The Therapeutic Goods Administration, the inward-looking arm of the Health Department that is the Australian counterpart of the US FDA, will need to lift its game after the Health Minister's announcement that the national government has accepted all 22 recommendations in the Sinclair Review of the therapeutic goods advertising regime.
In line with the Government's commitment made in 2018 to review the reforms to the therapeutic goods advertising framework within two years from implementation, the review examined the impact of the new advertising measures regarding the commencement of the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018, with reference to the advertising reforms from the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR Review) and other initiatives announced by the Minister.
Sinclair's report states
The Review assessed the impact of the:
A. new advertising measures as included in the Therapeutic Goods Act 1989 (the Act), in particular, the effectiveness of:
i. the amendments to the Therapeutic Advertising Code (No. 2) 2018 i.e. whether they have increased clarity and objectivity to support the compliance and enforcement powers in the Act and improved consistency between the requirements for medicines and medical devices;
ii. the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public; and iii. broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods.
B. other initiatives announced by the Minister in February 2018, namely:
iv. a comprehensive industry and consumer education program of the new advertising measures;
v. public performance measures for advertising complaints management, i.e. an assessment of the suitability of the TGA’s key performance indicators for managing advertising complaints; and
vi. stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the Therapeutic Goods Advertising Consultative Committee (TGACC).
It notes
The Therapeutic Goods Administration (the TGA) is Australia’s regulatory authority for therapeutic goods. The TGA is part of the Australian Government Department of Health (the Department). On 24 October 2014, the Australian Government announced the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) (‘the MMDR Review’).
The objective of that Review was to make recommendations to assist the Government to enhance the regulatory framework for medicines and medical devices so that: ▪ Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods, and ▪ areas of unnecessary, duplicative or ineffective regulation are removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia.
The Expert Panel reported in two stages and made a total of 58 recommendations, which reflected an overarching intention to remove unnecessary regulatory burden and support the regulator and industry transition towards a more self-regulatory regime, without compromising the safety or quality of therapeutic goods or diminishing protections for the Australian public. The principles underpinning that Review are relevant to the consideration of progress on the seven recommendations which related to the advertising of therapeutic goods:
1 The role of regulation is to manage risk in order to protect public health and safety;
2 The level of regulation should be commensurate with the risk posed by the regulated products;
3 A risk-benefit approach to the regulation of therapeutic goods is appropriate;
4 The regulation of therapeutic goods should take a whole-of-lifecycle approach; and
5 The ultimate responsibility for medicines and medical devices regulation should remain with the Commonwealth.
Of the 58 recommendations seven related to the advertising of therapejutic goods. The recommendations reflected the Panel’s view that “...controls on advertising provide an important assurance that consumers have access to accurate information in making health choices”. The Australian Government Response to the Review (‘Government Response’) was released on 15 September 2016, following consultation with stakeholders including consumers, healthcare professionals and industry:
“This response presents a strategic and systems-based approach to achieve long-term sustainable reform to the regulation of therapeutic goods in Australia. It identifies ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of therapeutic goods in Australia.”
Of the total 58 recommendations, 56 of the recommendations were supported by the Government. All the recommendations relating to the regulation of therapeutic goods advertising were accepted. This resulted in a suite of changes to the therapeutic goods advertising framework, with reforms led by the Department and more specifically, the TGA.
This Review of the Therapeutic Goods Advertising Framework (‘the Review’) was intended to examine the impact and effectiveness of key changes to the advertising framework catalysed by the MMDR Review. The advertising framework components to be considered in this Review included the relevant changes to the Therapeutic Goods Act 1989 (Cth) (‘the Act’), which establishes the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.
Specifically, the Review considered amendments to:
- the Therapeutic Goods Advertising Code, as the instrument made under the Act that sets out the legislative requirements for therapeutic goods advertising;
- disband the Complaints Resolution Panel and nominate a single-body to be responsible for the management of public complaints about the advertising of therapeutic goods; and
- broaden the sanctions and penalties available to respond to breaches of advertising requirements.
The Review also examined a number of other initiatives announced by the Minister for Health (‘the Minister) that supported the intent of the MMDR recommendations and implementation of changes to the advertising framework. These initiatives are led by the TGA and included: ▪ a comprehensive industry and consumer education program regarding the new advertising framework; ▪ development of public performance measures for the reformed complaints management function; and ▪ engaging with stakeholders regarding therapeutic goods advertising, particularly through a forum of relevant stakeholder representatives in the Therapeutic Goods Advertising Consultative Committee (TGACC).
