The Special Access Programme (SAP) considers physician request for access to drugs not sold in Canada. A physician must receive approval from the SAP to be allowed to order and receive the drug from outside the country. Applications are only considered by SAP for drugs that are needed for life threatening or serious conditions, under compassionate or emergency circumstances, after conventional therapies have failed. Applications cannot be made for new drugs in the process of review and approval by Health Canada for sale in the country.
General Process for SAP requests:
- A physician or hospital pharmacist must first secure a SOURCE for the drug. This is usually the pharmaceutical company that manufactures the drug.
- Once the source is secured, a letter is issued from the pharmaceutical company confirming that they are willing to release the drug to the prescribing physician/facility.
- The physician completes the SAP application and faxes it directly to the SAP office
- The application is triaged and scheduled for review by the SAP staff.
- If the drug has been previously approved for other patients in similar circumstances, it may be in the SAP list of approved drugs which will expedite processing. If the drug is new to SAP, it may take a bit longer. Processing times vary.
- If the request is approved, the SAP team will forward a copy of the approval to the prescribing physician and the pharmaceutical company.
- The pharmaceutical company holds the right to release the drug under specific conditions (e.g. they may charge for the drug, request information on use, restrict the amount released, etc.)
- If the pharmaceutical company chooses to charge for the drug (not all do), it is the patient’s responsibility to pay for the drug; provincial drug plans do not cover SAP drugs, but a patient is free to inquire with their insurer; most patients face paying out-of-pocket
- The drug must be shipped directly to the prescriber’s office or the hospital pharmacy
- The physician must report back to SAP on the results of using the drug or any adverse events
- If the physician must re-order, there is a specific form that can be used with SAP for repeat requests
For more information, go to the Special Access Programme website.