Thursday, 15 February 2018
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, Therapeutic Goods (Charges) Amendment Bill 2017; In Committee
by leave—I move amendments (1) and (2) on sheet 8358:
(1) Clause 2, page 2 (at the end of the table), add:
10. Schedule 10 The day after this Act receives the Royal Assent.
(2) Page 195 (after line 3), at the end of the Bill, insert:
Schedule 10—E-cigarettes Therapeutic Goods Act 1989
1 After section 52E Insert:
52EAAA Certain tobacco products to be treated in the same way
(1) The Secretary must ensure that the current Poisons Standard applies in relation to:
(a) nicotine in electronic nicotine delivery systems in concentrations no greater than 20 mg/mL; and
(b) nicotine in tobacco prepared and packed for heating;
in the same way as it applies in relation to nicotine in tobacco prepared and packed for smoking.
Example: If nicotine in tobacco prepared and packed for smoking is not included in Schedule 7 of the current Poisons Standard, the Secretary must ensure that Schedule 7 does not include nicotine in electronic nicotine delivery systems in concentrations no greater than 20 mg/mL or nicotine in tobacco prepared and packed for heating.
(2) For the purposes of subsection (1), an electronic nicotine delivery system is a product that can be used for the production and consumption of nicotine-containing vapour, or a component of such a product (including a liquid, cartridge or tank).
(3) Subsection (1) applies on and after the day that is 12 months after the commencement of this section.
(4) Subsection (1) applies despite anything in section 52E.
These amendments represent a first step towards removing the ban on e-cigarettes. Currently the Commonwealth's Poisons Standard has nicotine classified as schedule 7, which is for dangerous poisons. There are exemptions provided for a handful of products, including products packed and prepared for smoking, such as cigarettes, and nicotine-containing products for quitting smoking, such as gums and patches. The states and territories rely on the Commonwealth Poisons Standard when determining what can and cannot be sold. So, because the Commonwealth Poisons Standard provides an exemption for cigarettes but not e-cigarettes, the states and territories allow the sale of cigarettes but not the sale of e-cigarettes.
This makes no sense at all. There is no evidence that e-cigarettes are remotely as harmful as cigarettes. In fact, a report commissioned by Public Health England concluded that e-cigarettes are 95 per cent less harmful. And there's no evidence that e-cigarettes could lead to more people taking up cigarette smoking compared with the number of people who could use e-cigarettes to quit cigarette smoking. What evidence there is suggests that e-cigarettes would reduce the overall level of cigarette smoking.
What it comes down to is this: Australia bans e-cigarettes because our public health officials have a chip on their shoulder. They're happy for people to use patches and gums instead of cigarettes, but they don't like e-cigarettes, presumably because vaping looks something like smoking and because the tobacco companies, which they hate, will want a piece of the e-cigarette market—and I suspect also because they worry that people might actually enjoy using e-cigarettes. Either our public health officials need to get over their hang-ups or our government needs to stop taking their word as gospel. Comparable countries around the world, including the UK, the EU, the US and soon Canada and New Zealand, have allowed the sale of e-cigarettes. And right now Australians are free to purchase e-cigarettes as long as they import them from a business overseas. They can't buy them in Australia from an Australian business. This is reverse protectionism. It hurts Australian businesses, it misses opportunities to gather tax revenue and it prevents our regulators from regulating the sale of e-cigarettes for the good of consumers. Any notion that we can maintain this virtual prohibition policy once e-cigarettes become available in New Zealand is delusional.
My amendment would change the Commonwealth's Poisons Standard so that e-cigarettes would be classified the same as cigarettes. Whilst cigarettes remain exempted from the schedule 7 dangerous poisons classification, e-cigarettes would be exempted too. My amendments wouldn't commence for 12 months, which would give the Commonwealth an opportunity to make any regulations for e-cigarettes within its area of responsibility and to start discussions with states and territories on the treatment of e-cigarettes in their laws. It's modest, it's a sensible and practical amendment and I commend it to the Senate.
