ABC RN Roundtable: New regulatory framework for complementary medicines called into question


Presented by Hugh Riminton
Producer Skye Docherty


Broadcast Sunday 18 February, 2018. Listen or download here.

Hugh interviewed:

  • Adjunct Professor John Skerritt, Deputy Secretary for the Federal Department of Health in charge of medicines’ regulation
  • Dr Cameron Loy is the Chair of the Royal Australian College of General Practitioners in Victoria.
  • Dr Vicki Kotsirilos AM is a general practitioner who uses therapies such as acupuncture, nutritional and herbal medicine; also associate professor at Western Sydney University

Professor John Skerritt’s statements and my comment follow:

  1. ‘So, if you list a medicine in Australia you actually have to have evidence that the product works. And what we do is call in the evidence, so, let’s say there is a group of products making claims about weight loss, we call in that group, we assess the evidence, and if the evidence isn’t held, the product gets cancelled’.

This conveniently ignores the fact that TGA post-marketing surveillance, over many years, shows that non-compliance of Listed products with regulatory requirements runs consistently around 80% of products sampled; lack of evidence is the most frequent violation. The Complaint Resolution Panel reports similar findings for upheld complaints.

In addition, despite long-standing concerns about claims for weight loss products that lack evidence[1] the TGA has never called in the evidence for that group of products and on the rare occasion they have cancelled a weight loss product it has immediately been re-listed with a ‘traditional’ indication.[2]

  1. ‘There’s a small group, and we think in the marketplace it might be 5%, of medicines, that are allowed to be on the register but with a statement on the label, and a statement in the register, that they are based on traditional use’.

This ignores the fact that of 1019 final permitted indications (submitted by industry and endorsed by the TGA) only 14% the require the manufacturer to have scientific evidence to back them up. For the rest, evidence of “traditional” use can suffice; that is, use for more than 75 years in an alternative medical tradition, such as traditional Chinese medicine, Ayurveda, Unani, Western herbalism or Homoeopathy.

We anticipate this decision will result in a flood of ‘traditional’ products that will confuse, mislead and waste consumers money. Meanwhile, too many consumers are forgoing evidenced-based prescription medicines because they cannot afford increasing PBS co-payments.[3]

  1. ‘Most of those [traditional] products are actually provided through a relevant traditional medicine practitioner’ … ‘and generally, the traditional Chinese medicines are not advertised to the wider products [public?] so it will be the science-based claims that are on that list’.

I’m unaware of what data Professor Skerritt bases this statement on. Traditional medicines are increasingly being promoted to Australian consumers and their advertisements are being complained about (see examples). As noted above, the TGA decision to allow 86% of 1019 permitted indications to be based on traditional claims will accelerate this trend. Why else would industry have provided such a large list of traditional indications?

  1. ‘AHPRA regulate[s] Traditional Chinese Medicine practitioners’.

TCM practitioners were registered because of safety concerns, not because there was evidence their treatment modalities such as Chinese herbal medicine and acupuncture was clinically effective.[4]  In addition, there are increasing complaints about the advertising of these practitioners.[5]

More importantly, other traditional practitioners such as Ayurveda, Western herbalists, Homeopaths are not registered by AHPRA, yet the TGA has listed products citing these traditions that are increasingly being promoted to the public.

Australia is a multicultural and pluralistic society and it’s appropriate that we respect, understand and allow access to traditional, alternative and complementary medical traditions and products.However, it’s also important that we restrain purveyors of these medicines from taking advantage of consumer ignorance and that we protect consumers from misleading and deceptive claims about the products provided.

At a time when Australia’s health budget is severely stressed and Australians struggle to afford medical benefit cover and, quite often, proper medical treatment, it seems  highly questionable for a government to be knowingly supporting alternative health treatments that consistently fail to show any evidence of effectiveness and many of which the government’s own NHMRC has condemned in those terms.

The WHO Traditional Medicine Strategy 2014-2023 identified the following challenges for Member States: Development and enforcement of policy and regulations, Ability to control and regulate advertising and claims, and Ensure consumers can make informed choices.

This is why many civil society groups have demanded that these medicines be accompanied by an appropriate advisory statement to enable consumers not familiar with the ‘tradition’ to understand the often creative promotional claims involved.

