TGA Submissions: Draft Therapeutic Goods Advertising Code and Complaint Handling

Draft Therapeutic Goods Advertising Code Submission

Our submission noted that many previous Code recommendations made by civil society had been ignored. For example:

  • Submissions from consumer and health professional organisations wanting advisory statements on all products with “traditional indications” to assist consumers making an informed choice have been ignored.
  • Requests for stronger mandatory warnings on products containing vitamins, minerals and food extracts to support critical public health messages have been disregarded.
  • Recommendations to eliminate testimonials have been refused.
  • Recommendations to prohibit celebrity endorsement and recommendations by scientists or healthcare professionals have been ignored.
  • Requests from the Public Health Association of Australia and others to broaden the focus of the new Code to encompass all therapeutic claims, including those made about food, were rejected, “because the Therapeutic Goods Act 1989 excludes foods”.

We also advocated:

  • Part 1, 4, 1. A definition of “genuine news” must be added.
  • Part 1, 4, 2. The definition of “Health Professional” should include members of the Australasian Association of Ayurveda Incorporated, given the TGA advisory to consult these practitioners.
  • Part 1, 5. Object, add, “promotes the quality use of therapeutic goods”.
  • Part 2, 9. Accuracy (homeopathic and other traditional products), add
    “(d) if a homeopathic preparation, must satisfy the definition in the Part 1(2) of the Therapeutic Goods Regulations 1990 and the TGA evidence guidelines on traditional evidence” and
    “(e) if there is conflicting evidence between the history of traditional use and contemporary scientific evidence for your medicine, all labeling and advertising material must state: “this traditional use is not supported by scientific evidence”.
  • Part 2, 11 2(d) & 2, 12(1)(h). What must advertisements contain. Admirable provisions but they lack guidance on what adverse reactions, precautions, contraindications and methods of use must be included. These provisions cannot be legally enforceable until the TGA provides appropriate information on its list of approved ingredients.
  • Part 2, 15(b). Scientific representations. Unacceptable. (b) & (c) should be combined thus: “Research results can only be used in an advertisement if the study has been published in peer-reviewed literature and is sufficiently identified to enable access”
  • Part 2, 16. Endorsements. Unacceptable. Endorsements do not assist quality use of medicines and must be prohibited as does the U.K.
  • Part 2, 17. Testimonials. Unacceptable. Testimonials do not assist quality use of medicines and must be prohibited to be in accord with the Health Practitioner Regulation National Law.
  • Part 2, 20. Allergies. Another admirable provision but it cannot be legally enforced until the TGA provides updated information about these matters on its list of approved ingredients.
  • Part 3, 23. Complementary medicines, tradition of use. All claims invoking traditional paradigms must be accompanied by an advisory statement such as, “The claims for this product are based on traditional beliefs and not modern scientific evidence”.
  • Part 3, 25. Vitamins and minerals. Requires a more definitive statement to support public health campaigns such as, “Vitamins, minerals and other supplements are NO substitute for a healthy balanced diet. Except in special circumstances, vitamins, minerals and food extracts are best obtained from food”.

Complaint Handling Submission

There was considerable support for the concept of single body taking over the existing Therapeutic Goods Advertising Complaint System to provide a single, more efficient, complaint body, with powers to apply timely and meaningful sanctions for regulatory violations.

The Government then decided that the TGA would assume responsibility for handling all complaints about therapeutic goods advertisements directed to the public from 1 July 2018. This model would be independently reviewed after three years of operation to determine whether it was the most effective solution.

However, the TGA’s proposals for the  implementation of the new Therapeutic Goods Advertising Complaint Handling System leaves a lot to be desired!

Our submission (endorsed by Friends of Science in Medicine) notes that the TGA’s new system will be much less transparent than the current Complaint Resolution Panel; very convenient for both the TGA and Industry, but not for consumers or complainants.

We also reiterate the point made in other submissions; unless the TGA accepts that consumer protection is an equal objective to industry assistance, and gains the will to act, a revised Code and complaint system (including increased penalties and sanctions) will have no more impact than the current dysfunctional system.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Education, Medicine policy, Natural Therapies and tagged , , , , , . Bookmark the permalink.

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