Community Affairs Legislation Committee - May 31 2012

Senator Di Natale questions the Therapeutic Goods Administration on a range of issues

Senator DI NATALE: The 2012-13 budget included $1.14 million over four years to strengthen codes of conduct and transparency in industry promotion of therapeutic goods. My understanding is that the TGA blueprint essentially favours continuation of the current model of self-regulation. What is the money for?

Ms Halton: This is not TGA; this is regulatory policy. We will get the relevant officers to the table.

Senator DI NATALE: It is not?

Ms Halton: It is not a TGA issue.

Senator DI NATALE: I am sorry; I am confused. Why wouldn't it fall under TGA?

Ms Halton: It is one of the programs in the department, so we just have to get the relevant officers to the table.

CHAIR: Just for our reference, where would it normally go?

Senator DI NATALE: In the interests of time, do you want me to move on? I know that I only have 15 minutes.

Ms Halton: It is under program 1.4.

Senator FIERRAVANTI-WELLS: Can I just suggest something, Ms Halton, that I think might be worthwhile. There was a very useful document produced on cross-portfolio day. It was on A3 paper.

Ms Halton: You want your mud map again, Senator?

Senator FIERRAVANTI-WELLS: No. It is not the mud map; it is the actual individual programs listed under each outcome.

Ms Halton: I call that the mud map.

Senator FIERRAVANTI-WELLS: If you could produce that, it would be really helpful. CHAIR: Senator Di Natale has got limited time. We will do that after his time. Senator Di Natale.

Ms Halton: Yes, we will do that.

Dr Richards: In answer to your question, Senator, the TGA administers the regulatory framework that is currently in place. Any policy work that develops and changes to the regulatory framework are usually managed within the department as a policy issue. TGA is the regulator and the policy is handled within the department.

Senator DI NATALE: What is the $1.4 million for?

Ms McDonald: An industry working group provided a report to government with a number of recommendations in terms of strengthening the self-regulation arrangements under the current codes of conduct. That produced a number of recommendations. In the blueprint that the parliamentary secretary put out there were a number of recommendations that were agreed to a few months ago. Following that, there were a number of recommendations that involved joint work between government and industry. They are the things that were agreed to in the budget context. That would be the department supporting an advisory group—an industry advisory group—looking at having consistent arrangements for codes of conduct and strengthening those in line with the industry working group's recommendations, looking at a review of how the industry is going in terms of strengthening its codes of conduct and aligning those, looking at information technology for the design and development of an information website and a complaints portal that would then be available for complaints and then evaluation of the effectiveness of the program. The idea was to give the industry time to work together and, with government, to strengthen codes of conduct across all of the areas of therapeutics with a view then to the government looking at whether or not stronger co- regulatory arrangements were required in the future.

Mr Butt: You might recall this document being released—the blueprint on TGA reforms. It is the recommendations in there that Ms McDonald is referring to about consistency of therapeutic sector industry codes of practice being facilitated by each therapeutic industry association incorporating in its code the high level principles, operational coverage areas and governance provisions developed by the working group. There is a set of standards that people are trying to achieve. At that time we did not have a budget decision. It was supported, but we did not have a process. We now have that process to put it in place.

Senator DI NATALE: But weren't increased fees for industry also proposed as cost recovery arrangements? Wasn't that also one of the recommendations?

Mr Butt: I am not aware that it was in relation to these particular recommendations. These ones were about government looking at how it would support industry to improve its own regulation.

Senator DI NATALE: Okay. The review of packaging and labelling has been delayed. Do you have any idea when that consultation paper is going to be available?

Dr Richards: The consultation paper is available.

Senator DI NATALE: It is available?

Dr Richards: It is on TGA's website.

Senator DI NATALE: Do you know when that was made available?

Dr Richards: It was made available last Thursday.

Senator DI NATALE: Terrific. I will move on. When are the submissions around the new evidence requirements going to be made available?

Dr Richards: When are the submissions going to be made available?

Senator DI NATALE: Yes, public. I understand that consultations have closed.

Dr Richards: I am advised probably towards the end of June. We have received 49 submissions. Obviously we need to go through those submissions and draw out the issues.

Senator DI NATALE: Is there any sense of where that is heading? Is there support for the new evidence requirements?

Dr Richards: I cannot answer that. I have not yet read the 49 submissions.

Senator DI NATALE: Following on from the new evidence requirements, it seems that, with the draft paper, there really is no plan to provide either incentives or sanctions to ensure compliance. How do you ensure that there is regulatory compliance if there is no incentive for industry to comply, or sanction?

