Akademik Veri Yönetim Sistemi
NOBEL MEDICUS, sa.2, ss.77-84, 2024 (ESCI)
The liability of the pharmaceutical manufacturer refers to the compensation by the pharmaceutical manufacturer for the damage caused to the property or personal assets of the person using the pharmaceutical due to the manufacturing defect in the pharmaceutical. There is no contractual relationship between the pharmaceutical manufacturer and the person using the pharmaceutical. The legal basis of this non-contractual liability is the Act on Product Safety and Technical Regulations (Act. No. 7223). Since the product refers to "any substance, preparation or objects" according to Article 3 of the Act., pharmaceuticals are also included within this scope. As well as the production and placing on the market are prerequisites for the liability to arise within the scope of Act., in addition to these; the pharmaceutical must be defective, damage must arise due to the use of the pharmaceutical, there must be a causal link between the use of the pharmaceutical and the damage caused, and there must not be one of the exculpatory evidence regulated in the law. The manufacturing defect that causes the pharmaceutical to be unsafe could be like manufacturing / composition defect, fabrication defect, stimulation defect, development defect, or observation defect. The damage caused by the use of the pharmaceutical may be pecuniary or non-pecuniary. The pharmaceutical manufacturer is obliged to compensate for the damage caused by the pharmaceutical if these conditions are met. In addition, the pharmaceutical manufacturer cannot make a non-liability agreement that eliminates its liability for the damage. The period of limitations for the liability of the pharmaceutical manufacturer is regulated as three years from the date the injured party learns about the damage and the indemnity obligor and in any case ten years from the date of the damage.