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Turkey Revises Pricing Rules on Medicinal Products for Human Use – October 2017

Legal Alerts
Healthcare
General

Recent Development

The Ministry of Health (“MoH“) Communiqué on the Pricing of Medicines for Human Use (the “Pricing Communiqué“) entered into force on September 15, 2017, repealing the previous communiqué of June 15, 2015.

The new Pricing Communiqué sets out the implementation principles of the Council of Ministers ‘ Decision No. 2017/9901 on the Pricing of Medicines for Human Use (the “Pricing Decision“) of February 6, 2017.

What the Pricing Decision and Communiqué Say?

The Pricing Communiqué essentially parallels the amendments introduced in the Pricing Decision:

  • Under the Pricing Decision and Pricing Communiqué, the term “reference price” was replaced by “source price.”
  • The Pricing Decision and Pricing Communiqué introduced the term “price-protected products” for products first introduced to the market before August 1, 1987.
  • The new Pricing Decision introduces amendments to the pricing system:​
    • The previous wholesale price thresholds were set at TRY 3.84 and TRY 7.32, and were utilized to determine the actual source price percentage. These figures increased to TRY 4.24 and TRY 8.09, respectively.
    • A new method for the readjustment of wholesale prices if there is a decrease in the actual source prices of medicinal products. The determinants of actual source price percentage (corresponding to the foreign exchange value of the wholesale price) are the percent increase of the actual source price and the first base value of the medicinal products.
  • The Medicine Price Evaluation Commission was granted the authority to determine the prices of the products for which the prices cannot be determined based on the provisions of the Pricing Decision.
  • The newly coined term “price declaration certificate” is defined as an apostilled certificate or certificate approved by the Ministry of Foreign Affairs. The price declaration certificate replaces the previous “apostilled certificate” submitted during the application procedure.  In addition to the apostilled certificate’s content, the price declaration certificate must also include ex-factory costs, status of marketing authorization, reimbursement, market availability in the source countries, and price of products in source countries where the country utilizes its own currency.

Background

Turkey uses a source pricing system for medicines for human use. A medicine’s “source price” is the lowest price of the sale-to-warehouse prices in (i) the five EU reference countries (France, Spain, Italy, Portugal and Greece); (ii) the countries where the product series are released in or from which the product series are imported; (iii)  the EU countries where the product was released into the market; or (iv) the ex-factory price of the product in any country in the world,  if the product received marketing authorization and is genuinely sold in these countries.

Conclusion

The TİTCK continues to demonstrate its commitment to providing comprehensive guidelines for companies engaged in medicinal products for human use. Companies should take note of the new updates and take the necessary steps to ensure compliance.