EUCOPE Resources / News - July 19, 2022

?️Sounds of Science – Episode 7 on Unmet Medical Needs (UMN)

Sounds of Science Podcast – Episode 7

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

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:

This episode is hosted by Vittoria Carraro, Associate Director of Government Affairs at EUCOPE.

You can listen to Episode 6 and all other Sounds of Science episodes using the links below:

Episode Highlights

Dimitrios Athanasiou, Board Member of the World Duchenne Organization (WDO),

“What we care about is that we have new products up and running and really products that are having an impact that are affordable and they can save our people.”

“The regulation should include the flexibility that the science brings and translate it from end to end in a central regulatory EU document.”

“There should be something tangible enough where the market forces cannot deliver for the handmade need but broad enough to include technology that continuously innovates.”

Alexander Natz, Secretary General, EUCOPE

“The discussion about an unmet medical need is very much focused around pricing and reimbursement decisions in HTA procedures. So it’s not something new that we are inventing. I sometimes have the feeling that this is not stressed enough in the political discussions in Brussels.”

“We should focus on areas where there are a lack of alternatives and at the same time, allow for competition in areas where the development is ongoing to make sure that products can reach patients in the market and then benchmark and compete on price and compete on price.”