BMJ · 2010 · 52 citations · 0 references
PharmacyCompetition LawPharmaceutical PolicyCompetition PolicyDrug LawPharmaceutical RegulationCompetition-based PricingNew Drug ApplicationsOrphan Drug DesignationPharmaceutical EconomicsPharmaceutical MarketingRegulatory ExclusivityExclusive Marketing PeriodsOrphan Drug ActOrphan Drug CoverageOrphan Drug DevelopmentOrphan Drug IncentivesOrphan Drug PolicyOrphan Drug Pricing PolicyPharmaceutical Market Competition
EU legislation offers an exclusive marketing period as an incentive for companies to develop drugs for rare diseases. But pricing for orphan drugs hinders access and may warrant a competition law investigation, say <b>Jonathan C P Roos</b>, <b>Hanna I Hyry</b>, and <b>Timothy M Cox</b>