Amendments have been introduced in Turkey for determining prices, prices changes and reference price changes regarding human medicinal products. The Council of Ministers’ Decree for Amending the Decree on Pricing of Medicinal Products for Human Use (“Amendment Decree”) was published in Official Gazette number 29631 on 21 February 2016, entering into effect on the same date.

The Amendment Decree makes changes to the Decree on Pricing of Medicinal Products for Human Use, dated 15 June 2015 and numbered 2015/7752 (“Decree”).

Changes introduced by the Amendment Decree include:

  • The price of products which have been a reference product for 20 years and whose warehouseman’s sale price is above a certain value, cannot exceed 80% of the reference price. Under the Amendment Decree, the relevant value increases from TRY 6.93 to TRY 7.32.
  • The price list prepared by the Turkish Medicines and Medical Devices Agency (“Agency”) is used when determining warehouseman’s sale prices. The sale prices to the current warehouseman will be used as the reference price if there is no reference price for products that are 20 years old and whose warehouseman’s sale price is above a certain value, according to the price list. Under the Amendment Decree, the relevant value increases from TRY 6.93 to TRY 7.32.
  • Prices can be set independently from the Decree for products which are approved as medicines and are more than 20 years old (as per the Council of Ministers’ Decision dated 6 February 2004 and number 2004/6781) and whose warehouseman’s sale price is a certain value or less. Under the Amendment Decree, the relevant value increases from TRY 6.93 to TRY 7.32.
    Prices can also be set independently from the Decree for products that have a warehouseman’s sale price that is below a certain value. Under the Amendment Decree, the relevant values increases from TRY 3.63 to TRY 3.84.
  • Approved warehouseman’s sale prices which may result from reference price or reference state changes will not be reflected in prices until the changes exceed 3%.
  • If an amount in the Agency’s price list is voluntarily reduced, the updated price will apply without being subject to the statutory 60 day wait-period in certain circumstances. Price corrections by the Agency are introduced as one of these circumstances.

Please see this link for the full text of the Amendment Decree (only available in Turkish).

Information first published in the MA | Gazette, a fortnightly legal update newsletter produced by Moroğlu Arseven.