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CORD Chance for Life Fund |
One in ten Canadians has been diagnosed with a rare disorder. CORD works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada. CORD provides information, connects families to one another and supports rare disorder groups and organizations across the country.
“A Chance for Life Fund”
Canada is one of the only developed countries in the world that does not have an orphan drug policy. Not only does Canada not support research and development into treatments for rare and neglected disorders, Canadian patients with rare disorders often do not have the same access to life-saving therapies as patients in other countries. CORD requests immediate action on the following proposals.
∑ Establish a national (federal/provincial/territorial) “Chance for Life Fund” equivalent to 2% of the total annual public drug expenditure to be designated for therapies for rare disorders.
∑ Establish 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 (humanitarian, ethical and compassionate criteria).
∑ Establish Centers of Reference for specific rare disorders, comprised of national and international experts, who will develop criteria for treating patients based on scientific evidence and patient impact and provide on-going surveillance into the real-world safety and effectiveness of these treatments on individual and group basis.
∑ Provide incentives through Orphan Drug Regulation and policy equivalent to those in the United States and European Union to assure Canadian organizations and researchers are motivated to conduct research and development into treatments for rare and neglected disorders.
∑ Ensure internationally accepted standards for conduct of clinical trials in rare disorders appropriate for the challenges inherent to very patient populations (i.e. low number of individuals affected, limited long term data, lack of validated measures, etc.).
∑ Ensure Health Canada’s progressive licensing framework provides appropriate support to the design of clinical trials for very small patient populations and appropriate review of evidence submitted from these trials.
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