  1. ‘All complementary medicines, including those based on traditional indications… have ingredients where there is evidence of safety, positive evidence of safety…. what we can do as a regulator is make sure that the products are safe’.

The Therapeutic Goods Advertising Code 2015, s4(2)(i) states that advertisements must not claim that goods are completely safe, harmless, or free of side-effects. Yet Professor Skerritt states the TGA makes sure these products are safe.The reality is that the TGA’s ‘Catalogue of permitted ingredients for use in listed medicines’ includes substances that are regarded as ‘relatively safe’.[6] For example, Black cohosh (Cimicifuga racemosa) has sometimes been associated with liver failure[7] while allergic reactions to Echinacea have included anaphylaxis (the most severe type of allergic reaction), acute asthma attacks, severe urticaria (hives) and swelling.[8]

  1. ‘People are taking these things [vitamins and minerals] to supplement dietary deficiencies’.

Professor Skerritt should have pointed out that vitamin and mineral supplementation is not a substitute for a healthy diet. Indeed, some trials suggest that micronutrient supplementation in amounts that exceed the recommended dietary allowance (RDA) e.g. high doses of beta carotene, folic acid, vitamin E, or selenium—may have harmful effects, including increased mortality, cancer, and haemorrhagic stroke.’[9]

  1. ‘Within defined periods, and for the most serious ones a matter of days, where advertisements will be able to be pulled; there will be penalty notices, a bit like a speeding fine, but with a higher cost to the advertiser, or the ability to seek a court injunction’.

These timelines appear improbable.[10] Even if a penalty notice is issued quickly, the recipient has the right to dispute the notice in Court. If fast-track legal proceedings are contemplated, the TGA must, as a matter of the government’s own Model Litigant Policy, provide adequate opportunities for sponsors to consider claims against them and respond. Average case completion times for the ACCC are closer to a year than a few weeks. The Administrative Appeals Tribunal and the Australian court system will not tolerate lack of due process.











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Letter in ‘The Australian’ 16/02/2018 – A triple cash burner

The revision of surgical procedures deemed “unnecessary, wasteful and risky” (“Health waste: spinal fusion added to list”, 14/2) is good news for the troubled health budget, but you must ask why this approach is so lamentably piecemeal, especially at the hands of those entrusted with protecting the health of Australians.

The Therapeutic Goods Administration, the chief body that vets medicines and medical devices for the nation, has just approved a vast array of patently absurd so-called alternative treatments — under the poor excuse of their being “traditional medicines” — that can be freely advertised and offered with no evidence at all required to show they are effective and plenty to show they are not.

The TGA is allowing a variety of “medicines”, for each of which is a nonsensical claim, such as it “softens hardness”, “tonifies kidney essence”, can “open body orifices”, “replenish the gate of vitality”, “moistens dryness in the triple burner” and more. Yet, many consumers are forgoing evidenced-based prescription medicines because they have wasted their money on this heavily promoted rubbish and can no longer afford PBS co-payments.

It’s no wonder that the nation’s health bill is billions of dollars and growing apace without a comparable improvement in health outcomes. Given TGA regulatory craziness, the odd spinal fusion or two hardly rates a mention.

Professors John Dwyer, Hubertus Jersmann, Marcel Costa, Associate Professor Ken Harvey, Friends of Science in Medicine, Adelaide, SA

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Therapeutic Goods Amendment Bill 2017 passed by Senate

This Bill was passed this morning (15/02/2018) by the Senate with the Labor supporting a Government amendment to continue advertising pre-approval (in mainstream media) for 2 years with a review after 18 months.

The Government and Labor did not support Senator Di Natale’s amendment:

All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective’.

The main speakers:

Extracts from Hansard follow:

Senator DI NATALE (VictoriaLeader of the Australian Greens) (10:43): by leave—I move Greens amendments (1) and (3) to (6) on sheet 8353.

These amendments relate to the pre-approval process, which is an important safeguard for consumers. We think it’s critical that it remain. The government, which initially had indicated it was going to abolish the pre-approval process altogether, has decided, after some pressure from the Greens, to amend its own legislation, which was going to be passed as non-controversial legislation. We are pleased there has been a concession. We think it’s an important concession, but we think the government needs to go further, and that’s why we’re moving these amendments.

