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Appendix II

Emergency Drug Release Program and the Proposed Special Access Program

Sections C.08.010 and C.08.011 of the Food and Drugs Regulations (Food and Drugs Act) provide the conditions for the Emergency Drug Release Program (EDRP), a program whereby the Drugs Directorate may authorize a pharmaceutical manufacturer to sell a drug, not approved for sale in Canada, to a physician for the emergency treatment of a specific patient. A request to the EDRP for a drug must be made by a physician, who must provide details of the medical emergency and data on drug efficacy and safety. After consideration, an authorization may be granted and the manufacturer of the drug notified by telephone, followed by a Letter of Authorization with a copy to the physician. Manufacturers have the prerogative to provide or not provide the requested product. If it is provided, the physician is obligated to account for quantities used and to report on the results of drug use (adverse reactions). The original purpose of the EDRP was to provide unmarketed drugs on a case-by-case emergency basis; however, the program was increasingly used as a means of obtaining compassionate access to drugs that were in the latter phase of clinical trials or in the NDS submission review process.

The Drugs Directorate examined the EDRP and found it to be very labour and time intensive for both physicians and EDRP personnel. Further, there is the concern that the action of providing legal access to an unmarketed drug gives the erroneous impression that Health Canada is actually endorsing the efficacy and safety of the drug. To help correct these problems, the Drugs Directorate has proposed a replacement program called the Special Access Program (SAP). This program recognizes two categories under which unmarketed drugs may be legally obtained, first in an emergency situation, and secondly for a situation where the drug can be expected to maintain or extend quality of life.

Under the proposed SAP, an emergency situation is when the patient is seriously ill with a condition from which serious deterioration of the patient is reasonably likely to occur, or from which premature death is reasonable likely to occur, in the absence of immediate or early treatment. In this situation, the Drugs Directorate feels that its involvement is unnecessary and may, in fact, interfere with the speed in which the drug may be provided. Instead, it would be the physician's responsibility to determine if the situation is an emergency and to contact the manufacturer to obtain the unmarketed drug. The manufacturer would be required to notify the Drugs Directorate of all emergency releases within 48 hours of release, including the name of the drug, the indication for use, quantity of drug released, and the physician's name. The physician would also be required to notify the Directorate within 48 hours about the use of the drug.

In non-emergency situations, for example, where quality of life might be maintained or improved by an unmarketed drug, a different mechanism would apply. Following a physician's request, or in anticipation of a request, the manufacturer could apply to the Drugs Directorate for an authorization to release a drug to up to 50 patients. The manufacturer's request for authorization would be accompanied by an information package, later intended for distribution to physicians, that included the conditions of release for the product, recommendations for use, and all information respecting the risk, adverse events, and warnings and precautions respecting the use of the drug. After consideration, the Drugs Directorate might give the manufacturer authorization to release the drug, upon request by a physician, to up to 50 patients. If authorization was denied, the Directorate would be required to provide the manufacturer with the criteria used in deciding refusal. Authorization could be denied with the recommendation that a formal clinical trial be established. Once the manufacturer had supplied the drug for the treatment of 50 patients, a second request for authorization would be required. Physicians would be obligated to obtain informed consent prior to administration of the drug, maintain patient records, document adverse drug reactions and report these to the manufacturer. The manufacturer would have to maintain accurate records of drug releases and report all adverse drug reactions to the Drugs Directorate.

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