With medicines, the rule is clear: The general public cannot be the audience of 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”) notes more confusing regulation. The rule states that medical devices that are sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthotics centers, or optician institutions or dental prosthesis laboratories, must exclusively be applied by healthcare personnel, and cannot be advertised in any manner, whatsoever, to the general public.
By making a detailed amendment in the Medical Device Promotion Regulation on 2 September 2020, restrictions on medical device sales and advertising activities, notifications for personnel changes and sanctions were rearranged.
The advertising of:
i. Devices that are sold, adapted, or implemented, only in hearing aid centers, tailored prosthetics and orthotics centers, opticians or dental prosthetics laboratories;
ii. Devices that are intended to be used or implemented, exclusively by healthcare professionals, or that require implementation in medical device sales centers;
addressed to the consumer, is prohibited.
The advertising of:
iii. Devices other than these devices, only in the internet environment where the device is sold, addressed to the consumer;
iv. Devices included in Annex-3, without limitation;
However, the term “internet environment” is not defined in the Regulation in the Article regulating advertising. For this reason, it is not clear whether the advertisement can only be made from the website where the sale is made or from the page where it is located, or whether it can be made by redirecting the advertisement to the site where the sale is made with another website.
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, in the meantime, local regulations require notification of the HCPs by the companies, the member companies ceased to initiate the communication for sponsorship with the HCPs and offering HCPs to be their sponsors. 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 and, thus, both systems may be applied without breaching the local Regulation and the spirit of the MedTech Code.
In parallel with the pharmaceutical legislation, regulations have been made in the medical device promotion legislation within the scope of COVID-19 measures. Especially in this process, regarding scientific and educational activities in the form of web-based meetings, the “Guidelines on Scientific Meetings and Educational Activities to be Held within the Scope of the Medical Device Sales, Advertising and Promotion Regulation” has been updated by adding the provisions regarding web-based meetings.
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.