Promotion of medical devices - limited interactions with limited audience

The phrase “promotion” can be interpreted differently depending on the context, but when it comes to the promotion of medical devices, the playground is rather restricted. Public welfare is no doubt the priority in the promotion of medical devices, and the regulations are put in place with this focus rather than anything else. The Regulation on the Sale, Advertisement and Promotion of Medical Devices (the “Regulation”), the Guidelines on the Implementation of the Regulation on the Sale, Advertisement and Promotion of Medical Devices, and the Guidelines on Scientific Meetings and Educational Events published by the Turkish Medicine and Medical Devices Authority (“Authority”) set forth a framework in respect of the promotion of medical devices, whereby the boundaries of what should be considered as promotion and what would be considered as incentive (which cannot be tolerated) are clarified.

In General
Within the scope of the limitations applicable to the promotion of medical devices, these activities can only be performed by authorized sales personnel, and the target audience can only be healthcare professionals and technical personnel (collectively “HCPs”). HCPs cannot be enticed, offered or promised benefits of any kind or be encouraged to recommend a specific medical device to patients. Promotion itself cannot be misleading, exaggerated or be made in a manner to harm or risk human health or create unfair competition. Promotion of medical devices through lottery and similar games of chance are also forbidden. It is of utmost importance to ensure that HCPs are well informed of the device and to allow for HCPs to come up with their own conclusions as to the medical value of the device.

Specific Limitations
Promotion of medical devices are mainly done by way of (i) publications, (ii) scientific meetings, (iii) educational events and visits to HCPs and (iv) provision of promotion materials and product samples; each of which is subject to their specific do’s and don’ts under the Regulation.

Scientific Meetings. Scientific meetings are held for the purpose of presenting and discussing already available or new information regarding medical devices. Sector players can sponsor HCPs and technical personnel for attending scientific meetings provided that the meeting is related to the HCP’s area of expertise. An HCP can be sponsored for a maximum of four meetings in a calendar year, and the same entity can sponsor an HCP for a maximum of two times in a calendar year. Medical device companies are allowed to cover reasonable expenses of HCPs as well as general expenses of the scientific meeting. Registration, accommodation and travel costs should be paid directly to the organization holding the meeting rather than to the HCP. Organization of or sponsorships for meetings during high seasons at ski and seaside locations are banned. The location of the meeting should in any case be determined by taking into account the purpose of the meeting. In addition, prior approval of the Ministry of Health (the “Ministry”) must be obtained for the meeting and a post-meeting notification must be submitted to the Ministry.

Educational events. Educational meetings are mostly organized or sponsored by medical device companies and should last no longer than a day. HCPs may again be sponsored to attend these provided that the meeting is related to the HCP’s area of expertise. In case the event is organized by a medical device company, HCPs cannot be sponsored for accommodation, travel and registration expenses. If the sponsor of the event is a third party (i.e., not a medical device company), the content of the event should be set without the involvement of medical device companies, except that the companies may propose speakers or share views regarding the content. Again, the prior approval of the Ministry must be obtained for the meeting and a post-meeting notification must be submitted to the Ministry.

Promotion materials and free samples. Sector players can provide HCPs (i) promotion materials such as pens, notebooks, publications or booklets and display products and (ii) free samples which can only be provided for improving of health services rendered to patients, educating HCPs with regard to the product and ensuring or facilitating safe and effective use of the product. Value of promotional materials cannot exceed 2.5% of the applicable minimum monthly gross salary, and total monetary value of free samples cannot exceed 2% of the previous year’s sales turnover of the relevant medical device company. In addition, the free sample should bear the phrase “free sample not for sale” and records relating to the provision of the free sample should be kept for five years. Gifts are only allowed if (i) they are relevant to the medical practice of the HCP and (ii) they are either beneficial to patients or are considered as educational materials. Meals can be also provided to HCPs to the extent they are offered within the scope of a consultancy arrangement, scientific meeting or educational event, and the associated cost is reasonable.

On a final note, to serve for the purpose of digitalization of promotion of medical devices throughout the Covid-19 outbreak, the Authority has revised and published a new version of the Guidelines on Scientific Meetings and Educational Events on 12 February 2021, which addresses web-based meetings. Accordingly, medical device companies can now bear expenses for establishing an online system for webcast and can enable access to the relevant HCPs only.

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