MCN speaks with Australia’s Therapeutic Goods Administration about medical cannabis regulation and access.
The Australian Therapeutic Goods Administration (TGA), which operates under the aegis of the Department of Health, is responsible for regulating therapeutic goods – including pharmaceutical and complementary medicines, medical devices, tests, and vaccines – across Australia. It oversees the classification and manufacture of medicines and medicinal products; as well as conducting risk and safety assessments, standards enforcement, and post-market monitoring.
As the regulatory body in charge of determining the validity of applications to prescribe medical cannabis, the TGA has approved requests for cannabis prescriptions to treat conditions and symptoms including:
- Nausea and vomiting induced by chemotherapy;
- Neuropathic pain;
- Pain related to cancer;
- Severe forms of childhood epilepsy;
- Spasticity associated with neurological conditions;
- Anorexia and wasting associated with chronic illness; and
- Palliative care indications.
It should be noted, however, that applying to prescribe cannabis for one of the above conditions does not guarantee approval from the TGA.
MCN speaks with a spokesperson from the TGA about Australian cannabis regulation and access, the evolution of Australian cannabis policy, and the importance of continued education within the sector.
What is the current medical and legal status of cannabis in Australia?
Australia is a signatory to the United Nations Single Convention on Narcotic Drugs of 1961, as amended, which requires all signatories to implement controls on the cultivation of the cannabis plant. Commentary to the Single Convention provides an overview of the standard regime to which signatories have committed:
The principal features of that regime are: limitation to medical and scientific purposes of all phases of narcotics trade (manufacture, domestic trade, both wholesale and retail, and international trade) in, and of the possession and use of, drugs; and requirement of governmental authorization (licensing or state ownership) of participation in any phase of the narcotics trade and of a specific authorization (import and export authorization) of each individual international transaction.
The Commentary to the Single Convention makes it clear that possession, use, manufacture and cultivation of any drug covered by Schedule 1 of the Convention (including cannabis, cannabis resin and extracts and tinctures of cannabis) is limited exclusively to medical and scientific purposes.
It is the policy of the Australian government to treat medicinal cannabis products as medicines, subject to the same regulatory framework and strict standards of safety, efficacy and quality as other medicines. Generally, medicines used in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG). For a prescription medicine to be registered in the ARTG, a sponsor of the product (usually a pharmaceutical company) is required to submit a dossier of evidence on the clinical efficacy, safety and manufacturing quality for evaluation by the TGA.
Currently only one approved cannabis product, Sativex, is listed in the ARTG; all other medicinal cannabis products are unapproved products. Unapproved medicinal cannabis products can be accessed in the same way as other unapproved medicines in Australia, chiefly through the Special Access Scheme (SAS) and the Authorised Prescriber (AP) pathway. In Australia, currently, all cannabis products require a prescription from a prescriber, and access may also require state or territory authorisation (such as when they are Schedule 8 controlled drugs).
Can you give me a brief overview of how the Special Access Scheme works? How many patients have been able to access cannabis under the scheme so far?
Under the provisions of the Therapeutic Goods Act, the TGA administers a number of mechanisms to enable access to therapeutic goods which are not registered on the ARTG (or ‘unapproved’ therapeutic goods). These mechanisms include the Special Access Scheme (SAS), the Authorised Prescriber (AP) pathway and access through clinical trials. Information about these access pathways is available on the TGA website. Information about accessing medicinal cannabis products through the SAS is available at www.tga.gov.au/access-medicinal-cannabis-products-1.
The Special Access Scheme allows certain health practitioners to facilitate access for individual patients to prescribed therapeutic goods that are not included in the Australian Register of Therapeutic Goods. The TGA has a responsibility to encourage the use of medicines which are included in the ARTG, as these products have been thoroughly evaluated to ensure they meet strict standards of safety, quality and effectiveness. For this reason, it is expected that medical practitioners will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access and prescribe an unapproved medicinal cannabis product under the Special Access Scheme (SAS). It is important to note that the TGA does not vouch for the quality, safety and effectiveness of unapproved products accessed through SAS and the prescriber and patient accept responsibility for any adverse consequences of treatment via a process of informed consent.
