Chris Evans (WA, Australian Labor Party, Leader of the Government in the Senate) Share this | Link to this | Hansard source

I move:

That these bills be now read a second time.

ANTI-people SMUGGLING AND OTHER MEASURES BILL 2010

I seek leave to have the second reading speeches incorporated in Hansard.

Leave granted

The speeches read as follows—

That this bill be now read a second time. General Introduction Conflicts and turmoil in Afghanistan, the Middle East and Sri Lanka are driving a global surge in asylum seekers, with large numbers of displaced persons seeking resettlement in foreign countries.Figures published by the United Nations High Commissioner for Refugees in its most recent Global Trends Report reveal that, at the end of 2008, there were some 42 million forcibly displaced people worldwide. This includes 15.2 million mandated refugees, 827,000 asylum-seekers (pending cases) and 26 million internally displaced persons.The report indicates that people seeking asylum in Australia reflects a worldwide trend driven by insecurity, persecution and conflict.However, when looking for settlement in stable, democratic nations such as Australia, asylum seekers often fall prey to people smugglers.People smuggling is exploitive and dangerous. People smugglers are motivated by greed and work in sophisticated cross-border crime networks. They have little regard for the safety and security of those being smuggled, endangering their lives on unseaworthy and overcrowded boats.In two tragic incidents last year, people smuggling ventures ended in loss of life and serious injuries. It is nearly nine years since the tragic sinking on 19 October 2001 of “SIEV X” resulting in the deaths of 146 children, 142 women and 65 men.People smuggling is a pernicious trade. And the Government has a comprehensive, hardline approach to combating the scourge of people smuggling.The Government is devoting unprecedented resources to protecting Australia’s borders and developing intelligence on people smuggling syndicates. We are working cooperatively with Australia’s regional partners to disrupt people smuggling ventures overseas. And we are subjecting people smugglers to the full force of Australian law.This bill will strengthen the Commonwealth’s anti-people smuggling legislative framework, supporting the Government’s plan to combat people smuggling.First, the Bill will ensure that people smuggling is comprehensively criminalised in Australian law with tough penalties for the most serious forms of this crime.In particular, the Bill will amend the Criminal Code Act 1995 and the Migration Act 1958 to introduce a new offence of providing material support to people smuggling. The Bill will also introduce a new aggravated offence in the Migration Act for people smuggling involving exploitation or danger of death or serious harm.Second, the Bill will amend the Telecommunications (Interception and Access) Act 1979, the Surveillance Devices Act 2004 and the Australian Security Intelligence Organisation Act 1979 to ensure appropriate tools are available to investigate people smuggling activities and enable law enforcement and national security agencies to play a greater role in support of whole of government efforts to address people smuggling and other serious threats to Australia’s territorial and border integrity. New People Smuggling Offences This Bill will introduce new people smuggling offences. New Offence - Supporting the offence of people smuggling Organised criminal syndicates depend on enablers and facilitators who play a vital role in supporting the criminal economy. Targeting those who organise, finance and provide other material support to people smuggling operations is an important element of a strong anti-people smuggling framework.This Bill will introduce a new offence of providing material support or resources for people smuggling activities. Such support or resources could include, but would not be limited to, property that is tangible or intangible, currency, monetary instruments or financial services, false documentation provided by corrupt officials, equipment, facilities or transportation.The offence applies if a person is reckless as to whether the money or resources they provide will be used in, or to assist, a people smuggling venture.It will not apply to a person who pays smugglers to facilitate their own passage to Australia or who pays for a family member on the same venture.The Government is determined to reinforce the message that people should use authorised migration processes in seeking asylum and migrating to Australia, and in supporting others to come here. People in Australia should not support the life-threatening business of people smuggling by providing finance or other assistance.The maximum penalty for this offence is imprisonment for 10 years or 1,000 penalty units or both. This penalty reflects the gravity of supporting a person or organisation to engage in the serious, dangerous offence of people smuggling.New Migration Act Offence - People smuggling involving exploitation or danger of death or serious harmThe Bill will introduce a new aggravated offence in the Migration Act for people smuggling involving exploitation or danger of death or serious harm. The offence will apply to people smuggling ventures to Australia. The Criminal Code already contains such an offence, which applies to people smuggling ventures to foreign countries.The offence will apply where a person, in committing an offence of people smuggling, endangers the life of the victim or risks serious harm to them. The offence will also apply where a person commits the offence of people smuggling either with the intention that the victim will be exploited after entry into Australia or the victim is subjected to cruel, inhuman or degrading treatment.The maximum penalty for this aggravated offence is imprisonment for 20 years or 2,000 penalty units or both. Mandatory minimum penalties Currently, the Migration Act contains mandatory minimum penalties for aggravated offences involving five or more persons. A minimum sentence of eight years imprisonment with a non-parole period of five years is prescribed for people smugglers who are repeat offenders.  