The Government of Canada announced in a press release that it intends to launch a pilot project to include patient input during the drug submission review process. Input will help shape the role of public contributions to orphan drug approvals.
Patients will be asked to comment on the following:
- how the rare disease affects their ability to manage their day-to-day lives;
- what treatments are currently available (if any);
- what therapeutic benefits are most important to them; and
- their risk tolerance for any new treatments.
Health Canada will be asking patient advocacy groups including the Canadian Organization for Rare Disorders to assist in engaging specific Canadian patients affected by CLL or urea cycle disorders to participate in the project. The patient feedback provided during the pilot will assist Health Canada in assessing and refining its approach to gathering patient input. This will ensure that patient perspectives are considered in future orphan drug authorizations. Read more here