newsGP – TGA issues weight-loss drug safety alerts – Royal Australian College of General Practitioners (RACGP)

Report on Public Health Risks and Regulatory Actions Concerning Weight-Loss Medications

Introduction: Aligning with Sustainable Development Goal 3 (Good Health and Well-being)

A recent safety alert from the Therapeutic Goods Administration (TGA) regarding unapproved and illegally advertised weight-loss medications highlights significant public health challenges. These challenges directly impact the achievement of Sustainable Development Goal 3 (SDG 3), which aims to ensure healthy lives and promote well-being for all at all ages. The proliferation of unregistered GLP-1 products online undermines efforts to provide access to safe, effective, and quality medicines, posing a direct threat to consumer health.

Regulatory Oversight and Institutional Integrity (SDG 16)

In line with SDG 16, which promotes effective and accountable institutions, the TGA has taken decisive action to protect consumers. The administration’s safety advisory and enforcement measures underscore the importance of strong regulatory bodies in maintaining public health and safety.

• Safety Advisory: The TGA has issued a formal warning about the importation and supply of unregistered GLP-1 products, often marketed as ‘GLP-1 peptide’ oral drops. These products are not listed on the Australian Register of Therapeutic Goods and have no proven medical efficacy for weight loss.
• Consumer Risks: Consumers purchasing these products from unknown overseas websites face significant risks, including receiving counterfeit products, medications with undisclosed harmful ingredients, or substances that do not meet Australian quality and safety standards.
• Misleading Advertising: Many of these products are promoted with false claims of approval from international regulators or misleading quality marks to deceive consumers.
• Enforcement Action: The TGA has issued 10 infringement notices to telehealth operator Midnight Health Pty Ltd for the alleged unlawful advertising of prescription-only weight-loss medicines, including tirzepatide and semaglutide, reinforcing regulatory control over the promotion of such substances.

The Role of Healthcare Professionals in Promoting Public Health (SDG 3 & SDG 17)

General Practitioners (GPs) are identified as key partners in a multi-stakeholder approach (SDG 17) to safeguard public health. Their role is critical in educating patients and mitigating the risks associated with unapproved treatments, thereby contributing directly to SDG 3 targets for non-communicable diseases.

1. Patient Education: GPs are encouraged to proactively discuss the dangers of unapproved weight-loss medications and online scams with their patients.
2. Guidance to Trusted Sources: Healthcare professionals can counter misinformation by directing patients to reliable information from government and not-for-profit health organisations.
3. Adverse Event Reporting: Reporting adverse events involving any medicine, including unapproved ones, is crucial for the TGA to identify and address safety issues.
4. Comprehensive Care: The current focus on GLP-1 medications presents an opportunity to re-educate the public on obesity as a complex, chronic medical condition requiring multifaceted, multidisciplinary care, not just a prescription.

Addressing Health Inequity and Access to Treatment (SDG 10)

The report highlights significant barriers to accessing approved obesity treatments, which creates health inequities contrary to the principles of SDG 10 (Reduced Inequalities). The high cost of legitimate medication is a primary driver for patients seeking dangerous, unregulated alternatives online.

• Cost Barriers: The prohibitive cost of effective, approved obesity-management medications is the most significant barrier, preventing equitable access for many Australians.
• Stigma and Discrimination: Persistent stigma surrounding obesity can lead individuals to seek discreet, online solutions rather than consulting a healthcare professional.
• Consequence of Inequity: These factors combined push vulnerable individuals towards a dangerous unregulated market, exacerbating health risks and inequality of outcomes.

Policy Recommendations for Equitable Healthcare (SDG 3 & SDG 10)

To address these systemic issues and advance progress towards SDG 3 and SDG 10, the Royal Australian College of General Practitioners (RACGP) has put forward several policy recommendations. These proposals aim to create a more equitable and accessible healthcare system for managing obesity.

• Pharmaceutical Subsidies: The RACGP strongly advocates for subsidising proven obesity-management medications on the Pharmaceutical Benefits Scheme (PBS) to remove cost barriers.
• Increased Government Support: There is a call for greater government investment in clinical services and effective obesity-management adjunct therapies.
• Equitable Surgical Access: Ensuring equitable access to publicly-funded bariatric metabolic surgery is another key recommendation.

In response, the Federal Health Minister has requested the Pharmaceutical Benefits Advisory Committee (PBAC) to provide expert advice on equitable access to obesity medicines, with a discussion scheduled for its November 2025 meeting.

