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O ilaçların ruhsatı iptal ediliyor Sağlık Bakanlığı, piyasada bulunamayan ilaçlarla ilgili önemli bir düzenlemeye gidiyor. Bakanlık, piyasada belirli bir süre bulunamayan ilaçlara ruhsat iptali getirecek. 2014 yılında bazı hayati ilaçlarla esnek fiyat uygulamasına gitmeyi hedefleyen bakanlık, ruhsat almış herhangi bir ilacın, bir yıl piyasada bulunmaması halinde o ilacın ruhsatını iptal edecek. takvim.com.tr Giriş Tarihi : 07 Mart 2019 , 11:15 Güncelleme Tarihi : 07 Mart 2019 , 11:15
Türkiye'de kanser tedavisi için kullanılan bazı ilaçların temin edilememesi vatandaşı zor durumda bırakıyor. Sağlık Bakanlığı, çok sayıda kanser hastasının beklediği ve piyasada bulunamayan ilaçlarla ilgili önemli bir düzenleme yapacak. Bakanlık, fiyat düşüklüğü nedeniyle üreticisi tarafından ülkemizde satışı sona erdirilmesini engelleme adına yeni fiyat tebliği üzerinde çalışıyor.
Sağlık Bakanlığı, Maliye Bakanlığı, Sosyal Güvenlik Kurumu Başkanlığı, Devlet Planlama Teşkilatı Müsteşarlığı ve Hazine Müsteşarlığı temsilcilerinden oluşan Fiyat Değerlendirme Komisyonu bu tip riskli hastalıklar kullanılacak ilaçlara esnek fiyat uygulamasına getirecek. Fiyat Değerlendirme Komisyonu'nca kritik ürünlere en fazla yüzde 15 oranında artış verilebiliyordu. Firmalar tarafından yeterli bulunmayan fiyat artışları nedeniyle birçok ilacın temininde yaşanan sıkıntıları çözmek isteyen Sağlık Bakanlığı yeni bir ilaç tebliği hazırlıyor.
Fiyat değerlendirme komisyonunun kritik ilaçlar için halk sağlığını tehdit eden ürünler için fiyat değerlendirme yetkisi esnek hale getirilecek. Fiyat değerlendirmesi kısıtlanmayarak gerekirse ürünün özelliğine göre daha fazla artış verilebilecek. Özellikle son dönemde kanser ilaçları ile ilgili bulunamadığına dair sorunların bu sayede çözülmesi planlanıyor. Fiyat esnekliğinin sağlanması ile birlikte sadece kanser ilaçları değil, onkoloji ilaçlarından anestezi ilaçlarına, yeni doğan bebeklerde kullanılan ilaçlara şeker hastalarının kullandığı insülinlerden bulunmaması ile gündeme gelen antibiyotiklere kadar geniş bir yelpazede ürünlerle ilgili fiyat nedeniyle bulunamama sorununa çözüm getirilecek.
RUHSAT İPTALİ RESMİ GAZETE'DE DUYURULACAK Sağlık Bakanlığı, fiyat esnekliğinin getirilmesine rağmen piyasada bulunmayan ilaçlarla ilgili ayrıca ruhsat iptaline de gidebilecek. Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği'nde değişikliğe gidildi. Yönetmeliğe, "İlaç firmalarının ruhsat verilmiş bir tıbbi ürünün ruhsatlandırıldıktan sonra üç yıl içinde fiili olarak pazara sunulmaması veya daha önce pazara sunulmuş olan ruhsatlı bir ürünün kesintisiz bir yıl boyunca pazarda mevcut olmaması" ifadesi eklendi. Yönetmelikte yapılan değişiklikle birlikte ruhsat alan ilaçlar 1 yıl süreyle piyasada kesintisiz bulunamıyor ise o ilacın ruhsatı iptal edilebilecek. Ayrıca Resmi Gazete'de ruhsat iptali duyurulacak.
Sağlık Bakanlığı, Ekonomi Bakanlığı ve TÜBİTAK gibi kuruluşlar ile yerli firmaların ilaç Ar-Ge üretimine teşvik desteği vererek yeni molekül ve jenerik ilaç üretimini artırmayı hedefliyor.
YURTDIŞINDAN GETİRİLEN İLAÇ MİKTARLARI YIL - Miktar (Kutu) Toplam ödeme TL
2007 127.158 29.895.159
2008 243.905 72.145.568
2009 302.113 122.113.891
2010 377.841 164.534.925
2011 390.637 235.704.891
2012 591.798 473.208.510
TOPLAM 2.033.452 1.097.602.947