Tony Zappia (Makin, Australian Labor Party, Shadow Parliamentary Secretary for Manufacturing) Share this | Hansard source

Thank you, Mr Deputy Speaker! The Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016 primarily implements eight recommendations of the expert panel review of medicines and medical devices, which handed down its stage 1 report, which dealt with the regulatory frameworks for medicines and medical devices, in March 2015, and its stage 2 report, which dealt with the regulatory framework for complementary medicines and the advertising of therapeutic goods, in July 2015. The two reports contained 58 recommendations, of which the government, I understand, supported 56. I understand the government proposes additional legislation to deal with other recommendations in that report.

The intent of the expert panel review was to identify areas of regulation of medicines and medical devices that could be streamlined without compromising the safety, efficacy and quality of therapeutic goods available in Australia. The bill establishes a framework for the provision of regulations or legislative instruments that will enable the fast-tracking or expediting of the assessment and approval process of therapeutic goods.

The Therapeutic Goods Administration has existed for over 26 years. It has oversight of a large number of medicines, medical devices and complementary medicines. As at April 2016, the Australian Register of Therapeutic Goods had around 87,000 entries. Over those 26 years, there have been several changes to the TG Act to ensure it continues to be appropriate for the changes occurring in society, and, in 2002, medical devices were included in the act. Australian consumers rely on the TGA to ensure that the health products they use are safe. They put their trust in the TGA assessment, as do health professionals who prescribe, select or recommend the medical products. The implications of a poor assessment of a product can be very serious. There is a balance required between expediting the TGA's process and maintaining the safety, quality and efficacy of products. The reforms proposed by this legislation are substantial and complex. The critical details of the reforms will be in the ensuing regulations and legislative instruments, which we have yet to see.

I note that the bill was introduced by the government with a five-minute second reading speech, which I believe did not do this legislation justice. Furthermore, whilst the government advises that the regulations will be subject to extensive consultations, we do not know what consultations are proposed and with whom. If indeed consultations have already taken place, who was consulted and what were the outcomes? There are too many unknowns, and it is impossible to know whether the balance that is necessary will be achieved. The Senate Standing Committee for the Scrutiny of Bills raised similar concerns about the broad delegation of legislative power and the significance of the matters in the delegated legislation. The committee also highlighted further concerns about strict liability offences, reversal of the burden of proof and abrogation of the privilege against self-incrimination. That is why the bill was also referred to the Senate Community Affairs Legislation Committee.

Whilst we will be supporting this legislation, we do so with several reservations, which I will outline shortly. Australia's Therapeutic Goods Administration rates very well when compared with overseas regulatory authorities. For example, median approval times for new active substances are 391 days, or about five weeks longer than the fastest performing authority, Health Canada. Quoting directly from the expert panel's review:

According to the TGA's key performance indicators report for the period July to December 2014, 100% of new applications were processed within the statutory timeframe of 255 working days.

Whilst making the TGA approval process more efficient is strongly supported, expediting the process should not in any way raise the level of risk to consumers. In the past there have been cases of medical products being found to have serious adverse effects or failing to perform as expected.

In April 2010, the TGA recalled silicone breast implants manufactured by French company Poly Implant Prothese, otherwise known as PIP. The implants had been used in Australia since 1999. Concerns had been raised that the implants had a higher rupture rate. Investigations by French authorities found the manufacturer had been using a cheaper, industrial-grade silicone, which was not approved. I also understand that in 2013 the founder of PIP was sent to prison for four years and received a fine of 75,000 euros. Regulators around the world came to different conclusions and responded with different advice to patients on whether people who had the implants but had not yet experienced problems should have them removed. The TGA states on its website:

These investigations have not found any evidence to suggest that the risks involved with the use of PIP breast implants are any greater than those for any other brand of silicone gel-filled breast implants.

Expert advice provided to the TGA has concluded that the currently available scientific evidence does not support a recommendation to routinely remove (explant) PIP implants from people who do not have any evidence of problems associated with their implants.

However, the French government recommended that 30,000 women in France have the implants removed. I understand that around 500 women in Australia have been part of a class action lawsuit over the implants, with many individual stories from victims who have had to have the implants removed and have been left physically scarred. Symptoms reported include large lumps appearing on the neck and chest, migraines and headaches, nosebleeds and pain. In 2014 there was also a recall of Cereform breast implants made by another French company, CEREPLAS, which had not fully validated the sterilisation process as required.

There was also the faulty DePuy ASR hip replacement, which was implanted in around 5,500 Australian patients. The supply was discontinued in Australia in December 2009, with a worldwide recall in August 2010. The metal ball was found to be grating against its socket, resulting in metal fragments high in cobalt and chromium entering the bloodstream. Many people who had the device implanted suffered from symptoms including severe pain, partial loss of vision and hearing, depression, lethargy and heart problems. Faulty hip and knee devices can leave patients with bone degeneration and metal poisoning, and they may end up confined to a wheelchair or needing limbs amputated. These are very serious medical conditions. More than 13 per cent of the people who had these implants required revision surgery. That surgery comes at an additional cost to the patients and to the health system. As well as the financial costs, surgery is never risk free. It results in time spent in hospital or convalescing. In the case of joint replacements, the patients are more likely to be elderly, and surgery will likely take a greater toll on their body.

