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Wednesday, 3 December 2008
Page: 7941


Senator LUDWIG (Minister for Human Services) (9:32 AM) —I table the explanatory memoranda relating to the bills, and I move:

That these bills be now read a second time.

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

Leave granted

The speeches read as follows—

AUDITOR-GENERAL AMENDMENT BILL 2008

The Auditor-General Amendment Bill 2008 proposes minor amendments to the Auditor-General Act 1997.

The Bill amends the Auditor-General Act to implement certain recommendations of the 2001 Inquiry into the Auditor-General Act by the Joint Committee of Public Accounts and Audit.  The JCPAA inquiry was intended to assess the Act and determine if it was achieving its stated intentions.  Overall, the Committee found that the Act provided an effective framework for the Australian National Audit Office to carry out its functions.

While these are the first substantive legislative amendments to the Auditor-General Act since the JCPAA issued its report in 2001, some of its recommendations have been implemented administratively by the Auditor-General.  Amending the Act will provide legislative certainty for these administrative actions.  A number of the amendments also build on, or are additional to, the JCPAA’s recommendations as other areas of the Auditor-General Act which could be strengthened or require amendment have been identified in the time since the report.

The proposed amendments are minor.  For example, they clarify and extend the distribution of performance audit reports; make provision for the inclusion of comments on proposed reports in final reports, and clarify the circumstances in which audit information made available to entities and other parties in the course of a performance audit may be disclosed.  The Bill will also update the penalty provisions in the Auditor-General Act to bring them in line with current criminal law policy.

When the Auditor-General conducts a performance audit of a Commonwealth agency, a copy of the final report is provided to interested persons prior to the tabling of the report in the Parliament.  This gives the recipients an opportunity to consider the report in advance of tabling so that they are able to respond to any questions that may arise.  Although it is the Auditor-General’s practice to give the Chief Executive of an audited entity a copy of the final report prior to tabling, this is not an explicit requirement of the legislation.  To address this deficiency in the Act, the Bill would provide that the Auditor-General must give a copy of the report to the Chief Executive of an Agency or, if the audited entity is a Commonwealth authority or company, to an officer of the authority or to a director or senior manager of the company, as soon as practicable after the report is completed.  The Bill also provides that the Auditor-General may provide a copy of a report, or extracts from a report, to any person (including a Minister) or any body who, in the Auditor-General’s opinion, has a special interest in the report. 

With the increased outsourcing of government services in recent years, there are potentially many groups, such as contractors engaged to deliver government services, which may be involved in a performance audit.  There is no provision in the Act at present to require the Auditor-General to give draft reports to these people for comment.  To address this, the Bill would allow the Auditor-General to give a copy of a proposed report, or an extract from a proposed report, to any person who, in the Auditor-General’s opinion, has a special interest in the report.  The recipient of the draft report would then have 28 days to provide written comments, which the Auditor-General is obliged to take into account in finalising the report.  This process will help ensure that information in the report is correct.  It also provides for natural justice by giving persons who may be criticised in a report an opportunity to comment on the findings set out in the proposed report.  To preserve the integrity of the audit process, the recipients of such information would, of course, be subject to the confidentiality provisions in the Act that apply generally to persons who are in possession of audit information.

In the interest of fairness and completeness, the Bill also requires that the Auditor-General must include, in full, all written comments received on a proposed report under subsection 19(4) in the final audit report.  This amendment provides a legislative basis for the Auditor-General’s current practice.

The Bill also corrects a number of errors in the Act that were identified by the JCPAA in its 2001 report, particularly in those provisions relating to the omission of information from reports on public interest grounds.  These are explained in detail in the Explanatory Memorandum that accompanies the Bill. 

The amendments will have no financial impact.

The changes to the Auditor-General Act proposed by this Bill, while relatively minor, are an important step towards encouraging open communication and improving the fairness, effectiveness and integrity of the audit process.


