Wednesday, 17 June 2020
National Vocational Education and Training Regulator Amendment (Governance and Other Matters) Bill 2020, Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020; 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—
NATIONAL VOCATIONAL EDUCATION AND TRAINING REGULATOR (GOVERNANCE) AMENDMENT BILL 2020
The Australian vocational and education training (VET) sector is a vital engine that drives the Australian economy. The VET sector supports millions of students each year to obtain skills and expertise for success in future employment and further education. It provides agile pathways for people to enter the workforce, upskill or reskill.
VET qualifications and training need to be of a high standard to ensure they are trusted by students and employers and benefit the wider Australian community.
Delivering excellence in training lies at the heart of the Australian Government's skills agenda. That is why in October 2019, this Government announced reforms to the agency responsible for regulating the VET sector - the Australian Skills Quality Authority (ASQA).
The Government has committed $18.1 million towards reforms to enhance ASQA's engagement with the VET sector and ensure its regulatory approach is fair, transparent and effective. The reforms respond to the Braithwaite and Joyce reviews which both called on ASQA to adopt a greater educative role and improve its regulatory approach.
The first phase of reform is a rapid review of ASQA's governance, culture and processes which commenced in November 2019. The review is evaluating the effectiveness of ASQA's internal regulatory practices and processes, including how ASQA makes and reviews decisions. The review is due for completion in March this year and will inform a longer term program of improvements to support ASQA's continued evolution as a modern and effective regulator.
While the review is ongoing, initial work focussed on ASQA's governance. The regulatory experts undertaking the review evaluated the alignment of ASQA's current governance arrangements with best practice guidelines and arrangements of comparable bodies across Australia and recommended a revised model for ASQA to support effective, modern, fit-for-purpose governance.
The revised governance model in the Bill draws on best practice for Commonwealth regulators. It replaces the existing three commissioner structure with a single agency head, to be known as the Chief Executive Officer (CEO) of ASQA. This will enable the CEO to perform a role more consistent with that of the head of an agency, including leading ASQA's long and short-term strategy and making top-level managerial decisions that determine the organisation's objectives, resources and policies. This will be supported by a revised organisational structure which will better allocate and clarify operational responsibilities and improve regulatory decision-making.
Further, the Bill establishes a statutory Expert Advisory Council to advise the CEO of ASQA. The Advisory Council fills a gap at the strategic level. Rather than representing particular stakeholder or jurisdictional interests, the Council will provide ASQA with access to expert strategic advice to help it to continuously improve as a regulator while maintaining its independent regulatory decision making. The Council will also create a mechanism for meaningful sector engagement and demonstrate ASQA's commitment to ongoing improvement and learning from the expertise of others.
The members of the Advisory Council will bring to the table diverse skills such as expertise in regulation, communications, delivering training, and experience operating a training provider. To ensure the right mix of people and skills, I will seek out the views of the Ministerial Council for Skills before appointing the Chair or members to the Advisory Council. The Advisory Council will not be a decision-making body but rather a valuable source of strategic advice, a vehicle for confidential information-sharing and a strong foundation for stakeholder confidence in the regulator.
The revised governance model will enhance ASQA's organisational capability and support best practice regulation, continuous improvement and effective engagement with the VET sector. The changes will facilitate a shift towards a regulatory approach which focuses on combining educating and engaging with registered providers to foster excellence, and compliance monitoring and enforcement. The revised governance arrangements will hold ASQA in good stead to address future challenges such as changes to its internal practice, enhancements to ASQA's educative role, and the significant reform anticipated in the VET sector over the coming years.
The Bill also includes information sharing arrangements that support use of data collected by the National Centre for Vocational Education and Training (NCVER) under the Act. Improved information sharing will support governments and regulators, so that the diverse needs and requirements of all Australians, including groups with different needs, such as people with disability and those where English is not a first language, are considered in policy, funding and regulation.
Promoting quality in the system will ensure that VET is valued as a legitimate and reliable pathway enabling individuals to achieve personal and professional development, and industry to access a work-ready skills base with consistent, relevant and nationally recognised knowledge and skills.