Serious adverse effects have also been exposed with respect to medicines. In their submission to the recent Senate Community Affairs Legislation Committee inquiry, the Royal Australasian College of Physicians state:

The TGA has a strong history of identifying safety concerns before other regulators, examples of this include:

We know that patients want access to new medicines and medical products as soon as possible. Additionally, expediting the approval process will have economic benefits for the country. As noted by the expert panel, in 2013-14 Australia's pharmaceutical industry turnover was $23.4 billion, with exports of $3.89 billion. It directly employed about 41,000 people, of which nearly 15,500 were in manufacturing. The complementary medicine sector turns over between $2 billion and $3.5 billion in revenue each year and directly employs about 5,000 people in high-skilled manufacturing positions. Complementary medicines are a rapidly-growing industry sector with huge potential for overseas market growth. The medical device industry is equally important to Australia's economy. Australia's medical device industry has a turnover of around $10 billion per year. In 2013-14, Australia exported medical devices with a value of about $2.1 billion to 167 countries around the world. Australia has more than 500 medical technology companies, and they employ 19,000 people. Medical technology companies operate in a very competitive global market.

Turning to the specifics of this bill, the bill amends the Therapeutic Goods Act 1989. First, it will enable the making of regulations to establish new priority pathways for faster approval of medicines, medical devices, biologicals and conformity assessment certificates in Australia.

Second, it will enable the making of regulations to designate Australian notified bodies that would be able to appraise the suitability of the manufacturing process for medical devices manufactured in Australia and to consider whether such medical devices meet relevant minimum standards for safety and performance. This would be an alternative to the Therapeutic Goods Administration undertaking such assessments.

Third, it will allow certain unapproved therapeutic goods that are currently accessed by healthcare practitioners by applying to the secretary for approval. They will be more easily obtained by practitioners by notifying the secretary within 28 days of having supplied such goods to their patients, rather than requiring prior approval. The amendments would allow the minister to make a legislative instrument specifying which goods would be able to be accessed in this way, by which kinds of healthcare practitioners, and in what circumstances and in accordance with conditions specified in the instrument.

Four, it would provide review and appeal rights for persons who apply to add new ingredients for use in listed complementary medicines. Last, it would remove the requirement for the minister to consult the Therapeutic Goods Committee when making standards for therapeutic goods other than medical devices. The Therapeutic Goods Committee, along with three other committees, were effectively abolished by regulation on 1 January this year. I understand the TGC's role has been spread across other committees. The minister will have the option of consulting any of the other committees, but will not be compelled to do so.

The bill also includes a number of other, mostly minor, measures to provide greater consistency across the regulation of different kinds of therapeutic goods under the act, to reduce regulatory burden, to reduce health risks to the public and to make other minor changes. The reforms are intended to bring new medicines to market more quickly by entering into work-sharing arrangements with comparable overseas regulators, the increased use of assessments done by comparable overseas regulators and the implementation of expedited and provisional approvals.

With respect to medical devices, the reforms also allow for commercial bodies in Australia to be designated to undertake medical device assessments. The reliance on overseas regulators and assessments by designated commercial bodies, whether in Australia or from overseas, is not without risks. As the expert panel state in chapter 3 of their report:

In recent years the European system has been shown to have systemic weaknesses, which has led to concerns about the quality of conformity assessment undertaken by some EU notified bodies. A series of articles published in the BMJ raised a number of issues including:

I understand that there are some 70 such bodies operating currently in the EU. I understand that they are also competing to increase their profits, as one of them quite proudly mentioned in one of their reports. The fact that they are private entities with responsibilities to their shareholders raises the very concerns that are alluded to in the comments that I have just made. What comes first—their priority to their shareholders or their priority to the health and wellbeing of the people who are going to use the products which they have been tasked to assess and approve?

A report produced by the US Food and Drug Administration in May 2012 also found concerns with the European conformity assessment system, asserting that it has resulted in harm to patients through the application of less-stringent assessment standards than those that apply in the US. I quote from that report:

Because of the EU’s lower approval standard and degree of oversight, high-risk devices are more often approved first in the EU than in the US. The lack of valid evidence of effectiveness has several negative effects on patients, however. As shown in this report, the EU’s reliance on limited testing, generally without significant testing in humans, can fail to predict dangerous risks and ineffective treatment in actual use. As a result, approval of devices without a valid demonstration of effectiveness has permitted the marketing of products in the EU that turned out to cause severe harm to patients, either because the testing was inadequate to reveal the device's risks or because use of an ineffective device denied patients access to effective treatments for serious diseases. In addition, the lack of valid data on effectiveness has caused some of the biggest EU countries to delay reimbursement for some approved high-risk devices until a second, sometimes lengthy cost-effectiveness review is completed. In those cases, EU approval of a device does not necessarily mean that it is available to patients there.

