Direct-to-consumer telehealth access is outstripping regulation and the TGA says it will take ‘immediate regulatory action on any safety concerns identified’.
The Therapeutic Goods Administration will launch a public consultation to explore the possibility of expanding the regulation of unapproved medicinal cannabis products, particularly those accessed through the Special Access and Authorised Prescriber schemes via direct-to-consumer telehealth platforms.
The consultation will begin on 11 August “to gather information from stakeholders on their knowledge, experiences and observations of the use of unapproved medicinal cannabis products in Australia”.
Announced by Professor Tony Lawlor, deputy secretary of the Department of Health, Disability and Ageing’s Health Products Regulation group, at the AMA national conference in Adelaide on Saturday, the consultation has been prompted by “increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products, particularly those containing higher levels of tetrahydrocannabinol”.
“We will be undertaking consultation on potential reforms to access to medicinal cannabis through the unimproved goods pathway,” Professor Lawlor told the AMA conference.
“This consultation will also explore growing safety concerns in the context of the rapid growth in the number and type of unimproved medicinal cannabis products being used and accessed in Australia.
“Input will guide reform options to ensure appropriate regulatory oversight and market control.
“The TGA will take immediate regulatory action on any safety concerns identified, and further consultation with stakeholders will be undertaken regarding any proposed reforms.”
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Professor Lawlor said the DoHDA would be exploring three key issues:
- the appropriateness and effectiveness of the unapproved goods pathway for medicinal cannabis access;
- the safety and quality concerns about medicinal cannabis; and
- the impact in the growth of direct-to-consumer telehealth models of care.
However, “as the regulator of therapeutic goods, the focus of [the TGA’s] consultation paper will be on those first two issues: our unapproved goods pathway and the safety quality profile”, he said.
In a wide-ranging speech, Professor Lawlor acknowledged that the growth of direct-to-consumer closed-loop telehealth businesses had outpaced regulation.
“The overwhelming majority of medicinal cannabis is accessed in Australia through the unapproved goods scheme, which is not a regulatory control mechanism, and that’s one of the reasons why we need to look a lot more closely at it,” he said.
“[Before covid] people had been spruiking the benefits of telehealth for a long time, but the risk balance was not right – the concerns around fidelity, around validation and around the capacity to interact, always outweighed the need to have the patient in front of [a doctor].
“As covid provided different risks to be managed and accepted, the view was that telemedicine not only changed how we responded to covid, but would have a long tail on how we changed the world.
“But as we moved out of the pandemic and the intrusion and uncertainty about revenue streams, quality of care and the necessary skill mix, we saw a decline in its use,” he said.
“But now with the realisation of potential benefits and, importantly, profits, we see further innovation, investment and resources introduced to telehealth.
“So we find ourselves in a situation where, because this has grown out of pace with regulation, and to a certain extent societal maturity, we’re seeing, again, a situation where the risks are moving towards potentially out-balancing the benefits.”
The direct-to-consumer therapeutic goods and services accessible by Australians fall into three broad categories, he said.
The first two are:
- Services offering virtual consultations – These pre-date the pandemic. They’re provided by both government and private operators, and they seek to meet clinical need or provide concierge advice.
- Services that offer targeted treatment pathways for specific conditions – Some offer single therapeutic products and are established separately to existing healthcare systems, to address low-cost, low-impact and non-complex conditions.
“We’re seeing that change with really complex situations such as ADHD and gender-affirming care now being offered, and they often operate under a subscription model with intensive or downright aggressive marketing embedded,” said Professor Lawlor.
“It’s also worth noting that the private nature of these clinics presents a particular challenge for how we understand and respond as risk-based regulators.
“We rely on evidence of harm to make decisions around regulatory responses, and because many of these clinics are privately billed, activity doesn’t show up in MBS statistics, and private scripts don’t appear in PBS data.
“We therefore rely on proxy measures such as special access authorisations, anecdotal accounts and professional feedback to triangulate, quantify and respond effectively to risk.”
The third category is the virtual medicinal cannabis services.
“We’re seeing very high-volume descriptions of unapproved medicines in high doses, high THC concentration, and with escalating reports of adverse events,” said Professor Lawlor.
“There is little available and validated data in terms of the dose or nature of prescriptions issued. But companies obviously are promising exponential growth markets for their shareholders.
“Many of the direct-to-consumer platforms arise directly from the technology or retail rather than the healthcare sectors and this brings a market-driven mindset that shapes their approach to patient care with a focus on speed, scalability and targeting sectors.
“They can be nimble, and they can adapt very quickly in a tech-enabled environment,” he said.
Professor Lawlor said he was expecting a resistance to regulation in this space.
“Clearly, this is very big business,” he said.
“These are multimillion-dollar companies, multimillion-dollar investments led by large corporations and many powerful lobby groups continue to gather.
“At the same time, there is underlying debate on whether some of these products should simply be legalised for recreational use, and some see the current model as a way of achieving this.
“We can expect there to be resistance to regulation in a space that has such potential for financial return and such social ambiguity.
“This is also a complex issue, particularly given the arguable lag in regulatory robustness in the face of such rapid innovation and advancement, which is a feature we see around the world.”
He warned against taking a “binary, adversarial approach” however.
“[That would] risk losing any benefits that we can obtain from direct-to-consumer engagement,” he said.
“We need data to support our policy decisions, which should be agnostic to the underlying product in bringing about improvement in the regulatory frameworks.”
The TGA announcement of the consultation said it was seeking to understand whether current regulatory arrangements that enable patients to access medical cannabis via the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme provided adequate oversight for the “more than 1000 unapproved products currently supplied in Australia”.
“These schemes were initially designed to provide access to experimental products often used in clinical trials, or for exceptional circumstances at the discretion of the prescribing practitioner.”
Anyone seeking further information about the consultation before its launch on 11 August can email MedicinalCannabisReforms@health.gov.au.
The 2025 AMA conference was held in Adelaide on Friday 1 August and Saturday 2 August.
