Mr. Speaker, in response to (a), despite encouragements and repeated discussion with three manufacturers of animal insulin preparations, and despite the fact that these manufacturers were made aware of the potential financial incentives to them, including the reduction, even to zero, of fees charged for review of therapeutic products, they indicated that, without a sufficiently large, and guaranteed, market, none of the incentives offered were of sufficient interest to them.
It should be noted that two pork derived insulin products are already approved for market in Canada. Nonetheless, should there be additional applications for animal insulins and simultaneous filing in both Canada and the United States, in line with a memorandum of understanding and ongoing collaboration on a wide-variety of issues with the US, Health Canada would ensure that all regulatory requirements are harmonised between the two countries. Harmonisation of regulatory approaches and requirements is already an ongoing activity, and would not be limited to a single class of product(s).
In response to (b), Health Canada is working actively on an educational plan and materials to ensure that the medical community is aware of the issues surrounding the use of insulin of animal origin vs. biosynthetic insulin. These activities are directed at both physicians and patients.
In response to (c), Health Canada does not have the authority to pursue statements in treatment protocols through the Canadian Diabetes Association, CDA. As a professional body, the CDA is independent of the federal government. Despite this, Health Canada can introduce appropriate statements on the labels for all insulin products. The intent of these statements would be to inform physicians in a continuous manner of the reported issues surrounding animal vs. biosynthetic insulin products. Since labels contain a Consumer Information Section, patients would also be informed.
In addition, Health Canada is considering the publication of a short article on the subject in the Canadian Adverse Reaction Bulletin and even send letters to the editors of several continuous medical education publications to reinforce the messages. Finally, there may be an opportunity to update the Fact Sheet, published by Health Canada, on the treatment of diabetes.
In response to (d), the Canada Health Act requires provinces and territories to provide coverage of medically necessary pharmaceutical drugs administered in hospitals. However, there is no federal legal requirement for them to provide such coverage outside of a hospital setting. Provinces and territories of their own accord have developed publicly-funded pharmaceutical insurance plans, including insulin, and decide the terms and conditions for such plans for their residents, including eligible population groups, formularies, and pricing. The 2004 Health Accord has provided substantial additional funding to strengthen health care over a 10-year period to provincial and territorial governments, which they may use to enhance and expand publicly-funded drug plans, including coverage of increased drug costs for their residents.