Notice to Stakeholders: Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling

May 10, 2019
Our file number:  19-103917-252

In 2017, Health Canada undertook the Regulatory Review of Drugs and Devices (R2D2) with the objective of developing an agile regulatory system that supports access to therapeutic products based on healthcare system needs. As part of R2D2, the Department conducted a review of the Special Access Program (SAP) for human drugs and the regulatory authorities supporting the program. The SAP for human drugs supports access to drugs that have otherwise not been approved in Canada when needed for medical emergencies. While the existing emergency provisions in the Food and Drug Regulations administered by the SAP have been used by the Public Health Agency of Canada and the Canadian Armed Forces when an unauthorized drug is needed to respond to a public or military health emergency, the existing regulations were not designed to respond to or prepare for such emergencies.

On May 10, 2019, Health Canada pre-published in Canada Gazette, Part I, amendments to the Food and Drug Regulations (FDR) entitled "Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)" for a 70-day stakeholder consultation from May 10, 2019 to July 19, 2019. Through these amendments, Health Canada is proposing a new regulatory framework designed to facilitate access to drugs that are unavailable in Canada for emergency preparedness and response activities undertaken by public health officials (PHOs).

The proposed framework would allow PHOs to request unauthorized drugs to treat a mass population in a medical emergency such as new emerging diseases for which treatments are not available on the Canadian market, or to respond to events such as, but not limited to, chemical, biological, radiological or nuclear events, or during military missions that result in a population health event, incident or emergency. The proposed regulations would allow a PHO to request these drugs for immediate use or for stockpiling purposes. Drugs requested could be in development in any country, including Canada (i.e. a drug that is either in a clinical trial or in an earlier stage of development), or authorized (or not) in a foreign country.

The scope of who can make a request under the proposed regulations includes federal, provincial, territorial, and municipal medical officers of health as these jurisdictions have their respective legislations, regulations or by-laws governing emergency preparedness and response for public or military health emergencies.

To accompany the proposed regulations, Health Canada is pleased to announce the release of a draft guidance document entitled: "Draft Guidance - Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling". The draft guidance provides information on the interpretation of the proposed regulations. It also assists public health officials to comply with the proposed regulatory requirements by explaining the application process when requesting a drug for use in a public or military health emergency, as well as reporting, record keeping and drug labelling requirements.

We are seeking stakeholder comments on the draft guidance document that is to be read in conjunction with the proposed regulations. The proposed regulations can be found on the Canada Gazette website.