Special Access Scheme: Guidance for health practitioners and sponsors
Version 1.1, September 2017
This guidance is for health practitioners and sponsors involved in providing patients with access to unapproved therapeutic goods (goods which are not entered in the Australian Register of Therapeutic Goods (ARTG)) through the Special Access Scheme (SAS). It outlines the various access pathways and your regulatory obligations when accessing and supplying unapproved therapeutic goods.
Individual patients cannot apply for access to unapproved therapeutic goods through the SAS. If you are a patient, please consult your health practitioner about the suitability of using an unapproved therapeutic good and applying for access to an unapproved therapeutic good on your behalf.
Special Access Scheme
Most therapeutic goods are required to be evaluated for quality, safety and efficacy and included in the ARTG before they can be supplied in Australia.
Where patients need access to therapeutic goods that are not on the ARTG, TGA administers the SAS and other programs that provide access to therapeutic goods that are not registered, listed or included in the ARTG.
The SAS provides for the import and supply of an unapproved therapeutic good to a single patient on a case-by-case basis.
It is expected that the treating health practitioner will have considered all appropriate treatment options that are entered on the ARTG and are currently being supplied prior to considering accessing an unapproved good under the SAS for their patient(s).
The pathways available to access unapproved therapeutic goods through the SAS should not be used by health practitioners for the purposes of conducting a clinical trial. Health practitioners wanting to conduct a clinical trial (investigator-initiated trials) involving the use of an unapproved therapeutic good should consider the CTN or CTX pathways, as appropriate.
The regulatory controls placed on clinical trials conducted through the CTN and CTX pathways provide sufficient assurance that high quality, credible data that contribute to the answering of specific scientific questions is collected, while also protecting the rights, safety and well-being of clinical trial participants.
The following infographic describes prerequisites that the treating health practitioner must consider PRIOR to attempting to access any unapproved good via the SAS:
Under the SAS, health practitioner can access unapproved therapeutic goods through a number of pathways:
- Category A is a notification pathway which can only be accessed by medical practitioners for patients 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 is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through SAS Category C. An approval letter from the TGA is required before the good may be accessed.
- Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products for their respective indications. There is a separate list for medicines, medical devices and biologicals, as follows:
Overview of the SAS pathways
The table below indicates the key features of each SAS pathway.
|Category A notification||Category B application||Category C notification|
|Available for patients at risk of death or injury without treatment||
|Available for general patients|
|Who can apply|
|Medical practitioners can apply|
|Other health practitioners can apply||
(as per lists above)
|Type of goods|
|Specified list of goods available|
|Can be used to access Schedule 8 goods|
|Can be used to access Schedule 9 goods|
|Can be used to access Schedule 10 goods|
|Timing of approval|
|Requires TGA approval prior to supply|
|Requires notification to be sent to sponsor to authorise supply|
|Requires notification to be sent to TGA after supply|
Therapeutic goods accessible through the SAS
Any unapproved therapeutic good can potentially be supplied via the appropriate SAS pathway.
The SAS allows individual patients access to unapproved therapeutic goods in circumstances including where:
- critically ill patients require urgent, early access to therapeutic goods including experimental and investigational therapeutic goods
- therapeutic goods have been withdrawn from the Australian market for commercial or other reasons
- therapeutic goods are initially provided to patients through a clinical trial while a marketing application is being considered
- therapeutic goods are available overseas but not marketed in Australia
An unapproved good is a good which is not registered, listed or included in the Register.
Costs associated with the SAS
There is no cost associated with applications or notifications to TGA to access or supply unapproved therapeutic goods through the SAS.
Generally, the Commonwealth does not subsidise the cost of unapproved therapeutic goods through the Pharmaceutical Benefits Scheme (PBS). For more information on the PBS, visit Pharmaceutical Benefits Scheme or phone 1800 020 613.
In some circumstances and at their own discretion, a sponsor may provide the product on a compassionate basis (referred to as compassionate supply) at reduced or no cost to the patient.
TGA will not consider applications which cite monetary reasons as justification for supply of the unapproved good. The applicant must provide a clinical justification for the use of the good, including why any product on the ARTG and available in Australia is not appropriate for their patient.
In certain circumstances, patients may utilise the Personal Importation Scheme to import medicines from overseas.