On 14 December 2022, the presidential decree numbered 6546 (“Decree”) amending the Decision on Pricing of Medicinal Products for Human Use (“Decision”) was published in the Official Gazette numbered 32043.
With the provisional clause added to the Decision, the effective date of the changes made in real source price or ex-factory price as per Article 10 of the Communique on the Pricing of Medicinal Products for Human Use, was determined to be the publication date of this Decision for the year 2022.
Subsequently, it is regulated that the value of 1 Euro in terms of Turkish lira to be used in the pricing of the medicinal products for human use shall be increased by 36,77% in December 2022. It has been stated that while this increase is being applied, the netting transaction regulated in Article 3/3 of the Decision will not be applied and the said increase will be valid one day after the publication of the Decision. The increase in question will become effective one day after the publication of the Decree.
In subparagraph 3 of the provisional clause, it is regulated that the exchange rate value determined for December 2022 will also be continued to be valid for the year 2023 and no revaluation will be made for the year 2023. As a final note, in accordance with the amendment of the exchange rate, the price scales stipulated in the Decision were updated; the threshold value for price protected products has been determined as TRY 37.10 while it has been determined as TRY 19.39 for other products in line with the change in the exchange rate.
The exchange rate has been updated for the 3rd time this year.
In accordance with Article 2/2 of the Decision which is still in force, the value of 1 Euro in Turkish Lira to be used in the pricing of medicinal products for human use; is determined by multiplying the annual average Euro value, which will be calculated based on the daily Euro exchange sales rate realizations of the Central Bank of the Republic of Turkey, which is indicative of the previous year, announced in the Official Gazette, by the adaptation coefficient determined as 60%. The Price Evaluation Commission meets within the first 45 days of each year and announces the value of 1 Euro to be used in the pricing of medicinal products for human use.
In this regard, on 14 February 2022, the Turkish Medicines and Medical Devices Agency (“Agency”) Price Evaluation Commission raised the Fx rate to be used in pricing of the drugs to be 6,2925 TRY as of 19 February 2022. Afterwards, on 8 July 2022, 1 Euro value in Turkish Lira is increased by 25%. The new Fx rate is to be valid as of 10 July 2022 is TRY 7,8656. With this last change made before the end of the year the value of 1 Euro determined as 10.75 TRY.
It is known that the reference price and fixed exchange rate practice, which has been applied for many years in Turkey, is challenging for all sector stakeholders. Increasing the fixed Euro rate for the 3rd time is some consolation, but it might be considered as not enough. With the new regulation, the provision stating that there will be no revaluation in 2023 is worrying in the face of currency uncertainties and cost increases. On the other hand, we know that changes were made in the Decree in favour of or against pharmaceutical companies in the past years, with the provisional articles in question. Although these amendments are made in order to close the difference between the actual exchange rate realized due to exchange rate fluctuations and the exchange rate applied by the Agency, the frequent adjustments made with the Presidential decisions on the drug prices pose a problem regarding the predictability of the current legislation.
First published by ILO - Litigation Newsletter in 04.01.2023.