Medicinal Cannabis in Australia | Part 2: Patient access via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways

by , , | May 10, 2022

Introduction

As noted in part 1 of our blog series, the vast majority of medicinal cannabis products are not registered on the Australian Register of Therapeutic Goods (ARTG).  Rather, they are unapproved therapeutic goods, i.e., products that have not been assessed by the Therapeutic Goods Administration (TGA) as meeting the various efficacy, safety and quality standards necessary for registration on the ARTG.

In Australia most patients are prescribed medicinal cannabis via the Special Access Scheme (SAS) or Authorised Prescriber (AP) alternative pathways for products which are not registered on the ARTG.  This part 2 of our blog series provides further information about the SAS and AP pathways.[1]

Medicinal cannabis products which may be prescribed through the SAS and AP pathways

The SAS and AP pathways are available for supply of medicinal cannabis products which are not registered on the ARTG and which are classified as belonging in either Schedule 4 or Schedule 8 of the Poisons Standard:[2]

  • Schedule 4: medicinal cannabis products where CBD makes up at least 98% of their cannabinoid content and any other cannabinoid (such as THC) makes up no more than 2% of that content (Schedule 4 Medicines). Schedule 4 Medicines are prescription only.
  • Schedule 8: medicinal cannabis products where CBD makes up less than 98% of their cannabinoid content, i.e. other cannabinoids (such as THC) make up more than 3% up to 100% of their cannabinoid content (Schedule 8 Medicines). Schedule 8 Medicines are controlled drugs subject to additional restrictions, for example, prescribing permits.

Special Access Scheme (SAS) pathway

Under the SAS a registered medical practitioner or a registered health practitioner can prescribe an unapproved medicinal cannabis product to a specified patient. SAS prescriptions are divided into the following categories:

SAS Category A: A registered medical practitioner prescribing a product to a patient who is seriously ill.  A seriously ill patient is one having a condition from which death is reasonably likely to occur in a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment, as determined by the patient’s medical practitioner.  There is no application or approval process for Category A prescriptions; instead notification to the TGA is required within 28 days following supply of the product to patient.  In addition, permission for importation must be obtained from the Office of Drug Control.  As of May 2022 approximately 1500 Category A notifications have been made to the TGA.[3]

SAS Category B: A registered health care practitioner (this includes medical practitioners as well as other types of practitioners such as dental and nurse practitioners) prescribing a product to a patient under their care who does not meet the clinical requirements in Category A.  Approval by the TGA is required before the product is supplied to the patient.  Furthermore, the applying health care practitioner must provide a clinical justification including why approved products are not appropriate.  As Category B covers a broader range of practitioners who may prescribe medicinal cannabis, as well as a broader range of patients who may be prescribed (since there is no requirement that the patient be seriously ill), the majority of SAS prescriptions fall under Category B.  As of May 2022, 250,000 Category B prescriptions have been approved by the TGA.[4]

SAS Category C: This is a notification-only pathway like SAS Category A, but is limited to products on a list maintained by the TGA of products which have an established history of use.  The list also specifies the type of health care practitioner authorised to supply these products and the relevant indications and other circumstances.  Notification is required within 28 days after supply to the patient.[5]

Authorised Prescriber (AP) pathway

Under the AP pathway a registered medical practitioner may be authorised by the TGA to prescribe specified unapproved medicinal cannabis products to a class of patients in the practitioner’s care.  Once approved as an AP, the practitioner is not required to notify the TGA each time they prescribe a product, but must provide six-monthly reports to the TGA on the number of patients treated with the product.  The type of approval required to become an AP depends on the nature of the product:

Established history of use pathway: For medicinal products deemed by the TGA to have an established history of use, the TGA implemented a change in July 2020 so that approval from a Human Research Ethics Committee or endorsement from a specialist college is no longer required.  In November 2021 the TGA deemed medicinal cannabis products in the following categories (according to cannabinoid content) to have an established history of use:

