In response to (a), the motion called for exploratory work related to research, regulation and reimbursement of drugs for rare diseases, in collaboration with provinces and territories and stakeholders. The Motion did not establish a program or policy. Initial analysis on motion no 426 was undertaken after it was adopted in May 2008 and before Parliament was dissolved. The Government continues to consider the issue of drugs for rare diseases and the need, if any, for action in areas of federal responsibility. Further work in this area will require the active engagement of provinces and territories, who, as noted above, have primary responsibility for drug coverage.
In response to (b), No stakeholder consultations on the motion were held before the dissolution of Parliament. However, Health Canada officials have discussed related issues with stakeholders, notably the Canadian Organization for Rare Disorders CORD, on numerous occasions. CORD has been an active participant in formal consultations with respect to legislative and regulatory modernization since 2006. The organization has identified data challenges in the review and authorization of products for small populations as a key concern. They have been very supportive of efforts to modernize the Food and Drugs Act and Regulations.
In response to (c), Past analytical work related to the motion and the broader issue of drugs for rare diseases has been conducted within existing resources.
In response to (d), The federal government recognizes the challenges faced by Canadians with rare disorders, and will continue to examine issues related to treatments for rare disorders within the scope of federal role and responsibilities. For example, Health Canada is looking at the regulatory challenges posed by drugs for rare diseases, as part of the department’s ongoing work on regulatory modernization. CORD and other stakeholders have been consulted in this work. It is important to note that prescription drugs provided outside of hospital are outside of the scope of the Canada Health Act and hence, provincial and territorial governments determine, at their own discretion, whether, and under what terms and conditions, to publicly finance prescription drugs, including drugs for rare diseases. The only exceptions are federal populations, e.g., first nations and Inuit, military, veterans, for which the federal government directly provides services. However, the federal government continues to pursue constructive and collaborative work with provinces and territories, including finding ways to better assess drugs for rare diseases for potential reimbursement by our respective drug programs.
In response to (e) To clarify, no program was established through this motion, which called for exploratory work only.