Publication: İlaç hukuku bağlamında üreticinin hukuki sorumluluğu
Abstract
İlaçlar, çok eski çağlardan beri üretilmekte olup artık hayatımızın inkâr edilemeyecek düzeyde önemli bir parçası haline gelmiştir. İlaçlar, ilk zamanlarda insanlar tarafından geleneksel yöntemlerle az miktarlarda hazırlanarak tedavi amaçlı kullanılmışsa da yıllar içerisinde teknolojinin hızla gelişmesi ve nüfusun da artmasıyla birlikte geleneksel yöntemlerin yerini seri üretim almıştır. Günümüzde ilaçlar büyük miktarlarda üretilerek dünyanın neredeyse her yerine ulaştırılmaktadır. İlaçlar, faydalı olduğu kadar yan etkisi de olan ve doğrudan insan sağlığını etkileyen ürünlerdir. Bu nedenle üretim süreçleri oldukça maliyetli olup araştırma süreçlerinden başlanarak piyasaya sürülmesine kadarki süreç uzun yıllar almaktadır. İlacın hatalı üretilerek piyasaya sürülmesi, kullanıcılarda maddi ve manevi olarak ciddi zararlara sebebiyet verebilmektedir. Bu durumda ilaç hukuku bağlamında üreticinin hukuki sorumluluğu gündeme gelecektir. İlaç üreticisinin sorumluluğunun hukuki niteliğine ilişkin tartışmalar mevcut olupçalışmamızda bu tartışmalar ışığında uluslararası düzenlemeler de dikkate alınarak 6098 sayılı Türk Borçlar Kanunu, 6502 sayılı Tüketicinin Korunması Hakkında Kanun ve 7223 sayılı Ürün Güvenliği ve Teknik Düzenlemeler Kanunu çerçevesinde ilaç üreticisinin hukuki sorumluluğu incelenmiştir.
Pharmaceuticals have been produced since ancient times and have become an undeniably significant part of our lives. Initially, medicines were prepared in small quantities using traditional methods and used for therapeutic purposes. However, with the rapid advancement of technology and the increase in population over the years, traditional methods have been replaced by mass production. Today, pharmaceuticals are produced in large quantities and distributed almost everywhere in the world. While medicines are beneficial, they also have side effects and directly impact human health. Therefore, their production processes are quite costly, and the process from research to market release can take many years. The faulty production and subsequent release of a drug can cause significant material and moral harm to users. In such cases, the legal liability of the pharmaceutical manufacturer will come into question. There are ongoing debates regarding the legal nature of the liability of pharmaceutical manufacturers. In our study, considering these debates and international regulations, the legal liability of pharmaceutical manufacturers is examined within the scope of the Turkish Code of Obligations No.6098, the Law on the Protection of Consumers No. 6502, and the Product Safety and Technical Regulations Law No. 7223.
Pharmaceuticals have been produced since ancient times and have become an undeniably significant part of our lives. Initially, medicines were prepared in small quantities using traditional methods and used for therapeutic purposes. However, with the rapid advancement of technology and the increase in population over the years, traditional methods have been replaced by mass production. Today, pharmaceuticals are produced in large quantities and distributed almost everywhere in the world. While medicines are beneficial, they also have side effects and directly impact human health. Therefore, their production processes are quite costly, and the process from research to market release can take many years. The faulty production and subsequent release of a drug can cause significant material and moral harm to users. In such cases, the legal liability of the pharmaceutical manufacturer will come into question. There are ongoing debates regarding the legal nature of the liability of pharmaceutical manufacturers. In our study, considering these debates and international regulations, the legal liability of pharmaceutical manufacturers is examined within the scope of the Turkish Code of Obligations No.6098, the Law on the Protection of Consumers No. 6502, and the Product Safety and Technical Regulations Law No. 7223.