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.
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.
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 of which may result in the improper use of medicines or undue risk for customers.
Pursuant to the Advertisement Rules, an individual or a legal entity (producer, distributor or representative office) is now required to apply to an expert organization for the evaluation of an advertisement for compliance with Kazakhstan law. The Advertisement Rules further provide that the advertisement of medicines, medical items or medical equipment is possible only after such evaluation.
It should be noted that the Healthcare Code does not explicitly provide for such a requirement. Yet, Article 18.1 of the Healthcare Code provides that an advertisement must be made under specified order. Such order is provided in the Advertisement Rules that have been adopted in line with aforementioned provision of the Healthcare Code. As such, enforcement of the Advertisement Rules is secured by the Healthcare Code.
The Advertisement Rules provide for various parameters against which an advertisement will be evaluated. Generally, these parameters represent a mixture of requirements and prohibitions/ limitations set out in Kazakhstan law on advertisement as well as in the Healthcare Code. The Advertisement Rules particularly provide for:
- list of information that does not constitute an advertisement (e.g. logo or trade name disseminated among medical and pharmaceutical professionals (i.e. appearing on stationary, calendars, business card holders, etc.), instruction for medical use, sales catalogue, price lists, scientific and informative materials, etc.);
- list of general requirements (e.g. no comparison can be made, full and accessible information is provided, etc.);
- list of requirements on the content of an advertisement (e.g. trade name, prescription for use, main contradictions for use, etc.).
Furthermore, the Advertisement Rules contain a sample of the evaluation act (to be completed by an expert organization) that provides for an extended list of parameters against which the evaluation is to be made. This appears to contain a larger list of prohibitions compared to that provided in the Healthcare Code. For instance, according to the sample act in question, mentioning chronic insomnia (apart from other diseases a list of which is provided in the Healthcare Code) in an advertisement for population, making reference to recommendations of well-known people, providing information leading to an incorrect self-diagnosis (description of symptoms of a disease) are also prohibited.
Bearing in mind that the Advertisement Rules were adopted earlier than the Law on Amendments, revisions to the Advertisement Rules may be expected at a later stage.
State registration/ re-registration of medicines, medical items and medical equipment
The list of medicines, medical items and medical equipment which are subject to state registration/ re-registration has been substantially revised and extended. For instance, sets of medical items, laboratory diagnostic devices, inventory (with certain exceptions), and contraceptive devices are now subject to state registration/ re-registration.
The list of medicines, medical items and medical equipment which are exempt from state registration/ re-registration requirement has also been revised.
Labelling of medicines, medical items and medical equipment
The Healthcare Code now explicitly provides that medicines, medical items and medical equipment must be traded together with relevant instructions for medical use.
Prohibition/limitation/suspension of sale of medicines
The list of instances when the competent authority can prohibit or suspend use, realization or production of medicines, medical items or medical equipment, or order the withdrawal from circulation of such products, or limitations on their use, has been revised and extended. The Healthcare Code now provides that the competent authority can take one of the above decisions, for instance, where an increase in the incidence of serious adverse effects mentioned in instructions for use is detected, or when a low therapeutic effect (or lack of therapeutic effect) is detected; or in cases when there is information about suspension and (or) withdrawal of a medicine from the market in other countries due to detected serious adverse effect.
Individuals and legal entities engaged in pharmaceutical activity are no longer subject to accreditation.
The Healthcare Code now specifies that pharmaceutical inspections will be conducted in respect of pharmacies, pharmacy depots, organizations producing medicines, healthcare organizations conducting pre-clinical (non-clinical) and clinical testing. The subject matter of pharmaceutical inspections will be compliance with relevant proper pharmaceutical practice adopted by the competent authority (i.e. the Ministry of Healthcare and Social Development). For instance, pharmacies will be checked for compliance with the proper pharmacy practice (GPP), whereas pharmacy depots will be checked for compliance with the proper distributorship practice (GDP).
Unlike the above mentioned amendment to the Healthcare Code, the requirements that persons engaged in the wholesale supply of medicines must comply with the proper distributorship practice (GDP), and those conducting retail sales of medicines must comply with the proper pharmacy practice (GPP), shall become effective as of 1 January 2018.
The above suggests that pharmaceutical inspection will effectively be able to demand compliance with relevant proper pharmaceutical practice (GDP and GPP in particular) as of 1 January 2018.
The list of procurement items which are not subject to the state procurement rules has been extended to include, inter alia, selection of suppliers of such services as storage and transportation of medicines and medical items as part of the guaranteed volume of free medical aid (i.e. medical services provided free at the point of provision by the state); procurement of medical equipment for rendering the guaranteed volume of free medical aid, medical treatment and prevention of epidemiological diseases; procurement of goods and services for conduct of expertise during the state registration of medicines and medical items, and the assessment of the safety and quality thereof.
The Healthcare Code further provides that persons engaged in pharmaceutical activity holding a certificate on compliance with relevant proper pharmaceutical practice have a priority right to conclude a contract (to render services/ products) as part of the guaranteed volume of free medical aid. In particular, compliance with the following proper pharmaceutical practices will be required:
- GMP (proper production practice) for the procurement of medicines and the conclusion of long-term supply contracts in respect of medicines, medical items;
- GDP (proper distributorship practice) for the procurement of medicines, pharmaceutical services as part of the guaranteed volume of free medical aid and conclusion of long-term contracts on storage and transportation of medicines and medical items; and
- GPP (proper pharmacy practice) for the procurement of pharmaceutical services as part of the guaranteed volume of free medical aid.
The State Pharmacopeia of the Republic of Kazakhstan
The Healthcare Code has been revised to provide explicitly that the requirements set in the State Pharmacopeia of the Republic of Kazakhstan are mandatory for individuals and legal entities engaged in the production, manufacturing, realization, storage, control and use of medicines.
*Code of the Republic of Kazakhstan On Health of Population and Healthcare System dated 18 September 2009 as amended (Healthcare Code).