Manufacturer’s criminal responsibility against off-label drugs

Document Type : Original Article

Authors

1 PhD student in criminal law and criminology, Faculty of Law and Political Science, South Tehran Branch, Islamic Azad University, Tehran, Iran

2 Assistant Professor, Department of Law, Faculty of Law and Political Science , South Tehran Branch Islamic Azad University, Tehran, Iran.

3 Assistant Professor, Department of Criminal Law and Criminology, Faculty of Law and Political Science, Allameh Tabataba'i University, Tehran, Iran

4 Assistant Professor, Department of Criminal Law and Criminology, School of Law and Political Science, South Tehran Branch, Islamic Azad University, Tehran, Iran

Abstract

Sub-prescription is the recommendation of a drug for a disease which is not approved by supervising organizations for treating that disease. Such prescription is taken into consideration in recent events of Covid-19. One of the most effective methods in this field is the requirement of drug prescription based on the approved method. This method deals with the issue of sub-prescription of drugs and the necessary plans to deal with it, including criminal protections. It has become an executive law in countries such as the United States and the European Union because the large profits from selling drugs to patients and medical centers by pharmacies and encouraging doctors to receive cash and non-cash gifts as a result of the sale of these products will always result in the risk of prescribing drugs unrelated to the patient's illness. In this article, an attempt has been made to measure the place of sub-prescription of drugs in the criminal policy, clarify their commonalities and differences, and provide suggestions to eliminate possible gaps and attract the legislator's attention to the lack of an explicit law in this regard in the Iranian criminal policy. Studying the legal system of other countries and their criminal policy in facing this issue is the main method of this article. This research is a fundamental-applied study and is carried on based on descriptive and analytical methods with library tools, and its interdisciplinary analyzes lead to suggestions for enriching Iran's legal system and clarifying criminal liability in cases of health crises.

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