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:44): Thank you for your words. The government has listened to concerns raised and has agreed to move our own amendment, with respect to the pre-approval processes, to keep the current conditions in place for two years and then to run an evaluation of the whole new advertising framework in 18 months. I’m looking forward to moving those amendments, hopefully with the Greens’ support.

Senator POLLEY (Tasmania) (10:45): Labor are satisfied that the amendment we have negotiated with the government addresses our primary concern. We will not be supporting any further amendments, because we want to facilitate a speedy passage of the legislation so that the measures relating to the provisional approval pathway can commence as soon as possible. The negotiations that have taken place and the fact that the government have sought to amend their own legislation are evidence to us that, at this point in time, we will support this legislation, and it should be passed as soon as possible.

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:45): Just for clarity around that: given that we have been able to reach the middle ground with respect to review and the pre-approval processes, we won’t be supporting the Greens amendments at this stage, because it would actually delay any action for at least four more years.

Question negatived.

Senator DI NATALE (VictoriaLeader of the Australian Greens) (10:46): by leave—I move amendment (2) on sheet 8353.

(2) Schedule 2, item 15, page 19 (after line 24), after subsection 26BF(5), insert:

(6) All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective.

It is really important to note that the Sansom review suggested a range of changes. They suggested a change that meant that sponsors of products couldn’t list the indications for that product as free text—in other words, they couldn’t decide what they wanted to say about a particular product; there had to be a list of pre-approved options. We’ve got some concern that that list seems to be growing, but ultimately we do support the recommendation from the Sansom review which said that there have to be a range of pre-approved indications and that sponsors need to indicate that they’re going to choose one of those pre-approved indications rather than simply stating in their own words what they believe a product might do, which on a number of occasions has been found to be misleading.

But the second thing the Sansom review also recommended was that there needed to be a disclaimer put alongside these indications—in other words, basically a statement on all products sold so that, while a particular indication, say for a traditional medicine, has been listed, it’s followed up with a statement in the same space, using the same font, which basically says, ‘Look, this is what the traditional indication for this medicine is, but it has not been scientifically tested.’ That is very important because having an indication like that might give a consumer some confidence that, given that this product has been approved by the TGA, there’s been some scientific testing to validate that indication, when in fact that’s not the case. So the Sansom review said: ‘Get rid of this free text. Don’t allow sponsors of products to say what they want about a particular drug. That can be misleading and give the false impression to an individual that a product has a scientific basis behind it, so you’re going to have to basically tick a list of pre-approved indications, but you also need to make sure that you make it very clear to the individual purchasing the product that it hasn’t been scientifically tested.’

That was what the review recommended, and we support that. That recommendation was also supported by a number of other health bodies and consumer groups—for example, CHOICE, the Consumers Health Forum and the Friends of Science in Medicine. They all raised concerns in their submissions. We’re simply saying that, if you’re purchasing a product, you should have all the information available. You shouldn’t be misled about the particular scientific evidence behind a product, which I think is really important protection for people who spend often a lot of money on this stuff in the belief, sometimes mistaken, that there is a valid, scientifically tested indication for that product. So we’d like to see that statement included, and that’s effectively what this amendment does.

Senator McKENZIE (Victoria—Minister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:50): Thank you, Senator Di Natale.

Obviously, the government similarly wants to ensure that when Australians are purchasing products they have the required information to make informed choices. We agree with the Sansom review to that extent. We also recognise, again, that we have a $4 billion export industry in this type of product and we walk that line between recognising traditional medicine and ensuring that Australians’ safety is not compromised. We have to recognise that all of these products, all the ingredients in these products, have been approved for consumption, so there is not a safety risk per se.

But we have to get the balance right and recognise that for some, particularly those using Chinese medicine, the history of practising in that traditional medicine paradigm goes back thousands of years. It’s been extensively refined, practised and documented and in many cases incorporated into mainstream medicine. So, a statement required by the Australian government that the indication is not in accordance with modern medical knowledge and that there is no scientific evidence will be seen as arrogant and insensitive to those practising and using traditional Chinese medicines.

The government will not be supporting this amendment by the Australian Greens.

