Tracking the constantly changing landscape of laws and regulations with which life sciences must comply requires vigilance. Turkey recently made changes to their regulations governing interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs). In addition, Turkey has adopted two distinct transparency reporting requirements. The industry association in Turkey, Arastirmaci Ilac Firmalari Dernegi (AIFD), is a member of EFPIA and has adopted model language for their Code of Conduct, including transposition of the Disclosure Code. The second transparency reporting requirement is to the Ministry of Health. The regulations governing HCP/HCO interactions and transparency reporting were recently updated, and merit an overview to ensure complete data capture and compliance.
HCP/HCO Interactions Amendments
Turkey adopted a new regulation modifying and clarifying rules on promoting medicines for human use and beyond. The regulation went into force on July 3, 2015. Among others, changes to the law include:
- The law now permits the outsourcing of promotional activities from a pharmaceutical company (or market authorization holder, “MA holder”) to third parties. The MA holder must submit a copy of the written contract to the Medicines and Medical Device Authority (TMMDA).
- It decreased the number of scientific events an HCP may attend in a calendar year to four (down from five). A single MA holder is still permitted to sponsor an HCP’s attendance at scientific events two times in a calendar year.
- The new Ministry of Health transparency reporting requirements (see below).
- The regulation introduced new sanctions for violating promotion rules.
However, the regulation preserved certain important interaction rules, including:
- Only physicians, dentists and pharmacists may be informed of a product’s use and side effects. This restriction also covers non-prescription products.
- Medicines not granted marketing authorization in Turkey cannot be promoted. Off-label promotion is also prohibited.
- Healthcare professionals must declare the support they receive from MA holders during their presentations or in their scientific articles.
- MA holders’ donations to HCOs are permitted under certain limited conditions.
- MA holders must notify the TMMDA of their sponsorship for scientific events and the names of the HCPs they sponsor.
- With minor modification, the strict limitations on promotional materials and free samples.
- Product promotion personnel must be trained and accredited by the Authority.
Turkish Transparency Requirements
First, a quick overview of Turkey’s EFPIA reporting requirements since this is the more commonly recognized system being implemented across the EU. The AIFD adopted the disclosure code valid as of January 2015. Companies should be capturing data now, to be reported for the first disclosure deadline, June 30, 2016. These disclosures are due annually. These transfers of value include consulting fees, speaker fees, sponsorships, travel and accommodation, donations, and fees for research & development. Ahead of the reporting deadline, companies must not only capture the necessary data for reporting, but also ensure that they have scrubbed the data to comply with privacy laws and individual consent for reporting. Payments for meals and drinks are not reportable. However, it is not permissible to spend above the given limit of 60€ per person per meal. For these EFPIA/AIFD disclosures, the reports shall be uploaded to a publicly available website controlled by the member company, in Turkish and also preferably in English.
The second, and perhaps less well-known, avenue of required reporting is to the Turkish Ministry of Health (TITCK). This disclosure requirement was adopted as part of the regulation change earlier this summer, and will take effect as of January 1, 2016. Data collected during the calendar year 2016 must be reported by end of June 2017. These reports apply to ALL transfers of value to HCPs and HCOs, above the minimum threshold of 10% of the prevailing minimum wage (including for meals, which are not required in the AIFD/EFPIA report). Much like the French system, the details of the transaction together with the amounts allocated to each transfer of value shall be reported. The reporting will be to TITCK, directly. It has yet to be determined whether the Ministry will subsequently make this data public. In fact, many details regarding implementation are still being ironed out for the TITCK disclosure system.
Knowing about updates and changes to the law is the first step. Ensuring proper implementation and comprehensive compliance is the next. Come talk about what’s next with Polaris. Contact Polaris for business strategy consulting, software solutions, or business process outsourcing to help your company comply with Turkish pharmaceutical and medical device regulations.