RE Consultation: Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public – 31 May 2013
FROM; David Howell B.Nat.Dip.H.Sc(nurs) Naturopath, Herbalist Toowoomba Q 4350
To the TGA
The following comments relate to the above mentioned document sections as follows;
“The Problem – part 7 – “Advertising Directed to Health Professionals” Page 28
“Proposal 6 – Advertising Directed to Health Professionals” Pages 42-45
I strongly oppose the TGA Proposal 6 Option 2 (Pages 43-5) for the following reasons;
REMOVAL OF ADVERTISING
1) As a Naturopath and Herbalist in clinical practice, my interests would be significantly affected by this option. Advertising of Therapeutic Goods provides a concise gathering of scientific data that enables rapid appropriation of the main ingredients, uses and contraindications of a specific product. Within a busy clinical practice, such rapid analysis assists me in considering the relevance of a product within the scope of my clientele.
Should I consider purchasing such a product, I will then research the ingredients and their clinical trials via independent databases/search engines (Eg. Pubmed, E.Mims and other respected information sources) to verify the manufacturer’s information. This approach is as taught within a science based degree at University level, as per my tertiary qualification, and reflects the sound ability of a Naturopath and Herbalist to independently research the data, and exercise specialist judgment when treating patients with an advertised Therapeutic Good or advising a patient on the use of an advertised Therapeutic Good.
To remove manufacturer’s advertising of such goods is to deny Naturopaths and Herbalists the same style of information as is provided to Medical Practitioners via E.Mims and other Therapeutic Good producer-based information, and constitutes discrimination based on ignorance by the TGA. The TGA should avail itself of the knowledge it needs to discern the level of qualification and expertise of Naturopaths and Herbalists by investigating the necessary Tertiary qualifications and Continuing Professional Educational (CPE) standards of all recognized Practitioner professional associations, rather than making a blanket statement that it cannot be assured that these practitioners are able to correctly discern and utilise such advertising information in clinical practice.
Should the removal of advertising commence as proposed, the result will be increased time imposts on my practice in researching and gathering data.
2) Removal of advertising would then flow on to preventing Naturopaths and Herbalists from attending industry seminars, where research is presented with relevant clinical information. This is similar to seminars as attended by other NRAS health professionals, and represents an industry standard. Completion of CPE points for Naturopaths and Herbalists would then, unfairly, be harder to achieve than for other health professionals (Eg Pharmacists), and would constitute discrimination, again based on ignorance by the TGA.
3) Failure to complete CPE points disqualifies Naturopaths and Herbalists from maintaining membership of professional organisations. This prevents them from both purchasing Therapeutic Goods, and from offering clients consultation receipts for reimbursement via private health funds. The flow on effects of these points are obvious; loss of product purchasing ability removes the tools of trade that makes Naturopathic and Herbal medicine successful and safe in treating client disease or maintaining client wellness, as well as providing a large percentage of income. Loss of the ability to offer health fund receipts will reduce the number of clients attending consultations, again markedly dropping financial viability for Naturopathic and Herbal Medicine Practitioners.
4) Resulting loss of Naturopaths and Herbalists from the marketplace will not only significantly affect them and their families, but will limit the freedom of choice of clients to select a Naturopath or Herbalist as a viable form of healthcare. Limiting such freedom of choice in healthcare to the general public will be the ultimate result of this proposal, and will oppose a basic democratic right of the people. For many people, Naturopathic and Herbal Medicine is the best option for their particular need, and a future lessening of options in this type of healthcare will expose them to greater levels of disease through the application of inappropriate forms of medical treatment. With this occurrence, the TGA will be seen as contravening its own stated object of promoting the safety of the public, and thus will have failed in its relevance to the populace.
Handing over the responsibility of the interpretation of advertising of therapeutic goods, and the advising on their use or their prescription to NRAS health professionals raises the likelihood of danger to the client through lesser clinician knowledge and resulting inappropriate prescriptions.
While the TGA places the responsibility for policing this on each NRAS professional’s Registration Association, a brief perusal of one of these (The Podiatry Board of Australia Code of Conduct for Registered Health Practitioners) states…
“Practitioners have a responsibility to recognise and work within the limits of their competence and scope of practice. Scopes of practice vary according to different roles; for example, practitioners, researchers and managers will all have quite different competence and scopes of practice. To illustrate, in relation to working within their scope of practice, practitioners may need to consider whether they have the appropriate qualifications and experience to provide advice on over the counter and scheduled medicines, herbal remedies, vitamin supplements, etc”. (emphasis mine).
Within this statement, responsibility is loosely placed on the Podiatrist to consider their own level of expertise in providing supplements including therapeutic goods. This includes no form of policing of educational or experiential ability or relevance, and includes no external framework of reference to ensure that such self-consideration is based in fact.
