Helen Polley (Tasmania, Australian Labor Party, Shadow Parliamentary Secretary for Aged Care) Share this | Link to this | Hansard source

This bill amends the Therapeutic Goods Act 1989, mainly to support recommendations of the expert panel review of medicines and medical devices. The review reported in two stages in 2015 and contained 58 recommendations, and I understand the government supports all but two. This bill supports eight key recommendations.

Specifically, the bill will: ensure a greater consistency in the regulation of different classes of therapeutic goods; streamline the approval process for new medicines, medical devices and conformity assessment certificates in Australia, providing patients with faster access to these goods and medicines; enable regulations to be made so Australian notified bodies will be able to appraise the suitability of the manufacturing process for medical devices manufactured here in Australia; enable Australian notified bodies to consider whether such medical devices meet relevant minimum standards for safety and performance; make minor amendments to the act to reduce health risks or health regulations; allow certain unapproved therapeutic goods that are currently accessed by applying to the Secretary of the Department of Health to be made more easily obtainable by practitioners; adopt a risk-based approach to the management of variation to medicines by allowing certain kinds of variations that do not impact the quality, safety or efficiency of medicines to be made by the notification to the Therapeutic Goods Administration rather than requiring the approval of the secretary; allow practitioners the opportunity to notify the secretary within 28 days of having supplied therapeutic goods to their patients, rather than requiring pre-approval; allow the TGA to develop a more comprehensive post-market monitoring system for medicines and medical devices; provide review and appeal rights for persons who apply to add new ingredients to use in listed complementary medicines; reduce regulatory burden; reduce health risks to the public or make other more minor changes; enable the cancellation of registered or listed therapeutic goods from the register if the sponsor of the goods has supplied false or misleading information in relation to their application; strengthen post-marketing powers, recalls and public notifications and the obtainment of information about therapeutic goods; allow the secretary to reinstate therapeutic goods to the register that were cancelled, if the goods were cancelled for non-payment of annual charges and, if, principally, the sponsor has paid the charge; develop criteria for developing and identifying certain therapeutic goods that are not registered that may be able to be supplied to patients, other than those who are gravely ill, by notification to their TGA rather than, as is the case currently, requiring the prior approval of the secretary; allow the secretary to require manufacturing licence holders to provide informational documentation upon request; allow conditions on the inclusion of kinds of medical devices in the register to be either prescribed by a regulation or set out in a legislative instrument made by the minister to bring the situation in relation to conditions for medical devices in line with registered or listed; and, ensure the capacity to refuse to list in the Australian Register of Therapeutic Goods, the ARTG, medical products that have potential to undermine Australia's public health efforts. We require listed medical products to only include ingredients that have been approved for use in listed products. These are complex regulatory reforms. However, put simply, where the regulation of medicines and medical devices can be streamlined, they should be—provided that safety and quality is maintained. Increased use of assessment by comparable overseas regulators and work-sharing arrangements with those regulators have the potential to reduce duplication of effort. The aim is to provide faster access to new medicines and medical devices, which are often crucial for people whose health and wellbeing worsens each day they wait for access. That is why Labor will be supporting the bill.

Although we support the bill, Labor nevertheless has important concerns that we wish to highlight. It is absolutely critical that the government gets this right. Most of the substantive detail will be dealt with in regulations. High-profile failures of medical devices have been a feature in recent years and, therefore, the outsourcing of conformity assessments to Australian notified bodies rather than being undertaken by the TGA is a source of concern. We do not know if these bodies will be commercial for-profit businesses, not-for-profit organisations or a combination of both. In the case of a business which exists to make a profit for its shareholders, caution is needed if it is to be given a role which could induce a conflict of interest. Labor is aware that the government has proposed strengthening post-market monitoring and surveillance to mitigate this concern. But we do not know the detail and it is, therefore, not possible to determine if those enhanced measures will be adequate. We also do not know how the Australian notified bodies will be chosen, nor do we know how they will be monitored. These risks are very real.

We only need to look at the past month to see major and potentially life-threatening issues with medicines and medical devices. Four batches of lifesaving anti-allergy EpiPens have recently been recalled because it was discovered they may fail to activate. Approximately 80,000 EpiPens—300 microgram adrenaline auto-injectors, which are used to counter allergic reactions to some foods, medications, and insect stings and bites—were recalled because they may have contained a defective part. That could result in patients not receiving their required dose of adrenaline, which could exacerbate symptoms for users. That could be the difference between life and death.

