Stirling Griff (SA, Nick Xenophon Team) Share 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.