John Alexander (Bennelong, Liberal Party) Share this | Link to this | Hansard source

I move:

That this House:

(1) recognises the opportunities for an enhanced regulatory framework to better position Australia's health system to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods, and to improve access to vital life saving and enhancing drugs;

(2) commends the recent joint announcement by the Minister for Health and Assistant Minister for Health to undertake a review of medicines and medical devices regulations;

(3) supports the Government's Innovation and Competitiveness Agenda as a key step to removing ineffective regulation and encouraging greater competition and innovation for businesses in the medicines and medical devices industries; and

(4) applauds the Prime Minister for his recent Ministerial Statement to the House on deregulation, outlining the need to recognise trusted international approval processes to improve consumer access to therapeutic goods.

I thank the House for the opportunity to debate the important issues raised in this motion.

The health of our constituents is a matter that transcends the political bearpit that often characterises debate in this place. There is no greater duty as elected representatives than to do everything we can to ensure our constituents have access to the latest medical technologies and best medicines, whilst ensuring that access is provided in a safe and economically responsible manner.

As the founder and Chair of the Parliamentary Friends of Medicines Group, I have worked to promote the great work of our medicines and medical devices sectors and to create opportunities for members to interact with industry leaders, medical experts and patient groups to ensure we best understand and represent the health issues directly affecting our constituents. Through these events and my travels around Bennelong, I have received consistent feedback on the obstacles in our system that prevent patients from accessing the best treatments. This is no more evident than with medical devices.

As a small market, we cannot expect that global corporations will be lining up to host worldwide launches of new technologies or new generations of devices in Australia. Competitor First World markets offer far greater uptake and opportunity. Regardless, we should do everything we can to create a smooth process for these medical technologies to be made available to Australians at the earliest opportunity. And yet, despite the vast majority of therapeutic approval checks being identical to those of comparable nations like the United States, Canada or the UK, we still require companies to endure a complete rigorous approval process, meaning significant amounts of duplication and therefore delays before the products are made available in Australia.

One company told me that they had just received Australian approval for their second-generation heart stent technology, a key remedy for one of our nation's biggest killers, whilst patients in the US and Europe were already on the fourth-generation device. Each approval process took 18 months and incurred significant costs that needed to be passed on to the consumers, together with the huge cost to government of administering the regulation, meaning that, by the time a new stent was available for use, it had already been superseded and came at a considerably higher price.

I am very supportive of the need for a regulatory system that ensures safety and efficacy at the centre of approvals. However, when I questioned this company about how many of their devices had required even a single modification over their many years operating in Australia, the answer was zero. That is hundreds of thousands of dollars and many years in delays that had, in hindsight, been for nothing. Clearly, something has to change.

In October last year I was honoured to host the Prime Minister and the Minister for Health in Bennelong as we toured the facilities of Cochlear, one of Australia's most successful innovation companies. The cochlear implant has changed the lives of tens of thousands of people worldwide, yet some patients overseas could receive a better implant at a cheaper price prior to Australians. I was therefore delighted to witness the Prime Minister inform the House that, as part of this government's second repeal day, the Industry Innovation and Competitiveness Agenda was launched to directly address this issue. As a result of this policy, Cochlear is now eligible to use European Union certification to streamline and speed up the certification of its products by the TGA. This is a victory for common sense and an even bigger victory for people in our community disadvantaged by disability.

Two days after this speech, the Minister for Health and the Assistant Minister for Health announced an independent review of medicines and medical devices regulation to be conducted by three eminent experts. The review is examining the TGA's regulatory framework and processes to identify areas of unnecessary or ineffective regulation that can be streamlined without impacting on safety. As the Prime Minister concluded in his speech that day, I am proud of the progress that we have made so far and I pledge that there is much more yet to come, just as I am proud to be a member of this government, delivering real solutions for our local constituents on some of our most important policy challenges. I commend this motion to the House.

Russell Broadbent (McMillan, Liberal Party) Share this | Link to this | Hansard source

Is there a seconder for the motion?