The EU system for approving devices has now also come under criticism from the European medical community because of the number of devices that have turned out to be dangerous or ineffective. The medical community has also expressed dissatisfaction with the inconsistent review standards of the private bodies that approve devices in the EU and the secrecy surrounding the device approval process there.

The report goes on to say that the EU is in the process of reviewing its regulation of medical devices and that some notified bodies have had their authority to undertake assessments under the medical device directive withdrawn, while others have had the authority suspended or reduced in scope. Both of those actions suggest that the system does not always work as expected. The EU experience cannot be ignored and should serve as a warning about the risks associated with allowing private entities to undertake assessments. The expert panel also refers to concerns about the US regulatory system for medical devices.

The government also states that, as a result of the reforms, there will be enhanced post market surveillance of medicines and medical devices. How this will be done, and by whom, will be of interest, but it will inevitably require greater resources by either the product manufacturers or the TGA. This is of particular significance, given reports last year that TGA compliance staff had been reduced, that fake pharmaceuticals were being sold to consumers by organised criminal groups, and that the TGA did not have the resources to police this growing problem. Reforms to the regulation of complementary medicines include increasing the information available on the efficacy, introducing statutory time frames for the approval of new ingredients, and adopting a risk based approach to the variations of complementary medicines. There will also be a simplification of therapeutic product advertising regulations, and streamlining of the Special Access Scheme. It seems that there is a push towards self-regulation of product advertising. Again, self-regulation is not without its failings—as we have seen all too often in so many other industry bodies—which, ultimately, have led to the government having to, in some form or another, step in and correct the problems.

Lastly, I also raise concerns that the use of private commercial bodies for assessments will inevitably lead to downsizing of the TGA itself, and could lessen the ability of the TGA to perform its statutory obligations. This is a matter which the expert panel referred to in chapter 7 of their report. In particular, the report stated:

Reductions in de novo evaluations and introduction of abridged assessments for some variations will result in a reduction in NRA staffing needs, primarily highly skilled medical and scientific staff who will be difficult to replace if the need arises, especially quickly. Such a reduction, if significant enough, may undermine the NRA’s capacity to:

•   respond to sudden increases in workload, resulting in less timely evaluations of medicines and medical devices, thereby undermining one of the aims of the Review;

•   respond to emerging public health issues, such as the need to undertake recalls, manage medicine shortages, or manage major non-compliance. In these instances, resourcing would need to be redirected from other core business, which in turn will translate into reduced timeliness and responsiveness; and

•   undertake evaluations of orphan drugs or process applications for access to unregistered medicines in a timely way.

The report also raised concerns that continued investment in IT systems necessary for timely and cost-effective regulatory services may come at the expense of other activities. This is because those systems are likely to have similar costs, even if they end up being used by fewer people. If the NRA's income declines, other activities may be cut to make up the shortfall. These are serious concerns, which have not been adequately addressed. I am particularly concerned by any changes which, effectively, will reduce the ability of the TGA to continue to perform the very valuable work that it has performed over the last 26 years or so.

This is important legislation that enables changes to a complex regulatory system. The changes will mostly be made via regulations that have not been drafted, necessitating further scrutiny of the government's implementation planning once they are available. We accept that new medicines and medical devices are being developed and trialled around the world every day, and that where those products are showing encouraging results consumers want access to them as quickly as possible. If the approval process can be sped up then it should be. But in the rush to get new products onto the market, we should be confident that the people who take them are not placed at any level of increased risk. Once made, these changes will be very difficult to unwind.

This is legislation that affects most Australians. It is legislation that affects an important industry sector. It is legislation that changes longstanding practices of the TGA. The government is asking the parliament to support the legislation by saying: 'Trust us with the regulations.' We know what happens when this government says 'trust us'. In summary, Labor is concerned that the substance of this legislation will be in regulations that we have not yet seen. We therefore reserve our position on the regulations until we do see them. Labor is also concerned about the lack of detail surrounding third-party conformity assessments of medical devices. There is little information provided in this bill into the selection process of third-party conformity assessment bodies. Who will they be? What assessment process will be required of them? What oversight of the process used by the assessment bodies will be undertaken by the TGA itself? What accountability and reporting mechanism should be put in place? We have not seen any of that detail whatsoever. We are simply being asked to trust the government with respect to the regulations or legislative instruments, which effectively are the key to this legislation.

Finally, we have concerns about the details relating to post-market monitoring and what resources will be provided to the TGA for this measure. As I mentioned earlier, we already have some concerns about the scaling down of the TGA itself, which in turn will reduce its ability to carry out other functions. What resources will be provided to the TGA with respect to the post-market monitoring that is expected under the legislation? We do not know. We will wait to see what the details will be once the government provides those regulations. As I have said from the outset, Labor will support this legislation, but we do so with reservations, which I have outlined and which we reserve our right to reassess once we see both the regulations and the legislative instruments that will be brought into this place.

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