Introduction
“The Guideline for Electronic Scientific Meetings and Electronic Product Promotion Meetings based on the Regulation on Promotion Activities of Medicinal Products for Human Use" ("Electronic Meeting Guide") has been published with the Turkish Medicine and Medical Devices Agency's (“TMMDA”) announcement dated 14 March 2021. The relevant guideline regulates the procedures and principles regarding scientific meetings and product promotion meetings held by electronic means.
History
Promotional activities for medicinal products for human use, enteral nutrition products and medicinal formulas are regulated within the "Regulation on Promotion Activities of Medicinal Products for Human Use" ("Regulation") published in the Official Gazette dated 3 July 2015 and numbered 29405. Scientific meetings and product promotion meetings within the scope of the Regulation are regulated by the “Guideline for Scientific Meetings and Product Promotion Meetings based on the Regulation on Promotion Activities of Medicinal Products for Human Use” (“Scientific and Promotional Meeting Guide”).
While procedures and principles for physical meetings are regulated by the Scientific and Promotional Meeting Guide, almost all scientific meetings, congresses and product promotion meetings have, however, been held on electronic platforms throughout the country during the pandemic, which has given rise to the need for a specific regulation. Although the general principles provided in the Scientific and Promotional Meeting Guide have been adhered to, some new regulations specific to the digital structure of electronic meetings are also stated in the Electronic Meeting Guide to ensure that electronic meetings are held in accordance with the main principles determined by the Regulation.
It should also be highlighted that the Scientific and Promotional Meeting Guide will be applied to events that hold scientific meeting physically but also give participants the opportunity to attend online, regardless of the number of online participants.
What New Regulations Does the Electronic Meeting Guide Create?
1. Electronic Scientific Meetings
1.1. Who can organize/support electronic scientific meetings? What is the scope of the support that can be provided?
Probably the most important regulation is that pharma companies are prohibited from organizing any kind of electronic scientific meeting. According to the Electronic Meeting Guide, electronic scientific meetings cannot be organized by license/permit holders, regardless of the duration of the meeting. Unlike physical scientific meetings, license/permit holders cannot organize scientific meetings themselves even if the meeting's duration is under four hours. Electronic scientific meetings can only be organized by "the Ministry of Health, national and international associations that healthcare professionals are members of, health institutions and organizations, universities or medical doctor/dentist/pharmacist professional organizations" (“HCOs”); pharma companies can only provide specific sponsorships to these meetings.
The type of sponsorship that can be provided by pharma companies to scientific electronic meetings are counted in a numerus clausus principle, and stated as below:
i. General meeting sponsorship
ii. Participant registration fees
iii. Satellite speaker fees
iv. Satellite symposia fees
v. Booth participation fees
The TMMDA prohibits any kind of sponsorship or support apart from the permitted sponsorship types under any name, and especially states the following as prohibited:
i. Session sponsorship
ii. Panel sponsorship
iii. Text message sponsorship
iv. E-poster area sponsorship
v. Mobile application sponsorship
vi. Social programs, etc.
The Electronic Meeting Guideline clearly explains the scope of each type of sponsorship that pharma companies are permitted to provide. For example, the duration of each satellite symposium must be at least 30 minutes, and the total time allocated for satellite symposia in electronic scientific meetings cannot be more than 25% of the total duration of the scientific program.
The use of specific sponsorship fees by event organizers/agencies for purposes other than the permitted and intended purpose of providing such support by pharma companies is certainly forbidden. Besides creating this constraint for agencies, the Guideline also makes pharma companies responsible for preventing or tracking any such misuse of the sponsorship fees they provide. Pharma companies are also held jointly responsible with event organizers/agencies for taking the necessary technical and infrastructural measures to ensure booths and/or satellite symposia are only accessible to invited participants during the determined meeting dates/hours.
1.2. Limitations to the Monetary Value of Support
Another important new regulation is the limitation of the monetary value of support. General sponsorship support in electronic scientific meetings cannot exceed an amount greater than seven times the monthly gross minimum wage. In this context, for 2021, support provided for general sponsorship in an electronic scientific meeting cannot exceed TRY 25,042.50. Satellite symposia support and booth participation support in electronic scientific meetings cannot exceed an amount greater than ten times the monthly gross minimum wage. Satellite symposia support is evaluated separately for each satellite symposium in the program. In this context, for 2021, support provided for satellite symposia and booth participation in an electronic scientific meeting cannot exceed TRY 35,775. The provisions regarding monetary support limitations enter into force on 15 June 2021.