Stephen Jones (Throsby, Australian Labor Party, Shadow Parliamentary Secretary for Regional Development and Infrastructure) Share this | Link to this | Hansard source

I second the motion. I thank the member for introducing the motion. It gives me great pleasure to second it. It gives me an opportunity to speak on the importance of health care and consumer safety in Australia.

Australia has a world-class system of health care underpinned by universal health care and Medicare, fair and affordable access to medicines through the Pharmaceutical Benefits Scheme, a quality doctor and allied health professional system underpinned by excellent training, and a safe and effective system of regulating and introducing medicines, drugs and medical devices to the market. It is one of the reasons that we have some of the best health outcomes of any developed country anywhere in the world.

For all of this to continue to occur, we require certainty. We must continually review our regulatory arrangements, but we require certainty. With the importance of certainty in mind, even today we have heard some members of the government come out and say that the GP tax—an important part, according to the government, of its budget program—is about to be dumped and other members of the government saying that it is here to stay. The people of Australia require more stability and more certainty than they are currently getting from those opposite.

Why do we regulate medicines and medical devices in this country? That is on the point of safe and effective medicines and drugs that we all rely upon. It has been the role of the Therapeutic Goods Administration to provide protections to Australians, ensuring safe and effective medicines and medical devices. And the role of the agency has evolved over many years. Prior to the 1960s, regulation tended to focus on false claims made by manufacturers of medical devices and medicines and the quality of those devices and medicines.

After the 1961 discovery of the link between thalidomide in pregnancy and the incidence of congenital abnormalities in babies—and, I should say, a delay of some five years—it was Dr Jim Forbes, the then Minister for Health, who introduced the Therapeutic Goods Bill. At that time it enjoyed bipartisan support. The bill shifted the regulation towards the efficacy and safety of products that make a therapeutic claim, as well, of course, as the manufacturing processes and their quality. Labor still believes that safety of patients and the consuming public should always be at the centre of our therapeutic goods regulatory system.

Evaluating therapeutic goods for safety, quality and efficacy can, as the member for Bennelong points out, be a costly process. But the cost of getting it wrong, whether measured in patients' lives or in the crude and unfortunate means of money, is much, much greater. So it is absolutely critical—and I do not for a moment think that the member for Bennelong, by moving this motion in the House, disagrees with me on this point—that we put patient safety and the consuming public's interests at the centre of our regulatory system. Yes, it needs to be risk based. Yes, it needs to be aligned with best practice within the international regulatory regime but it needs to have the interests of the consuming public at its centre.

The cost of getting therapeutic goods into the market can have an impact, obviously, on the final prices the patients, or indeed the Commonwealth, pays. As one of the major funders of goods listed on the Australian Register of Therapeutic Goods, the Commonwealth itself has a keen interest in this. But when things go wrong all focus attends to the consumer and not to the cost of the regulatory system. Indeed, the public is saying, 'Where was the government? How could this have been allowed to occur?' That is why we need to hasten slowly. We welcome the fact that a review has been initiated. We will not rush to judgement. We will carefully consider not only the submissions to the review but the outcomes of that review. We will form a position based on putting the interest of the consuming public first. Once again, I thank the member for Bennelong for bringing the matter before the House.

Angus Taylor (Hume, Liberal Party) Share this | Link to this | Hansard source

I rise in support of this excellent motion and for an enhanced regulatory framework for medicines and medical devices in Australia. The reality of our health system is that we have costs rising at somewhere close to 10 per cent a year. We have demands for health outcomes that are continually rising with an ageing population, and particularly with increasing incidence of chronic disease. We could fund this by continually increasing taxes every year forevermore, but Australians will never thank us for that. We know that to deliver a better health system, to deliver a health system that is affordable, that does not have costs rising at eight or nine per cent every year, year after year, we need breakthroughs. We need breakthroughs in medical technology; we need breakthroughs in how we deliver health; and we need breakthroughs in the way we fund health.

