John Forrest (Mallee, National Party, Shadow Parliamentary Secretary for Regional Development) Share this | Link to this | Hansard source

I am pleased to have an opportunity to speak on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009. I am standing in for the member for Dickson, the shadow minister for health, who has been urgently called away for another meeting. This bill makes a series of amendments to the Therapeutic Goods Act 1989. There has been general support for the principles underlying this bill and the coalition supports the bill. The bill amends various technical aspects of the act. It is part of the ongoing reform of the act commenced by the Howard government and to which we have offered our support in opposition. The coalition supports ongoing streamlining and improvements of the regulatory processes surrounding the Therapeutic Goods Act. This is one of the important pillars of our healthcare system.

The most important aspect of this bill is the separation of the scheduling of medicines and poisons. Presently, medicines and poisons are scheduled jointly by a single committee, the National Drugs and Poisons Schedule Committee. The separation of scheduling for medicines and poisons has long been proposed and the coalition acknowledges the proposals put forward by the 2001 Galbally review and the 2008 Productivity Commission report. In fact, reviews dating as far back as 1954 have recommended that poisons and drugs be scheduled and regulated separately, citing (1) the efficiency gains in splitting up decision-making responsibility between the two areas, (2) the differences in the risk profiles associated with each area and (3) the different decision-making paradigms required. Legislative powers will remain with the states, which have agreed to introduce uniform schedules to implement this legislation.

The bill also gives the Secretary of the Department of Health and Ageing the power to preclude certain use for medical devices on the Australian Register of Therapeutic Goods. Other amendments include provisions for greater consultation with the Gene Technology Regulator on genetically modified organisms, changes to offence provisions and the empowering of the Minister for Health and Ageing to specify advisory statements on specific medicines.

The coalition welcomes the Senate inquiry report from the Community Affairs Legislation Committee, published on 7 August. The committee recommends that this bill be passed. The coalition supports the conclusion reached by the Community Affairs Legislation Committee, which in particular calls on the Minister for Health and Ageing, Nicola Roxon, and her department:

… to work constructively together through a number of areas where industry raised concerns, and which will be the subject of legislative instruments, including membership and expertise on the Scheduling Committees, chemicals scheduling, appeal and review of decisions by the Secretary, cost recovery and the publication of advisory statements.

The coalition also supports the conclusion by the committee:

… that the government should give a commitment that it will undertake the further consultation as foreshadowed with industry in a renewed sprit of openness and cooperation that will provide meaningful feedback to the proposals, issues and general concerns held by industry to ensure that the new system when fully implemented is supported by all parties and is totally transparent and accountable.

Industry groups have been very critical of the lack of meaningful consultation and feedback from the Department of Health and Ageing so far. I might add here as a general observation that this seems to be a common criticism of the current government’s approach to a whole range of issues, but we will put that matter aside. It is vital that industry has trust and confidence in the regulatory regime surrounding medicines and poisons, and the coalition acknowledges the commitment by the minister to pursue further reform in the coming 12 months. We do call on the government to proactively ensure that industry remains a part of the process of reform. The minister is responsible for ensuring that there is a good culture of consultation across all agencies under her control. It is the opposition’s intention to hold her to that commitment.

Not having had a lot of notice on this particular legislation, I will conclude my remarks by just reinforcing the point about the importance of consult by the government. I regularly receive complaints from industry bodies and commodity groups across my electorate, particularly in regard to agriculture—which is the very backbone of the part of the world that I represent. The complaints are about the government’s lack of willingness to consult, particularly in regard to agriculture but in other portfolios as well.

Whilst the government might have a view that the Mallee division is a very conservative seat, it needs to recognise the important contribution it makes across the board to the nation’s coffers. It contributes significantly to the GDP and no minister should be frightened to come and consult with my people. They will find them very even-handed and with a desire to enhance their own position, with the recognition that the government has been elected but it need not adopt that governing process and leave them out of the consultation loop.

