Promotion of medicinal products is restricted under Turkish law, as is the case in many other jurisdictions, due to ethical and public interest related concerns. This article discusses the main principles governing the promotion of medicinal products under Turkish law.
The main piece of legislation regulating the promotion of medicinal products is the Regulation on the Promotional Activities of Medicinal Products for Human Use ("Regulation"). Further, Turkish Medicine and Medical Devices Authority ("Authority") has, with a view to clarifying ambiguities in the implementation of the Regulation, published (i) Guidelines Regarding Scientific Meetings and Product Promotional Meetings ("Meeting Guidelines") (which has been recently amended as a result of which new restrictions on scientific and promotional meeting activities have been introduced), (ii) Guidelines Regarding Electronic Scientific Meeting and Electronic Product Promotional Meetings ("Electronic Meeting Guidelines"), and (iii) Guidelines on Procedures and Principles Regarding the Transfers of Value Within the Scope of the Regulation ("Transfers of Value Guidelines").
- General principles. The Regulation
prohibits promotion of medicinal products through instruments such
as drawings or chance games, receipt of cash or any advantage in
kind, making such a proposal or promise when promoting medicinal
products to doctors, dentists and pharmacists.
- Limited target group. Promotion of
medicinal products can only target a limited group of healthcare
personnel ("HCPs") consisting of medical
doctors, dentists, pharmacists. Unlike is the case in some other
jurisdictions, Turkish law does not in principle permit promotion
of medicinal products to public. As such, promotion of medicinal
products to public through any kind of media or communication
platforms broadcasting to public, including the internet, is
prohibited under Turkish law.
- Promotion methods. According to the
Regulation, promotion of medicinal products to HCPs can only be
conducted by way of (i) using promotional materials,
(ii) organising or supporting scientific meetings or product
promotion meetings, or (iii) visits to be paid by product
promotion representatives.
- Scientific meetings and product promotion
meetings. While scientific meetings may be organised
by the Ministry of Health ("Ministry"),
national and international associations, health institutions and
organisations, universities, HCP organisations or
license/authorisation holders to discuss a scientific topic,
product promotion meetings can only be organised by
license/authorisation holders for the promotion of their medicinal
products.
The Meeting Guidelines provides details regarding conditions for sponsorship of HCPs, methods and conditions for support to be provided to scientific and product promotion meetings, restricted venues and seasons for the meetings, formalities prior to and after the meetings, content and duration of the meetings, list of participants and speakers. Specific monetary limitations for support to be provided for scientific meetings and times allocated to satellite symposiums as well as conditions for one-day training support to be provided by university hospitals and training and research hospitals have been introduced through the recent amendments to the Meeting Guidelines.
- Electronic scientific meetings and product
promotion meetings. During the course of COVID-19
pandemic, the Authority has issued Electronic Meeting Guidelines to
regulate electronic scientific meetings and online attendance to
such meetings. The principles set forth under the Electronic
Meeting Guidelines and the Meeting Guidelines are aligned, apart
from that further restrictions have been set forth under the
Electronic Meeting Guidelines for organization of electronic
scientific meetings by licence/authorisation holders, who on the
other hand are permitted to support such meetings upon prior
approval of the Ministry. The Electronic Meeting Guidelines
prohibit licence/authorisation holders from supporting electronic
scientific meetings to be held on social media platforms or media
and communication platforms broadcasting to public and from
announcing and making invitations for such meetings through their
own social media accounts. Organisation of electronic product
promotion meetings by licence/authorisation holders are also
restricted under the Electronic Meeting Guidelines.
- Promotional materials and free
samples. Promotional materials that are allowed under
the Regulation are symbolic reminder visit materials that can be
used by physicians, dentists and pharmacists, the monetary value of
which do not exceed 2.5% of the current monthly gross minimum wage;
printed materials such as books, booklets, brochures containing
information about the product; films and slides audio/visual
materials presented through electronic storage means; all kinds of
publications that can be used as information/data/reference sources
or electronic access to these publications; free samples; demo
devices and materials for patients' training. Display of
promotional materials in health institutions in a manner that
patients can see is prohibited under the Regulation.
Free samples may be distributed to HCPs, provided that the amount of such samples to be distributed should not exceed (i) 5% of the sales amount of the previous year in the first and second calendar years from the launch of the product; (ii) 3% of the previous year's sales in the third, fourth and fifth calendar years; and (iii) %1 of the sales amount of the previous year following the fifth calendar year. Further, licence/authorisation holders should establish an adequate registration and control system regarding the importation and distribution of free samples. In addition, free samples, the packaging of which should bear the phrase "Free sample, not for sale" should be in reduced quantities.
- Transfers of Value. Licence/authorisation holders can transfer value (directly or indirectly, via cash or in kind payment) to health institutions and organisations, universities, HCPs, professional societies of which they are members, unions, associations, foundations, and NGOs, provided that the monetary value does not exceed 10% of the monthly gross minimum wage. According to the Transfers of Value Guidelines, "value" covers all kinds of gains including consultancy fees, donations, payments made under sponsorship agreements. The Regulation and the Transfers of Value Guidelines require licence/authorisation holders to notify the Authority of transfers of value made in the last calendar year within the first 6 months of the following year, obtain written consent of HCPs or authorised personnel of the relevant institution and keep information and copies of documents regarding all transfers for 5 years.
The Regulation and the Guidelines bring significant limitations on the promotional activities of licence/marketing authorisation holders. Failure to comply with these can result in imposition of sanctions such as administrative fines up to 5 times the total sales amount of the previous year, warning, temporary restriction of promotional activities including attending and supporting scientific and product promotional meetings.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.