The PRESIDENT (Senator the Hon. John Hogg) took the chair at 9:30, read prayers and made an acknowledgement of country.
… recognised that assessment of the costs and benefits of options has many dimensions and cannot be based on quantifiable matters alone.
The Consultation RIS acknowledges other potential benefits of better manage packaging, including the employment generated by more recycling, reduced use of energy and water, and the provision of infrastructure to support other recycling.
What happens (in South Australia) is that instead of seeing a bit of rubbish beside the road or the beach, you see a bit of money—and (the rubbish) is gone.
Adelaide's and South Australia's waste resources management system is in some respects global best practice. South Australia has demonstrated a high level of political commitment and willingness to 'stick its neck out' and implement some policies and legislation upon which other administrations take a more conservative position.
… the collecting body of a fee does not have to be a public body for the fee to be regarded as a tax. Therefore a levy collected by a private body dictated by a statute for public purposes gives the private body a public character.
Proposed laws appropriating revenue or moneys, or imposing taxation, shall not originate in the Senate—
Coca Cola Amatil brands like Coke, Coke Zero, Diet Coke, Sprite, Lift, Mt Franklin and Mother Energy drinks prices in Adelaide and Darwin are on average 22 cents more than those in other major cities …
The Senate divided. [11:26]
(The Acting Deputy President—Senator Crossin)
That the provisions of paragraphs (5) to (8) of standing order 111 not apply to the Environment Protection and Biodiversity Conservation Amendment (Declared Fishing Activities) Bill 2012, allowing it to be considered during this period of sittings.
Purpose of the Bill
To amend the Environment Protection and Biodiversity Conservation Act 1999 (Cth) to allow the responsible Minister to prohibit a new fishing activity while an expert scientific committee undertakes a full scientific assessment of the potential impacts of the fishing activity on:
Reasons for Urgency
There is significant community concern about the impact in Commonwealth fisheries of new fishing activities that are of a size and scale greater than has previously occurred in Australian waters. Further, there is not currently a general power available under the EPBC Act to suspend such new large-scale operations from fishing pending further scientific assessment by an expert committee.
An example of such a new large-scale fishing operation is the FV Abel Tasman which is about to commence fishing in the Small Pelagic Fishery.
Urgent passage of the bill will grant the Minister power to suspend new fishing activities (where the nature of the activity is new and its potential impact warrants a precautionary approach) while an independent assessment is undertaken of the potential impacts of the new activity by an expert committee.
SELECTION OF BILLS COMMITTEE
REPORT NO. 11 OF 2012
1. The committee met in private session on Wednesday, 12 September 2012 at 7.14 pm.
2. The committee resolved to recommend—That the Migration Amendment (Health Care for Asylum Seekers) Bill 2012 be referred immediately to the Legal and Constitutional Affairs Legislation Committee for inquiry and report by 20 November 2012 (see appendix 1 for a statement of reasons for referral).
3. The committee resolved to recommend—That the following bills not be referred to committees:
The committee recommends accordingly.
4. The committee deferred consideration of the following bills to its next meeting:
(Carol Brown)
Acting Chair
13 September 2012
APPENDIX 1
SELECTION OF BILLS COMMITTEE
Proposal to refer a bill to a committee
Name of bill: Migration Amendment (Health Care for Asylum Seekers) Bill 2012
Reasons for referral/principal issues for consideration:
To hear from medical, psychiatric and psychological experts about the proposal for an independent Health Care Panel to monitor and evaluate the health and wellbeing of asylum seekers who have been sent offshore to Nauru. There are a number of experts who were familiar with issues arising from the last Pacific Solution, and who are familiar with issues arising within the current Immigration Detention Network, who will be able to provide valuable feedback into the proposal for a Panel and its functions.
Possible submissions or evidence from:
Professor Louise Newman
Professor Patrick McGorry
Asylum Seeker Resource Centre
Hotham Mission Asylum Seeker Project
Refugee Advice and Casework Service Australia
Amnesty International
Refugee Council of Australia
Australian Children's Commissioners
Chilout
Headspace
Immigration Health Advisory Group (formerly DHAG)
Foundation House
Australian Medical Association (AMA)
Royal Australian College of General Practitioners (RACGP)
Royal Australian and New Zealand College of Psychiatrists (RANZCP)
Royal Australian College of Physicians (RACP)
Australian Psychological Society (APS)
DIAC
IHMS
Forum of Australian Services for Survivors of Torture and Trauma
Salvation Army
Save the Children
United Voice
Brigidine Nuns
Victorian Refugee Health Network
Committee to which bill is to be referred:
Legal and Constitutional Affairs
Possible hearing date(s):
week beginning 22 October
Possible reporting date:
20 Not! 2012
(signed)
Senator Siewert
Whip/Selection of Bills Committee member
That leave of absence be granted to the following senators:
(a) Senators Bob Carr and Singh, from 17 September to 20 September 2012, on account of parliamentary business; and
(b) Senator Farrell, for 19 September 2012, on account of personal reasons.
No. 2 Maritime Legislation Amendment Bill 2012
No. 3 Transport Safety Investigation Amendment Bill
No. 4 Legislative Instruments Amendment (Sunsetting Measures) Bill 2012
No. 5 Statute Law Revision Bill 2012
No. 6 Customs Tariff Amendment (2012 Measures No. 1) Bill 2012
No. 7 Customs Tariff Amendment (Schedule 4) Bill 2012
No. 8 Greenhouse and Energy Minimum Standards Bill 2012
Greenhouse and Energy Minimum Standards (Registration Fees) Bill 2012
No. 9 International Monetary Agreements Amendment (Loans) Bill 2012
No. 10 Statute Stocktake (Appropriations) Bill (No. 1) 2012.
That the order of general business for consideration today be as follows:
(a) general business notice of motion No. 926 relating to the Gillard Government's budget; and
(b) orders of the day relating to government documents.
That the general business order of the day relating to the Environment Protection and Biodiversity Conservation Amendment (Making Marine Parks Accountable) Bill 2012 be considered on Thursday, 20 September 2012 under the temporary order relating to the consideration of private senators’ bills.
That leave of absence be granted to the following senator:
(a) Senator Johnstone for 13 September 2012 on account of parliamentary business.
That the following matters be referred to the Rural and Regional Affairs and Transport References Committee for inquiry and report by 29 November 2012:
(a) the findings of the Australian Transport Safety Bureau into the ditching of VH-NGA Westwind II, operated by Pel-Air Aviation Pty Ltd, in the ocean near Norfolk Island airport on 18 November 2009;
(b) the nature of, and protocols involved in, communications between agencies and directly interested parties in an aviation accident investigation and the reporting process;
(c) the mechanisms in place to ensure recommendations from aviation accident investigations are implemented in a timely manner; and
(d) any related matters.
That the Economics Legislation Committee be authorised to hold a private meeting otherwise than in accordance with standing order 33(1) during the sitting of the Senate on Thursday, 13 September 2012, from 3.30 pm.
That the Select Committee on Electricity Prices be authorised to hold a private meeting otherwise than in accordance with standing order 33(1) during the sitting of the Senate on Monday, 17 September 2012, from 4.45 pm.
