Special Access Program - Draft Guidance

Author: Karen Zhou

The Food and Drug Regulations (“FDR”) contains emergency provisions (Part C, Division 8, sections C.08.010 and C.08.011 of the FDR) to provide Canadians with access to drugs in medical emergencies when the drugs are not authorized in Canada.  This is because some drugs, often due to the small size of the Canadian market, are not submitted to Health Canada for review.  The Special Access Program (SAP) is the vehicle by which the emergency provisions are administered.  It is a way for Health Canada to provide timely access to drugs in medical emergencies.  

A Special Access Program draft guidance has recently been released to build on the 2014 version by adding to its scope and clarifying various proposed amendments to the emergency provisions.

As in the 2014 guidance, the 2019 draft guidance clarifies the process for requesting an unauthorized drug and responsibilities for practitioners and manufacturers.  In addition, the scope of the SAP guidance has been expanded to include information on the process for reconsideration; personalized service for urgent life-threatening or end-of-life situations; and the process and conditions to be fulfilled to request drug pre- positioning by manufacturers.

The guidance clarifies that, as per C.08.010(1.01), the practitioner is no longer required to submit information about the use, safety and efficacy of the drug for a specified emergency provided that the drug has been previously authorized by SAP; the drug has been authorized without further restrictions by the EMA or USFDA for the same medical emergency; and the DIN or NPN number previously issued has not been cancelled for safety reasons.  This amendment provides a less burdensome process for a practitioner requesting a drug previously authorized through the SAP.

The guidance also reviews the reconsideration process, which provides the practitioner with an opportunity to be heard when the SAP is considering issuing a denial and the ability to request an independent review following the issuance of a denial recommendation.

A personalized service for physicians treating patients in urgent situations provides physicians with the option to access a Health Canada healthcare professional to establish direction communication between the treating physician and Health Canada.

As per amendment to C.08.011.1(1), foreign manufacturers would be allowed to “pre-position” the drugs in Canada through the SAP to allow for a shorter shipping time to the practitioner. This is critical for medical emergencies where timely administration of a drug is of the essence.  Under this proposed amendment, a Canadian importer of the drug must be a DEL (Drug Establishment Licence) holder.

The draft guidance is open for comment until July 19.

References

1.     Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/draft-guidance-industry-practitioners-special-access-program/document.html#2.5

 2.     Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/draft-guidance-industry-practitioners-special-access-program.html