Medical technology is absolutely at the centre of that. It is constantly evolving at an extraordinary pace. For Australia and Australians a modern regulatory framework is absolutely essential to ensure that we have access to the latest treatments in a timely manner. So in October last year the Minister for Health and the Assistant Minister for Health announced that the government would undertake a review in this area with a discussion paper that is to be released in March this year.

That review is looking at how we can encourage competition and innovation in the medicine and medical device sector, which operate in a very complex and costly regulatory environment. Because it is costly, we know that through streamlining that administration, through streamlining that regulation, we cannot only bring new technologies to market faster but we can reduce the costs for taxpayers of Australia. The review is also looking at how we can take away unnecessary duplicative and ineffective regulation.

The review ties in with Australia's industry, innovation and competitiveness agenda. Specifically, where we can trust international standards and risk assessments, we should. Not only are we taking out duplication within Australia; we are looking to make sure we do not have duplication across the world. That is exactly the kind of innovative thinking that will ensure that this government delivers better government services, like health, for less.

As a first step in pursuing this agenda, the TGA is enabling Australian manufacturers to register routine medical devices using conforming approvals from European bodies—that is, we are streamlining global, not just Australian, regulation. It is important to understand that the pharmaceutical industry in Australia is a major high-tech industry. We have exports of $3.9 billion, which is a big industry in its own right. Growing fast, it employs 15½ thousand people and spends over $400 million in product manufacturing research and development. This is an absolutely extraordinary Australian success story.

In 2012-13, the industry received $7.1 billion from the government's Pharmaceutical Benefits Scheme, the PBS. It has been responsible for some extraordinary and incredibly important medical breakthroughs and developments, with worldwide recognition—for example, CSL's swine flu agenda, the Gardasil vaccine for human papillomavirus; therapeutics for the prevention of transplant rejection and the treatment of multiple indications in autoimmune diseases such as rheumatoid arthritis; and the flu drug Relenza.

The review and its aims also tie in with this government's commitment to reducing red tape. We have prioritised streamlining overregulated sectors in our economy with two red tape repeal days, and that has already reduced annual red tape costs by over $2 billion.

The review works towards two complementary objectives for this industry: creating the best environment for innovation and job growth and encouraging more R&D and manufacturing of therapeutic goods within Australia; and at the same time, secondly, it maintains important protections for the community from substandard, unsafe and ineffective therapeutic goods.

We must ensure that our health system remains sustainable for many years to come and we must ensure that our great industries that rely on Australian smarts are successful. Sustainability of our health sector for many decades to come is absolutely central to this government's agenda, which the Labor Party ignores in its thinking about the future.

Tim Watts (Gellibrand, Australian Labor Party) Share this | Link to this | Hansard source

I thank the member for Bennelong for this motion which allows me the opportunity to talk about the kind of healthcare system that we want to see for Australia. I look forward to seeing the recommendations that will come out of this review, and hope that it aims to build upon and improve our system for the better. Our communities want us to promote better ways of providing efficient and effective delivery of healthcare services and therapeutic goods. I hope all policy reviews are set up with this end in mind, because our healthcare system truly is world class.

In Australia we have rigorous testing of medicines to ensure they meet the highest of standards. Through this system, Australians can always be confident in the safety and quality of available medicines. We have extremely well taught and educated doctors and nurses who dedicate their lives to their professions. We also have the Pharmaceutical Benefits Scheme, which aids Australians by subsidising expensive and prohibitively costly medicines. The PBS makes life-saving medicines affordable to people when they need them most. Thanks to all of this, Australia's health outcomes are amongst the best in the world. Most importantly though, we have a universal healthcare in the form of Medicare. Universal healthcare is the bedrock of our healthcare system, an essential public good that ensures vital protections for all Australians, regardless of their background or means. We have fought very hard to establish Medicare in this country.

In 1972, only 17 per cent of Australians had health insurance of any kind. Unsurprisingly, most of those people were low-income earners. Gough Whitlam, that great titan we tragically lost last year, changed all that. Gough set about creating a fair, equitable and efficient system that would provide health insurance for all Australians. There was opposition to universal healthcare then, and sadly, there is opposition to universal healthcare now. It is a little bit hard to stomach talking about the state of our country's regulatory framework for healthcare or medicines and medical devices when a broader attack on Medicare continues unabated. However, as the deputy chair of the Standing Committee on Health, I have watched on with interest as the Minister and Assistant Minister for Health announced their intent to undertake this review.

