Industry Wants EU Incentives for Orphan Devices, Diagnostics

The European Commission should offer incentives for research on medical devices for rare diseases similar to the ones it provides for orphan medicines, an industry group says.

In its comments on a public consultation on rare diseases, Eucomed also says it would be appropriate to analyze the current requirements set forth in Directives 90/385/EEC and 93/42/EEC for custom-made devices and in Article 11.13 for compassionate use devices.

While these requirements allow nonmass-produced devices to be marketed without a full conformity assessment, implementation is left to individual European Union (EU) member states, resulting in a lack of harmonization and uneven access to diagnosis and treatment, Eucomed says. An orphan regulation on devices and diagnostics also would help address the fragmented tracking of diagnoses of rare diseases, the group adds.

Eucomed recommends broadening the definition of rare diseases to encompass patients with more common diseases who have exhausted standard therapeutic options. “Such patients with severely impaired health status may eventually profit from extracorporeal therapy (‘last resort’ option),” Eucomed says.

The commission plans to publish a communication on a “European Action in the Field of Rare Diseases” in November 2008. The public consultation, “Rare Diseases: Europe’s Challenges,” is available at ec.europa.eu/health/ph_threats/non_com/docs/raredis_comm_draft.pdf.