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薬理と治療
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Abstract
Compassionate use(CU)is commonly known as limited supply of unapproved drugsto patients who suffer from life-threatening or chronically debilitating diseases for whomauthorized therapies have failed or do not exist and who cannot enter clinical trials. In drugregulation, CU casts very tough but relevant questions on its application; the trade-offbetween patients’ free access to such medications, on the one hand, and safeguarding thepatient and ensuring the continued integrity of the scientific process that collect data in randomizedcontrolled trial, on the other. Although some developed countries already have systemsfor CU as exceptional measures, Japan does not have yet. Consequently, the recentincrease in the personal imports of unapproved medicines has become a serious social problemwhich has awakened Japanese to the need for a kind of risk management. Inasmuch asone third of Japanese die due to cancer, many cancer patients want greater access to unapproveddrugs through CU. So the introduction of a system for CU in Japan is a matter ofutmost urgency. We reviewed the history and status of implementation of CU in the USA,Europe, and our neighboring country, Korea. We also reviewed Japanese history on the supplyof unapproved drugs for intractable diseases on humanitarian grounds in limited therapeuticareas. We showed our points of view, specifically, how we can meet the demands ofJapanese patients with intractable diseases. We believe this review will make a great contributionabout planning and developing the regulatory system for CU in Japan.KEY WORDSCompassionate use, Unapproved drugs, System introduction to Japan, Drug regulation
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