Publication: Dünyada ve Türkiye’de Jenerik İlaç Kullanımı ile İlgili _x000D_
Gelişmeler
Abstract
Jenerik ilaç, referans alınan orijinal ilaç ile aynı etkin maddeyi aynı dozda aynı ya da benzer farmasötik şekilde içeren ve orijinal ilacın patent koruma süresi bittikten sonra üretilebilen ilaçtır. 1984 yılında yürürlüğe giren “Hatch-Waxman Hareketi” olarak bilinen “İlaç Fiyat Rekabeti ve Patent Yenileme Kanunu” ile jenerik ilaçların kullanımının yaygınlaşmasında, preklinik ve klinik faz çalışması koşulunun jenerik ilaçların ruhsat başvuru sürecinden çıkarılarak “kısaltılmış yeni ilaç başvurusu” hâline getirilmesi etkili olmuştur. Sınırlı sayıda sağlıklı gönüllü ile yapılan biyoyararlanım/biyoeşdeğerlik çalışmaları ile jenerik ilacın referans ile terapötik eşdeğer olduğunun gösterilmesi yeterli olarak kabul edilir. Bu nedenle daha düşük maliyet ile piyasaya çıkan jenerikler referans ilaçlara göre genellikle daha ucuzdur. Bu sayede jenerikler, sağlık hizmeti kalitesinden ödün vermeden ilaç harcamalarının azaltılmasına kritik katkı sağlar. Nitekim özellikle gelişmiş ülkelerde, jenerik ilaçların kullanımının yaygınlaştırılması ile ilaçların sağlık bütçesinde meydana getirdiği baskının azaltılması amaçlanmış ve bu doğrultuda özel politikalar uygulanmaya başlanmıştır. Jenerik kullanımının yaygınlaştırılmasında, uygulanan idari politikalarının yanısıra tüketicilerin, eczacıların ve hekimlerin jenerik ilaçlar ile ilgili algıları ve davranışları, tanıya ve ilaca ilişkin özellikler vb. faktörler de etkili olabilmektedir. Bu derlemede, jenerik ilaçlara yönelik temel bilgilere yer verilmesi ve farklı yerlerde kullanımı gittikçe yaygınlaşmakta olan bu ilaçlara ilişkin dünyadaki ve Türkiye’deki gelişmelerin sunulması amaçlanmıştır.
The generic drug contains the same active substance as _x000D_ the referenced original drug, in the same dose, in the same or similar _x000D_ pharmaceutical form and can be produced after the patent protection _x000D_ period of the original drug expires. With "The Drug Price Competi?tion and Patent Term Restoration Act", informally known as the _x000D_ “Hatch-Waxman Act” in 1984, the requirement for pre-clinical and _x000D_ clinical phase studies was abolished in the approval process of gener?ics. In this context, replacement of the former process with the "ab?breviated new drug application" has streamlined the widespread use _x000D_ of generics. Generic drug is deemed as therapeutically equivalent to _x000D_ reference product by demonstrating bioequivalence through bioavail?ability/bioequivalence studies conducted with a limited number of _x000D_ healthy volunteers. Therefore, generic drugs introduced to the market _x000D_ with lower costs are generally cheaper than reference drugs. In this _x000D_ way, generic drugs make a critical contribution to reducing drug ex?penditures without conceding healthcare quality. In fact, especially _x000D_ in developed countries, it was aimed to off-load the pressure caused _x000D_ by drug costs on the health budget via increasing the use of generic _x000D_ drugs, and special policies have been implemented. Apart from ad?ministrative policies, many factors including consumers’, pharma?cists’, and physicians’ perceptions and behaviors about generics, _x000D_ diagnosis and drug-related characteristics, etc. can impact in spread?ing the use of generic drugs. In this review, it was aimed to provide _x000D_ fundamental information about generic drugs and present the devel?opments in the world and in Turkey for these drugs which are be?coming more widespread. _x000D_
The generic drug contains the same active substance as _x000D_ the referenced original drug, in the same dose, in the same or similar _x000D_ pharmaceutical form and can be produced after the patent protection _x000D_ period of the original drug expires. With "The Drug Price Competi?tion and Patent Term Restoration Act", informally known as the _x000D_ “Hatch-Waxman Act” in 1984, the requirement for pre-clinical and _x000D_ clinical phase studies was abolished in the approval process of gener?ics. In this context, replacement of the former process with the "ab?breviated new drug application" has streamlined the widespread use _x000D_ of generics. Generic drug is deemed as therapeutically equivalent to _x000D_ reference product by demonstrating bioequivalence through bioavail?ability/bioequivalence studies conducted with a limited number of _x000D_ healthy volunteers. Therefore, generic drugs introduced to the market _x000D_ with lower costs are generally cheaper than reference drugs. In this _x000D_ way, generic drugs make a critical contribution to reducing drug ex?penditures without conceding healthcare quality. In fact, especially _x000D_ in developed countries, it was aimed to off-load the pressure caused _x000D_ by drug costs on the health budget via increasing the use of generic _x000D_ drugs, and special policies have been implemented. Apart from ad?ministrative policies, many factors including consumers’, pharma?cists’, and physicians’ perceptions and behaviors about generics, _x000D_ diagnosis and drug-related characteristics, etc. can impact in spread?ing the use of generic drugs. In this review, it was aimed to provide _x000D_ fundamental information about generic drugs and present the devel?opments in the world and in Turkey for these drugs which are be?coming more widespread. _x000D_