Pricing
This article was originally published in SRA
Executive Summary
New pricing scheme for human medicinal products in Turkey
New pricing scheme for human medicinal products in Turkey
The Turkish Ministry of Health has issued a communiqué that amends the pricing scheme for human medicinal products in the country1. Under the new system, the units of raw material(s) in each pharmaceutical form of the original product will be evaluated separately. Previously, the unit amount in the drug package was not taken into consideration. The new scheme came into effect on 16 May 2005.
Proportioning
Units of raw material in the same form and in different packages shall be proportioned. In other words, when pricing the drug, proportioning will be based on the product with proportionally cheapest price, and the proportioning will be applied starting from the smallest package. For example, from among the following forms, the cheapest one (ie 10mg/10 tablets at €10) shall be taken as the basis for the proportioning: 10mg/5 tablets at €7; 10mg/10 tablets at €10; and 10mg/20 tablets at €30. The prices of larger packages will be calculated in proportion and the prices of smaller packages shall not change (a price of €20 shall be designated as the reference price). The price approved for one product form shall also be taken as the proportioning price for other forms of this product to be registered subsequently.
Original products
Pricing of original products will be calculated based on ex-factory prices in reference countries; if the product does not exist in the reference countries, the other EU countries in which the price of the referred original product is the cheapest shall be taken as the basis. Because of currency differences, such prices must be approved by the Turkish Foreign Ministry Representative in the related country or by the Public Health Authority of the country where Turkish Foreign Ministry has no Representative. Furthermore, a Declaration Form for Pharmaceuticals for Human Consumption must be completed and submitted to the ministry after converting the ex-factory price into Turkish currency based on the foreign exchange rates of the Turkish Central Bank on the date of the application.
If any pharmaceutical form of the relevant product (except for forms with modified effect) was been launched 20 years ago (or more) and has lost its originality, the new price will be determined upon adding the new profit rates to the current ex-factory sales price to these products.
Generic products
The price of generic products shall not exceed the reference price of the original product. Moreover, it shall not exceed the price of the highest-priced generic product if there are other generic versions of the same product on the market. If there are other generic versions on the market whose price exceeds the price of the original product, the price of the generic must be adjusted so that it does not exceed the price (in Euros) of the original product that was in effect on 15 June 2004.
Rebates
The rebates to be requested by companies for any form of their products shall not be implemented on the other forms of the relevant product without the submission of a separate application.
MELEK BOSTANC? ÖNOL
References
1. Turkish Ministry of Health communiqué, Official Gazette No 25799, 28 April 2005