For the TGA to propose removal of therapeutic goods advertising from Naturopaths and Herbalists with University level or other tertiary qualifications, (including science based degrees that offer 4 years of intensive education in the chemical, physiological and pathological basis for the safe and relevant utilisation of these products), and to hand the responsibility over to NRAS practitioners with no relevant tertiary education and a self-assessment of ability not based on fact indicates 2 things;
(a) The TGA is displaying disregard for true client/public safety, against its own tenets and purpose of existence and,
(b) The TGA displays strong and apparently willing ignorance to investigate the truth behind the relevance of qualifications of differing health professionals before making such an irrelevant and potentially dangerous proposal
TGA COMMENT REGARDING ADVICE OF & USE IN TREATMENT OF THERAPEUTIC GOODS
In Option 1 under “disadvantages”, the TGA has commented that;
“The TGA would not be assured that the non-NRAS registered health practitioners are able to exercise specialist judgement when either treating patients with advertised therapeutic goods, or advising them about the use of advertised therapeutic goods”
This suggests that the TGA is not only concerned about the ability of these practitioners to interpret the advertising material correctly, but is concerned with the ability of such practitioners to advise about and treat with such goods (Practitioner Only Products). The inference is that the TGA will not stop at preventing the advertising of therapeutic goods to Naturopath, Herbalists and Homeopaths, but will also target the products’ utilisation in practice by these practitioners. While this may be seen as inference only, in order to allay suspicion and provided the transparency the TGA purports to offer, the TGA needs to answer;
a) Why are the terms “treating patients with” and “advising them about the use of” included in the proposal?
b) Will the TGA make a written guarantee to not remove Therapeutic Goods from the clinical utilization of Naturopaths, Herbalists and Homoeopaths should option 2 proceed?
CHANGING OF TERMS OF REFERENCE IN THE PROPOSAL
The TGA’s proposal to;
“replace the current lists of ‘health professionals’ in section 42AA of the Act with references to ‘health practitioners’ who are registered with a National Board that is a signatory to a Health Profession Agreement under the National Registration Accreditation Scheme (NRAS). Advertising to groups of practitioners who are not registered with NRAS would be regulated in the same way as advertising to the general public” is of particular concern. This infers that those left off the accepted list of NRAS “Health Practitioners”, viz; Naturopaths, Herbalists and Homoeopaths, will not be referred to by the term. As the proposal is related to Therapeutic Goods (Practitioner Only Products), this appears to set the ground for the TGA to disallow the use of (Practice) such products to those not even recognized as Health Practitioners. While this may be supposition, there are 2 aspects the TGA needs to answer to allay suspicion of its motives in making this change in terms of reference under proposal 2;
a) Why is this change of terms being proposed?
b) Why are non NRAS professionals not referred to as “health practitioners”, but rather “practitioners” linked to the general public within this proposal?
c) Can the TGA give written assurance that it will continue to view Naturopaths, Herbalists and Homoeopaths as “health practitioners” should proposal 2 be passed?
TIMING AND TRANSPARENCY OF THE PROPOSAL – TGA CONTRAVENED 3 OF ITS OWN GUIDELINES
Against the guidelines written in the Best Practice Regulation Handbook Appendix C, the TGA released this proposal;
1) With no general media release, despite the public logically being stakeholders in the potential outcome of the proposal
2) Across a National School Holiday period
3) Over an end of financial year, despite the primary stakeholders being small businesses.
The TGA has clearly contravened its own guidelines in releasing this proposal in such a manner and time. While a caveat is provided that such guidelines may be contravened in matters requiring prompt attention due to public danger, the investigations and background to this proposal have been occurring over a great deal of time.
By contravening these guidelines, the TGA shows;
1) It has contempt for reasonable guidelines and is prepared to operate outside such guidelines without reasonable justification
2) It has contempt for stakeholders, including the public it purports to be protecting from danger, and Health Professionals who have every right to be a part of the consultative process and who should have been given the opportunity to research and consider the proposal without the constraints of staff holiday times or end of financial year housekeeping.
Based on this, the TGA should stop the proposal, and relaunch it with the correct media release and timing the public and industry deserves.
Note that this matter has been brought to the attention of industry leaders and politicians, and will form the basis of a future possible legal defense against the proposal.
When all above aspects are combined, the TGA appears to have released this proposal without due research or desire for true consultation, and specifically and unfairly targets Health Professionals who are providing a valid and scientifically quantifiable mode of healthcare, the effects of such a proposal placing the public at risk of greater danger and reducing its freedom of choice in personal and self-funded healthcare. The proposal should be relaunched appropriately, and option 1 chosen to leave the system in its current and workable status until such time that registration under NRAS can be provided for Naturopaths, Herbalists and Homoeopaths.
My online petition regarding this has garnered a strong public and industry response, and reflects the great deal of concern and anger among those whom the TGA purports to protect; the public. This is evidence of a strong reaction that the TGA perhaps tried to avoid by releasing the proposal in contravention of its own guidelines. Please note the 18,855 signatures attached, and take note of the public’s concern and reaction to your proposal. Further to this, my petition and signatures will be presented to the Senate at the next sitting (Mid-August), and should option 2 of the proposal go ahead, we will seek a reversal of the decision based on the TGA’s lack of transparency and the potential negative impacts of the proposal on both industry and the public. Ultimately, should the proposal go ahead, there will be grounds for legal action against the TGA based on a wrongly released proposal that is founded on ignorance, and that unfairly and significantly affects myself and others in my industry.
Naturopath & Herbalist