Last month, a draft report was presented by MEP Nicolás González Casares, member of the European Parliament Committee on Public Health (SANT), calling on the European Commission to develop legislation establishing a comprehensive European rare disease action framework. This represents an important step forward in efforts to establish a coordinated rare disease strategy at the EU level, particularly in light of the recent EPRS European added value assessment, and past calls from the European Economic and Social Committee (EESC) for an EU action plan on rare diseases.
The draft report discusses the persistent unmet medical need and additional challenges faced by the approximately 30 million people living with a rare disease in Europe, and proposes that the Parliament call on the European Commission to address these challenges by establishing a comprehensive and binding rare disease action framework. Such a framework would help reduce fragmentation and inequalities across diagnosis, treatment access, research coordination, data infrastructure, patient support, and governance.
One particular issue highlighted in the report is that of the diagnostic odyssey. The proposed text includes the objective that by 1 January 2030, Member States should ensure that patients with suspected rare diseases receive an accurate diagnosis within one year of the first medical consultation, where medically feasible.
Shortly after the draft report’s presentation, EURORDIS released a statement welcoming the report and praising its holistic approach to tackling rare diseases.
“We are very happy with this draft report, which reflects a growing recognition in Europe that rare diseases cannot be addressed through fragmented national policies alone. The scale of the challenge demands a coordinated European approach.” -Valentina Bottarelli, Head of Policy & Public Affairs at EURORDIS
For the moment, the text remains a draft legislative own-initiative report (INL), the mechanism used by the European Parliament to formally request that the Commission submit legislative proposals. Once it has moved through the Parliament’s process, further action will depend on how the Commission and Member States choose to respond.
