This article represents the Coalition for Better Health's policy analysis and advocacy position. It does not constitute medical advice. Patients seeking guidance on GLP-1 medications should consult their treating clinician.
Australia's experience with GLP-1 receptor agonist medications over the past three years represents one of the most instructive — and troubling — case studies in recent medicines policy. A class of drugs with genuinely transformative clinical evidence has been beset by manufacturing shortages, regulatory confusion, prescribing inequities, and a compounding pharmacy controversy that has pitted patient access against safety oversight. The result is a system in which access to effective treatment often correlates more strongly with postcode and income than with clinical need.
This analysis examines what went wrong, who is bearing the cost, and what Australia's policymakers must do to prevent the same failures from repeating as newer agents enter the market.
Background: What GLP-1 Receptor Agonists Are and Why They Matter
GLP-1 (glucagon-like peptide-1) receptor agonists are a class of injectable medications that mimic the action of an incretin hormone produced in the gut. By stimulating insulin secretion, suppressing glucagon, slowing gastric emptying, and reducing appetite via central nervous system pathways, they address both glycaemic control in type 2 diabetes and, at higher doses, significant sustained weight reduction. During shortage periods, some clinicians have directed patients toward dietary strategies that support endogenous incretin activity — research into foods that naturally stimulate GLP-1 production suggests that certain fibre-rich and protein-dense food patterns can modestly augment the pathway, though these are not substitutes for pharmacotherapy in patients with clinical need.
The class includes several agents now familiar to Australian patients and clinicians:
- Semaglutide (Ozempic): weekly subcutaneous injection, PBS-listed for type 2 diabetes since 2020
- Liraglutide (Saxenda): daily injection, TGA-approved for obesity management
- Tirzepatide (Mounjaro): a dual GLP-1/GIP receptor agonist, TGA-approved and PBS-listed for type 2 diabetes since 2024; trial data demonstrate superior weight loss outcomes to semaglutide alone
- Semaglutide 2.4mg (Wegovy): higher-dose weekly injection specifically indicated for obesity, PBS-listed from January 2025
The clinical evidence base is substantial. The SUSTAIN trial program established semaglutide's efficacy in type 2 diabetes. The STEP trials demonstrated mean body weight reductions of 14.9% with semaglutide 2.4mg versus 2.4% with placebo over 68 weeks. The SURMOUNT-1 trial showed tirzepatide achieving mean weight loss of up to 22.5% at the highest dose. These are not marginal effects — they represent outcomes comparable to bariatric surgery for a subset of patients, without the procedural risks.
For a country where 67% of adults are overweight or obese and where obesity-related conditions cost the healthcare system an estimated $11.8 billion annually, the PBS listing of effective pharmacotherapy represents a genuinely significant public health advance. The policy failure has been in everything that followed the listing decisions.
The Shortage Crisis: Global Origins, Australian Amplification
The global semaglutide shortage is rooted in a manufacturing capacity problem of Novo Nordisk's own making, compounded by a demand surge that outpaced every forecast.
Novo Nordisk's primary active pharmaceutical ingredient (API) manufacturing for semaglutide is concentrated in Denmark, with fill-and-finish operations in Denmark and the United States. When Ozempic's diabetes indication generated unexpected consumer interest in its weight-loss effects from 2022 onwards — driven substantially by social media and celebrity visibility — demand escalated at a pace the company had not planned for. Capacity expansion requires regulatory certification at each manufacturing step, a process that takes years, not months.
The TGA's shortage register recorded semaglutide (Ozempic) as being in shortage in Australia on multiple occasions between 2023 and 2025, with periodic notifications for specific pack sizes and delivery devices. The shortage register entries reflect a global allocation problem: with demand exceeding supply, Novo Nordisk has been rationing distribution across markets, and Australia — as a smaller market than the EU or US — has repeatedly been at the back of the queue.
The PBS listing of Wegovy in January 2025 dramatically worsened Australian supply dynamics. The listing was the right policy decision in principle, but it created a foreseeable demand surge that the TGA and the Department of Health had inadequate supply chain assurances to back. Within weeks of Wegovy's listing, shortages were reported nationally. Patients who had been stabilised on the medication — many of whom had been accessing it privately at significant cost — found themselves unable to fill prescriptions.
For a detailed examination of the Wegovy PBS listing and its clinical context, the analysis at weightlossnaturalandfast.com provides useful background on the listing criteria and patient eligibility.
