Recent Development

The Turkish Council of Ministers recently published a decision regarding the amendments to the pricing rules on medicinal products for human use ("Pricing Decision").  

The Pricing Decision provides that the monetary value of 1 euro in Turkish lira used in the pricing of medicinal products for human use in 2018 cannot exceed 15% of the monetary value of 1 euro used in the previous pricing period.  

In light of the decision, the Turkish Medicines and Medical Devices Agency ("TİTCK") set the monetary value of 1 euro used in the pricing of medicinal products for human use for 2018 as TRY 2.6934 and updated the other monetary values accordingly.  

The amendments entered into force on February 19, 2018.

Background

Under the Communiqué on the Pricing of Medicinal Products for Human Use that entered into force on September 15, 2017, Turkey uses a source pricing system for medicines for human use. The source price is determined based on the euro. The TİTCK's Price Assessment Commission determines and announces within the first 45 days of each year the equivalent monetary value of 1 euro in Turkish lira used in the pricing of medicinal products for human use.

Conclusion

Companies should review the new Pricing Decision, follow the TİTCK's upcoming announcements and take the necessary steps to ensure compliance with the decision.