SAS Category A (SAS A) is a notification pathway that allows a registered medical practitioner to access and prescribe an unapproved medicinal cannabis product for a patient who is seriously ill. ‘Seriously ill’ is defined as having 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, and is determined by the patient’s medical practitioner. Notifications are required to be provided to the TGA within 28 days of supply of the product.
Special Access Scheme Category B (SAS B) is an application pathway through which a registered health practitioner may apply to the TGA for approval to prescribe an unapproved medicinal cannabis product for a patient under their care. The applicant must provide a suitable clinical justification for the use of the therapeutic product, including reasons why products included in the ARTG are found to not be clinically suitable.
Up to 31 August 2020, the TGA has approved over 61,000 SAS Category B applications for unapproved medicinal cannabis products. SAS category B approval statistics are published on the TGA website.
What decisions and policy developments led to the legalisation of medical cannabis in Australia in 2016?
The cannabis plant and tetrahydrocannabinol (THC, a psychoactive component of cannabis) were historically included in Schedule 9 of the Poisons Standard in Australia as prohibited substances, which severely restricted patient access to medicinal cannabis for many years. Figure 1 below outlines the evolution of scheduling decisions which led to access to medicinal cannabis in Australia.
What challenges has the TGA faced in implementing policy on medical cannabis? Do you anticipate any future challenges stemming from the new and largely unregulated industry?
Education of the sector remains integral and the TGA will continue to use its website to educate health professionals, consumers and industry and provide updates with new information as it becomes available.
How can the government ensure that the medical cannabis products consumers are exposed to are safe and effective?
The TGA conducts targeted audits and testing of medicinal cannabis products imported or supplied in Australia, to ensure conformity with relevant standards. Medicinal cannabis products which have not been entered on the ARTG and which are accessed through various unapproved pathways are considered to be experimental, as they have not been evaluated by the TGA for safety, quality and efficacy.
The TGA provides quality standards for therapeutic goods that are imported, exported or supplied in Australia. In recognition of the fact that medicinal cannabis products differ from the vast majority of medicines accessed via unapproved product access pathways, in that they are not registered in comparable overseas jurisdictions, the TGA established the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93). The TGO 93 specifies the minimum quality requirements for all medicinal cannabis products available in Australia.
Is misinformation an issue when regulating cannabis, whether in terms of people’s misperceptions of the harms associated with cannabis or producers making inaccurate claims about the benefits of their product?
Advertising of prescription medicines directly to the public is prohibited in all Member States of the Organisation for Economic Co-operation and Development (OECD), except for the United States and New Zealand. Therefore, because individual medicinal cannabis products are Schedule 4 or Schedule 8 prescription medicines, their advertising to the public is not permitted, although they can be promoted to healthcare professionals.
As the national medicines regulator, provision of clinical practice education around the use of a particular group of medicines is outside the normal role and resourcing of the TGA. However, in recognition of the lack of clinical guidance material pertaining to medicinal cannabis available at the time, the TGA, in conjunction with state and territory governments and with the involvement of relevant clinical and patient groups, developed clinical guidance documents during 2017. The guidance documents, along with annotated bibliographies summarising individual clinical studies on medicinal cannabis, were published on the TGA website in December 2017.
In addition, the TGA has published specific information about accessing unapproved medicinal cannabis products, including the role of the TGA, guidance on the various access schemes, approval statistics and other pertinent information. The TGA has also worked with the Australian Medical Association and Pharmaceutical Society of Australia to publish online Continuing Professional Development modules outlining the SAS and AP pathways for healthcare professionals to improve understanding of regulatory processes. Apart from specific guidance on the regulatory system on the TGA website, a 1-800 telephone and email contact line is available for prescribers who have specific queries.
Therapeutic Goods Administration