CORPORATIONS AMENDMENT (No. 1) BILL 2008

Today I introduce a Bill that will amend the Corporations Act 2001 to fulfil a requirement under the Australian Government’s Memorandum of Understanding with the New Zealand Government on Business Law Co-ordination.  Fulfilling this requirement moves us another step closer to achieving the goal of a single, trans-Tasman economic market, based on common regulatory frameworks.

The Bill provides a mechanism for the recognition of a disqualification from managing companies that occurs in a foreign country by Australia.  This will close a regulatory gap where currently disqualification can be avoided simply by moving jurisdictions.

The Corporations Act currently provides a range of circumstances in which a person will be automatically disqualified from managing corporations, and circumstances in which the Australian Securities and Investments Commission can apply to a court to have a person disqualified.

The Bill adds to the automatic disqualification provisions and also provides the Courts with an additional disqualification power.

First, a person will be automatically disqualified from managing corporations where they have been so disqualified by a court in a prescribed foreign country.

Second, an Australian court will have the power to disqualify a person from managing corporations, on application by ASIC, where the person has been disqualified under the law of a prescribed foreign country.  This provision will cover situations where, for example, a person has been disqualified automatically by operation of law in a foreign country, or by a foreign regulator.

In this situation the Australian Court must be satisfied that the disqualification is justified before they can disqualify the person in Australia.

These arrangements will ensure that all people disqualified in Australia on the basis that they have been disqualified in a prescribed foreign country, have had their disqualification scrutinised by a court.

Prescribed foreign countries will be named in the Corporations Regulations.  Initially it is envisaged that only New Zealand will be named.  The mechanism will, however, allow for other countries to be added at a later date if it is considered that there is sufficient similarity with Australia’s regulatory regime, as is the case with New Zealand.

New Zealand enacted its complementary provisions in 2007.

In the interests of cross-border consistency these amendments have been modelled on those of New Zealand.

This Bill addresses concerns that people who are disqualified from managing corporations in New Zealand could still manage corporations in Australia simply by crossing the Tasman.  As such, it will enhance protection for investors and the integrity of Australia’s markets.

Finally, I can inform the chamber that the Ministerial Council for Corporations (MINCO) was consulted in relation to these amendments to the laws in the national corporate regulation scheme, and has approved them as required under the Corporations Agreement.

I have also commenced consultation with MINCO on the accompanying regulations.  Provided that approval is received, the Regulations should be ready to commence contemporaneously with the provisions of the Bill.

I commend the Bill to the Senate.


MIGRATION LEGISLATION AMENDMENT BILL (No. 2) 2008

The Migration Legislation Amendment Bill (No. 2) 2008 amends the Migration Act 1958 to clarify and enhance provisions relating to merits and judicial review of migration decisions.

The Bill has three sets of amendments.

Firstly the Bill clarifies that when the Migration Review Tribunal or the Refugee Review Tribunal seek information from review applicants or third parties, this may be done either orally, or by written invitation.

Secondly the Bill reinstates effective and uniform time limits for applying for judicial review of migration decisions in the Federal Magistrates Court, Federal Court and High Court. The Courts will have a broad discretion to extend that time where they consider an extension necessary in the interests of the administration of justice.

Thirdly the Bill limits appeals against judgments by the Federal Magistrates Court and the Federal Court that make an order or refuse to make an order to extend time to apply for judicial review of migration decisions.

These amendments will ensure a more efficient migration review system, while maintaining the rights of applicants to procedural fairness.

The first set of amendments seek to address a series of recent decisions of the Full Federal Court where the court held that the Tribunals may only seek additional information from review applicants or third parties if they do so by written invitation, that is, they cannot seek information orally.

In particular, the case of SZKTI v Minister for Immigration and Citizenship [2008] FCAFC 83 found that the Parliament did not authorise the Tribunals to get additional information from a person pursuant to its general power to obtain information, without complying with the specified procedures set out in sections 424, 424A, 424B and 424C of the Migration Act for obtaining such information.  This effectively means that the Tribunals are not able to seek information orally from an applicant. 