Tirzepatide (Mounjaro), manufactured by Eli Lilly, has faced its own supply constraints in Australia, though the shortage dynamics have differed given a different manufacturing footprint and a more recent market entry.
The PBS/Private Script Divide and Its Equity Consequences
One of the most significant — and least discussed — structural problems in the GLP-1 market is the dual-market dynamic created by separate PBS listings for diabetes and obesity indications.
Ozempic (semaglutide 1mg) is PBS-listed for type 2 diabetes with a specific set of prescribing criteria. Wegovy (semaglutide 2.4mg) is PBS-listed for obesity with a different set of criteria requiring BMI >30 kg/m² (or >27 kg/m² with at least one weight-related comorbidity), specialist initiation in many cases, and documented failure of lifestyle interventions. These are the same molecule at different doses for conditions that substantially overlap — and the separate listing pathways have created confusion for prescribers, pharmacists, and patients.
Patients who do not meet PBS criteria for either indication — or who cannot access a specialist for initiation — are left with a choice between paying out-of-pocket for a private prescription or going without. At current private pricing, Wegovy costs between $380 and $450 per month without PBS subsidy. This is beyond reach for a large proportion of Australian households, particularly those on fixed incomes, welfare, or low wages.
The result is that access to one of the most effective obesity pharmacotherapies available correlates directly with financial capacity. This is not a theoretical equity concern — it is a documented pattern that the Coalition regards as a structural injustice requiring policy correction.
The Compounding Pharmacy Controversy
When branded semaglutide became unavailable or unaffordable, many patients and clinicians turned to compounding pharmacies as an alternative source. Compounding pharmacies can legally prepare custom formulations using bulk pharmaceutical API when a TGA-registered product is in shortage or does not meet a patient's specific clinical needs.
During the height of the shortage, the TGA took a permissive stance toward compounded semaglutide, acknowledging that the registered product was unavailable and that patient need was legitimate. Compounded semaglutide was being offered at significantly lower prices — in many cases $150–$250 per month — and provided a pathway for patients who could not access the branded product.
The TGA's subsequent move to restrict compounded semaglutide — justified on safety grounds — has been the subject of intense debate within the medical community and among patient advocates.
The safety concerns are real and should not be dismissed. Compounding pharmacies operate under a different regulatory framework to TGA-registered manufacturers. There have been documented cases of concentration errors in compounded semaglutide preparations in Australia and internationally. A preparation nominally labelled at a given concentration but delivered at a higher dose poses genuine risk of adverse events including severe nausea, vomiting, and hypoglycaemia. The supply chain for bulk semaglutide API used by compounders has less rigorous traceability than the licensed manufacturing pathway.
But the policy response — moving toward outright restriction without ensuring adequate supply of the registered product — has created a cliff-edge for patients who were stable on compounded formulations. Clinicians report patients abruptly discontinuing effective treatment, with predictable weight regain and metabolic deterioration. The harm from sudden cessation is not hypothetical; it is occurring in general practices across the country.
The Coalition's position is that neither uncritical permissiveness nor outright prohibition is adequate. A proportionate regulatory response — one that establishes clear quality and safety standards for compounders, maintains oversight, and establishes transition pathways for stable patients — is both achievable and necessary.
Access Equity: Where the System Is Failing
General Practitioner Capacity and Training
The overwhelming majority of Australians' first point of contact for obesity management is their GP. Yet obesity medicine is not a mandatory component of Australian medical curricula, and many GPs have received limited training in the clinical management of obesity or the use of GLP-1 medications. This is not a criticism of individual clinicians; it reflects a systemic gap in medical education.
The consequence is that patients with obesity seeking pharmacotherapy are frequently referred to endocrinologists or bariatric physicians. Specialist waitlists in metropolitan areas run to six to twelve months. In regional and rural areas, access to specialist obesity medicine is effectively non-existent for most patients. The PBS restriction requiring specialist initiation for Wegovy in many clinical pathways compounds this problem — it inserts a gatekeeping step that creates months of delay and disproportionately disadvantages patients in non-metropolitan areas.
BMI Criteria and Cultural Inadequacy
The PBS criteria for Wegovy use BMI as the primary eligibility threshold. The clinical evidence base underlying BMI thresholds in Australian medicines policy was developed primarily in European and North American populations. There is well-established evidence that people of South and East Asian background carry significantly greater cardiometabolic risk at lower BMI values than white Australians. A patient of South Asian background with a BMI of 27 kg/m² and elevated waist circumference, visceral adiposity, and early metabolic syndrome may have equivalent or greater clinical need than a patient of European background with a BMI of 32 kg/m² — but may not qualify for PBS subsidy. Post-menopausal women represent another group disproportionately affected: hormonal shifts accelerate visceral fat accumulation and insulin resistance in ways that BMI alone does not capture, making the case for GLP-1 access particularly acute for women navigating weight loss after 40 whose clinical profile exceeds what the current PBS criteria recognise.
