Issue 43 / 7 November 2016

SINCE 2002, there have been 17 government consultations and reviews concerning the regulation of complementary medicines. A consistent theme has been the absurdity of a “light-touch” regulatory system for perceived “low-risk” products that involves no pre-market evaluation, trusts sponsors to obey the rules and has no timely or effective penalties for breaches of the regulations.

The end result is a market flooded with shonky products and unethical claims. There is also little incentive for sponsors of complementary medicines to undertake the research required to prove that their products work. A better return on investment comes from spending money on promotional hype and celebrity endorsement.

The Therapeutic Goods Administration (TGA) has recently published data concerning post-marketing reviews of listed complementary medicines, which were conducted from July 2015 to June 2016. Of the 408 products whose compliance status could be assessed, 80% were found non-compliant; primarily with labelling, advertising and evidence requirements. In addition, around 98% of all complaint determinations assessed by the TGA Advertising Complaints Resolution Panel (TGACRP) were upheld.

These appalling statistics, which have not improved over recent years, are a sad reflection of the sorry state of this industry. They are also the reason why many consumers no longer trust the TGA to protect their interests.

Reform has been stalled by consistent industry opposition, changing bureaucrats, changing ministers, changing government and changing policy, the latest of which was the Abbott government’s agenda for cutting red tape.

Despite this, the July 2015 Expert review of medicines and medical devices regulation (the MMD review) recommended many measures which, if implemented, could substantially improve the situation. These included a limited list of “permitted indications”, sponsors to publish evidence supporting the claims made, a disclaimer on product labels and promotion that efficacy claims have not been independently assessed, and providing a new pathway for the industry, whereby higher-level claims could be made if the TGA found the evidence acceptable.

In addition, increased and better targeted post-marketing surveillance was recommended, coupled with a better resourced and more effective complaint system. If this package was accepted, it was recommended that pre-approval of advertisements (currently limited to specified media) could be dropped in accord with the government’s desire to reduce red tape.

In December 2015, the Department of Health held limited “stakeholder forums” about these recommendations. A subsequent report noted “divergent views”, especially about the proposal to abandon pre-approval of advertisements. The TGA then advised the government about these recommendations, but refused to make their advice public. The government’s response, in September 2016, watered down (or refused to accept) several important recommendations. For example, the need for the industry to publish evidence supporting their claims was made optional and the disclaimer was rejected.

The Therapeutic Goods Advertising Code Council (TGACC) has the responsibility of advising the government about updating the Code. Since 2007, many suggestions by the TGACC had not been implemented because of ongoing reviews. The MMD review provided an opportunity for such matters to be raised again by the TGACC.

In September 2016, this resulted in an attempt by Complementary Medicines Australia (CMA) to abort discussion of these matters by the TGACC. They also submitted a complaint aimed at removing me from both the TGACC and the TGACRP, where I represent Choice (the Australian Consumers’ Association).

In October 2016, the TGA organised the first of several “targeted stakeholder forums” on complementary medicine reforms. The TGA “forgot” to invite a representative from either Choice or Friends of Science in Medicine (both of whom had been invited to the 2015 forums). After last-minute representations, I finally received an invitation to represent both these organisations

At this latest forum, there were 14 people representing the complementary medicines sector, including the President, Vice-President and Regulatory Affairs Manager of the CMA, nine staff from the TGA and two people representing civil society interests (Consumers Health Forum of Australia, Choice and Friends of Science in Medicine).

The Chair noted that the task was to determine how the Government’s response to MMD recommendations might be implemented; not debate the Government’s decisions. The discussion was deemed confidential to facilitate frank debate. The TGA has a timetable to publish public consultation papers on these matters to which people can subscribe. The TGA has also scheduled more targeted stakeholder consultations followed by broader public consultations in the new year.

The TGA was invited to talk about these matters at the Australian Skeptics National Convention from 25-27 November. Regrettably, despite stating that they wished to engage more with consumers, no TGA staff were available to accept this invitation.

My own view is that it is crucial to open the debate about the government’s response to the MMD recommendations beyond Complementary Medicines –TGA hegemony and obtain greater input from civil society. For example, the current TGA proposed list of “restricted indications” contains many problematic entries, while only two industry bodies are in favour of abandoning pre-approval of advertising; most other stakeholders believe it should be extended and made more effective.

It will be important to take the views of the TGACC, TGACRP and others into account in devising a new complaint and monitoring system. Whether the TGA’s proposed public consultations will allow this broader debate remains to be seen.

In conclusion, if the TGA (and the government) is to regain the trust of the community with respect to the regulation of complementary medicines, then a more open debate about reform options is required. The aim is to achieve a regulatory system that minimises unethical and misleading claims, encourages research and enhances Australia’s reputation as a source of high quality, evidence-based products.

Dr Ken Harvey is Adjunct Associate Professor in the School of Public Health at Monash University. He represents Choice on the TGACRP, the TGACC and the current TGA stakeholder consultations.


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9 thoughts on “Open debate needed for TGA to regain trust

  1. Anonymous says:

    Thanks Ken. Many people appreciate your leadership here which is in the public interest.

  2. Ken Harvey says:

    I’m unsure of the relevance of the comment about Copernicus and Galileo but I do support tough penalties for companies that repeatedly (and knowingly) breach the Therapeutic Goods Advertising Code. At long last, a number of such penalties have been put up as options in the latest TGA consultation paper. I encourage MJA Insight readers to respond to these suggestions.

  3. Anonymous says:

    A hypothetical question for Mr Harvey – if you had a time machine and went back in time to Renaissance Italy, would you campaign for Copernicus and Galileo to be executed?

  4. Anonymous says:

    Thanks for the article Ken and thanks for your efforts to protect consumers. Industry tactics for delaying meaningful reform is common across the board. From the ten year delays with traffic light labelling on packaged food to CAM advertising claims to failures in medical device and pharmaceutical industry regulation to delaying progress in environmental sustainability and scraping the carbon tax. The government is merely industry’s puppy fetching the ball, rolling over and playing dead…

  5. Anonymous says:

    A sorry story indeed. I agree that the term/name “complementary medicine” should be banned.

  6. John Buchanan says:

    The amount of money spent by an unsuspecting public who buy so-called complementary medicines from pharmacies, is a national disgrace. The TGA had an obligation to the public, and to the common good of the community, to tighten up the approval process. Where is the evidence of effectiveness of these products? The manufacturers must be forced to provide evidence or not get approval. John Buchanan


    KEN HARVEY is a national hero.
    THE TGA has been a complete joke whose sole purpose is to extort money in order to rubber stamp “therapeutic goods” so deemed by their manufacturers.
    … and of course this requires several overseas trips to see how it is done in Paris and New York.

  8. Oliver Frank says:

    Ken, Thanks for this very useful report of the history of the failure to regulate adequately medicines and other therapeutic goods that have in adequate evidence of their benefits and harms. It is a very sorry story indeed. The sooner we can have the expression ‘complementary medicines’ and any categorisation of medicines as such banned, the better.

  9. Dr David De Leacy says:

    What an absolute joke Ken.
    Where were the “ethical” pharmacists and perhaps a distant past ex-AMA president justifying themselves in these discussions? Clearly both the TGA & Ms Ley are both strongly in favour of dog eat dog free enterprise/capitalism in this area and strongly subscribe to Mr Barnham’s dictums that ”you can never go broke underestimating the taste or intelligence of your audience” and you must ”never give a mug an even break”.
    Pardon me for subscribing to conspiracy theories but do I smell behind the scenes channelled money from big Vitamin or perhaps the garnering “green” votes here?

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