That the Parliamentary Standing Committee on Public Works be authorised to meet during the sitting of the Senate on Thursday, 13 September 2012, from 5 pm, for the purpose of making an inspection.
That the following bill be introduced: A Bill for an Act to amend the Environment Protection and Biodiversity Conservation Act 1999, and for related purposes. Environment Protection and Biodiversity Conservation Amendment (Making Marine Parks Accountable) Bill 2012.
That this bill may proceed without formalities and be now read a first time.
That this bill be now read a second time.
ENVIRONMENT PROTECTION AND BIODIVERSITY CONSERVATION AMENDMENT (MAKING MARINE PARKS ACCOUNTABLE) BILL 2012
I present the Environment Protection and Biodiversity Conservation Amendment (Making Marine Parks Accountable) Bill 2012.
We face a choice in this country.
We can bumble along. Lurch from policy grab to policy grab. Adjust and realign policy settings as we get jostled by ENGOs and lobby groups.
Or we can put in place strong systems and processes. Proven over the test of time and trusted. Processes which engage the community and are based on methodical, scientific endeavour.
We know this country is bounded by the most magnificent stretches of ocean. I know this well, coming from the island state of Tasmania. It is intrinsically part of who we are.
It is possibly because of this love affair we have as a country with our oceans that Australia has built an international reputation for its management of marine areas which is absolutely second to none.
The Coalition has demonstrable record here. These are not empty words.
It was the Coalition Government in 2006 that began the process of establishing an integrated network of Marine Protected Areas around Australia’s coastline.
It was the Coalition Government that established the Great Barrier Reef Marine Park.
We are a central part of that proud history of world class environmental management.
We also support a balanced approach.
It’s not just substantial economic activity at stake. Some $2.2 billion a year recreational fishers put into the national economy. There is profound connection between our communities, our coastlines and our oceans.
We don’t believe these things are incompatible. We believe that in the overwhelming majority of cases, those things can exist harmoniously. We certainly don’t believe in locking people out of waters which are essentially theirs’.
This is now at risk though. This proud history is in danger. And that is what this amendment is about today. Restoring some commonsense. Restoring the science. Restoring some say on the part of the community.
Because that’s not where our Government is going.
We know this Government is poised to lock up great swathes of Commonwealth waters.
If left unchecked they will bring in a series of Marine Park Areas which make no real sense at all.
Because they are not based on science. They are not based on community engagement.
Instead they are based on a series of discussions which were selective. Which were secret. Which were not really representative. And were certainly not based on science. More a series of trade-offs between competing interests and brokered by the Environment Minister Tony Burke.
How do I know this? Because in my role as Parliamentary Secretary for Fisheries it’s my job. I’ve been following this black box marine park process with intense interest.
But also though personal experience.
In January this year, with my colleague, the Member for Hinkler Paul Neville, we had the chance to attend one of these sessions. The fishermen were happy for us to be there. But the Government formally refused. An open and transparent process? No. I can tell you from personal experience it has not been.
But that’s what this bill today is about. Bringing the engagement back. Bringing the science back.
To give the community to have faith in the way Marine Park Areas are nominated and managed.
This amendment will make the Government accountable. Make the Minister accountable.
It would make law that the community be consulted appropriately.
And it would establish an expert panel to review the science upon which our recent proud history of marine park management is based.
Not cynical tradeoffs. Not an exercise of political leverage and favour.
But proven experts. Reporting without fear or favour, the results of their work put on display for all to see. That’s something you can have faith in. That’s something you can trust.
So for mine the choice is pretty clear.
Do you want environmental policy which lurches from scenario to scenario.
Or a proud continuance of a recent history which has Australia rightly recognised as leading the world managing its marine areas.
I’d say that choice is pretty clear.
That the Senate—
(a) notes that Thursday, 13 September 2012 is R U OK? Day;
(b) recognises that:
(i) today, six Australians will die through suicide and more than 200 will make a suicide attempt,
(ii) one in four deaths among young people occur through suicide,
(iii) suicide is the leading cause of death for 15 to 24 year olds each year at 23.3 per cent,
(iv) suicide is the biggest killer of men under 44 and women under 34, and
(v) suicide currently ranks 15th in the overall causes of death in Australia;
(c) encourages people of all backgrounds to regularly check in with each other and ask the question, ‘Are you ok?’, because a conversation could change a life; and
(d) calls on the Government to increase efforts to raise awareness about the problems and complexity of suicide, especially among our young Australians.
That the Senate—
(a) notes:
(i) the intention of the Minister for Sustainability, Environment, Water, Population and Communities (Mr Burke) to transfer responsibility for protecting our nationally threatened species and wilderness places to state governments by March 2013, and
(ii) that the Victorian Premier (Mr Baillieu) is ready to sacrifice the endangered Leadbeater’s Possum for logging and development; and
(b) calls on the Government to retain responsibility for all major decisions on environmentally damaging projects that affect our nationally threatened species and wilderness places.
The Senate divided. [12:03]
(The President—Senator Hogg)
That the Senate—
(a) notes that 13 September 2012 is the 5th anniversary of the United Nations Declaration on the Rights of Indigenous Peoples;
(b) congratulates the Government on expressing support for this important document in 2009; and
(c) calls on the Government to continue to work towards implementing this declaration into policy and domestic law, including the ratification of the International Labour Organization Convention No. 169.
That this bill may proceed without formalities and be now read a first time.
That this bill be now read a second time.
Today I introduce a bill to amend the Commonwealth Inscribed Stock Act 1911 and the Corporations Act 2001.
This bill delivers another key plank in the Gillard Government's Competitive and Sustainable Banking Package, which the Deputy Prime Minister announced in December 2010. The overall objectives of the package are to improve consumer protection in banking services, to support smaller lenders in increasing competitive pressure on the big banks, and to secure the long-term safety and sustainability of the Australian financial system by reducing reliance on offshore wholesale funding markets.
As part of these objectives the Government has committed to fostering a deep and liquid corporate bond market. Establishing a strong and liquid retail market in the premium, AAA-rated debt security — Commonwealth Government Securities (CGS)— is a critical step in the formation of a wider retail debt market, including corporate debt. For the first time in our history, Australia has been awarded the gold-plated AAA rating from all three global ratings agencies. We are one of only 8 sovereigns around the world to achieve this with a 'stable' outlook.
Making it easier for mums and dads to invest in the safest bonds in Australia is an important step in building up their familiarity with fixed income investments more generally. It will provide retail investors with a visible pricing benchmark for investments they may wish to make in corporate bonds.
The Commonwealth Government Securities Legislation Amendment (Retail Trading) Bill 2012 contains a number of measures to facilitate trading of CGS on financial markets that are accessible to retail investors.
retail trading of commonwealth government securities
The first set of amendments contained in this bill allows retail trading of CGS to commence by making appropriate amendments to the Commonwealth Inscribed Stock Act 1911 (the CIS Act).
