Bridget McKenzie (Victoria, National Party, Minister for Regional Communications) Share this | Hansard source

I'd like to thank senators for their contributions to the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. The amendments in this bill provide for a number of reforms to Australia's therapeutic goods regulatory framework, to ensure it remains well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods. We all know how important medicines and medical devices are to the wellbeing of all Australians. We also know how important it is to ensure that the therapeutic goods available in Australia are of an acceptable safety, quality and efficacy, and that Australia's regulatory framework for therapeutic goods remains current with the rapid pace of innovation in the development of health products globally.

These amendments continue the implementation of the government's response to the Expert Review of Medicines and Medical Devices Regulation, which indicated support for 56 of the 58 recommendations for reforms to the regulatory frameworks for medicines, medical devices, complementary medicines and advertising of therapeutic products. The expert panel review was informed by a large number of submissions—in the order of 100—as well as a number of consultations held by the expert panel with stakeholders. Individual panel members also held informal discussions with stakeholders and their representatives.

In implementing the government's response, the department, through the TGA, has undertaken a number of significant public and targeted stakeholder consultations regarding the approaches for the implementation of the recommendations. Sixteen public consultations have been released to date, with feedback indicating general support for the overall policy changes. Stakeholders also provided advice on how best to implement the reforms. A stakeholder information day was held at the TGA offices on 4 September 2017 on this amendment bill. Approximately 60 stakeholders attended, representing consumers, health professionals, sponsors, broadcasters and advertising bodies.

In considering the Expert Panel Review of Medicines and Medical Devices Regulation, the government formed the view that overall the reforms strike the right balance between consumer protections and reducing regulatory burden for companies importing or manufacturing new medicines, medical devices or complementary medicines. The measures in this bill provide significant reforms in relation to establishing a provisional approval pathway for promising new medicines that address an unmet client need, allowing patients to have earlier access to potentially lifesaving or life-transforming medicines. The regulation of complementary medicines provides consumers with more informed product choices via a new assessment pathway which allows for efficacy-assessed-listed complementary medicines and introducing a streamlined approach to the advertising framework for therapeutic goods, coupled with improved compliance and monitoring provisions. Amendments enabling the greater use of assessments from comparable international regulators will allow for medical devices to reach our market sooner.

In considering these bills in the Federation Chamber on 25 October 2017, the member for Makin, the shadow minister for Medicare, Mr Zappia, indicated the Australian Labor Party's support for the bill. He indicated they did so because they agree that, on balance, the reforms are in the public interest, and we are pleased that that support has continued here in the Senate. We had extensive feedback from key stakeholders as part of the Senate Community Affairs Legislation Committee inquiry into the bill and from many senators here today.

The government has listened to this feedback, and further measures will be introduced to reassure Australians that they can have confidence in the regulation of medicines and medical devices. These include further strengthening provisions relating to advertising, including improved governance through the establishment of a therapeutic goods advertising committee, and performance management to ensure stakeholders have visibility and transparency of the advertising system. These additions will help to ensure that appropriate safeguards are in place in relation to the advertising of therapeutic goods to the public. Furthermore, to address concerns associated with the move away from pre-approval of advertisements to a self-regulated regime, we have agreed to some minor amendments that will see the transition from the pre-approval delayed for two years. We've also agreed to some non-statutory initiatives, including an evaluation of the system after 18 months. I understand the amendments agreed to with Labor are being circulated now, and I thank Labor and the crossbench for their engagement on this issue.

This overhaul of the advertising framework will provide consistency, transparency, and stronger compliance measures, and will retain a consultative approach to ensure that consumer protections are maintained. While we've focused on advertising, the bill, importantly, includes a package of reforms to the regulation of medicines and medical devices that provides benefits to consumers. Of particular benefit is establishing a provisional approval pathway for certain promising new prescription medicines. This will allow Australian patients with inadequate treatment options to access potentially lifesaving or life-transforming medicines up to two years earlier than under the current framework, and it builds on similar approaches available to patients in Europe and in North America. Some medicines will be registered on the basis of early clinical data which provides promising evidence that the medicine is likely to be of major therapeutic advantage to Australian patients. Provisional registration will be time limited and subject to strict conditions imposed by the TGA, including the requirement to collect more data to confirm the clinical benefit and safety of the medicine, and there will be specific communication with patients and healthcare professionals about these medicines.

The introduction of the provisional approval scheme for medicines will enable desperately ill patients to access new medicines up to two years sooner. Importantly, the bill will also provide patients with greater access to medical devices. Improved access to new medical devices will also be enabled through the use of assessments from comparable international regulators that will allow for medical devices to potentially reach our market sooner. There will be streamlined public awareness of products that support public health, such as tests for sexually transmitted diseases.

This bill, coupled with the recent amendments enacted last year, will strengthen Australia's therapeutic goods regulatory framework, ensuring it remains at the forefront to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

Debate adjourned.

Ordered that the resumption of the debate be made an order of the day for the next day of sitting.