Program, Papers and Presentations: The Advertising of Therapeutic Goods and Services (and its regulation)

Seminar program

Papers

Ken Harvey. Seminar Background Paper

Sitesh Bhojani and Jodie Valadon. The multi-regulator model for Australian Consumer Law: effective or useless?

Paul Lacaze & Jane Tiller. Online Direct-To-Consumer Genetic Testing in Australia: Concerns, Regulation and Recommendations

Presentations delivered

Some photos of presenters are also available thanks to Sasha Hall

Ken Harvey: Case study – AMI begat MWI begat AMHC

Ross Hawkins. Update on Medicines and Medical Devices Review: Advertising implementation

John Dwyer. Complaining about chiropractors to AHPRA

Megan Munsie. Curbing the big business of selling stem cells

Suzanne Crowle. NSW Fair Trading Complaints Register

Bill Dee. A better multi-regulator model?

Alan Asher. Australian Consumer Law Review

Presentations for reference

Michael Gordon: Advertising and the National Law

Relevant AHPRA communique (Sept 7, 2017)

Update to the Health Practitioner Regulation National Law

These changes will strengthen the management of complaints (notifications) and disciplinary enforcement powers of AHPRA and National Boards, including:

  1. Provision of practice information: A National Board may require a health practitioner to provide details of their practice arrangements, regardless of how they are engaged to practise. This will mean health practitioners that practise in multiple locations or under different employment, contractual or voluntary arrangements will be required under law to provide this information to their National Board when asked to do so.
  2. Public interest grounds for immediate action: Broadening the grounds by which a National Board may take immediate action against a health practitioner or student if it reasonably believes it is in the public interest.
  3. Extension of prohibition order powers: A responsible tribunal may issue a prohibition order to prohibit a health practitioner from providing any type of health service or using any protected or specified title. A breach of a prohibition order in any State or Territory will also become an offence with a maximum penalty of $30,000.
  4. Communication with notifiers: This change will improve communication for people who make a complaint or report concern to AHPRA and National Boards (notifiers) about a registered health practitioner’s health, performance or conduct. National Boards will now have the discretion to inform notifiers of a greater range of actions taken by the National Board in response to their complaint or concern and the reasons for their actions.

Additional powers for the COAG Health Council (formerly operating as the Australian Health Workforce Ministerial Council) to change the structure of National Boards: This means that Health Ministers may make changes to the structure and composition of the National Boards by regulation following consultation. There are no current proposals to change the structure of National Boards

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

Exposure draft: Explanatory Memorandum

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New TGA consultations relevant to Sept 8, 2017 Seminar

There were two new additions to the TGA web site yesterday that are relevant to next Friday’s seminar:

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Seminar: The Advertising of Therapeutic Goods and Services (and its regulation), Sept 8, 2017

Places for this free seminar to be held at the Monash Law Chambers  (555 Lonsdale St, Melbourne, 3000) are filling up.

If you wish to come, please contact me via email asap to see if there is still room:

kenneth.harvey@monash.edu

The latest program is now available as is a background paper.

See also the case study: AMI begat MWI begate AMHC.

 

 

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Case study (Sept 8, 2018 Seminar): AMI begat MWI begat AMHC…

In the beginning there was the Advanced Medical Institute (AMI).

 

AMI begat the Medical WeightLoss Institute (MWI)

 

MWI begat the Australian Male Hormone Clinic (AMHC)

 

 

There are still a few places left at this free seminar.

See also:

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AHPRA’s handling of complaints about pharmacist Gerald Quigley

My students involvement in this complaint about Gerald Quigley was reported last December in the Australian Journal of Pharmacy.

In addition to sending a complaint to the TGACRP, my students also sent a complaint about Gerald Quigley to AHPRA

AHPRA’s response was to ignore the concerns about Quigley, regard it as a matter for the TGA (who do not regulate practitioners) and close the case!

Whereupon I asked for a re-examination of the complaint (appended).

AHPRA’s response was to deny there were any problems.

Now, we have the TGACRP determination about Quigley’s promotion of Blooms Coenzyme Q10 150 Max which includes a request for a retraction (below).

I’ve appended yet another email sent to AHPRA requesting they revisit the original complaint by my students that alleged Mr Quigley’s conduct in endorsing this product was in breach of the:

  • Pharmacy Code of Conduct,
  • AHPRA guidelines for the Advertising of Regulated Health Services and the
  • Health Practitioner Regulation National Law Act.

