In view of the upcoming revision of the EU pharmaceuticals legislation (expected in Q1 2023), ESIP & MEDEV published a joint position on the EU legislation on medicines for rare diseases (orphan medicinal products - OMPs).
The ESIP & MEDEV position includes a compilation of amendments to Regulation (EC) 141/2000 & Regulation (EC) 847/2000 and the accompanying position paper. The ESIP & MEDEV amendments aim to address the unintended consequences in terms of market distortions brought about by the existing legal framework, such as concentration of R&D in specific disease areas (of higher profit), artificial segmentation of conditions into smaller subgroups as well as increasingly high price demands. The consolidated chart focuses on rebalancing the incentives systems, steering research and development towards areas of truly rare diseases and unmet needs.
To ensure that the revised legislation is fit for purpose we recommend to: Find our sets of ESIP-MEDEV amendments to the OMPs legislation and the accompanying position paper.
This position complements our detailed ESIP-MEDEV amendments to the EU general pharma legislation, published in June 2022 - here the key messages.