Regulatory Focus™ > News Articles > In Focus: Orphan Feast

In Focus: Orphan Feast

Posted 01 January 2011 | By

In just under 25 years, orphan diseases have been "adopted" by the pharmaceutical industry, primarily because several countries enacted laws granting significant financial incentives for companies to make and market new medications to treat or prevent conditions that occur but rarely. Legislation began with the US Orphan Drug Act of 1983, which offered tax incentives on clinical trials and seven years of marketing exclusivity for orphan drugs. In 2000, the EU adopted legislation that mimicked the US law but provides 10 years of marketing exclusivity (and as there is no centralized EU taxation system, any tax incentives are dependent upon the laws of the individual Member States). Similar legislation has been adopted in Japan and Australia, while other countries (notably China) are slowly working toward formulating orphan drug/rare disease legislation to benefit their citizens.

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