Thank you, Senator Leyonhjelm. I appreciate your raising UK Public Health's new evidence with respect to the regulation and efficacy of e-cigarettes. And I do suggest that those proponents of e-cigarettes follow the usual process rather than using this amendment. There are problems at law with the amendment itself that I'm happy to go through with you. But I'm sure you are well versed in the government's perspective on that, given that this is an amendment that you seek to include whenever we're discussing TGA matters. But given the recent evidence from the UK, I would encourage proponents of e-cigarettes to bring that forward to the TGA for consideration in an application in the way the TGA is supposed to work. As you stated in your comments, the evidence base on which the TGA and others have made decisions around e-cigarettes has been lacking. Now, if this is new evidence, the proponents of e-cigarettes should go through the usual process and submit an application to the TGA.
As you note—and I know you don't seek any further Commonwealth overreach into state and territory sovereignty—by using this amendment you are, in effect, actually increasing the Commonwealth's getting into matters that are, rightly, the purview of states and territories. So, the government does not support your amendment.
I too acknowledge the comments from Senator Leyonhjelm, but he would be aware that the rescheduling of nicotine was considered by the TGA and rejected in March 2017. Labor will continue to follow the advice of the independent and expert TGA on this issue. Labor will not be supporting this amendment.
The problem with the TGA is it deals with therapeutic claims. There is no therapeutic claim in relation to cigarettes. An alternative to cigarettes, which is required to substantiate therapeutic claims, is an anomaly. Replacing smoking tobacco, for which there is no therapeutic claim, with something which is less harmful and allows people to quit smoking tobacco, in the face of demands for a therapeutic claim, would be very unusual.
There is also a commercial issue involved in this demand that a therapeutic claim be substantiated. I've heard it quite a number of times before. There is no way that a commercial business would invest in a therapeutic claim, which is very expensive to generate, because it couldn't protect its property in that area. The e-cigarettes market, despite the worst fears of the health department, is not dominated by big tobacco. It is actually a very diverse market globally. There are hundreds of companies involved in it. It is a very competitive market, obviously not in Australia but in most parts of the world. You can find vaping shops all over the place. They sell an enormous range of products. You cannot spend many millions of dollars on substantiating a therapeutic claim and then say, 'Having invested that money, I can now capitalise on that by selling my product.' That is not how it works. You have to have a unique position to justify that sort of expenditure. That's never going to happen in this area. We have to take a different approach.
by leave—I move Greens amendments (1) and (3) to (6) on sheet 8353:
(1) Clause 2, page 2 (table item 6), omit the table item, substitute:
6. Schedule 6, The day 6 months after the day on which the
Part 2 report of the review provided for in item 51A
of Schedule 6 is tabled in the Senate.
(3) Schedule 6, item 38, page 97 (line 12), omit "may", substitute "must".
(4) Schedule 6, item 38, page 100 (line 5), omit "may", substitute "must".
(5) Schedule 6, item 38, page 100 (line 21), omit "may", substitute "must".
(6)Schedule 6, page 105 (after line 5), after item 51, insert:
51A Independent review
(1) The Minister must cause an independent review to be conducted into the operation of the
amendments made by this Part, including, but not limited to, the effectiveness of the Therapeutic Goods Administration in the handling of complaints about therapeutic goods advertisements directed to the public.
(2) The review must be conducted as soon as practicable after the end of 3 years after this item commences.
(3) The persons who conduct the review must give the Minister a written report of the review.
(4) The Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of that House after the report is given to the Minister.
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.
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.
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.
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.
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.
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, because the bill itself introduces a new pathway for products to have evidence assessed and be able to have a positive claim on their label. Hence, consumers will be able to differentiate between ones that have had the evidence assessed and those that have not, and at the end of the day it will be up to the consumer. 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. As noted by the review, there is a divergence of views. I know Senator Di Natale went to some submitters, but, equally, the government has assessed the range of submissions across the review and has come to the view that this amendment, and what it seeks to do, goes too far.
Other mandatory statements will be required if we go down this track. 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. So if you want to purchase something that is for traditional use, and you as a consumer understand what you're looking for and why you need it, that will be clear to you. But if you are seeking a different type of product as you shop around for your medicines and health products then you won't be selecting that type of product, or you'll be forced to actually think about whether that's the product you indeed want.
There will be a significant impact on our industry. As I've stated earlier, I think it is offensive and disrespectful to those who practise 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. It's great to recognise diversity, to talk about multiculturalism and to recognise traditional owners, but you also need to understand that cohorts within Australian society have been practising traditional medicines and forms of healing for centuries—for millennia. What we have sought to do is recognise that but also to underpin it with regard to human health and safety, which, obviously, is paramount.
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.
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.
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
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.
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.