Research, Ethics, Governance & Integrity Unit

Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

In recognition that there are circumstances where patients need access to therapeutic goods that are not on the ARTG, the TGA manages the Special Access Scheme (SAS) and other programs such as the CTN Scheme and Authorised Prescriber program.

The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme:

• Category A - patients are defined as 'persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment'
• Category B - patients are all other patients that do not fit the Category A definition. With the exception of drugs of abuse where the manufacture, possession, sale or use is prohibited by State or Territory law; any unapproved therapeutic good can potentially be supplied via the SAS.

Special Access Scheme applications

Applications under the SAS are made to the TGA by registered medical practitioners, preferably the treating doctor (see the TGA publication, 'Access to unapproved therapeutic goods via the Special Access Scheme'). Please see below for application forms.

Barwon Health Pharmacy review

SAS applications are forwarded to the Barwon Health Pharmacy Department for processing. SAS drugs which incur a significant cost to the organisation, are referred to the Barwon Health Drug and Therapeutics Committee for approval at the discretion of the Director of Pharmacy.

Patient consent

The medical practitioner is responsible for obtaining patient consent prior to use of a SAS drug.

Unapproved therapeutic goods have undergone little or no evaluation of quality, safety or efficacy by the TGA. Accordingly, use of all such goods carries with it some risks that have not been defined in the Australian context. As such, use of these products is considered to be experimental and should be guided by the principles and practices outlined in the National Statement. The National Statement contains detailed guidance in relation to informed consent.

Specifically in relation to the supply of unapproved therapeutic goods, the TGA recommends that the consent forms and/or patient information convey the following information adequately:

• The product is not approved (i.e. registered or listed) in Australia
• Any risks and side effects that are known
• The possibility of unknown risks and late side effects
• Any alternative treatments using approved products which are available.

Barwon Health approval

Medical practitioners working in an institution may also need approval from the Barwon Health Human Research Ethics Committee or Drug and Therapeutics Committee prior to using a particular medicine or device. Applicants should discuss the use of the product with the Chief Pharmacist or person fulfilling this role before submitting an application.

How to apply for the SAS

SAS applications, using the below forms, should be discussed with and forwarded to the Barwon Health Pharmacy Department for processing:

• Category A Form Special Access Scheme
• Category B Form Special Access Scheme
• SAS Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma

Please also see Medication Approval Process Guidelines from the Barwon Health Pharmacy Department.