These amendments are required because retail trading will be conducted differently from the current practices in the wholesale market. During consultation with stakeholders it has become apparent that the most timely and cost-effective way to implement this policy is to use an existing model whereby retail investors will buy and sell beneficial interests in CGS, known as depository interests. This is a widely used model—for example, there are already over 80 types of depository interests traded on the ASX and more are expected. Based on this model retail investors will be able to buy and sell depository interests in CGS on retail markets like any other listed share. Owners of depository interests will have the same claim to payments of principal and interest as if they owned the underlying CGS itself.
As the CIS Act currently does not contemplate beneficial interests in CGS, the amendments in the bill are required to ensure that the Australian Office of Financial Management (AOFM) is authorised to make the necessary payments in connection with the issue, sale and management of depository interests in CGS.
In order to enable retail trading of CGS depository interests to commence, the Government has sought proposals and tenders from industry stakeholders for commercial services necessary to implement this policy. In particular, proposals have been invited from market operators interested in quoting and trading CGS depository interests on their market. The Government anticipates that market trading will be able to commence in the near future.
The Government supports competition in financial services and will similarly engage with other market operators in the future should they be interested in hosting trading in CGS depository interests.
INVESTOR PROTECTION MEASURES
The second set of amendments in the bill will ensure that the investor protection and market integrity provisions in the Corporations Act 2001 (the Corporations Act) apply to retail CGS.
These measures will ensure that financial services providers will have to comply with a range of licensing, conduct and disclosure requirements when they provide their services in relation to CGS depository interests. As an example, financial advisers providing personal advice to a retail client about CGS depositary interests will have to be licensed and supervised by the Australian Securities and Investments Commission (ASIC) before they can do so. They will also have to give the client a Statement of Advice setting out a range of information relating to their advice as required under the law.
The amendments in the bill will also require information statements to be provided to retail clients when they are given personal advice about CGS depository interests. The information statements will take the place of the Product Disclosure Statement that is usually required for a financial product. The Government considers that tailor made disclosure documents are appropriate for CGS depository interests because they are a particular type of safe and simple investment.
The AOFM will consequently produce information statements providing concise information on CGS depository interests. These documents will be made available to the public on a dedicated website, together with other information related to CGS. Financial advisers will be able to download and print out the information statements from this website and provide them to their clients when they recommend investing in CGS depository interests.
The Government will pursue other avenues in addition to this bill to ensure that the information statements are provided to retail investors through on-market transactions, for example through the online trading platforms offered by online brokers.
The amendments in the bill also ensure that CGS depository interests quoted and traded on financial markets are subject to the same legal requirements and protections as other listed securities.
MINOR AMENDMENTS
In addition to the two key reforms I have outlined, the bill also contains some minor amendments in relation to the CIS Act that will facilitate the day-to-day administrative work of the AOFM.
MINCO APPROVAL
The Ministerial Council for Corporations has been consulted on the amendments to the Corporations Act contained in this bill.
SUMMING UP
This bill delivers another key plank in the Gillard Government's banking reform package.
Passage of this bill will allow retail investors to buy and sell CGS depository interests on a financial market. They will also be provided with appropriate disclosure documents when they obtain personal advice about investing in CGS depository interests.
The establishment of an active retail CGS market will constitute an important step in the formation of a deep and liquid corporate bond market.
A vibrant corporate bond market is critical to putting competitive pressure on bank lending rates to business.
It is also central to harnessing our national superannuation savings so we can domestically fund more productive investment in our economy, via both the banking system and the corporate sector, reducing our reliance on offshore wholesale funding markets.
This critical reform is part of the Gillard Government's broad agenda to promote Australia as a leading financial services hub and boost our reputation as one of the most attractive investment destinations in the world.
The public report must contain details of the matters specified in the instrument made by the Minister.
1.10 The majority report seeks to selectively highlight certain submissions received in support of the proposed legislation. The majority report fails to acknowledge the divergent evidence received by the Committee from business and industry representatives, unions, academics and lobbyists, with many of these submissions highlighting concerns with the proposed legislation and calling for it to be amended. The majority report seeks to conveniently ignore much of [the] material critical of the proposed legislation.
1.11 Coalition Senators recognise that it is employers who will have to implement these proposed workplace changes—not the public sector, unions, or lobby groups—and it is employers that will have to bear the additional costs of these changes notwithstanding that the government is unable to quantify these potential costs.
1.12 It is the view of Coalition Senators that the committee majority report was dismissive and indeed contemptuous of the views of industry representatives who represented and spoke for thousands of Australian employers.
1.16 The Bill is an example of 'coat hanger legislation' reliant on regulations that are yet to be drafted, or future Ministerial directives, with many important aspects proposed to be defined only after the legislation has been passed.
1.17 Coalition Senators consider that it is irresponsible to support and pass legislation which imposes significant burdens and financial ramifications on employers, without being fully informed of the intentions of the Minister in respect to the proposed regulations and potential Ministerial directions.
In considering the provision in the Bill that provides the Minister with these significant powers, the Senate Standing Committee for the Scrutiny of Bills concluded:
The Committee prefers that the use of delegated legislation is fully explained. In this case the explanatory memorandum does not address this point, but indicates at page 2 that the development of these standards will be evidence-based and that the Minister must consult the Agency prior to making the standards. It is also envisaged (see subsection 31(3)) that the Minister will consult with other relevant persons, such as industry and employee organisations. In these circumstances the Committee leaves the question of whether the proposed approach is appropriate to the consideration of the Senate as a whole.
.. the Bill is drafted to provide the Minister with an inordinate amount of discretion, 'without legislative constraint on the exercise of these powers'.
That this bill be now read a third time.
That this bill be now read a third time.
This bill is yet another example of government working with the community to create a clear, understandable and fair framework for doing business in Australia.
Data provided by the Office of Legislative Drafting and Publishing (OLDP) show ‘twin peaks’ in the number of sunsetting instruments that will see an estimated 2000 principal instruments sunset in October 2016 and a further 1000 in April 2018, with this pattern likely to be repeated every 10 years.
Around 6300 principal instruments are scheduled to sunset between 2015 and 2022. The bulk of these will sunset on or before 1 April 2018, the majority of which are regulations made prior to the commencement of the LIA in 2005.
While the exact extent of the forthcoming review task facing departments and agencies is not known at this time, it is potentially very large. Concerns have been expressed for some time about how the volume of reviews will be handled.
That this bill be now read a third time.
How can I convey to the reader any just impression of this extraordinary figure of our time, this syren, this goat-footed bard, this half-human visitor to our age from the hag-ridden magic and enchanted wood of Celtic antiquity?
That this bill be now read a third time.
That this bill be now read a third time.
That this bill be now read a third time.
That these bills be now read a third time.
To facilitate the expansion and balanced growth of international trade, and to contribute thereby to the promotion and maintenance of high levels of employment and real income and to the development of the productive resources of all members as primary objectives of economic policy.
… making the general resources of the Fund temporarily available to them under adequate safeguards, thus providing them with opportunity to correct maladjustments in their balance of payments without resorting to measures destructive of national or international prosperity.
… to shorten the duration and lessen the degree of disequilibrium in the international balances of payments of members.
That this bill be now read a third time.
That this bill be now read a third time.
