Letters Orphan drugs

EU regulations

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d136 (Published 11 January 2011) Cite this as: BMJ 2011;342:d136
  1. Segundo Mariz, regulatory physician1,
  2. Jordi Llinares, head1,
  3. Kerstin Westermark, chairperson2
  1. 1Orphan Medicines Section, Human Medicines Special Areas, European Medicines Agency, London E14 4HB, UK
  2. 2Committee for Orphan Medicinal Products, Läkemedelsverket, Dag Hammarskjölds vägen 42, 75103 Uppsala, Sweden
  1. segundo.mariz{at}ema.europa.eu

Two articles on orphan drugs misunderstand the interplay between European Union and national regulations and reimbursement schemes.1 2 They imply that under EU legislation there is a monopoly for orphan drugs, a minimal requirement for clinical data before licensing, and financial benefits before approval.

Article 8 of …

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