EUCOPE Resources / Events & Meetings - September 17, 2021

Event report: EUCOPE/IML roundtable ‘Revision of the European Orphan & Paediatric Regulation and impact for the Nordic rare disease community’

EUCOPE, in partnership with the Swedish Industry Association for Small and Medium-Sized Life Sciences Companies (IML), hosted a roundtable on the Revision of the European Orphan & Paediatric Regulation with Nordic stakeholders on 7 September.

Over the last 20 years, the orphan and paediatric legislation have successfully incentivised R&D for orphan drugs with more than 200 products receiving Marketing Authorisation (MA) and more than 6 million patients accessing treatments across the EU. However, it did not translate into equal access and development across disease areas. Most Orphan Medicinal Products (OMPs) are concentrated in certain disease areas, and 55% of MAs have been granted to rare diseases with a prevalence of 1-5 in 10,000 (the most prevalent).

The revision of the legislative framework will impact patients, the research environment, and the healthcare ecosystem as a whole. It is important that the regulatory environment be conducive to increased R&D and allow better access to innovative therapies for patients.

EUCOPE and IML organised a roundtable with a panel of experts to discuss the impact, challenges and opportunities of the OMP Regulation review for the rare disease community in Denmark and Sweden. The roundtable gathered patient groups, research experts, industry representatives, and public authorities. The event built from EUCOPE’s proposals on the revision of the Orphan and Paediatric Regulation available here.


  • Terkel Andersen, President, EURORDIS Board; Co-founder, Rare Diseases Denmark


  • Birthe Byskov Holm, President, Sjældne Diagnoser (Rare Diseases Denmark)
  • Pernille Weiss, Member of European Parliament, EPP
  • Lina Nordquist, Member of Swedish Parliament (Liberalerna), spokesperson on health policy
  • Jonas Vikman, Director Government and International Affairs, LIF Sweden


  • Line Friis Frederiksen, journalist and biologist

Re-watch the event here


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