Quality regulation is integral to ensuring the training system is equipped to deliver high quality student outcomes and to efficiently adapt to changing skill needs, labour market fluctuations and developing technologies. These reforms will benefit not only ASQA, but also the providers they regulate, VET students, graduates, employers, and the Australian economy at large.
The Bill is another critical step in this Government's reform process to support ASQA's continued evolution as a transparent and balanced regulator that engages effectively with stakeholders and builds quality in the VET sector.
This Bill supports the delivery of the highest quality healthcare for Australians by:
There are also a number of minor, unrelated measures outlined in the Bill, to reduce regulatory burden or make other improvements to regulation.
This Bill implements three main measures.
First, the Bill amends a number of foundational medical device definitions to support the closer alignment of the regulation of medical devices in Australia with the EU framework, and more broadly with the global regulation of medical devices.
In particular, the Bill ensures that the definition of 'medical device' expressly covers software, implants and reagents. This reduces uncertainty around the definition of medical devices as those intended to be used for the prediction or prognosis of disease, the investigation, replacement or modification of a pathological process or state, the support of conception and the in vitro examination of specimens derived from the human body for a specific medical purpose. The Bill also brings the 'accessory' and 'system or procedure pack' definitions more into line with the EU terms.
These changes are designed to assist efforts to improve access for Australian consumers to new medical devices, by identifying Australia as a market that is closely aligned with the EU and for which access may be sought by device manufacturers and sponsors without delay, following EU approvals of their products. They also support recommendation 20 of the Expert Panel Review of Medicines and Medical Devices Regulation, agreed to by the Australian Government in its Response to the Review in September 2016, in relation to aligning the regulation of medical devices in Australia with the EU, wherever possible. These changes improve the clarity of these definitions which, in turn, supports better regulatory compliance for industry sponsors and manufacturers of medical devices.
Secondly, the Bill enables the Secretary to provide scientific advice to an applicant about prescription and over the counter medicines – before they submit a formal application to the TGA for marketing approval.
In some instances, it can be difficult for sponsors of medicines to determine the nature of information needed to support an application for registration, particularly in relation to whether a bioequivalence study is needed for a generic prescription medicine or what is required to justify not submitting a bioequivalence study. This uncertainty may risk sponsors investing considerable time and resources on evidence that is not needed, or providing insufficient evidence resulting in applications being rejected. Both instances may delay consumer access to new medicines and savings to the public through availability of generic brands.
To better support the timely availability of medicines for Australians, the Bill allows the applicant to request non-binding, scientific advice on prescribed aspects of the safety, quality or efficacy of a registrable medicine. While it is anticipated that initially this will focus on bioequivalence issues, the new power would allow a range of matters relevant to safety, quality or efficacy to be prescribed in the regulations.
The advice will be non-binding in that an applicant who requests such advice may apply for registration of a medicine regardless of the advice given in relation to the medicine. However, the TGA will be required to have regard to such advice when evaluating a medicine for registration. This will ensure that, in addition to helping medicine sponsors to have greater confidence about the requirements for an application, the advice will also directly support and streamline any subsequent application for registration.
Thirdly, the Bill introduces a data protection regime for assessed listed medicines – these are lower risk complementary medicines that are assessed in relation to their efficacy claims before they are given marketing approval.
This regime is based on the existing data protection regime in the Therapeutic Goods Act for innovator prescription medicines, and provide 5 years' protection for clinical trial information that a sponsor submits in support of an indication (i.e. health condition) for an assessed listed medicine. This will be in cases where the information is not currently publicly available and no other medicine has that indication at the time the application for listing is made. This will mean that a sponsor of another assessed listed medicine will not be able to utilise the same information in the evaluation of its own medicine during that 5-year period.
This measure is designed to provide an incentive for sponsors of assessed listed medicines to invest in clinical trials research and innovation and, in so doing, to improve the competitiveness of the Australian complementary medicines industry.
Other, minor matters
The Bill also contains a number of other, minor measures, to reduce regulatory burden, improve the consistency of regulatory requirements or make other minor changes to remove spent and redundant provisions, correct headings and codify a long-standing condition of marketing approval for registered and listed therapeutic goods.
These include changes to:
Ordered that the bills be listed on the Notice Paper as separate orders of the day.