Overseas experience shows that the suggestions of the Australian Greens will actually be ineffective in practice. The evidence from the United States, where the US Food and Drug Administration has mandated such disclaimers, is that these disclaimers are ineffective in assisting consumers to make more informed choices when self-selecting medicines. So those who want to purchase a certain product, irrespective of the disclaimer made, will still choose to purchase such a product. It won’t change behaviour. Many stakeholders did not support this proposal. We consulted extensively on the bill itself and the stakeholders did not support it.

The reforms will introduce measures to improve transparency for consumers, including a new mandatory requirement for listed medicine products to identify their evidence base for efficacy. For example, they’ll be required to say, ‘traditionally used in Western herbal medicine’ or ‘traditionally used in Chinese medicine’. That will be required to be put on the product.

As I’ve stated earlier, I think it is offensive and disrespectful to those who practice traditional medicine. It’s not consistent with the World Health Organization. We, as a country, have endorsed the World Health Organization position on the role of complementary medicines in the national medicines framework, and this position acknowledges that traditional medicines do have a valid function in modern medicinal frameworks.

Traditional Chinese medicine practitioners are recognised under the national law governing medical practitioners administered by the Commonwealth and AHPRA. It follows a detailed review by government of which modalities are evidence-based and, therefore, have credibility. We have done a lot of thinking around this and we think we’ve hit the mark on the types of labels, disclosure and information that will be available to Australian consumers. We’ve committed to increased compliance activity for listed medicines. I know that Senator Di Natale in his comments made reference to past incidents of concern. We’ve actually strengthened compliance around that to ensure the health and safety of all Australians as much as possible. So the government will not be supporting the amendment.

Senator POLLEY (Tasmania) (10:56): As I outlined previously, in the debate on the first amendments, it has been Labor’s position that, first and foremost, there is always going to be concern for the consumer. We want the best health outcomes. We have negotiated with the government on this piece of legislation and we’re satisfied that this legislation is a good first step. This is a good framework that we, at this point in time, can work with. I do note the concerns that were raised by the Greens, but I acknowledge, too, the government’s responses to those amendments, and I don’t intend to take up the time of the Senate to reiterate those responses.

The TEMPORARY CHAIR ( Senator Williams ): The question is that Greens amendment (2) on sheet 8353 be agreed to.

Question negatived.

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (10:54): I move government amendment (1) on sheet JC487:

(1) Clause 2, page 2 (table item 6), omit the item, substitute:

6. Schedule 6, 1 July 2020. 1 July 2020

Part 2

As I said earlier, this amendment was reached, noting the concerns of the Australian Greens and in consultation and negotiation with the Australian Labor Party. We thank them for their approach and for being so proactive in finding a middle ground where we will be reviewing after 18 months and continuing the existing pre-approval process for two years.

Senator POLLEY (Tasmania) (10:57): As outlined during my speech in the second reading debate on this legislation, Labor had concerns about scrapping the pre-approvals and we intended to move our own amendment. Having extracted a key concession from the government that the pre-approvals will remain until 1 July 2020 and that there will be a review in 18 months—and I think that’s the important element that the minister has just touched on—the legislation is acceptable to Labor. We shall be supporting this amendment and, in fact, we will be supporting the bill.

The TEMPORARY CHAIR: The question is that amendment (1) on sheet JC487 moved by Minister McKenzie be agreed to.

Question agreed to.

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, as amended, agreed to; Therapeutic Goods (Charges) Amendment Bill 2017 agreed to.

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 reported with amendments; Therapeutic Goods (Charges) Amendment Bill 2017 reported without amendments; report adopted.

Third Reading

Senator McKENZIE (VictoriaMinister for Rural Health, Minister for Sport, Minister for Regional Communications and Deputy Leader of The Nationals) (11:00): I move:

That these bills be now read a third time.

Question agreed to.

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Complementary medicines: The Peoples Choice?

An article in AJP asks, ‘Are complementary medicines conventional medicine’s inferior cousin or a key player in health?

The arguments put forward in this article in favor of complementary medicines are:

  1. They are frequently purchased by consumers (which fails to mention the impact of the enormous amount of money spend on their promotion which make extravagant claims that often bear no relation to evidence supporting their use).
  2. They contribute to consumer health through primary and secondary prevention of illness (which fails to acknowledge the lack of evidence to support this assertion).