Requiring the Tribunals to seek information only by written invitation is problematic when the only available means to communicate with a person is orally, for example, where only a telephone number is provided (which was the case in SZKTI).

Conducting investigations only in writing can also cause considerable delay without necessarily improving procedural fairness to the applicant. 

Enabling the Tribunals to seek information from applicants or third parties either orally or in writing will ensure that review of migration decisions can be conducted more efficiently. This is of particular importance to the Refugee Review Tribunal which is required under legislation to meet a 90 day time limit for conducting reviews.

In all circumstances, where information is collected that is adverse to the applicant and which the Tribunal considers would be the reason or part of the reason for affirming the decision under review, clear particulars of that information will be put to the applicant in writing. The applicant would then have an opportunity to comment on such adverse information within a prescribed period before a decision on review is made.

The second set of amendments will reinstate effective time limits for applying to the courts for judicial review of migration decisions.

Without effective time limits, there is an incentive for unsuccessful visa applicants to take advantage of the delays that litigation may cause, for example, by waiting until their removal from Australia is imminent before lodging an application for review.

The current time limits in the Migration Act are largely ineffective as a result of the April 2007 High Court decision of Bodruddaza v Minister for Immigration and Multicultural Affairs [2007] HCA 14 and the July 2007 Full Federal Court decision of the Minister for Immigration and Citizenship v SZKKC [2007] FCAFC 105. 

In Bodruddaza the High Court held that the time limits imposed on the Court were constitutionally invalid because there was no discretion to extend time.

In SZKKC the Full Federal Court held that the time period for seeking judicial review of a Tribunal decision will begin to run only if the applicant is personally served with the written statement of reasons of the Tribunal by a person authorised by the Registrar of the Tribunal.

It would be expensive and impractical for the Tribunals to implement the practice of personally serving a written statement of the reasons for the decision.  As such, the time limits for seeking judicial review of a migration decision to the Federal Court and Federal Magistrates Court are now largely ineffective.

This Bill reinstates effective time limits in three main ways.

Firstly, it extends the time for lodging an application for judicial review of a migration decision from the current 28 days to 35 days.

The Bill also seeks to address the problems identified in SZKKC and Bodruddaza through two further key amendments. Firstly, the time period for seeking judicial review of a migration decision will start to run from the time the migration decision is taken to have been made, rather than from the time of actual notification which the Act currently requires. This addresses the practical difficulties associated with personally serving a written statement of reasons. To provide certainty, the Bill defines ‘date of decision’.

Secondly, the Bill provides the Courts with broad discretion to extend time where they consider it necessary in the interests of the administration of justice. This seeks to address the constitutional issues identified by the High Court in Bodruddaza and enables the Courts to protect applicants from possible injustice caused by the time limits.

Applicants will be required to state in their applications for an extension of time why they consider it necessary in the interests of the administration of justice for the order to extend time to be made.  This will assist the Courts to deal with requests for extensions of time more quickly and assists in more efficient use of court resources.

The third set of amendments in the Bill will limit all appeals against judgments by the Federal Magistrates Court and the Federal Court that make an order or refuse to make an order to extend time to apply for judicial review of migration decisions.

This measure will strengthen and enhance the new time limits for applying for judicial review of a migration decision as inserted by the Bill.

It may also help to prevent applicants from making weak or vexatious appeals to deliberately delay their removal from Australia.

The limitation on appeals does not affect any rights the applicant may have to seek review in the High Court’s original jurisdiction because such a limitation would be unconstitutional. The amendments do, however, limit appeals of decisions to make an order or refuse to make an order to extend time to apply for judicial review of migration decisions to the High Court in its appellate jurisdiction.

The amendments that limit appeals seek to encourage applicants to seek timely resolution of their cases.

In conclusion, these amendments bring about key reforms that will lead to a more streamlined migration review system but one that still delivers fair and reasonable outcomes to clients of my department.

