All three of the bleeding disorders organisations with the most influence in Europe have written a joint letter raising concerns about how the first longer acting clotting factor products to get market authorisation might be treated within the EU.
The European Haemophilia Consortium (EHC), The European Association for Haemophilia and Allied Disorders (EAHAD), and the World Federation of Hemophilia (WFH) have joined forces to oppose the classification of the new longer action clotting factor products as orphan drugs in Europe. Such a decision would mean that the first longer acting Factor VIII and Factor IX products to secure market authorisations would have a 10 year monopoly in the European Union.
The campaign highlights that the range of products currently being developed contain difference active substances so shouldn’t be considered as sufficiently “similar” to activate the orphan drug exclusion.
The letter raises four key concerns if ten year exclusivity was granted.
- The potential benefits from better products based on different mechanisms of action may never be realised in Europe;
- Patients will be deprived of potentially better clinical options for their individual clinical needs;
- There will be no competition and therefore higher prices – thereby potentially hindering or severely limiting patient access to these products in Europe; and
- There will be no cascading effect on lowering prices for current treatment products or broadening market access into European countries where patients have limited or severely limited access to treatment products.
Haemophilia Scotland are backing the campaign and have written to all six of Scotland’s newly elected MEPs urging them to give us their support.