Both these strategies are highlighted  in a complaint for Swisse Ultiboost Lung Health Support.

Finally, Friend of Science in Medicine (FSM) pharmacist, Ian Carr has written a nice article in response, ‘Supplements exploit consumer ignorance‘.

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More Publicity on the Therapeutic Goods Amendment Bill 2017

‘Softens hardness’: TGA under fire for health claim list that critics say endorses pseudoscience

New list of permitted advertising lines for complementary medicine products does little to protect consumers

‘The Project’ (09/02/2018)  also had a hilarious segment on TGA traditional indication craziness.

For background see: Government machinations: Therapeutic Goods Amendment Bill 2017

Next steps:

The Bill was on the Senate notice paper for Monday, Feb 12, 2018, with the government aiming to get it passed. However, to-date, it keeps on being bumped down the agenda by other items.

In the Senate second reading of the Bill (Transcript 036V1400):

Senator POLLEY (Labor Tasmania) said: Many stakeholders made submissions to the inquiry suggesting that there should be a disclaimer in relation to indications based on traditional evidence, stating that there is no scientific evidence of efficiency.

Senator DI NATALE (Victoria—Leader of the Australian Greens) said: The Sansom review said there should be a disclaimer that says explicitly: this doesn’t mean that these claims have been assessed or verified by the TGA or that they’re supported by the TGA. That was the view of a number of stakeholders—for example, the Consumers Health Forum of Australia They said: ‘Our concern is that the limitations of this list of permitted indications may not be understood by many consumers and it may give them some misplaced confidence in the evidence behind the list’. We also heard a similar sentiment from the Royal Australian College of General Practitioners, which is obviously the group that represents GPs here in Australia. It said: ‘We strongly recommend that the TGA mandates that manufacturers must include a statement to accompany all non-scientific therapeutic claims, in close proximity and in the same font as the health claim. can indicate that the Greens will be moving an amendment in my name that would see the requirement for the disclaimer, as was recommended by Professor Lloyd Sansom in his review’.

Senator BROCKMAN (Liberal, Western Australia) said: There is evidence from the United States that a strong disclaimer has no real impact. In that context it is something, I think, that should be looked at further in the future, but the government, at this stage, does not support it. In that context it is something, I think, that should be looked at further in the future, but the government, at this stage, does not support it.

There is dispute about the educational value of such advisories which I addressed in my supplementary Senate submission 2.2.  There is a need for appropriate independent research, in association with consumer organisations, into the best way of helping consumers make an informed choice about traditional and complementary medicines. NPS MedicineWise might be an appropriate partner in this endeavour. Until this has been conducted the illogical, inconsistent and ineffective measures suggested by the TGA should be put on hold (‘Seek advice from a registered Chinese medicine practitioner or Ayurvedic medicine practitioner to ensure this medicine is right for you’).

Australia is a multicultural and pluralistic society and it’s appropriate that we respect, understand and allow access to traditional, alternative and complementary medical traditions and products. However, it’s also important that we restrain purveyors of these medicines from taking advantage of consumer ignorance and that we protect consumers from misleading and deceptive claims (see attached). Hence the need for an advisory.

Finally, the permitted indications mentioned in Schedule 2, 26BF of the Bill must be activated by regulation. As with Regulations generally, the Legislative Instruments Act, requires registration of the permitted indications list before it comes into effect. It must be tabled in each house of Parliament within six days and members of parliament are able to move that the regulation be disallowed. This will allow another opportunity to get up the needed disclaimer.

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Government machinations: Therapeutic Goods Amendment Bill 2017

I have reported previously on the Senate inquiry on this Bill and the public forum held to discuss civil society concerns (which TGA staff were instructed not to attend).

The report of the Government controlled Senate Committee recommended that the Bill be passed without amendment. The Greens provided a strong dissenting report (Labor a weak one) and Senator Richard Di Natale proposed amendments to the Bill that addressed several of the issues of concern.

