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Using only Health Canada approved drugs for use on persons diagnosed with Vision-Threatening Eye Conditions

May 2015

Issue

In Canada, some physicians are treating vision threatening eye conditions with drugs not certified by Health Canada for that purpose. However, treatments of vision loss must also be proven safe. This position statement contains recommendations concerning the treatment of vision-threatening eye conditions.

Background

In the United Nations Convention on the Rights of Persons with Disabilities (CRPD), which the Canadian Government (with the support of all provinces and territories) ratified in March 2010, Article 25 states, in part, that states parties shall “Provide those health services needed by persons with disabilities specifically because of their disabilities, including early identification and intervention as appropriate, and services designed to minimize and prevent further disabilities, including among children and older persons.”   Canada has thus committed to providing health services aimed at minimizing disabilities such as vision loss.

In Canada, the determination of a drug’s safety, effectiveness and quality is made by Health Canada’s Therapeutic Products Directorate upon independent review of clinical trial evidence and other information provided by the drug manufacturer.

Advances in medical research have resulted in several pharmaceutical products which can dramatically reduce vision loss brought about by vision threatening eye conditions. Health Canada has approved specific products to treat these conditions, yet physicians are using products not designed or tested to treat these conditions.  Further, these untested products have not gone through the rigorous testing required by Health Canada.

The prevention and treatment of vision threatening eye conditions would dramatically reduce the practical, emotional and economic costs of vision loss for individuals and Canadian society at large and would help ensure that Canada meets its obligations under the CRPD. However, it is necessary that any prescribed treatment for vision-threatening eye conditions be approved by Health Canada (unless no Health Canada approved treatments exist). The below organizations have endorsed the following recommendations concerning the treatment of vision-threatening eye conditions.

Recommendations

1. Canadians diagnosed with vision-threatening eye conditions should have universal access to ophthalmic treatments that have been proven to be safe, effective and high quality and that have been approved by Health Canada to treat those conditions.

2. The reimbursement for off-label use of any other drug in the treatment of vision-threatening eye conditions should not be approved when there are alternative Health Canada approved drugs available.

Supporting Organizations

Access for Sight Impaired Consumers

Alberta Society for the Visually Impaired

Canadian Council of the Blind

Guide Dog Users of Canada


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