Tag: TGA

Responsible AI in healthcare

In June 2023 the Department of Industry, Science and Resources announced a consultation on steps Australia can take to mitigate the potential risks of AI.

Addressing the questions posed in the Discussion paper, Research Australia’s submission endorses a risk based approach to the regulation of the development of AI in healthcare, and expresses support for the existing role of the Therapeutic Goods Administration in respect of AI in medical devices. It also calls for dedicated research to understand where AI is posing risk in health care and how these risks can best be mitigated.

No place for exaggeration in advertising medicines

The advertising of medicines in Australia is subject to strict controls. The new Therapeutic Goods Advertising Code, due to commence on 1 January 2019, emphasises the importance of truthfulness and accuracy in all claims made in advertising for medicines, and the need for advertising to support consumers’ informed decision making.

The TGA has developed draft guidance to assist with the interpretation of the new Code, and discusses ‘puffery’, a claim so exaggerated that no reasonable person could take it seriously. The Guidance suggests that puffery may be permissible in the advertising of medicines. Research Australia’s position is that this should not be the case. It is both inconsistent with the Code and the low levels and wide variability of health literacy in Australia.  Some vulnerable consumers can be misled and unduly influenced by exaggerated claims that would be dismissed by most consumers as unbelievable and just ‘marketing’. It is our position that puffery should not be permitted in the advertising of medicines.

Research Australia’s submission

Update: The TGA issued a final version of the Guidance on the Advertising Code (and an amended Therapeutic Goods Advertising Code) on 31 October. The new Guidance states ‘Puffery by its nature is not truthful. It is exaggerated, inaccurate and unsubstantiated and should not be used in advertisements for therapeutic goods.’ 

The Code and the Guidance are available from the TGA website.

Research Australia supports TGA reforms

Research Australia made a submission to the Senate Committee inquiring into the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. This Bill is the latest instalment in amendments to implement the recommendations of a Review conducted in 2015 with the aim of improving the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration (TGA), and to provide consumers with better information.

Research Australia supported the amendments to improve access to potentially lifesaving medicines for patients with few or no other options. In doing so, it will implement a scheme that is similar to those already operating in the USA and European Union.

Research Australia also supported the proposed changes to the marketing of complementary medicines, although we urged the Senate Committee to recommend the legislation be amended to include disclaimers to the effect that the efficacy claims for the products have not been independently assessed and/or are based on traditional use rather than scientific evidence.

Research Australia Submission on the TGA amendments.

The Senate Committee issued its Report on 2 February, noting Research Australia’s submissions. It has recommended that the Senate pass the Bill. In responding to concerns raised by the Committee about advertising of complementary medicines, the Department has outlined measures that will be taken to ensure the public is aware that efficacy claims are based on traditional use rather than scientific evidence. The Committee has also urged the Government to ensure the TGA is adequately resourced to undertake its monitoring activities.

Research Australia supports TGA Reforms

The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 (the Bill) is part of the Government’s response to the recommendations of the review of Medicines and Medical Devices Regulation (MMDR), and the legislation is supported by Research Australia’s submission to the inquiry by the Senate Standing Committees on Community Affairs.

The aim of the Review’s recommendations is to improve the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration. Together the regulatory reforms are expected to reduce the administrative burden on applicants and make the approval process faster without jeopardising the safety of consumers.

Achieving this aim will provide consumers with earlier access to potentially lifesaving new medicines and devices. It is also an effective means of supporting Australia’s medical device and medicines industries; by accelerating their pathway to market it will enable them to become profitable more quickly, providing them with more resources to pursue the international markets needed to be truly successful and profitable.

Research Australia submission TGA Bill