Off-Label Prescription and How it is (Not) Regulated in China
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Off-label prescription—the use of a drug outside the scope of its marketing authorization (MA) and the content of its summary of product characteristics (SmPC)—is a medical practice spread all around the world, China being no exception. Several reasons, mostly related to financial strategies from pharmaceutical companies, can justify the decision of not requiring an MA for a certain drug use. The main reason is the purpose of having a profit without taking excessive risks, either economic or legal. This paper will define off-label prescription, discuss the various reasons leading to it, describe the general framework of this practice in Europe and in the United States and analyze off-label prescription in China, describe its regulation (actually, the lack of it) in the Chinese legal system and comment on the actual practice by Chinese health care providers. To conclude, the paper will sustain that a regulation for off-label prescription is essential to clarify for doctors the requirements of lawful off-label uses, and thus protect patients from injuries resulting from risky of-label prescriptions.
Abstract
Off-label prescription—the use of a drug outside the scope of its marketing authorization (MA) and the content of its summary of product characteristics (SmPC)—is a medical practice spread all around the world, China being no exception. Several reasons, mostly related to financial strategies from pharmaceutical companies, can justify the decision of not requiring an MA for a certain drug use. The main reason is the purpose of having a profit without taking excessive risks, either economic or legal. This paper will define off-label prescription, discuss the various reasons leading to it, describe the general framework of this practice in Europe and in the United States and analyze off-label prescription in China, describe its regulation (actually, the lack of it) in the Chinese legal system and comment on the actual practice by Chinese health care providers. To conclude, the paper will sustain that a regulation for off-label prescription is essential to clarify for doctors the requirements of lawful off-label uses, and thus protect patients from injuries resulting from risky of-label prescriptions.
참고문헌 (56)
- Peter Feldschreiber, "THE LAW AND REGULATION OF MEDICINES", pp.103~110 (2008)
- Peter Feldschreiber, "THE LAW AND REGULATION OF MEDICINES", pp.3~21 (2008)
- Sonja Obermann, "Off-Label Use of Medicines: General Aspects, Challenges and Strategies", Master, pp.2013
- Vera Lúcia Raposo, "Prescrição Off-Label de Medicamentos e de Dispositivos Médicos", LEX MEDICINAE, 11 (2014)
- Christopher M. Wittich, "Ten Common Questions (and Their Answers) About Off-Label Drug Use", MAYO CLINIC PROCEEDINGS, 87, pp.982~ (2012)
- "Off-label Use of Registered Medicines and Use of Medicines under the Personal Importation Scheme in NSW Public Hospitals: A Discussion Paper" (2003)[URL]
- C. Schoonderbeek, "Off-Label Use of Medicinal Products: A Legal Update", LIFE SCIENCES (2007)
- Towards a Better Managed Off-Label Use of Drugs, "Federaal Kenniscentrum Voor de Gezondheidszorg", KCE, 10~, pp.KCE REPORT 252 (2015)
- "Guideline on Procedures for the Granting of a Marketing Authorization Under Exceptional Circumstances, Pursuant to Article 14 (8) of Regulation (EC) No. 726/2004, EMEA/357981/2005" (2005)[URL]
- European Parliament and of the Council, "Title III, Directive 2001", 83, pp.2001, ~
- Pathma D. Joseph, "Clinical Trials in Children", BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 79, pp.357~ (2015)
- Dinah Duarte, "Melhores Medicamentos em Pediatria", ACTA PEDIÁTRICA PORTUGUESA, 39, pp.17~ (2008)
- Marchella Yasinta, "Use of Off-Label Nephrology-Related Drugs in Hospitalized Pediatric Patients: A Retrospective Study", WORLD J PEDIATR, 12, pp.236~ (2016)
- Zhiping Li, "Current Status of Pediatric Labeling in China and the near Future Efforts Needed for the Country", FRONT PEDIATR, 2 (2014)
- "Off-label Use of Medicinal Products and Product Liability" (2013)[URL]
- "European Parliament and of the Council of December 16, 1999, Regulation (EC) n. 141", 2000 (on orphan medicinal products)
- Apud Peipei Song, "Innovative Measures to Combat Rare Diseases in China: The National Rare DiseasesRregistry System, Larger-Scale Clinical Cohort Studies, and Studies in Combination with Precision Medicine", RESEARCH INTRACTABLE & RARE DISEASES RESEARCH, 6, pp.1~ (2017)
