Mr. Speaker, in regard to a) Health Canada has been working continuously for the past years to implement a multi-pronged approach to resolving the issues around the availability of animal insulin (beef and pork). Health Canada believes that it is important to have a variety of choices for treatment in order to provide the optimal care to all patients, as much as possible.
In regard to b) Since there are no longer any domestic manufacturers of animal insulin (beef or pork), Health Canada has approached several manufacturers of animal insulin abroad, in England, Argentina and Poland. Of these, only one filed information required to market insulin of animal origin. Also, this same manufacturer, Wockhardt, although producing both pork and beef insulin for domestic use, has refused to file for the marketing of beef insulin in Canada. Similarly, two other manufacturers of insulin from abroad, have declined to file for authorization to market their insulin, be it pork or beef. Despite having discussed Canadian requirements with two of the three manufacturers noted above, and despite the fact that these manufacturers were made aware of the potential for some financial incentives, including the reduction (even to zero) of fees charged for the review of therapeutic products, they indicated that unless there is a sufficiently large market, none of the incentives offered were of interest to them.
Health Canada does not have the authority to compel manufacturers to file a submission for a therapeutic product. Similarly, incentives other than the regulatory ones, would place Health Canada in a conflict of interest.
Furthermore, Health Canada does not have the legal authority to secure guarantees for continued insulin supply. Stockpiling of insulin is outside the scope of the mandate except for situations of emergency, such as Pandemic flu.
However, Health Canada does make beef insulin available via the special access programme for those who require it. There is a small number of patients who avail themselves of special access programme.
In regard to c) The federal government provides significant funds to ensure the sustainability of the whole health care system; the administration and delivery of health care, including drug coverage, is a provincial and territorial responsibility.
Under the Canada Health Act, all medically necessary drugs when administered in hospital must be insured by provincial and territorial health insurance plans. Prescription drugs provided outside of hospital are outside of the scope of the Act and therefore, provincial and territorial governments determine, at their own discretion, whether, and under what terms and conditions, to publicly finance prescription drugs. As to catastrophic drug coverage, i.e., coverage for high out-of-pocket drug costs relative to income, most jurisdictions, including Ontario (the Trillium Drug Plan), already offer a form of catastrophic drug coverage to their residents. As well, most jurisdictions (Ontario included) have, for persons who are eligible for coverage, exceptional access programs for drugs not listed on their benefit formularies.
Pursuant to the 2004 Health Accord, the federal government committed to providing an additional $41.3 billion over 10 years to provinces and territories in support of strengthening health care, including pharmaceuticals management. These monies are provided through the legislated Canada Health Transfer, which grows by six per cent annually and will reach $24 billion this year. How jurisdictions use these funds is their decision, but these funds can help provinces with the costs of their drug plans, including catastrophic coverage. Several jurisdictions (Saskatchewan, Nova Scotia, and Newfoundland and Labrador) have recently expanded drug coverage for their populations, and Health Canada welcomes such initiatives.
As part of the same accord, the federal government agreed to a shared agenda with provinces and territories to improve the collective management of pharmaceuticals, recognizing the complementary roles (federal responsibilities include regulating market access and patented drug prices, and post-market drug surveillance). The government continues to welcome opportunities for meaningful collaboration on pharmaceutical issues to realize efficiencies in the health care system, so that public resources can be used most effectively.
In regard to d)i) Health Canada convened an expert panel to examine the clinical/medical facets of the issues surrounding the usage and availability of animal insulin. The panel has recognized that there is a medical aspect to the question of animal vs biosynthetic insulin. The report of the panel has been submitted to Health Canada and it will be studied in order to develop an action plan for implementation of the recommendations in the report.
In regard to d)ii) Health Canada is preparing a plan for educational materials to ensure that the medical community is fully aware of the issues surrounding the use of animal vs biosynthetic insulin. The plan will be finalized in conjunction with the action plan following the recommendations of the expert panel on animal insulin.
If a manufacturer or potential manufacturer approaches Health Canada, it will ensure that such a sponsor can file a submission to market animal insulin, be it pork or beef, in the shortest possible time.
In regard to e) Health Canada regularly reviews safety data concerning insulins submitted by market authorization holders and adverse reactions submitted to the marketed health product directorate’s Canada vigilance database. The safety data submitted by market authorization holders and adverse reactions reports in the Canada Vigilance database are regularly reviewed to ensure that all insulins on the market remain safe for human use.
In regard to f) As indicated above, Health Canada is reviewing recommendations from an expert panel formed to address the issue of animal versus biosynthetic insulins. Educational materials are also being prepared to raise awareness of the medical community on this issue.
In regard to g) Under the Canada Health Act, the provinces and territories are required to extend provincial and territorial health insurance plan coverage to their residents for medically necessary hospital and physician services. For services that are outside the scope of the act, including prescription drug benefits, coverage is at the discretion of the individual provinces and territories, on their own terms and conditions.
