Mike Freelander (Macarthur, Australian Labor Party) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018. From the outset, I want to say that I'll be supporting this legislation. This bill enacts measures that will introduce a mandatory reporting scheme, as has already been discussed, for instances when there are medicine shortages in Australia, and it allows application for several penalties for noncompliance.

Shortages in medicines have become more and more of a problem in clinical practice in recent years. Such shortages can arise for a number of reasons and can be very difficult to deal with on a clinical basis. Up until fairly recently, in spite of there being some legislation involving medicine shortages, it's been very difficult to deal with. As an example, as a practitioner, I'm not infrequently required to ring the PBS Authority's hotline to request a phone approval for the use of a medication. The classic one has been methylphenidate, or Ritalin, and its derivatives, for use in children with ADD. I've been required to ring the hotline to get an authority number. You often have to wait on the phone a considerable period of time, sometimes 15 to 20 minutes, to get that authority number. So I've done that and got the authority number for the patient that I'm seeing, only for the patient to come back 20 or 30 minutes later to say that the medication has not been available from the pharmacy, and we would then have to go through the procedure again to get an alternative medication which, as you can imagine, is extraordinarily frustrating and time wasting for myself, the patient and the pharmacist.

This has happened time and time again. In particular, there were shortages of the long-acting form of Ritalin from time to time during the last couple of years. We're usually given very little notice by the pharmaceutical companies that this is the case. In fact, sometimes, the first time that we know that there's a shortage of medication is when the patient returns from the pharmacist or the pharmacist rings and says, 'I've not been able to get this medication anywhere.' This legislation will require better notification of medication shortages, and it will also enact significant penalties for the pharmaceutical companies themselves for not informing the government and, secondarily, medical practitioners and pharmacies about the medication shortages.

In my time in practice, these medication shortages in Australia have become more and more frequent. Part of the problem has been the virtual absence of pharmaceutical manufacturing in Australia for many of the major medications. Many of the bigger companies—Faulding's, for example, is one that I remember was an Australian manufacturing pharmaceutical company—have gone out of business or been taken over by multinational corporations. The multinational pharmaceutical corporations themselves have amalgamated. There were about 30 major international or multinational pharmaceutical companies when I started in practice. There are now about half a dozen. So the number of manufacturers has reduced, manufacturing in Australia has virtually disappeared, and we're reliant on a whole lot of supply chain difficulties before we do get medications in Australia.

The other thing that's happened is, with many of the older medications that are off patent, particularly if they're not used very frequently, there's very little incentive for the generic manufacturers to produce these medications. So they very often stop manufacturing, or the supply is so small that it's not worth importing them into Australia. Australia is really only about one to two per cent of the world pharmaceutical consumption, so there's not a huge incentive to develop really good supply chains for pharmaceuticals in Australia, particularly for the rarer drugs, so this has become a major problem. In fact, yesterday, my office was contacted by a local pharmacist in Macarthur saying that there was an Australia-wide shortage of one of the older diuretics called amiloride, which is often used these days and is mainly reserved for use in people with renal failure. He didn't know what he was going to do to get supplies for this patient who'd had a renal failure and then had had a renal transplant with very poor renal function.

It's increasingly a problem, and this legislation will go a small way to alleviate it. But it's something that needs further thought, I think, and further exploration because, in Australia, we are really struggling at the moment with some of these drug shortages. Some of the other common drugs that have been in Australia-wide short supply in the last 12 months include an antibiotic called vancomycin, which is used for very severe staphylococcal infections that are resistant to some of the common intravenous antibiotics used in hospital. The shortage of vancomycin is a major problem. Another is metronidazole, or Flagyl, which is used for some of the organisms that can be involved in wound infections that are treated in hospital and for some of the parasitic infections. Another antibiotic called norfloxacin, again, is used for multidrug-resistant staphylococcal infections—

Debate interrupted.

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