The PRESIDENT (Senator the Hon. Scott Ryan) took the chair at 10:00, read prayers and made an acknowledgement of country.
Fair Work Amendment (Repeal of 4 Yearly Reviews and Other Measures) Bill 2017
The cycle of almost continuous review sits uncomfortably with the stated objective in the Act of a modern awards system that is 'simple, easy to understand, stable and sustainable'.
(1) Clause 2, page 2 (table item 3, column headed "Provisions"), omit "3 and 4", substitute "3, 4 and 5".
[protecting take ‑home pay for all workers]
(2) Page 19 (after line 23), at the end of the Bill, add:
Schedule 5—Protecting take ‑home pay for all workers
Fair Work Act 2009
1 At the end of Division 2 of Part 2 ‑3
Add:
135B Protecting penalty rates
(1) A penalty rate in a modern award cannot be varied to make the penalty rate lower than that in force under the award on 30 June 2017.
(2) From the commencement day, a determination of the FWC made on or after 22 February 2017 that would reduce a penalty rate in a modern award so that the penalty rate would be lower than that in force under the award on 30 June 2017 has no effect.
(3) In this section:
commencement day means the day on which Schedule 5 to theFair Work Amendment (Repeal of 4 Yearly Reviews and Other Measures) Act 2017 commences.
2 At the end of section 193
Add:
Effect of removing or reducing penalty rates—award covered employees
(8) Despite anything else in this section, an enterprise agreement that is not a greenfields agreement does not pass the better off overall test under this section if:
(a) a penalty rate under the relevant modern award for an award covered employee, or a prospective award covered employee, is removed or reduced under the agreement; and
(b) because the employee usually works, or will usually work, on a day in relation to which a penalty rate is payable under the relevant modern award, the removal or reduction in the penalty rate disproportionately affects the employee as compared with employees who do not usually work on that day.
Effect of removing or reducing penalty rates—prospective award covered employees
(9) Despite anything else in this section, a greenfields agreement does not pass the better off overall test under this section if:
(a) a penalty rate under the relevant modern award for a prospective award covered employee is removed or reduced under the agreement; and
(b) because the employee will usually work on a day in relation to which a penalty rate is payable under the relevant modern award, the removal or reduction in the penalty rate will disproportionately affect the employee as compared with employees who will not usually work on that day.
3 Application of item 2
The amendment made by item 2 of this Schedule applies in relation to enterprise agreements made on or after the commencement of the item.
… I am breaking ranks with the government, and I do so for a number of reasons. First of all, legislation concerning people's livelihoods and their ability to put food on the table should be considered very carefully. It must be fair and it must be fair for all.
Penalty rates exist in awards for specific reasons. They recognise the fact that Saturdays and particularly Sundays are not like other days of the week. These are the days when children are not at school. These are the days when children participate in sporting, family and other activities.
These are the days when the majority of working Australians take time off.
Weekends are important.
… on Sunday, in fact, this penalty rate cut will take effect – 700,000 of the poorest-paid people in the country are going to have an effective pay cut.
Given the broad assumptions made, the 700,000 figure is not credible and far too high, but no one really knows what the net effect will be.
Senator Collins did not vote, to compensate for a vacancy caused by the resignation of Senator Nash.
Senator Canavan did not vote, to compensate for a vacancy caused by the resignation of Senator Kakoschke-Moore.
Senator Brown did not vote, to compensate for a vacancy caused by the resignation of Senator Parry.
The committee divided. [10:49]
(The Chair—Senator Lines)
Senator Collins did not vote, to compensate for a vacancy caused by the resignation of Senator Nash.
Senator Canavan did not vote, to compensate for a vacancy caused by the resignation of Senator Kakoschke-Moore.
Senator Brown did not vote, to compensate for a vacancy caused by the resignation of Senator Parry.
The committee divided. [10:53]
(The Chair—Senator Lines)
That this bill be now read a third time.
Senator Brown did not vote, to compensate for the vacancy caused by the resignation of Senator Parry.
Senator Collins did not vote, to compensate for the vacancy caused by the resignation of Senator Nash.
