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Yıl:2009; Cilt: 19; Sayı: 3>> Özet
TAM METİN
Klinik Psikofarmakoloji Bülteni; 2009;19(3):211-214
Orijinal ilaç, eşdeğer ilaç tartışmaları üzerine
M Çetin, F Arıcıoğlu
GATA Haydarpafla Egitim Hast, İstanbul, Türkiye
Orijinal ilaçlar, dünyanın birçok yerinde güçlü patent koruma yasalarıyla belirli bir süre korunmakta ve bu süre dolduktan sonra eşdeğer (jenerik) ilaçların üretilmesine izin verilmektedir. Eşdeğer ilaçlar orijinal ilaçların sadece farmasötik eşdeğeri değil, aynı zamanda biyoeşdeğeri de olması gerekir. Dünyada sağlık harcamalarını düşürmek isteyen ülkeler, eşdeğer ilaç kullanımıyla önemli oranlarda tasarruf sağlamaktadır. Çünkü Araştırma-Geliştirme (Ar-Ge) maliyeti olmayan eşdeğer ilaçlar, orijinal ürünün fiyatından ortalama %20-80 daha ucuzdurlar. Türkiye’de eşdeğer ilaç kullanımı sayesinde 2004-2008 yılları arasında sağlık harcamalarında toplamda 3 milyar 879 milyon TL’yi bulan tasarruf sağlandığı açıklanmıştır. Önümüzdeki dönemlerde genel sağlık sigortasının yürürlüğe girmesi ve dolayısıyla sağlık sisteminin nüfusun tümünü kapsaması planlandığından, orijinal ilaçlara göre daha ucuz olan eşdeğer ilaçların kullanılması, kamu sağlık harcamalarında tasarruf açısından avantaj sağlayacaktır. Klinik gözlemler ve araştırmalardan edindiğimiz izlenimlerimize göre, kanaatimiz odur ki, yasa, yönetmelik ve kurallara uygun, titiz ve denetimli üretilen eşdeğer ilaçlar, orijinal ilaçlar kadar etkilidirler. Ancak eşdeğer ilaç üreten çok az sayıdaki firmanın ürünleri ile ilgili -verilen teminatlara rağmen- zaman zaman klinisyenlerin kuşku duymalarını haklı çıkarabilecek klinik gözlemlerimiz de olmaktadır. Az sayıda da olsa bunun gibi güven sarsıcı durumların eşdeğer ilaç üreten firmanın ve yetkili kuruluşların sıkı denetimleri ve meslektaşlarımızın geribildirimleri sayesinde engellenebileceğine inanıyoruz.
On the debate of original versus generic drugs
certain period of time and sonar equivalent (generic) drugs may be manifactured at the end of patent protection period. Generic drugs should not only be pharmaceutical equivalent, but they should also be bioequivalent to the original drugs. Countries that want to reduce health costs, may achieve significant savings by using generics. Generic drugs are usually 20-80% cheaper than the originals. It has been announced that TL 3,876 billions were saved from the total health expenditures between the [year]s 2004-2008 by use of generics in Turkey. It is planned that the general health insurance system in Turkey will be expanded to cover almost all of the population. The use of generic drugs-which are much cheaper than the originals- would provide advantage in the public health expenditures in terms of savings. Based on our impression from clinical practice and research data, we think the generics, which are manifactured under strict controls according to laws, regulations, and rules, are as effective as the originals. On the other hand at times, we have had some negative clinical observations with products of very few generic drug companies that may justify the doubts of clinicians about generics. We think these few generic drug companies, which hurts the trust to generics, can improve quality and efficacy of their products by stricter controls of the regulators and the feedback of clinicians.

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