Tony Zappia (Makin, Australian Labor Party) Share this | Hansard source

I welcome the opportunity to make a contribution to this debate on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill. As the approval body for the release of medicines, biologicals and medical devices, the Therapeutic Goods Administration, more commonly known as the TGA, serves a critical role in the wellbeing of the nation through the provision of safe, affordable and effective medical products. The TGA has an enormous responsibility because its work and its decisions can have a profound effect on the health of the Australian people. A wrong decision can be devastating. Similarly, delays in the approval process that gets products to market, or making flawed assessments, can cause additional or prolonged suffering. We saw that with the pelvic mesh implants, which resulted in not only an adverse court ruling against Johnson & Johnson but, even worse, years of pain and struggle for so many women who had the implants. I note that Johnson & Johnson are now appealing the case.

Notwithstanding the TGA's role in that matter, I believe that there is widespread agreement that the TGA is rating very highly both here in Australia and overseas. Because of its professionalism and its thoroughness, it is one of the most reputable and trusted federal government agencies. Whilst that thoroughness is, of course, time consuming, the TGA approval process nevertheless compares very well with its overseas counterparts in the US, the UK, Canada and Europe. The TGA median approval times in 2019-20 was, I understand, around 162 days, having fallen from around 182 days in the previous year. Of course, the TGA approval is not the final step, as most medical products are still not accessible to consumers without government subsidies provided through the Pharmaceutical Benefits Scheme, otherwise referred to as the PBS. In regard to the PBS process, Australia does not rate so well. It lags behind many of the comparable countries that I referred to earlier. Acknowledging the importance of getting medical products to market quickly and safely, the Standing Committee on Health, Aged Care and Sport is currently inquiring into the TGA and PBS approval processes. As a member of that committee, I have to say that it has been an interesting journey so far and I look forward to the conclusion of the work of the committee and its report to this parliament.

As we know, medical science is moving at a rapid pace, and the TGA process needs to keep up with the innovations that occur almost daily across the word. However, if the TGA is to improve any of its processes, it will need to be adequately staffed, adequately funded and free from political interference. Since most of its funding comes from industry fees—I believe that over 90 per cent of its funding comes from industry fees—there is no reason for its work to be constrained by staff or other necessary resources. This legislation arose because of the urgency to roll out a COVID-19 vaccine and, therefore, the need to remove technical administrative barriers.

The legislation also deals with medicine shortages and with the establishment of a database of where medical devices have been used. Currently there is no database kept, which makes it difficult to track recipients of failed or faulty medical devices. As we saw with the pelvic mesh implants, it can sometimes be several years before a product fault is identified. It therefore is crucial that we have some sort of tracking system so that, when a fault is identified, we can then go back to those people who need to be supported and give them the support they need. Regrettably, however, the legislation doesn't go far enough and only provides for the making of regulations that will create a database. In essence, what we're doing is simply agreeing to a process that might establish a database, but we're not actually establishing a database. This is something that is long overdue and, as other contributors to the debate have pointed out, is something that Labor not only supports but has been calling for for some time.

My view is that, if we're going to make regulations, we should also go to the next step of establishing the database. However, there is no commitment to do so and, even more concerning, there is no information as to how that will be done, how the database will be established, who will administer it and how secure it will be. Securing personal information, particularly medical information, is increasingly becoming a problem for government departments, even more so when that information is held by a private sector entity, as the Morrison government is inclined to do. These are serious matters and, quite frankly, I believe the public have a right to know the details of how the database will be established.

Here in Australia and throughout the world, COVID-19 has indeed been devastating. The urgency in developing and rolling out a vaccine is well understood: every day matters. So, if the TGA process can be sped up without compromising the vaccine's safety and effectiveness, then that is what must be done. This legislation makes it possible to roll out the vaccine sooner by exempting administrative requirements relating to vaccine labels. The vaccine labels are of course important, but ultimately it's the product itself that is the most important. If we have confidence in the product, I think it will be quite reasonable to have a proposition whereby the labelling can be dispensed with if that means that their product can be rolled out even faster. So Labor, because of the current circumstances and the urgency required, will be supporting that exemption to the process.

