SPEECH TO THE HOUSE OF REPRESENTATIVES REGARDING THE THERAPEUTIC

GOODS ADMINISTRATION BILL

WEDNESDAY, 15 FEBRUARY 2006

Mr Deputy Speaker, I would like to begin by thanking the many constituents

that have contacted me both for and against this Bill and have put their views

to me. To each and every one I have given the assurance that I would consider

the matter carefully, that I would weigh the arguments, and I would take a decision

after very careful consideration.

Mr Deputy Speaker, it is illegal to import, manufacture or supply therapeutic

goods unless they are registered in the Australian Register of Therapeutic Goods.

A person may seek to have such goods registered by making an application in

accordance with requirements set by the Department of Health. In practice the

application is considered by the Therapeutic Goods Agency – the TGA –

although entry onto the register is a matter for the Secretary.

In order to be registered the goods must be shown to be safe for the purpose

for which they are intended, and to have efficacy for the purposes for which

they are to be used. This is the essence of the registration on the Australian

Register of Therapeutic Goods. It is designed to protect the public from unsafe

medicine, or unsafe manufacture of medicine, or false claims about the properties

of medicine.

As I have said the entry onto the Register is made by application supported

by scientific evidence. In one case however, the procedure is different. That

is the case of restricted goods. Restricted goods cannot be evaluated, registered

or listed without the written approval of the Minister. Restricted goods are

medicines intended for use in women as abortifacients and they include RU-486.

The Bill before the House would remove the definition of restricted goods and

leave the procedure for the registration of these goods the same as for any

other goods to be entered on the register.

A lot of the commentary on this Bill has revolved around the rights and wrongs

of abortion. This Bill does not affect the law on abortion. The law on abortion

is set by State statutes or by State courts that have laid down the common law.

In general terms abortion is legal if it is performed to prevent some serious

danger to a woman’s mental or physical health. I think this is an appropriate

test. I think it is now a settled test in Australian law and I would not change

it.

Mr Deputy Speaker, we all come to this debate with our own personal experiences.

Our personal experiences colour our outlook on this most personal of issues.

I think it is common knowledge that when my wife, Tanya, was pregnant and unconscious

in hospital some 18 years ago, I was faced with this terrible situation. I was

advised by expert medical opinion that the pregnancy was complicating the medication

she would need to survive. She was unconscious. I was faced with a choice –

an awful choice – but the choice I made was to continue both the treatment

and the pregnancy. By the grace of God, both survived.

I have no doubt that the law should not have prevented such a choice. The law

should allow a choice where the physical or mental health of the woman is at

risk.

By the same token I would do everything I could to dissuade people from taking

abortion as a first choice. Only in those limited circumstances do I believe

that the law should permit it and rather than being a first choice I believe

it should be a last choice.

I cover these issues only to re-state my views and put them on the record.

Again let me reiterate this Bill is not about abortion. It is not directed at

changing the abortion law nor is it directed at changing the enforcement of

that law.

RU-486 is not currently registered in Australia. It could be registered under

the current law. It could be registered under the law as amended by this Bill

but whatever happens the law on abortion would not change. The issue that the

Bill raises which is before the House is the procedure to apply if an application

is made.

Some will say that the requirement for the approval of the Minister makes it

less likely that the application will be made. They point to the view of the

current Minister. Can I say, I am totally uninfluenced by that. The Minister

will change. I have served in this Parliament with many Ministers, I expect

to serve with many more. Some have been anti-abortion and some have been pro-abortion.

The approval of the Minister would be easy under the latter and hard under the

former. But the Minister will change.

What we should be doing is thinking of a process that will have integrity under

Ministers of different views and inevitably under Ministers of different parties.

The Minister for Health – the current Minister – is a dear friend

of mine. I do not consider the amendments of this Bill to in any way represent

a rebuff to him or his competence any more than the decision to give the interest

rate setting function to the Reserve Bank of Australia was a rebuff to my Ministerial

capacity.

The critical thing is to have a structure that has integrity and works to the

benefit and safety of the Australian people.

Now it is said by some that requiring Ministerial approval is a necessary condition

to preserve the sovereignty of the Parliament and keep decision making in the

hands of elected officials.

I am a great believer in the principle of Parliamentary sovereignty and of

keeping elected officials accountable and of giving them the capacity to make

the decisions for which they are held accountable.

But I believe this is what we are doing here. As a sovereign Parliament we

are taking the decision here and now – in a way for which we are accountable

– for a procedure that will apply to an application to register RU-486

if one should be made.

If the procedure leads to a bad registration the Parliament could legislate

to overturn it.

The fact that the Parliament through legislation delegates a decision does

not lessen its power or its accountability provided that the Parliament retains

the right to withdraw that delegation or to overturn the decision of a delegate.

Having said all of those things, that leads me to conclude that a proposal

to make decisions of the Therapeutic Goods Agency disallowable instruments is

a proposal which the Parliament could not easily refuse.

I will listen to the debate carefully in the committee stage but in principle

I believe in Parliamentary control over all these decisions.

I have read the Senate report on this Bill carefully. In the limited time I

have I do have the time to go through the precise findings it made on the safety

of this drug. It noted that the drug has been approved in many countries. It

reported that serious complications are rare and adverse complications quite

comparable with other approved medicines, some of which are even sold over the

counter.

There is no suggestion that this drug would be sold over the counter, nor should

it be. If it were registered it would only be available on prescription from

a qualified medical practitioner for treatment under close medical supervision.

Any wider application would call for immediate intervention and restriction

on the terms of its availability.

The Senate Committee reported that it could find no evidence that the availability

of RU-486 in countries where it is registered had led to an increase in the

rate of abortion.

The main objection to the registration of the drug by those who reported against

it in the Senate Committee were safety concerns. In my view these safety concerns

should be carefully evaluated by the Therapeutic Goods Agency.

From my reading guided primarily by the Senate Committee and the evidence before

it, the safety issues are not so overwhelming as to prevent an application going

to the TGA if an application is made to do so.

In these circumstances I support a uniform procedure for applications and registration

under the Therapeutic Goods Act, not one that applies a different procedure

for one class – the class of restricted goods – of which RU-486

is apart.

In those circumstances and on the basis of the conclusions that I have drawn

I will be supporting this Bill but make it clear that the sovereignty of Parliament

is such that at any stage if the registration or use should go outside the understandings

that we have been given, Parliament as sovereign has the right to intervene

both as to the procedure and to matters following from it.

In those circumstances I believe the matter can go to the Therapeutic Goods

Agency and I will support the Bill as it stands.