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THERAPEUTIC GOODS BILL 2001 (No. 87)

Second Reading

Mrs JACKSON (Denison - Minister for Health and Human Services - 2R) - Mr Deputy Speaker, I move -

That the bill be now read the second time.

The term 'therapeutic goods' includes a wide range of medicines - orthodox and alternative - and therapeutic devices - such as pacemakers, other implanted devices, and condoms. Quality and safety standards for such medications and devices are of critical importance.

The object of the Therapeutic Goods Bill 2001 is to ensure that medicines and therapeutic devices manufactured, imported or exported in or from Tasmania meet accepted quality, safety and efficacy standards.

The Tasmanian bill is complementary to Commonwealth legislation covering these standards, in accordance with an agreement between the relevant Commonwealth minister and the relevant State and Territory ministers.

The safe manufacture, distribution and use of medication and therapeutic devices are all critical to the maintenance of health and treatment of disease. Substandard therapeutic goods have caused death and serious injury in Australia and in other countries, and they have the potential to have a serious impact on large numbers of people unless appropriate standards are applied. A coordinated national scheme is desirable to improve efficiency, remove conflict and duplication, and to make Australian manufactured goods more acceptable in overseas markets.

The Commonwealth's Therapeutic Goods Act provides a nationwide system for the regulation of manufacturing, importing and exporting of therapeutic goods - ensuring the quality of therapeutic substances and devices. It also provides for the application of quality standards, advertising standards and establishes the Australian Register of Therapeutic Goods. The provision of those laws will be applied as a law of Tasmania by Part 2 of the bill and will cover manufacturers who do not fall within the Commonwealth act at present.

The bill has undergone an extensive consultation phase, with a three-week consultation period from 15 September to 3 October 2001. I am informed that the main responses came from pharmacists who make up preparations to their own formulae - for example, some of the homeopathic pharmacists around the State. While in some cases, minor changes may be required to some labelling arrangements, there is a range of exemptions under the Commonwealth act and regulations for pharmacists and for the preparations they make and sell on site.

The bill will also repeal and replace the existing Therapeutic Goods and Cosmetics Act 1976. This act has never commenced and is inconsistent with the Commonwealth act.

There will be no duplication of requirements under the State and Commonwealth acts - the Tasmanian act will require manufacturers to have their products registered or listed under the Commonwealth act. Tasmania will not be applying a second approval arrangement on manufacturers. The bill therefore provides another example of the Labor Government's commitment to standardising legislation and to reducing 'red tape'. I commend the bill to the House.

Mr SMITH (Franklin) - Mr Deputy Speaker, this is, I guess to a degree a simple bill. It has some questions in it though. I do not see it, at this stage, needing to go into committee because it does have our support but there are some questions that I just ask now during the second reading debate which hopefully could be answered in the minister's response. From my understanding it is an interesting set. We see in this House a number of national uniform legislations agreed at ministerial councils. I have seen political commentators in all forms of media argue the pros and cons of a move toward national legislation and the use of these ministerial councils to decide that.

That argument aside, of the ones that I have seen come through this House in my time, it has been more standard to have a replica bill along with replica regulations and any provisions that are required rather than the opting directly into a Commonwealth piece of legislation. I am not arguing that one way is better than the other but the questions that I have would be in relation to the State's power to regulate at some point in time in the future.

Does this bill grant that power to the State if in a future time it was thought necessary? Just for example, the last paragraph in the second reading speech from the minister states:

'Tasmania will not be applying a second approval arrangement on manufacturers.'

That is, I think, a sensible way forward especially if you agree with the approval system that is in place nationally. However, there may be a time when Tasmania in this case or another State, does not agree with the approval ratings for manufacturers or certain standards of a new treatment or a new product that comes on the market. There may be a case where the State Government decides that the licence fee for that product could be higher or lower or the standards need to be greater or loosened in some way. So my question would be: what powers of regulation does the State retain subsequent to this bill seeing that we are directly opting in?

One of the points raised through this bill is that those manufacturers and from my understanding also people such as pharmacists, who may manufacture homeopathic products or some form of drug themselves and may also onsell somebody else's product, would have to be licensed to sell those goods under the Commonwealth act, and whether we at some point in time would have a need or desire to have our own system in place. If so, how does this legislation allow that, if it allows it at all?

