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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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Medicine policy, Natural Therapies, Pharmaceutical Promotion, Senate and tagged , , , , , , , . Bookmark the permalink.

One Response to Therapeutic Goods Amendment Bill 2017 passed by Senate

  1. Gary Allan says:

    Based on this, I know nothing it seems of human physiology … triple burner, gate of vitality … I need a new textbook, perhaps the Kama Sutra.

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