The Bill deserves the support of all members of this Parliament.

I commend the Bill to the chamber.


THERAPEUTIC GOODS AMENDMENT (MEDICAL DEVICES AND OTHER MEASURES) BILL 2008

This Bill amends the Therapeutic Goods Act 1989 in a number of ways.

Firstly, it incorporates into the Act provisions allowing the stockpiling and supply of medical devices to deal with emergency situations without the requirement for such devices to comply with the Act.

Second, it gives effect to a range of amendments which have been in contemplation for a number of years, and which were to have been adopted as part of the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

Following the decision by the New Zealand Government in July last year not to proceed with legislation enabling ANZTPA, the Rudd Government has decided to pursue these amendments in an Australia-only context.

Turning first to the medical devices amendments, these provisions are based on similar provisions allowing medicines to be stockpiled and supplied in emergency situations which were added to the Act in 2002.

It is unfortunate that other amendments made to the Act that same year to deal with medical devices did not include an emergency provision from the outset.  But be that as it may, the Government is now acting to include these provisions so that medical devices can lawfully be stockpiled in case of a future emergency and made available in an actual emergency without having to comply with the Act.

In 2002 the then Parliamentary Secretary, in introducing the Bill, explained that the amendments were necessary to strengthen the ability of the Commonwealth to plan for, and respond to, national emergencies in which there is the potential for large numbers of people to require emergency treatment.  She gave as examples of such emergencies acts of bioterrorism or the emergence of a new, highly contagious disease in Australia.

Exactly the same rationale applies today.

The Act presently operates very effectively to ensure that medical devices supplied in Australia to meet our daily health care needs meet very high standards of manufacture and quality control.  In general, it is an offence to supply devices that have not been approved by the Therapeutic Goods Administration (the TGA).

But in an emergency the Government may need to be able to supply very large volumes of devices such as face masks or injection kits.  It may need to source these volumes from manufacturers who do not regularly supply goods to the Australian market, and who have not sought to have their products approved by the TGA.

The amendments in Schedule 1 to this Bill allow the Minister to exempt devices from the requirements of the Act so that they can lawfully be stockpiled and made available in an emergency.

The Minister can only make such an exemption if she or he is satisfied that it is in the national interest to do so, and the Minister’s powers may only be delegated to the Secretary of the Department of Health and Ageing.

The Minister may impose conditions on the exemption, including limiting the people allowed to import, manufacture or supply the devices, and must notify those people of any other conditions on the exemption.  Breaching a condition of exemption is a criminal offence.

The Bill does not provide for parliamentary scrutiny of the exemption through disallowance.  This is because a security consultant engaged by the Government last year recommended that the contents of the stockpile should be classified as “confidential” to ensure that would-be bio-terrorists were not able to find out what preparations Australia had made for dealing with possible bio-terrorist acts. 

For this reason the Bill also amends the Act so that similar exemptions applying to medicines are not to be subject to disallowance.

Turning to the deferred ANZTPA amendments, the Bill deals with the “fit and proper person” test, default standards for medicines, information disclosure, and the use of restricted representations in advertising.  It also makes technical amendments to all offence provisions to bring them into line with the latest policy on how these should be expressed.

The Act currently requires the Secretary, in deciding whether to grant or revoke a manufacturing licence or a conformity assessment certificate for a medical device, to have regard to whether the applicant, a person taking part in managing the applicant’s affairs, or a person “likely to have effective control” over the applicant, is a fit and proper person. 

The test in deciding who is a fit and proper person is at once subjective - in that there is no limit on the matters the Secretary may consider, and there is no guidance on who is a person “likely to have effective control” - and unduly harsh - in that the Secretary must have regard to any conviction against any law of the Commonwealth or a State or Territory, no matter what the crime or when it took place.

Not only has the test been criticised by industry for these reasons, but it is also administratively problematic.

