TABLE 1-4Prevalence Criteria for the Definition of Rare Disease in Selected Countries

CountryPrevalence CriterionPrevalence Expressed as Rate for Year of Policy Adoption
United States200,000 people1984: 85/100,000
2008: 66/100,000
Australia2,000 people1998: 11/100,000
2008: 9/100,000
European Union5/10,000 population
(~250,000 people, 27 EU nations)
[Not applicable]
Japan50,000 people1993: 40/100,000
2008: 39/100,000

SOURCES: For policies, United States: Orphan Drug Act of 1983; European Union: Regulation (EC) No. 141/2000; Australia: Therapeutic Goods Act of 1989; Japan: Pharmaceutical Affairs Law (JPMA, 2008). For population data: Library of Congress (U.S.), 1994; U.S. Census Bureau, 2001, 2009; Australian Bureau of Statistics, 2008; Statistics Bureau (Japan), 2008; Eurostat, 2010.

From: 1, Introduction

Cover of Rare Diseases and Orphan Products
Rare Diseases and Orphan Products: Accelerating Research and Development.
Institute of Medicine (US) Committee on Accelerating Rare Diseases Research and Orphan Product Development; Field MJ, Boat TF, editors.
Washington (DC): National Academies Press (US); 2010.
Copyright © 2010, National Academy of Sciences.

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