The coalition supports this legislation and I am pleased that I had an opportunity to comment on it.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

I must say that I wholeheartedly agree with the comments that the member for Mallee made about consultation. In regards to consultation on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009, there has been extensive consultation over a very long period of time about the new scheduling arrangements, particularly in relation to medicines. There has been consultation—and I am sure he will be really happy to hear this—with the Department of Agriculture, Fisheries and Forestry, the Australian Pesticides and Veterinary Medicines Authority and Safe Work Australia. They are all bodies that I am sure he would like the government to consult with.

The most recent consultations occurred in May this year on the key documents that underpin the new arrangements. I also reassure the member for Mallee that the Rudd government is totally and absolutely committed to consultation in all areas, particularly in relation to health. I just refer him to the current consultation that is taking place under the reforming Australian health care agenda. I encourage him to consult with his community and to consult with the government about that because it is all part of the overall health care agenda for this country; ensuring that his constituents and the constituents of every member of this House gets quality health care, just as this Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 actually refers to another very important part of our health agenda.

Quite often these pieces of legislation relating to therapeutic goods slip through the parliament without people taking too much notice of them, but I have to say that each and every one of them adds to a different aspect of our health system and is vitally important. They actually streamline the way our health system works. They make our health system safe. They also ensure that the medicines, chemicals, appliances and various other products that the Therapeutic Goods Act 1989 applies to are actually going to benefit all Australians. They also ensure that they are appropriate.

This bill amends the Therapeutic Goods Act 1989. It implements new, separate scheduling arrangements for medicines and chemicals. It enables the Secretary of the Department of Health and Ageing—as we all know, the department responsible for therapeutic goods—to declare the purpose for which particular kinds of medical devices cannot be included in the Australian Register of Therapeutic Goods and thus made available. That is a very important aspect of this legislation.

The bill extends the circumstances in which consultation can occur with the Gene Technology Regulator on therapeutic goods that are or that contain genetically modified organisms, in addition to genetically modified products currently provided for under the act. I am sure the member for Mallee, given his commitment to the need for greater and ongoing consultation in this area, would also welcome this aspect of the bill that extends consultation; it is actually encouraging consultation with the organisations and authorities that he is particularly keen to see consulted.

The bill also amends the advertising offence provisions so that it is offence for any person to advertise a therapeutic good inappropriately, for a purpose that has not been accepted in relation to that product. In the past, I have had reason to be concerned about this particular area and I took a matter to the TGA. I have always found them very receptive. I have also taken this issue to state bodies because one case was contravening quite a few things. Once again, this simple provision shows how important these amendments to the Therapeutic Goods Act are and how important it is for every member to be mindful of legislation as it comes through.

The bill amends the delegation provisions to enable regulations to specify a relevant person for the purposes of exercising delegation under section 19A of the act. That is pretty self-explanatory. It helps make the legislation work, because you need to have someone who can exercise that delegation; otherwise, the whole system becomes unworkable.

Finally, the bill introduces provisions to enable the minister, by legislative instrument, to specify advisory statements that are required to be included on the labels of specified medicines. Once again, that is an extremely important amendment. I believe manufacturers of medicines are beholden to highlight what is in a certain product, and that should be on the label. That gives the consumer the ability to decide whether or not it is appropriate for them to take that medicine, as such labelling will flag whether there is an ingredient in that medicine that a consumer might be allergic to.

It is important to note there are further amendments planned for later in the year to establish a new framework for the regulation of human cellular and tissue based therapy products, and to make additional improvements to the regulation of therapeutic goods in Australia and the operation of the act. Once again, I emphasise that this will be done in close consultation with all sectors of the community—all interested parties.

It is vitally important that we support these changes to the Therapeutic Goods Act. I must thank the opposition, too, for giving its wholehearted support to these changes. They know, as we know, that changes like these are ensuring greater safety for the Australian community and keeping the act up to date.

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

Obviously, the therapeutic goods amendments that are being discussed today in this debate on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 touch on some very important ideas. Though it is not immediately obvious when you read the legislation, it is actually making some significant changes. The TGA of course plays a very important role in monitoring therapeutic goods and devices, and poisons as well, on behalf of the secretary of the department. Much of the debate on and consideration of this legislation has been about the responsibility of the Commonwealth, to be playing a role in the control of poisons—as they do for therapeutic devices and, of course, medicines themselves.