The weekend before the Bill was to be debated in the Senate, a letter from Health Minister Hunt to the Labor Party was circulated for comment. It proposed several non-statutory concessions. These included improved stakeholder engagement via a new Therapeutic Goods Advertising Committee to oversee the TGA’s new complaint system, transparent (albeit unrealistic) performance indicators, and an independent review of the new advertising measures within 2 years of implementation.

After a rushed and imperfect consultation with civil society colleagues on Saturday afternoon and Sunday morning (not all were contactable) a response was sent to the Labor Party.

On the morning of the Senate debate, the government proposed a further concession for Labor to support the Bill; extending the current pre-approval system for 2 years, with a review after 18 months. Labor agreed, the Greens amendments were ignored, and the Government amended Bill is now set to be passed.

Concerns about the improbable timeline for introducing the new advertising system and unrealistic performance indicators were ignored. For example, the centerpiece of the new regulatory system is a new Therapeutic Goods Advertising Code. The current Code is badly out of date and was not intended to be used as a black letter enforceable document. However, the TGA has yet to provide a draft of a new Code for consultation with stakeholders.  Even with modest subsequent amendments, approval, publication and implementation of the Code is unlikely by July 1, 2018.

Minister Hunt’s letter also proposed that critical complaints will be actioned by the TGA within 10 days and high and medium impact cases closed within 20 and 40 days. These timelines appear impossible to meet. Average case completion times for the Australian Competition and Consumer Commission (ACCC) is closer to a year than a few weeks. The Administrative Appeals Tribunal and the Australian court system will not tolerate lack of due process.

The Government also failed to act on concern about the TGA’s endorsement of traditional indications. The Bill allows numerous traditional indications for which no scientific evidence of efficacy need be provided. These include claims that Traditional Chinese Medicine can, ‘Disinhibit Water’, ‘Stimulate stagnant Qi’, and ’Subdue Yang’. Allowing such claims encourages industry to evade the need to have scientific proof that their products work, provides government endorsement of pseudoscience and further encourages consumer spending (now over $4.5 billion each year) on complementary products that are largely unnecessary. At the very least, consumer groups wanted such indications to be accompanied by a disclaimer making it clear that that these products are based on alternative health theories that have been discounted by modern medical science.

The battle now moves to the Code Council where the new Therapeutic Goods Advertising Code is to be drafted. In addition, civil society organisations have indicated they will test and evaluate the new system by submitting a flood of complaints.


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ACCC acts on Jacov Vaisman (AMI) and Peter Foster (SensaSlim)

Former Advanced Medical Institute director declared bankrupt

For background see: AMI begat MWI begat AMHC…

Peter Foster declared bankrupt

For background see: SensaSlim banned after medico’s exposure of bogus scientific claims

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Civil Society Public Forum on Therapeutic Goods Bill: Program, brief report and media coverage

A public forum was held at the Australian National University on 24 January, 2018  to air concerns about the impact on the regulation and advertising of complementary medicines under the Federal Government’s Therapeutic Goods Amendment (2017 Measures No. 1) Bill, The Bill was introduced to Parliament late last year and is currently before the Senate.

After discussion with Adjunct Prof John Skerritt, Deputy Secretary for Health Products Regulation, the Health Department Secretary, Glenys Beauchamp, instructed TGA staff not to attend this public forum.

Department of Health Secretary Glenys Beauchamp

Regardless, the Public Forum had excellent presentations, good questions from a varied audience and an informative panel debate.

One member of the panel, Tony Zappia MP (Shadow Assistant Minister for Medicare and the TGA) said that he valued attending the forum and that he would take the concerns expressed back to his parliamentary colleagues.

The program and a brief report on the proceedings is now available. A talk titled, ‘What claims should be permitted for therapeutic goods?‘ given by my students and me is also available.

Despite submissions being scheduled over the Christmas, New Year holiday period at least 55 submissions were received by the closing date of January 12, 2018. These are available on the Senate Inquiry web site.

In addition the issues raised have received extensive media coverage, for example:

The Senate Inquiry reporting date is  February 2, 2018.

