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About 7,000 rare conditions have been identified for which no medical or other diagnosis, prevention or treatment is available. These so-called ‘orphan conditions’ affect some 30 million people in the European Union (EU). The pharmaceutical industry has been reluctant to develop drugs to treat them as the economics have not stacked up. Regulation (EC) No. 141/2000 on orphan medicinal products (the Orphan Regulation) was introduced in 2000 to address this problem through the establishment of a procedure for designating orphan medicinal products and the introduction of special incentives for research, development and marketing in Europe.

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