She—
said that we know societies only reach their full potential if women are politically participating …
Women are destroying the joint—Christine Nixon in Melbourne, Clover Moore here—
Honestly.
YWCA Australia welcomes the focus in the Bill on caring responsibilities.
… … …
This legislation will contribute to real change in the lives of women and men in workplaces across Australia, and we look forward to its passage in the Parliament.
The two goals are totally in conflict … There's no way in the world we can meet the drive for quality that Gonski envisaged like this. It's simply impossible.
The implication of such a loss of revenue is that, as far as this state is concerned—
I sleep very well at night knowing the decisions that I've made and announced today are in the best interests of students across all schools.
That the Senate take note of the answers given by ministers to all questions without notice asked today.
That the Senate take note of the answer given by the Minister representing the Minister for Immigration and Citizenship, Senator Lundy, in question time today relating to the government's assurances to the Foreign Minister of Nauru.
That the motion agreed to earlier today, granting leave of absence for Senator Bob Carr, be varied by omitting 17 September and 18 September 2012.
Australian Government Response to Senate Community Affairs References Committee Report on The Regulatory Standards for the Approval of Medical Devices in Australia
August 2012
Government response to recommendations
Recommendation 1
The committee recommends that the Therapeutic Goods Administration make a list of the devices on the Australian Register of Therapeutic Goods publicly available.
Response:
The Australian Government agrees with the recommendation.
The Australian Register of Therapeutic Goods (ARTG) is a publicly searchable data base which includes all medical devices currently approved for supply in Australia. The Therapeutic Goods Administration is currently working to improve the searchability of the ARTG.
Recommendation 2
The committee recommends that the Department of Health and Ageing fully implement Recommendation 8c of the Health Technology Assessment Review regarding the need for increased rigour of regulatory assessment of higher-risk medical devices.
Response:
The Australian Government agrees with the recommendation.
The Therapeutic Goods Administration has consulted publicly on proposals to increase the rigour of regulatory assessment for higher risk medical devices.
Some reforms will be in place before the end of the calendar year, but the Government notes that timing and approach depends on the completion of the appropriate assessment of any potential regulatory and cost recovery effects, including on patients and the Australian medical device industry.
Recommendation 3
The committee recommends that the level of assessment of Class III medical devices be increased.
Response:
The Australian Government agrees to consult further with affected stakeholders on this recommendation.
The Government recognises that greater regulatory rigour for high risk, Class III medical devices would allow further evidential review prior to market entry for these devices.
International harmonisation is a critical element in medical device regulation. This harmonisation allows access for Australian patients to the best devices available around the world and avoids costly repetition for industry seeking to enter the market. As such, the Government believes that any increase to the level of assessment of Class III medical devices will be best achieved in harmony with international counterpart regulators.
The Therapeutic Goods Administration (TGA) has begun consultation with key stakeholders in Australia in relation to increasing this assessment. Further consultation with the international community may be required to identify the most appropriate approach. The Government has instructed the TGA to continue this dialogue. It is important to note that any change in pre-market regulation would need to consider the increase in the level of mitigation of risks to patients' safety, as well as the impacts on the Australian medical device industry and on patients' access to medical technologies. The TGA will be required to undertake consultation with domestic stakeholders on any proposed changes to increase assessment, including developing a Regulatory Impact Statement if required.
Recommendation 4
The committee recommends that the Therapeutic Goods Administration investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes; and whether a more judicious approach could improve pre-market assessment and post-market surveillance of higher risk medical devices, for the ultimate benefit of patients.
Response:
The Australian Government agrees with the intent of the recommendation, to improve the quality of medical devices available in the Australian market place, by continuing to refine requirements for pre-market assessment and post-market surveillance.
The TGA has no legal power to limit the number of applications made for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). Medical devices included in the ARTG are required to comply with standardised criteria for quality, safety and performance under the Therapeutic Goods legislation.
Further responses on pre-market assessment are provided in relation to recommendations 2 and 3. A further response on post-market surveillance is provided in relation to recommendation 7.
Recommendation 5
The committee recommends that the Therapeutic Goods Administration continue to consult widely with stakeholders, including consumer health organisations, on the amended proposals related to third party conformity assessment; and weigh carefully considerations of the advantages of streamlined international regulatory frameworks and patient safety.
Response:
The Australian Government agrees with the recommendation.
The TGA will conduct consultation with all stakeholders on the details of any specific proposals to implement third party conformity assessments and will develop a Regulatory Impact Statement, if required.
The Government notes that recent events have raised questions relating to the current framework governing the use of third party conformity assessments bodies overseas.
The European Commission has announced that it will review the current structure for third party conformity assessment in the European Union (EU) with a view to making amendments and the possible introduction of an accreditation process for notified bodies.
The Therapeutic Goods Administration (TGA) will monitor developments in Europe with a view to identifying the most appropriate arrangements for Australia which adequately balance the advantages of streamlined international regulatory frameworks and patient safety.
In order to provide certainty for all stakeholders, the Government commits to expedite its considerations, subject to regulatory developments in the EU.
Recommendation 6
The committee recommends that the Therapeutic Goods Administration continue its prudent approach to the regulation of reprocessed single-use medical devices, with due consideration for issues of informed patient consent and the need for suitable mechanisms to enable tracing of remanufactured medical devices in the case of adverse events.
Response:
The Australian Government agrees with the recommendation.
Current approach to regulation
The Australian regulatory framework for medical devices is designed to ensure that the reprocessing of devices that were not originally intended for reprocessing does not compromise the safety and effectiveness of the device. Under these regulatory controls, the reprocessing facility is regulated as a manufacturer, and is required to demonstrate that the reprocessed device is equivalent to the original and will continue to perform without additional risk to the patient.
Informed patient consent
The Medical Board of Australia (MBA) is responsible for all matters relating to the regulation of medical practitioners in Australia. It has produced Good medical practice: A code of conduct for doctors in Australia which provides guidance to medical practitioners on a range of matters including issues about informed patient consent.
The Government notes that the National Health and Medical Research Council has published General Guidelines for Medical Practitioners on Providing Information to Patients (2004). These guidelines recommend that doctors provide information to patients about the risks of any interventions, especially those likely to influence patients' decisions.
The Government undertakes to refer the issue of patient consent, in the context of reprocessed single-use medical devices, to the relevant National Boards and the Australian Health Practitioner Regulation Agency (AHPRA).
Tracing of remanufactured medical devices
The Therapeutic Goods Administration (TGA) has established regulatory guidelines for remanufactured medical devices, requiring compliance with the post-market requirements, such as reporting adverse events to the TGA associated with the use of the device, tracking the number of times the device is remanufactured and reused, tracing the device to the batch/serial number of the original device and recording to whom the device was supplied in case of recall or other regulatory action (Australian regulatory guidelines for medical devices 2007).
Recommendation 7
The committee recommends that the Department of Health and Ageing implements Recommendations 13, 14, and 15 of the Health Technology Assessment Review in a timely manner. These recommendations address the need for improved post-market surveillance by increasing the rate of reporting of adverse events, including by health service providers and consumers; facilitating the expansion and use of post-market surveillance data to inform safety, effectiveness and reimbursement decisions; and establishing further clinical registers for high risk implantable devices and procedures.
