Turkey has adopted a new regulation modifying and clarifying rules on promoting medicines for human use and beyond. With limited exception, the new regulation entered into force on July 3, 2015.
What the regulation says
- Extended scope
The new regulation extends the promotion rules beyond medicines for human use to include enteral nutrition products and medical infant formula.
- Modified rules
The regulation defines several previously undefined terms used in the regulatory framework. These include definitions for pharmaceutical companies' science services, scientific events and product promotion events.
The regulation permits outsourcing promotional activities, resolving a recent debate over whether the outsourcing of promotional activities was indeed permitted. To outsource these activities, the marketing authorization ("MA") holder should submit an executed written agreement with the outsourcing provider to the Turkish Medicine and Medical Devices Authority ("Authority"). Outsourcing does not reduce the MA holder's liability for violating promotion rules.
Unlike the previous regulation, the new regulation prohibits informing healthcare professionals other than physicians, dentists and pharmacists of a product's use and side-effects.
The number of scientific events a healthcare professional can attend in a calendar year with MA holders' sponsorship has been decreased from five to four. A single MA holder is still permitted, however, to sponsor a healthcare professional's attendance at events twice in a calendar year.
As of January 1, 2016, MA holders will be required to notify the Authority of transfers of value exceeding 10% of the gross minimum wage (i.e., over TRY 120.15 for 2015).
The regulation introduces new sanctions for violating promotion rules. Sanctions include a temporary ban from promotional activities, suspension of product promotion personnel licenses, and a temporary ban from sponsoring and participating in scientific and product promotion events.
An important change involves sanctions for repeat violations. Previously, repeat violations — no matter when they occurred — increased sanctions: a warning for the first violation, a three-month ban from promotional activities for a repeat violation, and a one-year ban from promotional activities for further violations, without regard to the amount of time between each violation. With the new regulation, repeating a violation after a one-year lapse will not result in increased sanctions.
- Preserved Promotion Rules
Medicines may still only be promoted to physicians, dentists and pharmacists. This restriction covers non-prescription products, similar to the previous regulation.
Medicines not granted marketing authorization in Turkey cannot be promoted. Off-label promotion is also prohibited. These prohibitions do not apply to promotional activities during international congresses organized in Turkey or conducted at the written request of a healthcare professional.
Healthcare professionals must declare the support they receive from MA holders during their presentations or in their scientific articles.
MA holders' donations to healthcare institutions are permitted under certain limited conditions.
MA holders must notify the Authority of their sponsorships for scientific events and the names of the healthcare professionals they sponsor. Sponsoring scientific events held on beachfront property or in ski resorts during high season is prohibited, except for international scientific events organized in a different country every year.
Strict limitations on promotional materials and free samples are preserved, with slight modification.
Product promotion personnel must be trained and accredited by the Authority.
Actions to consider
Companies selling or promoting enteral nutrition products and medical infant formula must take immediate action to comply with the new regulation. We recommend introducing policies on interactions with healthcare professionals and promotional activities, as well as training sales and marketing teams.
Pharmaceutical companies may now consider outsourcing their promotion activities. Since outsourcing does not remove the MA holder's liability, outsourcing contracts must be well-drafted to ensure recourse mechanisms and legal safety for the outsourcing company.
Pharmaceutical companies should also develop compliance rules and notification mechanisms for transfers of value.
We recommend that pharmaceutical companies undertake a full revision of internal policies on interactions with healthcare professionals and promotional activities.
As part of the evolution of Turkish healthcare regulations, the new regulation significantly changes the legal framework for promoting medicines, and now covers enteral nutrition products and medical infant formula. Further changes to pharmaceutical and medical device regulations are expected, including modifications to pricing rules and an OTC regulation.