Journal of Criminal Law and Criminology

Journal of Criminal Law and Criminology

Manufacturer’s Criminal Responsibility Against off-label Drugs

Document Type : Original Article

Authors
Mohammad Pirvaram 1
Shadi Azimzadeh 2
Tahmores Bashirieh 3
Fatemeh Mohamadi Moghanjoy 4
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
10.22034/jclc.2023.393287.1844
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.
Keywords
Criminal Liability
Criminal Policy
Sub-Prescription Drug
Criminal Responses
Substitution Requirement
Pirvaram, Mohammad and Shadi Azimzadeh. "Iran's criminal policy against the induction of drug administration". Research Journal of Criminal Law and Criminology 18(1400): pp. 257-280. (in Persian)
Iran University of Medical Sciences. "Clinical Trial Registration Center of Iran", 03/09/2019, https://fa.irct.ir/trial/48226(in Persian)
Dasht, Sadiq. Mohammadi, Pejman. Mr. Jennet Makan, Hossein, "Civil and criminal responsibility of producers of non-standard goods", Research Journal of Criminal Law and Criminology, No. 1, (2012): 159. (in Persian)
Justice and Transparency Watch Organization, organized pharmaceutical corruption in the Food and Drug Organization, http://daad.ir, dated July 2, 2016. (in Persian)
Suhrvardi, Mojtaba. Guide to prescribing and rational use of drugs. Tehran: Konkash Publishing, 2015. (in Persian)
Safari, Ali and Seyed Abdul Majeed, Ijtihadi, "Differential criminal policy for health-oriented product smuggling", Law Enforcement Science Quarterly (2016), 19th year, p. 14. (in Persian)
Alizadeh Same, Sonia and Babak Pourkoherman, "Supporting the victims of trafficking of health-oriented goods in Iran's criminal policy and international documents", Scientific Quarterly of International Science Research (1401), number 54. (in Persian)
Fattahzadeh, Zahra and Alireza Amini, "The scope of the manufacturer's warranty due to product defects and lack of information on the correct way of consumption", Fiqh and Islamic Law Quarterly (1391), year 4, number 6, pp. 138-145. (in Persian)
Chen H, Reeves JH, Fincham JE, Kennedy WK, Dorfman JH, Martin BC, (2006), “Off-label use of antidepressant, anticonvulsant, and antipsychotic medications among Georgia Medicaid enrollees in 2001”, J Clin Psychiatry. (in English)
Gazarian M, and Kelly M, McPheeand JR, Graudins LV, Ward RL, Campbell TJ, “Off-label use of medicines: consensus recommendations for evaluating appropriateness” Medical Journal of Australia, 185(2006), November20, https://doi.org/10.5694/j.1326-5377.2006.tb00689.xCitations.
An official website of the European Union, https://eur-lex.europa.eu/homepage.html(in English)
Good Distribution Practices (GDP) For Pharmaceutical Howard, Paul; Copland, James. “Off-Label, Not Off-Limits: The FDA Needs to Create a Safe Harbor for Off-Label Drug Use”. The journal of the Missouri State Medical Association (2013):106-109.
Google. “Federation of American Scientists.” Last modified June 1, 2020.
Google. “PRACTICAL LAW.” Last modified 01-May, 2013(in English)
https://eur-lex.europa.eu, 9 February 2006. (in English)
https://fas.org/sgp/crs/misc/r43609.pdf.
Illuminating the Art of Medicine, (2012):576-581. (in English)
 
Joan McPhee, (2005), “Corporate Criminal Liability and Punishment in the 21st Century: Departures from Constitutional and Criminal Norms and Anomalies in Practice”, 2005 ABA White Collar Crime Conference, at 8-11 (Mar. 2005) (and authorities cited therein), available at http://www.ropesgray.com/files/tb1 s20News/FileUploadl16/878/Article 2005 Corporate%20Cr iminal%20Liabi1ity McPhee.pdf. (in English)
McPhee, Joan, (2006), “THE CRIMINALIZATION OF TRUTHFUL, NON-SLEADING OFF-LABEL PROMOTION: CONSTITUTIONAL, LEGAL AND POLICY CONCERNS”, Ropes & Gray LLP Boston, Massachusetts, Health care fraud,2006, pp 22-29. (in English)
Mithani, Z. “Informed consent for off-label use of prescription medications,” AMA Journal of Ethics
Radley, DC. Finkelstein, SN. Stafford, RS. “Off-label prescribing among office-based physicians.” Arch Intern Med (2006):166. (in English)
Richard C.Ausness, "There’s Danger here, Cherie!: liability for the promotion and marketing of drugs and medical devices for Off label uses", university of Kentucky Collrge of law (2008).p: 19 -25. (in English)
Shariful A. Syed. “The Law and Practice of Off-Label Prescribing and Physician Promotion”. The Journal of the American Academy of Psychiatry and the Law 49)2021):2. (in English)
Stefhanie Greene and False Claims,(2005), “Act Liability for Off Label Promotion of pharmaceutical products”. 110 PENN. ST.L.Rev. (in English)
Steven R and salbu,(1999), “Off label Use , Prescription and regulatory policy”. 51 FLA. L.Rev. (in English)
The United States Federal Food, Drug, and Cosmetic Act. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301–92, (Suppl. 5) (1934). (in English)
Wittich, CM. Burkle, CM. Lanier, WL. “Ten common questions (and their answers) about off-label drug use”, Mayo Clin Proc. (2012) View Article PubMed Google Scholar.938. (in English)
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000357.jsp&mid=WC0b01ac05806361e1.
www.practicallaw.com/lifesciences-mjg. (in English)
 
Journal of Criminal Law and Criminology
Volume 12, Issue 23
September 2024
Pages 123-156