On Monday the Prime Minister made an announcement in his Press Club speech about his government's commitment to a rapid national rollout of the COVID vaccine. However, like so many of the government's program announcements, I hope that this one is delivered much more timely than most others have been, because the whole nation depends on it. I hope this is not simply another announcement that the Prime Minister is not able to live up to. Labor will of course support the rollout, just as we have been constructive with all other COVID measures that the government has announced, but also, importantly, because we know that bipartisanship is crucial in building public confidence in the vaccine rollout.

This is particularly the case in light of the widespread antivaxxers' campaign that I'm sure we in this place are all aware of—the COVID-19 conspiracy theories that are rife on social media, both here and throughout the world, and comments from political leaders questioning the effectiveness of the vaccines and competency of the TGA and other comparable global agencies. All of that makes the rollout much more difficult. I'm aware, through the studies that have been carried out, and I've read reports of them, that most Australians—I believe in the order of three-quarters of all Australians—support the vaccine rollout, but many are also understandably cautious because of other comments that they are hearing and reading. Their caution may mean that they will not have the vaccine even when it is available in the early stages. That is not in the nation's interest. My concern is that, unless we have bipartisanship and unless we have a strategy whereby the Australian people are absolutely confident in the vaccine, not all of them—not because they're antivaxxers—will take up the opportunity to become vaccinated. That, in turn, will mean that the problem will be with us for much longer. So it is important that we not only have bipartisanship on this issue but we also have a common message right through to the Australian people.

We know that COVID-19 has devastated communities. Whilst here in Australia—and other speakers have made this point and used the Prime Minister's own words—we are in fact one of the world leaders with respect to the way we've managed COVID-19, the reality is there are still many, many people doing it tough because of COVID-19 and indeed will continue to do it tough for many, many months to come. It's in the national interest, and it's in the individual interests of those people and their families to ensure that we get on top of the COVID pandemic. The best way to do that is through the rollout of the vaccine, and therefore it's important we do so as quickly as possible.

Can I say, even with respect to the rollout itself—again, I don't have the details of how that is going to be done—that I hope the government has a carefully thought through strategy to do so because it's a huge task. In fact, I'm not aware of a similar challenge being placed on the Australian government ever before. Whether it's going to be rolled out under the direction of the federal government or the individual states, I don't know, but it is something that needs to be managed very, very carefully.

The third matter I will refer to in respect of this legislation relates to medical shortages. Other speakers have made the point that this is something that's not new and has not been caused solely by COVID-19. COVID-19 might have added to the problem but, quite frankly, medical shortages have been with us for some time. This highlights of the issues that I and others in this place have been talking about for some time now—that is, our reliance on other countries for many of the essential products that we need here in Australia. Whilst in the past we might have had liberal trade and easy access to many of those products, COVID-19 has highlighted that when there's a crisis of some sort our access to essential products can be severely disrupted. It was disrupted with COVID-19 and it might be disrupted again if there's another crisis in the future. We need to stop relying on overseas countries for the things that we need to have at all times in Australia.

I believe that here in Australia we have the ability to improve our production of pharmaceuticals. In my own electorate, Mayne Pharma has a major production facility. I've been through it on more than one occasion; it's an impressive facility. Mayne Pharma also has facilities overseas. I know that it's a very competent organisation, and I believe there are others like them. We should be supporting Australian companies to manufacture products here in Australia just as we are with CSL's facilities producing the vaccine in Victoria. We should be doing that because medicines and medicinal products and medicinal goods are essential items; they are not something that we choose to have from time to time. If they are needed they become an essential product.

To simply say, as this legislation does, that doctors and pharmacists will be able to dispense a substitute product is nothing more than a bandaid measure. That shouldn't be the answer. That already exists if there is agreement between the doctor, the pharmacist and the patient. It already occurs. The real answer to the problem of medicine shortages is to ensure that we have adequate stocks in Australia at all times. That's done through the reporting process—which has been shown to be flawed from time to time—but, more importantly, it can be done by manufacturing medicines and medical products here in Australia. It is no good having a great reporting system or the ability to dispense an alternative product if we cannot access the products from overseas because there is a shortage for whatever reason or because supply lines have been cut off. When that happens people whose health is entirely reliant on the medicines they take will be placed at serious risk. At a time when we're looking to rebuild our nation, it's an opportunity to invest in the manufacture of medicines and medical products.

Labor will be supporting this legislation because it is the right thing to do right now. During the COVID pandemic that we are all experiencing it is in the national interest to do so. As I said in the course of my remarks, I hope that the rollout is carried out as smoothly and as quickly as possible.

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