Another key issue that comes up every time we talk about TGA related issues is the role of complementary medicines. It was good to see the CHC and the Australian self-medicating industries having some say as well in these changes. But in the end we come back to the Australian Constitution—to subsection (60 (i) and the fact that it really does not clearly spell out the role of the Commonwealth. Those who have worked in this area—and I can go back to 2001 as an adviser to the then health minister—would know that we have worked very hard to get synchronisation between the states, to make sure that we do not have too much expectation on the TGA to operate on its own. It has to do so with other offices: the offices of, I think, chemicals and environmental health in the Department of Health and Ageing, all of which come together—as I note Charles Maskell-Knight has noted in his submission—under the secretary. Why do they do that? Obviously, you cannot afford to have every single decision about regulation coming back to this parliament. At some point that has to be devolved to the secretary, which it is—and remember that the TGA operates as a division within that department.

But I do recall the RU486 debate, which obviously galvanised both the country and this chamber back in 2005. The debate there, of course, was on a highly controversial therapeutic agent. Where the TGA alone is responsible for safety, clinical efficacy and quality, can they actually be expected to be making moral and ethical decisions around pharmaceuticals? It is relevant to this legislation that one of the amendments that I put up, with the support of a coalition senator, was that, for truly controversial pharmaceuticals, there probably should be some kind of recourse beyond the secretary and the TGA back to this parliament. Of course, that amendment was defeated, and the prime reason for that was that you cannot imagine that every single therapy could potentially be referred back to this chamber, and I have some sympathy for that. But I am also mindful that, in the two or three decades where we have had these issues, RU486—which has been around for a number of decades—has been the only pharmaceutical of which it has ever been contemplated that it should come here for debate.

So we are hardly going to be overwhelmed with requests. But I think it would be an important avenue, because we are all aware what is just around the corner in therapeutics: genetically modified organisms and pharmaceuticals that will be testing the boundaries. At the risk of describing a therapy that does not actually exist at the moment, there may be a day where there is a pharmaceutical that one could take, as a mum, to abort, selectively, a male or female foetus. We would be completely unable to deal with that through the TGA under the current arrangements, and there may be, one day, a rush to look at these regulations and provisions again when something highly controversial comes along, where I think ordinary Australians would like to have a say about what is on the pharmaceutical shelves around this country or, for that matter, what is sold in health shops.

That aside, what we are doing today is extending the powers, somewhat—first of all by separating medicines and poisons, and that has always been a little bit of an issue. We can go back to 2001, when the Australian Health Ministers Conference turned their minds to it and commissioned the Galbally review of 2001, which was responded to by an advisory committee’s working group in 2003. There was some hope that we could one day move to an Australia-New Zealand arrangement for therapeutic products, through a transnational authority. It was the great vision of the early 2000s. It was disappointing that, around July 2007, that was delayed. Subsequent groups have worked to still bring forward some of those fairly sensible regulations in an Australia-only context.

So what do we have? We have a separation of medicines and poisons—and I am aware that you do not want them to be too separate but you do want them close enough so that we have effectively the one, overarching, structure, so that there can be transmission and dissemination of information between those two bodies. But you still do not want to join them completely so as to have both medicines and poisons being regulated by the same body. There is a sense that that would be a little cumbersome under the constitutional arrangements that exist at the moment—those arrangements where the states still do take the lead, in the main, for the regulation of poisons. I think they turn to the Commonwealth, in this slightly vexed federal arrangement, for the overall guidelines, but then we hope that, through identical structures in states and territories, they can make their own decisions—and that seems to be where we fall so often on federal issues like this.

Secondly, we are enabling the secretary also to determine purposes for which medical devices cannot be used on the Australian Register of Therapeutic Goods. That makes sense. You can imagine that there is a wacky little device that can be used by, say, a medical specialist, and they talk amongst themselves at conferences and say: ‘Do you know what? You can also use this device for something else.’ All of a sudden you have moved beyond the good work of the TGA, because this device is being used in some other context. So, instead of boring out one hole in the human body, it is being used to bore something else. Clinicians may well have some information, some evidence from overseas, but it has not been submitted to the TGA and has not been scrutinised. I think that it is only fair that we should be pushing for that to occur. One way to do that is to enable the secretary to make some decisions about how devices cannot be used.

