The long awaited The Regulation on the Sales, Advertisement and Promotion of Medical Devices ("Regulation") that has banned the advertisement to the public of some categories of medical devices has been published in the Official Gazette dated May 15, 2014 and has thus come into force as of the date of publication1.
The fact that the Turkish Pharmaceutical and Medical Device Institution cooperated with the stakeholders within the industry during the preparation stage of this Regulation and as the opinions submitted pursuant to previous drafts have been taken into account, the Regulation was not viewed as a surprise within the industry. On the other hand, the provisions of the Regulation are fairly remarkable for many countries, particularly those in the EU, that do not have detailed regulation in these areas.
The most important provision introduced by the Regulation is the fact medical devices that must be used and administered by Healthcare Providers (HCP) and medical devices that are within the scope of reimbursement cannot be advertised to the public. Additionally, in relation to the Ministry of Health restrictions on promotion applied specifically to pharmaceuticals, provisions relating to the maximum monetary value applied to reminder promotions given to HCPs, quotas relating to the amount of congress sponsorships HCPs can make use of every year and the obligations of transparency and notification are now also applicable for medical devices. It has been envisioned for the places engaged in the distribution and sales of medical devices to be documented as "sales centers", and for the qualified persons that must be present in these sale centers being jointly liable along with the operator regarding the operations falling within the scope of the Regulation.
The provisions introduced by the Regulation relating to the sales, advertisement and promotion activities of medical devices and the real or legal persons engaged in these activities can be summarized as below.
1. Provisions Relating to the Distribution and Sales Channels of Medical Devices
The places where medical devices are distributed or sold have been defined as "sales centers" and these sales centers have held liable for all of the responsibilities introduced by the Regulation.
The Regulation envisions the authorization and auditing by the Ministry of Health of the places engaged in the distribution and sales of medical devices, in a similar way to the system applied to pharmaceuticals. In order for these sales centers to operate, they will need to have the "Authorization and Work Certificates" that are granted upon application to the Ministry of Health.
Sales centers that have been open since before the date of publication of the Regulation shall be able to continue operating on the condition that they receive the correct documentation as per the provisions of the Regulation within eighteen months of the date of publication of the Regulation. Places of work that do not receive the authorization certificate within this time will be shut down by the local health authorities.
Sales centers are obligated to employ a qualified person that satisfies the conditions stated in the provisions of the Regulation. In addition to the qualified person, each sale center must employ a sufficient number of clinical support personnel as required by the operations of the sale center and at least one sales and promotion representative. In order for permission to be granted for the operations of the personnel of the sales centers consisting of the qualified person, the sales and promotion representative and the clinical support staff, they must successfully complete the training determined by the Ministry and receive their work certificates.
Opticians, prosthetics and orthesis centers and hearing aid centers are kept outside of the scope of Regulation and are thus not liable for the responsibilities introduced by the Regulation. However, the advertisement and promotion activities of the devices sold in these places have been included within the scope of the Regulation.
2. Provisions Relating to the Advertisement and Promotion Activities of Medical Devices
The Regulation has made a clear distinction between the advertisements to the public of medical devices and the promotion of medical devices to HCPs and to technical staff working in the medical device field who are employed by healthcare institutions and organizations. The scope and fundamental principles of both activities have been stated separately in the provisions of the Regulation. A basic distinction made between devices that are exclusively used or administered by HCPs and devices that are intended for personal use also stands out.
a. Advertisement to the public
Medical devices that have to be used or administered by HCPs and devices within the scope of reimbursement cannot be advertised to the public in any way, either directly or indirectly. The advertisement of devices that are intended for personal use and are not within the scope of reimbursement is allowed.
The advertisements for medical devices that are within the scope of the aforementioned allowed devices cannot be in a form that will constitute unfair competition, be contrary to the truth, be misleading, be exaggerated or be based on information that has not been verified.
b. Promotion Activities
Promotion activities cover the promotion of the medical devices that fall within the scope of the Regulation, to HCPs and to technical staff working in the medical device field who are employed by healthcare institutions and organizations and the activities aimed at informing these people on subjects such as operating manuals. Technical support services and clinical support services are not regarded to be within the scope of promotion activities.
It can be seen that the rules and principles introduced that relate to promotion and relationships with HCPs, such as those relating to promotion materials, scientific activities and sponsorships, free samples and donations, are very similar to the established rules and principles applied to the pharmaceutical sector. Consequently, provisions that come from pharmaceutical practices and are significant for being unique to Turkey, such as a maximum monetary value applied to reminder promotions given to HCPs, quotas relating to the amount of congress sponsorships HCPs can make use of every year and the obligations of transparency and notification are now also applicable for medical devices.
It can be said that an essential matter that differs from pharmaceutical practices is the persons and institutions that are authorized to conduct promotion activities. While in the pharmaceutical industry promotion to HCPs can only be done by the license holder, in the area of medical devices the aforementioned promotion activities can also be conducted by distributor companies and re-sale companies that are engaged in wholesale and retail sales that fall under the definition of "sales center".
An obligation has also been placed on sales centers to provide training after sales. In the situation that a sales center has sold a device requiring user training, they are obligated to provide training to HCPs, technical staff working in the medical device field who are employed by healthcare institutions and organizations and real persons during and subsequent to the delivery of the device and document said training.
3. Audit and Inspection
To ensure the sales centers' compliance with the provisions of the Regulation, a compulsory audit and inspection system taking place once every two years has been introduced. The sales, promotion and advertisement activities conducted in the sales centers and all kinds of materials and methods used for these activities are subject to audit and inspection.
In the situation that nonconformity with the provisions of the Regulation is determined following an audit, sanctions such as the temporary suspension of the activities of the sales center or the indefinite shutting down of the sale center maybe applies. In the case that a sales center is shut down indefinitely, it is stated that the authorization certificate will be cancelled and no authorization certificate shall be issued again to the relevant real or legal person within a period of two years.
As the Regulation introduces provisions regarding areas of the medical device sector that have previously not been regulated, it is advisable for medical device companies operating in the Turkish market through affiliates or distributors to review and revise their procedures currently applied in the scope of these areas, in light of these new provisions.
1. The application of Article 21 relating to Scientific Educational activities has been postponed to one year after the date of publication.
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