A minimum sentence of five years imprisonment with a non-parole period of three years is prescribed in any other case for these offences.The use of mandatory minimum penalties reflects the seriousness of the activity being prosecuted. It allows the court to determine an appropriate penalty within the minimum and maximum set by the Parliament.This Bill extends the application of the higher mandatory minimum penalty to the new aggravated people smuggling offence involving exploitation or danger of death or serious harm. Extending the higher minimum penalty for people smuggling offences involving exploitation or danger of death or serious harm will reflect the very serious nature of this offence and the harm and danger caused to the victim.The Bill will also extend the application of the higher mandatory minimum penalty to persons who are convicted of multiple aggravated people smuggling offences in the same hearing. Currently, the higher mandatory minimum penalty for repeat offenders only applies where a person has a previous people smuggling conviction. The new provisions will ensure the mandatory minimum penalty can be applied where the people smuggler has organised numerous ventures over a period of time but is coming to the court for the first time in relation to multiple charges. Harmonisation of Laws The legislative framework for criminalising people smuggling is contained in the Migration Act and the Criminal Code. Together, the legislation covers ventures entering Australia and ventures entering foreign countries, including those that transit Australia. The Bill will harmonise offences in both Acts.For example, the Bill will provide greater alignment between the Criminal Code and the Migration Act offences by addressing an existing discrepancy which requires the prosecution to prove that a people smuggler obtained or intended to obtain a benefit when prosecuting a people smuggling offence under the Code, an element not required by the Migration Act.As noted, the Bill will also introduce the aggravated offence of people smuggling involving exploitation or danger of death or serious harm into the Migration Act. This offence will align with the existing offence in the Criminal Code relating to exploitation or danger of death or serious harm.The amendments introduced by this Bill will also restructure and retitle the Migration Act provisions relating to people smuggling to ensure they are readily identifiable.These amendments will also achieve greater clarity and consistency, improving the readability of the legislation.Greater harmonisation across Commonwealth legislation will ensure the strongest possible framework for prosecutorial and investigative action on people smuggling activities.Better tools to investigate people smugglingConsistent with the Government’s national security strategy, the Bill will amend the Interception Act, the Surveillance Devices Act and the ASIO Act to ensure that Australia’s law enforcement and intelligence agencies have the appropriate tools to combat people smuggling.The protection of Australia’s territorial and border integrity from serious threats such as people smuggling is critical to Australia’s national security. It is therefore appropriate that Australia’s national security agencies should be given greater flexibility to respond to people smuggling and other serious threats to our territorial and border integrity.ASIO powers to investigate serious border security threatsThe Bill will amend the ASIO Act to enable ASIO to use its capabilities to respond to serious threats to Australia’s territorial and border integrity, including people smuggling. This will support the Government’s intelligence led approach to combating people smuggling, and is consistent with the ‘all hazards’ approach to national security.ASIO is currently limited to using its intelligence capabilities in relation to prescribed heads of security, which do not include border security threats. The amendments contained in the Bill will enable ASIO to specifically use its capabilities to assist the whole-of-government effort in combating people smuggling and other serious threats to Australia’s territorial and border integrity. Interception and surveillance powers for people smuggling offences The Bill will make consequential amendments to the Interception Act and the Surveillance Devices Act to ensure that investigative tools under both Acts are available in relation to the new and amended people smuggling offences. These tools are already available in relation to a range of serious people smuggling offences in the Migration Act and the Criminal Code. Existing accountability and reporting mechanisms in those Acts will continue to apply to these powers.Amendment to the definition of ‘foreign intelligence’The Bill amends the definition of foreign intelligence in the Interception Act to align it with the concept of foreign intelligence in the Intelligence Services Act 2001 (ISA).Currently the definition of foreign intelligence in the Interception Act limits the collection of foreign intelligence to information relating to foreign governments and foreign political organisations where it is important to the defence of the Commonwealth or to the conduct of the Commonwealth’s international affairs.This position no longer adequately reflects the contemporary threats to Australia’s national interests. The amendments recognise that in an increasingly interconnected global community, activities such as people smuggling are usually undertaken by non-State actors, and will enable information about foreign individuals or groups operating without government support to be collected.The Bill also recognises the broader nature of the contemporary threat environment by allowing the collection of foreign intelligence about non-State actors where it is in the interests of Australia’s national security, foreign relations or national economic well-being.These amendments will ensure that there is consistency in the scope of functions undertaken by national security agencies. In practice, this will enhance the ability of national security agencies to collect intelligence about people smuggling networks and other non-State actors threatening national security. Conclusion In conclusion, this Bill bolsters the Government’s hardline and comprehensive approach to combating people smuggling, by enhancing the Commonwealth’s anti-people smuggling legislative framework.The Bill ensures that people smuggling activities are consistently and comprehensively criminalised, with a new offences of providing material support for people smuggling.The Bill equips our law enforcement and national security agencies with effective investigative capabilities to detect and disrupt people smugglers.It demonstrates the Government’s commitment to addressing the serious nature of people smuggling activities and to targeting those criminal groups who seek to organise, participate in and benefit from people smuggling activities.I commend this Bill to the Senate.

