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KMID : 0986720120200020021
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Korean Journal of Medicine and Law
2012 Volume.20 No. 2 p.21 ~ p.49
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The Review of Legal Problems Arising from Financial Supports for Investigators Initiated Trials
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Kang Han-Cheol
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Abstract
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The current pharmaceutical and medical device fair trade codes explicitly permit provision of drugs and the supply or rental of medical devices for investigators initiated trials. However, the codes require "member companies to design" such trials with respect to other financial support and actually exclude financial supports for investigators initiated trials from the safe harbors enumerated under them. Considering the fact that activities which meet the requirements provided by the safe harbors under the codes can be easily admitted as legally permissible in the course of investigations conducted by the authorities concerned. However, other activities involving financial supports, including but not limited to financial support for investigators initiated trials, are highly likely to be put under strong suspicion of illegal rebates based on "generally prohibited, but exceptionally permitted" doctrine under the codes. So, pharmaceutical companies, medical device businesses and healthcare professionals could bear the de facto burden of proof as to legality and legitimacy of such activities involving financial supports. In this context, it is recommended that the players in the healthcare arena shall be more cautious to comply with strict requirements for ensuring legitimacy, taking into account that the safe harbors under the codes seem not to cover the financial supports for investigators initiated trials except for provision of drugs and supply or rental of medical devices. For this purpose, healthcare professionals as well as pharmaceutical companies and medical device businesses shall try their best to (1) ensure the ex post and ancillary participation of pharmaceutical companies and medical device businesses in the planning process of investigators initiated trials, (2) minimize any details of research expenses which can cause misunderstanding or suspicion, (3) exclude involvement of sales or marketing departments or personnels in decision making and execution of expenses process relating to investigators initiated trials, (4) calculate compensations for investigators or researchers based on the fair market value of services actually provided in the course of such trials, and finally, (5) comply with all procedural requirements provided under the Pharmaceutical Affairs Act or the codes.
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KEYWORD
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Investigator Initiated Trial, Clinical Trial, Research Expenses, Unfair Customer Solicitation, Dual Punishment System
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