News Press Release

OD Expert Group kicks off Phase 3

Yesterday, 13 May 2024, the multi-stakeholder OD Expert Group officially launched its Phase 3 during an online workshop. Thanks to all the experts who joined and contributed to making the workshop a great success.

The workshop allowed for fruitful discussion to take place on principles and best practices related to access to orphan medicinal products (OMPs) for people living with rare diseases. The members of the OD Expert Group contributed with informative comments and insightful ideas on the future of access within the European Union (EU).

The OD Expert Group, recognizing the timely and significant nature of the political debate surrounding the issue of access to OMPs, has chosen to dedicate the third phase of its work to treatment access. Previously, in its first two phases, the Group developed and presented a report with 14 recommendations to address existing gaps through the entire rare disease lifecycle, a report with policy proposals on the revision of the OMP Regulation, and a two-part report on an EU HTA for Rare Diseases (clinical evidence in joint clinical assessments; stakeholder involvement in joint clinical assessments). Now, the third phase aims to develop policy proposals that promote broader and more equitable access to OMPs for people living with a rare disease across the EU.

Phase 3 will address two related key questions:

  • How can existing access tools be leveraged more broadly across Member States to improve access to OMPs for European citizens today?
  • How could a common EU access pathway for priority OMPs look?

The solutions identified by the OD Expert Group aim to provide input within the rare disease community to help chart a path forward for a more effective legislative and regulatory framework, capable of addressing the needs of people living with rare diseases.

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Posted on 14. May 2024