Planning for monitoring the impact of whatever legislation eventuates continues (below):

ANU, Canberra, Monash University & Access 2 Public Hearing / TGA Planning Meeting


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Civil Society Hearing on Therapeutic Goods Amendment Bill, ANU 24 Jan 2017

Hosted by Prof John Braithwaite, School of Regulation and Global Governance (RegNet), Australian National University

The Therapeutics Goods Administration (TGA) has tried to bypass the Senate Committee system on the Therapeutic Goods Amendment (2017 Measures No.1) Bill by arguing that it was non-controversial! Which it certainly is not regarding its provisions for advertising and complementary medicine regulation! Fortunately, Senator Richard Di Natale (Greens) responded to requests to get the Bill reviewed by the Senate Community Affairs Legislation Committee.

In response, submissions were scheduled over the Christmas, New Year holiday period and the public hearing requested was rejected because Senators were on holiday. Regardless, several civil society organisations have joined together to hold a public hearing to debate contentious provisions of the Bill. The venue is the Australian National University, 24 Jan 2018, from 2:00-5:00 pm.

While leading experts in regulation, public health, and civil society are supportive of the positive aspects of the Bill proceeding, they ask that three contentious aspects be excised so that they can receive better consideration.

First, the Bill removes pre-approval of advertisements for therapeutic goods in favour of self-regulation.

Pre-approval is the only defence against seriously misleading advertisements appearing on prime-time television or in national newspapers. The current pre-approval process reviews over 2000 advertisements per year with an average turnaround time of 7 days. Most advertisements require changes, sometimes wholesale revisions.

The complaint system takes a long time to remove bad advertisements. Meanwhile, the damage has been done. Prevention is better than cure. It is also more economically efficient given that fraudulent therapeutic claims create unnecessary health expenditure and diverts scarce health resources from remedies that work, to ones that don’t.

We want pre-approval of advertisements to continue until the other measures being introduced (increased post-marketing reviews and more stringent penalties for regulatory violations) have shown pre-approval is no longer necessary.

Schedule 6, Part 2 ‘Removal of requirement for advertisements to be approved’ should be excised.

Second, the TGA is taking-over of the advertising complaint system without ensuring ongoing stakeholder input or transparency of complaint outcomes.

Stakeholder involvement is currently provided by the independent Complaint Resolution Panel and Code Council which are to be abolished from July 1, 2018. That’s happening even though the TGA has a track record of making bad decisions in isolation and an unenviable reputation as a ‘blackhole’ with respect to advertising complaints.

In addition, loop-holes in the complaint system such as those at the food-medicine interface need to be addressed by broadening the scope of the Therapeutic Goods Advertising Code and Complaint System to cover all therapeutic claims, regardless of whether they refer to a medicine, food or medical device.

Schedule 6, Part 1, Advertising system should be excised.

Third, the Bill will authorise an industry submitted list of ‘permissible indications’ for complementary medicines.

The TGA recently circulated a final list of 1019 such indications. It contains 140 indications which must be supported by scientific evidence and 879 indications that can be supported by a tradition of use, such as Traditional Chinese Medicine (TCM), Ayurveda, Homeopathy, etc. Examples of traditional indications include, ‘Balance Yin and Yang’, “Upraise/lift sunken middle Qi’, ‘Pacifies Kapha’, ‘Increases Pitta’ and ‘Replenish Essence’.

The TGA have ignored submissions that pointed out that including numerous traditional indications encourages industry to evade the requirement to have scientific proof of efficacy for their products, endorses pseudoscience and will confuse the average consumer as the terms used will not be understood.

The TGA have ignored requests that claims based on ‘traditional use’ should always have an advisory along the lines of what the US Federal Trade Commission uses for homeopathic products, ‘This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works’.

Schedule 2, Part 1, 26BF, ‘Permissible indications’ should be excised.

More information is now available at the ANU RegNet site. 

Further information is available from: Assoc Prof Ken Harvey, Monash University (0419181910), Katinka Day, Choice (02 9577 3307), Allan Asher, Access2, (0408375642) and Prof John Braithwaite, Australian National University (0437788006)


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Monash School of Public Health & Preventive Medicine Students: A Tribute

An end of year tribute to the Monash SPHPM students I’ve been engaged with, especially those who worked with me on the Summer Vacation Scholarship Program and those who presented at the Victorian Skeptics meeting on 18 December, 2017.

2017 Summer Vacation Students

Victorian Skeptics Presentation Students 18 December 2017 



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