I3h Institute publication in the Lancet: Rebalancing innovation, affordability, and access for orphan drugs in the European Union

August 31 2026
I3h researchers from life sciences and economics Hilde Stevens, Georges Siotis, Micael Castanheira, Mathias Dewatripont, Sanae Akodad, PhD, Sam Daems and Michel GOLDMAN have, together with Alain Fischer, published the paper Rebalancing innovation, affordability, and access for orphan drugs in the European Union in the journal The Lancet – Regional Health Europe.

 

It starts from the observation that orphan drug policy in the European Union faces a double price-and-innovation gap: a small fraction of rare diseases receive important resources while the overwhelming majority are under- or un-researched, leaving most rare disease patients facing high unmet medical needs. To address this double problem of innovation and affordability and access, we propose an integrated strategy to develop affordable innovative solutions for patients with rare diseases. It would include a set of measures included in the EU Pharma package, the EU Biotech Act and the Draghi report, complemented by public-private Specific Purpose Vehicles to de-risk innovative endeavours and joint procurement of orphan drugs to facilitate their availability to European patients.

 

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