The existing incentive schemes within the OMP regulatory framework have led to market failures where patients' access to effective medicines was endangered by high prices, as highlighted by the Council conclusions of June 2016. In addition, the increasing “orphanisation” of disease by targeting subgroups of broader disease groups is a further source of concern. As a result, rather than tackling real unmet medical needs, OMPs are often developed to maximise profit. 

Therefore, ESIP proposes to amend the OMP Regulation by revising the current prevalence threshold, by combining the two existing criteria for orphan designation, by including a refined definition of "significant benefit", by requiring that EMA regularly reviews the case for market exclusivity and including a definition of “sufficiently profitable”, among other proposals. 

You will find more about our proposals in our position paper.