TGA's Advertising Regulation Impact Statement Consultation
Call to Action
1. The CHC encourages all interested parties to provide comment to the TGA by 19 July 2013, about how the proposals may affect their business.
The Therapeutic Goods Administration has published the document Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public, calling for public comment to help inform the Australian Government in decision making on proposed regulatory reforms to improve the management of public health risks in relation to the advertising of therapeutic goods to the general public.
This advertising consultation RIS includes a range of proposed reforms to the therapeutic goods legislation regulating the advertising of therapeutic goods to the general public.
It should also be noted that these are just proposals at this stage, and further recommendations of future advertising arrangements will be informed by the submissions received in response to this consultation.
Proposal 6: Advertising directed to health professionals
The TGA propose the following two options to ensure that only appropriately qualified health professionals are exempted from the advertising requirements:
- Option 1: Status quo - maintain the current system or;
- 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.
This specifically relates to those professions not currently regulated under the Health Practitioner Regulation National Law such as naturopaths, homeopathic practitioners and herbalists (other than Chinese herbal medicine practitioners registered by the Chinese Medicine Board of Australia). Under option 2, advertising to groups of practitioners who are not registered with NRAS, (administered by AHPRA) would be regulated in the same way as advertising to the general public.
The CHC has been advised that the TGA will receive other options or recommendations in relation to this proposal.
In addition, the CHC has received requests to clarify whether Proposal 5: Advertising of higher risk medical devices will impact on the advertising of services where IVD’s are currently used by Practitioners as part of their daily practice.
Proposal 5: Advertising of Higher Risk Medical Devices
- Option 1: Status quo - maintain the current system.
- Option 2: Prohibit the advertising of higher risk medical devices (applicable to Class III, Active Implantable medical devices and Class 4 in vitro diagnostic devices).
The TGA has advised the CHC that this advertising proposal does not affect low risk medical devices including IVDs that complementary medicine health professionals may use in clinical practice.
The consultation paper can be found here:
The TGA invites comments from interested persons or organisations on this Consultation RIS by close of business 19 July 2013
(one week extension).
In particular, comments are sought on:
The CHC encourages all interested parties to provide comment to the TGA about how the proposals may affect their business.
CHC Principle Points to Advertising RIS Consultation
- how your interests may be affected by the proposals outlined in this paper
- the likely impacts of the proposals on consumers and businesses
- matters relevant to the implementation of the proposals.
Review of the Australian Government Rebate on Private Health Insurance
The Department of Health and Ageing, as part of the 2012-13 Budget, committed to undertake a review of the Australian Government Rebate on Private Health Insurance for natural therapies (the Review). The Review will examine the evidence of clinical efficacy, cost effectiveness and safety and quality of natural therapies.
Following the completion of the review, the Government will introduce through regulation a list of natural therapies that have demonstrated the necessary evidence base and which can continue to attract the rebate. It is proposed that these changes will take effect from 1 January 2014.
The National Health and Medical Research Council (NHMRC) is assisting the Department with the review by undertaking an evidence review of all in-scope therapies, including assessing stakeholder submissions. The Department received 46 submissions in relation to the review:
Natural Therapy Review Submissions
The NHMRC’s findings will be examined by the Department’s Natural Therapy Review Advisory Committee (Advisory Committee). The Advisory Committee will provide advice to the Australian Government about the natural therapies that have been found to be underpinned by an evidence base. Information about the membership of the Advisory Committee can be found here:
http://www.nhmrc.gov.au/your-health/complementary-and-alternative-medicines, along with further information about the review.
Open Call for Comment - Complementary and Alternative Medicine Resource for Clinicians
The National Health and Medical Research Council (NHMRC) has called for comment on two draft documents, prepared with the aim of promoting awareness amongst clinicians of the importance of discussing complementary and alternative medicine (CAM) use with their patients. Submissions are welcomed to the NHMRC before Friday, 13 September at 5:00pm (AEST).
More information on this consultation can be found here
The NHMRC is currently reviewing the evidence for the effectiveness of homeopathy, conducting an overview of all available systematic reviews of the effectiveness of homeopathy in treating a variety of clinical conditions in humans. The NHMRC will also evaluate and consider published guidelines, other government reports and evidence submitted to the NHMRC. The findings of this homeopathy review will inform the development of an NHMRC information paper and position statement on homeopathy, which will be made available to the Australian community to assist people in making informed decisions about their health care.
A Homeopathy Working Committee has been established to advise on this work. The committee membership includes researchers and experts in evidence-based medicine and complementary and alternative medicine. Information about the membership of the Homeopathy Working Committee can be found here: http://www.nhmrc.gov.au/your-health/complementary-medicines/membership-homeopathy-working-committee
The Australian public will be invited to provide feedback on the NHMRC’s information paper and position statement through public consultation. Public consultation will occur later than originally expected and is now expected to open in the fourth quarter of 2013.
If you have any queries regarding the homeopathy review, please contact NHMRC at ComplementaryMedicine@nhmrc.gov.au