1.3. Prohibition of Support for Disease Awareness Meetings
Regardless of whether there is transfer of value, including any kind of technical support, it is prohibited for license/permit holders to provide direct or indirect support for informational meetings held electronically for patients, including meetings conducted for disease awareness.
1.4. Prohibition of Support for Public Meetings Carried Out on Social Media Platforms
License/permit holders cannot provide direct or indirect support for electronic meetings held on social media platforms or on any media and communication platform open to the public, regardless of the transfer of value.
1.5. Recording Satellite Symposia
In accordance with the Electronic Meeting Guide, it is stated that a license/permit holder can record a satellite symposium that they hold, excluding the symposium's question and answer section. These recordings can be used in product promotion meetings. However, in order for these recordings to be used an application must be made to the TMMDA. The use of the relevant recordings by product promotion representatives is prohibited.
1.6. Prohibition of Displaying Logos
The display of logos and products by license/permit holder(s) who provide any kind of support in electronic scientific meetings is forbidden. Pharma companies must be careful to avoid any kind of sponsorship offers under various headings such as "logo sponsorship" and "advertising sponsorship".
1.7. Prohibition of Invitation Through Social Media Platforms
The TMMDA prohibits any kind of announcement of, and invitation to electronic scientific meetings through license/permit holders' social media accounts.
1.8 Prohibition of Pharma Companies' Infrastructure and Technical Support
Electronic scientific meetings cannot be held using license/permit holders' technical infrastructure systems. In this context, it is understood that license/permit holders cannot provide HCOs with online meeting platforms to hold scientific meetings and cannot allow such meetings to be conducted through their own infrastructure. If pharma companies intend to provide such technical support to meet particular technical needs, they should provide this support within the scope of general electronic meeting sponsorships.
2. Electronic Product Promotion Meetings
2.1. Who can organize electronic product promotion meetings?
It is not a new restriction that only license/permit holders can organize product promotion meetings, regardless of whether they are held physically or online. Organizing electronic product promotion meetings directly or indirectly with associations or other organizations in return for donations is prohibited. Pharma companies cannot organize these meetings by using HCOs' electronic infrastructure, or enable HCOs to publish and archive meeting records on their web pages.
2.2. What is the scope of electronic product promotion meetings?
Only information regarding a license/permit holder's promoted products can be exchanged during an electronic product introduction meeting. Any information such as scientific statistics, article writing, legal rights, etc, cannot be shared. The extent to which this provision will apply remains a question for now.
2.3. Technical Obligations for License/Permit Holders
The main principle of both scientific and promotional meetings is that they are closed to the public. Any persons other than the listed healthcare professionals cannot attend these meetings. Ensuring this principle is the exclusive responsibility of license/permit holders in their own product promotion meetings. Licence/permit holders who organize electronic product promotion meetings are obliged to take the necessary measures, such as personalized passwords, personalized links, verification codes, etc., in order to ensure the sole access/participation of invited HCPs.
2.4. Prohibition of Gifts/Catering Services
In physically-held product promotion meetings, pharma companies usually provide great hospitality for their participants, including giving branded corporate merchandise, promotional gifts and catering services. Following the widespread move to online meetings, some pharma companies began a new practice of delivering these services to participants' notified addresses. In the scope of the Electronic Meeting Guideline, all of these kinds of services are prohibited in electronic product promotion activities.
Conclusion
It is important for pharma companies to understand and comply with the new requirements regulated in the scope of the new guideline. Pharma companies must take the necessary technical and infrastructural measures in electronic product promotion meetings that they organize. They must also comply with their responsibilities and obligations as sponsors of electronic scientific meetings. Since promotion and advertising activities conducted via electronic platforms are more vulnerable to misuse and noncompliance, it is expected that the TMMDA will check meeting records and notifications. We highly recommend that pharma companies be aware of and comply with all their responsibilities and obligations to mitigate the risk of facing any operational sanctions brought about by compliance failures.
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.