Our pharmaceutical and medical device industry is robust, competitive and flourishing. The medicine industry employs around 41,000 people. There are around 13,000 people working in the pharmaceutical manufacturing sector and 19,000 in the medical technology sector. The Therapeutic Goods Administration plays a vital role in ensuring only safe and effective medicines and medical devices are used here in Australia. The implications of this scheme are undoubtedly positive. Stringent testing and assessment are essential to ascertain the validity and quality of all therapeutic goods. These practices ensure the safety of patients will always remain the industry's primary focus.

There are, however, some costs associated with such a rigorous system. Understandably and inevitably, evaluating therapeutic goods can be a long and costly process. The process is complex in a range of ways and such stringent measures mean that innovations in the healthcare sector cannot be immediately passed onto patients. These could include things such as new therapeutic goods, which are prohibited until they are properly tested. Sadly, the duration of the testing period may mean that patients go without these drugs in the meantime. The cost of assessment can also have an impact on the final cost to the Commonwealth that patients have to pay. With this in mind, I believe there is a case to be made for a review into the regulation of therapeutic goods. We should seek harmonisation and international cooperation between regulators.

Likewise, I am interested in seeing some of the recommendations on using international standards and risk assessments in Australia. This will need to be closely reviewed, as international standards may not be as stringent as those in Australia. As someone who has worked closely with regulatory schemes in other sectors of the Australian economy, I do believe that there is much to be gained from such international harmonisation and streamlining processes. Commonality of regulation of this kind can benefit us all when different nations have consistent outcomes and objectives from their regulatory schemes.

So let's be clear. Labor only supports a regulatory framework that does not compromise the safety and quality of our system, and one that continues to put patients' safety at the centre of its approach.

Finally, Labor does thank the Prime Minister for his recent statement to the press on the need to consider international approval processes in this space. The last year has been a tough year on the beleaguered Prime Minister. We hope that whoever is Prime Minister after this week will continue this approach in the future.

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

I rise to support the motion commended already by several speakers, but particularly the possibility of an enhanced regulatory framework, a full review of the medicines and medical device regulation and, in particular, the TGA and its processes.

For Australia to continue to thrive and for our health system to thrive, we must remain competitive and innovative in all sectors, particularly in our new emerging medical devices and pharmaceutical industries. It is also important for Australian citizens to have access to the best and the safest drugs and medical devices. But for this to occur, everything has to be affordable. Australia needs to have an efficient and thorough evaluation process of all medical devices and medications. But I am very pleased that both the previous minister for health and the Assistant Minister for Health, Senator Fiona Nash, announced the TGA review within a couple of days of the Prime Minister making his announcement.

The review includes the possibility of incorporating processes that other competent related authorities overseas have already gone through and looks at competent authorities like European Medicines Agency, the FDA and the Canadian medical authority. They are also charged with looking after the safety of their citizens and they have very rigorous processes too. For us to reinvent the wheel and start from scratch seems very time-intensive and cost-intensive, so this review is really quite timely.

There is a problem in our system. I will give you a few examples: cochlear implants; coronary artery stents; endoscopic devices; new and exciting classes of drugs, like PD-1 inhibitors for late stage melanoma; new vaccines, like the zoster vaccine and the multistrand meningococcal vaccine. They all cost money, but there is a time delay and a cost delay in getting them into Australian hospitals and into Australian patients. Time costs money. A review, a quarter of a million dollars and 18 months or two years led to the farcical situation that people needing new cochlear implants in Australia were getting the base model yet there were two improvements in other models that have been available overseas for a couple of years. It was a similar situation with new coronary artery stents; we want the very best for the Australian patient.

