Therapeutic Goods Amendment Bill 2016

27 March 2017

Mister Speaker

I commend the comments by the previous speaker, the member for Dobell. I agree entirely. Call me old and cynical, but 38 years as a medical practitioner before coming here taught me to be suspicious of streamlining proposals and efficiency measures touted by governments, state and federal. In the case of Liberal and coalition governments, it was good practice to set the bulldust detectors to Spinal Tap's 11 on the 10-point scale. With Labor governments as a medico you had to sometimes comfort yourself however with the simple thought that, 'At least they mean well.' But in every case—and I am sure I am not alone in this—you seldom went far wrong in assuming that the departmental officialese of 'efficiency, economising and enhanced productivity' being parroted by the minister was code for either cost cutting or cost shifting back onto unsuspecting public patients.

As a newly minted member of parliament, I have tried to modify those personal prejudices and curb the ingrained and battle-hardened scepticism. The trouble is, though, I keep talking to patients and medical colleagues and those discussions sometimes lead pretty quickly back to that darkest of all dark questions: what are they really up to? So I still tend to wonder how seemingly nice or anodyne-sounding ideas such as those contained in this Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 might work out in practice.

This bill, of course, takes a very sensible steps towards facilitating the more rapid take-up of new medicines and other medical advances. Our medical armamentarium has improved dramatically over the last 200 years. As a doctor, the number of medications available to treat common candidates such as asthma, epilepsy, cardiovascular disease and infection are so numerous that it is almost impossible to know them all and all their side effects. Increasingly, we are faced with new drugs targeted to specific and sometimes rare disorders. These new medications can be lifesaving, as already mentioned in the case of Kalydeco for certain forms of cystic fibrosis. New classes of drugs, such as the biologics, are very expensive but can also be very effective for some of the rare immunological disorders and for some forms of cancer.

Increasingly, demand for medications for some disorders in old age is rampant. Some of the newer cancer medications such as those for lung, bowel and prostate cancer are in constant demand, and new treatments are being developed all the time. Genetic disorders such as cystic fibrosis can now for the first time be treated with drugs directly targeted to the underlying metabolic disorder. The next generation of these drugs is already in the pipeline.

Most of the research into the effectiveness and safety of these medications occurs in Europe, Japan or the United States. Data about the effectiveness and side-effects profiles are available from overseas institutions which are very reputable. Australia does not have the research ability to undertake strict double-blind trials on all these new medications. Our health consumers and medical professionals are well aware of the availability of new treatments and regularly review information from other countries about new modalities and will actively seek out these treatments, often available through various internet sites. That certainly happened to me in practice. Therefore, it is important that we are able to approve access to, recommend and prescribe these treatments as soon as we can where warranted. Sometimes it has taken a very long period of time for medication that has been approved overseas to be approved in Australia. Ondansetron is one that comes to mind. It is a medication used for severe vomiting due to severe illness and chemotherapy.

More generally, though, these days I recognise that there are two, not three, truisms about efficiency measures in health. The first is that Liberal and coalition governments are not the most wholehearted defenders of the universality principle and public health spending to walk the earth. They have form that dates back to their early opposition to Medibank, its repeal and their reluctant acceptance of the general public's continued support for Medicare bulk-billing and proper protection from the potentially crippling costs. This I do not believe is a contentious point.

Three days after last year's 2 July election, a somewhat chastened Prime Minister rightly observed in relation to those legitimate expectations on the issue of public trust:

That

the election result—

is a very clear lesson. We have to do more to reaffirm the faith of the Australian people in our commitment to health and to Medicare.

He said the coalition had to:

… work harder to rebuild or strengthen the trust of the Australian people in our side of politics when it comes to health. There is no question about that.

I am sure that the Prime Minister actually believes that. What I am less sure of is that all those who sit behind him or on the Treasury bench, including two former health ministers—Mr Abbott and Mr Dutton—do.

But let's move on. The second truism is less contentious but should not for that reason go unmentioned. It is, of course, that all governments must deal with the rising cost of medicines and health care. Those rising costs have to be met from increased levies or taxes or through savings in other areas. That inevitably means that all governments are always on the lookout for savings in health. How could it be otherwise with health expenditure by governments, state and federal, now in excess of $108 billion per annum, of which the Commonwealth's share is $66 billion?

Medicare Benefits Schedule spending has risen by more than 60 per cent annually over the last two decades, and medical costs have been on average the fastest-growing component of the CPI over the last 15 years. Ross Gittins in his usual insightful way picked up on this policy dilemma in one of his excellent columns earlier last week. As Gittins argues—and I firmly agree with him:

… the intergenerational reports make it clear health will be by far the fastest growing.

That's not so much because of ageing as because advances in medical technology are hugely expensive, and it's quite unrealistic to imagine that Australian voters will settle for anything less than gaining subsidised access to the latest and best technology …

Add 'earliest' to Gittins' list and you can see immediately what this bill is trying to do, even if I have some current qualms about how it is trying to do it. Gittins goes on—and I still think he is on the right track—to say:

Our politicians … need to be brave and tell voters the truth: if they want ever more and better healthcare then, as with everything else, they'll have to pay more for it—in the form of, say, regular increases in the Medicare levy.

