There are a number of ways that patients can gain access to products that have not been approved for use in Australia.
Special Access Scheme
The Special Access Scheme (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. Applications for special access are coordinated by the Office for Research. Contact ResearchGovernance@mh.org.au.
There are two schemes under which clinical trials involving therapeutic goods may be conducted in Australia – CTN and CTX schemes. Further information, including copies of any forms that need to be completed, is available on the TGA website.
The Therapeutic Goods Administration (TGA) is able to grant medical practitioners authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients. Under the Authorised Prescriber Scheme (APS), individual medical practitioners can apply to be granted authority to become an “Authorised Prescriber” of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific groups of patients with a particular medical condition.
Therapeutic goods not included on the Australian Register of Therapeutic Goods (ARTG) cannot legally be supplied unless the TGA grants an exemption. The APS allows medical practitioners who become Authorised Prescribers to access and legally supply an unapproved therapeutic good or class of goods to appropriate patients/categories of patients. Only registered medical practitioners are able to become Authorised Prescribers.
On 24 July 2020, the TGA implemented a change to the APS to streamline the application process for medicines considered to have an established history of use in Australia. The application form and process have been updated for medical practitioners to apply under the new arrangements. This change removes the requirement for HREC approval or specialist college endorsement to be submitted to the TGA in circumstances where the medical practitioner is applying to become an Authorised Prescriber of medicines specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. Please refer to the TGA website for a list of medicines with an established history of use.
A medical practitioner will still need to obtain prior HREC approval or specialist college endorsement for products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.
To become an Authorised Prescriber, a medical practitioner must first obtain approval from a human research ethics committee (HREC) or endorsement from a specialist college. They will then need to submit an application to the TGA for evaluation. This submission should include:
- a completed APS application form
- evidence of either approval from a HREC or endorsement from a specialist college.
For more information on how to become an Authorised Prescriber, refer to the guidance document, Authorised Prescriber Scheme - Guidance for Medical Practitioners, Human Research Ethics Committees and Specialist Colleges.
How to submit an Authorised Prescriber Application at Melbourne Health
As per the Authorised Prescriber Scheme Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors (Version 4.0, dated October 2020) all the items outlined below are required for submission of an Authorised Prescriber application.
Following consideration of an Authorised Prescriber application, the HREC will issue (if application is approved) a formal letter of approval. This letter should be provided to the TGA together with the completed Authorised Prescriber Application Form – ensure the indication listed on the application form is the indication approved by the HREC.
Submit a cover letter which includes the following information:
- the reason for the Authorised Prescriber application; and
- the name of each registered medical practitioner seeking endorsement to become an Authorised Prescriber.
Provide details of exactly how the drug or device will be obtained/supplied.
Will an agreement between Melbourne Health and the provider be required? If so, provide an electronic copy of the agreement from the supplier for review and execution by the Office for Research.
Authorised Prescribers are responsible for obtaining the unapproved therapeutic good. If the Authorised Prescriber is an employee of Melbourne Health, these arrangements will be made by Melbourne Health on behalf of the approved Authorised Prescriber.
Complete the Authorised Prescriber Site Specific Authorisation form which requires Head of Department or Divisional Director sign off.
An Authorised Prescriber applicant must not approve their own authorised prescriber requests on behalf of their department. If an AP applicant is also Head of Department approval must be sought from the person to whom the Head of Department is responsible (e.g. Division Director).
Submit a curriculum vitae (CV) for each registered medical practitioner.
The clinical justification for use of the unapproved good should provide sufficient evidence to demonstrate that this use is appropriate, considering the availability of any approved goods that may be suitable alternatives. Specifically, provide information on:
- the indication for which the good will be used
- the seriousness of the condition
- the expected benefits of the proposed treatment versus its potential risks
- It should also address the circumstances where there are approved treatments for the same indication, specifically:
- have they been attempted?
- will they be attempted prior to supplying the unapproved good?
- why are they inappropriate?
- why is the proposed unapproved good a more appropriate option than any approved available alternative
- how the risk associated with the use of an unapproved good will be managed
- the monitoring that will be undertaken
- the process for investigating and reporting adverse events
Provide product information or an investigator brochure including toxicology and safety information.
Provide a copy of the template of the informed consent document to be provided to each patient receiving the unapproved therapeutic product. Often the template will be provided by the supplier of the unapproved therapeutic product. The Authorised Prescriber must obtain the written informed consent of each patient for whom they prescribe the unapproved product. This consent form must be in plain and simple English and include statements about the following:
- that the TGA has not evaluated the unapproved good’s safety, quality and efficacy
- that the product is not approved for marketing in Australia;
- the possible benefits of treatment and any risks and side effects that are known;
- the possibility of unknown risks and side effects; and
- any alternative treatments using approved products which are available.
For the Melbourne Health HREC to endorse your application you must either:
- have an appointment at Melbourne Health or Western Health; or
- your practice must be located within the geographical area that the MH HREC serves.
Submit both 1 hard copy and 1 electronic copy to the Office for Research.
Deliver a hardcopy to:
Manager, Human Research Ethics Committee
Office for Research
Level 2 South West, 300 Grattan Street
PARKVILLE VIC 3050
Email the electronic copy to: HRECSubmissions@mh.org.au and include "Authorised Prescriber Request" in the subject line