How does Australia ensure patients can access potentially life-saving or clinically necessary treatments that have not yet been approved for general use, without undermining the integrity of the medicines regulatory system?
The answer: the Special Access Scheme (SAS), established under the Therapeutic Goods Act 1989, providing a pathway for access to medicines that are not included in the Australian Register of Therapeutic Goods (ARTG).1
This pathway recognises that there are certain circumstances where patients should have access to medicines which are not registered, including where:
it is not commercially viable to register the product in Australia (e.g. rare diseases) the therapeutic good is still new or undergoing evaluation.2
Initially, there were two pathways: SAS-A and SAS-B (see table 1 below), primarily used by specialists managing patients with rare, complex or life-threatening conditions. However, in July 2017, a new category was added: SAS-C for therapeutic goods with an established role in the treatment of specific health conditions.4
Recently, SAS-C has been used as a mechanism to implement public policy for therapeutic agents which don’t fit neatly into Australia’s medicine regulation model – such as medicinal cannabis and nicotine-containing therapeutic vapes.
This shift has accompanied a dramatic increase in volume. In 2023, the Therapeutic Goods Administration (TGA) received more than 264,0005 SAS submissions, compared to fewer than 60,000 a decade earlier.6 As a result, most pharmacists in patient-facing roles now need to be familiar with the scheme to support prescribing, dispensing or review of these medicines.
Regulatory obligations
Depending on the SAS pathway, the TGA must be notified or approve the use of the prescribing of unapproved medicines. The TGA website provides extensive guidance to help health professionals navigate these pathways. Sponsors may also request evidence of TGA notification or approval when products are ordered to meet their obligation that the product is only being used under the SAS.7
Increasingly, pharmacists have reported being asked to submit SAS documentation to the TGA on behalf of prescribers. While generally supported, the TGA notes that, due to an agreement with state and territory health departments, SAS submissions for medicinal cannabis products should be made by the prescribing health practitioner.3 In circumstances where a pharmacy imports unapproved therapeutic goods from overseas for use via the SAS, they become the sponsor of the product, with additional obligations applying. These mandatory obligations apply in addition to all other professional and legal obligations when prescribing or dispensing medicines.
Professional responsibilities
The SAS requires more than an understanding of the regulatory pathway; it also requires pharmacists to navigate the ambiguity and greater professional responsibilities associated with unapproved therapeutic goods.
Lack of approved Product Information, CMI and clinical guidelines
In the absence of TGA-approved product information, it can be unclear what an appropriate therapeutic dose is, difficult to determine adverse effects, and not possible to provide written patient information. While pharmacists should draw on overseas product information and published evidence, this can be difficult.
Drug interactions
Identifying and resolving drug interactions can be more complex and may not exist within standard references such as MIMS or the Australian Medicines Handbook.
International databases may provide insight for products registered overseas. For medicinal cannabis, interactions affecting drug metabolism between cannabinoids and commonly prescribed medicines are well documented.8
Entry in clinical software
Selecting the right strain of medicinal cannabis in clinical software and ordering systems can be difficult. Hundreds of products do not appear in standard dispensing software and must be entered manually, increasing selection error risk. The risk of the item not being visible through interconnected health systems, such as My Health Record and Real Time Prescription Monitoring (RTPM), also increases.
Pharmacies should have a standardised approach to manual addition of unapproved therapeutic goods, including correct coding to ensure upload of prescribing and dispense events to RTPM systems where relevant.
Informed patient consent
Patients must be informed that SAS products are unapproved, what this means in terms of limited evidence on long-term risks, and that their use involves greater personal risk. Pharmacists dispensing SAS medicines should have clear protocols for this process, keeping a consistent record of protocol adherence and patient consent.9
Direct importation becomes sponsorship
Practitioners who directly source a medicine from overseas become recognised as the product sponsor, meaning they become responsible for the safety and efficacy of the product. Managing this risk will require establishing the bona fides of a repeat supplier. In other cases, it can necessitate a far more sophisticated risk assessment process.