Senator Smith did not vote to compensate for the resignation caused by the vacancy of Senator Kakoschke-Moore
The Senate divided. [11:05]
(The President—Senator Ryan)
Superannuation Laws Amendment (Strengthening Trustee Arrangements) Bill 2017
Try working in your local bakery where a customer paws the girl behind the counter (for girl she is, in Year 10 in her first job, and she's being told she has luscious lips). Or a customer waits to rape the woman locking up the shop at night. Try stacking shelves while some arsehole rubs his unzipped pants across your buttocks. Or dealing with a customer whose only request of you is to have "quick sexual intercourse", or with a customer who is buying a Bluetooth speaker for the shower and suggests you have a shower with him. Or the young retail worker approached by two twenty-something guys who said they were doing a bet.
"They needed me to give them a kiss. I felt very awkward and confused as my training instructs me to be polite and acquiesce to customers, but I felt violated. After a few minutes of awkwardness a colleague saw I was distressed and when they spoke to her she awkwardly told them I had other work to do, so they left."
… providing for independent directors shouldn't diminish the representation of members but actually enhance it.
So, rather than the model being broken, I think this is the 21st-century answer to our highly successful superannuation system—how we can govern it better and, most particularly, how we can make people who are forced to save into it feel confident that the standards of governance is at or near world's best practice.
… for funds in the equal representation frame at the moment, the reform is sympathetic to that model in the sense that they merely need to rearrange themselves … to allow for one-third representation by independent directors. To me, that does not disrupt the benefits of equal representation: you still have member representatives and employer representatives—
… I don't draw a great distinction between the structures of corporate governance; I'm more concerned about the reality of it.
Where you've got proprietors or sponsors that are heavily involved in the board … there's a tendency for the skills metrics to be less relevant.
A system that is trusted with the retirement savings of all Australians needs the highest standards of governance ...
The inclusion of independent directors is widely recognised as a critical element of good corporate governance.
… providing for independent directors shouldn't diminish the representation of members but actually enhance it. So, rather than the model being broken, I think this is the 21st-century answer to our highly successful superannuation system—how we can govern it better and, most particularly, how we can make people who are forced to save into it feel confident that the standards of governance is at or near world's best practice.
When a governing body sits to serve the interests of the people it's meant to serve, it shouldn't be constrained by peripheral interests. That's why, in my view, independence is very important—independence from the executive and independence from peripheral interests.
The AICD considers that introducing a requirement for at least one-third of the board to be comprised of independent directors will strengthen governance within the superannuation sector.
This is compulsory legislation, therefore the level of trust and accountability must not be less than what … corporations in Australia apply, it should be greater.
What really got up my goat … on Sunday was to hear the Prime Minister of this nation say there were no federal issues that affected the state election. That's just a joke.
Turnbull is the problem, the Prime Minister is the problem.
The banking royal commission was a big win for the National Party …
The Commonwealth government commit to voluntarily acquire property and land which is no longer fit for purpose due to PFOS/PFOA contamination …
That so much of the standing orders be suspended as would prevent me moving a motion to provide for the consideration of a matter, namely a motion to vary the order of the Senate of 30 November 2017, relating to the hours of meeting and routine of business, and that it may be moved immediately and determined without amendment or debate.
Omit "and determined without amendment or debate".
Senator Collins did not vote, to compensate for a vacancy caused by the resignation of Senator Nash.
Senator Singh did not vote, to compensate for a vacancy caused by the resignation of Senator Kakoschke-Moore.
Senator Brown did not vote, to compensate for a vacancy caused by the resignation of Senator Parry.
The Senate divided. [15:36]
(The President—Senator Ryan)
Senator Collins did not vote, to compensate for a vacancy caused by the resignation of Senator Nash.
Senator Singh did not vote, to compensate for a vacancy caused by the resignation of Senator Kakoschke-Moore.
Senator Brown did not vote, to compensate for a vacancy caused by the resignation of Senator Parry.
The Senate divided. [15:39]
(The President—Senator Ryan)
That a motion to vary the order of the Senate of 30 November 2017, relating to the hours of meeting and routine of business, may be moved immediately and determined without amendment or debate.