Response:
The Australian Government agrees with the recommendation in principle.
Recommendation 13 of the Health Technology Assessment Review (HTA Review) states that in order to improve the contribution of post-market surveillance to patient safety, the Therapeutic Goods Administration (TGA) take steps to increase the rate of reporting of adverse events, including by health service providers. The Government's response to this is set out in the response to recommendation 8 of this inquiry (below).
Recommendation 14 of the HTA Review states that, in order to improve the contribution of post-market surveillance to the sustainability of the health system and the longer term regulatory efficiency of HTA Review processes, the Department of Health and Ageing (the Department) explore options for consideration by Government in 2011 to facilitate the expansion and use of post-market surveillance data to inform safety, effectiveness and reimbursement decisions for devices and procedures.
The Government supports the expanded use of post-market surveillance data from adverse event reporting in assessing the safety and effectiveness of medical devices. As set out in the response to recommendation 8 below, the Government will seek to improve the reporting of adverse events by health practitioners and the general public in order to provide greater data relating to the devices in use in Australia. In addition, the TGA will provide reports of adverse events, as well as any relevant conditions the TGA imposes on a sponsor in order to register their device (including the provision of post-market data), to the TGA's newly established Advisory Committee on Medical Devices (ACMD). The ACMD will use this data as part of its post-market monitoring responsibilities.
The TGA will inform the Prostheses List Advisory Committee, through the Department, when a prosthesis is withdrawn from the ARTG, so that the Government may receive timely advice on any consequent changes to private health insurance reimbursement arrangements for that device.
The Government announced in the 2012-13 Budget that it will remove joint replacement prostheses with evidence of higher than acceptable revision rates from the Prostheses List, so that private health insurers are no longer required to pay benefits for those prosthetics.
Recommendation 15 of the HTA Review is that registers for high risk implantable medical devices and/or procedures be established.
The Government supports the development of clinical registers for high risk implantable medical devices and has to date supported the establishment of the National Joint Replacement Registry.
The Government will continue to work with industry and medical groups to identify the most effective ways to track the use and performance of high risk implantable medical devices, balancing benefits and costs to patients, providers and the wider community.
As part of this process, the Government is also currently considering funding options for the establishment of these registers, including the feasibility of the use of cost recovery from industry through the TGA cost recovery arrangements.
The Government further undertakes to review the communication and reporting links between existing registries/registers, the TGA and the Department.
Recommendation 8
The committee recommends that the Therapeutic Goods Administration put in place mechanisms to educate and encourage doctors to report adverse incidents associated with the use of medical devices. The committee further recommends that the Department of Health and Ageing introduce mandatory reporting for health practitioners to the Therapeutic Goods Administration on relevant issues, in certain circumstances including problems with medical devices.
Response :
The Australian Government agrees that adverse event reporting by medical practitioners is a vital component of a comprehensive system of post-market surveillance, and in that context, commits to the following course of action.
The Government has recognised that further work is required to encourage greater reporting of adverse events from therapeutic goods (including medical devices). As announced in TGA Reforms: A Blueprint for the Future on 8 December 2011, the Australian Government has agreed to implement recommendations 19 and 20 of the Transparency Review: to more effectively facilitate the recognition and reporting of adverse events by health practitioners and consumers, and promote the adverse event reporting system; and to make the Adverse Events Database available to, and searchable by, the public in a manner that promotes the quality use of therapeutic goods. In this context, the Therapeutic Goods Administration (TGA) will investigate ways to upgrade the value of individual clinician input and subsequent information exchange.
The TGA has included additional information on its website on reporting adverse events and published a brochure outlining ways to report an adverse event. This brochure is being disseminated at conferences and other venues where it will reach healthcare professionals. An online reporting form for adverse event reporting for medical devices was made available on the TGA website from mid-March 2012. The Government also undertakes to draw this recommendation to the attention of medical educators and organisations funded to provide training and support to medical practitioners.
On the matter of mandatory reporting for health practitioners on problems with medical devices, the Government undertakes to raise this matter with the Medical Board of Australia (Board) which is responsible for the regulation of medical practitioners. The Government notes that any changes to standards set by the Board, or to codes and guidelines produced by the Board, are subject to requirements set out in legislation, including consultation and, in the case of changes to registration or accreditation standards, the agreement of the Australian Health Workforce Ministerial Council.
The Department of Health and Ageing (the Department) will work with the states and territories to identify opportunities to coordinate adverse event reporting currently required in the public hospital sector in each jurisdiction. The Department will also work with the Australian Commission on Safety and Quality in Health Care to investigate the Commission's capacity to provide safety oversight of the use of therapeutic devices through the development of standards and indicators.
Recommendation 9
The committee recommends that the Government implements the Recommendations of the Therapeutic Goods Administration Transparency Review in a timely manner.
Response:
The Australian Government agrees with the recommendation.
The Government announced its response to the recommendations of the Therapeutic Goods Administration Transparency Review on 8 December 2011. An implementation plan for the actions agreed in the report TGA Reforms: a Blueprint for the TGA's Future became available in July 2012.
Recommendation 10
The committee recommends that the Therapeutic Goods Administration consider simultaneously allocating or aligning the great variety of codes used to identify medical devices, in order to facilitate more efficient regulation and more rapid identification of devices when problems occur.
Recommendation 11
The committee recommends that the Department of Health and Ageing consider a mechanism for flagging billing codes in order to identify devices subject to an alert or recall; as well as a consequent adjustment to benefits paid, based on industry feedback as to the performance of the device.
Combined Response:
The Australian Government notes recommendations 10 and 11.
There are practical challenges in simultaneously allocating codes. Catalogue numbers are established by industry internationally, and Australian Register of Therapeutic Goods (ARTG) and Prostheses List billing codes are allocated through consecutive approval steps. Market approval can occur in advance of any decision to reimburse, and many devices are never considered for reimbursement. To delay the allocation of an ARTG number until a billing code for private health insurance purposes was granted, would unduly delay the availability of the product onto the Australian market.
Nevertheless, the Government acknowledges that better integration and alignment of identifiers can assist post-market surveillance and device identification when problems occur. A new database is under development to support Prostheses Listing arrangements which will allow the Department of Health and Ageing (the Department) to link catalogue numbers with billing codes to assist with identification of specific products. This work is scheduled for completion by the end of 2012.
The Department and the Therapeutic Goods Administration (TGA) are also liaising with the National E-Health Transition Authority on scope to link its National Product Catalogue to billing codes and ARTG numbers to assist identification of devices.
In relation to benefit setting, the Department is implementing recommendation 12 (b-e) of the Health Technology Assessment Review in Australia (HTA Review), to refine grouping schemes and develop single group benefits for clinically similar products on the Prostheses List. Once this work is completed, the Department, with advice from its expert and advisory committees, will review benefit setting arrangements into the future.
Recommendation 12
The committee recommends that the Therapeutic Goods Administration consider whether custom made dental devices are adequately regulated; and whether the approach used in the United Kingdom of requiring a statement of manufacture to be provided to patients, and retained by the dental practitioner, has merit.
