Following the adoption of amendments to the Code on Public Health and Healthcare System, which introduced for the first time in Kazakhstan certain standards for ethical business practices with regard to the promotion of pharmaceutical products and medical devices, the Ministry of Healthcare recently published rules for ethical promotion of pharmaceutical products and medical devices ("Ethical Rules").1 The Ethical Rules will take effect on 27 May 2019.
1.The general framework for the industry's ethical interaction
The Ethical Rules set forth a number of rules for ethical promotion of pharmaceutical products and medical devices to healthcare professionals and pharmacies. Specifically, among other things:
- Pharmaceutical and medical device companies are now banned from visiting healthcare professionals and pharmacists for the purposes of promoting their products during healthcare professionals' and pharmacists' working hours.
- Pharmaceutical and medical device companies are allowed to promote their products during professional meetings, congresses, symposia or daily doctors meetings (the latter, however, is subject to a 10-day prior written approval from the head of the medical institution).
- Donations and grants that support scientific research and sponsorship of healthcare professionals to attend training or events is generally allowed, provided that healthcare professionals are not expected to prescribe or, in any manner, promote the sponsor's products.
2. Specific requirements applicable to promotional and advertising materials
In addition to earlier established rules applicable to pharmaceutical product and medical device advertising, the Ethical Rules provide certain additional requirements. Specifically, among other things, the Ethical Rules require that all statements about pharmaceutical products and medical devices used in promotional and advertising materials be confirmed by reference to a specific article or research (links to the relevant materials should be provided) with an indication of the author and date of publication as well as the method of performed studies (i.e., in vitro, animal testing or human trials).
3. Ethical Commission
In accordance with the Ethical Rules, special committees dealing with matters relating to ethical promotion of pharmaceutical products and medical devices should be established by territorial subdivisions of the Committee for Control of the Quality and Safety of Goods and Services of the Ministry of Healthcare.
Committees will be composed of representatives of public health departments, medical institutions and professional associations and, among other things, will review complaints relating to unethical promotion of pharmaceutical products and medical devices.
Should any complaint confirm the fact of violation of the Ethical Rules, committees will issue their recommendations to local public departments, medical institutions, professional associations, manufacturers or distributors about responsibility and preventive measures.
Currently, effect of these recommendations is not clear as the law does not provide for any specific consequences for violation of the Ethical Rules.
If you have any questions or wish to receive a copy of the Ethical Rules, please contact Azamat Kuatbekov, Andrei Yorsh or Alissa Inshakova.
This LEGAL ALERT is issued to inform Baker McKenzie clients and other interested parties of legal developments that may affect or otherwise be of interest to them. The comments above do not constitute legal or other advice and should not be regarded as a substitute for specific advice in individual cases.
1 Order of the Minister of Healthcare of the Republic of Kazakhstan No. ҚР ДСМ-69 dated 8 May 2019 "On Approval of the Rules for Ethical Promotion of Pharmaceutical Products and Medical Devices."