That the order of the Senate of 30 November 2017 be varied to omit the following bills:
Treasury Laws Amendment (Improving Accountability and Member Outcomes in Superannuation Measures No. 1) Bill 2017
Superannuation Laws Amendment (Strengthening Trustee Arrangements) Bill 2017
Treasury Laws Amendment (Improving Accountability and Member Outcomes in Superannuation Measures No. 2) Bill 2017.
Senator Collins did not vote, to compensate for a vacancy caused by the resignation of Senator Nash.
Senator Singh did not vote, to compensate for a vacancy caused by the resignation of Senator Kakoschke-Moore.
Senator Brown did not vote, to compensate for a vacancy caused by the resignation of Senator Parry.
The Senate divided. [15:44]
(The President—Senator Ryan)
That the Senate take note of the answers given by the Attorney-General (Senator Brandis) and the Minister for Employment (Senator Cash) to questions without notice asked by Senators McAllister and Cameron today relating to remarks made by the Deputy Premier of New South Wales and to evidence given at supplementary Budget estimates hearings of the Education and Employment Legislation Committee.
That the Senate take note of the answer given by the Attorney-General (Senator Brandis) to a question without notice asked by the Leader of the Australian Greens (Senator Di Natale) today relating to political donations.
That if the bills listed in theSenate Order of Businessof 30 November 2017 varying the routine of business have been finally considered then general business order of the day No. 57, which is the Taxation Administration Amendment (Corporate Tax Entity Information) Bill 2017, be considered on Thursday, 7 December 2017 at the time for private senators' bills.
That leave of absence be granted to the following senators for personal reasons:
(a) Senator Collins for today; and
(b) Senator Gallagher for 5 December 2017.
That the following matter be referred to the Foreign Affairs, Defence and Trade References Committee for inquiry and report by 29 November 2018:
The United Nations Sustainable Development Goals (SDG), with particular reference to:
(a) the understanding and awareness of the SDG across the Australian Government and in the wider Australian community;
(b) the potential costs, benefits and opportunities for Australia in the domestic implementation of the SDG;
(c) what governance structures and accountability measures are required at the national, state and local levels of government to ensure an integrated approach to implementing the SDG that is both meaningful and achieves real outcomes;
(d) how can performance against the SDG be monitored and communicated in a way that engages government, businesses and the public, and allows effective review of Australia's performance by civil society;
(e) what SDG are currently being addressed by Australia's Official Development Assistance (ODA) program;
(f) which of the SDG is Australia best suited to achieving through our ODA program, and should Australia's ODA be consolidated to focus on achieving core SDG;
(g) how countries in the Indo-Pacific are responding to implementing the SDG, and which of the SDG have been prioritised by countries receiving Australia's ODA, and how these priorities could be incorporated into Australia's ODA program; and
(h) examples of best practice in how other countries are implementing the SDG from which Australia could learn.
That the Senate—
(a) notes that 3 December 2017 will mark the 25th anniversary of International Day of People with Disability, and the United Nations’ theme for 2017 International Day of People with Disability is 'Transformation towards sustainable and resilient society for all'—the overarching principle of this theme is to 'Leave no one behind' and to empower people with disability to be active contributors to society;
(b) further notes that people with disability must first have full access to justice, healthcare, infrastructure, education and employment, as outlined in the United Nations 2030 agenda for Sustainable Development Goals; and
(c) calls on Commonwealth, state and territory governments to ensure that people with disability are able to realise their right to participate fully and equally in Australian society as a whole.