And yes, the last Labor government was brave enough to increase the Medicare levy to help fund the NDIS; and no, the electorate apparently did not react as if it was the end of civilisation. I also agree with Gittens that part of the solution is cutting out waste and efficiency. Again, this bill is highly pertinent, and where I think there is a strong measure of agreement across the chamber is that the introduction of new medicines, medical devices and procedures should not be unduly impeded, particularly when they can be life-saving. Gittens goes further—and I think this is where some of those opposite might be a little less sanguine about his proposed course of treatment. Gittens makes for me the not unreasonable point that those who want over and above the basic service provided by government should usually pay for it themselves. Taxes should not be levied or expended to finance, entrench or sustain inequality. That brings me to what I consider the third truism of Australian health policy, and back to the detailed elements of this bill.

From the time I considered giving up my career in medicine and standing for the seat of Macarthur, it seemed to me that the problem with government health policy was the lack of an overarching plan. Related to this was the sometimes haphazard or clumsy way in which policy was made and implemented. If you look at the health bills before this House over the last couple of weeks—some are admirable in their own way—you get a sense of government nibbling at the edges of policy, rather than trying to foster a broader consensus about how $108-plus billion of government spending annually on health care might be more effectively deployed. Perhaps what we are seeing that this week is no more than an incident of how the drafting resources of the Office of Parliamentary Counsel line up with the parliamentary timetable. But it does play into a wider unease I think we might all share about the delivery of health care, and the formation of health policy more broadly, with this government. The first bills I spoke on in this place were the National Cancer Screening Register Bill 2016 and the National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016. The object of those bills was unexceptional enough, and even welcome—you did, though, need to ignore the fact that the proposed register was long overdue, and might have been extended to a national register for breast cancer and other cancers. What was really concerning to many, and even slightly dodgy, was that the bills as first presented trespassed on privacy rights, and that the proposed register had already been flogged off—in advance of parliamentary approval—to a private body not noted for its experience or expertise in the field of handling medical records.

I was reminded of those concerns when I tuned into the Health Report on Radio National, as I do quite often, to hear doubts being expressed about unexplained delays in implementing a national strategy to deal with type II diabetes, and the delay in implementing promises made at the time of the election about insulin pumps for children with type I diabetes. Diabetes is a huge problem in Australia and costs our economy over $14 billion a year. Acting Deputy Speaker Hogan, you would think that a strategy developed to prevent diabetes would not be bogged down in a government working group for the best part of two years; you might expect it would have a bit of a higher priority and some urgency—so too with this bill. We have here a bill introduced late last year to streamline the processes for getting new medicines and medical devices onto the Australian market, a worthy idea but not a new one. The bill encompasses the work of the Sansom review established in 2014—which reported in 2015—to which the government responded some two years later, in September 2016. There has also been a Senate inquiry by the Standing Committee on Community Affairs, which recommended a comprehensive review of the system for registration and subsidisation of medicines. So the government and the policymakers, in effect, have been working on this for the best part of at least three years, even if you ignore any work done prior to the Sansom inquiry getting underway. It is at that point that you start to wonder about whether the process, for reasons unexplained, has gone a bit off the rails; if the wheels have not totally fallen off, they are certainly displaying a few disconcerting wobbles.

For starters, the current bill was introduced prior to the government responding to the community affairs committee report—something you think might easily have been done. That is something the Senate also seems to have thought a bit remiss, because the substance of this bill was promptly referred off to the Community Affairs Legislation Committee by the Senate Standing Committee for Selection of Bills. That is no huge drama of itself, although you do wonder if that might not have happened if the process had been handled more adroitly or in a more conciliatory fashion. I also note that this House is being asked to consider the merits of the bill without the benefit of the work or findings of the Senate Community Affairs Legislation Committee, which is not due to report for a few days yet. The other Senate committee to look at the bill is the Standing Committee for the Scrutiny of Bills. The task of that committee is to ensure that legislation, amongst other things, does not unduly trespass on individual liberties; and does not undermine the rule of law or parliamentary sovereignty by making rights and liberties unduly dependent on administrative powers, inappropriately delegating legislative powers, or insufficiently subjecting the exercise of legislative power to parliamentary scrutiny. The scrutiny of bills committee reported its findings on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 —which are quite numerous for such a short bill—to the Senate on 8 February and asked for a detailed response by 23 February. One arrived on 2 March.

The scrutiny of bills committee has now considered the minister's response and it has commented in a number of ways: firstly, that the explanation memorandum was insufficiently candid and informative; that more significant elements of the assessment regime should be included in the primary bill and not in delegated legislation; and that authorised persons under the act have defined qualifications or skills. The committee also commented that processes by an advisory body under the proposed act be subjected to legislative control; and that defences available to manufacturers accused of providing false or misleading information or documents unduly cast the onus on the Therapeutic Goods Administration. These are matters which I expect will be addressed in another place, and need not be fatal to the bill. But they are significant matters and, as with the case of the national cancer screening registry bills that I referred to earlier, the net effect is that you are a little less confident than you might otherwise have been about supporting these proposals. If we are to make the sort of progress required in advancing the quality of medical care by guaranteeing value for money, we must ensure that the policy processes are working a little more smoothly than may be the case in the health portfolio. The health portfolio seems to follow much of the other government legislation, in that it is thought-bubble policymaking. There is no overarching plan; there is no real plan for a health policy for all Australians in 2017. Let us hope the new minister can bring some of his well-known and not inconsiderable talents to the task. I wish him well. We support this bill, but I have some concerns about the whole process of policy and health policy determination, and the real mishmash of ways that it is being organised by this government.