Earlier in March, the TGA ordered the recall of more than one-quarter of the 40 home pregnancy kits on the market because almost 20 per cent of those tested failed to work properly. There is the case reported last year of a Western Australian man who lost his liver after taking freely available weight-loss protein powders and supplements. That man needed an emergency liver transplant after taking the powder that contained green tea extract and a supplement containing garcinia cambogia. The latter is a tropical fruit that can in certain circumstances cause liver failure, even in moderate doses.

After one of the most extreme and disturbing examples of health issues after the use of a medical device, a Senate inquiry has commenced into the approval of pelvic mesh devices. These devices were developed in Australia during the 1980s and 1990s to assist women dealing with incontinence after childbirth and have led to some shocking outcomes. Their use has led to one of the largest medical civil court cases in Australia's history. We know that many women who had mesh inserted have been left with appalling injuries—needing to have vital organs removed—and a bleak medical future. Further back in 2009 there was an issue with metal-on-metal hip replacements which were discontinued in Australia ahead of a world-wide recall some eight months later. I have just cited a handful of cases—one of them affecting women—right across the country that we all hope and expect to be closely looked at by the TGA. These issues when they arise will inevitably cast regulatory agencies across the globe in a poor light, rightly or wrongly. In some of these cases the TGA has itself faced criticism from some quarters. Nevertheless, the TGA has a reputation for identifying safety issues ahead of other regulators.

It is never going to be possible to ensure that nothing ever goes wrong with medicines and medical devices. However, on account of the extreme consequences on patients when things do go wrong, we need to ensure that the risk is properly managed and kept to an absolute minimum. Striking the right balance between ensuring that patients do not face unnecessary long waiting times for medicines and medical devices that are life-changing or perhaps even lifesaving and ensuring that they are safe is extremely difficult. If nothing else, examples like these show just how difficult that task can be.

The regulatory system needs to have the trust of the health professionals, consumer organisations and the most important people: the patients. That trust can only be maintained and strengthened if reforms are implemented in a thorough and careful manner. We will consider the examples of adverse effects on patients that have occurred under existing the regulatory regime that indicate that any reforms need to be closely scrutinised. For that reason Labor did seek to have this legislation referred to the Senate Community Affairs Legislation Committee. The committee handed down its report earlier in recent weeks. The committee recommended that the bill be passed, and, as I outlined earlier, Labor will support the bill. We support it on the principle that the expert panel reviews the recommendation. However, as the committee heard, so much of the detail of the implementation has been left to regulations. The most significant issues seem to occur with medical devices; consequently, most of our concerns centred on schedule 2 of the bill, which deals with the conformity assessment for medical devices. We therefore will be paying particularly close attention to regulations made under schedule 2.

We know that different regulatory agencies around the world have different standards. The European system is considered to have less stringent standards than those applying under the US system and, consequently, high-risk devices are more often approved in the EU before they are approved in the US. The European system has come under some criticism for patients being harmed by devices which were not adequately tested. We need to be very careful to learn from the experiences of overseas regulators rather than repeat the same mistakes.

In ensuring these reforms expedite access to therapeutic goods without compromising safety, we also need to make sure that the TGA has adequate resources and capacity to do its job. Special care needs to be taken that shifting the workload away from the TGA does not result in a loss of expertise or reduce its ability to respond when major public health issues arise. Health and medicine are one area we should approach with caution.

There will always be a need to produce new therapeutic goods and not to unduly delay their release, but first and foremost we need to make sure they are safe. Labor reserves its right to scrutinise the regulations closely, as I have said, and to disallow any regulations that do not strike an appropriate balance between fast access and safety.

Stirling Griff (SA, Nick Xenophon Team) Share this | Link to this | Hansard source

I rise to very briefly speak on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. The aim of this bill is to streamline regulatory approvals of medicines and medical devices without compromising the safety and quality of the therapeutic goods available in Australia. It supports the 2015 recommendations made by the expert panel review of medicines and medical devices regulation to reduce the regulatory burden on industry and on medical practitioners and to help patients to access new medicines and medical devices faster.