That the Senate—
(a) notes:
(i) that this week is National Asbestos Awareness Week,
(ii) the success of this week’s Asbestos Safety and Eradication Summit, which was hosted by the Asbestos Safety and Eradication Agency at Old Parliament House in Canberra, in reviewing what has been achieved in coordinating and implementing the 2014-18 National Strategic Plan and setting the scene for the next phase of asbestos safety and eradication in Australia’s next National Strategic Plan, and
(iii) that the Government has not committed to ongoing funding for the Asbestos Safety and Eradication Agency;
(b) further notes:
(i) the ongoing importance of the Parliamentary Friendship Group on Asbestos Related Diseases in raising awareness in Parliament of the asbestos scourge,
(ii) that Australia has one of the highest rates of mesothelioma in the world,
(iii) that as many as 40 000 Australians will be diagnosed with an asbestos-related disease in the next 20 years, and
(iv) that Australians are being exposed to a wide range of imported goods and materials containing asbestos that are not being detected by our customs services, including fibre cement sheets and children’s crayons; and
(c) supports:
(i) the 2017 Asbestos Awareness Month national campaign which aims to inform homeowners, renovators, tradespeople and handymen about the dangers of asbestos in and around homes and how to manage it safely, and
(ii) the recommendations in the recent interim report of the Economics References Committee, Protecting Australians from the threat of asbestos , inquiring into the effects of non-conforming building products on the Australian building and construction industry.
That the Senate—
(a) notes that:
(i) 1 December 2017 is World AIDS Day, which is held every year to raise awareness about the issues surrounding HIV/AIDS, and to show support for people living with HIV,
(ii) while significant advancements in treatment and diagnosis have been made over the past 30 years, HIV/AIDS remains a major health concern worldwide and in our region,
(iii) the most recent data shows that:
(A) in 2016, 36.7 million people were living with HIV globally, and 1.8 million people became newly infected,
(B) in 2016, in the Asia-Pacific, 5.1 million people were living with HIV, the largest population outside Africa, and 270 000 people became newly infected, representing 15 per cent of all new infections, and
(C) our nearest neighbour, Papua New Guinea (PNG), has high rates of HIV infection – UNAIDS estimates there are 46 000 people living with HIV in PNG, including 3,000 children under the age of 14,
(iv) HIV infection rates are highest among certain populations, including sex workers, people who inject drugs, transgender people, prisoners, and men who have sex with men – the discrimination and stigma faced by these populations often prohibit them from accessing HIV prevention and treatment services,
(v) Australia is one of the few countries that advocates for HIV treatment and prevention and rights for these populations,
(vi) Australia also plays an important role in the fight against HIV in the Asia-Pacific and is committed to the 90-90-90 treatment targets and the Sustainable Development Goal (SDG) target 3.3 to end the HIV epidemic by 2030, and
(vii) globally, 11 million people living with HIV receive anti-retro viral therapy treatment through Global Fund supported programs, comprising more than half the total number of people on treatment worldwide; and
(b) recognises that:
(i) Australia has a long bipartisan history of supporting the fight against HIV in our Indo-Pacific region – over the past decade successive Australian Governments have provided over one billion dollars to support HIV-specific programs through the aid program,
(ii) access to quality health care services for HIV treatment is a challenge in PNG, where budget, population growth, urbanisation, and remoteness constrain service delivery,
(iii) Australia is committed to strengthening PNG’s HIV prevention and treatment activities and has invested in HIV interventions working to reduce sexually transmitted infections and HIV, and increase access to HIV prevention and treatment,
(iv) Australia recognises the commitment and engagement of local PNG community organisations and their supporters who have worked on HIV education and service delivery in the region for many years,
(v) Australia benefits from our support to PNG health because a healthy, prosperous region is in Australia’s interest,
(vi) Australia recognises that good health and strong and resilient health systems support productive societies and economic growth, and
(vii) Sustainable Development Goal (SDG) 3, healthy lives and wellbeing for all, includes target 3.3, to end the HIV epidemic by 2030 – to achieve this target we need to continue our strong support for action against HIV in our region.
