April 2021 – On 14 March 2021, the Turkish Medicine and Medical Devices Authority (“TITCK”) issued the Guidelines on Applications for Electronic Scientific Meetings and Electronic Product Promotion Meetings (the “Guidelines on Electronic Meetings”). Scientific meetings and product promotion meetings organised or sponsored by pharmaceutical companies are primarily governed by the Regulation on Promotional Activities of Medicinal Products for Human Use (published in the Official Gazette numbered 29045 and dated 3 July 2015) (the “Promotion Regulation”) and the Guidelines on Applications for Scientific Meetings and Product Promotion Meetings, issued on 29 June 2016. As such, they are subject to notification to and approval of TITCK. Given the increasing use and importance of electronic meetings following the Covid-19 outbreak, the Guidelines on Electronic Meetings stipulates the application procedures for such meetings of pharmaceutical companies , such that they are in line with the principles and restrictions of the Promotion Regulation.
Electronic Scientific Meetings
The Guidelines on Electronic Meetings introduces the definition of “electronic scientific meetings”. While the definition is largely based on the existing definition of “scientific meetings” under the Promotion Regulation, the Guidelines on Electronic Meetings provide that “electronic scientific meetings” are to be held electronically without being open to the public and accessed only during the meeting day(s) with the attendee’s specific username and password.
The Guidelines on Electronic Meetings provide that marketing authorisation holders (MAHs) may not organise electronic scientific meetings (although they are not prohibited from organising “physical” scientific meetings under the Promotion Regulation). Therefore, as per the Guidelines on Electronic Meetings, MAHs can only sponsor electronic scientific meetings, and a single MAH may only sponsor an electronic scientific event that is (i) national in scope and (ii) completed within four hours and in a single day. Any other electronic scientific meetings (subject to certain exceptions, such as continental or worldwide congresses and surgical courses and training programmes) must be sponsored by at least two MAHs under the Guidelines on Electronic Meetings. Further, such electronic scientific meetings cannot be held using the technical infrastructure systems of MAHs.
In order to sponsor electronic scientific events, MAHs must provide information to TITCK such as (i) the content of the meeting; (ii) a list of the potential attendees; (iii) expense items to be made; and (iv) events to take place at least (a) fifteen days in advance for national electronic scientific meetings; and (ii) thirty days in advance for international electronic scientific meetings.
During the application process for sponsoring national electronic scientific meetings, MAHs must submit a letter of undertaking addressed to TITCK signed by the official of the health institution/organisation organising the meeting, including (i) the total duration of the electronic scientific meeting; and (ii) the statements stipulated in the Guidelines on Electronic Meetings in details about (a) allocating sponsorship fees and (b) product promotion principles.
The scope of sponsorship by MAHs is limited (subject to further conditions listed in the Guidelines on Electronic Meetings) to the payment to the organisers of (i) the general meeting sponsorship fee; (ii) the participant registration fee; (iii) the satellite symposium fee; (iv) the satellite symposium speaker fee; and/or (v) the stand participation fee. The amount of payment by MAHs for (i) may not be higher than seven times the gross minimum wage (which is TRY 3,577.50 [approx. EUR 370] in 2021) and the payment for (iii) and (v) may not be higher than three times the gross minimum wage. Other types of sponsorships, such as those for sessions or panels, or via SMS or mobile apps, etc., are not allowed under the Guidelines on Scientific Meetings.
Electronic Product Promotion Meetings
Under the Guidelines for Electronic Meetings, electronic promotion meetings organised by MAHs should be completed within four hours in a single day. Such meetings cannot be held using the technical infrastructure systems of healthcare institutions, or published or otherwise achieved on their websites. In such meetings, MAHs may finance only the transportation and accommodation expenses of the speakers.
The Guidelines for Electronic Meetings provide that electronic meetings organised or sponsored by a foreign representative or license holder of a MAH are not considered within the scope of electronic product promotion meetings.
During the application process for organising an electronic product promotion meeting, MAHs must provide information to TITCK such as (i) the title and content of the meeting; (ii) the beginning and end dates of the meeting; (iii) the list of attendees; (iv) the payments to be made to the speakers and other costs; and (v) the list of speakers (other than the MAH’s employees, foreign speakers, and scientists who are not healthcare professionals). MAHs are required to ensure that only the relevant healthcare professionals attend and have access to the electronic product promotion meeting.
TITCK’s Guidelines on Electronic Meetings not only clarify the conditions of the Promotion Regulation for MAHs to organise or sponsor such meetings, which have attained significant frequency due to the continuing Covid-19 circumstances, but they also introduce important restrictions for MAHs. The latter is necessitated by the fact that electronic platforms are readily accessible by a large number of individuals, as opposed to physical meetings. This seems to be interpreted by TITCK as a threat to the restrictions of the Promotion Regulation, such as Article 5(1) providing that pharmaceutical products can be promoted only to medical doctors, dentists and pharmacists. Accordingly, the Guidelines on Electronic Meetings implement certain means to monitor and ensure that electronic meetings are not used as a way to promote pharmaceutical products in contravention to the framework established by the Promotion Regulation.