Australian Research Council Amendment Bill 2010

This is an appropriation Bill to support:

• the ongoing operations of the Australian Research Council
• and three specific initiatives.

It will fund the high-quality research we need to address the great challenges of our time, to improve the quality of people’s lives, to support the development of new industries, and to remain competitive in the global knowledge economy.

The bill updates the special appropriation amount administered by the Australian Research Council to include:

• new funding for Research in Bionic Vision Science and Technology
• new funding for the Super Science Fellowships Scheme
• continued funding for National ICT Australia
• an additional out year
• and indexation of existing appropriation amounts in the Australian Research Council Act 2001.

Inventing a bionic eye was one of the big ideas proposed by the Australia 2020 Summit in 2008.

The Government has embraced this idea, which promises not only to give and restore sight to tens of thousands of people around the world, but also to generate know-how that can be applied in many other areas.

Australia is already a global leader in bionics. This new investment will reinforce our leadership in one of the most demanding and inspiring fields of scientific research.

The Super Science Fellowships Scheme is an integral part of the $1.1 billion Super Science Initiative announced in the 2009 Budget.

The Super Science Initiative furthers the objectives of the Government’s innovation strategy, Powering Ideas, by building on Australia’s strengths in space science and astronomy, marine and climate science, and the sciences that will underpin the industries of the future, including biotechnology and nanotechnology.

While the Super Science Initiative is primarily about building the infrastructure needed to support cutting-edge research, it is also about nurturing the talented individuals who will perform that research.

The Super Science Fellowships Scheme will offer 100 three-year fellowships to early-career researchers working in fields targeted by the initiative.

This is one of several measures the Government has introduced to give the best local and international researchers a real chance to build a career in Australia.

Super Science Fellowships are designed to encourage and support the next generation of researchers. They complement our Australian Laureate Fellowships for established researchers and Future Fellowships for researchers in mid-career.

National ICT Australia – better known as NICTA – is the largest information and communication technology research organisation in Australia.

As well as undertaking user-inspired basic research, it also plays a vital part in research training and commercialising research outcomes through spin-out companies and technology licensing.

NICTA is funded jointly by the communications portfolio and by the innovation portfolio through the Australian Research Council.

The 2009 Budget extended NICTA’s funding for another four years from 2011-12 so that it can continue its vital work. This Bill gives effect to that decision.

In addition to providing for these specific measures, the Bill also adjusts the Australian Research Council’s funding cap for the financial years beginning on 1 July 2009, 2010 and 2011 in line with indexation, and sets the funding cap for the financial year beginning on 1 July 2012.

The Bill will increase spending by approximately $889.6 million over these four financial years.

The proposed amendments change only the administered special appropriation; they do not alter the substance of the Act or increase departmental funds.

This is routine but important legislation that will advance our efforts to build a fairer and more prosperous Australia through innovation.

I commend the Bill to the Senate.

Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009

This bill is the fourth in a series of bills to implement reforms to the regulation of therapeutic goods in Australia through amendments to the Therapeutic Goods Act 1989.

The bill reflects the Government’s commitment to maintaining the position of Australia’s Therapeutic Goods Administration as a leading global regulator of therapeutic goods and to continue to strengthen and enhance this well-deserved position.

This bill builds upon the other therapeutic goods reform bills approved by Parliament over the past year to further strengthen and improve Australia’s therapeutic goods regulatory framework.

