Issues surrounding orphan disease and orphan drug policies in Europe

@article{Denis2010IssuesSO,
  title={Issues surrounding orphan disease and orphan drug policies in Europe},
  author={Alain Denis and Lut Mergaert and Christel Fostier and Irina Cleemput and Steven R A Simoens},
  journal={Applied Health Economics and Health Policy},
  year={2010},
  volume={8},
  pages={343-350}
}
An orphan disease is a disease with a very low prevalence. Although there are 5000–7000 orphan diseases, only 50 orphan drugs (i.e. drugs developed to treat orphan diseases) were marketed in the EU by the end of 2008. In 2000, the EU implemented policies specifically designed to stimulate the development of orphan drugs. While decisions on orphan designation and the marketing authorization of orphan drugs are made at the EU level, decisions on drug reimbursement are made at the member state… 

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