I also had a question which may be a standard provision but Schedule 1 provides provisions in respect of search warrants which allows for a justice of the peace to authorise a search warrant. I just had conflicting advice from people with law backgrounds as to whether that was standard practice or not. My understanding was that a magistrate or a judge had to appoint a search warrant but it may well be that it is a standard provision for a justice of the peace to have that power and, if so, what education are we looking at for the justices of the peace in order to make sure that they stay within the act as the powers are provided through this?

The minister said there had been an extensive consultation phase, a three-week period from 15 September to 3 October. Was that a national consultation, seeing that this is uniform legislation, or was that consultation that the State itself conducted? If it was a State-conducted consultation on this, were there any changes suggested and consequently rejected and, if so, what were the reasons for that? I think they are the main questions I had on this bill. The Opposition supports this; at the end of the day it is a move towards standardisation and uniform safety, I guess, with our therapeutic goods, orthodox and alternative, and any therapeutic devices. Pacemakers, implanted devices and condoms are therapeutic devices under this legislation. There is probably an argument for that to be included in there. Quality and safety standards must be maintained. That is of the highest importance. Any move towards that and certainly to make sure that goods are not manufactured in other States at a lower standard and then on-sold here - which of course would come through a national system - is very good.

The last thing I would ask is whether we are the only State opting directly into the Commonwealth legislation. Or has this been a move that all States will operate directly under the Commonwealth legislation? I guess that adds to my questions about whether the State retains the power to regulate at some future date. I believe my colleague might have a few points on that matter.

Mrs SWAN (Lyons - Deputy Leader of the Opposition) - I do not want to make a long contribution but it is a matter that the shadow minister has spoken on with regard to uniform legislation. The minister might be able to inform me with regard to a matter that I have had a long interest in at the national level and in fact spoke on to some extent while I was a member of the Subordinate Legislation Committee and that was the capacity of various State parliaments to combine with regard to scrutinising uniform legislation. This would give a capacity for State governments to be involved to the extent that they may be able to monitor or moderate aspects of legislation that were being presented on a uniform basis. As I said, I have a particular interest in this matter because it seems to me that the relevance of the State parliament is to some degree somewhat dependent on the ability to intervene, inspect, offer comment, and moderate with regard to a broad range of uniform matters that are now coming before us. I, for a start, have absolutely no disagreement or problem with the fact that in today's age it is necessary for uniform legislation to be implemented in many areas.

If we are to have a consistent system then quite clearly the Federal Government of any persuasion is likely to continue with this theme because increasingly nations are having to present on a national basis, on a broad range of legislative matters and that of course increases efficiency, increases market capacity to act as a unit, increases consumer confidence and addresses a broad range of matters which are simply absolutely sensible and thus must be implemented. I argue for the moderating effect of the other side of the agenda, if you like, and that is our ability as a State Parliament to offer some comment through that process of scrutiny.

The simple question is, Minister, can you indicate to me whether any further work has been done by the Government in this regard? It was, as I say, under way when I was a member of the Subordinate Legislation Committee and there seemed to be across the nation a degree of interest in the setting up of one coordinated body from a national perspective with membership by all States that would have a capacity to scrutinise on that basis when uniform legislation was being presented to us. I would be most interested if you could indicate to me what progress has been made. We in all other matters would agree with the legislation because, as I say, it is sound and sensible to have uniform standards to apply a consumer regime which protects the consumer in all of these sorts of therapeutic goods. Therefore we know, no matter where we are, in whatever State we are, that we will have a uniform standard; that is immensely important from the point of view of the consumer and also in respect to the market overall in delivering a degree of confidence to those who are involved in purchasing from the market and relying on those standards. So we agree with the legislation. We will just be interested in whether there has been any follow-up at the subordinate legislation level.

Mrs JACKSON (Denison - Minister for Health and Human Services) - First of all, this legislation was agreed in 1992, I am advised. Health ministers then agreed to have this national situation in 1992. That would have been in Roger Groom's time. It has taken this long to get the legislation, nearly nine years. I suppose that is not too bad. This legislation is not a replica - I think `template' is the word you are looking for -

Mrs Swan - Okay, so there are some modifications.

Mrs JACKSON - Yes. So I will just read this out, because I think it explains it quite well. 'The amendments to the Commonwealth act in 1993, which came about after the agreement of all the States to those changes, allowed the Commonwealth to exercise functions transferred to it under the complementary State or Territory legislation, so that actually happened in 1993. An agreement between the Commonwealth minister and the State and Territory ministers provided for the Commonwealth to assume responsibility for regulating the manufacture, export and import of therapeutic goods and for the States and Territories to regulate wholesaling of such goods.'

