October 16, 2012
Previously published on October 2012
Summary On October 3, 2012, the Minister of Health, the Honourable Leona Aglukkaq, announced the government’s intention to introduce regulations that would govern the submission for and approval of drugs for rare diseases, often termed “orphan” drug products, in Canada. These regulations, it is expected, will be introduced as the first of several regulatory amendments that will, over time, completely overhaul and modernize the current Food and Drug Regulations. The government’s news release states: Today, when an orphan drug is not available in Canada, the patient’s doctor can apply individually for each patient through Health Canada’s Special Access Programme. While facilitating access - the current approach also represents a significant burden to the healthcare system. A regulatory framework designed and used specifically to approve drugs to treat small, vulnerable populations will more effectively address this need. A key focus of this new approach will be on international information-sharing and collaboration for the development and regulation of orphan drugs. As part of the announcement, the launch of the Orphanet Canada was introduced; this is an online reference portal, that contains a “comprehensive database of information contributes to improvements in the diagnosis, care and treatment of patients with rare diseases. It is being launched with the support of the Canadian Institutes of Health Research (CIHR), and will “provide Canadians with expert, peer-reviewed information on rare diseases, as well as a specialized services directory.” The move to recognize drugs for rare diseases in Canada and launch of the portal will be a welcome one for many stakeholders, including manufacturers of these products as well as patient groups. These products have not, to date, had a formally recognized status in Canada. While it remains to be seen what the system will look like for Canada, in other countries the manufacturers of such products typically are entitled to a reduction in submission fees, as well as a priority review of the submission, aimed at providing more timely patient access. In addition, a form of “market exclusivity” is available to the manufacturers of these products in countries including the US, throughout the European Union and Japan, aimed at providing incentives to conduct research into small patient populations. Once the regulations are announced, a consultation process will follow. The regulations will be finalized after consultations have been considered and adjustments to the package that are considered advisable, based on those consultations, have been made. Norton Rose Canada LLP will be monitoring the development of an orphan drug pathway in Canada.
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