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Australian Government response to the Review of the Reforms to the Therapeutic Goods Advertising Framework

10 August 2020

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 this review, which was conducted during the first half of 2020. The Australian Government has accepted all 22 recommendations in Ms Sinclair's report and responses to each recommendation are set out below.

Australian Government response to the Review of the Reforms to the Therapeutic Goods Advertising Framework

Review recommendation Response
Regarding amendments to the Therapeutic Goods Advertising Code (No. 2) 2018 (Code)

Recommendation 1: To further increase clarity and objectivity of the Code, the TGA should consider using emerging case experience and decisions to create examples of the application and interpretation of the Code, including cases where provisions are considered by stakeholders to be ambiguous. The selection of case studies to publish may also be informed by the TGA's compliance priorities (Rec 5) and education priorities (Rec 12).

Accepted. Some case studies were published as part of the Therapeutic Goods Advertising Compliance Annual Report 2018-19, but a significant number of additional contemporary case studies will be developed to support advertisers in understanding the TGA's application and interpretation of the therapeutic goods legislation.

Target timeframe: Further case studies will be published prior to end 2020.

Recommendation 2: The TGA should maintain and share a log of Code issues that stakeholders confirm after discussions in TGACC sub-groups (Rec 20) as being unclear, inconsistent, or difficult to work with. Where case examples and educational materials are not sufficient to improve clarity and objectivity, the TGA should consider publishing policy clarification.

Accepted. The TGA currently maintains a log of issues with the Therapeutic Goods Advertising Code and other advertising legislation, as reported by stakeholders or identified through compliance matters. This log will be shared with the Therapeutic Goods Advertising Consultative Committee (TGACC) at its August 2020 meeting for members input on the issues. The TGA will continue to publish guidance to provide clarification and pursue changes to the Code where necessary.

Target timeframe: Discussions to commence at the August TGACC meeting, and further guidance published as needed.

Regarding the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods

Recommendation 3: The Government should maintain the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public. The TGA should continue to build its complaints handling capability and systems as outlined in Recs 4 to 7.

Accepted.

Target timeframe: See recommendations 4 and 5.

Recommendation 4: The TGA should use the recommendations made in the concurrent management initiated review to reset the complaints management system to focus on achieving improved compliance outcomes through intelligence gathering, strategic triaging and integrated response.

Accepted. The Australian Government will design and implement a new model based on the recommendations from the concurrent management-initiated review of advertising complaints handling. This model will deliver improved advertising compliance outcomes, including through targeted compliance activities identified using intelligence. In addition, complaints that are associated with advertisements that could cause significant harm to individual or public health will still be received and handled individually, and their resolution treated as a priority.

Target timeframe: Implementation by end September 2020.

Recommendation 5: The TGA should develop and publish Compliance Priorities which are reviewed annually. In setting these priorities the TGA should develop factors to be considered, consult with stakeholders, and focus on consumer benefit. The Compliance Priorities should inform key performance indicators (KPIs) and reporting (Recs 14 and 15).

Accepted. Annual compliance priorities should be established and communicated. The TGA will still need to be able to respond to emerging issues, especially where there are public health and safety implications, such as is currently the case in response to the COVID-19 pandemic. The KPIs and reporting needed to support compliance priorities will be considered by the TGACC and Government.

Target timeframe: Proposed compliance priorities to be considered at the August 2020 TGACC meeting.

Recommendation 6: The TGA should work to further integrate the management of complaints about advertising of therapeutic goods with other relevant areas within the TGA. This could be achieved by developing information-sharing practices across the TGA, to support:

  • the compliance priorities across the TGA's regulatory areas; and
  • identification of trends identified across high-volume complaints regarding products, types of therapeutic claims made, manufacturers, or suppliers.

Accepted. Work has commenced on improving information sharing across the TGA about advertising complaints and other compliance information through customised, integrated software and improved reporting. This will assist in the identification of trends across compliance areas, which will in turn inform the development of compliance and education priorities.

Target timeframe: Software solutions to facilitate information sharing in place by end 2020.

Recommendation 7: The TGA should co-develop information-sharing protocols to facilitate active information-sharing with relevant regulators, including Food Standards Australia New Zealand (FSANZ) and the Australian Competition and Consumer Commission (ACCC) regarding complaints and trends on relevant cross-sector products or issues. This should be supported by focused engagement with regulators (Rec 21) to define information-sharing needs and priorities.