The World Health Organization has recommended lower BMI cut-offs for Asian populations since 2004. Australia's PBS criteria have not been updated to reflect this evidence. This is a remediable policy failure with a clear evidence base for correction.
Regional and Rural Disadvantage
Compounding pharmacies — which have served as a critical access pathway during the shortage — are concentrated in metropolitan areas, particularly in capital cities. Patients in regional and rural Australia seeking compounded semaglutide often face additional costs and delays associated with courier delivery, with cold-chain integrity concerns for temperature-sensitive peptide formulations. The effective price premium for regional patients undermines any equity benefit the compounding pathway might provide.
The Bulk-Billing Gap
Under current Medicare and PBS structures, the consultation required to initiate GLP-1 therapy — typically requiring a longer, more complex appointment — is increasingly unlikely to be bulk-billed in the post-2023 fee environment. Patients who are not bulk-billed face out-of-pocket consultation costs on top of medication costs. For patients on the threshold of PBS eligibility, these cumulative costs create effective barriers even when subsidy is technically available.
International Comparison: What Australia Can Learn
United Kingdom
NHS England's approach to GLP-1 medications in obesity management has been characterised by a more structured rollout through specialist weight management services, with explicit phased expansion of access criteria tied to service capacity. The National Institute for Health and Care Excellence (NICE) approved semaglutide 2.4mg (Wegovy) for obesity in 2023, but NHS commissioning has been deliberately staged to avoid overwhelming services. While this approach has its critics — the staging delays access for patients with established need — it has avoided the cliff-edge supply crises seen in the Australian market.
The UK has also invested in NHS weight management services at a primary care level, which provides a capacity pathway that does not require specialist referral for all patients. This model — integrating pharmacotherapy with structured behavioural support — is more clinically aligned with the evidence base than a pure prescribing model.
United States
The US FDA's approach to compounded semaglutide has been instructive, though not a model for direct adoption. When the FDA declared semaglutide to be on the drug shortage list, it permitted compounding under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The FDA also issued guidance on what constitutes a compliant compounded preparation and took enforcement action against entities producing non-compliant formulations.
As Novo Nordisk increased supply and the branded shortage eased, the FDA moved to remove semaglutide from the shortage list — triggering legal challenges from compounders and patient groups. The US experience illustrates that shortage declarations create legal and commercial ecosystems that are difficult to unwind quickly, and that transition management requires explicit regulatory planning, not abrupt discontinuation.
Australia should note both the proactive FDA enforcement during the shortage period (which Australia did not replicate with comparable rigour) and the US's explicit transition framework as supply recovered.
Six Policy Reforms the Coalition Recommends
1. TGA Fast-Track Certification for Additional Manufacturers
The TGA should establish an expedited pathway for certifying additional semaglutide and tirzepatide manufacturers — including third-party contract manufacturers — when an active shortage notification is in place. This would not lower safety standards; it would apply existing standards more rapidly through dedicated assessment resourcing. The TGA's existing provisional approval framework provides a model that could be adapted for manufacturing site certification. Australia should also advocate within the International Council for Harmonisation (ICH) framework for mutual recognition of manufacturing certifications across comparable regulatory agencies, reducing duplicative assessment burden.
2. PBS Criteria Review: Ethnicity-Adjusted BMI Thresholds
The Department of Health and the Pharmaceutical Benefits Advisory Committee (PBAC) should review PBS eligibility criteria for GLP-1 obesity medications to incorporate ethnicity-adjusted BMI thresholds consistent with WHO recommendations. Specifically, the threshold for patients of Asian background should be lowered from 30 kg/m² to 27.5 kg/m² (or 25 kg/m² with comorbidities) to reflect the evidence base on differential cardiometabolic risk. This reform would expand PBS eligibility for an underserved population at demonstrably elevated risk, at modest additional cost to government.
