| What are the Mechanisms? |
- Provides access to unapproved drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.
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- Provides the Minister of Health with authority to initiate immediate action to deal with a significant risk to health, safety or the environment.
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- Provides regulations to import foreign authorized drugs, not approved in Canada, that would help address an urgent public health need.
- These drugs are authorized for sale in the United States, European Union or Switzerland.
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| Who Requests Access to the Drugs? |
- Practitioner (Physician).
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- Federal, Provincial or Territorial public health official.
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| What’s the Target Population |
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- General population of Canada.
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- Population under the public health official’s authority.
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| What’s the Process to Acces Drugs? |
- Application from practitioner on behalf of a patient.
- Application is reviewed by Health Canada.
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- Requires Governor in Council approval.
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- Streamlined notification by a public health official to Health Canada.
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| When Can Imported Drugs be Used? |
- As deemed by practitioner.
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| How Long Will Access to Drugs be Granted? |
- Time limited. Practitioner-based process for renewal of additional quantities.
- Subsequent authorization is needed to treat additional patients.
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- One year. Renewable based on the urgent public health need.
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| What about Security? |
- Any drug that is a controlled substance would continue to be subject to the requirements of the Controlled Drugs and Substances Act.
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