Orphan Drugs are medicines to be used for the treatment of rare deseases (definition of the European Union: less than 230,000 patients concerned per year or 5 per 10.000 inhabitant). Since for such preparations no sufficient market exists, this market segment is only from small interest for the pharmaceutical industry.
The European Union set the regulation (EEC 141/2000) for medicament for rare suffering into force in January 2000, which assures the companie the exclusive marketing right for the certified indication for the duration of ten years, which has developped the Orphan medicament. The licensing procedure for permission is also facilitated. An own committee for medicaments for rare suffering in the European medicament agency (EMEA) was established. At present (January 2007) 35 Orphan medicaments are certified in the European Union.