Permalink : http://hdl.handle.net/2115/80354

Serious adverse effects caused by pharmaceuticals are a systemic risk, and proper risk management is essential to prevent such occurrences. When adverse effects occur, the decision whether to continue to provide the drug or withdraw from the market cannot be made based on scientific data alone, and the decisionmaking process is often influenced by social, economic and other factors possessed by various stakeholders. This paper analyzes the mutual interaction among social factors in risk decision-making on market withdrawal using O. Renn's framework of Risk Governance, based on the case of troglitazone, a drug withdrawn from the US, UK and Japan markets due to hepatotoxicity.