Health Minister Mark Butler has requested that the Therapeutic Goods Administration consider ‘options to improve standards of telehealth’ in online prescribing.
The Australian Therapeutic Goods Administration met with State and Territory counterparts this week, signalling the likelihood of a co-ordinated review of virtual prescribing — a rapidly expanding industry since the COVID-19 pandemic. Although no concrete proposals have emerged, regulators have hinted at tighter accreditation requirements, clearer advertising rules, and more robust data-sharing obligations between prescribers, pharmacies, and regulatory bodies.
What does this mean for the industry?
For providers, the increasingly difficult challenge is navigating a regulatory environment that is changing rapidly, and tightening, in real time. Future reforms may include mandatory clinical governance frameworks, external audits of prescribing patterns, and stronger sanctions for non-compliance.
The regulatory landscape for telehealth and prescribing in Australia is complex and involves several authorities. This multi-layered approach means that telehealth providers must comply with a range of overlapping federal and state obligations.
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KEY REGULATORS OF TELEHEALTH |
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| The Therapeutic Goods Administration (TGA) is responsible for regulating therapeutic products, including medicines and medical devices.
The TGA is also responsible for enforcing the Therapeutic Goods Advertising Code that applies to the promotion of therapeutic products. |
The Australian Health Practitioner Regulation Agency (AHPRA) oversees the registration and conduct of health care professionals, including doctors and nurse practitioners.
AHPRA is also responsible for enforcement of the National Law that applies to the advertising of regulated health services. |
State and territory regulators are responsible for the regulation of pharmacies and dispensing, including restrictions on pharmacy ownership and control. |
Some parts of the sector are proactively developing voluntary standards. Large operators have published best-practice principles that emphasise independent clinician decision-making, weight-based dosing algorithms for GLP-1s, and safeguards to screen out patients with contraindications to THC-containing cannabis products. Working groups chaired by senior industry figures are exploring uniform consent forms, interoperable electronic health-record templates, and shared adverse-event reporting protocols. Constructive engagement of this kind will likely carry weight as the TGA formulates its recommendations.
What should we expect from here?
Key areas where we expect to see change include:
- Clinical governance frameworks and prescribing standards: Regulators and medical oversight bodies are concerned that patients can obtain prescriptions via telehealth without adequate clinical assessment. For example, the Medical Board of Australia published guidelines in 2023 stating that providing healthcare (including referrals and prescribing) via online questionnaires alone in the absence of a real-time patient-doctor consultation is not consistent with good practice. We expect further guidelines to be issued in relation to online prescribing.
- Data privacy and security: Reform to strengthen data protection standards is expected with an increased flow of sensitive health data through telehealth platforms, the rising prevalence of vertically integrated models, and models that rely on overseas based providers delivering healthcare services to patients in Australia (which raises further questions on data sharing and protection) alongside ongoing reforms to the Privacy Act.
- Advertising compliance: There has been a spike in TGA enforcement activity relating to the advertising of therapeutic goods. We anticipate monitoring and enforcement activity to continue to increase, particularly given the advertising of therapeutic goods commonly prescribed via telehealth (such as medicinal cannabis, weight loss medications and cosmetic injectables) is a priority area for the TGA.
Telehealth remains critical to providing access to health services in Australia, particularly for patients in regional areas and those managing chronic conditions. A balanced regulatory framework should preserve its efficiencies while protecting public safety. Providers that embed rigorous clinical governance now, review their marketing content for compliance and maintain transparent prescribing data will be best placed to adapt — whatever shape the reform takes.