I just state one caution there. There are some very common-sense ways in which devices can be used. Some rarely-used devices—often very expensive devices or devices for which there is an enormous cost for the manufacturer to go through the approval processes in a range of the developed economies where they are available—could be looked at using common sense. There is a countervailing view that clinicians in the end are responding to cutting-edge science. It may well not be the sponsor who has the energy to bring it forward to the TGA and the TGA’s hands are tied, in a sense, in that respect. If it has not been brought to them, the TGA can hardly be expected to go out and do the research on very specific uses of these products. So I can see that there is a balance. I would like to know that there is still an opportunity for unusual medications and unusual devices to be used within the current expectation of clinical experts in their field. We can only hope that either sponsors or manufacturers make the effort to apply for approval and have it granted in this country.

Finally, we are looking at increasing the provisions for consultation with the Gene Technology Regulator. The area of genetically modified organisms—that is, products that either are genetically modified or contain genetic modifications—is very controversial. It is an emerging area. One thing we know is that the field is moving faster than politics, which is moving faster than community understanding, and whenever that happens there are tensions and uncertainty. There has been a great deal of unease within the community about the use of GMO. so all I can recommend is that the government spends more of its time and resources making sure that people fully understand and are brought up to date with the implications and the potential for GMO—without the scare campaign that often goes with it.

The last area, which is just a tiny change, is obviously increasing the offences for not just sponsors but also anyone who advertises a therapeutic good. I do recall some of the situations where the supply chain, particularly around complementary medicines, has been brought into question. Whilst still having great integrity in this country, many of these products are deemed to be less dangerous, and I commend the TGA for still having at the moment a fairly balanced view. You can have a scheduled pharmaceutical or you can have one that is more freely available, and then you can have complementary therapies. Most of them are amino acids and natural ingredients, and there comes a point where overregulation just becomes completely ridiculous. We do have to strike that balance—and I can see the nods from the other side of the chamber. There is just no point setting the TGA loose on certain natural therapies that have well-known and well-tried natural ingredients. Again, there has to be a balance. Where they are combined or in unusual strengths, where they report certain adverse reactions or where they are used for indications that are not conventional, I can understand the requirement of sponsors and people who import them to hold the evidence. I think it is very important that that information is available.

I will give you an example. A well-meaning lady in her 70s is diagnosed with dry macular degeneration and she obviously turns both to conventional and complementary medicine for anything that will preserve her sight. There is no surgical option and at the moment there is no pharmaceutical option for the treatment of dry macular degeneration. But there are plenty of complementary medicines out there, which must be incredibly luring to someone desperate to save every bit of vision that they can in a disease that has a fairly relentless progression. So she goes and purchases these products. She purchases them in a fairly unregulated environment and there is potentially a very serious adverse reaction, which in the end can be tied back to that therapy. What role does the TGA have there? I would like to believe that anything that is on the shelf can make a health claim only if it is backed up by evidence. That is fair enough, and that is how it is at the moment.

In this legislation I support further efforts to increase some of those offence provisions, and not just against the sponsor, if that were to occur. Let me explain why. We need to be able to turn to those importers and know that those pharmaceuticals have been manufactured in the highest quality manufacturing facilities, just as we would apply to local producers. You can see that if you are manufacturing locally with standards that are far higher than you accept from your imports, you are already setting up an unlevel playing field.

There is an even greater concern for me, which is that, when you try to block these products, what can you do? You can take action against the sponsor or the importer, but is that enough, because another sponsor can potentially appear. At the same time, this sponsor has actually disseminated the product around the country and it is sitting on shelves. Small business people have expended inventory, time, space and resources on stocking this product but of course no action can be taken. So we have this sort of invidious position where the TGA can potentially target a sponsor for errors in advertising or for making claims that cannot be backed up by evidence, but we still have the retailers who have made significant investments. In the past, many of them were unable to remove those products from the shelves if those advertising provisions did not apply to anyone, not just the sponsor.

