TGA proposal to amend regulations on advertising therapeutic goods to the general public. This could also affect other health professionals, including naturopaths and herbalists. Concerns regarding this proposal relate to Point 7 (pg 28) Advertising directed to health professionals and Proposal 6 (pg 42) which relates to this. Also Proposal 5, which relates to Advertising of higher risk medical devices. The NHAA and individual members put it submissions on this consultation.
There was much discussion and uncertainty around this proposal and we encourage you to read the rest of this article for an overview of the facts, links to more information, and details on what you can do including a proforma letter you can use to make your own submission.
What are the issues?
The proposed changes affect what advertising material product suppliers will be able to supply to the general public. The general intention of these changes is to better protect the public, and some of the suggested changes are positive. However, the proposed changes will mean that it is ok to provide information to a nationally registered health professional regardless of whether or not they are trained in prescribing those medicines, and excludes health practitioners (including naturopaths and herbalists) who are not registered under the Australian Health Practitioners Regulatory Authority (AHPRA). Under Option 2 of Proposal 6, naturopaths and herbalists are considered consumers and not health professionals. Also if proposal 6.2 is accepted, the concern is that option 2 of Proposal 5 will then deny Western Herbalists and naturopaths access to tools of the trade such as In-Vitro Diagnostic devices for example, bio-impedance analysis, live blood analysis, urine analysis and other in-clinic testing and monitoring devices or tools.
Important points to note
This is a consultative process. There has been much discussion and reaction on this topic and the TGA are hearing the practitioners and industry loud and clear. They extended the deadline for submissions in July 2013 and want to hear proposed solutions.
The TGA have assured us that this will NOT affect practitioner access to complementary medicines. The proposed changes refer to advertising material only and will NOT affect the ability of companies to send technical research information to practitioners. It is their advertising material to practitioners (& their customers) that will be subject to the advertising code.
Where can I learn more?
To learn more about the details and be part of the discussion:
- Go to the NHAA Discussion Forum thread (in Industry & Professional Affairs) NB: Members only
- Follow the updates on our facebook page.
- Listen to Brendan Penwarden interviews with Dr Wendy Morrow from the CHC and John Wardle from ARONAH on the Health Masters Live site.
- Read the CHC practitioner update, developed in consultation with the TGA people involved with the advertising code. www.chc.org.au/Practitioner-Update
What is the NHAA doing?
The NHAA has been in direct talks with both the CHC and ASMI, along with other industry members to discuss implications and strategies. We have also spoken with the TGA and following these discussions can confirm that if there is a change to the Advertising Code it will NOT affect access to Complementary Medicines for naturopaths or herbalists. In addition, as long as devices are used for their registered purpose, practitioners can still use them and advertise their use.
The NHAA has made a submission on behalf of our members.