In 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new therapeutic goods advertising measures within two years from the commencement of the changes to the Therapeutic Goods Act 1989 to support these measures. Ms Rosemary Sinclair AM led the independent review, which was conducted during the first half of 2020 and recently published. The Australian Government has accepted all 22 recommendations in her report.
However, if these recommendations are to be implemented the TGA will have to radically change its culture.
Key recommendations and my comments follow:
Recommendation: The complaints management system should be ‘reset’ to focus on published priorities that provide public health and consumer benefit and improved compliance outcomes.
Comment: To-date the TGA has failed to deal with complaints about misleading and deceptive advertising of therapeutic goods in public health priorities such as obesity and alcohol. See: Complementary medicine weight loss products complaints submitted to the TGA in 2018-2019 and Complaints about numerous hangover products submitted to the TGA in 2018
Recommendation: The TGA should develop a clear regulatory position on the use of the broadened sanctions and penalties to protect public health and safety, enhance its compliance and enforcement skills and reflect on the lessons learned from the COVID-19 experience.
Comment: The report notes that the TGA tended to adopt a ‘light-touch’ approach to industry advertising violations. Consumer groups noted that enforcement actions were not used effectively to deter behaviour, with an overuse of educational obligations letters, and a reluctance and time-consuming process for enforcing harsher penalties. See: TGA Therapeutic Goods Advertising Compliance 2018-19 Annual Report: Comments. More recently, the TGA has taken useful action on COVID-19 problem advertisements, but this has yet to be replicated in other areas of public health importance. See: The TGA and COVID-19: Starting to use its compliance teeth!
Recommendation: KPIs should focus on priorities and compliance outcomes rather than processes and deadlines.
Comment: The broad consensus from Departmental staff and stakeholders was that the current KPIs were not fit for purpose as they do not show achievement of advertising compliance outcomes. It was also suggested that the current KPIs, which focus on the timeliness of ‘closing’ complaints may lead to the risk that compliance officers prioritise deadlines over consideration of broader public health and compliance outcomes. See: The TGA, KPI’s and the budget surplus
Recommendation: Case studies of the TGA’s application and interpretation of the Code should be published and educational activities more effectively focus on consumer and industry benefit.
Comment: The previous Complaint Resolution Panel (CRP) published determinations on all complaints dealt with. These were educative for both complainants, advertisers, and industry. In the new TGA system around 80% of complaints are classified as ‘low priority’ and closed by sending the advertiser a regulatory obligations letter. No details of the product, sponsor or alleged Code breaches are published in the advertising complaint database. While the current volume of complaints may preclude detailed determinations, representative case studies are required. See: Launch of TGA Advertising Hub – Initial experience of submitting complaints
Recommendation: Information on cross-sector issues and complaint trends should be shared with other regulators such as FSANZ and ACCC.
Comment: See Where food meets medicine: reform needed.
Recommendation: The Therapeutic Goods Advertising Consultative Committee (TGACC) should be refocused to enhance its effectiveness as a collaborative forum focused on better outcomes for consumers through effective advertising compliance by industry.
Comment: To-date, the TGA has largely failed to use TGACC member’s expertise to discuss problems and solutions. Typically the TGA talks at the TGACC rather than talk with the group.
Recommendation: The TGA should develop a periodic (e.g. every two years) stakeholder survey to evaluate satisfaction with stakeholder engagement efforts and perceptions of the effectiveness of the TGA’s compliance framework.
Comment: The TGA has conducted regular stakeholder surveys but only recently have some non-industry stakeholders been surveyed. In addition, the methodology has not been consistent. See: TGA stakeholder survey 2019 and Share your views in the 2020 TGA stakeholder surveyby