In summary, this is important legislation. It has a history going back at least 10 years for the great vision that we had for Australia and New Zealand working together. It does not seem extraordinary that, for 26 million people, we could not find a way of working together for a trans-Tasman agreement. Let me remind members that the implication of parting from New Zealand is not insignificant; there are significant import situations where New Zealand authorised products appear on shelves here and are effectively able to bypass our TGA arrangements—one area is stimulant sports drinks. I know that mums and dads around the country have valid concerns about stimulants being added to sports drinks, and that is one tiny area in which we cannot afford New Zealand to be the back door to Australian supermarket shelves. That is an area we have tried and have fallen back somewhat, so this legislation, important to mention today, starts to make sure that those regulations become realistic, even though we fell away from that trans-Tasman agreement of a therapeutic products authority.

It is good that these additional powers fall to the secretary of the Department of Health and Ageing; it is excellent that these provisions for advertising are being strengthened; and, last of all, it is important that therapeutic devices cannot be used too far beyond the area for which they have already made their application to the TGA. It will keep some balance between common sense and, of course, the risk that clinicians will tear off on their own and use devices, in those rare opportunities, for other clinical causes for which evidence is not available. For all those reasons, it is really important that both sides support this bill.

Ms Anna Burke (Chisholm, Deputy-Speaker) Share this | Link to this | Hansard source

I rise to support the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009. This bill makes a series of amendments to the Therapeutics Goods Act 1989, and while we might look at the bill and think that it is pretty mundane and there is not a lot happening, a lot of the work of the TGA is something that we need to pay greater attention to. I am pleased that the bill has come before us and that there are ongoing amendments and reviews of the great work of the TGA. It reflects the government’s commitment to ensuring the ongoing safety and efficiency of therapeutic goods available in Australia by reducing the regulatory burden on the therapeutic goods industry.

The amendments made in the bill include: introducing new arrangements for the separate scheduling of medicines and poisons; enabling the secretary of the Department of Health and Ageing to declare purposes for which a device cannot be included in the register; extending the circumstances in which consultation can occur with the gene technology regulator regarding applications for the listing in the register of therapeutic goods that are or that contain genetically modified organisms; amending the advertising offences provisions to provide that it is an offence for any person to advertise a therapeutic good inappropriately; amending deregulation provisions to enable the regulations to specify a relevant purpose for the purpose of exercising delegation under section 19A of the act; and introducing provisions that would allow the minister, by legislative instrument, to specify advisory statements that are required to be included on the labels of specified medicines.

The main amendment to this bill allows the separate scheduling of medicines and chemicals. As the member for Bowman has said, this has been an issue discussed for many years. Many medicines and chemical products may present a risk of poisoning if inappropriately used. Some may require poisoning scheduling as part of the control mechanisms available. One of the interesting things that members of parliament put out is information to the electorate, and one of the interesting things to find is that the poisons line is one of the most rung lines by panic stricken mothers who do not know what a child has put down their throat. So it is of great concern to many people that we know in a chemical sense what is actually in a product that someone is consuming or using.

Scheduling is the process by which substances are grouped into categories or schedules under which specified requirements are attached regarding supply, availability and oversight. This bill implements amendments to improve the current scheduling arrangements. It will provide that medicines, including biological and other therapeutic goods and poisons, will be assessed and scheduled by the Secretary of the Department of Health and Ageing, replacing the role of the National Drugs and Poisons Schedule Committee. The secretary will make these decisions based upon advice from two new advisory committees to be established by this bill, the advisory committee on medicines scheduling and the advisory committee on chemicals scheduling.

The advisory committee on medicines scheduling will provide advice regarding substances to the extent that they are included in therapeutic goods such as medicine. The advisory committee on chemicals scheduling will provide advice in relation to substances not used in therapeutic goods, such as agricultural chemicals and veterinary medicines. This is a very sensible way to proceed and it is quite surprising we have not done it before now. Both committees will include members from the Commonwealth, states and territories as well as other experts to be provided for in the subordinate legislation. We need to indicate that there has been great collaborative work on making these changes between the Commonwealth and the states.