That the Senate—
(a) notes that: (i) on 3 December 2017, the world observed International Day of People with a Disability, an opportunity to focus on how society can strive for inclusivity through the removal of barriers for people with disabilities,
(ii) the theme of this year’s International Day of People with a Disability is ‘Transformation towards sustainable and resilient society for all’ – this reflects an ambition, grounded in the 2030 agenda for Sustainable Development Goals, to empower people with disabilities to be active contributors to society through increasing access to justice, infrastructure and accessible communities,
(iii) people with a disability are the largest and most disadvantaged minority in the world and make up approximately 15 per cent of the global population – around 80 per cent of all people with a disability live in a developing country,
(iv) in developing countries, people with disabilities and their families are more likely to be poor and remain poor because of higher living costs, barriers to education, health and employment opportunities, and unpaid caring responsibilities,
(v) to be effective in reducing poverty, development efforts should be led by and must actively include and benefit people with disabilities, and
(vi) Australia’s Development for All Strategy is being implemented through the Australian aid program and through our diplomatic efforts – it aims to improve the quality of life of people with disabilities through: (A) enhancing participation and empowerment of people with disabilities as contributors, leaders and decision-makers in the community, government and the private sector,
(B) reducing poverty among people with disabilities, and
(C) improving equality of people with disabilities in all areas of public life, including service provision, education and employment; and
(b) recognises that:
(i) Australia is committed to protecting and strengthening civil society, including disabled people’s organisations, internationally,
(ii) Australia is widely regarded internationally as a global leader in many areas of promoting disability inclusive development and disability rights, and
(iii) the 2017 Foreign Policy White Paper identifies the promotion of the rights of persons with disabilities as a key focus for Australia’s term on the United Nations Human Rights Council.
(d) calls on the President of the Senate to revoke permission for Mr Yiannopoulos to speak at Parliament House.
That the Senate—
(a) acknowledges:
(i) the contributions of charities and not-for-profit organisations in Australia and their advocacy on issues that matter to Australians, including human rights, social services, foreign aid and development, environmental protection and medical research, and
(ii) the important role these organisations and their advocacy play in Australia’s democracy;
(b) notes the Government’s attempts to limit their ability to engage in advocacy on the matters and causes they champion; and
(c) expresses its support for these charities and not-for-profit organisations and their advocacy.
That the Senate—
(a) notes the dire humanitarian situation in Yemen where 21 million Yemeni are reliant on humanitarian assistance;
(b) observes this is being made worse by the ongoing disruption to the free movement of lifesaving humanitarian assistance with the United Nations Office for the Coordination of Humanitarian Affairs raising grave concern about the impact on the capacity to respond to the continued cholera outbreak and the growing incidents of diphtheria;
(c) welcomes reports that United Nations planes and a single ship have been given access to Yemen in recent days, allowing much needed humanitarian supplies to be distributed;
(d) believes that, with 7 million Yemeni on the brink of famine and estimates of 130 children dying daily, it is imperative all parties ensure the free entry and movement of lifesaving humanitarian assistance within Yemen; and
(e) calls on all parties to heed the calls of the United Nations and international non-government organisations operating in Yemen to allow the free movement of humanitarian and commercial trade.
At the end of paragraph (e), add:
", and in particular, reiterates the UN’s call for the Saudi-led coalition to fully lift its blockade of Yemen’s Red Sea ports, so as to avoid devastating famine."
That the Senate—
(a) acknowledges that the Federal Government is continuing to advance plans to locate a federal radioactive waste facility in regional South Australia;
(b) notes that all three sites under consideration are actively contested by community members, and that the project in its current configuration is inconsistent with South Australian law;
(c) notes that around 95 per cent of the waste planned for any future federal facility is currently in secure storage at two existing federal sites; and
(d) calls on the Federal Government to advance responsible radioactive waste management by committing not to impose any federal facility on an unwilling community, acting in a manner consistent with state laws and leading practice, and facilitating an open review process to explore the range of long-term future management options.
That the Senate—
(a) notes that, according to:
(i) census data, the proportion of renting households in housing stress, whose reference person is aged 65 years or over, has risen from 31.7 per cent in 1996 to 54.2 per cent in 2016,
(ii) the 2017 report Older People at Risk of Homelessness in New South Wales, since 2012, the number of households in housing stress in receipt of Commonwealth Rent Assistance, whose reference person is aged 65 years or over, has increased 53.7 per cent, and
(iii) the Society of St Vincent de Paul, women aged 55 or over make up the fastest growing group of people experiencing homelessness; and
(b) calls on the Federal Government to:
(i) raise real levels of funding for homelessness services and social housing,
(ii) work with stakeholders to ensure the specific needs of older people are addressed in National Housing and Homelessness Agreement negotiations with states, and
(iii) review the Commonwealth Assistance with Care and Housing Sub-Programme to ensure it is meeting the needs of Australia’s ageing population.
