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Wednesday, 27 October 1993
Page: 2651

Senator CROWLEY (Minister for Family Services and Minister Assisting the Prime Minister for the Status of Women) (5.32 p.m.) —I would like to thank honourable senators for their contributions to this debate. I will make really two groups of responses.

  First, the points raised by Senator Newman went to comments about the TGA. She raised two main points. The first one was a concern about the failure to sufficiently consult the states, particularly Victoria, about the amendments to the Therapeutic Goods Act to take account of the matching legislation that could be introduced in the states to correspond with this legislation.

  I find this a bit surprising. Essentially, the Therapeutic Goods (Charges) Amendment Bill, this amending legislation, is in all ways the same as legislation that was in this place late last year and not able to be proceeded with, so it is hardly a new area of legislation.

  Secondly, there has been extensive consultation with the officers involved at both the Commonwealth and state level. Members of the National Coordinating Committee on Therapeutic Goods, which is a Commonwealth-state-territory committee, have been involved in this process of discussion and consultation, very extensively over the preparation of the legislation; indeed, at a meeting in May this year they were all present. If all the officers were present at that meeting, and also at the AHMAC meetings, it is hard to conclude that they could not have properly known. It is certainly our understanding that they did properly know.

  I am also a little disappointed that Victoria should make the points that it did, particularly through Minister Tehan, suggesting that it was not fully consulted. Indeed, Victoria has assisted the federal government very much with this matter because it is the Victorian draft legislation that has been circulated as proposed prospective draft legislation for states and territories to use as part of the complementary legislation that goes with this bill. Indeed, when the current version of these amendments was being discussed with the federal Office of Parliamentary Counsel, an officer from the Victorian Health Department attended that meeting. So it is perhaps a comment that goes to insufficient consultation within the Victorian department, but it is very difficult for the Commonwealth to accept that there was not adequate consultation or adequate information. So I cannot accept those comments from Senator Newman without making my remarks by way of refutation.

  Senator Newman also expressed concerns about the grandfathered goods under the TGA. These provisions have been in place since the principal act was put in place, and the amendment contained in clause 52 clarifies but does not change the existing arrangements. Senator Newman really wanted to know exactly what would happen to all the items listed under the grandfathering provision.

  The TGA is behaving sensibly in this matter. First of all, it intends to evaluate those grandfathered products if there is a matter of a public health interest. For example, if there were any reported adverse reaction in Australia or even overseas, the good or listed item would be evaluated or a case argued for it to be evaluated by the TGA because the TGA would be concerned to protect the interests of the public in Australia. Secondly, this would also occur if any sponsor of any such good asked for an evaluation by the TGA—indeed, for example, to enhance the status, and perhaps the export potential, of its product. So, apart from that, the TGA will not see its way to moving through every grandfathered good. If grandfathered goods are not covered by a public health concern or if a sponsor does not apply, they will be considered to be listed. So I think that should answer the concerns Senator Newman raised about this matter.

  Finally, it is important to note that if a sponsor objected to an evaluation of a grandfathered good, the Senate should know—and, indeed, this legislation makes clear—that the TGA can only enforce such an evaluation through actions under part 3 of the principal act. Decisions under that part of the act are subject to two levels of review: firstly, by my delegates—that is, the people approved to do that on my behalf; and, secondly, by the Administrative Appeals Tribunal. I am absolutely sure that the TGA has no inclination to misuse its discretion, but I am also equally satisfied that there is a formal accountability process in place should there be that kind of objection.

  I believe that Senator Newman raised the matter of silicone injections. The TGA has acted to see that that product has been listed before the drugs and poisoning scheduling, and it is now recommended for listing as a poison. In fact, that means it is listed as a poison. That should allay the people's concerns—particularly Senator Newman's but also certainly mine and others'—that the women of Australia might have been subject to injection by silicone not knowing the negative effects of it. But, in fact, the more concerning matter is that very often they were not advised that it was a silicone injection.