—————————————————————-

From: Kenneth Harvey <kenneth.harvey@monash.edu>
Date: 10 February 2017 at 11:50
Subject: Re: Correspondence from AHPRA about Mr Gerald Quigley; Reference Number: 00321441
To: Diana Newcombe <Diana.Newcombe@ahpra.gov.au>
Cc: Sasha Hall <shal47@student.monash.edu>, Tiana Angela Moutafis <tamou1@student.monash.edu>, Genevieve Grant <genevieve.grant@monash.edu>

Attention: Diana Newcombe
National Director, Legal Services, AHPRA

Dear Diana,

I’m emailing you about this matter as the letter received by my student from Camilla Worsnop (AHPRA Senior Legal Adviser) provided no contact email address or telephone number. I’ve attached Ms Worsnop’s letter and the original complaints sent to both AHPRA and the TGACRP.

I have the following concerns.

First, the AHPRA Senior Legal Adviser sent her response to my student, not kenneth.harvey@monash.edu as requested.

Second, she did not address the allegation that Mr Quigley’s behaviour is in breach of the Health Practitioner Regulation National Law Act nor did she provide advice on whether Mr Quigley’s action constitutes a regulated health service under s 133(4) of the Act as requested.

Third, she considered that this matter was more appropriately dealt with by the Therapeutic Goods Administration (TGA) and noted that a complaint has been sent to the TGA. This is incorrect. The complaint about the alleged breach of the Therapeutic Goods Advertising Code was sent to the TGACRP, not the TGA and it has been acknowledged as Complaint 2016/12/003 Blooms Coenzyme Q10 150 Max. However, given the current lack of resources of the TGACRP it will be 6-8 months or more before we hear the outcome of that complaint! In addition, the TGACRP can only consider a complaint about the advertising of a therapeutic good; they cannot consider a complaint about a registered health practitioner.

Finally, no response was provided about the previous unanswered complaints about Mr Quigley sent to the AHPRA in 2013.

I should be grateful if you could review this matter.

Cheers
Ken


From: Ken Harvey [mailto:ken.harvey@medreach.com.au]
Sent: Sunday, 16 July 2017 11:28
To: ‘Diana Newcombe’ <Diana.Newcombe@ahpra.gov.au>; Chris Robertson (Chris.Robertson@ahpra.gov.au) <Chris.Robertson@ahpra.gov.au>; Martin Fletcher (Martin.Fletcher@ahpra.gov.au) <Martin.Fletcher@ahpra.gov.au>
Cc: Tiana Moutafis (tamou1@student.monash.edu) <tamou1@student.monash.edu>; Sasha Hall (shal47@student.monash.edu) <shal47@student.monash.edu>; ‘Genevieve Grant’ <genevieve.grant@monash.edu>; ‘Basia Diug (basia.diug@monash.edu)’ <basia.diug@monash.edu>; John Dwyer (j.dwyer@unsw.edu.au) <j.dwyer@unsw.edu.au>
Subject: Re: AHPRA’s handling of my student’s complaints about pharmacist Gerald Quigley (PHA0000958745); Reference Number: 00321441
Importance: High

Dear Diana, et al.

I noted Bryan Sketchley’s response to our concerns (attached).

I now attach the TGACRP determination of the complaint my students sent to them.

Para 16 states, “Phytologic acknowledged that “the article written by Mr Quigley breached the Therapeutic Goods Advertising Code 2015 (the Code) in the ways described by the complainant, and have removed the page from our website.”

Para 35 states, “The Panel requests Phytologic Holdings Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

e) to arrange for publication on the website bloomshealth.com.au, of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination” (appended).

In the light of this determination, I request that AHPRA revisit the original complaint by my students that alleged Mr Quigley’s conduct in endorsing this product was in breach of the Pharmacy Code of Conduct, AHPRA guidelines for the Advertising of Regulated Health Services and the Health Practitioner Regulation National Law Act.

In my opinion, given Mr Quigley’s repeated (and serious) offences in this regard, I believe that he should be prosecuted by AHPRA, ordered by a court to pay a $5,000 penalty per offence and have a condition placed upon his registration prohibiting him from promoting &/or endorsing complementary medicines.

I should be grateful for your response.

Sincerely,
Ken

 

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Garvan Institute $6,400 genetic test

https://www.garvan.org.au/genome-one-news-australia2019s-first-whole-genome-and-health-assessment-service-to-provide-an-unprecedented-insight-into-our-current-and-future-health

The Garvan Institute’s Sydney based Genome.One lab has launched a new ‘whole genome sequencing’ test which is claimed to provide genetic insight into a person’s propensity to develop a range of serious diseases including heart conditions and cancer.

Costing $6,400 the genome sequencing also provides details on a subject’s response to 220 medications, with the fee including genetic counselling and a comprehensive health assessment.

