In certain medical situations, conventional treatments may not be suitable, effective, or even available. This is where the Special Access Scheme (SAS) comes into play. In Australia, the SAS provides a legal pathway for healthcare professionals to access unapproved therapeutic goods, such as medicines, biologicals, and medical devices, for individual patients when necessary.
In this article, we’ll explore what the Special Access Scheme is, how it works, who is eligible, and how patients or healthcare providers can legally request access to unavailable medications.
What Is the Special Access Scheme (SAS)?
The Special Access Scheme is a regulatory framework governed by the Therapeutic Goods Administration (TGA) in Australia. It allows for the supply of unapproved therapeutic goods to patients on a case-by-case basis, under the supervision of a qualified healthcare provider.
These unapproved products may include:
- Medications not registered in Australia
- Experimental treatments
- Medical devices still undergoing evaluation
- Medications that have been discontinued or are in short supply
The SAS is not an alternative to clinical trials or registered treatments—it is only used when there are no viable alternatives and the treating practitioner believes the potential benefit outweighs the risks.
Why Might a Patient Need Access Through the SAS?
There are several circumstances in which a patient may benefit from accessing medications through the SAS:
- They have a rare disease with no approved treatment
- They are undergoing palliative care and need symptom relief not provided by registered products
- They require access to a life-saving drug not yet available on the Australian market
- They have tried all approved treatment options without success
Categories of the Special Access Scheme
There are three categories under the SAS, depending on the level of risk and urgency:
1. SAS Category A – Life-Threatening Conditions
This is a notification pathway (not approval-based). It applies to patients who are seriously ill or terminally ill, and whose condition is life-threatening. The healthcare provider must notify the TGA after the product has been supplied.
2. SAS Category B – Non-Life-Threatening Conditions
This is an application pathway. A registered medical practitioner must apply to the TGA for approval to supply the unapproved product. This includes providing clinical justification and supporting evidence.
3. SAS Category C – Pre-Approved Products
This is a notification pathway for specific medicines that the TGA has deemed suitable for certain patient groups. The healthcare provider must notify the TGA but doesn’t require formal approval beforehand.
How to Request Unavailable Medications Legally via the SAS
Here’s a step-by-step guide on how healthcare professionals can legally request access:
Step 1: Clinical Assessment
The treating doctor evaluates the patient’s condition and determines that an unapproved medicine is necessary and justifiable.
Step 2: Check the SAS Category
Identify the correct SAS category (A, B, or C) based on the patient’s condition and the medicine involved.
Step 3: Submit the Application or Notification
- Category A: Complete the SAS Category A form and notify the TGA within 28 days of supply.
- Category B: Submit an application to the TGA, including clinical justification and relevant documentation. Await TGA approval before supplying the product.
- Category C: Notify the TGA using the SAS Category C form and proceed with the supply.
Step 4: Supply and Monitor
Once approval or notification is complete, the product may be supplied to the patient. The healthcare provider must monitor for safety and effectiveness.
Important Considerations
- Patient Consent: Informed consent is essential. The patient must be made aware that the product is not approved by the TGA.
- Product Sourcing: The product must be sourced through legal supply chains (e.g., from overseas manufacturers who meet TGA requirements).
- Record Keeping: Documentation of supply, consent, and outcomes should be retained for compliance and patient safety.
Commonly Accessed Medications via SAS
Some examples of medications commonly accessed under SAS include:
- Medicinal cannabis products
- Treatments for rare cancers or neurological disorders
- Certain biologics and gene therapies
- Overseas-registered medications for drug-resistant infections
Final Thoughts
The Special Access Scheme is a vital part of the Australian healthcare landscape, enabling ethical and legal access to life-changing medications that are not otherwise available. While the process is highly regulated, it ensures that patients with serious or unmet medical needs can still receive potentially life-saving treatment when all other options have been exhausted.
If you’re a healthcare provider, it’s essential to stay informed about SAS pathways and TGA requirements. For patients, understanding this process empowers you to have open, informed discussions with your healthcare team about all possible treatment options.
FAQs
Q: Is the SAS the same as participating in a clinical trial?
A: No. SAS is for individual patient use, while clinical trials involve multiple patients and controlled research protocols.
Q: Can patients apply for SAS access themselves?
A: No. Only registered healthcare professionals can apply on behalf of a patient.
Q: Are SAS medications covered by Medicare or private insurance?
A: Not usually. Most SAS medicines are accessed at the patient’s own cost unless other funding options are available.
