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Minister of Natural Resources June 9th, 2009
Mr. Speaker, this is a very serious issue. The shortage is a concern. Canadians can have confidence that I will take the necessary steps to protect the health and safety of Canadians.
For the last 18 months, my department has been working very closely with the experts, the provinces and the territories on contingency measures that are being used in situations like this.
Health June 8th, 2009
Mr. Speaker, I have been in regular contact with my provincial and territorial counterparts in managing this situation. The medical expert community has provided alternatives for procedures in the provinces and territories. I continue to meet with the medical experts in managing this situation.
Health June 8th, 2009
Mr. Speaker, since 2007, government and health care providers have developed contingency measures to minimize the impact on patients. That includes using alternative isotopes such as thallium for cardiac scanning.
This morning I again had a conference call with the medical experts community in how we are managing this situation. In terms of how to move forward, we are meeting with them this weekend to again discuss how we can provide assistance and alternatives to the provinces and territories.
Health June 8th, 2009
Mr. Speaker, again, let me repeat that the medical experts community has advised of alternatives that are available to provinces and territories. That means other isotopes can be used to assist provinces and territories in managing their supplies. The alternatives, such as thallium, iodine or gallium, can be used in the provinces and territories to deal with the shortage.
Health June 8th, 2009
Mr. Speaker, again, we are working with the medical isotopes experts and they have advised that in terms of alternatives, Thallium-201 can be used. What does that mean for treatment? This can be used as an alternative for most heart tests, which accounts for approximately half of all the Tc-99 procedures in Canada. Iodine-123 can be used to image kidney and thyroid glands. Gallium-67 is used for the detection of Hodgkin's disease and lymphoma, among other things.
That list of alternatives and options was provided by the medical experts on medical isotopes to provinces and territories.
Medical Isotopes June 8th, 2009
Mr. Speaker, Health Canada has taken measures, providing advance warning to update the provinces as well. Working with isotope medical experts, we are looking at alternatives. Many tests can be completed using other options. What this means for Canadians is that we are making alternatives available so medical isotopes can be used where most needed.
While Health Canada does not regulate the price of pharmaceutical products, including isotopes, we will continue to work with the provinces and territories in addressing the issue.
Medical Isotopes June 8th, 2009
Mr. Speaker, in 2007 our government and health care providers developed contingency measures to minimize the impact on patients. This includes using alternative isotopes, such as thallium-201, for cardiac scanning.
We are working closely with the experts on medical isotopes who are assessing and assisting in identifying alternatives for provinces and territories. Health Canada is taking every possible step to ensure access to alternative isotopes where possible.
Medical Isotopes June 8th, 2009
Mr. Speaker, as far as the current medical isotope shortage is concerned, I have engaged the provincial and territorial ministers and the medical experts in this field. In fact, this morning I had another conference call with medical experts to deal with the situation.
Canada is dealing with the situation by identifying alternatives to medical isotopes. We will continue to monitor the situation as we deal with it.
Questions on the Order Paper June 5th, 2009
Mr. Speaker, recent data indicate that sales to the U.S. have decreased significantly from their 2004 peak. While there are initiatives underway in the U.S. that may potentially increase the volume of sales in the future, these are not yet in effect or finalized. Pre-emptive action is not required at this time, and it would be more prudent to assess the final version of any U.S. initiative before making a determination on a course of action.
Cross-border drug sales, CBDS, have been occurring for some time now, via both “foot traffic” and mail order. Health Canada has monitored CBDS levels and U.S. legislative activity in this regard since approximately 2002, assessing potential risks to Canada's drug supply. CBDS from Canada to the U.S. via mail order rose steadily from the beginning of 2000 until it peaked in 2004 at approximately $850M. Latest estimates of annual mail-order sales are about $173M, approximately 20% of the 2004 peak. Primary factors explaining the decline include: the implementation of U.S. Medicare Part D (seniors’ prescription drug benefit); supply restrictions to Canadian-based Internet pharmacies by the drug industry; and the surge (until recently) in the value of the Canadian dollar (relative to its 2003-2004 value).
Foot traffic, which existed prior to Internet commerce, remained steady at approximately $500M annually from 2004 to 2008. While the same factors as listed above would be expected to have reduced foot traffic, more recent data are not available.
Recent events in the U.S., such as the newly re-introduced bill seeking to legalize the bulk import of drugs, may have the potential to increase American demand for Canadian drugs if implemented successfully. The primary concern from some stakeholders has been with the potential impact on the Canadian drug supply and prices. This has led to renewed calls for possible Government of Canada interventions that could be used to address future drug supply issues in Canada. However, export prohibitions at this time are not consistent with Canada’s international trade obligations unless they fit within recognized exceptions, namely to protect human health or to prevent/relieve critical shortages.
This Government is committed to the health and safety of Canadians and would explore all available options in the event that Canadian supplies were jeopardized. Even if the U.S. legalizes bulk imports, actual implementation would take longer than a year, allowing time to prepare for any concern with the potential impact of bulk imports.
Health Canada officials, in co-operation with their colleagues at the Canadian Embassy in Washington, continue to monitor the export of drugs to the U.S., as well as the progress of U.S. legislation. Current CBDS levels, which are actually declining, do not warrant government intervention. As the American initiatives pass through the U.S. legislative process and evolve, Government of Canada officials will continue to assess them and formulate appropriate policy responses based on those assessments.
Questions on the Order Paper June 5th, 2009
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.