Sunday, July 14, 2013

TGA Proposal Proforma Patient Letter


Your name
Your street address
Your suburb & postcode

Today’s date

Advertising Consultation
Recalls and Advertising Section
Office of Product Review
Therapeutic Goods Administration
PO Box 100

WODEN ACT 2606


Re: Advertising Consultation

As a member of the public who is/has been a patient of the naturopath, Claudette Wadsworth, for x years and has received significant health benefit from her practice, I want to express my concern about the proposed regulation of advertising of therapeutic goods to consumers and the effects of the proposed changes on the professions of Western herbalists and naturopaths.

Western herbalists and naturopaths currently hold TGA exemption from Part 5-1 of the Therapeutic Goods Act; this allows them to receive technical information from companies regarding herbs and supplements regarded as tools of trade for these professions. It has been noted that proposal 6.2 will have a detrimental impact on the practise of Western herbal medicine and naturopathy, and proposal 5 will also have a deleterious impact should proposal 6.2 be implemented.

My concerns relate to the following proposal:


Option 1: Status quo - maintain the current system.

Option 2: Update the exemption for health professionals in section 42AA of the Act to only recognise health practitioners regulated under the Health Practitioner Regulation National Law.

Either the current list of health professionals should remain (option 1) or Western herbalists and naturopaths be added to the new list. As previously mentioned, option 2 deprives herbalists and naturopaths tools of trade to practise effectively and safely.

The potential consequences of not considering these suggestions will have an impact on the following:

Public safety: Currently practitioners receive important technical information on efficacy and safety of listed therapeutic goods from companies both in written material and via face-to-face seminar activities that comprise a portion of continuing education for the professions. Such activities encourage not only the updating of knowledge vital for safe professional practice but also employ critical analysis of research, sharing of professional knowledge, and promote other professional behaviours such as adverse reaction reporting. All these elements contribute to public safety.

Maintaining expertise: Herbalists and naturopaths currently hold expertise in herbal and nutritional medicine, in particular holding the highest qualification resulting in the prescription of herbal medicines. A recent study confirmed herbalists and naturopaths had similar knowledge to pharmacists in clinically proven benefits of herbal medicines, and significantly better knowledge than pharmacists of clinically significant interactions[1]. These findings provide evidence that contradicts the TGAs argument for excluding naturopaths and herbalists as recognised health professionals. 

Scope of Practice: The current minimum standard to practice Western herbal medicine and naturopathy is an advanced diploma. However, the professions are moving toward Bachelor degree as minimum standard, and many hold post-graduate qualifications. The professions are also moving from a mainly tradition based body of knowledge to evidence based practice (EBP)1. This is supported by current education standards in all tertiary education sectors and NHAA course accreditation requirements for research, clinical sciences, herbal therapeutics and toxicology.

ARONAH: In 2011 an independent register The Australian Register of Naturopaths and Herbalists (ARONAH), was formed to mirror the government statutory regulated boards of AHPRA. ARONAH began taking applications for registration on 1 July 2013. The main stated purpose of ARONAH is the provision of minimum education standards for herbalists and naturopaths in Australia, and it will also provide an easily transferable model of statutory registration should herbalists and naturopaths achieve registration with AHPRA. ARONAH may provide a good interim solution with regards to identifying appropriately trained herbalists and naturopaths once it is better established.

In conclusion I recommend that the TGA either maintaining the status quo (6.1) or add herbalists and naturopaths to the new exemption list as they are legitimate qualified health practitioners. To do otherwise is to add risk to public safety and adversely affect the practice of herbal medicine and naturopathy, potentially resulting in professional and financial hardship.

Yours sincerely


Your name and qualifications





[1] Braun, LA, Spitzer, O, Tiralongo, E, Wilkinson, JM, Bailey, M, Poole, SG, & Dooley, M. (2012). Naturopaths and Western herbalists’ attitudes to evidence, regulation, information sources and knowledge about popular complementary medicines. Complementary therapies in medicine. 2012;21:58-64.