Response:
The Australian Government notes the recommendation.
Custom made dental devices are not required to be included on the Australian Register of Therapeutic Goods. However, there are a number of requirements that must be met.
The therapeutic goods legislation requires that the importers of custom made dental devices hold certain information about the device including information identifying the manufacturer, the device and any special characteristics of the device.
The Australian Government will consult with the Dental Board of Australia on this recommendation, as the governing body with the authority to regulate the dental profession.
Recommendation 13
The committee recommends that the Therapeutic Good Administration carry out an investigation to ascertain whether importation of medical devices via the internet is adequately regulated.
Response:
The Australia Government agrees with this recommendation.
The Therapeutic Goods Administration (TGA) will continue to work with all stakeholders to examine evidence in relation to the adequacy of existing arrangements for the importation of medical devices.
Under the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002, therapeutic goods are required to be approved and included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied unless there is an exemption.
It is illegal to import commercial quantities of therapeutic goods into Australia without the goods being entered onto the ARTG. This applies even if the importer is a healthcare provider. If products are imported for on-sale, including for use within a professional practice, they would need to be appropriately entered onto the ARTG by the importer who would be recognised as the sponsor of the product. The importer would need to meet the appropriate responsibilities of a sponsor as set out in the legislation. Therapeutic goods imported directly from international websites and not entered in the ARTG may not meet the standards of quality, safety or efficacy prescribed by the therapeutic goods legislation. Registered health practitioners who import directly need to be aware how their sponsor responsibilities interact with their professional responsibilities for registration within their relevant sector.
It is possible for individuals to import therapeutic goods into Australia for their own personal use (www.tga.gov.au/pdf/access-personal-import-guidelines.pdf). Such importation is subject to various conditions and it is the responsibility of individuals wishing to import unapproved therapeutic goods for their own use to ensure they have complied with all relevant Commonwealth and state/or territory laws. If care is not taken, consumers may inadvertently break the law, waste their money, or risk their health.
The potential consequence of the importation of medical devices via the internet is limited as private health insurance and Medicare benefits are only payable for medical devices purchased and used with professional services rendered within Australia. Consumers and health professionals are likely to choose devices for which benefits are payable.
From time to time, in the course of routine surveillance activity, the TGA becomes aware that Australian consumers may have purchased potentially dangerous therapeutic goods from overseas sources via mail-order or the internet. In these cases the TGA will issue a safety alert via its website advising consumers to cease using the goods and to consult a healthcare practitioner if there are any health concerns.
Recommendation 14
The committee recommends that the Therapeutic Goods Administration, in consultation with the National Joint Replacement Registry, investigate ways in which information provided by the National Joint Replacement Registry can be used and responded to in a more timely way for the benefit of patients, and to inform future evidence based decision making on the listing of prostheses on the Australian Register of Therapeutic Goods.
Response:
The Australian Government agrees with the recommendation.
Recommendation 15
The committee recommends that the Department of Health and Ageing prepare, as a matter of priority, a comprehensive communications strategy to inform medical practitioners, patients and the general public about the issues associated with De Puy hip and hip resurfacing devices as well as options for treatment, obtaining further information, and reporting adverse outcomes. The committee further recommends that such a strategy be implemented as a standard process for any future adverse event reporting.
Response:
The Australian Government agrees with this recommendation in principle.
The communications strategy
In announcing TGA reforms: a blueprint for TGA's future, the Government has agreed to implement the recommendations of the Therapeutic Goods Administration (TGA) Transparency Review which will make further information available to medical practitioners and the public where any issues arise associated with therapeutic goods, including adverse outcomes and recalls.
The Government notes that the device sponsors, Johnson & Johnson Medical, working closely with the TGA and the Australian Orthopedic Association (AOA), have put in a place a communications strategy to inform medical practitioners about the issues associated with De Puy hip and hip resurfacing devices.
Information for the general public and patients has also been published on the TGA website: http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm#patients. The Government notes that patients who suspect that they may have side effects related to their hip replacement surgery were advised to contact their surgeon for further clinical review as appropriate. In addition, following recall of the DePuy ASR implant, the TGA worked with DePuy and the AOA to ensure that all Australian orthopaedic surgeons were aware of the recall and appropriate advice was available to be provided to patients.
Communication between health practitioners and patients
The Medical Board of Australia (MBA) is responsible for all matters relating to the regulation of medical practitioners in Australia. It has produced Good medical practice: A code of conduct for doctors in Australia which provides guidance to medical practitioners on a range of matters including issues about provision of information to patients.
The Government undertakes to bring to the attention of the MBA and the Australian Health Practitioner Regulation Agency the need to ensure that surgeons are communicating any emerging concerns relating to medical devices to patients in a timely manner, including options for treatment.
Standard processes
The Department has standard procedures in place to respond to health crises and issues management, including development of appropriate communication strategies. These strategies are tailored to the specific situation as each issue is different and the response required can differ significantly.
Nevertheless, the Department and the TGA will undertake to review the efficiency, timeliness and comprehensiveness of standard processes to communicate with consumers and clinicians in the event of major recalls of implantable medical devices that may have public health consequences.
Recommendation 16
The committee recommends that the Department of Health and Ageing, as a matter of urgency, consider the best way of establishing a process for monitoring the levels of cobalt, chromium, and other toxic metals; and any possible health effects, in all patients who have received metal-on-metal hip replacements.
Response:
The Australian Government notes the recommendation and will continue to monitor the emergence of evidence on the need for, and most effective approaches to, monitoring effects of metal levels associated with metal-on-metal hip replacements.
The TGA, in consultation with the AOA, has developed advice for healthcare professionals and patients regarding De Puy's ASR metal-on-metal hips. The AOA has notified orthopaedic surgeons of the issues and they have been advised to contact patients implanted with an ASR hip replacement system to arrange assessment and regular follow-up. Surgeons have been advised to follow patients closely, including annual review, for at least five years following surgery.
Currently, the health effects of increased blood metal levels are uncertain. Moreover, the effectiveness of monitoring blood metal levels to identify suspected problems with metal-on-metal hips has not been established, and such results are generally considered in the context of other clinical findings. The type of monitoring should be determined on a case-by-case basis following a detailed consideration of each patient's circumstances by their surgeon. This may involve diagnostic imaging and blood tests as determined by the treating surgeon in consultation with each individual patient. Chromium testing is reimbursed under the Medicare Benefits Schedule.
Recommendation 17
The committee recommends that the Government consider the best mechanism for initiating and advancing research on the health effects of cobalt, chromium, and other toxic metals, on the human body. The committee also recommends that consideration be given to ensuring adequate funding for that research is made available.
Response:
The Australian Government agrees with this recommendation in principle.
Australia is participating in a world wide study of patients who have received the ASR Hip. This study will be the largest of its kind in determining the relevance, extent and impact of raised metal ion levels, in patients who have had hip surgery using the ASR prostheses.
The Department of Health and Ageing and the Therapeutic Goods Administration are also having ongoing discussions with the Australian Orthopaedic Association National Joint Replacement Registry about ways in which the registry may assist in assessing the outcomes for patients who have received other metal-on-metal hip replacement and any potential for ongoing medical problems.