As I announced in late June during the introduction of the previous amendment bill, this Bill includes a new regulatory framework for cellular and tissue based therapy products, known as biologicals, so these products can be regulated as a specific therapeutic goods group.

Implementation of the biologicals framework was agreed to in 2006 by the Australian Health Ministers’ Conference and it was among other improvements that were to have been adopted as part of the legislation underpinning the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA [anz-ter-puh].

The Rudd Government committed to moving forward to implement these improvements. We have delivered on that commitment with the majority of improvements now implemented through the reform bills that have been passed by the Parliament this year and in this current bill that I put before the House today.

Schedule 1 of this bill will implement the new framework for the regulation of biologicals and will bring Australia’s regulation of these products in to line with other leading therapeutic goods regulators around the world including the United States, Canada and the European Union.

Biologicals include such things as skin tissue for use in grafts following burns and bone for grafting.

It is envisaged that a legislative instrument will be made under the biologicals framework to declare that organs donated for transplantation and assisted reproductive tissues, such as IVF embryos, will not be classified as biologicals for regulation under the Act. Instead organs will continue to be regulated by the Organ and Tissue Donation and Transplant Authority established by this Government and Assisted Reproductive Tissues will continue to be regulated under current arrangements.

The new framework will enable the overarching regulatory principles that apply to all other therapeutic goods to be adapted and applied to biologicals by including a new Part 3-2A in the Act. The principal benefit of the new biologicals Part is its ability to apply different levels of pre- and post-market regulation requirements based on the relative risk of each biological.

It will also ensure that all biologicals used in Australia are properly assessed and regulated, as currently many are exempted and do not fit neatly under the medicines or medical devices frameworks.

To enable this to occur, classes of biologicals will be set out in the regulations to be made under this Bill. The lowest class will include biologicals that are of a relatively low risk level while the other classes with apply to biologicals of incrementally higher risk levels. For example, those biologicals that have been extensively manipulated or are intended to be used for a purpose that is not their usual or original purpose would fall under the highest risk class.

The rigour of the application and assessment process and post market monitoring for biologicals will be aligned to these risk-based classes, so that higher risk biologicals will be required to provide a higher level of information to confirm their safety, quality and efficacy.

This approach means that sponsors of biologicals in lower risk classes are not required to comply with unnecessary requirements that are relevant only to higher risk biologicals.

Only those biologicals that are approved and included in the Australian Register of Therapeutic Goods or otherwise given an exemption under this new Part will be able to be imported, exported, supplied or used in Australia. This is consistent with all other therapeutic goods such as medicines.

The new Part will also apply criminal offence and civil penalty provisions to dealings with biologicals in the same way as they apply to other therapeutic goods. Were this not the case, the Act would be inconsistent in its application, and sponsors of biologicals or other therapeutic goods might have an incentive to frame the claims in relation to the nature of their product so that it would come under the more lenient offence and civil penalty provisions.

A feature of the new Part 3-2A for biologicals is its ability to deal flexibly with urgent medical circumstances. Unlike medicines which may be readily mass produced, biologicals are produced from cells and tissues. As a result the amount able to be produced and available on-hand at any one time may vary. Also, there will always be minor differences between biologicals of the same product – for example, bone tissue from one donor will not be exactly the same as bone tissue derived from another donor.

The new Part will require that all biologicals must meet certain standards and be manufactured according to good manufacturing practice.

However, there may be exceptional circumstances where a patient is critically ill and urgently requires a biological for treatment but where none that conform to the requirements are available and no other approved therapeutic good is appropriate.

The Part will provide that non-conforming biologicals can be used in such circumstances if the patient’s doctor believes it is clinically necessary and the patient or their guardian consents.

The decision to use non-conforming biologicals in exceptional circumstances would be made as it is now on a case-by-case basis by the doctor and the patient or their guardian. It is important that this bill reflect the limited but critically important role for exceptional release.

The bill provides that details for exceptional release will be set out in the Regulations. The requirements will be similar to those for access to unapproved medicines under category A of the current Special Access Scheme where patients are critically ill and no other approved therapeutic good is appropriate.

In implementing the new arrangements, the Government is committed to making sure that sponsors and manufacturers of these products will be able to transition smoothly and easily to the new regulatory arrangements so that the supply of biologicals to those who need them will not be affected. As part of this commitment the Government has undertaken extensive consultation with the industry over the past year, including explaining the proposed framework to sponsors and manufacturers and setting out the steps they will need to take to comply with the framework.

