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e-4697 (Health)
- Keywords
- Diabetes
- Obesity
- Pharmaceuticals
Original language of petition: English
Petition to the Prime Minister
- November is National Diabetes Awareness Month;
- 4 million Canadians have been diagnosed with Diabetes (Type 1 & 2), 1.7 million have undiagnosed Type 2 Diabetes & or 6 million are prediabetic;
- The British Columbia government, in March 2023, raised the issue of an Ozempic shortage (15% going from BC to the USA);
- In 2022, in Canada, 3.5+ million Ozempic prescriptions ($1.2 billion) were dispensed by retail drugstores (data provided to the National Post from IQVIA CompuSript);
- CBC Ottawa reported that Barry Power with the Canadian Pharmacists Association (CPhA) stated that an internal survey conducted by CPhA found that between 25% to 50% of Canadian prescriptions for Ozempic are for weight loss;
- Health Canada confirms the shortage of Ozempic will continue until March 2024 with the Belgian government stating until June 2024;
- Other governments are regulating ‘off-label’ use of critical medications to Diabetics (if not available would cause death or bodily harm). For weight loss is an ‘off-label’ use of Ozempic in Canada; and
- Urgent action is required to prevent unnecessary death or bodily harm.
Response by the Minister of Health
Signed by (Minister or Parliamentary Secretary): Yasir Naqvi
Health Canada recognizes the importance of Ozempic (semaglutide) and other Glucagon-Like Peptide-1 (GLP-1) and Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor agonists used for the treatment of type 2 diabetes. There have been concerns about the availability of Ozempic (semaglutide) and other GLP-1 and GIP receptor agonists used for the treatment of type 2 diabetes. Ensuring there is adequate supply of these products is a top priority for the Government of Canada. Supply issues have impacted the Canadian supply of GLP-1 and GIP receptor agonists because of high global demand. While manufacturers are continuing to receive supplies in Canada, and improvements are being seen, certain products are still experiencing some constraints and may not always be available at pharmacies.
Efforts are being made to increase manufacturing capacity but it will take time to build up supply levels to meet the demand. Novo Nordisk Canada Inc. (NNCI) has advised Health Canada that the shortage of Ozempic 1mg pen was resolved on January 18, 2024. The shortage of their lower-dose product (0.25mg/0.5mg) was also resolved on February 17, 2024. NNCI is not currently experiencing any supply issues for Rybelsus and Victoza. Eli Lilly Canada Inc. (Eli Lilly) has advised Health Canada that shortages of Trulicity (dulaglutide) and Mounjaro (tirzepatide) are expected throughout early 2024 due to increased demand and competitor shortages. AstraZeneca Canada Inc.’s Bydureon (exenatide) has not been marketed in Canada since 2022.
Health Canada is working with manufacturers and stakeholders to monitor supply, mitigate the impacts of the supply disruptions on patients, look at how these products can be made more available and ensure that patients living with diabetes can access the medication they need. Health Canada has issued a supply notice on Ozempic where Canadians can find the latest information on the supply and use of the product.
The GLP-1 and GIP receptor agonists currently authorized and marketed in Canada are indicated for the treatment of type 2 diabetes. Prescribing these products for weight loss would be considered off-label use as it is not an indication approved by Health Canada. Off-label use refers to the use of a marketed health product outside of indications included in approved drug labeling. While Health Canada oversees the regulation of drugs, it has no jurisdiction over how health care professionals prescribe drugs once they are approved. Health Canada understands the concerns related to the off -label use, however, the decision to prescribe a drug for off-label use is part of the “practice of medicine”, which is regulated by the provinces and territories. The decision involves the health care professional diagnosing a patient's symptoms and deciding which treatment would be most appropriate. The practice of medicine allows a healthcare professional to use their professional judgement/knowledge to determine whether a drug can be useful to a patient if used off-label. Practice of medicine is under the purview of the provincial and territorial Colleges of Physicians and Surgeons, which oversee medical practice and well-established clinical guidelines.
On December 6, 2023, Health Canada published recommendations from clinical experts for prescribers while Ozempic and other GLP-1/GIP agonists are in shortage. These expert groups recommended that prescribers:
- do not start new patients on these drugs that are in shortage, unless there are no suitable alternatives and there’s a clinical reason to do so;
- consider prescribing an alternative drug for patients taking a GLP-1 and GIP receptor agonist that is in shortage, as a continuous supply can’t be guaranteed; and
- conserve the existing supply for patients who are stabilized and have no other treatment options.
Health Canada will continue to work with manufacturers and stakeholders to ensure the supply of Ozempic and other GLP-1 and GIP receptor agonists are made available for patients living with type 2 diabetes. Health Canada encourages patients who have concerns about access to these drugs to speak to a health care professional about their options.
- Open for signature
- November 22, 2023, at 11:45 a.m. (EDT)
- Closed for signature
- January 21, 2024, at 11:45 a.m. (EDT)
- Presented to the House of Commons
-
Anita Vandenbeld
(Ottawa West—Nepean)
January 29, 2024 (Petition No. 441-02022) - Government response tabled
- March 18, 2024
