EUCOPE Resources / News - May 15, 2020

A 20th Anniversary Analysis of the EU OMP Regulation

The 10th European Conference on Rare Diseases (ECRD), the largest patient-led event on rare diseases and orphan products, presented an excellent opportunity for exchange among the patient community and experts from various backgrounds.

The conference allowed EUCOPE to share the key findings of the study EUCOPE commissioned to the Office of Health Economics aimed at assessing how far the legislation has incentivised investment in the R&D of OMPs and what would be the impact of changing some of its core legislative elements.

In an online poster presentation at the ECRD, EUCOPE presented the key takeaways as to how the EU OMP Regulation has successfully incentivised companies to invest in the development of OMPs.

  • Orphan Designations granted by the European Commission have grown at a rate of 15% since 2000
  • 35% of the marketing authorisations granted between 2008 and 2018 were to OMP companies focused solely on developing products for rare conditions.

The poster is available to download here below.