Helen Coonan (NSW, Liberal Party, Manager of Opposition Business in the Senate) Share this | Link to this | Hansard source

I present the first report of 2009 of the Senate Standing Committee for the Scrutiny of Bills. I also lay on the table Scrutiny of Bills Alert Digest No. 1 of 2009, dated 4 February 2009.

Ordered that the report be printed.

I seek leave to have the tabling statement incorporated in Hansard.

Leave granted.

The statement read as follows—

In tabling the committee’s Alert Digest No. 1 of 2009, I would like to draw the Senate’s attention to provisions in both the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 and the Trade Practices Amendment (Cartel Conduct and Other Measures) Bill 2008.

The committee is particularly disappointed with several provisions in the Therapeutic Goods Bill, along with parts of the bill's explanatory memorandum, which it considers have been poorly drafted and will be drawing these to the attention of the Minister.

Two of the provisions causing concern for the committee relate to exemptions from the Legislative Instruments Act 2003. First, proposed new subsection 41GS(6) of the Therapeutic Goods Act, to be inserted by item 2 of Schedule 1, provides that a Ministerial exemption of specified kinds of medical devices under subsection (1) of that section ‘is not a legislative instrument’.

As outlined in Drafting Direction No. 3.8, where a provision specifies that an instrument is not a legislative instrument, the committee would expect the explanatory memorandum to explain whether the provision is merely declaratory (and included for the avoidance of doubt) or expresses a policy intention to exempt an instrument (which is legislative in character) from the usual tabling and disallowance regime set out in the Legislative Instruments Act 2003. Where the provision is a substantive exemption, the committee would expect to see a full explanation justifying the need for the provision.

In this case, the explanatory memorandum states that the exemption referred to ‘is not a legislative instrument within the meaning of the Legislative Instruments Act 2003’ and that subsection (6) ‘explains rather than creates the exemption’ from registration on the Federal Register of Legislative Instruments or from parliamentary scrutiny.

The committee considers that this statement is inaccurate, because, for one thing, a Ministerial exemption under new subsection 41GS(1) appears to change the law with respect to the types of medical devices to which it refers; and, in addition, existing Ministerial emergency exemptions for therapeutic goods, which may be made under section 18A, are stated in current subsection 18A(9A) of the Therapeutic Goods Act to be ‘disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901’ (and therefore subject to parliamentary scrutiny and possible disallowance).

Confusingly, the explanatory memorandum also notes that the amendments in the bill relating to exemptions for specified kinds of medical devices ‘largely mirror the exemption provisions that currently apply to therapeutic goods, other than medical devices’. The committee has therefore sought the Minister’s advice about whether this apparent inconsistency can be resolved.

Similarly, proposed new subsection 18A(9A), to be inserted by item 1 of Schedule 2, provides that an emergency Ministerial exemption of specified kinds of therapeutic goods under subsection (1) of that section ‘is not a legislative instrument’. The explanatory memorandum states that the purpose of new subsection 18A(9A) is ‘to explain, for the benefit of readers, that an exemption made under subsection (1) is not a legislative instrument. As the exemption is not a legislative instrument within the meaning of the Legislative Instruments Act 2003, it is not subject to requirements of that Act such as registration or parliamentary scrutiny. This subsection explains rather than creates the exemption’.

The committee considers that this statement is open to question, because subsection 18A(9A), as currently in force, provides that an exemption under subsection (1), and a revocation or variation of such an exemption under subsection (8), ‘are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901’. Since the bill seeks to amend only subsection 18A(9A) of the Therapeutic Goods Act, it is difficult to understand how an exemption under subsection 18A(1) can change from being a legislative instrument to a non-legislative instrument. Again, the committee has sought the Minister’s advice about whether this apparent inconsistency can be resolved.

The committee also considers proposed new subsection 13(6) of the Therapeutic Goods Act, inserted by item 15 of Schedule 4, to be problematic. This subsection provides that a Ministerial order determining that a particular standard is not applicable to certain goods under proposed new subsection 13(5) ‘is not a legislative instrument’. The explanatory memorandum states that ‘(a)s the exemption is not a legislative instrument within the meaning of the Legislative Instruments Act 2003, it is not subject to requirements of that Act such as registration or Parliamentary scrutiny. This subsection explains rather than creates the exemption’.

Since the Ministerial order is not legislative in character, it may be assumed that the Minister’s decision to make the order is an administrative decision. If that is correct, it is not clear to the committee why that decision is not then subject to merits review under the Administrative Appeals Tribunal Act 1975, when so many other decisions of the Secretary to the Department, and of the Minister, are reviewable under section 60 of the Therapeutic Goods Act. The committee has also sought the Minister’s advice about this issue.

In relation to the Trade Practices Cartel Conduct Bill, the committee has commented on a number of provisions which abrogate the privilege against exposure to a penalty in certain circumstances. For example, new section 86F of the Trade Practices Act, to be inserted by item 5 of Schedule 2, abrogates the privilege against being exposed to the penalty of being disqualified from managing a corporation for a person required to answer a question, produce a document or do any other act in civil or criminal proceedings under, or arising out of, the Trade Practices Act. The explanatory memorandum does not offer any explanation of this particular amendment so the committee has sought the Treasurer’s advice as to the reasons for the abrogation of the privilege against exposure to a penalty in these circumstances.

Similarly, subsection 155(7) of the Trade Practices Act is to be amended by items 43 to 47 of Schedule 2, with the effect that the abrogation of the privilege against self-incrimination is extended to also abrogate the privilege against being exposed to a penalty. The subsection is further amended so as to no longer provide any immunity for any document produced in pursuance of section 155, although it continues to provide ‘use immunity’ to the information so provided.

The committee notes that the explanatory memorandum explains the effect of the relevant items in Schedule 2, however it does not provide a reason for either the abrogation of the privilege against being exposed to a penalty, nor for the removal of the immunity which currently attaches to the production of a document under section 155. Accordingly, the committee has considered it necessary to seek the Treasurer’s advice as to these reasons.

I commend the committee’s Alert Digest No. 1 of 2009 and First Report of 2009 to the Senate.

I move:

That the Senate take note of the report.

I seek leave to continue my remarks later.

Leave granted; debate adjourned.