The Therapeutic Goods Administration (TGA) has invited comments from interested persons or organisations on this consultation regulatory impact statement (Consultation RIS) before 5pm, 12 July 2013.
About the consultation
The purpose of this Consultation RIS is to seek 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 Consultation RIS:
- describes the existing regulatory framework
- documents problems associated with the existing regulatory framework
- outlines the objectives for reform
- suggests proposals for reform
- invites comments on likely impacts of implementation of the suggested proposals.
After consideration of public comment on this Consultation RIS, the TGA intends to prepare a final RIS to assist Government consideration of the next steps.
Comments are sought on
- how your interests may be affected by the proposals outlined in this paper
- the likely regulatory impacts and costs of the proposals on consumers and businesses
- matters relevant to the implementation of the proposals.
Timetable
Document released for consultation on Friday 31 May 2013.
Interested parties should respond before 5pm, Friday 12 July 2013.
Feedback will be released following consideration of submissions.
Comment?
Ken Harvey from MedReach will believe change when he sees it:
It’s hard to take TGA “reform” seriously when progress is so slow. Concerns (and recommendations) about advertising reform date back to the 2003 report of the “Expert Committee on Complementary Medicines in the Health System”.
How disingenuous for the TGA board to exclude naturopaths and western herbalists from the exemption for health professionals under section 42AA of the Act and to deny them access to information and tools of trade under para 6.2.
The TGA states that it has no formal assurance that those groups of practitioners, not statutorily registered, are able to exercise specialist judgement when either, treating consumers with advertised therapeutic goods, or advising consumers about the use of advertised therapeutic goods.
Considering that registered professionals, such as chiropractors, dentists, medical practitioners, nurses and midwives, optometrists, osteopaths, pharmacists, physiotherapists, podiatrists, and psychologists, have received little, if any, formal training in either Herbal Medicine or Nutrition, naturopaths / western herbalists would indeed be the most appropriate professionals to treat and advise the public seeking to improve their health.
Perhaps the TGA Panel – in the interest of public health safety – should exchange those board members who are unable to discern the difference health care practitioners who are trained or untrained in the areas of herbal and nutritional medicine and elect members who do have the competence to devise a formal mechanism to determine which health care professionals are best qualified to practice nutritional and herbal medicine.
Furthermore, I am concerned that the current membership arrangements of the TGA Panel could lead to a potential source of conflict of interest. I feel that any “conflict of Interest” should be declared and as we need people with a background in the area they are supervising; any perceived financial gain or “conflict of Interest” within the TGA Panel should be discontinued or the person replaced.