These reforms will see modifications to the Special Access Scheme (SAS), including the development and implementation of transparent criteria for the automatic approval of access to certain unapproved therapeutic products for use in patients who have a non-life threatening condition. These products would need to be inherently lower in risk or have well-established patterns of use. In addition, these reforms will also:

• establish an integrated, online system to manage SAS notifications; and
• reduce the regulatory requirements for Authorised Prescribers of unapproved therapeutic products.

These reforms will apply a risk-based approach to accessing products that are not on the Australian Register of Therapeutic Goods (ARTG), thereby reducing regulatory burden. Patients will be more efficiently protected from potential harm through better monitoring of the use patterns of these products.

What is the Special Access Scheme (SAS)?

In Australia, therapeutic products for human use can usually only be supplied if they have been included on the ARTG following an assessment of the safety, quality and efficacy of the product. The SAS allows a prescriber to provide a therapeutic good that is not on the ARTG to an individual patient in certain circumstances. SAS Category A is for patients with serious, life-threatening illnesses or conditions from which death is reasonably likely to occur soon, or in the absence of early treatment. Category B is for all other patients (i.e. with non-life threatening conditions).

Automatic approval of certain Category B applications

Currently, the use of a product under SAS Category B requires individual approval by the TGA. These reforms will remove this requirement for certain products that are either inherently lower in risk or have well-established patterns of use for particular indications. Transparent criteria will be developed for Category B applications that would be subject to automatic approval. These criteria will be based on a combination of the inherent risk of the product and the proposed indications for use.

Particular products, along with proposed indications for use that are considered to represent an 'acceptable risk' for that product will be included on a list.

If a clinician wants to prescribe a product that is not on the ARTG, they can refer to the list.

If the product is on the list for the indication, that they wish to use it for, then they can submit a streamlined application which would be auto-approved by the TGA.

If the product is not on the list or the prescriber wishes to use it for a different purpose, the application will be subject to an individual assessment by a TGA Medical Officer.

Automatic approval of certain products will result in:

• a reduction in the number of assessments required by the TGA, which will allow Medical Officer resources to be focussed elsewhere
• faster access to products that have a lower level of risk.

Online system to manage SAS notifications

An integrated, online system to manage the SAS will increase the efficiency of the SAS and facilitate the use of data analytics and auditing to identify trends and prevent potential abuse of the system. It will do this by automating procedures via an integrated online system which makes use of 'smart-form' technology to pre-populate selected fields and provide data for real-time monitoring.

The new online system will provide greater capacity to capture important data regarding adverse events and supply patterns, as well as reducing the administrative burden on prescribers.

Appropriate monitoring of the usage of particular products will ensure the scheme is not used as a de facto system to market significant quantities of particular therapeutic goods that are not on the ARTG.

Reducing the regulatory burden on Authorised Prescribers

The Authorised Prescriber Scheme enables a prescriber to provide a particular product(s) that is not on the ARTG to a particular cohort of patients, and authorises the sponsor to supply that medicine or device to that prescriber. To become an Authorised Prescriber, practitioners must have the endorsement of an appropriate ethics committee or clinical college; and are required to address a number of criteria including the clinical justification for use of the product, the risk-benefit of the choice of treatment and informed consent procedures.

The reforms will streamline this process by simply requiring the practitioner to submit to the TGA a copy of:

• the ethics committee or clinical college application;
• the ethics committee or clinical college approval letter, including any specified conditions of approval;
• a one page application that identifies the practitioner, the sponsor, and the medicine or device to be used.

For renewal of Authorised Prescriber status, the practitioner could provide evidence that they continued to have appropriate ethics approval.

The reforms will focus the role of the TGA on confirming that there has been appropriate ethics approval, that there are no suitable alternative products on the ARTG, and that there are no emerging safety concerns for the requested medicine or device.

The reforms will reduce unnecessary duplication while ensuring that the TGA has records of Authorised Prescribers and can rescind approvals if appropriate (e.g. if safety concerns arose or an alternative product has since been registered).