HEAL Committee Report

Ms. Bonnie Brown, M.P., Chair

Standing Committee on Health

Room 147, Confederation Building

House of Commons

Ottawa, Ontario

K1A 0A6

 

Dear Ms Brown:

 

I am writing in response to the recommendations that were raised in the June 13^th, 2003  report from the House of Commons Standing Committee on Health on Animal-Sourced Insulins: Availability for Diabetics.  First of all, I would like to thank the Committee for their work on this important issue, and for making the detailed recommendations in their report.

 

I would like to begin by reviewing the scope and mandate of my Department’s regulatory role.  Health Canada is the national authority that regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians.  The Food and Drugs Act, from which Health Canada derives its authority, provides the Department with the necessary powers to address the safety, efficacy and quality of a product.  These powers are exercised in several ways, including pre-market and post-market review of scientific and clinical information (including assessing the veracity of claims and the appropriateness of labels); the Department also inspects and licences the facilities which manufacture the products.

 

Under the rubric of safety and efficacy, Health Canada can, for example, cause a product to be withdrawn or require a label change; however the Food and Drugs Act does not provide Health Canada with the authority to oblige a company to either develop a new product or to maintain an existing product on the market.  The Department has no authority whatsoever in compelling a company to either seek marketing authorisation in Canada or to supply the Canadian market with a product once it has been approved for sale in Canada.

 

With respect to the Committee’s report, I would like to recognize the importance of each of the recommendations and the concerns underlying them.  I would like to advise the Committee that indeed my Department has taken a number of recent measures to address the issue of the availability of animal insulins in Canada; and these include revising our information bulletins and advisories to advise Canadians that pork insulins are still available in Canada as a treatment option, working with the Canadian Medical Association to include in their next revised edition of the Clinical Practices Guidelines about the availability of pork insulins, as well as working with Rx&D (Canada’s Research-based Pharmaceutical Companies) to develop recommendations in terms of best practices to adopt when a company intends to discontinue a prescription in Canada.

 

I would now like to turn to each of the recommendations and discuss what action or consideration the department has taken on it.

 

Recommendations by the Standing Committee on Health

 

Recommendation 1: That Health Canada make necessary adjustments to the Special Access Program (SAP) such that (a) any costs that place an undue burden on a patient are absorbed by the federal government and, (b) the bureaucratic burden is reduced.

 

Response

 

Reducing bureaucratic burden

 

I would like to briefly explain the purpose of the Special Access Programme (SAP); this program allows medical practitioners to request access to drugs that are unavailable for sale in Canada.  This access is limited to patients with serious or life‑threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable.  These range from pharmaceutical, biologic, and radiopharmaceutical products that are not approved for sale in Canada.  Most of these drugs treat patients with life threatening diseases or serious conditions such as intractable depression, epilepsy, diabetes, transplant rejection, hemophilia and other blood disorders, terminal cancer, and AIDS.  The SAP can also respond to specific health crises, such as an outbreak of a communicable disease, by providing access to nonmarketed drugs.

 

SAP procedures are drawn from regulations based on the Food and Drugs Act, and have been streamlined to be the least complicated possible.  The SAP is prepared to entertain requests for larger volumes of drug supplies up to 1 year instead of the current six months to give some flexibility to those patients who would like to make larger orders to save on shipment costs.  Any further changes would require a review of the relevant provisions.

 

Reducing costs incurred by patients

 

The department undertook an analysis of the aggregate costs for procurement and shipment to determine what the costs being faced by patients would be to procure SAP-released insulin products.  Annual costs on shipment are directly proportional to the number of orders made; this portion of the total cost would be alleviated by the additional flexibility in processing drug release applications in the SAP as described earlier.  This falls within federal purview.

 

Drug procurement costs form an important part of the total cost incurred during private transactions and are normally covered by the patient, or private prescription insurance, or provincial drug formularies for purposes of reimbursement, and therefore outside of Health Canada’s mandate and authority to regulate.

 

Recommendation 2: That Health Canada report annually to the Standing Committee on Health through the House of Commons on the status of animal-sourced as well as human recombinant insulins.

 

Response

 

Submission of an Annual Report

 

There is considerable information that can be obtained about the status of adverse reactions of any product by sending a request for information to the following email address: cadrmp@hc-sc.gc.ca, which is also indicated on Health Canada’s website, or by calling 1-866-234-2345, or by faxing the request to 1-866-678-6789.  This contact information is also available to consumers and patients through their local pharmacists and doctors.

