Monday, 4 December 2017
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, Therapeutic Goods (Charges) Amendment Bill 2017; Second Reading
That these bills be now read a second time.
I seek leave to have the second reading speeches incorporated in Hansard.
The speeches read as follows—
Australians rely on medicines and medical devices to prevent, treat or cure their illnesses, injuries and conditions. The Therapeutic Goods Administration (TGA), as regulator, enables the therapeutic goods available in Australia to be of an acceptable safety, quality and efficacy and that the latest therapeutic advances are available to the Australian public when they need them.
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 builds on recent amendments to the Therapeutic Goods Act1989 to support the continued implementation of the Government's response to the Expert Panel Review of Medicines and Medical Devices Regulation.
The Review assessed the regulatory framework for medicines and medical devices in Australia, providing a number of recommendations aimed to position the TGA to effectively respond to the increasing globalisation of the therapeutic goods industry, expectations from patients that they should have access to new medicines and medical devices at the same time as their peers in Europe and North America, and to the rapid pace of innovation in the development of health products. It is imperative that we update the regulatory framework for medicines and medical devices in Australia, ensuring it remains in a position to continue to support the availability of high quality, safe and efficacious products in a timely way to the community.
2. Summary of the Bill
This Bill provides for:
This Bill will build on the recent changes enacted through the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017.
2.1 Provisional Approval Pathway
First, this Bill will establish a provisional approval pathway for certain promising new prescription medicines. This would allow Australian patients with inadequate treatment options to access potentially life-saving or life-transforming medicines up to two years earlier than under the current framework. It builds on similar approaches available to patients in Europe and North America.
Such medicines would be registered on the basis of early clinical data which provides promising evidence that the medicine is likely to be a major therapeutic advance for 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. A number of enhancements to the TGA's post-market monitoring scheme are being implemented in parallel. These do not require further legislative changes, but will be important to monitor the safety of provisionally registered medicines.
2.2 Use of overseas assessments for medical devices
Medical devices will also potentially reach the market sooner through the greater use of overseas assessments afforded by this Bill. Under the amendments, the work of comparable overseas regulators will be accepted as evidence when determining whether a medical device should be included on the Australian Register of Therapeutic Goods. Provision of an additional pathway for seeking approval for inclusion in the Register provides the potential for faster access to market for industry and therefore earlier access of innovative devices to address specific needs of patients.
To strengthen the regulation of advertising of medicines and medical devices, while also reducing regulatory burden, this Bill will overhaul the current structure for therapeutic goods advertising into a more streamlined framework.
Industry will no longer have to navigate an often complex co-regulatory system which has incomplete coverage, as it requires only some medicine advertisements to be approved prior to publication or broadcast.
Similarly, advertising complaints can be heard by multiple bodies and currently take many months or longer to resolve. Instead, the shift will be to a single, centralised complaint handling system managed by the TGA, and enhanced enforcement and compliance powers to deter inappropriate or misleading advertising of therapeutic goods. This will be supported by better education and guidance for advertisers, to encourage greater understanding of and compliance with the advertising regulatory framework.
2.4 Compliance powers
To further protect consumers, this Bill looks to strengthen and broaden the current range of investigation and enforcement powers under the Act. Powers relating to monitoring, investigation, infringement notices and injunctions will be standardised to align with comparable Commonwealth regulators and contemporary government policy.
The changes will allow for a graduated approach to compliance and enforcement and provide the TGA with a full suite of sanctions and penalties to protect public health – this includes such things as more ready use of infringement notices for minor offences while at the same time providing the regulator with the ability to seek a court injunction for more serious matters.
2.5 Complementary medicines
The reforms to the complementary medicines regulatory framework will also lead to increased information on the products and stronger protections for consumers. This Bill provides for a list of permitted indications from which industry sponsors must exclusively select when entering a listed complementary medicine on the Australian Register of Therapeutic Goods.
Only low level, pre-approved claims will be permitted for these products.
This Bill will also provide sponsors of listed complementary medicines with a new assessment pathway that bridges the gap between existing listed and registered complementary medicines. Sponsors will have the option of utilising this pathway for indications that address more than the most minor of conditions. Under this pathway, the TGA will assess the evidence of efficacy that supports the proposed indication and make a decision whether or not to approve the complementary medicine product for the market.
Complementary medicines assessed via this new pathway will be eligible to contain information on the packaging and advertising material to indicate that the product has been assessed by the TGA for the approved indication. This new pathway is intended to encourage greater development of evidence relating to complementary medicines; increase consumer confidence in the evidence around product efficacy; and improve competitiveness of the sector.
3. Other changes from the Review
A number of other recommendations from the Review, which are being implemented without the need for legislative changes, also aim to strengthen consumer protections.
3.1 Better reporting of adverse events
The TGA will create a means for more efficient reporting and analysis of adverse events, work with other stakeholders to analyse electronic data (including myHealth records) to detect adverse events, and have the powers to inspect companies to check that they have systems for timely action on adverse event reports for their products.
3.2 SME Assist
A further initiative to encourage innovation has been the establishment of SME Assist which I launched on 9 June 2017. SME Assist provides targeted tools and content to help small and medium enterprises and research and development groups developing new medicines and new medical devices to navigate the complex regulatory system, to help in getting Australian technology to the market and helping patients sooner.
This Bill contains a number of other supporting amendments which are intended to provide consistency across the different types of therapeutic goods. Further details of the measures are available in the explanatory memorandum.
The overwhelming stakeholder support for these reforms is evident from the many consultations undertaken—right from the initial stages of the Review, through to consultations on options on how to implement the relevant recommendations and on the exposure draft of the Bill in response to which there were a small number of revisions.
I want to thank:
The changes outlined in this Bill, coupled with the recent amendments already enacted, will strengthen Australia's therapeutic goods regulatory framework, ensuring it remains well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
This is our opportunity to make significant reforms to the regulation of therapeutic goods in Australia. Reforms that will ensure better access to medicines, streamlined administrative processes, and stronger consumer protections. Reforms that will ensure Australia remains at the forefront of therapeutic goods regulation, now and into the future.
The Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017 amended the Therapeutic Goods Act 1989 to allow Australian corporations to be designated as Australian conformity assessment bodies. Once designated, these bodies will be able to undertake conformity assessments of manufacturers of medical devices.
The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 further amends the Therapeutic Goods Act to make it clear that an annual conformity assessment body determination charge is payable by the Australian corporation that is the subject of a determination.
This bill makes consequential amendments to the Therapeutic Goods (Charges) Act 1989 to enable regulations to be made to specify the relevant amount of the charge. Different charges may apply depending on the scope of the conformity assessment body determination.
The introduction of such a charge will ensure that the Department of Health, through the Therapeutic Goods Administration, is able to recover the costs of its post-market monitoring activities of conformity assessment bodies, which will ensure the safety and performance of the devices assessed by those bodies.
The bill also provides that where the Secretary suspends a conformity assessment body determination, the obligation for the conformity assessment body to pay an annual charge will continue during this period. This is because a suspension is temporary and during the suspension period the usual regulatory work in relation to the determination continues.
The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 also establishes a new provisional approval pathway for promising new prescription medicines. This bill clarifies that annual charges prescribed in relation to provisionally registered goods, will also apply to any provisionally registered goods entered in the Australian Register of Therapeutic Goods by Commonwealth officers in accordance with a corresponding State law. Similar provisions are currently in the Charges Act in relation to registered goods, listed goods, biologicals and medical devices.