To further support the transition, the amendments in this bill establishing the framework will not commence until a date to be proclaimed within 12 months. This will ensure that the remaining consultation and work on the supporting details, such as the product-specific standards, can be finalised and in place to commence at the same time.

Schedule 1 also includes specific transitional provisions for applications for inclusion of a biological in the Register as a medicine or a device that are under consideration by the TGA at the time the new biologicals arrangements commence.

Those applications will continue to be assessed as either a medicine or a device depending on which group they are currently regulated under. Where the application is approved the biological will then be included in the Register and moved to that part for biologicals.

This will prevent applicants needing to make a new application or having the application assessment process being restarted or protracted as a result of the application being transferred for consideration by the biologicals assessment area. However, input is routinely provided by the biologicals assessors into these applications to ensure they meet the necessary standards.

The existing arrangements in relation to advertising of therapeutic goods, review of decisions and other general provisions in the Act will be applied to biologicals in the same way that they are for other therapeutic goods.

Associated amendments will also be made to the Therapeutic Goods (Charges) Act 1989 to enable annual charges to be payable by sponsors to maintain the inclusion of their biological in the Register. These charges apply to all therapeutic goods and reflect the work of the TGA to monitor products on an ongoing basis.

The biologicals industry sector has long-awaited this new framework and has begun readying itself to implement the new arrangements.

Turning now to Schedule 2 of the Bill, this Schedule brings together the current range of somewhat inconsistent provisions that indemnify the Minister, the Secretary and others acting as required under the Act and replaces these with a single provision.

This Schedule does this by including a new section 61A in the Act to provide that the Commonwealth, the Minister, the Secretary and others with powers and functions under the Act, the National Manager of the TGA and others empowered or authorised to do certain things under the Act can do so without fear that civil legal action can be taken against them for doing so, as long as they do not act in bad faith.

This is consistent with Commonwealth legislation for other regulatory agencies, such as the Australian Prudential Regulation Authority Act 1998.

In other amendments in the Bill, Schedule 3 will provide greater flexibility to recall specific batches of therapeutic goods where there are safety, quality, efficacy, presentation or performance concerns about only those affected batches.

Currently in some cases where there are safety, quality, efficacy, presentation or performance concerns the entire entry for the good must be suspended or cancelled to enable recall of batches to occur. This approach is unnecessary and excessive in some circumstances where only a small number of batches are affected.

Consistent with the provisions included in the Therapeutic Goods Amendment (2009 Measures No 2) Act 2009 which enable information to be sought from a person who previously held a conformity assessment certificate for a medical device, Schedule 4 of this Bill enables information to be sought from people who previously had a medicine included in the Register.

Schedule 5 clarifies that unpaid annual charges are a debt due to the Commonwealth to ensure that they are able to be recovered as the TGA operates on a full cost-recovery basis through the work it undertakes.

Finally, Schedule 6 of the Bill includes a number of minor amendments.

These include providing that where a person asks to vary the conditions of registration or listing for a medicine the application for this must be accompanied by the relevant fee to enable the TGA to assess and respond to the request. This will principally support post-market monitoring of those medicines that are required to have an approved risk management plan as a condition of their registration and where the sponsor may wish to make a change to the agreed plan.

This final Schedule of the Bill will also clarify what is meant by new information in regard to reviews of decisions made under the Act so that it now includes any information that the sponsor had at the time of the original decision but was not provided to that decision maker. This is referred to as initial new information. It will also include any information that the sponsor had at the time the original decision was reconsidered and a new decision was made, but was not provided to the Minister or their delegate. Such information is referred to as later new information, reflecting that it relates to the later review of the original decision.

This will ensure that where such information exists the original decision maker or the Minister is given the opportunity to review it and make a decision having taken it into account. Currently the later new information can be provided directly to the Administrative Appeals Tribunal as part of a review of a decision made under the Act and the Tribunal does not need to remit the matter to the original decision maker to give her or him the opportunity to consider it.

The amendments in this Schedule will support the Minister or their delegate being provided with all pertinent information on which to make a decision and remove a loophole that enables such information to be withheld from that decision maker and lodged later for consideration by the Administrative Appeal Tribunal.

The Government intends to make further improvements to the therapeutic goods regulatory regime in the coming year to round out the improvements implemented through legislative amendments this year.

In particular, we intend to introduce further legislation to improve the advertising arrangements for therapeutic goods which are broadly acknowledged to be less than ideal at present.

In conclusion, this Bill provides a substantial raft of improvements to the Act and the regulation of thera