In Turkey, all activities pertaining to the promotion of medicinal products are performed in accordance with the rules under the Regulation on Promotional Activities of Medicinal Products ("Regulation") and surveilled by the Turkish Medicines and Medical Devices Agency ("Agency"). Recently, on June 30th, 2016, the Agency has published the new Guidelines on Applications for Scientific and Product Promotion Meetings ("Guidelines") on its website. Upon the publication of the Guidelines, the Guidelines on Applications for Scientific and Product Promotion Meetings published on May 27th, 2016, has been abrogated.
The Guidelines, while outlining the general rules as to the applications, set forth the detailed liabilities imposed on license holders for organizing scientific and product promotion meetings.
To that end, here we will outline the highlights that the Guidelines have introduced.
(i) Scientific meetings
In addition to the regulations under Article 7 of the Regulation, the Guidelines introduced that:
- scientific meetings which would last less than four hours can be supported by a single license/permit holder and can be organized on a "one-day/daily" basis,
- national and international scientific meetings organized by national and international associations, health institutions, universities, trade bodies of surgeons/dental surgeons/pharmacists, to which the Ministry of Health and healthcare professionals are members and which last more than four hours, must be supported by at least two companies/corporate groups manufacturing the related product,
- for international scientific meetings limited to world and continental congresses and for surgical trainings and training programs initiated in training research hospitals within the country as well as university hospitals within and outside the country, the "two-supporters" condition specified above, would not be sought,
- in case the scientific meeting is related to product promotion and is organized /supported by license/permit holder's foreign representative/license holder, license/permit holder can only support the spokespersons,
- it is prohibited to promote products during scientific meetings organized/supported by a single license/permit holder. Also, for these meetings, while it is allowed for them to use their corporate logos for the meeting, license/permit holders cannot realize honorarium payments to spokespersons and cannot provide organizing associations/institutions with a booth attendance and satellite symposium support.
In addition to the foregoing, the Guidelines impose that scientific meetings can only be supported by way of (i) scientific meeting general sponsorship, (ii) participant, satellite spokesperson and (iii) satellite symposium support and booth attendance payment. Descriptions as to "scientific meeting general sponsorship", "participant and spokesperson support", "satellite symposium" and "booth attendance support" are also included under the Guidelines.
(ii) Product promotion meetings
As per the Guidelines, product promotion meetings are organized only by license/permit holders in order to promote their products to surgeons, dental surgeons and pharmacists. Meetings for demonstration of products to other healthcare professionals are considered within the scope of product promotion meeting. Product promotion meeting can be organized on a "daily" basis in a way to last less than four hours.
The Guidelines also bring certain limitations/prohibitions as to product promotion meetings, namely;
- product promotion meetings can only be organized by license/permit holders. These meetings cannot be organized with associations or other institutions in return of donations,
- these meetings cannot target students of healthcare professional training faculties or graduate schools.
(iii) Information to be provided for organizing and supporting meetings
The Guidelines list the information to be submitted to the Institution for organizing and supporting the meetings. Information required for both meetings seem to be in parallel with one another. In this respect license/permit holders will have to provide the Institution with the information such as name, location and dates of the meetings as well as the name of the organizer agency and payments to be made to spokespersons.
(iv) Organizational changes and cancelations
- Meeting cancelations: Cancelation of scientific and product promotion meetings should be notified priorly to the Institution by way of submitting an official written letter. - Location changes: Location changes of scientific and product promotion meetings should be notified to the Institution at least three days prior to the meeting date, by way of submitting an official written letter.
- Date changes: For scientific meetings, the Guidelines oblige license holders to apply to the Institution for cancelation of their current application and make a new application for the re-scheduled date of the meeting. However, for product promotion meetings, it is deemed sufficient to notify the Institution at least five days before the meeting date through an official written letter and request permit for a later date.
This article was first published in Legal Insights Quarterly by ELIG, Attorneys-at-Law in September 2016. A link to the full Legal Insight Quarterly may be found here.
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.