A Draft Regulation on the Promotional Activities of Human Medicinal Products and Food For Special Medical Purposes Has Been Published

On May 28, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) published a Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (“Draft”) on its official website and announced that opinions regarding the Draft can be delivered to the Agency’s official e-mail address until the end of working hours on June 10, 2024. Significant changes that differ from the current regulation are as follows:

In General

In addition to physicians, dentists, and pharmacists, promotion activities may also be carried out for dieticians, provided that they are limited to foods for special medical purposes.

Product promotion representatives will also be able to carry out promotional activities via video calls.

The threshold for notifiable value transfers has been reduced by stating that any transfer of value to healthcare professionals or healthcare institutions with a monetary value exceeding 5% of the current gross monthly minimum wage, instead of 10%, shall be notified to the Agency.

The promotion of products that have marketing authorization in Türkiye but are not available in the Turkish market and are authorized by the Agency to be procured from abroad on a prescription basis will only be allowed, provided that it is for pharmacovigilance purposes.

It is foreseen that as of January 2025, marketing authorization holders will be uploading the promotional materials regarding their products that they have prepared or revised before the date of distribution on the electronic database of the Agency. Similarly, marketing authorization holders will be making the notifications of manufacture, import, and distribution of free promotional samples.

Donations, Incentive Ban, Meals

Although it is stated that donations may be made to healthcare institutions in accordance with the legislation, it is emphasized that no payment in-kind and/or in-cash, even under the name of donation or similar names, can be made to health institutions for the entry of product promotion representatives to the establishment. Likewise, it is stated that healthcare professionals and healthcare institutions cannot request incentives from marketing authorization holders or those who carry out promotional activities on their behalf.

It is explicitly regulated that product promotion representatives cannot offer food/beverages, and similar treats to healthcare institution and/or healthcare professionals during their product promotion activities.

Scientific Meetings and Product Promotion Meetings

It is specified that scientific meetings and product promotion meetings can be organized in three different ways: (i) physical meetings, (ii) electronic meetings and (iii) hybrid meetings.

In order to organize scientific meetings and product promotion meetings, regardless of their types, the availability of the relevant products on the Turkish market will be a condition in addition to the condition of being authorized in Türkiye.

Marketing authorization holders will be able to support scientific meetings, electronic scientific meetings, and hybrid scientific meetings held in Türkiye only if the costs of the expense items are charged in Turkish lira.

The initial registrations of scientific meetings must be made by healthcare institutions and marketing authorization holders. Before the initial registration, the scientific program must have been announced by the healthcare institution. After the initial registration, notifications of support can be made until the day before the meeting. Similarly, product promotion meetings can also be organized by making notifications until the day before the meeting.

It is envisaged that after the scientific meetings and product promotion meetings are held, the details of the meetings must be reported in detail via the Agency's electronic system within 60 days at the latest.

Sanctions

The sanctions that can be imposed on the marketing authorization holders are stipulated in a tripartite structure within the context of: (i) infringement of the provisions regarding scientific meetings and product promotion meetings in general, regardless of the type; (ii) infringement of other provisions; (iii) infringement of the regulation by the employees or product promotion representatives operating promotional activities. It is stipulated that administrative sanctions, which typically begin with a warning, to include a 1 month - 3 months - 6 months - 1 year ban from engaging in promotional activities by gradation based on repetition of the infringements within 1-year periods. Furthermore, it is foreseen that the sanctions imposed on the marketing authorization holders to be published on the Agency's website.

In terms of infringing acts of product promotion representatives, it is stipulated that the administrative sanctions to follow a similar pattern, beginning with a warning and following with the suspension of the qualification certificate for 1 month - 3 months - 6 months - 1 year by gradation based on the repetition of the infringing acts within 1-year periods.

The administrative sanctions for healthcare professionals in terms of the infringement of the provisions regarding scientific meetings and product promotion meetings in general, regardless of the type, start with a warning in line with a similar system, and follow with not being provided with the sponsorship of marketing authorization holders directly or indirectly for 1 month - 3 months - 6 months - 1 year by gradation based on repetition of the infringing acts within 1 year periods.

In addition, disciplinary actions may be initiated before the relevant institution or professional organization for all infringements by healthcare professionals and healthcare institutions within the scope of the Draft.

First published by Gün + Partners in Jun 04, 2024.