EU regulationsBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d136 (Published 11 January 2011) Cite this as: BMJ 2011;342:d136
- Segundo Mariz, regulatory physician1,
- Jordi Llinares, head1,
- Kerstin Westermark, chairperson2
- 1Orphan Medicines Section, Human Medicines Special Areas, European Medicines Agency, London E14 4HB, UK
- 2Committee for Orphan Medicinal Products, Läkemedelsverket, Dag Hammarskjölds vägen 42, 75103 Uppsala, Sweden
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 …