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Thursday, 13 September 2012
Page: 6922


Senator SIEWERT (Western AustraliaAustralian Greens Whip) (15:39): by leave—I move:

That the Senate take note of the documents.

I wish to take note of the two responses that the government has tabled today to the two Senate Community Affairs References Committee reports. I particularly wish to take note of the government's response to the Regulatory standards for the approval of medical devices in Australia report. I will try to remember at the end of my remarks to seek leave to continue my remarks, because I am sure Senator Xenophon, who is not in the chamber at the moment, would also like to talk about this report. I chaired this inquiry and, as the chamber may recall, it was Senator Xenophon who made the referral.

We have done two inquiries into this particular issue over the past 18 months. Obviously I am pleased the government has responded, and I would like to comment on a few of the responses to our recommendations. However, I have only just seen this response. I should put on the record that I have been trying all day to get this response after I saw it on the Notice Paper. I have only just received it, which makes it hard for committee members who have worked so hard on these documents to comment. I know it will go on the Notice Paper, but obviously we would like to be able to respond in a speedy manner once the government responds to our recommendations.

The community affairs committee always seems to have references that are particularly emotional. This one was also emotional. We heard some devastating accounts from people who have suffered as a result of faulty medical devices. I am pleased—well, I am sort of pleased—to see the government's response to the committee's recommendation 2, which was about implementing recommendation 8c of the Health Technology Assessment Review. The government says that it agrees with the recommendation and that the TGA has consulted publicly on the proposals to increase the rigour of regulatory assessment for high-risk medical devices. It says:

Some reforms will be in place before the end of the calendar year—

that is good—

but the Government notes that timing and approach depends on the completion of the appropriate assessment of any potential regulatory and cost recovery effects …

The point here is that I think this might be the third time that this recommendation has been made, and people are getting a bit sick of the time delays all the time. When the affected and interested communities see this, I think they are going to be very disappointed that it looks again as if the government is buying itself time, or putting this on, when what these people want is for this recommendation to be implemented as a matter of urgency.

The government also agrees with recommendation 3—partly. I remind the chamber that recommendation 3 was about the level of assessment for class III medical devices and that the level of assessment be increased. The government's response is that it 'agrees to consult further'. Yes, I am always out there saying that you need to consult—but consult further on this? This is another issue that the community feels has been consulted on and consulted on and consulted on, and they have had enough! They want some action taken.

So it is disappointing that the government says, 'We're going to consult further'. We have now had two Senate inquiries, saying the same thing: that we need to be looking at these class III medical devices. This is not good enough, government; you need to go back, please, and have another look. The government falls back on the fact that you have to have international harmonisation and says:

As such, the Government believes that any increase to the level of assessment of Class III medical devices will be best achieved in harmony with international counterpart regulators.

That is not what the community wants to hear. That is not what Australians want to hear. Australians want to hear that their government has heard that there are concerns here and they want more rigorous action. I urge the government to please have a look at that recommendation because it is one that the community feels very strongly about.

The committee also recommended that the TGA:

… investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes …

We heard quite a lot of information around this, with a number of people being very critical of the numbers on there and that there is not enough pre-market assessment or post-market surveillance of the higher risk medical devices. On this one, the government said:

The Australian Government agrees with the intent of the recommendation, to improve the quality of medical devices available in the Australian market place, by continuing to refine requirements for pre-market assessment and post-market surveillance.

The government also said:

The TGA has no legal power to limit the number of applications made for inclusion …

However, I think you will find that the community will say that, if you actually do the pre-market assessment and the post-market surveillance better, it would improve the situation very significantly. The concern is that those pre- and post-market assessments have not been done.

I am pleased that the government is picking up on recommendation 5, which is 'continuing to consult with various organisations on the proposals related to third-party conformity assessments and to weigh carefully the considerations of the advantages of the streamlined international regulatory frameworks and patient safety'. The government says that it agrees with this recommendation and will conduct consultations with the various stakeholders. You can bet your bottom dollar that the affected community will be looking at that one very substantially.

The government sometimes agrees with the rest of the recommendations but then goes into an explanation about why you cannot actually do it. It seems to me that that is what they are saying. It gets even worse when they say 'agree in principle', because that means that they do not really and that they will find another way of not following through with these recommendations.

The bottom line here is that, if we do not see some changes in the way that medical devices are regulated, I am desperately afraid that we will see a recurrence of the problems we have seen just recently. We heard such emotional accounts of people's lives being absolutely devastated by some of these devices. It is a very important issue and I thank the government for responding in a fairly timely manner.

I would now like to move to the government's response to the social and economic impacts of rural wind farms, which was another substantial inquiry. I want to particularly go to the recommendation about carrying out thorough research—that is, 'A matter of priority for thorough adequate research, epidemiological and laboratory studies and the possible effects'. The government say that they accept the recommendations in principle. They say that the NHMRC is already actively engaged in supporting the assessment of the available research and that a review will include audible noise, infrasound and low-frequency noise. They say that they are looking at a literature review and, further, that there is a range of funding mechanisms within the Australian government, in particular in the NHMRC, that could be used to fund additional research.

I think the community was looking for a broader commitment from the government to actually fund some of that research and not just say that it can get funding from here. It is pleasing that the government is responding to that issue. That is the recommendation I think you will find that the community will be looking for. We need to make sure that those are thorough assessments to ensure that people are comfortable with the science and, in particular, we need to make sure that they are independent.

As I said, I am sure the community will be looking at these recommendations very carefully. I suspect that people will not be totally happy with the government's response and so I am flagging here that I expect to be hearing very shortly from people who will be looking at this recommendation and saying that they do not think it goes far enough, because there does need to be some further funding for looking into these issues. I seek leave to continue my remarks on both the government responses that have been presented.

Debate adjourned.