Most of the changes regarding the therapeutic goods advertising framework noted above, have occurred within the last 12-18 months, with the TGA taking an approach of continuous improvement to implementing the reforms.
The Review's 'overall assessment' is
The changes to the therapeutic goods advertising framework within scope of this Review have been implemented in the last 12-18 months. In this regard, the Review has taken place at a timely crossroads, to reflect on the early experiences of implementation of the reforms, and to inform further improvement to the effectiveness of the regulatory framework for therapeutic goods advertising and a strengthened strategic focus on implementation.
The Review involved extensive stakeholder consultation, both with key stakeholder groups represented on the TGACC, and with a selection of Departmental staff members and senior executives. In undertaking these consultations, the Review noted a high degree of openness and highly thoughtful responses, which reflected an invested stakeholder base and a commitment to continuous improvement by the TGA. All stakeholders understood the importance of consumers having accurate information in making health choices. This was reflected in stakeholder commitment to supporting effective regulation of advertising in the interest of public health and safety.
Conducting the Review in the COVID-19 environment posed some interesting challenges, leading to innovative and amended ways of completing the Review. As a result, most consultations were held via teleconference, and the work conducted by the review team mostly occurred online and offsite. The COVID-19 crisis required the TGA to develop and execute new strategies and approaches to cope with a public health emergency and as a result, the Review was able to identify some pertinent and significant changes in the operation of the TGA. A number of observations regarding this response have been captured in this review report. The COVID-19 environment provided an opportunity for the TGA to demonstrate the value to consumers of focusing on compliance priorities, taking a strategic approach to communication and education tasks, and adopting an agile approach to the use of its enhanced powers. The Review suggests there is much for the regulator and industry to learn from this recent experience. The Review noted that across all reform elements examined, the TGA has implemented the changes with a clear understanding of its accountability for public health and safety. The TGA has also demonstrated a positive and open-minded approach to continuous improvement to the regulatory framework and associated processes, such as through seeking feedback from stakeholders and reflecting on its approach in an iterative way.
Overall, the changes that have been implemented by the TGA have moved in the right direction in giving effect to the intended outcomes and benefits noted in the MMDR Review and Government Response. In initiating and implementing the reforms to the therapeutic goods advertising framework, the TGA efforts to date have emphasised an approach of informing and assisting industry with regards to the advertising framework. This is a natural course given the shift to a self-regulatory landscape and the large suite of reforms to the rules and processes that regulate therapeutic goods advertising. In this way, the TGA has taken on a role of assisting industry to understand the new framework as the first step to enabling improved self-compliance.
The Review notes that in some areas, such as with enforcement responses and developing educational materials, the TGA has gone to great lengths to support industry. The Review suggests that the TGA, with the regulatory framework and supporting processes for therapeutic goods advertising in place, is now well-placed to shift its approach and focus to achieve the aims of the reform program. For industry, the next phase will involve more responsibility, with industry further developing their practices for self-compliance, becoming responsible and accountable ‘partners’ in achieving the aims of the regulatory framework and the intended consumer protection outcomes.
The Recommendations made as part of this Review are intended to facilitate this approach. For the TGA, the next phase will involve a more strategic approach to its responsibilities as the regulator of therapeutic goods advertising. The TGA should focus more directly on the intended outcomes and priorities of its compliance functions. A clearer vision of the outcomes and priorities of compliance activities should guide the TGA in updating its processes, performance measures, and aligning resources. The Recommendations made as part of this Review are intended to facilitate a more strategic and outcomes-focused approach to the TGA’s regulatory framework for therapeutic goods advertising.
Summary assessment against Terms of Reference items
The key observation to report is that while good progress has been made implementing the Government’s response to the MMDR Report, the focus has necessarily been tactical given the timeframes for implementation. With the benefit of the experience now gained over the last 12-18 months, and the need for rapid response in the early days of the COVID-19 pandemic, this Review finds that there has been progress in achieving the aims of the framework. The next phase in achieving further effectiveness and impact from the Therapeutic Good Advertising Framework will depend on a more strategic approach to a number of the review scope items. It should be noted based on stakeholder consultations, that the Department’s approach is already one of continuous improvement and that stakeholders are also committed to contribute to further improving the regulation advertising of therapeutic goods to the public.
