paper presented at American Public Health Association, Health Law Forum @Indianapolis, in November 1997
WHAT CONSTITUTES PHYSICIANS' PROFESSIONAL NEGLIGENCE and CONFLICTS of INTEREST---An ANALYSIS on CONSTITUENT ELEMENTS and JAPAN'S LAW ENFORCEMENT POLICY
AtoZ OKAMOTO (Kinki University Medical School, Osaka, JAPAN)

[Learning Objectives]
1)Describe the constituent elements of physicians' "professional negligence" and "conflicts of interest" in Japan's criminal laws.
2) Analyze the changes in law enforcement policy observed in the recent cases involving the iatrogenic HIV infection and clinical trials.
3)Discuss the implications these changes will have on physicians and other parties.
[Constituent Elements and Law Enforcement Policy]
Although constituent elements or "what constitutes a certain act as a crime and hence punishable" are defined by law, the rigor with which the law is enforced is more or less a matter of policy. In the year of 1996, two cases evidenced contrasting changes in the law enforcement policy.
[Iatrogenic HIV Infection] Physicians who commit harmful acts due to lack of diligence have occasionally been prosecuted for "professional negligence". However those who failed to take necessary actions to prevent the future harms have seldom been prosecuted. In the case of the iatrogenic HIV infection, the MD officer of Ministry of Health supervising pharmaceutical industry failed to order the manufacturers to retrieve HIV tainted unheated blood products thereby spreading the epidemic unnecessarily. The agency took a rigorous policy and prosecuted him together with the then executives of the manufacturers.
[Clinical trial] Japan's law enforcement agency has been enthusiastic about prosecuting physicians on misconducts over clinical trials. The misconducts include from bribery taking to data forgery. The cases were so numerous that doctors and patients alike became discouraged in participating in clinical trials. In the case involving the trial of a new drug for dystonia, the law enforcement agency arrested a doctor on charges of receiving cash prohibited by GCP (Good Clinical Practice) but later released him because no evidence of data forgery was revealed.
[Discussion] The more rigorous policy over professional negligence will hold those in supevisory status more accountable. However, the case over clinical trial may give a false idea that conflicts of interest may be permissible as long as there is no data forgery.
Law enforcement can not be free from social, and many times, political considerations. Whatever the background, those cases will The sheer size of the iatrogenic HIV infection made it too disastrous for the enforcement agcy to overlook. The petition signed by ten thousand dystonia patients who were afraid of losing a new drug with no substitutes might have made the fate of the arrested doctor different from those of the doctors arrested over hypertensive drugs or eye lotion.
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