Frequently Asked Questions: Animal-Sourced Insulin

Q1) What is insulin?

A1) Insulin is a hormone that is made by beta cells in our pancreas. These beta cells manufacture and release the insulin into our blood so that it may circulate and allow glucose to enter and fuel the cell. As such, when insulin enters the cells the remaining supply of glucose in our blood decreases. That is, the presence of insulin in our body has the effect of lowering blood glucose. Insulin also controls other aspects of metabolism that are required by the body to sustain life, such as converting fat into glucose and glucose into fat.

Diabetes (diabetes mellitus) is the term used to describe higher-than-normal glucose levels in the blood. There are different causes and types of diabetes, but all have the common abnormality of a high level of glucose in the blood. Since the presence of insulin in our body lowers our blood glucose, insulin injections are often used to control glucose levels. Failure to control blood sugar levels leads to complication such as loss of vision, diseases of the arteries, the kidneys and the heart.

Insulin is an absolute requirement when treating type 1 diabetes; in persons with type 2 diabetes, insulin is used when other means of treatment, such as diet and pills, are insufficient or no longer work.

Q2) What are animal-sourced insulin and biosynthetic human insulin?

A2) Two types of insulin may be used in the management of diabetes: animal-sourced insulin and biosynthetic (man-made) (human) insulin.

Insulin was originally derived from the pancreases of cows and pigs. Animal-sourced insulin is made from preparations of beef or pork pancreases, and has been used safely to manage diabetes for many years. With the exception of beef/pork insulin, which is no longer available, they are still being used safely today.

Over the years, insulin products have evolved; this evolution includes the development of biosynthetic human insulin and insulin analogues. Biosynthetic human insulin, its analogues and derivatives, are produced via gene technologies. These biosynthetic forms of insulin have been authorized for use in Canada, in some form, since 1983 and have been shown to be safe, effective and of high quality for treating both type 1 and type 2 diabetes.

Please visit the Health Canada website for more information about insulin products, diabetes, and type 2 diabetes.

Q3) What is Health Canada's position on animal-sourced insulin?

A3) Health Canada is aware that the availability of animal-sourced insulin has become a rising area of concern for some Canadian patients with diabetes. Health Canada (HC) is also aware of the limited sources for animal insulin. However, while Health Canada does not have the authority to require a manufacturer to make or sell any particular product, HC has, in the past and continues to work with manufacturers and stakeholders, within the limits of its mandate, to support the availability of animal-sourced insulin in Canada.

Q4) What is Health Canada doing to address the availability of animal-sourced insulin?

A4) The availability of animal-sourced insulin was raised in the past when the issue was presented to the House of Commons Standing Committee on Health on February 3 and April 29, 2003. During these two sessions, witnesses represented the perspectives of affected individuals, the pharmaceutical industry and Health Canada. Health Canada then stated that there are patients who need animal-sourced insulin to manage their diabetes. The outcome of the hearing identified the continuing reduction in the availability of animal insulin products as a major concern for Committee members. Recommendations were put forward by the committee that proactive measures are taken in order to ensure that the animal-sourced products remain available to those patients who need them.

Since then, Health Canada has taken an active role to address issues related to the knowledge, availability and labelling matters regarding insulin preparations, with specific focus on animal-sourced insulin. Most notably, on October 30, 2008, Health Canada convened an Expert Advisory Panel for this purpose. The report of the panel and related documents can be found on the Health Canada website.

Health Canada continues to implement the recommendations of the panel and expects that the responses will represent a significant step forward in the control and quality of life of patients with Type 1 diabetes in general and, in particular, for those who depend on animal-sourced insulin.

Q5) Why has the availability of animal-sourced insulin decreased worldwide?

A5) With advances in recombinant and biosynthetic human insulin products, manufacturers have focussed on the production and sales of recombinant or biosynthetic human insulin. Thus, the use of animal insulin has declined. In addition, the production of animal-sourced insulin has become globally more complex as a result of Bovine Spongiform Encephalopathy (BSE) / Transmissible Spongiform Encephalopathy (TSE) issues related to the raw animal tissues used to make animal-sourced insulin.

Although the majority of patients with diabetes now use biosynthetic human insulin or insulin analogues, there remain a small number of patients with diabetes who cannot manage their disease with biosynthetic insulin and are concerned over the availability of animal-sourced insulin for the future.

Q6) What animal-sourced insulin products are currently available for purchase on the Canadian market?

A6) Since April 1, 2006, the pork insulins under the brand names of Hypurin Regular and Hypurin NPH, manufactured by Wockhardt UK Limited, have been available for purchase at Canadian pharmacies.

The Product Monographs may be accessed online by searching the Drug Product Database.

Q7) How do I transition from my insulin to Hypurin insulin?

A7) If you are considering a change in insulin product, see your physician as switching insulin should be done only under medical supervision.

Q8) Is beef insulin still available in Canada?

A8) Hypurin beef insulin is available to Canadians from Wockhardt UK Ltd.. Wockhardt UK has a licensed importer/distributor in Canada to distribute the pork insulin. This distributor may facilitate access of beef insulin to patients who use the Special Access Program.

Q9) Who can I contact if I have questions about Hypurin beef insulin?

A9) For further information on Hypurin beef insulin, please contact the manufacturer directly at:

Ash Road North, Wrexham Industrial Estate,
LL13 9UF, Wales
United Kingdom
Tel: 011- 44 - 1978 661261

For information on Hypurin pork insulin, you may contact the Canadian importer/distributor:

2000 Ellesmere Road
Scarborough, Ontario
M1H 2W4
Tel: 1- 416 - 438-6727
Fax: 1- 416 - 438-3463

October 2010

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