Health Canada
Biologics and Genetic Therapies Directorate
3rd Floor, LCDC Bldg.
Tunney's Pasture
Address Locator # 06030
OTTAWA, Ontario
K1A 0L2
03-100653-245
February 11, 2003
Ms. Karen Butler
Chairperson, National Advocacy Council
Canadian Diabetes Association
Varette Building
130 Albert Street, Suite 421
Ottawa, Ontario
L1P 5G4
Dear Ms. Butler:
I am writing in response to your letter of January 10th.  As you may know, we have recently appeared before the Standing Committee on Health, with the Society for Diabetic Rights, to provide information on animal-sourced insulin.  At that hearing, Health Canada formally recognised that there are indeed some Canadians who need animal-sourced insulin not only to manage their diabetes, but in fact to maintain their lives.  As partners in the health care of Canadians, we too believe that this access issue must be resolved.
In response to your specific questions about the costs of insulin acquired through the special Access Programme (SAP), I must first clarify a few points:
Health Canada does not charge any fees, including 'import fees' for the SAP;
Health Canada does not set the price - and has no authority over the price - of the product being imported;
Products imported through the SAP have not been assessed for safety and effectiveness and thus have not been approved by Health Canada;
The actual transaction or purchase occurs directly between the physician (on behalf of the patient) and the manufacturer;
The role of the SAP occurs prior to the actual transaction and is intended to ensure that Health Canada shares with the importing physician any known (to Health Canada) risks associated with the product;
The decision to import and use the product falls within the practice of medicine; and finally
The decision to include a specific product on provincial/territorial formularies, and thus to cover the consumer's costs, is made by individual Provinces and Territories.
Having said all that, we do nonetheless believe that Health Canada can play an important role in facilitating access to this essential product.
As a first step, we have researched other possible sources of animal insulin with a view to encouraging manufacturers to seek marketing authority in Canada.  As a general rule, products not licensed for market in Canada are not included on provincial/territorial formulary, it is our hope that by encouraging manufacturers in this way, we may eliminate one potential hurdle.  One company expressed a possible interest several years ago.  We have recently communicated with them to determine what we might do to transform this expression of possible interest into an actual submission.  To date, this has not yielded the desired results.  It may be that an invitation from the Canadian Diabetic Association would help rekindle the interest.
Other steps which we are currently taking include rewriting the July 2002 It's YourHealth on insulin.  We will be consulting with the CDA as well as with the SDR on the final text for this document; the objective is to ensure factual, balanced information about bio-synthetic and animal-sourced insulin.
Health Canada takes this matter of product access very seriously and is in the process of developing a specific project team and action plan to address a number of related concerns.  To make progress, it will be important that partnerships be strengthened with organizations such as the Canadian Diabetic Association and the Society for Diabetic Rights as well as with industry.  Further, communication will be forthcoming in this regard.  In the meantime, should you wish to raise any further concerns, I would be very pleased to hear from you.
Yours sincerely,
Julia Hill
Acting director General
Cc:  The Society for Diabetic Rights
Congratulations to the Society for Diabetic Rights!!!
This breakthrough made by the Society for Diabetic Rights is, indeed, wonderful progress and was done for the benefit of all diabetics around the world that have found that beef or pork insulin is better suited to treat their diabetes.
This is a copy of the letter they received from Health Canada.
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House of Commons/Sub-Committee on Health hearing with Society of Diabetic Rights

FULL
transcripts of the meeting are now available at:
http://www.parl.gc.ca/InfoComDoc/37/2/HEAL/Meetings/Evidence/HEALEV18-E.HTM#int-400916
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