  So, clearly, having moved to have that listed as a poison ought to offer protection and some assurance to the community. Senator Newman suggests that there was some delay in having that implemented. But, since the matter has been drawn to my attention, the TGA acted expeditiously in getting that process up and running when it did move for its listing.

  The other matter raised in this place by Senator Lees—and I did not have the opportunity to hear all of her contribution—I believe goes very much to the same issue that Senator Tambling raised; that is, clause 4 of the bill. Let me make it clear that what the government was trying to do with the original paragraph was to make clear on the face of the legislation the immunity which the minister already enjoys. It was not the intention to extend the immunity that the Minister might enjoy, but to make explicit that he does have an immunity under the law as it is. That immunity has been confirmed by the Attorney-General's Department.

   The proposed amendment would not have extended the minister's immunity beyond statements made in good faith. However, as there appears to be a misunderstanding about this provision and because both Senator Lees and Senator Tambling have made their position quite clear, the government will withdraw the original clause 4 and replace it. The amendment that the government is proposing has been circulated to honourable senators.

  I understand that Senator Tambling is not comfortable with the proposed amendment. I would certainly be happy to hear what Senator Lees and the Democrats think of it. The replacement clause extends the common law to ensure that the publication of the minister's statement in good faith enjoys immunity from defamation. I note Senator Tambling's comment earlier that, if the words `in good faith' were explicit, it would cause less difficulty.

Senator Tambling —No, that was in relation to the minister; not this bit.

Senator CROWLEY —If I understand Senator Tambling's comment across the chamber, `in good faith' only applies to the minister. Let me make it clear: the replacement clause 4 extends the common law to ensure that the publication of the minister's statement in good faith enjoys immunity from defamation. If we do not replace clause 4 with the government's preferred amendment, the Attorney-General's Department advises that, except in limited circumstances, there is no protection from defamation for people who repeat the information contained in the minister's statement; nor is there any protection for any subsequent publisher.

  Without the protection offered by the replacement clause, people with a disability, their families and carers may never know if the service they use or want to use falls short of accepted standards. In effect, they would be denied access to the information.

Senator Tambling —Why does it have to be put in defamatory terms?

Senator CROWLEY —In the end what we may be deciding here is a balance of rights—the rights of people to have access to that information versus the rights of people to have their good name protected.

Senator Tambling —In defamatory terms.

Senator CROWLEY —Senator Tambling cannot keep insisting that publishing facts about a centre—particularly if the review panel's analysis and examination conclude that it is insufficient or not up to standard—cannot be taken, on the face of it, as defamation. What is of concern is that if there is no protection for that information to be made more widely known, then families of a disabled person may not be able to assess whether or not that service falls short of accepted standards. They would be denied access to the information. Anyone else who publishes the minister's statement about the service may be liable to defamation action. The defence of fair report may not be available to, for example, self-help groups or a parent network which want to republish the minister's statement under section 14J.

  I am advised that a precedent for the replacement clause 4 is subsection 134A(4) of the National Health Act 1953. Senator Tambling and Senator Lees have raised concerns about this matter. The government did take note of those concerns. It has agreed to withdraw clause 4 and replace it in an amended form. The proposed amendment will remove any doubt about the immunity the minister enjoys, but it also insists on putting into the law a protection against claims of defamation for people who might publish the information or even, indeed, mention it.

  Two points need to be understood about this matter: firstly, the people who might actually announce, circulate or want to publish that information have the protection from defamation; and, secondly, that the family of a person with a disability also ought to have access to that information. In the end, it is, I think, a matter of balance and a matter of judgment.

  Those opposite should note from the government's response that the comments made in the House of Representatives have been taken seriously as indeed, one would have to say, has the substance of the comments made by Senator Tambling in his contribution here as well as those made by Senator Lees. I ask that honourable senators opposite give serious consideration to the government's amended clause 4. We understand that it addresses the principal concerns raised by opposition senators and by the opposition in the other place.

  Question resolved in the affirmative.

  Bills read a second time.


  The bill.