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Plans for a shake-up of therapeutic good promotion need more work

The Parliamentary Secretary for Health, Mark Butler, last week launched two related initiatives at the National Medicines Policy Partnership Forum: a position paper on the promotion of  therapeutic goods and a consultation paper on advertising arrangements.

The former was produced by the Regulatory Policy & Governance Division of the Department of Health and Ageing, while the latter was produced by the Regulatory Reform Section of the Therapeutic Goods Administration (TGA).

Dr Ken Harvey, Adjunct Senior Lecturer in the School of Public Health, La Trobe University, has some major reservations about the proposed reliance on industry self-regulation, insufficient focus on the promotion of so-called “lower-risk” complementary medicines and medical devices to the general public, and proposals to refer all  all complaints about “efficacy” to the TGA “when this organisation has a proven track record of non-responsiveness and non-transparency”.

Harvey has prepared a detailed response to both papers, which Croakey is happy to forward to interested readers. Here is the summary of his response:

“While many of the measures proposed have merit, I have the following major concerns:

• A reliance on industry self-regulation (which has proven to be weak and self-serving);

• Apparent failure to involve other stakeholders, especially consumers and health professionals, in developing the common high level set of Code principles proposed;

• The focus on the promotion of so-called “higher-risk” medicines and medical devices to health practitioners which ignores the fact that most of the problems in this area come from the promotion of “lower-risk” complementary medicines and medical devices to the general public.

In addition, the current Code of Conduct of the Complementary Healthcare Council of Australia is arguably the weakest and least transparent of all industry Codes but this problem is ignored;

• The suggestion of referring all complaints about “efficacy” to the TGA when this organisation has a proven track record of non-responsiveness and non-transparency in complaint handling (although they do keep promising to do better).

The Consumers Health Forum and others have proposed that the current complex and convoluted co-regulatory system for therapeutic promotion would be better simplified and unified by creating one overarching principles-based Code applicable to all therapeutic claims and promotional practices supported by one monitoring process, one complaint (and appeal) process and one set of effective sanctions, including corrective advertising orders and fines related to the sales income of the product and company involved.

The system should be funded by government and administered transparently by an expert independent committee representing the therapeutic goods sector, the advertising industry, consumers, healthcare professionals and government. Specific panels could deal with promotional activities targeting health professionals on the one hand and consumers on the other.

The system should have a legislative base in the Therapeutic Goods Act &/or regulations and be capable of being enforced. This would meet the requirements of the 2007 World Health Assembly Resolution (60.16.5) on Rational Use of Medicines that urged Member States (including Australia) to: ‘Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines and to monitor promotion of medicines’.”

Update, 8 July: Carol Bennett of the Consumers Health Forum has sent in this response:

The Consumers Health Forum has long championed the need for an ethical and transparent code covering both the promotion and advertising of therapeutic goods in Australia.  Whilst the position papers released by Parliamentary Secretary Mark Butler do not go as far as we might want towards this goal, they do put industry on notice that if it doesn’t put its own house in order, the Government could legislate to do just that.

Health consumers have been calling for action in this area for many years, as they’ve watched a range of questionable products advertised and marketed in misleading ways.  Examples include products in areas like weight loss and sexual health being promoted as ‘miracle cures’ with little or no evidence to support their claims.

CHF acknowledges that some industry groups have made strong efforts to improve regulation of their own sectors.

However, too many organisations and shonky operators are able to escape scrutiny, which is why we have argued for a strong, enforceable, transparent and overarching code that would apply to prescription, over the counter, generic, complementary medicines and medical devices.  This is an important way of building consumer confidence in an industry that has been marred by incidences of misleading claims.

Health Consumers look forward to being at the table and having their say as well as reporting on our views of how the new promotion and advertising arrangements are going.“

Related Posts

Comments 4

  1. loretta says:

    The current regulation of ‘low risk’ therapeutic goods is honesty-based – which is an open invitation for creative sponsors/manufacturers to apply for listings for products that they know do not have proof of efficacy.

    The TGA only check one in ten new listings, which means that sponsors only have a 10% chance of being picked up in a random post market audit.

    If the TGA asks them for ‘evidence’ all they do is put in new applications (using different names) with a 90% chance of escaping audit. They are therefore guaranteed to get a listing.

    The internet is now flooded with incorrect information on therapeutic goods, many of which are TGA approved goods, and consumer complaints are increasing.

    Consequently, there are hundreds of ineffective products that can claim to be “TGA approved”, and with no threat of legal action from recalcitrant sponsors, and complaitns system that lack teeth, it has become a free-for-all. Sadly, this means that thousands of practitioners are using ineffective, potentially harmful, products on some of our most vulnerable patients at sometimes great cost to their health and wallets.

    The TGA continues to focus on the ‘the industry’, with no transparency, contempt for complaints and no interest in consumer protection. You can drive a semi load of ‘low risk’ goods through the loop-hopes in the current regulation. It should be scrapped.

