TGA lifts ban on GPs promoting COVID-19 vaccines

I posted the following comment to: TGA lifts ban on GPs promoting COVID-19 vaccines | Australian Doctor Group (ausdoc.com.au)

Of course, health practitioners should be able to educate the public about COVID-19 vaccination!

But “Such rewards can be monetary or for example, include store vouchers, discounts, or frequent flyer points, but cannot include alcohol, tobacco or medicines (other than listed medicines)”.

Is this opening the floodgates to complementary medicine companies offering ineffective “immune boosters” to get the public hooked?

And isn’t a “reward” an inducement for the patient to return and thus a breach of the Medical and Pharmacy Board’s Codes of conduct which prohibit offering inducements or entering arrangements that could be perceived to provide inducements?

Antony.Scholefield@adg.com.au got a response from AHPRA about inducements and Codes of Conduct

“Offering rewards for COVID-19 vaccination consistent with TGA guidance is considered part of a public health campaign rather than advertising.

The National Law’s advertising requirements do not apply to public health information and advice.

Unless the promotion involves other advertising of a regulated health service, the advertising requirements of the National Law would not apply. 

As Good Medical Practice reflects the advertising provisions of the National Law, there is no conflict between the TGA advice and the code of conduct.”

Ok, but what about allowing complementary (but not other) medicines as a ‘reward’?

I do not yet have a response from a phone call to the Department of Health Media unit on 8/6/2021 and a follow up to Advertising Enquiry · Custom Portal (tga.gov.au) on 10/6/2021 where I asked,

Would this not be a breach of the Therapeutic Goods Advertising Code (No.2) 2018 s.20(1) which says an advertisement must not contain an offer of a sample (subject to Schedule 3)? 

In addition, I cannot see a blanket acceptance of gifts of listed medicines in the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2021. What is the legal basis for allowing complementary (but not other) medicines as a gift?

Also, given the latest death from the AZ vaccine, what about tackling the issue of no-fault medical compensation. By 2010, 19 countries around the world had accepted that society owes a duty of care (or of gratitude) to the very few individuals damaged by a vaccine and had introduced no-fault vaccine compensation schemes. Germany has had such a scheme for 50 years; New Zealand, the United States, Britain, and most European countries have compensation schemes. However, to date, Australia has not had a no-fault compensation scheme for vaccine injury, despite policies that compel Australians to vaccinate their children.

Update 16 June 2021

From: Advertising Enquiries Advertising.Enquiries@tga.gov.au
Sent: Wednesday, 16 June 2021 3:20 PM
To: Kenneth Harvey kharvey@bond.edu.au
Subject: Your advertising enquiry (our reference: AQ-818MQZI4/2021) [SEC=OFFICIAL]

Dear Dr Harvey

Thank you for your enquiry to the Therapeutic Goods Administration (TGA) dated 10 June 2021 (our reference: AQ-818MQZI4/2021) regarding the new regulatory arrangements for communicating about COVID-19 vaccines.

At the outset I would like to emphasise that these new regulatory arrangements have been designed to facilitate the dissemination of information about COVID-19 vaccines to support the Government’s national vaccination program. Importantly, all independently created promotional material must accord with Government messaging, which has been carefully crafted to encourage optimal uptake of the vaccines while ensuring information provided about the vaccines is accurate, balanced and readily understood by Australians.

These regulatory arrangements are time limited and will cease on 31 December 2022.

In terms of the offer of listed medicines as a reward, I note that item 2 of Schedule 1 of the Therapeutic Goods (Restricted Representations – COVID-19 Vaccines) Permission 2021 (the Permission), has the effect of allowing any party to provide valuable consideration to a person who has been fully vaccinated under the Government’s national COVID-19 vaccination program. Section 4 of the Permission defines valuable consideration as “any consideration of value but does not include alcohol, tobacco or medicines (other than listed medicines)”

The rationale for allowing the giving of listed medicines (but not registered medicines) as a reward for being fully vaccinated is as follows:

  1. This approach is in line with the TGA’s risk based regulatory approach where there are more rigorous controls on higher risk registered medicines than lower risk listed medicines. While no medicine is 100% risk-free, in general terms the risks associated with listed (mainly complementary medicines) are not as great as those associated with registered medicines. Listed medicines can be purchased off the shelf from pharmacies, health shops and supermarkets. Listed medicines contain only pre-approved low-risk ingredients and only low-level health claims can be made of them. Claims cannot be made that a listed medicine can treat a disease for example. While some registered medicines can be purchased off-the-shelf, the majority of them cannot.
  2. As there is generally more risk of harm from the use of registered medicines, and many of them cannot be advertised in Australia, these were excluded. Permitting the giving away of registered medicines that are for use in relation to specific health conditions, and where the imperative to select such a medicine on the basis of clinical need is greater than with listed medicines, was considered inappropriate. Alcohol and tobacco were similarly excluded due to the health risks associated with their use. The giving away of alcohol or tobacco as a reward for being fully vaccinated would contradict public health messaging about the dangers associated with tobacco use and alcohol overuse.
  3. It was considered that large complementary medicine companies that may be effective in positively influencing vaccination should not be excluded from participating in the ‘reward’ scheme.

To facilitate this arrangement, on 4 June 2021, an amendment was made to the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), to remove the requirement for advertisements that are made in accordance with the Permission to comply with the Code. The Permission includes relevant requirements from the Code. Simply stated, the legislative requirements regarding the advertising of therapeutic goods set out in the Code (including, inter alia, section 20(1)) do not apply.

See also:

And (Oh dear):

TGA allows alcohol as a reward for COVID-19 vaccination – (medreach.com.au)

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Advertising, Complementary medicine and tagged , , , . Bookmark the permalink.

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