Health Canada has recently amended the requirements of the Special Access Program (SAP) and Emergency Drug Release Program (EDR). The changes are intended to streamline procedures, but only for those drugs previously approved under the SAP and EDR. SAP and EDR provide access to human and veterinary drugs which have not been approved for sale in Canada, but which are medically necessary.
What you need to know
- The changes to the SAP and EDR programs are intended to reduce administrative burdens on health care professionals and to permit limited stockpiling of unapproved drugs in Canada in anticipation of future emergency requests under the programs.
- The SAP and EDR programs require that prescribers file requests for access to unapproved drugs with Health Canada, and Health Canada has discretion to decide whether to fulfill the requests and allow for importation of the drugs. The changes to the programs reduce the information that must be submitted with a request for drugs that have previously been approved under the SAP or EDR, if:
- the proposed use of the unapproved drug is the same as previously approved by Health Canada under the SAP or EDR;
- the drug has been approved for that same use by the European Medicines Agency or the U.S. Food and Drug Administration; and
- Health Canada has not previously revoked approval for sale of the drug in Canada for safety reasons.
- Physicians and veterinarians can now request unapproved drugs to keep on hand for emergency use, and no longer need to identify an individual patient with each request under the SAP or EDR.
- Manufacturers may request permission from Health Canada to stockpile small quantities of unapproved drugs at licensed facilities in Canada, in anticipation of future requests under the SAP or EDR.
Health Canada's changes to the SAP and EDR streamline access to unapproved drugs
Health Canada administers two programs to provide medically necessary access to unapproved drugs, the SAP (for human drugs) and the EDR (for veterinary drugs)1. Health Canada has recognized that many of the requests under these programs are repeated requests for the same unapproved drugs, in some cases for emergency use. Health Canada has enacted amendments to the Food and Drug Regulations which are intended to streamline the request procedures for frequently requested unapproved drugs for physicians and veterinarians, and to reduce the amount of time and logistical hurdles in delivering frequently requested unapproved drugs to treating physicians and patients. Updated forms have also been published by Health Canada reflecting these regulatory changes.
Reduced information requirements for SAP and EDR requests
When making a request to the SAP or EDR, the requesting prescriber must provide information to Health Canada about the medical need, quantity of drugs required, the address where drugs will be shipped, and information supporting the safety and efficacy of the requested drug.
Recognizing that many requests are repeat requests for drugs that have been previously approved under the SAP and EDR, Health Canada has waived the requirement for requests to include supporting information on the use, safety, and efficacy of the unapproved drug, provided that: i) the drug has been previously approved for the same proposed use under the SAP or EDR; ii) the proposed use of the drug has been approved by the European Medicines Agency or the U.S. Food and Drug Administration; and iii) Health Canada has not previously revoked regulatory approval for the drug in Canada for safety reasons. This means that where the drug has already been approved under the SAP or EDR, physicians and veterinarians now only need to submit information about the medical need for the drug, the quantity required, and where the drug will be shipped.
Health Canada has also recognized that SAP and EDR requests may be for emergency use of drugs, where time is of the essence. Under the previous system, requesters had to provide the identity of a specific patient who would receive the unapproved drug. Health Canada has now removed the requirement to identify an individual patient. This means that unapproved drugs may now be requested in advance of emergencies and kept on hand at healthcare institutions, physician/veterinary offices, or in pharmacies for immediate use on an emergency basis.
Improving patient access and delivery times
Under the previous regulations, the SAP and EDR did not allow for imports or stockpiling of unapproved drugs, which could lead to delays for patients as manufacturers could only begin imports and shipments after an SAP or EDR request was approved. Under the new SAP and EDR regulations, manufacturers may now apply for permission to import and store quantities of unapproved drugs at Canadian facilities that hold a Drug Establishment License, in anticipation of future requests under the SAP or EDR. The unapproved drugs may not be distributed further until an SAP or EDR request is approved by Health Canada.
For unapproved drugs imported and stored in Canada by manufacturers, some regulatory requirements relating to import and storage are waived. However, unapproved drugs must still be stored in a way that prevents the product from becoming unstable or inactive, and the licensed facility storing the drugs must have a control system in place to allow rapid recall of the drugs. The new SAP and EDR regulations also permit drugs to be shipped directly to community pharmacies, to another physician or veterinarian, or (for veterinary drugs) to an authorized dealer of medicated animal feed. Previously, drugs could only be shipped to the requesting physician or veterinarian, and only to healthcare institutions and offices approved by Health Canada. By permitting shipments to other locations, Health Canada is seeking to improve and simplify patient access to drugs approved under the SAP and EDR, by allowing patients access outside of approved healthcare institutions and physician/veterinarian offices.
We expect that the SAP and EDR will continue to be used by practitioners to gain access to drugs that are not approved for sale in Canada. Health Canada's online guidance states that these programs are not intended to promote the early use of drugs, or to bypass the clinical trial or regulatory review and approval processes for new drugs. It is unclear at this stage if Health Canada will be increasing scrutiny of how these programs are used, given Health Canada's recognition that some unapproved drugs are frequently requested and approved.
These amendments were previously published in draft form for public comment together with additional proposed amendments to facilitate access to drugs by public health officials to address public or military health emergencies, events, or incidents. Health Canada has indicated that revisions to those emergency access amendments are ongoing and is proceeding separately from these changes to the SAP and EDR programs. No timeline for the publication or coming-into-force of those emergency access amendments has yet been announced.
1. An average of 16,000 requests are made for unapproved human drugs under the SAP each year, with an average of 500 drugs listed as "active" under the SAP at any given time.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.