Madam Speaker, it is a pleasure for me to be able to give a more detailed answer to the member for Hochelaga—Maisonneuve about the approval process for AIDS medication.
The Canadian approval process is still one of the most highly respected drug regulation mechanisms in the world. At the present time, 13 antiretroviral drugs have been approved for AIDS therapy in Canada. There are several other medications especially designed to target opportunistic infections and illnesses affecting AIDS victims.
HIV-AIDS drugs submissions are eligible for priority review or fast tracking where there is probable clinical evidence that the drug may provide an important therapeutic gain. A number of HIV-AIDS drugs were reviewed on a priority basis. New drug submissions for HIV-AIDS drugs are generally reviewed within defined performance standards which are comparable to international standards.
Medication for HIV/AIDS that is still experimental, or is not for general sale in Canada, is accessible to Canadians through clinical trials, extended access programs, and the special access program. The latter provides AIDS patients with rapid access to experimental drugs on special authorization at the attending physician's request.
Additionally, with the announcement of the notice of compliance with conditions policy, drugs are permitted to be marketed in Canada when there is predictive rather than conclusive evidence of clinical benefit in the treatment of serious life threatening diseases. Under this policy the drug product manufacturer is required to continue to study the drug in order to confirm its benefit.
Health Canada is involved in several initiatives which ought to simplify the drug examination process. These include development of an electronic drug submission system, harmonization—