Special Access Scheme (SAS)
/Special Access Scheme/
Also known as: SAS, compassionate use pathway
Definition
The Special Access Scheme (SAS) is a TGA pathway that permits medical practitioners to access therapeutic goods that are not registered in the ARTG for use in individual patients. The SAS is designed for urgent or compassionate situations where a patient has a serious medical condition that cannot be adequately treated with registered alternatives. A doctor can apply to the TGA for permission to supply an unapproved medicine to their patient; if approved, the patient can receive the treatment provided informed consent is obtained and safety monitoring protocols are followed. The SAS is not a blanket approval system; each application is assessed individually for the specific patient, condition, and proposed use. Use of peptide compounds in research and clinical investigations may sometimes proceed through the SAS pathway, particularly if the compounds show promise but have not yet completed full regulatory approval. The SAS provides a mechanism for access to potentially beneficial treatments while maintaining oversight and safety standards.
The Special Access Scheme has specific requirements: the patient must have a serious condition, there must be no registered alternative available or suitable for the patient, and there must be a reasonable expectation that the unapproved good may benefit the patient based on available evidence. Practitioners must submit applications with supporting clinical and scientific information. The TGA assesses these applications and can approve, conditionally approve, or decline access. The scheme is not intended for routine prescribing or for conditions that can be adequately treated with existing registered medicines.
Researchers investigating novel peptide compounds sometimes interface with the SAS pathway when they identify patients with medical needs who may benefit from an investigational compound. However, clinical research studies typically operate under separate regulatory approvals (clinical trial approval) rather than the SAS. The distinction is important: the SAS is for individual therapeutic use outside of a research protocol, while clinical trials are structured research studies with specific protocols, informed consent processes, and ethical review.