Ending much confusion and uncertainty among medical device companies, the Turkish Medicines and Medical Devices Authority has finally adopted a Regulation on the Sales, Advertisement and Promotion of Medical Devices. The Regulation entered into force May 15, 2014, establishing concrete rules and eliminating previous regulatory ambiguities.
What the Regulation says
The Regulation includes detailed rules on the advertising and promotion of medical devices, sales center staff, scientific events, donations, free samples and other matters. Below are some highlights:
• Scope of the Regulation
The Regulation covers the sale, advertisement and promotion of medical devices, implantable medical devices, and in-vitro diagnostic medical devices. It does not, however, apply to optical stores, prosthetic and orthotic stores selling made-to-order products, and hearing aid centers, all of which are covered by other regulations.
• Sales Centers
To become an authorized medical device sales center ("Sales Center"), an applicant must submit the documents listed in the Regulation to the local health authorities.
• Sales Center working principles
The Regulation prohibits Sales Centers from (i) directing users to any particular health care institution or physician; (ii) soliciting users from health care providers or physicians through promotions; or (iii) serving as intermediaries for users. All promoted devices must be registered with the Medical Devices Authority.
Sales Centers must stop selling any device the Medical Devices Authority declares unsafe or noncompliant, and must return these products to the manufacturer/importer.
• Sales Center staff
Sales Centers must employ a manager with the qualifications listed in the Regulation. The manager cannot be the head of staff at more than one Sales Center, and must report any negative feedback on a device to the importer or manufacturer.
Sales Centers must employ a sufficient number of sales and promotion and clinical support personnel. Sales and promotion personnel are required to have the qualifications listed in the Regulation, obtain work permits from regional health authorities and register with the Medical Devices Authority. They can only distribute promotional materials to health care professionals ("HCPs"), health care institutions' medical devices technical staff ("Medical Device Personnel") and other Sales Center employees. They have the duty to report negative feedback on medical devices to the manager in charge. Clinical support personnel must have the qualifications listed in the Regulation and work permits issued by regional health authorities, and they must be registered with the Medical Devices Authority.
Medical devices that can only be operated by HCPs and those on the Social Security Institution's reimbursement list cannot be advertised to the public. Ministry of Health-authorized periodicals targeting HCPs and information on Sales Centers' websites are exempt from this prohibition.
Promotion is defined as providing information to HCPs and Medical Device Personnel. This can be done through brochures, symposiums, meetings or personal visits. The Regulation includes detailed rules on permitted promotional activities.
The Regulation also provides a detailed list of permitted promotional materials. For instance, reminder items must have a value of less than 2.5% of the minimum gross salary, currently TRY 26.77 (approx. USD 13).
• Scientific events
Sales Center sponsorship of HCP participation in scientific events is subject to a number of conditions. For instance: (i) meetings must be related to the HCP/Medical Device Personnels' areas of expertise; (ii) HCPs/Medical Device Personnel can be sponsored for no more than three events a year, with no more than two events by the same Sales Center and two events abroad; and (iii) the sponsorship must go to the organizations hosting the meeting and not directly to HCPs/Medical Device Personnel. The Sales Centers must inform the sponsored HCPs/Medical Device Personnel to the Medical Devices Authority. No meeting can be held or sponsored at seacoast or ski centers during high-season, except for international congresses regularly held in different countries.
The rules on sponsoring scientific events enters into force a year from now, on May 15, 2015.
• Providing benefits
The Regulation prohibits granting benefits or incentives to HCPs and Medical Device Personnel to incentivize prescribing, using, buying or recommending a medical device.
A Sales Center can donate to public or non-profit health care institutions provided a number of conditions are met, including prior approval from the authorities, and properly recording the donation in its books and records. The donation must also not influence decisions relating to public tenders or result in unethical behavior in connection with the sale of medical devices. Donations must also be intended for general use, not a specific individual.
• Free samples
Only medical devices conforming to Turkish technical requirements can be given as free samples. Sales Centers must retain data on the free samples distributed. The free sample packaging must state "free promotional sample, not for sale." The value of the free sample cannot be more than 2% of the device's turnover for the previous year; this restriction, however, does not apply to first year placement on the market.
Manufacturers can donate free medical devices and accessories that are necessary for the use of medicines (e.g., infusion pumps, injection needles, catheters); these are not regarded as free samples.
• After-sale trainings
Sales Centers must train HCPs and Medical Device Personnel on those medical devices requiring training to use them, and document this training.
• Audits and sanctions
The local health authorities are obligated to audit Sales Centers at least once every two years.
Violations of the Regulation may result in suspension or revocation of Sales Center authorization certificates or work permits, as well as criminal sanctions, if applicable.
Actions to consider
Medical device companies are recommended to revise their policies to ensure compliance with the Regulation.
It is also recommended to ensure that authorized resellers comply with the Regulation to avoid any disruption in the distribution chain.
Medical device companies must also follow the Medical Device Authority's upcoming guidelines on the Regulation's implementation.
In the absence of a regulation on the promotion of medical devices, the Turkish Pharmaceutical Promotion Regulation has been relied on for guidance; many medical device companies have been using these rules as a point of reference when establishing and localizing their promotion policies and codes of ethics. Now, with the new Regulation, rules specifically designed for medical devices, promoters and promotional materials provide much needed clarity as to what is permitted. The upcoming guidelines are expected to further assist medical device companies in adopting compliant policies.