Noted. The TGA has access to a range of tools which support information sharing with other regulators. These include protections under the Therapeutic Goods Act 1989 for releasing certain types of information (including compliance information). A regulators forum has been in place for several years with chairing alternated between ACCC and TGA. The COVID-19 pandemic has led to improvements in the quality and frequency of information-sharing between the TGA and other Australian Government regulators.

Target timeframe: Protocols to be reviewed and changed if required by mid-2021.

Regarding broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods

Recommendation 8: The TGA should develop and promote a clear regulatory position on its approach to the use of the broadened sanctions and penalties to protect public health and safety. This should include the balance of focus between educative and punitive responses, and the principles that guide the use of more punitive compliance tools. The position should be clearly communicated to Departmental staff involved in advertising compliance and other stakeholders.

Accepted. While the approach to the use of sanctions and penalties is published on the TGA website, the introduction of the new advertising compliance model (see Rec 4) provides an opportunity to convey stronger messaging to deter non-compliance and protect consumers. The TGA will also ensure that compliance staff fully understand the new regulatory position and reinforce it regularly.

Target timeframe: New compliance model to be published by end September 2020.

Recommendation 9: The TGA should provide focused skills development on compliance and enforcement practice to support the advertising compliance team in implementing the TGA's regulatory position. This may include developing an understanding of case management and enforcement response at other regulators, and sharing lessons learned.

Noted. Departmental investigators for advertising, import/export and supply compliance matters hold formal qualifications in investigations. The Department conducts a range of supplementary training and networking activities to support development of legal, procedural and other skills and knowledge. Additional opportunities will be explored, including through other regulators.

Target timeframe: Ongoing.

Recommendation 10: The TGA should reflect on the lessons learned from the COVID-19 experience in responding to non-compliant advertising with sanctions and penalties in a timely manner. The COVID-19 experience also has useful learnings regarding the use of media and publicising the compliance actions taken by the TGA to raise awareness of the negative consequences of using non-compliant advertising.

Accepted. The TGA will publicly report on its advertising compliance performance in 2019-20 by the end of September 2020. Learnings from the nimble response in relation to compliance, enforcement and educational activities during the COVID-19 pandemic will inform improvements.

Target timeframe: End September 2020.

Regarding the industry and consumer education program on the new advertising measures

Recommendation 11: The TGA should develop an Advertising Framework Education Strategy with clearly defined priorities that are aligned to Compliance Priorities and consumer outcomes.

Accepted. The TGA will develop an advertising education strategy that is grounded in compliance priorities, education priorities (recommendation 12) and consumer outcomes.

Target timeframe: Proposed education strategy to be drafted for consideration at the first TGACC meeting of 2021.

Recommendation 12: The TGA should develop Education Priorities to more effectively target educational activities. In setting these priorities the TGA should develop factors to be considered, consult with stakeholders and focus on consumer and industry benefit. The education priorities should be publicised and clearly communicated to stakeholders. The priorities should be reviewed annually.

Accepted. Consistent with the current approach, the TGACC will be consulted on education priorities. Consideration will be given to how best to communicate these priorities to stakeholders and review the priorities to ensure that they remain contemporary.

Target timeframe: Proposed education priorities to be considered at the first TGACC meeting of 2021.

Recommendation 13: The Review recommends that the TGA use the COVID-19 experience, particularly in priority-setting and developing activities and mobilising the media in support of agreed priorities, as part of developing a more strategic approach to its education program.

Accepted. The TGA will utilise the mass media to a greater extent to communicate compliance priorities and achievements.

Target timeframe: Ongoing.

Regarding the public performance measures for advertising complaints management

Recommendation 14: The TGA should redevelop a suite of advertising compliance performance measures and indicators which focus on priorities and outcomes rather than processes and deadlines.

In considering a new approach to measures and indicators, the TGA should use the recommendations made in the concurrent management initiated review of the complaints handling process.

Accepted. Also see response to recommendations 5 and 8.

Target timeframe: Following consultation with TGACC, the TGA will publish the new KPIs as part of the new compliance model by the end of September 2020.

Recommendation 15: Once the TGA has developed new performance indicators for advertising compliance and complaints management, the TGA should publicise the measures, and report performance against the measures using the TGA website and annual reporting and media channels.

Accepted. New KPIs will be published on the TGA website, along with the corresponding changes to the complaints handling framework. The TGA will continue to provide information about performance against the advertising compliance KPIs in its annual and half-yearly performance statistics reports and annual advertising compliance reports.