The Senate divided. [16:44]
(The President—Senator Ryan)
That the Senate—
(a) notes that:
(i) the Prime Minister is responsible for the decision to abandon optical fibre and instead deploy a second-rate National Broadband Network (NBN),
(ii) NBN Co abandoned use of the Optus Hybrid Fibre Coaxial (HFC) infrastructure because it was deemed not fit for purpose,
(iii) NBN Co has announced the company will immediately halt the HFC rollout because the technology is delivering poor service quality,
(iv) NBN Co has indicated up to 2 million homes could have their NBN connection delayed by 6 to 9 months because of the mismanagement of the HFC rollout, and
(v) it is nearly 2018 and the NBN still does not work properly; and
(b) calls on the Minister for Communications to:
(i) stop attacking the Australian Broadcasting Corporation, and instead focus on making the NBN work, and
(ii) apologise to the 48 000 households and small businesses in the electorate of Bennelong who are currently scheduled to be served by the unreliable HFC network.
The Senate divided. [16:50]
(The President—Senator Ryan)
That the Senate:
(a) notes that the Prime Minister:
(i) has failed to represent people in northern and regional Queensland,
(ii) has failed to connect with people in northern and regional Queensland and identify with their values, and
(iii) is only concerned with Brisbane and the south-east; and
(b) applauds Senator Macdonald for calling out the Prime Minister's neglect of northern and regional Queensland.
The Senate divided. [16:54]
(The President—Senator Ryan)
It is the proper duty of a representative body to look diligently into every affair of government and to talk much about what it sees. It is meant to be the eyes and the voice, and to embody the wisdom and will of its constituents. Unless Congress have and use every means of acquainting itself with the acts and the disposition of the administrative agents of the government, the country must be helpless to learn how it is being served …
… to watch and control the government: to throw the light of publicity on its acts …
In practice, it is rare for a committee to order the attendance of a witness because it is rare for anyone to refuse a committee’s invitation to give evidence.
There is not a crime, there is not a dodge, there is not a trick, there is not a swindle, there is not a vice which does not live by secrecy.
That the Senate take note of the document.
Men still dominate the faces around these top tables and the data suggests boards are not engaging with gender equality issues. As the guardians of organisational strategy, boards must step up if we are to continue building momentum for change.
That Senator Steele-John be appointed as a participating member of the Joint Standing Committee on the National Broadband Network.
Question agreed to.
Defence Legislation Amendment (Instrument Making) Bill 2017
Treasury Laws Amendment (Housing Tax Integrity) Bill 2017
Foreign Acquisitions and Takeovers Fees Imposition Amendment (Vacancy Fees) Bill 2017
Veterans' Affairs Legislation Amendment (Omnibus) Bill 2017
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017
Therapeutic Goods (Charges) Amendment Bill 2017
That these bills may proceed without formalities, may be taken together and be now read a first time.
That these bills be now read a second time.
1. Introduction
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 Act 1989 to support the continued implementation of the Government's response to theExpert 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.
2.3 Advertising
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.
Conclusion
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 theTherapeutic 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.
National Disability Insurance Scheme Amendment (Quality and Safeguards Commission and Other Measures) Bill 2017
That the Senate take note of the report.
That the Senate take note of the report.
Treasury Laws Amendment (Reducing Pressure on Housing Affordability Measures No. 1) Bill 2017
First Home Super Saver Tax Bill 2017
To provide income in retirement to substitute or supplement the age pension.
It is emphasised that this measure is yet to be legislated, and under the current law it is not possible to withdraw superannuation contributions to buy a house. Therefore, if the law does not get enacted, any voluntary contributions made for the purpose of withdrawing them under this scheme, will remain in superannuation until such time that they would ordinarily be able to be released.
… there is no room in Australia for a party of reaction. There is no useful place for a policy of negation.
