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- Title
INCENTIVISING INNOVATION OR SUPPORTING OTHER INTERESTS? EUROPEAN REGULATION OF ORPHAN MEDICINAL PRODUCTS.
- Authors
Bache, Gordon; Hervey, Tamara
- Abstract
The author discusses the decision of the European Medicines Agency (EMA) not to designate CSL Behring's human fibrinogen as an orphan medicinal product. CSL Behring stated that the agency's refusal to approve their designation application was unlawful. According to the authors, the claim on the unlawfulness of the agency's decision was weak. An overview of the impact of literal and wider approaches on patient and economic interests is provided.
- Subjects
FIBRINOGEN; ORPHAN drugs; DRUG development; EUROPEAN Medicines Agency; CSL Behring LLC
- Publication
Medical Law Review, 2011, Vol 19, Issue 1, p123
- ISSN
0967-0742
- Publication type
Opinion
- DOI
10.1093/medlaw/fwq035