- Peipei Song, "Rare Diseases, Orphan Drugs, and their Regulation in Asia: Current Status and Future Perspectives", INTRACTABLE & RARE DISEASES RESEARCH, 1, pp.3~ (2009)
- Y-X Chen, "Urgent Action Needed to Raise Public Awareness of Age-Related Macular Degeneration in China", ZHONGHUA YAN KE ZA ZHI, 45, pp.389~ (2009)
- Weilan Wang, "Off-Label and Off-NCCN Guidelines Uses of Antineoplastic Drugs in China", IRANIAN JOURNAL OF PUBLIC HEALTH, 42, pp.472~ (2013)
- Jiong Tu, "Yinao: Protest and Violence in China’s Medical Sector", BERKELEY JOURNAL OF SOCIOLOGY (2014)
- Alex Jingwei He, "The Doctor-Patient Relationship, Defensive Medicine and Overprescription in Chinese Public Hospitals: Evidence from a Cross-Sectional Survey in Shenzhen City", SOCIAL SCIENCE AND MEDICINE, 123, pp.64~ (2014)
- Feng Ma, "Chinese Regulation of Off-Label Use of Drugs", FOOD AND DRUG LAW JOURNAL, 68 (2013)
- Muriel Gillick, "Controlling Off-Label Medication Use", ANNALS OF INTERNAL MEDICINE, 150, pp.344~ (2009)
- Jacob Rogers, "Freedom of Speech and the FDA’s Regulation of Off-Label Drug Uses", THE GEORGE WASHINGTON LAW REVIEW, 76, pp.1429~ (2008)
- "Promotion and Use of Off-Label Pharmaceuticals in Europe, the US and China" (2011)[URL]
- "Off-Label Use of Prescription Drugs should be Regulated by the FDA" (2003)[URL]
- Food and Drug Administration, "Use of Approved Drugs for Unlabeled Indications", FDA DRUG BULL, 12 (1982)
- R. S. Stafford, "Regulating Off-Label Drug Use: Rethinking the Role of the FDA", N ENGL. J. MED, 358, pp.1427~ (2008)
- "Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices" (2011)[URL]
- "Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices:Information Sheet" (2014)[URL]
- "Buckman Co. v. Plaintiffs' Legal Comm. (98-1768), 531 U.S. 341 (2001), 159 F.3d 817", ~ (2001)
- R. W. Pretorius, "Reducing the Risk of Adverse Drug Events in Older Adults", AM. FAM. PHYSICIAN, 1, pp.331~ (2013)
- G. P. Velo, "Medication Errors: Prescribing Faults and Prescription Errors", BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 67, pp.624~ (2009)
- Vikram Gota, "Off-Label Use of Drugs: An Evil or a Necessity?", INDIAN JOURNAL OF ANAESTHESIA, 51, pp.767~ (2015)
- Jamie J. Coleman, "Adverse Drug Reactions", CLINICAL MEDICINE, 16, pp.481~ (2016)
- S. M. Walton, "Prioritizing Future Research on Off-Label Prescribing: Results of a Quantitative Evaluation", PHARMACOTHERAPY, 28, pp.1443~ (2008)
- X. Chao, "Medical Liability Laws in China: The Tale of Two Regimes", TORT LAW REVIEW, 19, pp.65~ (2011)
- Hanbin Wu, "Strategy to Address Innovative Off-Label Medication Use in China: Grading Management", EUR. J. CLIN. PHARMACOL, 70, pp.1271~ (2014)
- "Promotion and Use of Off-Label Pharmaceuticals in Europe, the US and China: Briefing Note" (2011)[URL]
- "Second Medical Use or Indication Claims" (2014)[URL]
- Xiaodong Sun, "Profile of Conbercept in the Treatment of Neovascular Age-Related Macular Degeneration", Drug Design, Development and Therapy, 9, pp.2311~ (2015), Dove Medical Press Ltd[DOI]
- "Provision Rules on the Classifications of Prescription Drugs and Non-Prescription Drugs (SFDA Order No. 10)"[URL]
- "The Measures for the Administration of Prescriptions" (2007)[URL]
- "Law on Practicing Doctors of the People’s Republic of China"[URL]
- "CHINA DAILY" (2010)[URL]
- F. Wang, "Acute Intraocular Inflammation Caused by Endotoxin after Intravitreal Injection of Counterfeit Bevacizumab in Shanghai", China, 120, pp.355~ (2013)
- Hong-Bing Huang, "Shanghai Eye Treatment Outbreak: Bevacizumab Therapy for AMD in China", CLIN. EXP. OPTOM, 96, pp.106~ (2013)
- X. Sun, "Counterfeit Bevacizumab and Endophthalmitis", N. ENGL. J. MED, 365, pp.378~ (2011)
- "Off-Label Use of Drugs and Access to Medicines for All: A Thailand Example" (2016)[URL]
- Hanbin Wu, "Improving Good Practice: A Survey of Unlicensed and Off-Label Drug Use in a General Hospital in China", THER. INNOV. REGUL. SCI, 47, pp.397~ (2013)
- C. Ronald Keith, "SARS in Chinese Politics and Law", CHINA INFORMATION, 21, pp.401~ (2007)
- Z. Zheng, "Chinese Pharmacists Propose Patient Consent for Unlabeled Use of Medications", J. MANAG. CARE PHARM, 16, pp.640~ (2010)
- Zhihua Zheng, "Changing the Perspective of Off-Label Drug Use in China", BMJ, 12 (2016)
- "Tort Law of the People’s Republic of China"[URL]
- "The Tort Liability Law of the People’s Republic of China, that came into effect as of July 1, 2010"[URL]