We took the name Liberal because we were determined to be a progressive party, willing to make experiments, in no sense reactionary, but believing in the individual, his rights, and his enterprise, and rejecting the Socialist panacea.
… we have nothing but the warmest human compassion—towards those … compelled to live upon the bounty of the State …
The home is the foundation of sanity and sobriety; it is the indispensable condition of continuity; its health determines the health of society as a whole.
… in most material difficulties, the rich can look after themselves.
… provide income in retirement to substitute or supplement the age pension.
We see, from time to time, a lot of fiddling at the margin—
with propositions around how to make first home buyers' lives easier, which appear substantially to just drive up the price of property rather than deal directly with the issue.
It's hard to think of any government policy that has been pursued for so long, in the face of such incontrovertible evidence that it doesn't work, than the policy of giving cash to first home buyers in the belief that doing so will promote home ownership.
And to make matters worse, the proposed diversion of these savings into housing would simply push up the price of the current stock of properties. It would add to demand while doing nothing to supply.
To date the HBP—
has been used about 2.5 million times, with roughly $30 billion removed from savings and investments and ploughed into real estate. When combined with dirt-cheap mortgage rates … it's helped push home prices into the clouds.
In other words, if you think letting people steal money from their financial futures in order to buy houses today which they really can't afford is going to make real estate more affordable, you've been spending too many evenings with the goat. The opposite is probable. In Canada, it's fact.
… there is a war on our roads and we have to keep working together to win each of the battles. Like any war, it needs a national focus, it needs a national response, and it needs national leadership. We have to battle together for funds, we have to battle our own internal bureaucratic systems, and we have to battle complacency. On that point, I fear we've become too accepting of the casualties on our roads. We seem almost resigned to the bloodshed. We seem immune to the horrific losses we sustain on a daily basis, and perhaps that comes from the mistaken belief that it won't happen to us, that I'm a good driver, it won't affect me. But as each and every person in this room knows, it affects us all.
Road crashes are a major cause of death and injury in Australia, and incur costs estimated to be in excess of $6 billion annually.
Some 160,670 lives have been lost—
… this death toll greatly surpasses the aggregate Australians killed in the four major wars in which this country has been involved (89,850 deaths). Whereas this should be an ongoing cause for concern to all Australians, it is worth noting what has been achieved in eliminating the problem.
Whichever graph you study, it shows there are about 90,000 people alive today who would have been dead without the work of scientists, engineers, road safety lobbyists and politicians who refused to accept the industry's propaganda that the fault lay with the drivers.
It is faster, cheaper and more enduring to build operationally safe and crash-worthy automobiles that will prevent death and injury than to build a policy around the impossible goal of having drivers behave perfectly at all times under all conditions in the operation of a basically unsafe vehicle and often treacherous highway conditions.
… it's important not to lose sight of smaller improvements that could more immediately save lives and reduce injuries and economic costs of highway crashes.
… elements of self-driving car systems, such as adaptive cruise control, lane-departure warnings and head-on collision-avoidance systems, could reduce road deaths by up to one-third if these were available on every car in the U.S. Other researchers have confirmed the benefits of these incremental automotive innovations, but they're not universal yet. For instance, only 6 percent of new cars in model year 2017 have lane departure warning as a standard feature.
A re-established Federal Office of Road Safety to coordinate the national policy response to the ongoing deaths and injuries caused by road crashes—
Improved data collection — To help identify gaps in road safety and measure success.
Promoting best practice and research — All states and territories should be equipped with the tools to address emerging and critical issues in road safety—
Funding of land transport infrastructure — Proven risk assessment methods such as AusRAP should be used to prioritise projects which have a positive road safety outcome to put risk assessment at the heart of strategic decisions on road improvements, crash protection and standards of road management.
Safer vehicles — Ongoing Government funding should be provided for ANCAP to continue conducting independent crash tests and vehicle safety assessments. Resourcing should also be provided to engage in proactive assessment of international developments which may affect the Australian Design Rules.
… changes in diet and reductions of losses in the food supply chain, have a significant, but uncertain, potential to reduce GHG emissions from food production …
A substantial reduction of impacts would only be possible with a substantial worldwide diet change, away from animal products.