With respect to M-426, adopted in the second session of the 39th Parliament, calling on the government to respond to the challenges faced by Canadians with rare diseases and disorders, has the government: (a) established a definition for serious rare diseases; (b) examined options, including the possible creation of a specific fund, to improve access to rare disease treatments, building on recent work undertaken by federal, provincial and territorial governments under the National Pharmaceuticals Strategy; (c) considered the establishment of a multi-stakeholder advisory body, including treaters and patients, to recommend treatment access for life-threatening or serious rare disorders, based on scientific standards and social values; (d) explored options to consider national and international expert advice in developing criteria for treating patients based on scientific evidence and patient impact, and to link these activities with ongoing post-market monitoring of real world drug safety and effectiveness; (e) considered options to encourage research and development into treatments for rare diseases and other unmet health needs; (f) considered internationally accepted standards for conduct of clinical trials in rare disorders appropriate for the challenges inherent to very small patient populations; (g) considered how Health Canada’s work on a progressive licensing framework could provide appropriate support to the design of clinical trials for very small patient populations and appropriate review of evidence submitted from these trials; and (h) reported to the House the progress accomplished as of October 19, 2010?
In the House of Commons on December 2nd, 2010. See this statement in context.