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37 Hong Kong L.J. 805 (2007)
Comparison of Surveillance Systems for Adverse Events Following Immunisation in Hong Kong and the United States, and Suggestions for Improvements of the Hong Kong System

handle is hein.journals/honkon37 and id is 811 raw text is: COMPARISON OF SURVEILLANCE SYSTEMS FOR ADVERSE EVENTS FOLLOWING IMMUNISATION IN HONG KONG AND THE UNITED STATES, AND SUGGESTIONS FOR IMPROVEMENTS OF THE HONG KONG SYSTEM 0 Gillis Heller* This article compares the systems for surveillance of adverse events following immunisation (AEFI) in Hong Kong and in the United States. It starts with an explanation of why AEFI surveillance is important from the standpoint of public health and good governance. The article proceeds with an examination of the Hong Kong AEFI surveillance system, established administratively recently within the Hong Kong Department of Health. It then describes the US AEFI surveillance system, established by law in circumstances of great controversy over legally required immunisations. The article then compares and contrasts the two systems and examines the legal reasons for the differences. The US system for AEFI surveillance is far more extensive than the system in Hong Kong. Aside from the obvious difference in size, the reasons for the disparity may largely be historical. However, the article argues that, pending improvements in computer integration at the Department of Health and the Hong Kong Hospital Authority, the Hong Kong system for AEFI surveillance could leapfrog that in the United States. Finally, the unfortunate situation of the AEFI surveillance system in mainland China and the consequent disqualification of the China State Food and Drug Administration as a fully functioning national regulatory authority for important purposes of the World Health Organization is noted. Introduction The purpose of this article is to compare the system in Hong Kong for de- tecting, reporting, investigating, and responding to adverse events following immunisation (AEFI and AEFI surveillance), operated by the Adverse Drug Reactions Monitoring Unit (ADR Monitoring Unit), with the AEFI sur- veillance system in the United States, called the Vaccine Adverse Events Reporting System (VAERS), operated jointly by the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention JD, MPH, former Assistant Professor (Hon), Clinical Trials Centre, Li Ka Shing Faculty of Medi- cine, University of Hong Kong, now General Counsel, Asia Clinical Research Institute.

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