Dr Richards: The discussion paper was aimed at eliciting a conversation, or having a conversation, with a range of stakeholders on the principles and the issues. Discussions around sanctions that might apply are a later stage of that process. First of all, you need to decide what it is that you are going to do before you start seeking—

Senator DI NATALE: Okay. You have got an open mind on that; that is what I take out of that. That is good.

Dr Richards: Yes.

Senator DI NATALE: Has there been any discussion about what form they may take, or is it far too early?

Dr Richards: I have not been involved in any discussions around the form of such sanctions.

Senator DI NATALE: One of the things that was not mentioned in the guidelines—and I wonder whether any thought has been given to it—is the issue of an implied claim in the actual label on the bottle: 'Fat Buster', 'Fat Magnet', 'Undo it as a detox treatment', 'Intense Cleanse' and so on. They all have an implied health claim. Has any thought been given as to whether that is, in fact, appropriate and whether, if they are going to make a claim through the label on the bottle, it needs to be substantiated?

Dr Richards: There is another piece of work that TGA is doing in response to recommendations from the Auditor-General in relation to claims made by complementary medicine sponsors. That work is ongoing around having a drop-down menu of allowed claims rather than allowing them free text to make whatever claims. If the name of the preparation was in some way misleading, I guess that would be a matter that might be taken into account.

Senator DI NATALE: Where is that work being done?

Dr Richards: It is being done currently within TGA but in consultation with the relevant industry.

Senator DI NATALE: Did I hear you say the A-G, for some reason?

Dr Richards: The Auditor-General. The Australian National Audit Office did an audit of complementary medicine compliance and made a number of recommendations which we are implementing over the course of this year.

Senator DI NATALE: You are saying that potentially the names of those preparations are included in the mandate of that? It is one thing to say that a preparation is going to do something; it is another thing to imply it through what you call it.

Ms Hefford: When the ANAO audit was completed, there were five recommendations. The first was the recommendation which goes to the document that you talked about initially, the guidelines on the levels of evidence. Beyond that, there are a series of other recommendations and we are working through those sequentially. A second recommendation is the one that we refer to, and it is in the blueprint, as 'coded indications'. It is where the sponsor of a product wants to claim that there are particular indications, perhaps for healthy bone development or whatever, a claim that they want to make about that particular product. At the moment the system that allows you to list a product on the ARTG has some existing indications that you can use through a list that has been established. We are seeking initially to extend that list quite a lot and then we are seeking to find ways of ensuring that the list of indications that are agreed to be used are based in some way on existing evidence or existing scientific data and, therefore, we will be able to move to deal with the claims that are perhaps misleading or unable to be justified. In some cases, the electronic system that does this, that allows people to list their own products, will also pick the name of the product as part of that assessment process.

Senator DI NATALE: That is good to hear. The other question I have is around comparing like with like. Often with herbal products the processing of the preparation actually changes the profile of the particular compound, and there are obvious examples: St John's wort—different preparations, proven efficacy for mild depression, and yet you cannot compare one bottle with another because they are all different. It is the same with glucosamine, although the evidence around that is a little less clear. Is anything being done about that? It is really important for consumers to know that one bottle of St John's wort is not the same as another bottle of St John's wort. What is being done around that area? I am getting some blank looks. Do you follow what I am saying? Is the question clear?

Dr Kelly: The product label has to include not just the name of the herb but also the plant path and the extraction ratio of the herb. It is intended to be specific enough to allow consumers to choose either plant paths of a given herb or the extraction types.

Senator DI NATALE: Let us take the example of glucosamine. Somebody has OA and their dog is getting it from the vet and someone says, 'You should go and get some glucosamine.' You can get glucosamine chondroitin and glucosamine sulphate—a whole range of preparations. From the point of view of the consumer, is there any way of trying to standardise what is available so that the consumer has information? Some of these preparations have not even been tested, or at least the evidence for efficacy is for one particular compound—and yet we do not have evidence for any of the related compounds. I am just interested to see whether there is some work being done to try to resolve that issue.

Dr Kelly: There are two parts. One is about the evidence—and we have already spoken about what we are doing about levels of evidence and the requirements for evidence for complementary medicines and the ingredients—and the other part is about clear labelling. As I have mentioned, things like glucosamine, for instance, have to be labelled with the exact name of the active ingredient. So if it is glucosamine sulphate, it has to say 'glucosamine sulphate'. If it is glucosamine hydrochloride, it has to say 'glucosamine hydrochloride'. It is then for the consumer to understand the differences.

