Second Round of Comments on Draft Regulation for Pharmaceutical Promotions

In the second quarter of 2024, the Turkish Medicines and Medical Devices Agency (the “Agency”) published an announcement on its website, opening the Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (the “Draft”) for external comments. Significant amendments proposed in the initial version can be reviewed by clicking here.

Updates have been made to the Draft based on the opinions of sector stakeholders. The revised version was opened for comments for the second time, as announced on the Agency's official website on September 25, 2024, with the deadline for feedback set for October 4, 2024. In this second version, while some points from the first version are included verbatim, there are notable differentiations and additions at various points.

General overview

The new Draft explicitly states that all activities not classified as “promotion” shall be regarded as “advertising”, emphasizing the legal distinction between the concepts of promotion and advertisement, which are often conflated in practice. Furthermore, the scope of the current Regulation on Promotional Activities for Human Medicinal Products has been maintained in the new Draft, with detailed provisions concerning the responsibilities of contracted companies engaged in co-promotion and patient support programs.

Key updates include:

• – Promotion can be made to dietitians limited to foods for special medical purposes.

• – Product promotion representatives are allowed to make video calls in electronic environments.

• – Promotion of licensed products that are procured from abroad with a prescription and not available in the Turkish market can be conducted for pharmacovigilance purposes.

• – The prohibition of incentives and meals, reiterated from the first version, is expanded for clarity.

The provisions requiring marketing authorization holders to notify the Agency of promotional materials and to upload them in the electronic database prior to use will come into effect on July 1, 2025, while other obligations will take effect on January 1, 2025.

Scientific Meetings and Product Promotion Meetings

The new Draft adopts the system outlined in the first version but introduces additional regulations regarding speaker fees and support for investigators presenting papers. The established conditions include:

• – Products related to the meetings must be available on the Turkish market.

• – Marketing authorization holders can provide support if the expense items are charged in Turkish Liras.

• – Initial registration of scientific meetings must be conducted by health-related institutions/organizations and marketing authorization holders.

• – The scientific program must be announced prior to the initial registration.

• – Notifications concerning the meetings can be submitted until the date of the meeting and must be provided within 60 days following the meeting.

Sanctions

It is understood that the sanction system established in the first version of the Draft has been generally adopted in the new version of the Draft with minor amendments aimed at ensuring uniformity in the sanction systems to be applied to all actors. Consequently, an administrative sanction model is in place that commences with a warning and is structured in stages of 1 month - 3 months - 6 months - 1 year.

Unlike the first version, the new Draft expands the scope of infringements subject to sanctions for health-related institutions and organizations, as well as healthcare professionals. It also provides that the names of banned healthcare professionals will be shared with marketing authorization holders. Additionally, based on the detailed regulation introduced within the scope of patient support programs, it is envisaged that administrative sanctions will be imposed on marketing authorization holders and institutions licensed within the context of the Regulation on the Delivery of Home Care Services. When evaluated collectively, the issues subject to administrative sanctions in the proposed system are as follows:

• – for marketing authorization holders: (i) infringement of meeting rules established in the regulation, (ii) infringement of obligations within the scope of patient support programs, (iii) infringement of other provisions of the regulation, (iv) infringement of the regulation by the employees or product promotion representatives operating promotional activities,

• – infringement of the provisions of the regulation by product promotion representatives,

• – infringement of the provisions of the regulation by healthcare professionals,

• – infringement of the provisions of the regulation by health-related institutions/organizations.

As in the first version of the Draft, disciplinary actions can be initiated for infringements by healthcare professionals and health-related institutions, with sanctions on marketing authorization holders (other than warnings) being announced on the Agency's website. 

Conclusion

In conclusion, the new version of the Draft prepared by the Agency reflects the input received from the stakeholders and aims to provide a clear framework for promotion and advertising practices. The Draft is regarded as a positive development that establishes a basis for content regarding product education, such as patient support programs. However, it falls short of addressing other issues frequently encountered in the sector, such as difficulties in product access and the training needs of healthcare professionals. While the new sanctions for healthcare professionals and health-related institutions are intended to enhance regulatory effectiveness, the lack of a comprehensive strategy for enforcing these sanctions and resolving sectoral problems is noteworthy. Although the steps taken by the Agency to raise ethical standards in the sector are significant, other pressing issues also require attention.