The pharmaceutical industry has been at the forefront of research and development for many years, and its promotional phase plays an important role as well. Promotional and marketing activities are significant as a means of informing about the availability, use of new drugs, and supplementing the existing knowledge of medical professional (health care providers) for effective treatment of patients. However, behind the modest intention of increasing medical professional’ awareness and knowledge of the latest advances in medicine, it is important to avoid aggressive marketing strategies where commerce overshadows a commitment to patient health care.
In this article, we will consider the main aspects of regulating activities for the promotion of medicines under the legislation of the Republic of Kazakhstan (Kazakhstan/RoK).
Promotion is any activity organised and financed by a pharmaceutical company to facilitate prescription, supply, use and recommendation or consumption of pharmaceutical products (medicines, medical devices (MDs) and preventive care products (PCPs).
Advertising, in turn, as a tool to promote pharmaceutical products is information distributed or placed in any form, by any means, intended for an indefinite audience, containing certain details on medicines and MDs, facilitating their promotion and distribution.
What are the basic requirements for advertising pharmaceutical products (medicines and MDs)?
Advertising must be accurate, recognizable, exclude comparisons with other medicines and MDs, should not mislead consumers, including in relation to characteristics, composition, consumer properties, cost, intended results of use, research and test results, and should contain complete and reliable information about the drug or medical device.
Meanwhile, inappropriate advertising is related to unfair, misleading, unethical, deliberately false, and hidden advertising, which violates the requirements for its content, time, place, manner of distribution and placement established by the legislation of Kazakhstan.
To avoid certain legal and reputational risks, the subjects of pharmaceutical industry should attach great importance to the restrictions imposed by Kazakhstani legislation, which prohibits:
- advertising of medicines and MDs, PCPs not registered in Kazakhstan;
- advertising of prescription medicines (PMs) in the media;
- distribution of PM samples for advertising purposes;
- use of children, their images and voices in advertising of medicines and MDs, except for medicines and MDs for children;
- distribution and placement of advertisements for medicines and MDs in public transport, organizations not related to their prescription, use or dispensing, except for advertising medicines at medical or pharmaceutical conferences, congresses, symposiums and other scientific meetings;
- placement of advertising information on industrial products, prescription forms;
- placement of outdoor (visual) advertising of medicines and MDs;
- the use of health professionals authorised to prescribe medicines and MDs as distributors of advertisements, unless they provide accurate information about medicines and MDs for scientific or educational purposes or to inform patients;
- advertising of services in the absence of a license to perform the relevant type of activity;
- advertisement for services provided by persons who are not certified healthcare professionals, including foreign specialists;
- to specify in advertisements for the population treatment of the following diseases: sexually transmitted diseases, cancer, mental and behavioral disorders (diseases), dangerous infectious diseases, HIV infection, tuberculosis, diabetes mellitus;
- to make reference in advertisements on recommendations of scientists, healthcare professionals as well as public officials who may encourage the use and/or prescribing of medicines and MDs;
- advertise services, medicines and MDs as unique, safest and most effective;
- claim that the safety and efficacy of a medicine is due to its natural origin;
- suggest that the effectiveness of the service or treatment with the advertised medicinal product is guaranteed and no side effects are experienced during product use;
- advertisements do not directly pertain to the advertised service, medicines or MDs;
- advertisement of offers for transactions involving human organs (part of an organ) and (or) tissues (part of a tissue).
Current legislation of Kazakhstan prohibits promotion of medicines and MDs by medical professionals, representatives of manufacturers and/or distributors in medical organisations and educational organisations in the field of healthcare, except for daily medical conferences, scientific conferences and/or specialised seminars.
Meanwhile, according to paragraph 13 of the Rules of ethics for the promotion of medicines and MDs, individual contacts of pharmaceutical manufacturers, distributors and their representatives with medical and pharmaceutical professionals/workers during their working hours and in the workplace to promote medicines and MDs are not allowed.
What about the risks?
Violation of Kazakhstani legislation create risks both for the medical/pharmaceutical professionals/worker and for the subjects of pharmaceutical industry (companies, manufacturers, distributors of medicines and MDs).
For example, a medical/pharmaceutical professionals/worker may be disciplined by an employer in the form of a comment, a reprimand, a strict reprimand, and the termination of an employment contract.
Meanwhile, the subjects of pharmaceutical industry (companies, manufacturers, distributors of medicines and MDs) are administratively liable for obstructing the lawful activities of medical/pharmaceutical professionals/worker. Obstruction of the professional activities of medical/pharmaceutical professionals/workers, as well as unlawful interference in their professional activities in the form of a demand for illegal acts entail a non-criminal fine of 30 MCIs for individuals, 50 MCIs for officials, and 100 MCIs for legal entities.
Promotion of medicines and MDs through individual meetings with medical/pharmaceutical professionals/workers in their workplace during their working hours entails violation of Clause 13 of the Rules of ethics for the promotion of medicines and MDs, which prohibits individual contacts of subjects of pharmaceutical industry (companies, manufacturers, distributors of medicines and MDs) with medical/pharmaceutical professionals/workers during their working hours and in their workplace for promotions of medicines and MDs. Thus, a judicial authority may qualify a violation of this requirement as the commission of illegal actions aimed at interfering with the professional activities of medical personnel/workers.
How to promote the medicines and MDs?
As noted above, the promotion of medicines and MDs is allowed at daily medical conferences, scientific conferences and/or specialised seminars (events).
The purpose of the above activities should be to share knowledge, raise awareness of the pharmaceutical products of the manufacturing company and/or distributor, provide scientific, educational and/or professional information, or any combination of these, relevant to health professionals or the health care organisation, benefit patients, provide health professionals/workers with scientific, educational information about the products of the manufacturing company and/or distributor.
Activities may be provided in the form of round tables, lectures, conferences, seminars, webinars, exhibitions, sponsorship of external events and other similar events of a scientific or professional nature.
In practice, mentioned activities are carried out within healthcare organisations and hospitals only with the prior obligatory written approval of the head (director) of the relevant organization/hospital in accordance with their internal rules and regulations.
Finally, it is important to note that activities and meetings that create conflicts of interest for health professionals, as well as quid pro quo, i.e. offering, promising, providing or giving remuneration in any form to health professionals for prescribing or recommending a certain medical product to patients, as well as entering into agreements with them to prescribe or recommend a product to patients – are prohibited.
For further information, please contact:
Saniya Perzadayeva, Managing Partner, Unicase Law Firm