3. Pharmacist Prescribing Pilot for Stable Patients
Australia should implement a pharmacist prescribing pilot for GLP-1 medications, limited to patients who have been stable on a GLP-1 receptor agonist for at least twelve months, have no recent dose adjustments, and whose treating clinician has provided a collaborative care agreement. This model — already operational for some chronic disease medications in Queensland — would reduce reliance on GP appointments for routine maintenance prescribing, freeing GP capacity for initiation and monitoring while removing a friction point for stable patients. The pilot should be evaluated against defined outcomes including medication continuity, adverse event rates, and patient satisfaction.
4. Mandatory Obesity Medicine CPD for GPs
The Royal Australian College of General Practitioners (RACGP) should be engaged to develop and integrate obesity medicine as a mandatory continuing professional development (CPD) module for all practising GPs. The module should cover the evidence base for pharmacotherapy, safe prescribing of GLP-1 medications, recognition and management of adverse effects, and culturally appropriate approaches to weight management conversations. This is not a short-term fix — systemic change in GP prescribing confidence takes years to manifest — but it is essential for any durable reform of the access landscape. This reform aligns with the broader case for preventive health investment as a cost-effective system priority.
5. Compounding Regulation: A Proportionate Framework
Rather than a binary approach of permissiveness or prohibition, the TGA should develop a clear compounding framework for GLP-1 medications that includes: mandatory accreditation for compounders producing GLP-1 formulations; batch-level testing requirements with independent laboratory verification; prescriber notification requirements when compounded formulations are dispensed; and an explicit shortage-linked activation mechanism that allows compliant compounders to operate during declared shortage periods, with suspension when supply of registered products is adequate. This framework would address documented safety concerns without eliminating access during supply failures.
6. Mandatory Advance Shortage Notification
The TGA should introduce mandatory supply chain reporting obligations for sponsors of high-demand PBS-listed medications. Specifically, sponsors should be required to notify the TGA of anticipated supply constraints at least six months before they materialise, based on manufacturing capacity forecasts versus projected demand. This would give the TGA, the Department of Health, and clinicians lead time to manage transitions, explore alternative sources, and communicate with patients — rather than responding reactively once shelves are empty. Penalties for failure to notify should be sufficient to create genuine compliance incentives.
The Broader Policy Imperative
It would be a mistake to read the GLP-1 shortage as merely a logistical problem — a temporary mismatch between supply and demand that will resolve itself as manufacturing capacity expands. The shortage has revealed structural features of Australia's medicines access system that will recur with any high-demand, high-cost, newly listed medication unless they are addressed directly.
The PBS listing of Wegovy was the right decision. The evidence base for semaglutide in obesity management is robust, the disease burden it addresses is substantial, and the cost-effectiveness modelling that informed the PBAC recommendation was sound. But a listing decision is only the beginning of a policy intervention. The supply assurance, the prescribing infrastructure, the equity of access criteria, and the regulatory framework for alternatives during supply failures are all equally critical — and all were inadequate at the time of listing.
The case for evidence-based preventive medicine is clear when applied to effective obesity pharmacotherapy: obesity drives type 2 diabetes, cardiovascular disease, sleep apnoea, osteoarthritis, and several cancers. Effective treatment that reduces the prevalence of these downstream conditions generates system-wide savings that dwarf the cost of the medication subsidy. But this return on investment is only realised if patients who need the medication can access it, afford it, and continue it without disruption.
The patients most harmed by the current failures — those in regional areas, those from culturally and linguistically diverse backgrounds, those without the financial capacity to navigate the private market — are precisely the patients whose unmet need has the greatest system-wide cost. The equity case and the efficiency case for reform point in the same direction.
Conclusion
The GLP-1 medication shortage in Australia is a policy failure, not merely a supply chain inconvenience. It reflects inadequate supply assurance at the time of PBS listing, prescribing infrastructure that cannot support equitable access, PBS eligibility criteria that embed outdated and culturally inadequate parameters, and a regulatory response to compounding that prioritised bureaucratic tidiness over patient welfare.
The reforms outlined here are not radical. Each has precedent in Australian or international policy. Together, they would represent a meaningful shift toward a system in which access to effective obesity and diabetes pharmacotherapy is determined by clinical need rather than by wealth, location, or ethnicity.
The Coalition calls on the TGA, the Department of Health, the PBAC, and the RACGP to treat these reforms as urgent. The patients currently unable to access or afford their medication do not have the luxury of waiting for the next policy cycle.
The Coalition for Better Health is an independent health policy and advocacy organisation. For further information on our policy positions and submissions, contact us through this website. For clinical information on GLP-1 medications, visit the TGA website or consult a registered healthcare practitioner.