The Regulation on the Promotional Activities of Medicinal Products for Human Use (“Regulation”) defines the scientific and product promotion meetings and regulates how the marketing authorization holders can support or organize these activities. However, the Guidelines on the Application of Electronic Scientific Meetings and Product Promotion Meetings (“Guidelines”) which has been prepared taken into consideration the electronic scientific meetings and electronic product promotion meetings of which the practice has increased during the COVID-19 pandemic period within the framework of the Regulation, has been published on March 14, 2021 on the website of the Turkish Medicines and Medical Devices Agency (“Agency”).
The Guidelines regulates the rules regarding the applications concerning the electronic scientific meetings and electronic product promotion meetings and sets forth crucial restrictions to meeting contents.
i. The Regulations Regarding the Electronic Scientific Meetings
- No electronic scientific meetings shall be organized by the license/marketing authorization holders; however these meetings can be sponsored. Regarding the supports to be provided in these meetings:
- In case the global company/licensor of Turkish license/marketing authorization holders organize/sponsor an electronic scientific meeting, the Turkish license/ marketing authorization holder is solely able to sponsor the speakers. No sponsorship shall be provided by the license/ marketing authorization holders to the participants, even if this consists of sharing links and translation support.
- The license/marketing authorization holders providing only general sponsorships to electronic scientific meetings shall not receive booth or satellite symposium sponsorship free of charge.
- License/marketing authorization holders shall only be able to provide general sponsorship at electronic scientific meetings in which the participation is free of charge.
- Electronic scientific meetings consisting of modules spreading over time, each module shall be assessed as a separate electronic scientific meeting and shall be notified separately. The license/ marketing authorization holders shall solely sponsor participants in these meetings.
- No direct or indirect sponsorship shall be provided by the license/marketing authorization holders at meetings (including disease awareness meetings) organized for patients on electronic platforms.
- No direct or indirect sponsorship shall be provided by the license/marketing authorization holders to electronic meetings organized on all kinds of media and communication platform broadcasting publicly.
- A monetary limit has been introduced to the electronic scientific meetings’ sponsorships except sponsorships provided for world or continent-wide congresses organized in Turkey. The referred monetary limit shall be effective as of June 15, 2021:
- The upper limit for the general sponsorship is determined as seven times of the gross minimum wage,
- The upper limit for satellite symposium sponsorship and booth sponsorship is determined as ten times of the gross minimum wage.
- A time limit has been introduced regarding the satellite symposiums:
- The total period of time allocated to the satellite symposiums shall not exceed the 25% of total time of the scientific program.
- The duration of each satellite symposium shall be at least 30 minutes.
- No increase in costs for general sponsorship, satellite symposium or booth participation sponsorship notified to and preapproved by the Agency shall be made after the meeting. No products other than the products notified and preapproved shall be included to the booth or satellite symposium activities.
- Another requirement which imposed additional obligations to license/marketing authorization holders is to notify the Agency about the names of healthcare professionals attending the electronic scientific meetings for which the license/marketing authorization holders provide only a general sponsorship (without any booth participation and satellite symposia even if they are free of charge,) and which are organized without receiving any registration fee.
ii. The Regulations Regarding the Electronic Product Promotion Meetings
- The meetings shall not be organized by using the electronic meeting infrastructures of health authorities/organizations and shall not be broadcasted or archived at website of health authorities/organizations.
- The electronic meetings organized/sponsored by the global company/licensor of Turkish license/marketing authorization holders shall not be evaluated within the scope of the electronic product promotion meeting.
- Regarding the content of the meetings, no information shall be provided on any subject (statistics, article writing, legal rights, etc.) other than information about the product of the license/marketing authorization holder.
- The license/marketing authorization holders shall take the required precautions to ensure the access/participation of only the relevant healthcare professionals. Practices such as private password, personal hyperlink or verification code should be implemented.
- The meeting name shall be relevant to the meeting subject and contain no exaggerated expressions.
- Services such as offerings shall not be provided by the license/marketing authorization holders at the electronic product promotions meetings.
Evaluation
The Guidelines shall serve as basis for electronic scientific and product promotion meetings since they include detailed and new rules regarding the content and the planning of electronic meetings as well as procedures and principles for their application. The content of each meeting shall be scrutinized to be compliant with the Guidelines. Nevertheless, the companies are also required to comply with the obligations within the scope of the Law on Personal Data Protection. The obligation of the notification of the participants’ names to the Agency is introduced with the Guidelines particularly for electronic scientific meetings organized without registration fee and to which only general sponsorship is provided by the license/marketing authorization holders. In this regard, to be in compliance with the personal data protection rules, both the scientific meeting organizer and the sponsor must inform the participants whose data is processed about the purposes of this data processing and the persons to whom the data shall be transferred.
First published by Gün + Partners in Jun 08, 2021.
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