Considering risks of treatmentObligations for considering evidence and risks for unapproved therapeutic goods include taking the following into account3: ‘Unapproved’ therapeutic goods have undergone little or no evaluation by the TGA for quality, safety, efficacy or performance. The prescribing health practitioner takes responsibility for the use of an ‘unapproved’ therapeutic good and outcomes, including any associated adverse reactions. The treating health practitioner has the right to decline to prescribe an ‘unapproved’ therapeutic good if they believe there is insufficient clinical justification or evidence to support the use of the product, or both. |
The SAS timeline
| 1989 | Establishment of the SAS
The SAS was established as part of the Therapeutic Goods Act to maintain access to essential medicines not listed on the ARTG, while maintaining public safety.1 |
| 2016 | Legalisation of medicinal cannabis
Decades of restricted research and patent difficulties reduced the commercial incentive to fund the large clinical trials needed for full TGA registration. The SAS has become the default pathway for medicinal cannabis submissions10 – particularly for chronic pain and anxiety – increasing almost 100-fold since 2018.11 |
| 2017 | Introduction of SAS-C
New access pathway introduced in response to TGA medical devices review.3 |
| 2021 | Discontinuation of opioids used in palliative care
SAS volumes increased between 2021 and 2023 following discontinuation of several oral opioid products (e.g. hydromorphone).12 |
| 2024 | Restriction of vapes to therapeutic use
Government policy response to address rising child and adolescent use of unregulated nicotine-containing vapes. Adult smokers seeking to use vaping as a cessation tool now use the SAS-C pathway.13 |
References
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Therapeutic Goods Administration. Therapeutic Goods (Charges) Act 1989. Canberra; 1989. At: www.tga.gov.au/resources/legislation/therapeutic-goods-charges-act-1989
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Sydney Local Health District. Special Access Scheme. Sydney; 2024. At: www.slhd.nsw.gov.au/rpa/research/APSAS.html
- Larter NT, Gadzhanova SV, Rossi S, et al. The Special Access Scheme: access to unapproved medicines in Australia. Med J Aust. 2017;207(9):374–6.
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Therapeutic Goods Administration. Transition to paperless digital access to unapproved therapeutic goods through Special Access Scheme and Authorised Prescriber Scheme. Canberra; 2024. At: www.tga.gov.au/sites/default/files/2024-02/transition-paperless-digital-access-unapproved-therapeutic-goods-through-special-access-scheme-authorised-prescriber-scheme.pdf
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Therapeutic Goods Administration. Half yearly performance reports July–December 2013. Canberra; 2013. At: https://webarchive.nla.gov.au/awa/20220819204159/https://www.tga.gov.au/half-yearly-performance-reports-july-december-2013
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Therapeutic Goods Administration. Supply of an unapproved therapeutic good by a sponsor. Canberra; 2024. At: www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways/supply-unapproved-therapeutic-good-sponsors
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Therapeutic Goods Administration. Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods. Canberra; 2023. At: www.tga.gov.au/resources/resource/guidance/special-access-scheme-sas-guidance-health-practitioners-accessing-unapproved-therapeutic-goods
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Brown JD, Winterstein AG. Cannabidiol interactions with medications, illicit substances, and alcohol: a comprehensive review. J Gen Intern Med. 2020;35(7):2152–65. At: link.springer.com/article/10.1007/s11606-020-06504-8
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Australian Commission on Safety and Quality in Health Care. Informed consent. Sydney; 2025. At: www.safetyandquality.gov.au/our-work/partnering-consumers/informed-consent
- Australian Medical Association. Submission: Reviewing regulatory oversight of unapproved medicinal cannabis products. Canberra; 2025. At: www.ama.com.au/sites/default/files/2025-10/AMA_submission_Reviewing_regulatory_oversight_of_unapproved_medicinal_cannabis_products_0.pdf
- Nissen LM, Henderson C, Moore A, et al. The rise and rise of medicinal cannabis, what now? Medicinal cannabis prescribing in Australia 2017–2022. Expert Rev Clin Pharmacol. 2022;15(7):787–93.
- South Australian Health. Medication Safety Notice: Discontinuation of several oral opioid products. Adelaide; 2024. At: www.sahealth.sa.gov.au/wps/wcm/connect/7df380e8-f840-49e5-bd69-8acdef876246/Medication+Safety+Notice++Discontinuation+of+Several+Oral+Opioid+Products.pdf
- Therapeutic Goods Administration. New regulation of vapes starting January 2024. Canberra; 2023. At: www.tga.gov.au/news/media-releases/new-regulation-vapes-starting-january-2024
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Pharmaceutical Society of Australia. Guidelines for pharmacists providing smoking cessation support. Canberra; 2021. At: www.psa.org.au/practice-support-industry/nicotine-dependence-guidelines/
