Bruno Sepodes, the chair of the European Medicines Agency’s Committee for Orphan Medicinal Products briefed the EMA Management board on the ongoing plans that the Committee has in order to approve effective treatments for rare diseases in a faster manner.
Due to the increasing number of medicines with orphan designation coming to market and their challenging access, he highlighted the need to “fully exploit” the legal possibilities in the Regulation with the aim of reducing market exclusivity by reducing protection periods for orphan medicines that no longer meet the criteria over time.
The EU orphan medicines regulation says that marketing authorisation cannot be granted or extended for a drug that serves the same therapeutic purpose as an orphan drug. This is for a period of ten years however, the law states that this time can be reduced to 6 years if at the end of the 5th year the orphan drug is “sufficiently profitable” and therefore no long needs market exclusivity.
The outcome is that EU countries should look for ways to allow companies to offer alternatives to these “sufficiently profitable” medicines for rare diseases that no longer need market exclusivity to make a high profit.