On May 28, 2024, the Draft Regulation on Promotional Activities of Medicinal Products for Human Use and Foods for Special Medical Purposes ("Draft") was published on the official website of the Turkish Medicines and Medical Devices Agency (“TMMDA”).
In this information note, we have analyzed the differences between the current Regulation on Promotional Activities of Medicinal Products for Human Use ("Regulation") and the Draft Regulation and summarized the changes introduced by the Draft Regulation under different headings.
Definition of “Food for Special Medical Purposes" and Other Definitions
According to the draft, the definition of "food for special medical purposes" will be added to the scope of the Regulation. With this amendment, in addition to physicians, dentists and pharmacists, dieticians will also be allowed to carry out promotional activities, limited to foods for special medical purposes only.
In addition to the definition of "promotional items" in the Regulation, the definition of "promotional materials", which covers written, visual and audio documents prepared for the purpose of informing about diseases, will be introduced to the legislation.
In addition, the Regulation will introduce a number of definitions for promotional activities.
Promotion Activities
Under the Draft, visits to the facilities of marketing authorization or license holders in Türkiye may be organized.
To introduce the products to physicians, dentists and pharmacists, it will be possible to organize visits to the production facilities of the marketing authorization and license holders in Türkiye.
Product promotion representatives will also be allowed to promote products through video calls in electronic media.
For products authorized by the TMMDA to be procured from abroad within the scope of the "Regulation on the Procurement of Pharmaceuticals from Abroad", promotional activities will be allowed, provided they are only for pharmacovigilance purposes.
The Draft forbids the news to be published in the print and visual media, including the internet, in a way to point to the product.
The Draft regulates that the packaging content of free promotional samples must be exactly the same as the product and the most recently approved sample of the package insert must be provided with the free promotional sample.
A separate article regulates the press announcement procedure for notifying healthcare professionals that the licensed or authorized product has been placed on the market for the first time. Provisions on publication periods and announcement formats are included.
Although it is regulated that promotional materials other than documents prepared for disease information purposes may contain the product name, promotional materials may not be distributed directly or indirectly to patients and their relatives, with the exception of promotional materials used for disease information purposes.
Promotional materials other than documents prepared for disease information purposes will be able to include the product name. Except for promotional materials used for disease information, promotional materials may not be distributed directly and/or indirectly to patients/patient relatives.
Value Transfers, Donations, Incentive Prohibition, Food and Drink Offerings
According to the Draft, changes will be made in the transfer of monetary value to healthcare professionals or healthcare institutions. Accordingly, any transfer of value exceeding 5% instead of 10%, the current rate, of the current monthly gross minimum wage will be reported to the TMMDA.
While it is stated that donations can be made to health institutions in accordance with the legislation, it will be regulated that product promotion representatives will not be able to make any in kind and/or in cash requests, even under the name of donations and similar names, in order to gain access to health institutions. This expands the scope of the previous provision stating that "no fee may be charged" for health institutions and organizations.
Product promotion representatives will be prohibited from offering food and drinks to healthcare institutions and organizations and healthcare professionals during product promotion activities.
Scientific Meetings and Product Promotion Meetings
Scientific meetings and product promotion meetings can be organized in three ways:
- physical meetings
- electronic meetings
- hybrid meetings
Authorization holders will only be able to support scientific meetings held in Türkiye if the expenses are charged in Turkish Liras.
Initial registration of scientific meetings will have to be made by health institutions and license holders. Before the first registration, the scientific program will need to be announced by the health institution. After the initial registration, notifications of support can be made before the meeting date. Product promotion meetings will also need to be announced before the meeting date.
It is regulated that support for meetings will not be provided directly to the individual, but to the health institution/organization organizing the meeting or the agency undertaking the organization.
In the event that products licensed or authorized according to the relevant legislation are not available on the market, satellite symposia cannot be organized for these products at scientific meetings.
The names and/or logos of all marketing authorization or license holders who support the meeting will only be allowed to be placed in a separate area under the name of "supporters" on the scientific meeting internet announcement page and in the meeting foyer area.
Administrative Sanctions
The draft stipulates a similar systematic of sanctions for different stakeholders.
Accordingly, the administrative sanctions that may be imposed on marketing authorization or license holders are as follows:
- violation of the provisions on scientific meetings and product promotion meetings
- violation of other provisions
- product promotion representatives working within the organization or carrying out promotional activities on behalf of the organization are in breach of the provisions of the Regulation
We have presented the sanctions to be imposed on different stakeholders in the table below:
Furthermore, the sanctions to be imposed on license holders will be published on the TİTCK's website.
On the other hand, disciplinary proceedings may be initiated for violations by healthcare professionals and healthcare institutions before the institution or professional organization to which they are affiliated.