  • Category 1: ‘CBD medicinal cannabis product’ (CBD ≥98%)
  • Category 2: ‘CBD dominant medicinal cannabis product’ (CBD ≥60% and <98%)
  • Category 3: ‘Balanced medicinal cannabis product’ (CBD <60% and ≥40%)

Standard AP pathway: For other unapproved medicinal products such as those listed below, HREC approval or endorsement by a specialist college is required before applying to the TGA:

  • Category 4: ‘THC dominant medicinal cannabis product’ (THC 60-98%)
  • Category 5: ‘THC medicinal cannabis product’ (THC >98%)

The SAS and AP alternative pathways in practice

The TGA provides an online portal for the SAS and AP pathways to streamline applications for approval by the TGA and by the applicable state or territory.  All states and territories other than Tasmania participate in the portal.  For commonly requested products, the TGA website indicates that a response to an SAS Category B (SAS-B) application will be provided in around 2-3 working days.  The TGA does not provide an estimate of the approval timeframe for AP applications.

The Senate Community Affairs Reference Committee Report on Current Barriers to Patient Access to Medicinal Cannabis in Australia, in March 2020 (Senate Report) highlighted difficulties patients have in accessing medical practitioners sufficiently knowledgeable about the clinical benefits of medicinal cannabis and the available access pathways.  Furthermore, medical practitioners did not always have the necessary resources to complete the application process.  (At that time, only SAS applications could be made online; the portal did not cover AP applications.)

In particular, submissions to the Committee highlighted the complexity and onerous requirements for SAS-B applications, despite being online.  Particular areas of concern were the fact that each application is limited to a specified patient and product, and that an application must be resubmitted if the specified product is not available.  Furthermore, there was uncertainty among practitioners as to the extent of the clinical justification required.

Despite these difficulties, at the time of the Senate Report the overwhelming majority of prescriptions were made through the SAS-B pathway.[6]  In fact submissions indicated that the AP pathway, rather than the SAS-B pathway, had been anticipated to be the main route by which patients would access unapproved medicinal cannabis products.  Given that the AP pathway is not limited to specified patients and may cover a range of unapproved medicinal cannabis products, the lack of an online application process may have been a significant factor.

Concluding remarks

The transition to the online approval process and the inclusion of ‘lower risk’ (Categories 1, 2 and 3) unapproved medicinal cannabis products onto the TGA’s list of products with an established history of use could increase the number of practitioners applying for approval as an AP.  If not, pharmacy dispensing without prescription in future (as discussed in part 1 of our blog series) will likely have the biggest effect in increasing use of medicinal cannabis.

[1] A third pathway to obtain medicinal cannabis in Australia, not discussed in this article, involves the supply as part of a clinical trial.

[2] Also known as the ‘Standard for the Uniform Scheduling of Medicines and Poisons’.  The Poisons Standard, as updated from time to time, can be found at this link.

[3] Refer to the TGA’s Medicinal Cannabis Access Data Dashboard at https://www.tga.gov.au/medicinal-cannabis-access-data-dashboard

[4] See reference 3.

[5] The TGA’s Medicinal Cannabis Access Data Dashboard does not include data on Category C prescriptions.

[6] The Report stated that only about 650 AP prescriptions had been notified to the TGA.  The TGA website does not provide more recent statistics for AP prescriptions.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

Emily Dwyer

Emily Dwyer

Graduate Lawyer, Trainee Trade Mark Attorney

Pearce IP’s law graduate Emily Dwyer offers legal and intellectual property services, with particular focus on patents and trade marks.

Emily co-authors Pearce IP’s blogs including the biopharma focussed blog BioBlast®, and Pearce IP’s regular pharma/biopharma industry news updates, and ensures that Pearce IP’s life sciences clients are kept abreast of important industry and legal developments.

Naomi Pearce

Naomi Pearce

Executive Lawyer, Patent Attorney & Trade Mark Attorney

Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory.  Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

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