A joint position in favour of revoking the exclusive haemophilia treatment market
The EU Orphan Medicinal Product Regulation (OMPR 141/2000) grants orphan medicinal products a ten year marketing exclusivity period, preventing similar drugs being approved for another ten years. In an article published in Haemophilia, O’Mahony et al. present a case against this legislation concerning haemophilia treatments. While they support the OMPR to encourage drug development to treat rare diseases for which no treatment exists, they believe the haemophilia market is sufficiently large to withstand competition.
With seventy plasma-derived and recombinant treatments for haemophilia A and B worldwide, generating over US$ 7 billion annually, the authors maintain the haemophilia market does not need the OMPR's support to grow. The European Haemophilia Consortium (EHC), the European Association for Haemophilia and Allied Disorders (EAHAD) and the World Federation of Haemophilia (WFH) appealed to the European Commission and the EMA, in a joint position, to open up competition to manufacturers of longer acting haemophilia treatments for improved patient quality of life. The joint position argues that longer acting products are not similar to existing treatments. The authors further argue that preventing the development of new products denies haemophilia patients the right to adequate and improved treatment.