Genome.One says the added insight provided by the genetic testing can “empower individuals to take control and more proactively manage their health”.

The health management service, GoNavigateTM, is delivered by Genome.One in partnership with Life First at St Vincent’s Clinic, Sydney.  See:and  https://oneome.com/

See also:  https://www.nps.org.au/australian-prescriber/articles/retail-genetics

https://www.nps.org.au/australian-prescriber/articles/genomic-testing-as-a-tool-to-optimise-drug-therapy

https://theconversation.com/gene-testing-for-the-public-a-way-to-ward-off-disease-or-a-useless-worry-79757

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Monash University SPHPM “Whack-a-mole” project 2017

Whack-a-mole

Overview: The aim is to provide students with practical experience of the role of regulators in protecting the public from false and misleading therapeutic claims by product sponsors and health practitioners.

Why “Whack-a-mole”: Because, given deficiencies in the current regulatory system, no sooner does one miscreant get “whacked” than another (or the same one) pops up!

Hence the forthcoming seminar, “The Advertising of Therapeutic Goods and Services (and its regulation)“, Monash Law Chambers, Sept 8, 2017.

Methodology:  Evaluate the evidence for questionable claims made about therapeutic goods and services and, if appropriate, submit a complaint to the appropriate regulator.

More information about this project is available here.

Some examples of upheld complaints based on work submitted by students last year are available below:

Feel free to submit URLs of questionable claims for the 2017 students to assess by leaving a reply (below) or emailing me direct: ken.harvey@medreach.com.au.

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Order of Australia Honour

MEMBER (AM) IN THE GENERAL DIVISION OF THE ORDER OF AUSTRALIA

Associate Professor Kenneth John HARVEY, Melbourne VIC 3004

For significant service to community health and the pharmaceutical industry through roles in developing guidelines for the ethical use of antibiotics. See also:

Associate Professor Ken Harvey (AM)

Public health campaigner Associate Professor Ken Harvey has been honoured for his leading role in improving antibiotic prescribing in Australia.

In the late 1970s, he was among a group of doctors working in Melbourne’s teaching hospitals increasingly concerned about the incidence of antibiotic-resistant micro-organisms and inappropriate prescribing.

It led to the creation of a working party, which produced what Professor Harvey describes as a “slim booklet” running to 30 pages.

“It was designed to fit into a hospital doctor’s white coat pocket”.

With the help of a small grant, it was handed out free of charge to resident medical officers working in Victoria.

Nearly 40 years later, the guidelines have been through 15 editions running to 30 chapters, with antibiotics and their continuing misuse recognised across medical profession as a global concern.

“I’m pleased and honoured. It is good to know you have made a difference,” says Professor Harvey.

“The guidelines were for the first time providing independent information about these drugs. [Given how far we have evolved], it has been hugely important. It also influence other areas of medical practice so that we have guidelines that go right across medicine.”

The honours citation for Professor Harvey refers to his “significant service” to the pharmaceutical industry.

And this reference — because of his reputation as a vociferous critic of the industry’s excesses — makes him chuckle.

“It’s a touch unusual I guess. I think quite a few of my colleagues would be surprised to hear that I had made a contribution.”

The industry itself has described him as an “agitator”, a tag that he is happy to accept.

Related: Ken Harvey Profile (Outrageous claims)

“It’s what public health is all about. You make your analysis. You find out what is wrong and then you have to jump up and down to get change.”

Yes, the pharmaceutical industry has improved. “Transparency and openness has got much better.”

But he says scrutiny of all those companies who make their dollars from advertising therapeutic goods — particularly those that make up the booming complementary medicine industry — has to continue.

He is now 73 and recovering from a recent hip replacement. But Professor Harvey doesn’t seem the retiring type. His work will continue, he says.

Part of his work involves inspiring a new generation of “agitators”.

Each year, he gets his public health students at Monash University to investigate the rich and strange variety of bogus health products marketed to the public.

Ostensibly, it’s to help these students understand how the regulatory system works in Australia.

But Professor Harvey puts it more eloquently: “They are about to embark on a ‘wack a mole’ project. There are still plenty of moles to wack.”

 

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Retail genetics

Harvey K, Diug B. Editorial: Retail genetics. Aust Prescr 2017; 40:86-71 Jun 2017

See also: Somogyi A, Phillips E. Genomic testing as a tool to optimise drug therapy. Aust Prescr 2017; 40:101-41 Jun 2017

 

 

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Kid’s vitamin gummies: unhealthy, poorly regulated and exploitative

See: https://theconversation.com/kids-vitamin-gummies-unhealthy-poorly-regulated-and-exploitative-76466.

Taken up by:

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