With medicines, the rule is clear: The general public cannot be the audience to any promotional activity, whatsoever, of pharmaceutical products. However, with medical devices, the rule in place in the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Medical Device Promotion Regulation”) has caused confusion in the past. The rule states that medical devices that must exclusively be applied by healthcare personnel, and those that are included in the reimbursement scheme of the SSI, cannot be advertised in any manner, whatsoever, to the general public.
Laws that govern medical device companies are becoming more extensive each day, with medical device companies that are members of international associations, as well as local associations, finding themselves governed by the rules of both. Following the rules of ethics and other advertising and promotion rules that are set by both international and local associations can sometimes confuse medical device companies, especially when local conditions beckon the setting of different, sometimes more stringent, rules on member companies.
In Turkey, the provision of sponsorship to HCPs by medical device companies for the purpose of congressional attendance is regulated with the Medical Device Promotion Regulation that provides a system in which HCPs are subject to annual quotas for support, and companies are required to notify the HCPs of such sponsorships. Therefore, Turkish medical device companies, as members to MedTech Europe, implemented a new sponsorship model as of the beginning of 2018. As the MedTech Code requires indirect sponsorship, and local regulations require the notification of the HCPs by the companies, the member companies ceased to initiate the communication for sponsorship, and offered HCPs the sponsorship. The selection of HCPs is made by HCOs (associations, non-profit organizations, hospitals). The names are obtained, and the quotas are checked, while notifying the TITCK. Thus, both systems may be applied without breaching the local Regulation and the spirit of the MedTech Code.
The industry now expects the publication of a new Promotion Regulation that will introduce new rules and, as well, amend some of the rules with respect to the advertising of medical devices.