Get a free lesson
Just type your contacts
It's totally free
Under construction
Contact us
Leave a request and we will call you back
Subscribe to the Unicase Newsletter
Be the first to know about current events
Unicase Law Firm
Promotion of medicines: are you ready
to take a risk?
The pharmaceutical industry has been at the forefront of research and development for many years, and its promotional phase plays a significant role as well. Promotional and marketing activities are important for informing people about the availability and use of novel drugs, as well as supplementing medical professionals' (healthcare providers') existing knowledge for effective patient treatment. However, behind the modest intention of increasing medical professionals’ awareness and knowledge of the most recent advances in medicine, it is critical to prevent 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).
Advertisement
Promotion is any activity organised and financed by a pharmaceutical company to facilitate prescription, supply, use, recommendation, or consumption of pharmaceutical products (medicines, medical devices (MDs), and preventive care products (PCPs).
In turn, advertising, as a tool for promoting pharmaceutical products, is information distributed or placed in any form, by any means, for an indefinite audience, containing specific details on medicines and MDs, facilitating their promotion and distribution.
What are the basic requirements for advertising pharmaceutical products (medicines and MDs)?
Properly advertising must be accurate, recognisable, 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 intentionally violates the specific 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:
In turn, advertising, as a tool for promoting pharmaceutical products, is information distributed or placed in any form, by any means, for an indefinite audience, containing specific details on medicines and MDs, facilitating their promotion and distribution.
What are the basic requirements for advertising pharmaceutical products (medicines and MDs)?
Properly advertising must be accurate, recognisable, 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 intentionally violates the specific 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)
Promotion
Current legislation in Kazakhstan prohibits the 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 the 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 unallowed.
Meanwhile, according to the 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 unallowed.
What about the risks?
Violation of Kazakhstani legislation creates 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 professional or worker may be disciplined by an employer in the form of a comment, a reprimand, a strict reprimand, or the termination of an employment contract.
Meanwhile, the subjects of the pharmaceutical industry (companies, manufacturers, distributors of medicines, and MDs) are administratively liable for obstructing the lawful actions of medical/pharmaceutical professionals/worker. Obstruction of the professional actions 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 fines of 30 MCIs for individuals, 50 MCIs for officials and 100 MCIs for legal entities.
Individual meetings with medical and pharmaceutical professionals and workers in their workplace during working hours constitute a violation of Clause 13 of the Rules of Ethics for the Promotion of Medicines and MDs, which prohibits individual contacts of pharmaceutical industry subjects (companies, manufacturers, and distributors of medicines and MDs) with medical and pharmaceutical professionals and workers.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.
For example, a medical/pharmaceutical professional or worker may be disciplined by an employer in the form of a comment, a reprimand, a strict reprimand, or the termination of an employment contract.
Meanwhile, the subjects of the pharmaceutical industry (companies, manufacturers, distributors of medicines, and MDs) are administratively liable for obstructing the lawful actions of medical/pharmaceutical professionals/worker. Obstruction of the professional actions 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 fines of 30 MCIs for individuals, 50 MCIs for officials and 100 MCIs for legal entities.
Individual meetings with medical and pharmaceutical professionals and workers in their workplace during working hours constitute a violation of Clause 13 of the Rules of Ethics for the Promotion of Medicines and MDs, which prohibits individual contacts of pharmaceutical industry subjects (companies, manufacturers, and distributors of medicines and MDs) with medical and pharmaceutical professionals and workers.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 medicines and MDs?
As noted above, the promotion of medicine and MDs is allowed at daily medical conferences, scientific conferences, and/or specialised seminars (events). T
he purpose of the above activities should be to disseminate knowledge, raise awareness of the pharmaceutical products of the manufacturing company and/or distributor, provide scientific, academic, and/or professional information, or any combination of these, relevant to health experts or the health care organisation, benefit patients, and provide health professionals/workers with scientific, academic, and/or professional 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 ethical nature.
In practice, the mentioned actions are carried out within healthcare organisations and hospitals only with the prior, obligatory written approval of the head (director) of the relevant organization/hospital upon their internal rules and regulations.
he purpose of the above activities should be to disseminate knowledge, raise awareness of the pharmaceutical products of the manufacturing company and/or distributor, provide scientific, academic, and/or professional information, or any combination of these, relevant to health experts or the health care organisation, benefit patients, and provide health professionals/workers with scientific, academic, and/or professional 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 ethical nature.
In practice, the mentioned actions are carried out within healthcare organisations and hospitals only with the prior, obligatory written approval of the head (director) of the relevant organization/hospital upon their internal rules and regulations.
In conclusion, it is noteworthy that activities and meetings that cause conflicts of interest for health professionals, as well as quid pro quo, i.e. offering, promising, providing or performing 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.
Authors
- Saltanat SuyunshaliyevaAssociate
Subscribe to blog