Conclusion: A Multi-faceted Approach to Achieving Health and Equity Goals

The issues surrounding unapproved weight-loss medications require a coordinated response from regulatory bodies, healthcare professionals, and policymakers. By strengthening regulatory enforcement (SDG 16), empowering GPs to provide comprehensive care and education (SDG 3), and implementing policies that ensure equitable access to treatment (SDG 10), Australia can better protect public health and ensure that the management of obesity is safe, effective, and accessible for all citizens.

Analysis of Sustainable Development Goals (SDGs) in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

The article primarily addresses issues related to two Sustainable Development Goals:

1. SDG 3: Good Health and Well-being

   This is the most prominent SDG in the article. The entire discussion revolves around public health, specifically the management of obesity, the safety and efficacy of medicines, and the role of healthcare professionals. The article highlights the dangers of unapproved weight-loss products, the importance of medical supervision, and the need for access to safe treatments for chronic conditions like obesity and type-2 diabetes. It directly engages with ensuring healthy lives and promoting well-being for all.

2. SDG 10: Reduced Inequalities

   The article connects the issue of health to inequality by focusing on the accessibility and affordability of proper medical care. It points out that the high cost of approved obesity-management medication is a significant barrier for many people, creating health inequity. The call by the RACGP for these medications to be subsidised on the Pharmaceutical Benefits Scheme (PBS) is a direct appeal to reduce inequality in access to essential healthcare, ensuring that treatment is not only available to those who can afford it.

2. What specific targets under those SDGs can be identified based on the article’s content?

Based on the article’s discussion, the following specific SDG targets can be identified:

SDG 3: Good Health and Well-being

• Target 3.4: By 2030, reduce by one-third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.
  
  Explanation: The article frames obesity as a “chronic medical condition” that requires “multifaceted care, just like what we talk about with type 2 diabetes or heart disease.” Effective management of obesity is a key strategy in preventing and treating these non-communicable diseases, thereby reducing premature mortality associated with them.
• Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.
  
  Explanation: This target is central to the article’s argument. The Therapeutic Goods Administration (TGA) issuing a safety advisory about “unregistered GLP-1 products” addresses the need for “safe, effective, quality” medicines. Furthermore, the RACGP’s call for “effective obesity-management medication to be subsidised on the Pharmaceutical Benefits Scheme (PBS) to reduce health inequity and remove the cost barrier” directly advocates for “affordable essential medicines for all.”
• Target 3.d: Strengthen the capacity of all countries… for early warning, risk reduction and management of national and global health risks.
  
  Explanation: The actions of the TGA, such as issuing a “safety advisory” and encouraging GPs to “report adverse events,” are concrete examples of national health risk reduction and management. These measures aim to protect the public from the dangers of unapproved and potentially harmful medical products circulating online.

SDG 10: Reduced Inequalities

• Target 10.3: Ensure equal opportunity and reduce inequalities of outcome, including by eliminating discriminatory… policies and practices and promoting appropriate legislation, policies and action in this regard.
  
  Explanation: The article highlights that “cost is the biggest barrier” to accessing proven treatments, which leads to inequalities in health outcomes. The push for PBS subsidies for obesity medication is a proposed policy action aimed at ensuring more equal opportunity for health. The article also mentions that “stigma and discrimination in regard to treating obesity” contribute to the problem, touching on the need to eliminate discriminatory practices.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

The article implies several indicators that could be used to measure progress:

Indicators for SDG 3 Targets

• Indicator for Target 3.8 (Access to affordable medicines): The proportion of essential, approved obesity-management medicines included on the Pharmaceutical Benefits Scheme (PBS). The article notes that currently “there are no medicines specifically for the treatment of overweight or obesity currently being considered for listing on the PBS,” indicating a baseline from which progress can be measured.
• Indicator for Target 3.d (Health risk management): The number of safety advisories issued by regulatory bodies like the TGA concerning unapproved medicines. The issuance of the alert mentioned in the article is a data point for this indicator.
• Indicator for Target 3.d (Health risk management): The number of adverse event reports related to unapproved medicines submitted by health professionals. The article explicitly states that GPs are “encouraged to report adverse events involving medicines… to assist the TGA in identifying… safety issues.”

Indicators for SDG 10 Targets

• Indicator for Target 10.3 (Policy for equal opportunity): The existence and implementation of government subsidies for obesity-management medications. The article points to the Federal Health Minister seeking “expert advice on equitable access to obesity medicines through the PBS,” which is a step towards creating such a policy. Progress would be the eventual listing and subsidisation of these medicines.

4. Table of SDGs, Targets, and Indicators

Source: www1.racgp.org.au