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KMID : 1234820210220040059
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Korean Society of Law and Medicine
2021 Volume.22 No. 4 p.59 ~ p.88
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The Meaning and the Legislative Suggestion about Data Manipulation of Pharmaceutical Companies in the Aspect of the Medicine Approval System
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Park Sung-Min
Shin Young-Kee
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Abstract
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The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients’ life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the ‘unfair’ profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.
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KEYWORD
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The medicine approval, Data manipulation, Safety, Effectiveness, The medicine safety management
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