34 min
Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas EUCOPE's Sounds of Science
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- Life Sciences
SOUNDS OF SCIENCE - EPISODE 7
The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days.
Recent literature has identified no less than 15 different definitions of unmet medical needs. These include various elements ranging from the absence of therapeutic options to disease burden and severity, just to name a few.
UMN is not a foreign concept in EU Legislation and national assessment, but now it has become quite central to the discussion on the revision of the Orphan, Paediatric and General Pharmaceutical Legislation.
We expect proposals for the revision of these pieces of legislation at the end of this year. The European Commission is contemplating the option of defining or including criteria to identify unmet medical needs in the General Pharmaceutical Legislation context and possibly include a concept of high or highest unmet medical needs in the orphan legislation context.
To help us unpack the ongoing discussion and provide some perspectives on it, we’re joined by:
Dimitrios Athanasiou, Board Member of the World Duchenne Organization (WDO), European Patients' Forum (EPF) and a member of the Paediatric Committee of the European Medicines Agency (EMA)
Alexander Natz, Secretary-General, EUCOPE
This episode is hosted by Vittoria Carraro, Associate Director of Government Affairs at EUCOPE.
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The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) gives a bigger voice to small to mid-sized health technology companies in Europe. Representing 2600+ innovative biopharmaceutical companies directly or through national associations, EUCOPE advocates for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through innovative therapies and medical technology. Learn more at www.eucope.org
SOUNDS OF SCIENCE - EPISODE 7
The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days.
Recent literature has identified no less than 15 different definitions of unmet medical needs. These include various elements ranging from the absence of therapeutic options to disease burden and severity, just to name a few.
UMN is not a foreign concept in EU Legislation and national assessment, but now it has become quite central to the discussion on the revision of the Orphan, Paediatric and General Pharmaceutical Legislation.
We expect proposals for the revision of these pieces of legislation at the end of this year. The European Commission is contemplating the option of defining or including criteria to identify unmet medical needs in the General Pharmaceutical Legislation context and possibly include a concept of high or highest unmet medical needs in the orphan legislation context.
To help us unpack the ongoing discussion and provide some perspectives on it, we’re joined by:
Dimitrios Athanasiou, Board Member of the World Duchenne Organization (WDO), European Patients' Forum (EPF) and a member of the Paediatric Committee of the European Medicines Agency (EMA)
Alexander Natz, Secretary-General, EUCOPE
This episode is hosted by Vittoria Carraro, Associate Director of Government Affairs at EUCOPE.
-----------------------------------
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) gives a bigger voice to small to mid-sized health technology companies in Europe. Representing 2600+ innovative biopharmaceutical companies directly or through national associations, EUCOPE advocates for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through innovative therapies and medical technology. Learn more at www.eucope.org
34 min