Richard Colbeck (Tasmania, Liberal Party, Shadow Parliamentary Secretary for Health) Share this | Hansard source

To continue from where we were yesterday in the debate with respect to the National Health Amendment (Pharmaceutical and Other Benefits—Cost Recovery) Bill 2008, I was talking about, in particular, the concern of the committee and many in the medical profession in relation to the use of pharmaceuticals off label. It was quite disturbing to hear in that inquiry, in the day of hearings, that in paediatrics nearly all medicines are used off label. I acknowledged the work of the advisory groups in working with palliative care particularly to the extent where once upon a time in palliative care nearly all medicines used were off label. That is now down to something in the order of 50 per cent. But there still remains a lot of work to be done for Indigenous people.

Obviously if a medicine is not licensed to be used for a particular indication, the pharmaceutical companies cannot promote a medicine for that particular use. That does not mean that a doctor cannot necessarily provide a prescription for that medicine, and that is quite often the case, but technically under the Pharmaceutical Benefits Scheme it should not be provided under the scheme for those off-use indications.

So you have in paediatrics almost all medicines used being off label; in palliative care it is 50 per cent; and there is an unknown number—but most, I think—with respect to Indigenous people. Again, I commend this government, the previous government and the PBAC for the work that they are doing to try to resolve that, but I do express some concern that fees for the additional indications may provide a significant disincentive for companies to put some of these products up for additional approvals.

It is also important to note that it is not just the pharmaceutical companies that provide submissions for these indications. You are put in a situation where sometimes small groups of individuals in the community or professional bodies decide that it is important that they put a submission in for listing for a medicine for a certain use, and at this point in time it is not specifically clear how those are going to be treated.

We know that there is some discretion in the regulations. The committee has had those regulations only for a week and, as I mentioned earlier in my presentation, the committee was effectively prohibited from completely interrogating this measure because the real workings of it are in the regulations. Even the industry, which has had them for only a week, has not had a chance to look in detail at the regulations, so they cannot tell us yet what their implications will be. That again demonstrates quite a disturbing element in this whole process.

The government seems to be very keen to have this legislation passed; as we heard during the inquiry and as has been indicated during the debate so far, it was announced without warning and without consultation on budget night for implementation on 1 July. The government is now trying to have the legislation passed through the Senate when the real workings of the measure are in fact in the regulations, which we received last Friday afternoon after the report that criticised the government for not releasing the regulations or using the regulations in their consultations with industry was tabled. The question on notice came to the committee after the report was tabled. Now the government wants the legislation put through the parliament this week without the opportunity for the industry, much less the parliament, to effectively scrutinise the regulations. It is very disappointing that we have been put in this position. The consultation was, I think, insufficient. I do not believe that the government could simply pick up this measure as if nothing had happened. The only indication the industry had from the government was the statement from the minister that I read out earlier.

The other concern is how this measure fits in respect of cost recovery. There were a number of submissions from industry, not necessarily from the manufacturers but from the College of Physicians, Palliative Care Australia and the Pharmacy Guild, who indicated their concerns about how this particular measure fits in with the government’s cost recovery guidelines. The government obviously continues to maintain that it does, but I think that good evidence was given to the committee that it does not meet the cost recovery guidelines. It certainly does not meet the cost recovery guidelines when it comes to consultation because one of the key elements in the cost recovery guidelines actually relates to consultation with industry. So the government clearly have not done that. They seem to be trying to rely very heavily on guidelines from the Productivity Commission rather than on their own published cost recovery guidelines. I find that of concern. Cost recovery guidelines have been submitted for consideration by the public, by industry and by people who might have those measures imposed on them, and yet the government are relying on some guidelines put out by the Productivity Commission—and that is relied on very heavily in their report.

I believe that the government needs to give the industry some time to satisfactorily look through the regulations. I would not rule out the possibility that the Senate will want to have another look at the regulations. That could be potentially a reasonable aspect for us to consider. I know that we were not able to properly consider this measure when it came before the committee because we did not have the regulations. Effectively, all we had was the product of some consultation between government and industry since the budget. There were some promises to consider these particular matters—things like additional indications being registered and the way that certain medicines would be considered with respect to fees—but all of this leads to considerable uncertainty, particularly for those who are looking for quick access to the pharmaceuticals.

I am not convinced that this additional layer of costs will not prohibit medicines from being brought to the market or to the PBS in a timely way. I think that this additional layer of red tape is going to take additional time, despite the department saying that they do not believe that it will. I do not believe that that is the case. Any additional work that has to be done and any negotiation over what classification the medicines may have when applications are submitted will take additional time.

On my reading of the regulations at this point in time I think that there is scope for them to be amended. I know that the Senate does not have the opportunity to amend the regulations; that has to be done through a negotiated process between the government, the industry and perhaps even the Senate itself. We can disallow parts of a regulation or disallow or approve the whole regulation, but we cannot amend them. This approach of putting up a bill that allows for the implementation of regulations really does prevent the Senate from doing its job in respect of making modifications to the measure. I would like to see the industry given some time.

I am not sure exactly what the government’s intentions are with respect to the legislation at this point in time, and I would appreciate their letting us know that. I think we need more time for proper assessment of the regulations that were released but, as I said earlier in my presentation, I do give the government credit for doing that. I would have appreciated it having occurred much earlier in the process so that we could have looked at it through the Senate process. That would have been very helpful. But we do need time to understand properly what the impact of these regulations will be if the legislation is passed. I would prefer that the legislation not be passed until we and the industry have had the opportunity to properly interrogate the measures. In that circumstance, I indicate that the opposition will not be supporting the legislation at this time. We believe that there is real scope for additional work to be done on this particular measure, and that needs to be done before we could support it.