In addition, as the Government's peak funding body for health and medical research, the National Health and Medical Research Council (NHMRC) invests in research through a variety of funding mechanisms including investigator-initiated research projects and clinical trials, broad programs of research, training awards for scholars and postdoctoral fellows, career research fellowships and special strategic research programs. The majority of these schemes operate according to annual funding rounds and the details of opening and closing dates are available on the NHMRC website.
Investigator-initiated research proposals into the health effects of cobalt, chromium, and other toxic metals on the human body will be considered as part of annual funding rounds. These funding schemes are highly competitive with each application considered on its merits through a rigorous peer review process.
Recommendation 18
The committee recommends that the Department of Health and Ageing undertake further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals, in line with the Physician Payment Sunshine provisions of the Patient Protection and Affordable Care Act of 2009 in the United States. The definition of inducements should include a commercial interest in a company or device; any cash payments or discounts offered to medical practitioners; and any other gifts provided to medical practitioners.
Response:
The Australian Government agrees with the recommendation in principle but notes that a legislative framework for ethical conduct of industry in the promotion of therapeutic goods to healthcare professions is not warranted in the Australian context at this time.
The Government is committed to achieving a level playing field in this area. Recognising the need for improvement, the Government established an industry-led working group in 2010 to examine the issues around promotion of therapeutic goods and opportunities to strengthen the current self-regulatory arrangements.
The Government announced its response to the working group's recommendations as part of the TGA reforms: a blueprint for TGA's future. In this response the Government gave strong support to industry's initiative to harmonise their codes of conduct to incorporate the high level principles agreed to by the Working Group. Robust and consistent codes of conduct are a powerful first step in strengthening oversight of the relationship between therapeutic goods companies and healthcare professionals.
As part of the 2012-13 Budget, the Government will provide $1.4 million over four years to further assist industry to respond to the Working Group's recommendations. The resources provided through this measure will support stronger self-regulation, better communication and shared systems for complaints reporting.
The Government will work with industry to evaluate the effectiveness of this approach and consider the need to provide further support, or changes to the current self-regulated arrangements if the therapeutic goods industry requires greater encouragement to achieve universal adherence to consistent, high ethical standards. The Government notes that a legislative framework for ethical conduct of industry in the promotion of therapeutic goods to healthcare professionals is not warranted in the Australian context at this time.
In relation to standards for ethical conduct of healthcare professionals, the Australian Government undertakes to bring the recommendation to the notice of the Australian Health Workforce Ministerial Council, and to refer the recommendation to the relevant National Boards and the Australian Health Practitioner Regulation Agency.
The Government has also been working with its partners in the Asia Pacific Economic Cooperation (APEC) to develop and endorse principles to guide business ethics in the medical device and pharmaceutical sectors. These principles clearly set out expectations for companies operating within APEC economies in regard to ethical behaviour and identify activities that are inappropriate influences and inducements.
Amended recommendations
The Australian Government notes the proposed timeframes and additional considerations proposed by Senator Xenophon and has considered and responded to these matters in the main recommendations.
Response to the Senate Community Affairs References Committee Report
THE SOCIAL AND ECONOMIC IMPACT OF RURAL WIND FARMS
JULY 2012
Introduction
On 27 October 2010, the Senate Community Affairs References Committee (the Committee) was established to consider the social and economic impact of rural wind farms, and in particular:
The Committee received more than 1000 submissions, many letters and other documents, and had access to much published information. Public hearings and site visits were held in various capital cities and regional areas.
The Committee tabled its report, The Social and Economic Impact of Rural Wind Farms in parliament on 23 June 2011 making seven recommendations.
The Australian Government welcomes the Committee’s report and thanks the Committee for its considered approach to the recommendations made in the report.
Some of the Committee’s recommendations are directed to state and territory governments, local authorities and professional bodies. The Australian Government encourages those agencies to respond positively to the recommendations.
The Government recognises that this Senate Committee report has captured a range of issues for many individuals and the wider Australian community with regard to wind farms. These include noise, health effects, planning laws, property values, employment and farm income. The Government also recognises that in order to meet the legislated Renewable Energy Target of 20 percent by the year 2020, the number of wind farms can be expected to increase significantly in the next few years.
The Department of Health and Ageing has led the coordination of the whole of government response to the Senate Inquiry. Input to the response was provided by agencies within this department and by the departments of Sustainability, Environment, Water, Population and Communities (DSEWPC) and Resources, Energy and Tourism (DRET) where recommendations relate to their respective portfolios.
Government Response to Recommendations
The Australian Government recognises that while the Senate Committee report has captured a range of issues for many individuals and the wider Australian community, there is no strong evidence either way as to the impact of wind farms on the health of Australians.
The lack of evidence therefore makes it difficult for the Government to determine what course of action to take, if any. The Government recognises it has responsibility for consideration of recommendations four, five, six and seven and these are addressed further in the response. As for the remaining recommendations, these are areas that lie outside of the Government’s responsibility and should be considered by relevant state/territory governments, local governments and planning authorities.
Recommendation 1
2.44 The Committee considers that the noise standards adopted by the states and territories for the planning and operation of rural wind farms should include appropriate measures to calculate the impact of low frequency noise and vibrations indoors at impacted dwellings.
Response:
This is a matter for consideration by state/territory governments, local governments and planning authorities.
Recommendation 2
2.58 The Committee recommends that the responsible authorities should ensure that complaints are dealt with expeditiously and that the complaints processes should involve an independent arbitrator. State and local government agencies responsible for ensuring compliance with planning permissions should be adequately resourced for this activity.
Response:
The Australian Government accepts this recommendation, but notes that it is a matter for consideration by state/territory governments, local governments and planning authorities.
It is also important to note the level of complaints about wind turbines and wind farm projects can be aligned with a lack of effective community consultation in the planning and development stages. As highlighted in the Australian Psychological Society’s submission and in the Committee’s report, early consultation with the community could improve community understanding of wind turbines and could therefore reduce community anxiety and complaints. In the Committee’s report, it is acknowledged that research on the societal acceptance of wind farms is currently being undertaken by the Commonwealth Scientific and Industrial Research Organisation.
It is also noted that the draft National Wind Farm Development Guidelines July 2010 (the draft Guidelines), produced by the former Environment Protection and Heritage Council of Australia and New Zealand, provides extensive advice on how to conduct community consultation. The draft Guidelines remain a valuable reference document for industry and planning authorities and may assist effective community consultation and possibly reduce complaints.
Recommendation 3
2.69 The Committee recommends that further consideration be given to the development of policy on separation criteria between residences and wind farm facilities.
Response:
This is a matter for consideration by state/territory governments, local governments and planning authorities.
Recommendation 4
2.101 The Committee recommends that the Commonwealth Government initiate as a matter of priority thorough, adequately resourced epidemiological and laboratory studies of the possible effects of wind farms on human health. This research must engage across industry and community, and include an advisory process representing the range of interests and concerns.