The amendments in Schedule 3 of the Bill replace this test with a much narrower test, requiring the Secretary to have regard to breaches of the Act or offences against it, together with offences involving fraud or dishonesty over the previous ten years.

The amendments also replace the undefined concept of “effective control” with an objective definition of a “major interest holder”, defined as a one-fifth shareholder of a body corporate.

When the Act was introduced it provided that unless the Minister determined standards for therapeutic goods, they had to comply with the requirements of the British Pharmacopoeia.  The British Pharmacopoeia thus effectively served as the default standard for therapeutic goods.

Since the Act came into effect many manufacturers based in the United States or Europe have entered the Australian market.  As part of the ANZTPA consultation process industry pressed for the inclusion of the United States Pharmacopeia and the European Pharmacopoeia as alternative default standards. 

Schedule 4 of the Bill contains a series of amendments to include these pharmacopoeias as default standards with the same standing as the British Pharmacopoeia.  The amendments also remove references to the veterinary version of the British Pharmacopoeia, as the Act no longer regulates veterinary medicines, and makes a number of consequential amendments to remove other references to the regulation of therapeutic goods for use in animals.

The Act sets out when the Secretary can release information obtained under the Act to other regulatory agencies or to the public.  These provisions are unduly restrictive as they relate to the public release of information, and they have proved operationally difficult as they relate to providing information to other agencies.

The Government has decided to broaden the public access to information under the Act.

In particular, the TGA will publish a greater range of information about goods included on the Australian Register of Therapeutic Goods on its website to inform members of the public about the therapeutic goods and devices that are available in Australia, and assist them to make better informed choices and decisions about their use of therapeutic products.

It will publish the minutes and deliberations of expert advisory committees, as well as a greater range of information about information considered in, and the reasons for, making particular decisions, including summaries of the evaluation of applications for the entry of prescription medicines on the Register.

The amendments in Schedule 5 will support this by allowing the Minister to determine, by legislative instrument, classes of therapeutics goods information which may be published by the Secretary.  The amendments also widen the definition of information that may be released to include information held by the TGA, as well as information acquired by the TGA under the Act.

Other amendments in the Schedule resolve the practical difficulties with the provisions relating to the release of information to other government authorities.

The Act currently regulates advertising of therapeutic goods.  It includes a regime providing for the pre-approval of some categories of advertisements, together with limits and restrictions on the kinds of representations that may be made in advertisements.  For example, advertisements to the public cannot refer to serious illnesses, or make claims that a cure is infallible.

While the limits and restrictions are intended to apply to all advertisements, the current structure of the Act implies that they only apply to advertisements that do not require pre-approval.

The amendments in Schedule 6 are intended to clarify that the limits and restrictions apply to all advertisements.

Finally, Schedule 7 contains a series of purely technical amendments to align all criminal offences provisions in the Act with current policy on the expression of such provisions.

The changes made by this Bill do not encompass all the reforms the Government intends to make to the therapeutic goods regulatory regime.

We intend to introduce further legislation next year to give effect to other changes that were foreshadowed as part of the ANZTPA process, including new frameworks for the regulation of human cellular and tissue-based therapies and homeopathic medicines.

We will also be pursuing changes to the current advertising arrangements.  The Productivity Commission has recommended that the Government should streamline and clarify the advertising regime for therapeutic goods.  At this stage, I intend to carry out informal consultations with industry over the next few months before releasing a formal consultation document for consideration next year.

The amendments in this Bill are thus the first instalment in an ongoing program of reform to the Act.

Australia has been served well by the TGA in the past, and it is important that the regulatory regime the TGA implements is kept up to date so that the TGA and the industry it regulates can operate as efficiently as possible, and so that Australian consumers can continue to have timely access to safe and effective therapeutic goods.

Ordered that further consideration of the second reading of these bills be adjourned to the first sitting day of the next period of sittings, in accordance with standing order 111.

Ordered that the bills be listed on the Notice Paper as separate orders of the day.