Rare Reflections: Impact of the OMP revision on rare disease companies in Europe
EUCOPE's Sounds of Science
EUCOPE
0 • 0 Ratings
🗓️ 11 July 2023
⏱️ 40 minutes
🧾️ Download transcript
Summary
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
=============================================================================================================
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 [email protected]
Transcript
Click on a timestamp to play from that location
| 0:00.0 | Hello everybody and welcome to Sounds of Science, a series of podcasts hosted by |
| 0:09.5 | Yukope, a European trade body representing small and mid-sized companies active in health technologies. |
| 0:15.9 | My name is Victor Martens. I'm the Government Affairs Director at Yukope. Before moving forward, if you like this sort of content, |
| 0:22.5 | please consider subscribing to our podcast and following us on Twitter and LinkedIn |
| 0:26.0 | to stay up to date to all the latest news and initiatives within the world of European |
| 0:30.0 | life sciences. |
| 0:42.8 | On today's episode, we will explore the revision of the Orphan Medicinal Products, or OMP, |
| 0:48.9 | regulation as part of the pharmaceutical package, and its impact on mid-sized pharmaceutical companies, |
| 0:51.0 | key engines of innovation in Europe. |
| 0:56.7 | As listeners will undoubtedly be aware, the planned revision is the most significant review of the EU's pharmaceutical legislation in two decades, and the most significant review |
| 1:01.7 | of the Orphan Framework since it was introduced. |
| 1:04.7 | The changes we bring about now will shape the direction of research and the therapies |
| 1:09.7 | that become available for the next two to three decades. |
| 1:12.5 | Thus, the stakes are high. |
| 1:15.4 | We'll like to deep dive into the implications of specific commission proposals |
| 1:19.1 | and how innovative small and mid-sized pharmaceutical companies see the introduction of concepts |
| 1:24.7 | such as high on medical need as a basis for a modulated incentive framework. |
| 1:29.3 | Help us understand the impact of the review and how the European innovative pharmaceutical industry sees the current proposals. |
| 1:37.3 | We've got two colleagues with us here today. First of all, Dr. Alexander Nats, Secretary General of Yuko, great to have you again. |
| 1:45.3 | Thanks for having me. |
| 1:47.1 | And our special guest on this podcast, Dr. Diego Ardigo, head of research and development, |
| 1:54.1 | Global rare diseases at Kiezi. Thank you for joining us. |
... |
Please login to see the full transcript.
Disclaimer: The podcast and artwork embedded on this page are from EUCOPE, and are the property of its owner and not affiliated with or endorsed by Tapesearch.
Generated transcripts are the property of EUCOPE and are distributed freely under the Fair Use doctrine. Transcripts generated by Tapesearch are not guaranteed to be accurate.
Copyright © Tapesearch 2025.