    There should be one system for all therapeutic goods.

  2. carlt says:

    I have just read Dr Harvey’s position paper in full and I have to say that I agree with him, although I would like to go further.
    I work for a company that markets listed medicines. My experience from the inside has shown me that the entire system needs to be overhauled.
    At present, we have some listed medicines that are, to be it bluntly, ineffectual rubbish, about which unsupportable claims are made. There are other listed medicines that in other parts of the world have the standing of registered medicines because they have the published peer-reviewed science behind them.
    In Australia it is close to impossible to get registered status for a natural medicine. The system is so biased in favour of the patented synthetics from big pharma that anything natural is locked out, regardless of how much evidence can be presented.
    This creates a situation in which some highly effective and safe natural medicines cannot be promoted for what they have been shown in published science to do.
    This is because what the Act classifies as ‘serious medical conditions’ are the exclusive preserve of registered medicines.
    Someone would have to be naive in the extreme to not see that the Therapeutic Goods Act was written to protect the interests of big pharma by denying both the public and doctors access to information. Truth and public interest are not considerations in the legislation.
    What I believe Australia needs is a classification for natural medicines that have been shown in published peer-reviewed science to be effective. This category should be able to make claims based on the evidence, regardless of whether the condition is ‘serious’ or not.
    The original intent of the medicines classification system was to require that medicines that were potentially dangerous needed a prescription and medical supervision. What it has morphed into is a system that protects the interests of big pharma by creating a closed shop.
    In summary, I believe there should be three classifications.
    1. Registered medicines that are prescription only because of the risk to the patient if they are used incorrectly.
    2. Medicines that are both natural and synthetic (currently registered non-prescription) that have published science on record with the TGA, but are low risk.
    3. Listed medicines that are not required to produce evidence and are low risk.
    Claims made in advertising should be on the basis of the evidence, not whether a condition is ‘serious’ or not.

  3. Doctor Whom says:

    Pharmacists, who are trained in the scientific method, are some of the worst boosters.

    It’s possible to walk into a pharmacist shop in any suburb and see sales displays for slimming “potions” and all sorts of new age and old age woo woo cures.

    One doesn’t even have to go far to find a chemist doing homeopathy!

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health impact assessment
Health in All Policies
health inequalities
health literacy
human rights
illicit drugs
injuries
legal issues
marriage equality
Media Doctor Australia
media-related issues
nanny state
National Preventive Health Agency
obesity
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public interest journalism
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Web 2.0
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Social determinants of health
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NBN
Newstart
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Summer reading 2020-2021
Tasmanian election 2021
Testing Croakey News category 1
The Croakey Archives
#cripcroakey
#HealthEquity16
#HealthMatters
#IHMayDay (all years)
#IHMayDay 2014
#IHMayDay15
#IHMayday16
#IHMayDay17
#IHMayDay18
#LoveRural 2014
Croakey Conference News Service 2013 – 2019
2013 conferences
Australian Centre for Health Services Innovation Forum 2013
Australian Health Promotion Association Conference 2013
Closing the Credibility Gap 2013
CRANAplus Conference 2013
FASD Conference 2013
Health Workforce Australia 2013
International Health Literacy Network Conference 2013
NACCHO Summit 2013
National Rural Health Conference 2013
Oceania EcoHealth Symposium 2013
PHAA conference 2013
2014 conferences
#IPCHIV14
AIDA Conference 2014
Congress Lowitja 2014
CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014
Racism and children/youth health symposium 2014
Rural & Remote Health Scientific Symposium 2014
2015 conferences
#CPHCEforum
#CRANAplus15
#HSR15
#NRHC15
#OTCC15
Population Health Congress 2015
2016 conferences
#AHHAsim16
#AHMRC16
#ANROWS2016
#ATSISPEP
#AusCanIndigenousWellness
#cphce2016
#CPHCEforum16
#CRANAplus2016
#IAMRA2016
#LowitjaConf2016
#PreventObesity16
#TowardsRecovery
#VMIAC16
#WearablesCEH
#WICC2016
2017 conferences
#17APCC
#ACEM17
#AIDAconf2017
#BTH20
#CATSINaM17
#ClimateHealthStrategy
#IAHAConf17
#IDS17
#LBQWHC17
#LivingOurWay
#OKtoAskAu
#OTCC2017
#ResearchTranslation17
#TheMHS2017
#VMIACConf17
#WCPH2017
Australian Palliative Care Conference
2018 conferences
#6rrhss
#ACEM18
#AHPA2018
#ATSISPC18
#CPHCE
#MHED18
#NDISMentalHealth
#Nurseforce
#OKToAsk2018
#RANZCOG18
#ResearchIntoPolicy
#VHAawards
#VMIACAwards18
#WISPC18
2019 Conferences