 

My Department regularly responds to queries regarding the status of a drug’s license in Canada.  However, once a drug is approved to be marketed in Canada, questions relating to availability, distribution and marketing of a product can be obtained from the company itself.

 

Human recombinant insulin is a regulated drug which was approved by Health Canada after a rigorous drug review process, and is used safely by the majority of Canadian diabetics.  This recommendation for an annual report involves a fairly intensive task and my Department would be further challenged to balance the different priorities in order to derive the greatest benefits for the work that would be required.  Given the available information that can be obtained from existing sources, I am proposing that this recommendation not be followed through.

 

Recommendation 3: Health Canada request significant advance notice from Eli Lilly, (for example, five years), on any change in the company’s policy regarding the provision of animal-sourced insulins.

 

Response

 

Requirement for advance notice from companies on drug supplies policy changes

 

Although it should be noted that the current regulatory provisions require the manufacturer to whom a Drug Identification Number has been issued to only notify Health Canada within 30 days for such changes, Eli Lilly Canada has agreed to work closely with Health Canada to maintain access for Canadians to animal insulins, as well as providing early notice of any proposed changes to their product lines.  Requiring companies to provide 5 years notice on such changes is also not in keeping with current international practices or regulations.

 

Furthermore, Eli Lilly Canada has been the proponent of the current initiative by RxD (Canada’s Research-based Pharmaceutical Companies) which is working with Health Canada to develop Best Practices for the Discontinuation of a Prescription for the Canadian Market, which aims to establish best practices guidelines when a company decides to discontinue a drug product from the Canadian market.  These guidelines have been reviewed by Health Canada working closely with the Advisory Committee on Management, which is an advisory body composed of physicians, pharmacists, industry as well as consumer representatives, who meet regularly with Health Canada officials to discuss current and emerging issues with the view of offering the department advice and recommendations relating to their concerns.  Rx&D will release the guidelines to their members once they have been finalized.

 

Recommendation 4: Health Canada, in partnership with the Canadian Food Inspection Agency (CFIA), facilitate the work done by Eli Lilly through active support for various measures, including the provision of tissue for insulin purification through the relationship established between the Agency and the abattoirs.

 

Response

 

Working with Eli Lilly Canada to secure animal tissue

 

There is currently no impediment for any company to secure animal tissue from the CFIA for purposes such as insulin purification.  Indeed, securing animal tissue for insulin purification purposes was never the reason for which Eli Lilly Canada decided to cease manufacturing animal insulins in Canada.  As was indicated in the company’s press release, it was based on a business decision that related to the size of the investment required to upgrade their Canadian manufacturing facilities for the small market demand that exists.

 

Secondly, legal risk considerations make it difficult for Health Canada to work with any company on product development, and still maintain the department’s independence as a regulatory authority.  It is for this reason that this recommendation will not be followed through.

 

Recommendation 5: Health Canada work closely with the Food and Drug Administration of the United States (USFDA) such that a concerted strategy is developed to ensure a North American supply of animal-sourced insulins.

 

Response

 

Discussing a possible North American strategy with USFDA

 

In response to this recommendation by the Committee, Health Canada did raise this issue with the USFDA recently but the U.S. agency did not consider this to be a priority issue, and did not agree to consider this any further.

 

Similar discussions were also held this past summer with British, European and Australian regulatory agencies but none of the agencies considered this to be a priority issue either.

 

Recommendation 6: Health Canada work closely with the Canadian Medical Association (CMA), the Royal College of Physicians and Surgeons of Canada and other professional bodies to ensure that the use of animal-sourced insulins is an option considered in the education and subsequent practice of physicians.

 

Response

 

Working with professional bodies and associations

 

Although Health Canada cannot regulate professional bodies, the Department has facilitated on-going discussions with the CMA, the Canadian Diabetes Association (CDA) and Diabète Québec.  These professional associations have agreed to coordinate communications on raising awareness of the availability of animal-insulin products through various media.

 

The government welcomes the attention of the Standing Committee on this important issue, and would like to assure the Committee that Health Canada will continue to work closely with key players in the healthcare community to facilitate continued access to and availability of animal insulins for Canadians.

 

Respectfully submitted,




A. Anne McLellan