That is the problem. I will just bring to the House's attention to what we have already done. With our red tape review we have already achieved many cost-reductions in the health portfolio by looking at unnecessary red tape. Hearing Services Australia now has an online portal for 600,000 customers and 220 businesses that interact with them. TGA submissions are already now delivered online—they were not before. So that is 24,000 items—and 170 businesses interacting with TGA can now do it all online. Research grant submissions and monitoring alone is also online. PBS script supply and claiming is being streamlined between private and public hospitals. The regulatory red-tape burden for pharmacies making claims on the PBS have had the threshold lifted to $10,000 from $5,000. All these generate cost savings to the department, hence the taxpayer, which means there is more money to spend on the actual drug or device delivery.

With this review the most important thing to remember is that we are not going to replace TGA. The sovereign sign-off of Australian approval is critical. We have a gold standard; TGA approval is well regarded around the world, and going through TGA approval is a great marketing tool for any device or any medicine, and that is because we are so rigorous. But that rigour can use stuff that has been done already. Not only do we have to do that, but also the investment and growth of our $4 billion pharmaceutical industry and medical device industry relies on us being competitive with other countries. Our R&D tax regime is effective, but our development of IP and data exclusivity is way inferior to other countries, and that is something we also need to put on the table. (Time expired)

Nick Champion (Wakefield, Australian Labor Party) Share this | Link to this | Hansard source

I commend the member for Bennelong for this motion and I pay tribute to all the other speakers. I think it has been a sensible debate about this review into the TGA and about some of the issues that the industry is facing; the need to maintain a rigorous patient-first TGA that puts the safety of people first, both for medicines and for medical devices.

The shadow minister made it clear in his speeches that one of the key things we are looking for in all these processes is certainty. And that is exactly what we have not seen from the government. Today is a classic example of the uncertainty that they have thrown into the mix for the people of Australia. It has spread from health outwards into other areas of government. Of course we know they have worried every general practitioner in Australia and every patient of a general practitioner in Australia with their GP tax or their 'co-payment'; first of all it was $7 and then it was an attack on fee-for-service models for general practice. We know tremendous uncertainty was introduced into people's primary healthcare arrangements. We know our pharmaceuticals have been driven up. We know there are $80 billion in cuts; $50 billion in health. We know that there is a scoping study into the privatisation of Australian Hearing. There are many people out there who are uncertain about the services that they will get. The very good services that are currently provided by Australian Hearing may be privatised, and of course the uncertainty related to that is very worrying for all of those Australians with a hearing issue. They have introduced unparalleled uncertainty into the healthcare of all Australians and those working within the health sector.

We have heard Cochlear talked about a number of times. In late January—30 January this year—I paid a visit to the Australian Hearing Hub, which I think is in the electorate of Bennelong, at Macquarie University. With Doug Cameron, I had the opportunity to meet with a number of organisations, and I would just like to list them and thank them for welcoming us and giving us such a great demonstration of all of the really wonderful things that are happening out there in research, technology, service provision and of course jobs and exports in this area. We had the opportunity to meet with: Macquarie Speech and Hearing Clinic, Centre for Cognition and its Disorders, Cochlear, The Shepherd Centre, Royal Institute for Deaf and Blind Children, Sydney Cochlear Implant Centre and Australian Hearing and National Acoustic Laboratories.

As I said before, it is hard not to be very impressed indeed by the Hearing Hub and the services that are provided there, and the research that is being done there—not just into hearing but into its effects on cognition and its relationship with other cognitive disorders, like Alzheimer's. I learnt a lot about the research they are doing—world-leading research, cutting-edge research and research that is reliant on government commitment in part, a commitment to the services provided by Australian Hearing. This centre, the Hearing Hub, was created with money out of the higher education infrastructure fund and with research grants from the ARC.

So we know that these institutions are tremendously important. We know that TGA is particularly important. Regarding regulation in this area, as the shadow minister said, we should hasten slowly. We should be very cautious about calls for efficiency; we should allow this review to be undertaken. We should be calm and methodical. And we should give certainty to people, because people need certainty around Medicare, they need certainty around their GP services, around primary care, and they need certainty around the operation of the TGA. With that, I commend the motion to the House.

Debate adjourned.