Sunshine Labs pioneers Global Health Solutions by producing and delivering cutting-edge pharmaceuticals and medical technologies. We often direct enquiring healthcare practitioners and patients to Canada’s Special Access Program, which facilitates access to novel treatments for patients when conventional treatments have failed.
What it is
Health Canada’s Special Access Program (SAP) allows healthcare practitioners to request access to drugs that are not approved or available for sale in Canada for treating patients with serious or life-threatening conditions.
This applies when conventional therapies have failed, approved treatments are unsuitable, or there are no existing alternatives in Canada.
How It Works
- Application by a Healthcare Practitioner
- The request must come from a licensed healthcare provider, who may be informed of the program by their patient.
- The practitioner outlines the medical need, prior treatments tried, and rationale for the requested drug.
- Health Canada Review
- Health Canada evaluates the request, considering the patient’s condition, available scientific evidence, and potential risks.
- The review is usually done quickly, given the urgency of most requests.
- Authorization and Access
- If approved, Health Canada issues an authorization.
- The manufacturer or supplier then provides the drug for that specific patient under defined conditions.
- Practitioners must report on patient outcomes, side effects, and any safety concerns.
Why It’s Important in Canada
- Ensures patient access: Canadians with urgent medical needs have options despite a necessary treatment not being available in Canada.
- Has flexibility: It can be used for both rare diseases and emerging therapies.
- Helps gather evidence: Real-world use of SAP can inform regulatory decisions around the availability of certain drugs for medical purposes.
- Ensures compassionate care: Aligns with medical commitments to patient well-being when time is critical.
Global Context
Canada’s SAP is not unique — most major regulatory bodies have similar mechanisms:
- United States: FDA’s Expanded Access (also known as “compassionate use”).
- European Union: EMA’s Compassionate Use Program.
- UK: MHRA’s Early Access to Medicines Scheme (EAMS).
- Australia: TGA’s Special Access Scheme (SAS).
Sunshine Labs is at the forefront of these unconventional treatments with exclusive partnerships, cutting-edge medical devices, and a compliant international supply chain to address the need for innovative therapeutic approaches that save lives.