The framework for pricing of pharmaceutical products in Turkey
is set by the Council of Ministers decision numbered 2007/12325
published in the Official Gazette on 30.6.2007 and numbered 25568
(last updated on 04.12.2009) ("Decision"). The
Pharmaceutical Pricing Decree published in the Official Gazette on
22.9.2007 and numbered 26651 (last updated on 11.06.2010)
("Decree") lays down the grounds for the implementation
of the pharmaceutical pricing system in further detail.
The below overview aims at providing general information
regarding the pharmaceutical pricing system in Turkey.
The pricing system is primarily based on the reference prices of
the relevant pharmaceutical product in the reference countries
declared annually by the Turkish Ministry of Health
("MoH"). The MoH can declare at least 5 and at most 10
European Union countries (including countries which are on the path
to membership) as "reference countries". Currently, the
reference countries are France, Italy, Spain, Portugal, and
The MoH determines the prices of both original and generic
pharmaceutical products based on the "reference price",
namely; the official lowest sale price to wholesalers, (excluding
VAT and discounts) of the original product which is registered and
sold in the market amongst the reference countries.
In the event the country of manufacture (batch release) or
import of the relevant product is not one of the reference
countries (or the EU countries), and there is an officially
declared lower sale price to the wholesalers at this country, the
sales price of the country of manufacture/import shall be accepted
as the reference price.
The Decree stipulates various calculation and
proportionalization techniques for specific circumstances where the
general rules need to be interpreted to effectively determine the
Following the initial license registration of a product, the
license holder needs to apply to the MoH with the price declaration
form and supporting documentation for the determination of the
price. The relevant transaction shall be conducted in the light of
all information and documents submitted by the relevant company to
Applications for receiving an initial price shall be concluded
within 60 days. This period may be extended by 30 days depending on
the work load of the administration. Price related applications
other than the initial pricing shall be finalized within 10 days.
The price is set based on the information provided by the license
The license holder is liable for the accuracy of the information
provided to the MoH. Furthermore, the license holder is clearly
held liable to duly inform the MoH regarding the reference prices
and the decreases. The MoH at its discretion may control the said
price information through the use of the national or international
data bases and through official inquiries.
In the event the license holder does not act in accordance with
the above mentioned declaration liabilities, the relevant
provisions of the Turkish Criminal Code shall be applied and the
public loss arising from the violation shall be collected by the
Ministry of Finance and the Social Security Institution. In
practice, the questions in the implementation of the system are
attempted to be settled through contacts with the MoH without
resort to legal recourse.
Once the sales price to wholesalers is determined, wholesalers
and pharmacy sales prices are calculated based on a progressive
scale of respective profit also fixed by the Decree.
The pharmaceutical pricing system in Turkey is complex and the
subject of great controversy. The Social Security discount and
public procurement systems also have an important impact on the
pricing of pharmaceuticals, which are also very detailed.
Consequently, the pricing system has undergone numerous changes in
the past 7 years within the Turkish government's health reform.
The most recent changes to the legislation adopted in 2010 have
adjusted the implementation, aiming for further clarity.
Undoubtedly, these changes will not be the last.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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