This article examines the liability of individuals involved in the production and application of novel pharmaceutical and therapeutic methods within the Iranian legal system. This issue has gained increased significance in light of rapid scientific advancements in fields related to medicine, pharmacy, and biotechnology, including gene therapy, genetic engineering, stem cells, pharmaceutical and therapeutic biotechnologies, artificial reproduction, organ transplantation, and other innovative treatment methods. The expansion of these approaches has not only introduced new tools, processes, and products into the realm of treatment but has also paved the way for new specialists and actors in the treatment and pharmaceutical production process—individuals who operate outside the traditional frameworks of healthcare personnel and have yet to acquire a clear legal status within Iran’s civil, legal, and contractual liability system.
The research findings indicate that despite the practical acceptance of many of these methods within the country’s medical and therapeutic structures, the Iranian legal system remains grounded in traditional principles and regulations, such as the Civil Code and the Law on Civil Liability, and has failed to incorporate modern legal doctrines, practices, and frameworks that correspond to the complex and multidimensional characteristics of new pharmaceutical and therapeutic methods. In this context, novel therapeutic contracts based on the provision of specialized services using advanced technologies also lack sufficient clarity in the legal system, and the duties and liabilities arising therefrom—during diagnosis, prescription, implementation, supervision, and even post-treatment stages—have not been clearly defined.
Moreover, there is no clear distinction between the liability of traditional pharmaceutical companies and knowledge-based enterprises active in the production of drugs and therapeutic technologies, resulting in significant gaps regarding the identification of responsible parties and the manner of compensating potential damages. Therefore, this study, employing a descriptive-analytical method and relying on library resources, emphasizes the necessity for a fundamental revision of existing legal regulations, the enactment of specialized and updated laws, and the establishment of novel frameworks to identify and attribute civil, legal, and contractual liabilities concerning new therapeutic and pharmaceutical methods. This is essential both to ensure the proper compensation of injured parties and to enable practitioners in these fields to operate with full awareness of their responsibilities and the limits of their interventions within a clearer legal environment.