Some of the key changes include fast-tracking medicines, medical devices and therapeutic goods to priority patients by removing the requirement for TGA approval in cases where the goods have a history of safe use overseas. If passed, the bill will also allow the Secretary of the Department of Health to delegate power to private companies to undertake conformity assessments of medical devices to ascertain whether evidence shows a device is safe, acceptable and performs as intended. These assessments will then be used to decide whether the item should be included in the Australian Register of Therapeutic Goods. In essence, these are sensible moves, as long as there is absolutely no compromise to patient safety as a result. The Department of Health did provide assurances to us during the inquiry stage that there will be no compromise to standards by fast-tracking approvals. Priority processing would entail the same level of scrutiny, but the order of processing would give preference to urgent requests.

We support efficiencies, which is why we are broadly supportive of this bill. Having said that, we have questions and concerns about how these reforms will be put into practice. The fact of a regulatory role being outsourced to private entities gives us pause for thought. Whenever regulatory power is vested in private hands, we very much need to take a close look at it to ensure that it does not give rise to potential conflicts of interest or market-distorting powers. We appreciate that there is a benefit in providing timely decisions to industry and patients, but we have concerns about the secretary being able to delegate powers to external decision-makers. It raises a range of questions, such as: what happens in the rare circumstance when the wrong decision is made and a faulty or unsafe item gets through the net? How will indemnity be provided for this, for instance? What degree of risk and responsibility will be delegated to third-party conformity assessors? How will any potential conflicts of interest—or worse, collusion—be monitored and rooted out? What process will be used to assess the suitability of delegated bodies and to ensure that there is no potential conflict, such as direct or indirect links to a manufacturer, over the conformity assessments they will conduct? Again, we need to ensure that streamlined approvals and faster access to therapeutic goods do not come at the expense of patient safety.

In saying that, we recognise that the majority of submissions made to the Senate community affairs legislation committee inquiry actually supported the proposed reforms and wanted to see the bill passed. This support came from a broad spectrum and included patient advocacy groups such as Rare Cancers Australia, the Consumers Health Forum, medical device bodies, manufacturers and practitioner groups. While we still have to see the entirety of what is being proposed, it would be churlish to stand apart and reject this bill, given that the regulations would be disallowable and parliament could intervene if any of our concerns come to pass. Any unintended compromise to our robust regulatory system through these amended measures would amount to a false economy, with potentially significant consequences. We will need to remain vigilant to ensure that these reforms operate as intended.

To end, I would like to note that senators have been asked to consider an amendment to section 52 of the Therapeutic Goods Act to effectively have electronic nicotine delivery systems, or ENDS, treated in the same way as tobacco in the Poisons Standard. NXT acknowledges that there is an inconsistency with how ENDS are treated compared to cigarettes and other nicotine products, but this is a much more complex issue than it appears at first glance and deserves to be considered in more depth than this amendment allows.

Nigel Scullion (NT, Country Liberal Party, Minister for Indigenous Affairs) Share this | Link to this | Hansard source

I would like to thank senators for their contribution to the debate on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016.

The measures contained in this bill will support the implementation of eight key recommendations of the Expert Review of Medicines and Medical Devices Regulation, which aim, in particular, to enable faster access to important new medicines and medical devices for Australian patients, as well as to streamline administration and reduce regulatory burden in several areas. Some of the streamlined processes, for example, replacing the need for pre-approval with notification for some variations to products that do not affect product safety, will lower cost to industry and potentially customers through decreased TGA fees. The bill will also enable regulations to be made to allow Australian companies to undertake conformity assessments of medical devices, make it easier for doctors to prescribe unapproved products with a safe history of use to patients, give sponsors of complementary medicines review and appeal rights when decisions are made about proposed new ingredients for listing complementary medicines, and will enable regulations to support accelerated access to certain vital and lifesaving prescription medicines, which may be available to Australian patients up to three months faster than under the current framework.

The reforms in the review cover far-reaching aspects of the regulatory framework for therapeutic goods, including prescription medicines, complimentary medicines, medical devices, advertising and enhanced post-market monitoring in order to realise the benefits to industry and consumers as soon as practicable. The government is committed to a staged approach to implementation over 18 to 24 months, with a second bill covering further reforms expected to be introduced in the 2017 winter sittings. I commend the bill to the House.

Question agreed to.

Bill read a second time.