Chamber Senate on 5/02/2018 Item BILLS – Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, Therapeutic Goods (Charges) Amendment Bill 2017 – Second Reading Speaker :Di Natale, Sen Richard
Senator DI NATALE (Victoria—Leader of the Australian Greens): I rise to speak to Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. This is the second tranche of legislation arising from the Sansom review, which was an expert review of medicine and medical device regulation. It was a review that was long overdue. The Greens supported the review and we support most of the recommendations that have come from that review. The reason, in fact, we’re standing here today and speaking about the report of the findings of the Senate Community Affairs Legislation Committee is because the Greens moved this bill to an inquiry. It was through that process we learned of the significant concerns of a number of stakeholders. We referred this bill to inquiry because we had a number of concerns about the bill, particularly in relation to schedules 2 and 6.
The TGA plays a very important role in Australia. It ensures that we have a regulatory body that assesses medicines that come into this country and ensures that the claims made about therapeutic products are substantiated and that people get access to therapeutic products in a timely way. It must be said that there are significant elements of this bill that we do support and are keen to see come into effect as soon as possible with regard to the regulation of therapeutic goods in Australia. Part of the reason for this legislation is ensuring that people get timely access to medicines. That’s an important change. Changing the fast-track registration process does mean that we’re going to get effective treatments into the hands of patients sooner than they otherwise would’ve been able to get access to those medications, and some of these medications may indeed save lives. It’s a very important change and one that we welcome. But, as I said earlier, we do have some concerns about this bill. While we support changes to the fast-tracking process and other changes to therapeutic goods registration, there are other changes in this bill that we think have the potential to undermine consumer protections.
Schedule 2 of the bill allows the minister to determine the list of ‘permitted indications’ that can be made for medicines listed on the register of complementary medicines. At the moment, what you have is a process for listing a complementary medicine on the Australian Register of Therapeutic Goods that allows the sponsor of that medicine to include a free-text description of the indications for the products. It basically allows the people who are sponsoring a product to write what they like about the product, to walk that line—and sometimes walk cross that line—between a claim that may have some merit and one that is clearly in the interests of getting the product moving through into consumers’ hands.
The change to determine a list of permitted indications is something that might be supported, provided that it comes with what was also recommended through the Sansom review. As I say, the removal of the free-text option is a good thing. It provides some boundaries around what the sponsors can say about products. The list of permitted indications was originally a very well-defined list, but pressure from industry has meant that we’re going to see a much larger list of permitted indications than we otherwise might have. It’s also going to be within the discretion of the minister. This is a power for the minister via a legislative instrument to establish that list of pre-approved permitted indications. We have to remember that happens without any formal assessment by the TGA. The sponsors will look through a list of permitted indications and choose which one they think is appropriate for their product, but that doesn’t mean that the product has been rigorously assessed by the TGA to determine that those claims can be made.
The Sansom review did recommend this change. They said, ‘Get rid of the free-text option, but you need to replace it with a list of permitted indications.’ But they also did it in combination with a further recommendation that there should be a disclaimer on those medicines so that consumers are aware that they haven’t been tested for efficacy, and that, while this claim might be made by the sponsor, this is not something that has been proven through an assessment by the TGA. That’s very important. A number of stakeholders from a range of sectors raised their concerns about this with the committee, and they made it very clear that it was important that this additional disclaimer be inserted to make sure that the list of permitted indications are seen within their proper context. Just because the TGA have said, ‘This is our list of indications, and we’ve said to you, “You can choose one of these,” it doesn’t mean that we endorse or have assessed your product to ensure that it complies with that indication.’ 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. We all know who the Consumers Health Forum are. They basically advocate for patients to ensure that they have the right information to make the right choices to get access to medicines. 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.
It must be said that the TGA have been generous with their time in providing us with briefings, and we certainly appreciate that, and I understand that the rationale for their not endorsing that recommendation from the Sansom review is that they believe it won’t make a difference. My argument in return would be: if it doesn’t make a difference then there should be no issue in terms of including it.
I think it does behove our regulatory authority to ensure that consumers have all the right information in front of them and aren’t led to believe that a particular claim made by the sponsor of a therapeutic product has somehow been assessed and endorsed by the TGA. As a result of these concerns I 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.