Decisions of the secretary will be incorporated into the poisoning standards, which will be retained as a single reference point to scheduling information. The separate scheduling of medicines and poisons follows a key recommendation of the Galbally review and a report from the Productivity Commission. It is also supported by the Australian Health Ministers Conference. This amendment will provide clarity and opportunity for individuals to make applications to the secretary to seek scheduling arrangements. The secretary will be in a position to seek the advice of either the medicines or chemicals committee, or both, in considering applications. The new arrangements will commence on 1 July 2010 to provide sufficient time to enable affected industries to make any necessary changes which will reflect the new arrangements. We need to indicate also that a great deal of consultation has gone on prior to this, so this will not come as a shock to anybody involved in any of the sectors.

This bill also allows for the secretary to declare purposes for which medical devices cannot be included on the register. Presently medical devices that satisfy all of the applications and certified requirements can be included in the register. Despite devices satisfying these requirements, there may be certain uses in specified circumstances where they could pose a risk to public health or be otherwise inappropriate. The internet is an amazing thing and it has opened up many opportunities for us as individuals, but in some cases it is a dangerous field in which people play. One of the most dangerous is in the medical world, where individuals nowadays are happily going online and individually diagnosing their own illnesses and then going online and purchasing devices and pills and have no idea what they are actually getting, and then using those pills and their devices at home. They think that they know what they are doing. It is a fairly unregulated and, I would hazard to guess, scary market.

We need to ensure that a device which might have a legitimate use, but which is put into the wrong arena or the hands of an individual at home, is not inappropriately used, and we also need to ensure we know that what it is being used for is what it has actually been registered for. Someone getting kits that provide self-diagnosis at home, which in a clinical setting and for those environments is perfectly reasonable, is highly dangerous outside those settings. I think information is a great thing, but we need to ensure that we are getting actual information. My child who was writing an assignment the other day said to me, ‘But it was on the internet.’ I said: ‘Well, that doesn’t prove anything. Where is the source and where is the backup?’ We need to ensure that appropriate organisations such as the TGA can monitor and ensure that devices out there are actually being used for the reasons that they were put on the register in the first place.

This bill will ensure that certain medical devices can be precluded from the register if the purpose of the device is determined as an excluded purpose. This will support safety and quality in the use of certain devices that would otherwise be unsafe, such as home tests for serious illnesses. In these situations people do not have the necessary medical support to understand the implications of the result or to notify health authorities if necessary. Amendments in this bill will ensure that medical devices are only available for appropriate purposes to support high-quality, safe medical care.

This legislation will impact on quite a number of pharmaceutical companies based within my electorate. Part of my electorate, around the Clayton area, has a rather large number of small industrial sites and many of these are home to a large number of pharmaceutical companies and factories. Right on the Chisholm-Clayton border—I claim it as mine, and not the Minister for Trade’s—is the head office of Sigma Pharmaceuticals, which is one of Australia’s leading manufacturers and marketers of pharmaceutical products. It is also the owner and operator of the country’s two largest pharmaceutical retail banners, Amcal and Guardian.

One of the other amendments today is about advertising and what can and cannot be claimed on certain products. We are now all-day purchasers of over-the-counter medicine. We all need to know that what is written on the box is telling us what the product can do. The member for Bowman said of complementary medicines that it is about knowing what reaction might occur when taking a natural product if it is taken in conjunction with other natural products or other pharmaceuticals. A lot of people do not think beyond that. They think that a pill is safe. But they need to know it is and what reaction it may cause when taking it with other medications. This will have an impact on Sigma Pharmaceuticals.

Another organisation, Kendle, is a leading global clinical research organisation, whose head office is based in Oakleigh, another suburb in my electorate. The Australian arm of the business was established in 1994 and employs around 80 people. Kendle provides a full range of early to late stage clinical development services for the world’s biopharmaceutical industry. The amendments in this bill will improve the efficiency of both these companies and will lead to better operational outcomes.

Also housed within my electorate is Monash University, at Clayton, and the Monash Medical Centre. Both of these are at the cutting edge of research into medicine, pharmaceuticals and gene technology which involve a whole range of issues that are covered by regulation within the TGA. I have had discussions about how myriad changes within something that seems downstream can impact on people who are at the top end of the stream regarding research work. They are always happy to see guidelines and greater provisions coming into place and commonsense arrangements coming through, as this amendment before us today does.

