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e-3588 (Health)

E-petition
Initiated by Kanji Nakatsu from Kingston, Ontario

Original language of petition: English

Petition to the Government of Canada

Whereas:
  • Early outpatient treatment utilizing multiple repurposed medications for COVID-19 have been demonstrated in numerous clinical trials to reduce hospitalization and death;
  • Vaccine efficacy declines over time, in part due to new variants, rendering all people susceptible to SARS CoV2 infection;
  • Accordingly, both vaccinated and unvaccinated persons with COVID-19 benefit from early treatment;
  • Ivermectin has been determined to be remarkably effective in prophylaxis (~86% fewer cases) and treatment (~68% fewer deaths) for COVID-19 by the British Ivermectin Recommendation Development panel;
  • Ivermectin has proven to be very safe, as one-third of the world’s population (~7,850,000,000) has taken ivermectin to prevent various parasite (worm) infections; only 16 deaths and 5663 adverse events reported through WHO/VigiAccess pharmacovigilance from 1992 to September 2021;
  • Several countries (many or all regions), including Bangladesh, Belize, Bulgaria, Egypt, India, Japan, Nigeria, Peru, Portugal, Slovakia, South Africa have made ivermectin readily available (often over-the-counter or free);
  • Ivermectin is already approved in Canada for anti-parasitic use and is now generic and inexpensive;
  • Ivermectin is a candidate to provide protection and prevention against COVID-19;
  • Many Canadians are taking veterinary ivermectin with risks to their health as reported by Health Canada; and
  • Schedule II medications provide additional safety through advice from a pharmacist.
We, the undersigned, physicians, scientists, and other concerned residents of Canada, call upon the Government of Canada to urgently examine the evidence in favour of ivermectin and consider making ivermectin available immediately to Canadians as a schedule II medication, obtained directly from a pharmacist.

Response by the Minister of Health

Signed by (Minister or Parliamentary Secretary): Adam van Koeverden

Health Canada is closely tracking all potential therapeutic treatments, vaccines, diagnostic tests, medical devices, and disinfectants currently available and in development in Canada and abroad. Every day, we are adding to our knowledge of COVID-19, keeping pace with the rapid growth of new scientific evidence as it emerges.

Health Canada authorizes drugs based on the safety, efficacy and quality information that is submitted by pharmaceutical companies looking to market their products in Canada. Ivermectin (brand name STROMECTOL) is a prescription antiparasitic drug authorized by Health Canada in 2018 for the treatment of parasitic worm infections, specifically intestinal strongyloidiasis and onchocerciasis. To date, Health Canada has not received any applications from a pharmaceutical company seeking market authorization for ivermectin in the prevention or treatment of COVID-19. As such, the effectiveness of ivermectin as a therapeutic option for a COVID-19 indication has not been established by Health Canada.

At this time, Health Canada does not intend to change the status of ivermectin from a prescription to non-prescription drug. These types of changes are generally initiated by a manufacturer filing an application to Health Canada to seek a switch from prescription to over-the-counter status.  Applications must be supported by evidence to demonstrate that the drug and its conditions of use remain safe and effective in a self-care environment. As ivermectin has not been authorized as a prescription drug for use in COVID-19, its suitability for use as a self-care product has not been established. No manufacturers of ivermectin have made an application for this drug to be changed to non-prescription status.

There are serious risks associated with ivermectin interacting with other commonly used medications, such as blood-thinners, which raises concerns about whether it would be safe in a non-prescription setting without physician oversight of potential risks and complications. At this time, it would be inappropriate to remove this product from the Prescription Drug List.

For drugs that have potential to be helpful in treating COVID-19, Health Canada encourages drug manufacturers to conduct clinical trials. Evidence from well-designed studies is needed to determine whether a drug might be helpful in preventing or treating COVID-19 and provide an opportunity for the healthcare community to collect information on the effectiveness of the treatment and its associated risks. To date, Health Canada has not received any clinical trial applications for ivermectin in COVID-19 patients.

Health Canada is aware of publicly available information promoting the use of ivermectin in COVID-19 patients. The Department cannot conclude, however, that ivermectin provides any clinical benefit for the treatment or prevention of COVID-19 without conducting a comprehensive review of the safety, efficacy and quality of the data that would be provided as part of a drug submission. Evidence-based recommendations published by McMaster University also conclude that a positive effect cannot be established for ivermectin in COVID-19.

Healthcare practitioners may prescribe drugs, including ivermectin, outside of their authorized indications (also known as “off-label use”), based on other sources of information, such as medical literature. Off-label use falls under the practice of medicine and is regulated at the provincial and territorial level. Heath Canada has no jurisdiction over how health care professionals prescribe drugs once authorized. Given the potential risks outlined above, it would be more appropriate for off-label use of ivermectin to be done under the care and supervision of a physician. Maintaining ivermectin’s prescription status helps to ensure professional oversight. 

Open for signature
October 26, 2021, at 11:31 a.m. (EDT)
Closed for signature
December 25, 2021, at 11:31 a.m. (EDT)
Presented to the House of Commons
Dean Allison (Niagara West)
March 2, 2022 (Petition No. 441-00201)
Government response tabled
April 25, 2022
Photo - Dean Allison
Niagara West
Conservative Caucus
Ontario
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