1.5.1 The amendments to the Therapeutic Advertising Code (No. 2) 2018 i.e. whether they have increased clarity and objectivity to support the compliance and enforcement powers in the Act and improved consistency between the requirements for medicines and medical devices
The Review finds that the changes to the Code have resulted in improvement, with the new Code being clearer and easier to understand. Compliance is more straightforward for industry and advertisers and supports progress to a more self-regulatory regime. Assessment of advertising breaches is more straightforward for the TGA. There are opportunities for further refinement which are identified in the recommendations.
1.5.2 The TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public The Review finds that the TGA is well-placed to be the single-body for managing complaints about the advertising of therapeutic goods. Stakeholders reported that TGA has the relevant scientific and regulatory knowledge to effectively regulate the quality and safety of therapeutic goods. The single body has reduced complexity and potential confusion in making complaints about advertising of therapeutic goods. A complaints management process has been implemented. There are opportunities for a more strategic approach to using complaints within the regulatory framework which are identified in the recommendations.
1.5.3 Broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods
The Review finds that the broadened sanctions and penalties provide an appropriate breadth of responses for the TGA in deterring misleading advertising and achieving compliance outcomes for consumer protection in a self-regulatory environment. There are opportunities for the TGA, having focused on its role to inform and educate industry, to build on its experience in using the full range of broadened sanctions and penalties.
1.5.4 A comprehensive industry and consumer education program of the new advertising measures The Review finds the TGA has been effective in developing and distributing information about the advertising framework and Code requirements. The TGA has been very responsive to industry requests for further information. There are opportunities for the TGA to move to a more strategic approach to providing information and education for both industry and consumers including setting priorities based on key regulatory outcomes and working with industry as responsible and accountable partners in achieving better consumer outcomes.
1.5.5 Public performance measures for advertising complaints management, i.e. an assessment of the suitability of the TGA’s key performance indicators for managing advertising complaints
The Review finds significant opportunity for the TGA to revise its performance measures and key performance indicators to include a focus on priorities and outcomes for consumers rather than the current emphasis on timeliness of processes. The Review notes that the TGA has already begun work in this area through a focused concurrent management initiated review into the complaints management function.
1.5.6 Stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the TGACC
The Review found that the TGA applies considerable effort to stakeholder engagement with a very broad range of stakeholders. There is opportunity to engage more strategically with stakeholders, to provide focused opportunities for engagement and to shift from informing stakeholders to engaging them more effectively to build shared responsibility for achieving improved compliance outcomes.
Sinclair's Summary of Recommendations for Further Improvement is
Regarding amendments to the Therapeutic Advertising Code (No. 2) 2018
Recommendation 1: Case Studies 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 (Recommendation 5) and education priorities (Recommendation 12).
Recommendation 2: Focus Issues
The TGA should maintain and share a log of Code issues that stakeholders confirm after discussions in TGACC sub-groups (Recommendation 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.
Regarding the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods
Recommendation 3: Maintain TGA as the single body
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 Recommendations 4 to 7.
Recommendation 4: Strategic Re-set
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.
Recommendation 5: Compliance Priorities
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 (Recommendations 14 and 15).
Recommendation 6: Integrated Information - TGA
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.
Recommendation 7: Integrated Information – other Regulators
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 (Recommendation 21) to define information-sharing needs and priorities.
Regarding broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods
Recommendation 8: Regulatory Posture
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.
Recommendation 9: Skill development
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.
Recommendation 10: COVID-19 Response
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.
Regarding the industry and consumer education program of the new advertising measures
Recommendation 11: Education Strategy
The TGA should develop an Advertising Framework Education Strategy with clearly defined priorities that are aligned to Compliance Priorities and consumer outcomes.
Recommendation 12: Education Priorities
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.
Recommendation 13: COVID-19 Communications
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.
Regarding the public performance measures for advertising complaints management
Recommendation 14: Indicators for Outcomes
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.
Recommendation 15: Performance Reporting
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.
Regarding stakeholder engagement activities on therapeutic goods advertising
Recommendation 16: Stakeholder Engagement Plan
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.
Recommendation 17: Communications Plan
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.
Recommendation 18: TGACC Ways of Working
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.
Recommendation 19: TGACC Work Plan
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.
Recommendation 20: TGACC Focus Sub-groups
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.
Recommendation 21: Regulator Meetings
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.
Recommendation 22: Stakeholder Survey
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.