The second issue is the issue of the deregulation of advertising and the removal of preapprovals. Schedule 6, part 2 of this bill removes the current system of preapprovals for advertisements of therapeutic goods. Currently, if you’re a sponsor of a particular medicine and you want to advertise it, you’re submitted to a pre-vetting process. The ad is submitted to a pre-vetting process under a power that’s delegated to the Australian Self Medication Industry and Complementary Medicines Australia. That’s to ensure that it meets approved standards.
A number of people who submitted to the inquiry raised concerns about the removal of this current layer of oversight, which guards against the distribution or broadcast of ads that are in breach and which protects consumers from misinformation about any of the claims made in that ad, including those which might be about the efficacy or indications of the products. The submitters said we shouldn’t remove that level of oversight.
The Australian Self Medication Industry estimated in their submission that 60 to 70 per cent of advertisements submitted to ASMI’s advertising services office for preapproval required some form of amendment. Some 60 to 70 per cent of ads submitted to the Australian Self Medication Industry advertising services office were changed. They needed to be changed. It might have been a minor change or a significant change. Some of the changes were small; some were significant changes to the claims that were made through the ad. That’s a lot of ads, many of which, if they’d not been pre-vetted, would have been broadcast, meaning that consumers would have been exposed to false or misleading claims.
We don’t see why you would seek to change a system that protects consumers. The Australian Greens concur with the concerns raised by many of the stakeholders about this change and that there is little sense in removing this layer of regulatory protection, at least not until we have seen what the replacement regime looks like. The change seeks to implement a range of new sanctions for breaches. We want to make sure that the effectiveness of these new sanctions have been assessed and reviewed through the formal three-year review of the reforms, which the government has already committed to. Therefore, I also want to highlight that the Australian Greens will move a further amendment—that the removal of preapprovals for therapeutic goods advertising be delayed at least until after the three-year review of the reforms to the advertising regime.
Our amendments also legislate for that review to take place and for public reporting of its findings. It’s very important that that occurs. I understand that the government has written to the Labor Party and that there has been some discussion between the government and the Labor Party—both of whom, it must be remembered, were prepared to see this bill go through without any changes and without any amendments. But I’m pleased it appears that the government has written to the Labor Party and made a commitment for a non-mandatory preapprovals service for two years. It’s an improvement, but it’s still not good enough. The commitment won’t, as I understand it, be statutory. It means that the government, of course, won’t be amending the bill to make sure this occurs. If there’s a change to that, I look forward to hearing from the government on that point. I’m surprised that the Labor Party would agree to that and, effectively, roll over on that change, because if they want a guarantee that we don’t remove protections for consumers, then they need to make sure that the change is legislated. That’s why they should be supporting the Greens’ amendment—to ensure, in law, that the preapprovals process remains in place until the review is concluded. I always worry about handshake agreements between governments and oppositions: governments change, prime ministers change, ministers change. It is important that this change should be reflected in law.
I understand that the letter from Minister Hunt to the Labor shadow minister sets out a range of non-statutory commitments. It is a series of commitments which the government has already made through the process of the committee inquiry. Again, I remind you that it was initiated through the Greens, so it is pleasing that we have some change in that area. But I do, again, stress my concern that without the appropriate legislation we cannot guarantee that this change will be binding. I think that the Labor Party was a little hasty in accepting the list, but, again, I hold out some hope that they may support our amendments.
Let me conclude by saying that we are, of course, very supportive of Australians having access to complementary and traditional medicines. We think it’s very important to give people access to both of those things, to ensure that the traditional use of medicines continues and that complementary medicines are made available to people who feel they may be of benefit. But we think it’s very important that consumers are protected from false or misleading claims or ads which can confuse people about the level of evidence supporting these claims and the level of regulatory oversight for these products. Let’s not forget this is very big business. This is a multibillion-dollar industry; there is a lot of pressure that comes to bear on our regulatory authorities to ensure that the pathway is cleared for industry. What that often means is that that comes at the cost of protections for consumers. I hope that the government might see fit to acknowledge that these commonsense amendments by the Greens are worthy of support. And, at the very least, I hope that the Labor Party and the crossbench will join the Greens to uphold consumer protections by supporting the Greens’ amendments.
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