Recommendation 5
2.102 The Committee recommends that the NHMRC review of research should continue, with regular publication.
Recommendation 6
2.103 The Committee recommends that the National Acoustics Laboratories conduct a study and assessment of noise impacts of wind farms, including the impacts of infrasound.
Response:
The Australian Government accepts these recommendations in principle.
The National Health and Medical Research Council (NHMRC) is already actively engaged in supporting the assessment of available research on this issue and will shortly commission a comprehensive review of the literature to inform any update to its 2010 public statement. The review will include audible noise, infrasound and low-frequency noise. A reference group will be established to advise on the review and will include members of the public, industry, researchers, sound engineers/consultants and planning representatives.
The results of the literature review and the revised public statement will be published on the NHMRC website.
Further, there are a range of funding mechanisms within the Australian Government, in particular within the NHMRC, that could be used to fund additional research on the possible impacts of wind farms on human health, including epidemiological and laboratory studies.
Recommendation 7
3.99 The Committee recommends that the draft National Wind Farm Development Guidelines be redrafted to include discussion of any adverse health effects and comments made by NHMRC regarding the revision of its 2010 public statement.
Response:
The Australian Government does not accept this recommendation.
The former Environment Protection and Heritage Council of Australia and New Zealand (EPHC) released the Guidelines in July 2010 for a twelve-month consultation period. The draft Guidelines outlined best practice for industry and planning authorities and were not mandatory, nor did they seek to change existing jurisdictional statutory processes.
The Australian Government understands that jurisdictions have developed, or are currently developing, planning application, assessment and approval processes within their own planning frameworks to manage community concerns about wind farm developments such as turbine noise, shadow flicker, electromagnetic interference and impacts on landscapes and wildlife. The EPHC Standing Committee therefore has decided to cease further development of the Guidelines. The draft Guidelines remain a valuable reference document for industry and planning authorities and may be used and reproduced for non-commercial purposes.
The Australian Government recognises the important role research will continue to play in informing state/territory planning and development approval processes. The Australian Government would like to emphasise that the revision of the NHMRC’s 2010 public statement will depend on the outcomes of the literature review, which it will commission shortly.
Some reforms will be in place before the end of the calendar year—
but the Government notes that timing and approach depends on the completion of the appropriate assessment of any potential regulatory and cost recovery effects …
As such, the Government believes that any increase to the level of assessment of Class III medical devices will be best achieved in harmony with international counterpart regulators.
… investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes …
The Australian Government agrees with the intent of the recommendation, to improve the quality of medical devices available in the Australian market place, by continuing to refine requirements for pre-market assessment and post-market surveillance.
The TGA has no legal power to limit the number of applications made for inclusion …
That the Senate notes the Gillard Government’s $120 billion budget black hole.
FEDERAL government departments and agencies are spending more than $10.3 million a year checking what is said about them in the media.
The hefty monitoring bill from external companies would pay for more than 100 full-time staff each earning $100,000 a year. An analysis by The Australian —
revealed the Department of Health and Ageing ploughs more than any other department or agency into monitoring with a bill of—
I will tell you what we are doing. We are going through the budget, line by line and item by item. The government will spend -Liberal or Labor-will spend $1500 billion over the next four years. It is a massive amount of money. Therefore finding 50, 60 or 70 billion is about identifying waste and identifying areas where you do not need to proceed with programs.
That the Senate take note of the documents.
That the Senate take note of the document.
The petition of the undersigned shows our support for Avalon Airport to operate as an international passenger airport. The provision of international passenger services at Avalon Airport will provide very important economic benefits for the Geelong region and Victoria as a whole, particularly with respect to employment, tourism, trade and the development of new industries.
Your petitioners ask that the Senate calls on the Gillard Labor Government to honour its 2010 election commitment to the resident of the Federal elections of Corangamite and Corio by permitting Avalon Airport to operate as an international passenger airport by:
SUPPORTING INTERNATIONAL FLIGHTS AT AVALON AIRPORT
The Gillard Labor Government supports Avalon Airport's plan to become an international airport and will work with the Airport to develop its plans for an international terminal.
… … …
The Government's Aviation Policy White Paper made clear our support for growing international air services to support trade, tourism and jobs in regional communities
… … …
"Increasing services to Avalon Airport is a shot in the arm for tourism on the Surf Coast and the Great Ocean Road,"—
The election ventilated a number of local issues in Geelong—the future of Avalon Airport …
I have had a longstanding interest in the aviation industry, particularly with Avalon , down in my part of the world …
Our region has a long-term ambition to increase the services available out of Avalon as well as, importantly, to harness the potential opportunities that would come from converting it to an international airport
Avalon Airport is a strategic asset in our region. The member for Corio and I have been working diligently with stakeholders locally and with the government to recognise any potential that Avalon has.
That the Senate take note of the document.
You don’t have to be an expert to support someone going through a tough time, you just need to be able to listen without judgment and take the time to follow up.
The federal Parliament is responsible for approving considerable sums of money for local government. Federal laws can also affect the rights and responsibilities of councils. Where interests do not coincide, would Gash—
give priority to her local government area or federal electorate?
Since 24 June 2010, has the Prime Minister’s office engaged any individuals, consultants or other business, to provide any form of speechwriting assistance and/or communication advice; if so:
(1) For each month from June 2010 to August 2012, can details be provided of: (a) the cost; (b) the names of each individual, consultant or business engaged; and (c) the amounts paid on each occasion.
(2) Can details be provided of the particular speeches, communications or other projects for which such engagements were made.
(3) On what basis were these individuals, consultants or businesses: (a) selected; and (b) engaged.
Other than ministerial staff engaged under the Members of Parliament (Staff) Act 1984, the Prime Minister’s Office has not engaged any individuals, consultants or other business, to provide any form of speechwriting assistance and/or communications advice since June 2010.
For the period 1 January to 30 June 2012, in regard to the department and each agency within the responsibility of the Minister/Parliamentary Secretary:
(1) How many Freedom of Information (FOI) requests were received?
(2) How many FOI requests were granted or denied?
(3) How many conclusive certificates were issued in relation to FOI requests?
(1) During the period 1 January 2012 to 30 June 2012, Defence received 177 section 15 FOI requests, and six section 48 requests. Defence Housing Australia received four section 15 requests.
(2) The following tables provide a breakdown of completed requests:
Defence Section 15
Notes
1. Where a document is identified and exempted in full, access to the document can be denied, with reference to the relevant exemption provisions of the FOI Act. During the period in question, one denial related to documents where section 47E 'certain operations of agencies' provisions applied, three section 37 where 'enforcement of law and protection of public safety' provisions applied, one section 46 where 'contempt of court' provisions applied, one denial related to documents where section 33 'national security' provisions applied and three section 38 where 'secrecy provisions" applied.
2. Section 24A of the FOI Act provides for requests for access to documents to be refused if the documents cannot be found or do not exist. Access may also be refused under section 24 if the work involved in processing the request would substantially and unreasonably divert the resources of an agency. For the period in question, all 12 refusals related to documents that did not exist or could not be found.
Defence Section 48
Defence Housing Australia Section 15
(3) This question has been previously answered under Parliamentary Senate Question on Notice Nos. 1 615 to 1617 tabled on 8 May 2011.