Ms Anna Burke (Chisholm, Deputy-Speaker) Share 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.

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