The amendments outlined in this bill are important to the therapeutic goods regulation regime and will be welcomed by key stakeholders in the industry. The government will continue to make further improvements to the regulation of therapeutic goods in Australia and the operation of the act to ensure the best outcomes for industry and consumers. I commend the bill to the House.

Mark Butler (Port Adelaide, Australian Labor Party, Parliamentary Secretary for Health) Share this | Link to this | Hansard source

I thank members for their contributions to this debate on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009. I thank the opposition for its support for this bill and particularly recognise the member for Mallee’s cameo performance at very short notice standing in for the shadow minister for health and ageing. As mentioned in the second reading speech, this bill amends the Therapeutic Goods Act 1989 in a number of ways. Most importantly, it implements new arrangements for the separate scheduling of medicines and poisons, reflecting the recommendation from the review of the Council of Australian Governments of drugs, poisons and controlled substances legislation undertaken by Ms Rhonda Galbally in 2001 and reiterated in a Productivity Commission report published in July last year.

This bill is the third in a series of bills making improvements to and strengthening the regulation of therapeutic goods in Australia. I am pleased to advise the chamber that the Senate Community Affairs Legislation Committee has inquired into the bill and recommended in its report of 7 August this year that it be passed without delay. Since the release of the Galbally review in 2001, the Therapeutic Goods Administration has undertaken negotiations with both state and territory governments, as key partners in scheduling, as well as consultations with industry. Most recently in May, the TGA undertook consultations in relation to the details to be developed under the bill. Feedback on submissions made during this consultation, detailing the comments made and proposed amendments to the framework, has been posted on the TGA website.

However, as members will appreciate, not all of the suggestions made over the past eight years were able to be taken on board and reflected in the bill that is before the House today. This is because the arrangements need to strike a balance between the flexibility and responsiveness sought by industry with the safety and access needs of consumers. They also need to fit within the overarching Commonwealth, state and territory structures within which the arrangements exist. Nonetheless, many improvements have been achieved in the drafting of this bill as a result of comments and suggestions made during the consultations. I am also stating here today that the government’s agreement that the chairs of the first expert committees for medicines and for chemical scheduling, formed under this bill, will be independent of the Commonwealth. This suggestion was made by ASMI, the self-medication industry group, and I am pleased to agree to it. Further discussions will be had with industry to ensure that the regulations underpinning this bill will promote both transparency and accountability. This government is committed to open and cooperative consultations with industry and, as I have said, further consultations are set to occur with industry to finalise the details of the arrangements to be established under this bill. I am confident that through these consultations administrative processes for scheduling will be developed that will be responsive to industry needs while maintaining the necessary balance between safety and access to medicines and chemicals.

Another issue raised during the Senate committee’s consideration of this bill was its constitutionality. Under the Constitution responsibility for controlling the access to and supply of substances rests with the states and territories. The Therapeutic Goods Act currently empowers the Commonwealth to establish a national schedule of medicines and chemicals that can then be adopted by the states and territories as a way of achieving national consistency. The amendments in the bill simply put in place a different process for setting the national schedule. The Senate Community Affairs Legislation Committee, in considering the bill, received submissions which on the one hand included calls from industry for the Commonwealth to take over the role of the states and territories and fully nationalise scheduling, while on the other hand presenting legal advice that called into question the constitutionality of the Commonwealth’s involvement in scheduling at all. Both extremes involve a misunderstanding of the constitutional position. While there is no power for the Commonwealth to legislate to impose a comprehensive national scheme, there is no doubt about its power to legislate to establish a schedule as part of a collaborative arrangement with the states and territories.

The bill also makes a number of smaller changes to the act to improve its operation. As indicated in the second reading speech, the changes made by this bill did not encompass all of the reforms the government intends to make to the therapeutic goods regulatory regime. The amendments in this bill are the third instalment in an ongoing program of reform to the act. Australia has been served well by the TGA in the past and it is important that the regulatory regime the TGA implements is kept up to date so that the TGA and the industry it regulates can operate as efficiently as possible, so that Australian consumers can continue to have timely access to safe and effective therapeutic goods. I commend the bill to the House.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

Ordered that this bill be reported to the House without amendment.