Senator DI NATALE: It is a pretty big ask for the consumer; it is hard enough for a medico to understand the difference. Is any work being done to perhaps educate the public that this is actually a real issue and that people need to pay close attention to it?

Dr Richards: It is important to understand the TGA's role under the regulatory framework that we operate within. Our role is to regulate for the quality of complementary medicines. A manufacturer cannot, for example, put on 'glucosamine carbonate' if glucosamine carbonate is not on the list of approved indications. They can only select ingredients from a list of approved ingredients and they must also comply with good manufacturing practice. TGA's role is in the regulation of products entering the market—in the same way, with prescription medicines or medical devices, that we cannot dictate the way they ultimately are used on label or off label; but we regulate their entry to the market.

Senator DI NATALE: That is not your role; I understand that. I suppose it is probably a question for somebody else, but I think it is a fair question. One of the statements in the draft document I found a little worrying: 'The availability of evidence that disputes the efficacy of the preparation does not disprove the history of use and the traditional indication remains valid.' Does that statement ring true?

Dr Kelly: It sounds credible to me, if there is a history of use based on traditional evidence. Is that the point that you are making?

Senator DI NATALE: Yes.

Dr Kelly: With a lot of these herbal preparations, their effectiveness and their use is based on traditional use. So we have to take note of the traditional use, if it can be demonstrated.
Senator DI NATALE: I would have thought that the evidence, the science, around proving effectiveness is a lot more important than the history of use. I am just worried. Just because something has been used for a long time for a particular indication does not mean it is actually useful.

Dr Kelly: I think it is saying that it is getting the balance right between those two things.

Senator DI NATALE: I am trying to work out where the balance is.

Dr Richards: Clearly, this is a discussion paper which is intended to elicit responses, so this is an issue on which I would expect to receive submissions. It is quite reasonable for someone with a medical qualification to make such an observation, but many proponents of complementary medicines say that is today's science. We know science constantly changes its answers. This stuff has been used. We can document a traditional use and it has worked and people are using it still because people believe it works. To the degree to which that should be accepted as evidence is what this discussion paper is trying to have a discussion about.

Senator DI NATALE: Well, I am glad that it is a live discussion. Was there any reason that homeopathic preparations were excluded from the Australian Register of Therapeutic Goods? I should explain that am talking about dilutions—the ones that are very dilute.Ms Halton: They are not covered under the framework.

Senator DI NATALE: For what particular reason?

Ms Halton: Because when the policy arrangements were being considered, this was not considered appropriate in terms of the net that was being cast. Certainly, there is nothing from an evidence or other perspective that would suggest that it needed to be caught in this regulatory framework.

Senator DI NATALE: What was the reason? What was the thinking at the time? I am interested to know why it was not considered to be—

Ms Halton: This is going back quite a long time, Senator. This is now from my memory of it, and I was not the secretary of the department when this was being undertaken. My memory is that the NHMRC, when it has looked at this on various occasions, thought there was no evidence for any of it. Given it is not something—

Dr Richards: It is water.

Ms Halton: That is basically the way to put it. It is water with a few potential drops of something in it; it was not therefore considered appropriate to be caught in a regulatory framework.

Senator DI NATALE: There has been an issue around sunscreens and particularly around nanotechnology. I have been given a couple of studies and I want to know whether you have seen them. They are studies around the fact that some nano-ingredients may behave as photocatalysts. There was some media attention around it at the time. Are you aware of the studies I am referring to?

Ms Hefford: Yes.

Senator DI NATALE: Was there a response to those two studies? What is the view of the validity of that evidence?

Dr Richards: The TGA does keep track of the scientific literature and does assess whether or not there is any emerging evidence that should influence the way it does its work. There has been no change to the regulatory framework for sunscreens as a result of that information. So it has not impacted on TGA's approach to regulation.

Senator DI NATALE: The statement came from a fairly credible source, it seemed to me—the head of CSIRO's nanosafety group. The concern was that there might be free radical generation on the skin that could potentially cause damage when nanoparticles get into cells of the body. I understand there is a discussion about whether in fact that happens.

Dr Richards: TGA is not aware of any evidence that nanoparticles from sunscreens do get into living cells, past the dead layer of skin on the surface. There is a lot of hypothesis but very little evidence of any such effect.

CHAIR: Thank you to the officers from the TGA. We will now move on to the officers from FSANZ and also the Office of the Gene Technology Regulator.