On 5 November 2018 the Medicines and Medical Devices Agency, the regulatory authority for pharmaceuticals and medical devices in Turkey, published an announcement on its website entitled "Announcement for Medical Device Sales Centres Supporting Scientific Meetings and Educational Activities".
The announcement clarified that the agency's information management system for medical devices (currently the product tracking system and formerly the national databank for pharmaceuticals and medical devices) will be updated as of 9 November 2018.
The Medicines and Medical Devices Agency is responsible for the licensing and registration of and all promotional and advertising activities concerning pharmaceuticals and medical devices in accordance with the relevant legislation. The agency is an affiliate of the Ministry of Health.
A real or legal person which wants to import or sell medical devices must be authorised by the local health authority (referred to as provincial health directorates) as a medical device sales centre by providing a petition and proper documentation, including the sales centre's address, its trade name and information about the centre's ownership. The petition must also include:
- details of service agreements with the sales centre's managers where the sales centre operator is not the responsible manager;
- documentation concerning responsible managers, sales or promotional personnel or clinical support personnel, if any; and
- other regulatory approvals (eg, workplace permits and other corporate documents).
The operating principles for sales centres are strictly regulated under the Regulation on the Sale, Advertisement and Promotional Activities of Medical Devices 20991/2014. Accordingly, sales centres must:
- store devices in line with the producer's instructions or international standards;
- register devices sold in the Medicines and Medical Devices Agency's information system;
- maintain records relating to their activities, infrastructure, devices and personnel;
- ensure that personnel are trained appropriately;
- have a qualified responsible manager present;
- not direct users to health organisations or physicians; and
- adhere to any other relevant legislation.
The regulation determines that some devices cannot be advertised to the public directly or indirectly – namely, devices to be used solely by healthcare personnel or those under the scope of repayment by the Social Security Institution. The regulation also includes:
- basic principles for promotional activities;
- the support terms that sales centres must provide to healthcare professionals or relevant personnel regarding scientific meetings and educational activities; and
- other terms in the relevant guidelines, as examined below.
Regulation of support for scientific meetings
The Announcement for Medical Device Sales Centres Supporting Scientific Meetings and Educational Activities clarifies that the principles and procedures regarding the sale and advertisement of and promotional activities for medical devices are regulated under Article 21 of the Regulation on the Sale, Advertisement and Promotional Activities of Medical Devices.
In addition, the rules regarding the support provided by medical device sales centres to scientific conferences and educational activities organised to provide existing or new information to healthcare professionals or technical personnel working in the field of medical devices employed by health institutions and organisations is detailed in the Guidelines Regarding Scientific Meetings and Educational Activities Conducted Within the Scope of the Regulation on Sales, Advertisement and Promotion Activities of Medical Devices.
Article 21 of the regulation sets out the obligations for medical device sales centres regarding the sale and advertisement of and promotional activities relating to medical devices, while Article 28 sets out the administrative penalties for violation of these obligations. The aforementioned update to the agency's information management system concerns the implementation of these penalties.
Article 21 of the regulation also stipulates that sales centres can support healthcare professionals or technical personnel who work in the medical devices field and are employed by health institutions and organisations for their attendance at scientific meetings in Turkey or abroad (eg, congresses or symposiums) in accordance with the conditions defined therein. Accordingly, alongside other obligations, such meetings must concern the attendees' area of expertise. Such personnel can benefit from said support four times per year, but this support can be provided by the same sales centre or be used abroad only twice. Support is provided to the organisations that organise the scientific meeting and information on the personnel supported is notified in the format determined by the agency.(1)
Latest update to information management system
Article 28 of the regulation was adapted in 2015 to include penalties for the violation of Article 21. Accordingly, it was determined that medical sales centres in breach of the aforementioned article would be initially warned by the agency. In the case of a subsequent breach within the year following such warning, the sales centre would be prohibited from conducting 'promotional activities', as defined under Article 21, for three months. If said sales centre repeats its violation of Article 21 within the year following the three-month prohibition, it will be prohibited from attending or supporting scientific meetings and educational activities for one year.
The Announcement for Medical Device Sales Centres Supporting Scientific Meetings and Educational Activities has clarified that in the case of failure to meet the agency's notification obligations, penalties will be applied automatically and will be notified to the penalty through an official letter.
Given the publication of the Announcement for Medical Device Sales Centres Supporting Scientific Meetings and Educational Activities and the automatic penalties regulated therein, medical device sales centres must assess the Medicines and Medical Devices Agency's obligations carefully in order to avoid any potential penalties as of 9 November 2018.
Some medical device manufacturers whose products are sold in Turkey prefer not to establish their own sales centres and instead sell their products via distributors or importers. These manufacturers should ensure that clauses reflecting the obligations on sales centres are included in agreements between them and the relevant sales centres. It is also important to address liabilities from promotional activities to ensure the safe transfer of business or assets in potential transactions involving medical devices. Finally, it is critical for manufacturers looking to enter into the Turkish market or establish partnerships with existing sales centres to be sufficiently aware of their obligations and the potential penalties for breaches of said obligations.
For further information on this topic please contact E Sevi Firat or Ata Umur Kalender at Firat Izgi Attorney Partnership by telephone (+90 212 235 25 25) or email ([email protected] or [email protected]). The Firat Izgi Attorney Partnership website can be accessed at www.firatizgi.com.
Endnotes
(1) Due to its relevance to the subject matter, some obligations under Article 21 of the Regulation on the Sale, Advertisement and Promotional Activities of Medical Devices have been summarised in this article. To view all obligations that medical device sales centres and other persons must adhere to, please see the full text of the regulation.
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