Target timeframe: The new KPIs are part of the new compliance model to be published by end September 2020.

Regarding stakeholder engagement activities on therapeutic goods advertising

Recommendation 16: The TGA should ensure its Stakeholder Engagement Plan includes a focus on supporting effective regulation of therapeutic goods advertising. The stakeholder engagement plan should consider the TGA's compliance priorities (in line with Recommendation 5) and education priorities (in line with Recommendation 12). The plan would define purpose and objectives, priorities, and engagement methods specific to TGA's advertising compliance role.

Accepted. The TGA is currently developing an overarching stakeholder engagement plan for all of its regulatory activities, which will include compliance and education priorities. A range of engagement methods will be adopted to address the barriers to targeted stakeholder engagement on therapeutic goods advertising.

Target timeframe: The TGA will finalise a stakeholder engagement plan by end first quarter 2021.

Recommendation 17: The TGA should ensure its Communications Plan reflects a strategic approach to communications including use of external channels (particularly media) to support its advertising framework compliance priorities, education strategy goals and stakeholder engagement strategy goals. Use of media and external channels should focus on increasing both consumer and industry awareness of the TGA's regulatory position in regard to advertising compliance. Well-targeted consumer information and regular public reporting on regulatory decisions made and outcomes achieved would be elements of effective communication.

Accepted. The TGA's current communications strategy, which includes the use of the TGA website and use of social media channels to disseminate important messages, will include more proactive media and external communications, as well as the promotion of advertising compliance priorities and outcomes.

Target timeframe: The TGA will finalise its communications plan by the end of September 2020.

Recommendation 18: The TGACC should be refocused to enhance its effectiveness as a collaborative forum focused on better outcomes for consumers through effective advertising compliance by industry. This may be achieved by updating the Governance Arrangements or developing an accountability charter which details:

  • the refreshed objectives of the TGACC;
  • roles and responsibilities of the TGA and members, which may include more opportunity for members to share their experiences, concerns or recent activities such as member education activities; and
  • expectations of both the TGA and members.

Accepted. The efforts of the TGACC will be refocused through a clarification of member roles and responsibilities to produce better outcomes for consumers.

Target timeframe: This will be scheduled for further discussion at the November 2020 TGACC meeting.

Recommendation 19: The TGA should develop a list of key tasks and associated timeframes that require the input of the TGACC to finalise. This would include:

  • developing annual compliance priorities;
  • developing annual education priorities; and
  • identifying significant case studies for use in the education program or media.

Accepted.

Target timeframe: This will be scheduled for further discussion at the November 2020 TGACC meeting.

Recommendation 20: The TGA should consider hosting focused sub-groups with representation from the most relevant sector members from the TGACC. These should be hosted on an as-needed basis. A summary of key considerations and outcomes from these focused roundtables should be reported back to the wider TGACC group.

Accepted. TGACC subgroups will be convened on an as-needs basis and will to report to the TGACC with agreed recommendations on how to address issues.

Target timeframe: The first subgroup meetings, which may address updates to the Advertising Code will be scheduled for late 2020.

Recommendation 21: The TGA should continue to hold regular meetings with other regulators to develop approaches and actions to address regulatory interface issues. A summary of key considerations and outcomes from the regulator meetings should be reported back to the wider TGACC group.

Noted. The TGA and other relevant regulators already meet regularly through a Consumer Health Regulators Group. The TGA will share information to the TGACC on the outcomes of these meetings, subject to the agreement of other participants. See also rec 7.

Target timeframe: The TGA will commence reporting to TGACC meetings following the next Consumer Health Regulators Group meeting (August 2020).

Recommendation 22: The TGA should develop a periodic (e.g. every two years) stakeholder survey to evaluate stakeholder satisfaction with stakeholder engagement efforts. The survey may also be used to gauge perceptions of the effectiveness of the TGA's compliance framework, which may inform performance reporting.

The survey should include input from key stakeholders consulted with and other partnering regulators. Areas of weakness or opportunities for improvement identified from the survey should inform updates to the TGACC Ways of Working, stakeholder engagement plan and communications plan.

Accepted. It is noted that the TGA already conducts annual stakeholder surveys, and these are published on the TGA website. Future surveys could contain questions that evaluate stakeholder satisfaction in relation to advertising compliance.

Target timeframe: Introduce additional questions in the June 2021 stakeholder survey.

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