Tim Hammond (Perth, Australian Labor Party) Share this | Hansard source

I too rise to speak to the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 and I thank my honourable members for their contribution to this debate. This bill is principally a measure to cut red tape. It consolidates, streamlines and reorganises a number of the rules, regulations and processes around the approval of therapeutic goods in a way that is aimed to get medicines and other goods to patients when they need them. I aim to speak with some more specificity in a moment about the merits, or otherwise, of the measures in the bill, but let's start at first principles.

From the consumer affairs perspective, there are significant product safety considerations when assessing for approval any new therapeutic good. Therapeutic goods are products used in humans in connection with preventing, diagnosing or treating an illness or injury; testing a person; affecting conception; pregnancy testing; or replacing or modifying parts of the anatomy. They range from paracetamol to condoms, prescription drugs and prosthetic feet. But product safety concerns do not exist in a vacuum. When a patient is dying or suffering pain, the calculus changes—and so the role of the Therapeutic Goods Administration in approving and regulating these goods, which requires specialist knowledge and skill as well as a robust regulatory environment.

In terms of the mechanics, therapeutic goods are assessed by the TGA and then entered into the Australian Register of Therapeutic Goods before they can be sold. TGA takes a risk based approach to regulation, focusing on high-risk medicines like prescriptions, which must be registered. Lower risk therapeutic goods such as sun screens or vitamins may be listed if the applicant certifies that the claims about the effectiveness of the product are accurate and that certain standards are met regarding ingredients, quality, labelling and packaging. So the TGA relies upon applicant certification with a compliance regime for low-risk therapeutic goods but does a direct evaluation for high-risk goods. It should be noted too that certain programs allow products that are not on the register. For example, the Special Access Scheme allows import or supply of unapproved goods for a single patient. This is linked to the single patient's doctor. The TGA monitors products that are approved. This includes risk management plans; collecting reports of adverse events or reactions; audits; and environmental scanning for safety issues.

I would now like to go through some of the provisions of this bill individually because I think it is important to consider the balance between product safety and patients' therapeutic needs. This bill amends the Therapeutic Goods Act 1989 primarily to support some of the key recommendations of the Sansom review of medicines and medical devices, which reported in 2015. The review's intent was to reduce unnecessary duplicative or ineffective regulation without jeopardising the safety or quality of therapeutic goods. The review also aimed to position Australia to respond to emerging global trends. Two reports were provided in 2015. The first report had 32 recommendations, including to expand pathways for sponsors to seek approval, the enhancement of post-marketing monitoring and improvements to the transparency and predictability of TGA decision-making. The second report focused on complementary medicines and advertising and made 26 recommendations, including around improving market approval and advertising requirements and streamlining the advertising framework. The then health minister responded to the report formally last year, agreeing to a majority but not all of the recommendations in those two reports.

Whilst Labor is supportive of the aims of this bill, some of the specifics are probably not ideal. Fast access to new medicines and medical devices is critical for people whose health and wellbeing worsens each day, and then they are required to wait for access. Furthermore, duplication of effort is wasteful and, again, should be avoided where it can. That is why Labor will be supporting the bill. Labor will also be watching very closely the development of regulations as yet undrafted—and I will come back to that—and it is important that regulatory regimes around consumer safety are monitored on an ongoing basis.

Specifically, the bill will ensure greater consistency in the regulation of different classes of therapeutic goods; streamline the approval process for new medicines, medical devices, biologicals 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 would be able to appraise the suitability of the manufacturing process for medical devices that are manufactured in Australia; enable Australian notified bodies to consider whether such medical devices meet relevant minimum standards for safety and performance; allow certain unapproved therapeutic goods that are currently accessed by applying to the secretary of the Department of Health to be more easily obtained by practitioners; adopt a risk based approach to the management of variations to medicines by allowing certain kinds of variations that do not impact the quality, safety or efficacy of medicines to be made by notification to the TGA 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 to allow the TGA to develop a more comprehensive post-market monitoring scheme for medicines and medical devices ; provide review and appeal rights for people who apply to add new ingredients for use in listed complementary medicines; and 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. This ought to protect consumers and, hopefully, reduce breaches of the Australian Consumer Law in relation to therapeutic goods.

The bill will also serve to strengthen post-marketing powers, recalls and notifications and the obtaining of information about therapeutic goods. This is particularly important from a consumer affairs/public safety point of view. The bill will 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 in the register that may be able to be supplied to patients other than those who are gravely ill by notification to the TGA rather than, as is the case currently, requiring the prior approval of the secretary; require manufacturing licence holders to provide information or documents upon request; allow conditions on the inclusion of kinds of medical devices in the register to be either prescribed by 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'; ensure the capacity to refuse to list on the Australian Register of Therapeutic Goods—

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