David Gillespie (Lyne, National Party) Share this | Hansard source

The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 involves some rather technical changes to the operations of the Therapeutic Goods Act. The TGA, the Therapeutic Goods Authority, is a world renowned regulator which analyses drugs, vaccines, medical devices, implants, prostheses et cetera that are then defined as therapeutic goods. The amendments support existing processes that ensure Australians continue to get the medical devices, drugs and vaccines that we have been used to, particularly in the post-COVID world. I'll outline some of those changes in subsequent comments. As you can appreciate, Mr Deputy Speaker, with the COVID crisis there were interruptions to supply chains around the world—not only in Australia but really worldwide. Some of these changes have been brought to fruition as a result of that, but they are basically very safe, commonsense responses to a problem that emerged.

There are also regulations to enable a system to be set up so that there's a universal device indicator, so that we can create a register of the ever-increasing numbers of medical devices, prostheses, implants or medical gadgets that remain inside humans, like pacemakers, hip replacements, knee replacements or meshes—things like that—so that we become in tune with what other regulators around the world are doing, including in the EU and the US. That is a really great initiative. Some prostheses and medical devices already have registers and, in the orthopaedic world, have had them for some years. But this will, over a period of four years, allow for digital recording, such as in My Health Record, and allow for surveillance of side effects, for recalls, for health statistics on outcomes et cetera. It's an initiative which I think will add another layer of safety in that sort of device use in humans. There is a history of problems with devices that only become apparent after a certain time, like some of the side effects of breast implants or the pelvic mesh, which was hailed as a breakthrough, only to find out that it caused problems later on.

But the main change is allowing, in a regulatory and legislative sense, the application of common sense if there is a critical shortage of medicines. Currently in the system, if there is a shortage and there is a Serious Shortages Substitution Notice issued by the TGA, then, state-by-state, each state can allow the pharmacist to dose-substitute. This bill will allow the pharmacist to make authorised delivery of an equivalent generic or equivalent dose or formulation—so, rather than a capsule, a tablet, say. Or, instead of a 20-milligram tablet, give them two 10-milligram tablets. Or if there was a patch that delivered a medicine absorbed through the skin and that wasn't available, a cream could be used. So a lot of this is just putting legislative clarity and power behind what are sensible, professional decisions. If there's a shortage of a particular original brand, it can be replaced with a generic, or an equivalent molecule made by a different maker.

It will also, as the previous speaker mentioned, offer some protections for officers of the Therapeutic Goods Administration who are analysing drugs which were hitherto illegal. We're all familiar with the black market of illegal muscle-enhancing drugs, or drugs that are used to improve sporting performance. For us to know what's going on with these drugs in humans, at some stage the TGA will have to analyse them, but we don't want our chemists and biochemists being nabbed because they are in possession of illegal goods.

Another issue is creating what's called data protection. Everyone's familiar with patents for drugs. Data protection is for all the information that's behind getting a drug or a device evaluated and proved to be safe and effective. It's all the data that goes with it. It's allied to part of the patent but it's a separate process. People who've spent billions of dollars and many years getting all this information together to get it licensed have some legal rights to have their data protected so that some subsequent manufacturer can't just come along and get its equivalent drug licence on the basis of that data. So this will clarify data protection. It is for a limited number of years, but it means the secretary will know—it'll be recorded—that that data is protected to the use of that drug or that owner of that information.

It also clarifies in a legislative sense the declaration of a good as not being a therapeutic good. A lot of claims are made about substances that are sold for people's health. It's a bit of a vague area, and this declaration will mean that people won't be able to make outrageous claims about a so-called therapeutic effect of a drug or a device if it doesn't have it. To me, this seems like a really sensible idea, because there are some lotions and potions that people think are a registered therapeutic good and are definitely going to have an effect. If it has been analysed by an internationally renowned organisation, like Australia's TGA, and it has been proven not to have any therapeutic outcome, people can still buy it but the makers can't use and advertise that.

This bill is very technical. There are a lot of things that maybe only boffins or pharmacists or pharmaceutical companies will appreciate the benefit of, but it's all sensible stuff. It all keeps our system up to date. If there are disruptions to the supply chain again and there are shortages, pharmacists, who have a lot of university training and learning behind them, will be able to substitute appropriate medications without having to go through a rigorous process or contact the original prescribing doctor.

It also incorporates pretty much commonsense legislative changes to include the poison standard in other sections from time to time. Obviously the poisons schedule changes, and it will facilitate appropriate use of that information elsewhere.

Our TGA has been very busy analysing all the vaccines that are coming through the works. It is a national asset. Our pharmaceutical system really is a highly regarded system internationally, both the TGA and our allied processes for putting things on the Pharmaceutical Benefits Scheme. I support this bill, which has a lot of commonsense and safe procedures in it, and I commend it to the House.

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