Making urgently needed drugs available

Responding to the Opioid Crisis and Other Emergency Situations
EXISTING NEW
Emergency Mechanisms to Access Drugs Mechanism to Access Drugs to Meet an Urgent Public Health Need
  Special Access Programme Interim Order Access to Drugs in Exceptional Circumstances Regulations
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.
  • Provides the Minister of Health with authority to initiate immediate action to deal with a significant risk to health, safety or the environment.
  • 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.
Who Requests Access to the Drugs?
  • Practitioner (Physician).
  • Minister of Health.
  • Federal, Provincial or Territorial public health official.
What’s the Target Population
  • Individual patients.
  • General population of Canada.
  • Population under the public health official’s authority.
What’s the Process to Acces Drugs?
  • Application from practitioner on behalf of a patient.

  • Application is reviewed by Health Canada.
  • Requires Governor in Council approval.
  • Streamlined notification by a public health official to Health Canada.
When Can Imported Drugs be Used?
  • As deemed by practitioner.
  • Immediately.
  • Immediately.
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.
  • One year
  • One year. Renewable based on the urgent public health need.
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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Organization: Health Canada

Type: Infographic

Date published: 2017-06

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