Andrew Laming (Bowman, Liberal Party) Share this | Hansard source

by leave—I move amendments (1) to (4) together:

(1)    Schedule 1, item 1, page 3 (lines 4 and 5), omit the item.

(2)    Schedule 1, item 3, page 3 (lines 8 and 9), omit the item.

(3)    Schedule 1, item 4, page 3 (lines 10 and 11), omit the item, substitute:

4  Section 23AA

Repeal the section, substitute:

23AA  Evaluation and registration of restricted goods

        (1)    Subject to this section, restricted goods may be evaluated and registered in accordance with the provisions of this Division as they apply to therapeutic goods.

        (2)    In spite of any provision of this Division, if the Secretary’s decision under paragraph 25(4AA)(d) is to register restricted goods, the Secretary must as soon as practicable notify the Minister of the decision to register the goods.

        (3)    The notice under subsection (2) is a legislative instrument.

        (4)    The registration of restricted goods must not take effect before the expiration of time within which a House of Parliament may disallow the instrument.

        (5)    If the instrument is disallowed or deemed to be disallowed under section 42 of the Legislative Instruments Act 2003, the decision that the Secretary made ceases to have any effect.

(4)    Schedule 1, page 3 (after line 13), at the end of the bill, add:

6 Subsection 25(4)

After “therapeutic devices”, insert “and are not restricted goods”.

7 After subsection 25(4)

Insert:

  (4AA)    If:

(a)  the therapeutic goods are not therapeutic devices and are restricted goods; and

(b)  the evaluation of the goods for registration has been completed;

                 the Secretary must:

(c)  notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(d)  if the decision is to register the goods:

                   (i)    notify the applicant in writing that he or she has notified the Minister under section 23AA; and

                  (ii)    after the expiration of time within which a House of Parliament may disallow the instrument, and subject to disallowance of the instrument under section 23AA:

                      (A)    notify the applicant in writing as soon as practicable that the goods will be included in the Register if the applicant gives the Secretary the certificate required under subsection 26B(1); and

                       (B)    include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary the certificate required under subsection 26B(1).

                 To avoid doubt, subject to disallowance of the instrument under section 23AA, if the applicant gives the Secretary the certificate required under subsection 26B(1), the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate.

I mean no disservice to the great civility, the grace and the thoughtfulness with which we have participated in this debate over the last 2½ days. But as a person of scientific training I put it to you that this question is no longer just science, and I summarise the amendments that I put to the chamber today as follows: if there is in the mind of every member in this place no doubt that RU486 is just another medication, then you will strike down my amendments. If it is your view that the laws we have for abortion in every state are immutable and that everything within those laws, everything that subscribes to those laws and is simply added to the menu of options for women, will never change, then you will strike down my amendments. And if you believe that there is no counter to that libertarian view that every individual, given the right information, can simply work their way through all the information and make an informed decision, that there is no need for a corridor of tolerability in the social services we deliver and that government has no role in that, then you will strike down these amendments.

But, more importantly, we will uphold first and foremost that the Therapeutic Goods Administration is unimpugnable in its efforts to analyse the science. The debate is not about the science. We move beyond that with these amendments. But it is vital that the analysis of science never trumps the option to consider more detailed views in this place, and that is why many of us left our professions to come here and consider just those issues and never walk away from them, never avoid the truly tough decisions that we believe in our own hearts to be right. The unintended consequence of this bill is that it strips away that final look at decisions made by well-meaning, highly educated and expert bodies—and I list the TGA among those. This is an issue of science and then some, and we simply cannot airbrush away those extra issues. I do not share the views of the extremes of both sides of this debate, but I will fight for those views to be heard after we have had an informed debate.

We have had an informed debate using overseas information filtered to us through different agencies but never—and this is a good thing in this bill—has that evidence been taken to the TGA. When it comes through, it will most likely recommend this drug as safe and this drug will come here and probably not be stopped by the proposals I recommend. They will go through both houses without a disallowable instrument ever being effective in stopping the drug. So do not mistake my actions today as an effort to scuttle RU486. Do not mistake my view, either, as one to complicate the debate. I stand here purely to leave that option open—to leave the option open for the tough decisions, through community views, to filter up here so that we do the things that we have, after all, been elected to do.

Isn’t it ironic that the very 2½ days of energised debate we have had, without my amendment, will become impossible in the future? This amendment is about having the option to come back and do just what we are doing today. I take no pride in the fact that we keep the issue of abortion out of this chamber. We have managed to do it for decades on end and we think it is not something we want to raise here—it is too venomous and too difficult to resolve. That is not the attitude that we should be taking. Nor should we view this as just another pill—that is completely obvious. One hundred and thirty-seven of us have come down here in a conga line to express our feelings one after the other for 2½ days.

So let us not fool ourselves that RU486 is anything as simple as a general therapeutic to be decided by an expert body. This is a medication; we know the mechanism of action and it raises great concerns with some. I am not asking us to adjudicate upon this as experts; clearly we are not. The TGA are the scientific experts aiding the women in this terrible predicament when they have to make these tough decisions. They have the frustration of infertility, to which we dedicate enormous efforts and resources. But, in the end, it is the community that sets what we do. It is not left to an expert body. So cast this not as politicians stepping into bedrooms nor parliamentarians stepping into consulting rooms. This is done with embryonic stem cell research and with therapeutic cloning. It is done in every state House when these tough decisions on abortion come back to parliament. I have argued that the use of a disallowable instrument is the best of the three options we have. One is to live with tough decisions; one is to use a disallowable instrument; and one is to legislate every time this question arises.

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