert organization in the field of drug, medical products and medical equipment, and state authority in the field of drug, medical products and medical equipment circulation does not allow, without applicant's consent, to disclose and use confidential information in commercial purposes that is provided for state registration of drugs, which information is contained in the application on state registration, examination materials of the drug as well as in the registration dossier of the drug comprising new chemical substances, during six years from the date of state registration of the drug".

In practice, the above-mentioned description of "terms and order of data exclusivity use" arises dozen of questions.

Thus, for example, in the opinion of separate representatives of the "National Centre for Expertise of Drugs, Medical Products and Medical Equipment" of the Ministry of Healthcare of the RK, such proscription only relates to the state authority and expert organization, which conduct examination and registration of the drug in Kazakhstan, and lies in non-disclosure of materials of the registration dossier of the drug within said 6-year term.

In our opinion, we cannot fully agree with this statement, since Article 71 (19) of the the RK Code on Health envisages ban not only of the disclosure of the registration dossier materials by the state expert organization, but also of use of data and information contained therein in commercial purposes both by the expert organization itself and by third parties.

In case...