We have been waiting for the development of a suitable legislative model by other jurisdictions on which to base reform of our therapeutic goods act. Victoria and New South Wales have both passed complementary legislation and, as I understand it, what that means is that the Commonwealth legislation already covers import and export of goods into and out of Tasmania. What is not covered by that Commonwealth legislation is what is manufactured here and stays here, so what this legislation does is cover that. But also there were the two models. Victoria evidently have gone for covering the field, I suppose you would say. Their legislation includes all the Commonwealth legislation and their own needs, and I am advised here they have a bill which is about 100 pages long and needs to be amended every time the Commonwealth amends their legislation. We have gone for the New South Wales model which is more specific to us and it is obviously shorter, as we can see, and we will only need to change that if it pertains particularly to what is manufactured in Tasmania and stays in Tasmania. When the Commonwealth legislation is amended, we will not need to change our legislation because we will just continue to follow the situation that exists now and has, I believe, since 1993.

The current Victorian legislation, as I said, duplicates much of the Commonwealth act, but I am advised they are also considering adopting the New South Wales approach because of the resource implications in frequently updating the act to maintain parity with the Commonwealth act. The New South Wales act was passed in April 1996 and simply states that the law of the Commonwealth applies as if it were the law of New South Wales, which is what our legislation does.

Mr Smith - Do we still have the power to regulate if we wanted?

Mrs JACKSON - Not for things that come in here or are exported, but if it is manufactured here we still have the power. This is, I believe, something that has been talked about for years, in fact, going back to the early 1980s at least, and it is one reason why the 1976 act here was never proclaimed because it was always envisaged that we would get a national system. The 1976 legislation was not proclaimed, as I say, because over the years when the act was a relevant resource it was not assigned to do anything and then the passing of the Commonwealth act after lengthy debate between the States - and I think that was an act in the 1980s that preceded the 1993 act - made most of the act redundant. This is going back probably 20 or 30 years of debate and we are finding the end of it here today.

The need obviously is to have not just uniform standards but national standards for the goods that we are talking about and obviously good standards and also to have the infrastructure to judge those standards. Somebody might remember that we have a bill in this State called the Weights and Measures Act. I do not know if we still have it - but I remember when I had some shadow responsibility for it, it was very interesting because we did not have the equipment here to calibrate the weights and measures we had in this State. In fact we did not even have enough resources to check or calibrate the weighing scales in shops. I think petrol stations were another area where they had to have this continual calibration. I know the big thing was the EZ company, which had to have its equipment properly certified to be able to export. Obviously if they said they were exporting a tonne of zinc or whatever it could not be 99.9 so it had considerable implications. We just did not have the resources in this State to do that and in fact I think they brought in some of these machines from interstate -

Mrs Swan - Can I interject rather than take you into committee and ask you that if something is manufactured here in the State do we have many different arrangements that apply to those goods that don't get exported?

Mrs JACKSON - I do not think we have many goods that come under this that are actually manufactured in Tasmania but I will check. Those we do have are very few. I have been advised that advertisements have been put in the newspaper about this on a regular basis, or they were before this legislation. The only queries were from pharmacists whom they exempted to make their own homeopathy concoctions, as I said in my second reading. They are exempted but there is nothing else in the State.

Mrs Swan - No other manufactured -

Mrs JACKSON - There is no manufactured item or anything.

Mrs Swan - Okay.

Mrs JACKSON - There is a note here that there will be no duplication of requirements under the State and the Commonwealth acts. The Tasmanian act will require manufacturers, if they are not exempted by the Commonwealth act's own exemptions - and they are the exemptions we are talking about - to have their products registered or listed under the Commonwealth act. It is desirable however that the State legislation applies nationally except to standards to those areas which are beyond the constitutional reach of the Commonwealth and that is the intrastate trade and non-corporate manufacturers. Of course I assume that the Commonwealth has powers under that under the Corporations Act and that is probably how they instigated this legislation in the first place and also I take it under the overseas trade. So that is how they have attached their power to this legislation. Is that -

Mrs Swan - Yes, thank you.

Bill read the second time.

Mr DEPUTY SPEAKER - Minister, you will be pleased to know there is a company now doing the calibration within the State and they are now looking after that.

Mrs Jackson - Excellent. But who pays for it?

Mr DEPUTY SPEAKER - The companies.

Bill read the second time and taken through the remaining stages.