PERTH, Australia – An independent review of recent reforms to Australia’s Therapeutic Goods Administration (TGA) advertising framework confirmed that the changes to the new advertising code resulted in improvement, with the new code being clearer and easier to understand.

The advertising reforms are part of larger regulatory reforms implemented to increase the pathways for marketing approval for drugs and devices while reducing regulatory red tape and redundancies.

Of the 58 recommendations from an Expert Panel Review of Medicines and Medical Devices Regulation (MMDR), seven related to the advertising of therapeutic goods.

Previously, direct-to-consumer (DTC) advertisements required pre-approval, and the agency is simplifying the process for advertising regulated products and eliminating the vetting and approval process for certain therapeutic goods in favor of a more self-regulating model.

In exchange, the agency is beefing up its postmarketing monitoring activities and stiffening penalties for noncompliance. New actions include sanctions, penalties and injunctions to address serious cases of non-compliant advertising.

Industry welcomed the changes to Australia's regulations for direct-to-consumer (DTC) advertisements for medical devices, complementary medicines and over-the-counter medicines.

The independent review assessed the impact of the new advertising reforms, particularly the effectiveness of the amendments to the Therapeutic Advertising Code and whether they increased clarity and objectivity to support compliance and improved consistency.

The review assessed the TGA as the single body responsible for implementing a complaints management process and the broader sanctions and penalties to deter inappropriate and misleading advertising. 

For products such as medical devices and in vitro diagnostics, advertising must also comply with the Therapeutic Goods Advertising Code. The code sets out a number of requirements, including that DTC advertisements carry only statements that have been substantiated and don't overstate effectiveness.

There are currently no restrictions on device advertising not being directed to the public; however, the types of devices advertised to the public are mainly class I devices. Implantable and higher risk devices tend only to be advertised to health care practitioners in the same way that advertising for prescription drugs is directed to doctors.

Only devices that are included on the Australian Register of Therapeutic Goods may be advertised and only for the intended purpose for which a product is approved. There are also provisions of the legislation that apply to advertising to health care professionals.

Compliance more straightforward

Compliance is more straightforward for industry and advertisers under the new reforms “and supports progress to a more self-regulatory regime,” the independent review said.

The review found that the TGA was “well-placed” to be the single body for managing complaints about the advertising of therapeutic goods. The single body has reduced complexity and potential confusion in making complaints about advertising of therapeutic goods.

Most of the changes to the therapeutic goods advertising framework were implemented over the last 12 to 18 months, so the review was a timely one. It involved extensive consultations with key stakeholders and with TGA staff.

“In undertaking these consultations, the [MMDR] 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,” the review said.

“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.”

The review highlighted that the COVID-19 pandemic posed some challenges, leading to innovative ways of completing the review, such as consultations via teleconference.

Even so, 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 identified some significant changes in the operation of the TGA.

“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 MMDR review said.

In initiating and implementing the reforms to the therapeutic goods advertising framework, the TGA efforts have emphasized an approach of informing and assisting industry with regards to the advertising framework.

“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 report concluded that while “good progress has been made implementing the government’s response,” the focus has been tactical, and the next stage should be more strategic, particularly when it comes to compliance.

For example, it said the TGA should use the recommendations to reset the complaints management system to focus on achieving improved compliance outcomes through intelligence gathering, strategic triaging, and integrated response. And, the TGA should develop and publish compliance priorities that are reviewed annually, the review said.

Moreover, public complaints should be used as sources of public intelligence that are analyzed and responded to more strategically, while considering other information available to the regulator, the review said, noting that there should be further collaboration with other compliance investigations and enforcement areas, or educational efforts.

The feedback received indicated widespread agreement that the broadened sanctions and penalties introduced “are beneficial in achieving compliance outcomes, and are necessary to adequately protect consumers and deter inappropriate or misleading advertising,” the review said, and TGA staff said the broadened sanctions and updated enforcement tools provided the necessary mechanisms to support compliance and to deter prohibited advertising.

However, some industry stakeholders indicated that the broadened sanctions and penalties were negatively impacting industry. For example, some stakeholders suggested that some sponsors were removing all product information from their websites over fears that it may be perceived as non-compliant advertising.

Stakeholders suggested that industry’s risk-averse behavior was limiting the genuine product information available to consumers to support informed decision-making.

However, the review agreed that broadened sanctions and penalties are necessary for protecting consumers through deterring inappropriate and misleading advertising of therapeutic products.

The review highlighted 22 recommendations to improve the advertising framework, which were all accepted by the Australian government. Once implemented, these actions aim to deliver improvements and refinements to the therapeutic goods advertising framework, including:

  • Developing annual advertising compliance priorities that focus on outcomes and consumers;
  • Implementing more strategic advertising complaint handling that use complaints as a source of intelligence to be used for individual case selection and in determining compliance priorities;
  • Developing and publishing new key performance indicators focused on priorities and outcomes rather than processes and deadlines;
  • Publishing case studies based on case experience to assist advertisers and consumers to understand the legal requirements for advertising therapeutic goods;
  • Improving flexibility to adapt to emerging issues, and improved transparency through media and publications, as modeled on the agency’s response to compliance during the COVID-19 pandemic;
  • Implementing an education and stakeholder engagement strategy that is aligned with compliance priorities and supported by education priorities;
  • Enhancing collaboration and engagement with other Australian regulators; and
  • Enhancing the operation of the Therapeutic Goods Advertising Consultative Committee.

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