The special access program is meant to be accessed by practitioners who have authority in provincial jurisdictions to prescribe unapproved medication. It's a process that begins with a physician making a decision that the unapproved therapy is the best choice for the patient in front of them given their condition and the current available therapies on the market.
Once they have made a decision that the best choice would be an unapproved therapy and that they are dealing with a serious and life-threatening condition, they complete a special access program request form, which is a two-page document that has five sections to complete. They submit that to Health Canada. It's reviewed by the special access program team to ensure that the request meets the requirement of the regulations, that there is actually a serious and life-threatening condition, that the therapies available on the market have been considered and tried or are unavailable, and that there is use on the safety and efficacy of that drug available to support the authorization.