Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas

EUCOPE's Sounds of Science

EUCOPE

Science, Life Sciences

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🗓️ 18 July 2022

⏱️ 34 minutes

🔗️ Recording | iTunes | RSS

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Summary

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

Transcript

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0:00.0	Hello everybody and welcome to Sounds of Science, a series of podcasts hosted by
0:10.4	Yuko, the European Trade Body representing small and medium-sized companies active in pharmaceutical
0:15.8	and medical technologies.
0:17.7	My name is Victoria Carraro, and I am the Associate Director for Government Affairs at
0:21.7	Yukop and your host on today's podcasts. Before moving forward, if you like this sort of content,
0:27.7	consider subscribing to our channel and follow us on Twitter and LinkedIn to stay up to date
0:32.7	on all the latest news and initiatives within the world of European life sciences.
0:37.4	The topic of today's podcast is Unmet Medical Needs, a topic that is quite high up on the
0:42.7	agenda in European health policy these days. Recent literature identified no less than 15
0:48.5	different definition of unmeted medical needs. Those include various elements ranging from
0:53.3	absence of therapeutic options to
0:55.2	disease burden and severity, just to name a few. A medical need is not a foreign concept in new
1:00.6	legislation and national assessment. But now it has become quite central to the discussion on the
1:05.8	revision of the orphan, pediatric and general pharmaceutical legislation. We expect proposals for the revision of these pieces of legislation at the end of this year.
1:16.2	The European Commission, who is responsible for proposing these reviews,
1:19.6	is contemplating the option of defining or including criteria to identify medical needs
1:25.8	in the general pharmaceutical legislation context, and
1:28.3	possibly include the concept of high or highest unmet medical needs in the orphan legislation
1:33.3	context.
1:34.3	We have been discussing the option for revision of these important pieces of legislation
1:39.3	for about two years, with a pandemic in between.
1:42.3	And the debate has been quite intense on what would be
	...

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