2．About the Meaning of “Describe a False or Exaggerated Article” in the Pharmaceutical Affairs Law
- VernacularTitle:2．薬事法 66 条 1 項に定める「虚偽または誇大な記事を記述し」の意味について
- Author:
Hiroshi YASUHARA
1
Author Information
- Keywords: clinical trial; Diovan judicial trial; pharmaceutical law; description and advertisement; advertisement of academic articles
- From:Japanese Journal of Pharmacoepidemiology 2019;24(2):75-78
- CountryJapan
- Language:Japanese
- Abstract: A judicial trial in which a pharmaceutical company and a former employee were prosecuted for violation of the Pharmaceutical Affairs Act： the pharmaceutical company and former employees have published papers in academic journals by providing researchers with fake data, such as providing false data disguised as having therapeutic effects on the results of multicenter clinical trials for hypertensive drugs.Regarding the case, the Tokyo District Court decision on March 16, 2017, and the Tokyo High Court of Appeals decision on November 19, 2020 indicated that both the pharmaceutical company and its former employees were not guilty. The reason is that the Pharmaceutical Affairs Law is a provision that punishes only when false or exaggerated articles are written for advertising purposes, so publication of scientific papers does not apply.However, there is a question about the interpretation that the provisions of the Pharmaceutical Affairs Law are limited to advertising purposes, and there is room to be identified as advertising purposes from the publication process of the academic dissertation in this case, so I can't agree with the judgment.
