Rare Reflections: Impact of the OMP revision on rare disease companies in Europe EUCOPE's Sounds of Science

EUCOPE's Sounds of Science - Episode 16

On today’s episode, we explore the revision of the Orphan Medicinal Products (OMP) Regulation as part of the Pharmaceutical Package, and its impact on small and mid-sized pharmaceutical companies, the key drivers of innovation in Europe.

We’d like to deep-dive into the implications of specific Commission proposals, and how innovative pharmaceutical companies see the introduction of concepts such as high unmet medical need as the basis for a modulated incentive framework.

EUCOPE is no stranger to proposals to modulate the orphan incentive, having worked with the multi-stakeholder Expert Group on Orphan Drug Incentives to establish an alternative model, and today’s guest played an important role in developing that approach.

Building on the success of the past 20 years, and establishing a system that continues to drive research, and crucially address the 95% of rare diseases that have no established treatments is no small task. This requires creative and alternative solutions, and small and mid-sized innovative pharmaceutical industry is keen to play its role.

To help us understand the impact of this review, and how the European Innovative pharmaceutical industry sees the current proposal, we’ve got two rare disease experts joining us today:


Diego Ardigò, Head of Research & Development, Chiesi Global Rare Diseases
Alexander Natz, Secretary General, EUCOPE


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For more information on EUCOPE’s efforts on rare diseases and orphan drugs or how your organisation can contribute to it, please contact Victor Maertens maertens@eucope.org