Adressing the market failures in the orphan medicinal products

At the end of 2017, the European Commission launched a joint evaluation of the legislation on paediatric and orphan medicinal products (OMPs). The European Social Insurance Platform (ESIP), welcomes the initiative of evaluating Regulation nº 141/2000 on OMPs and takes this opportunity to raise concerns regarding its implementation.

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.