On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice, Overview and Final Guidance related to the amendments. As originally set out in the proposed Regulations (see here1), the final Regulations contain provisions to minimize the burden with providing access to unauthorized drugs in medical emergencies under the Special Access Program (SAP) (human drugs) and Emergency Drug Release (EDR) program (veterinary drugs).
Key provisions in the Regulations are below:
- The Regulations remove the requirement for physicians to provide full use, safety and efficacy data when certain requirements are met, including previous SAP/EDR approval for the same medical emergency and if the drug is authorized for sale without terms and conditions by the European Medical Agency or US Food and Drug Administration for the same use being requested.
- The Regulations also permit “pre-positioning” (i.e. a manufacturer may submit a request for a letter of authorization allowing the import by a drug establishment licence (DEL) holder, for storage until a letter of authorization permits sale).
- Products no longer have to be shipped only to an institution such as a hospital or practitioner’s office and can be shipped directly to certain persons such as a pharmacist, helping to minimize delays in treating patients.
- The patients’ identity (human or animal) does not need to be known at time of request, in order to capture future use situations where a drug is needed for administration in an emergency by a first responder or in the hospital, such as in an emergency room setting, where the patient may not be known in advance of the emergency.
The Final Guidance, which applies only to SAP, highlights some key points manufacturers should remember, including:
- Manufacturers can decide whether or not to charge for an SAP drug and should consider any Patented Medicine Prices Review Board (PMPRB) implications.
- Controlled substances trigger various additional requirements, including the requirement for an Import Permit to be issued to the importer by Health Canada's Office of Controlled Substances before the drug can be imported into Canada.
- The following new language (which was not in the Draft Guidance) has been added:
“Manufacturers are expected to ensure that significant new information respecting the safety, efficacy and quality of drugs released under the SAP is made available to practitioners and the Program as soon as it is known. This information should be vetted through the SAP prior to communication with practitioners."
- A transition time of no more than 90 days may be allowed for drugs authorized through SAP which receive market authorization from Health Canada.
Should you have any questions, please do not hesitate to contact a member Life Sciences Regulatory & Compliance of the group.
References
1. Though the proposed Regulations in 2019 also contained a proposal to facilitate access to drugs by a public health official to address a public or military health emergency, event or incident, the changes to the proposed Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) will proceed separately.
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