Shayne Neumann (Blair, Australian Labor Party) Share this | Hansard source

I rise to speak in support of the Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011. This bill has three main changes. The first is in support for a new streamlined procedure for prescription medicine; the second are changes to the way evaluation fees are collected; and the third are some changes to the standard conditions. I was interested to hear the member for Boothby talk about that because, as the parliamentary secretary and member for Ballarat said in her second reading speech on 23 March 2011: 'The TGA has only failed to complete evaluations on time on about 15 occasions' since 1992, which is not too bad a record in the circumstances when you consider the amount of work the TGA has undertaken and the number of therapeutic goods that would have been considered by the TGA during that time.

The minister was quite correct in saying that any additional costs are passed on to the industry, as the TGA operates on a full cost-recovery basis. The member for Boothby was undertaking a bit of a thought-bubble at the table today wondering whether he wants the taxpayers to bear the cost in relation to an additional evaluation process or is standing up for the industry. I am not quite sure whether or not that is coalition policy. It was a thought-bubble that we heard from the member for Boothby; waxing and waning lyrically on the topic. I was quite interested to hear that. I wonder whether we will see that in coalition policy at some stage in the future.

There are three changes and I will go through what is going on in relation to these changes in the bill. The bill is about streamlining procedures and practices to create efficiencies. I am not sure that constituents across my electorate of Blair and across Australia would truly grasp what goes on behind medicines, pharmaceuticals and devices which are offered at the local pharmacy, or whether they know the background of what happens in the provision of medicine and devices through hospitals, doctors and the like. We have terms like the PBAC, the PBS, Medicare, the TGA and others which have become commonplace in the lives of Australians involved in the health and hospital sector and the pharmaceutical industries, but I do not think the average Australian really understands what is going on behind the scenes. The TGA performs a valuable role in Australia in its evaluation of therapeutic goods and they are to be commended. Obviously this is an important part of our health and hospital system and it is good to see, generally, bipartisan support for the therapeutic goods process.

The bill makes important changes to the Therapeutic Goods Act by enhancing the regulatory framework and by providing some additional support for a new streamlined procedure being implemented to improve the time taken for evaluation of prescription medicines. A review of the application and evaluation process for prescription medicines was undertaken by the TGA with the aim of eliminating unnecessary delays. As I said, the TGA has a pretty record but you can always make improvements. A number of initiatives were identified that, when implemented, aim to reduce the current 500 days for an application to termination to about 300 days. This is a difficult process and we want to get it right. The consequences of the TGA getting it wrong are devastating potentially, not just to the health and welfare of Australians but also to their families and to the community generally. There are serious consequences of the TGA not getting it right. Making sure that the TGA takes a considered approach to medicines and to the evaluation process is appropriate.

The TGA wants to streamline the submission process in two ways, and the government has listened to what has been said. One is in terms of the registration of new prescription medicines and the other is to changes to the entries of prescription medicines in the Australian Register of Therapeutic Goods, known as the ARTG. After wide consultation the TGA initiated a new streamlined submission process that commenced in November 2010. It unfolded after what, as I said, was a long process—a 12-month implementation phase.

The bill before us today amends sections of the legislation to support the new processes and comes very much from the TGA itself. Prior to the implementation of the streamlined procedures, applications that were made by way of submission were accepted with the idea that supporting documentation could be lodged during the evaluation process. This could create unnecessary delays and have the effect of bogging down the whole evaluation process. The changes presented in this amendment ensure that information application fees occur upfront for changes to information already on the ARTG. Applications that do not meet these requirements will not be accepted for evaluation. This mirrors requirements for applications to be included in a new prescription medicine on the ARTG.

Also the bill will make a change to the way evaluation fees are collected by the TGA. That is a second major reform. Completion of evaluation must occur within defined timelines, 175 or 255 working days, depending on the circumstances. Timeliness is important to industry and to the Australian public because time is money in this area. If the TGA fails to meet these timelines the evaluation fee payable by an applicant is reduced by 25 per cent. Currently the system requires a 75 per cent payment by the applicant with the final 25 per cent payable only if the TGA completes the evaluation within the designated timeframe. As I said, the TGA completes evaluation for prescription medicines on time in the large majority of cases with very few exceptions. Additional invoicing application monitoring needed under the previous system was burdensome and not warranted given the TGA's evaluation completion record. This amendment means the TGA will collect a full evaluation fee when the application is accepted and then must refund 25 per cent only if the TGA does not complete the evaluation process within the designated period.

As I said, there is a third aspect of the changes. It includes amendments to ensure the old standard conditions cease to apply when the first instrument takes place. Any unique or special conditions applying to specific therapeutic goods entered on the register will continue to apply. The bill contains some amendments which enable the instrument imposing the standard conditions to apply only to the registration or listing of therapeutic goods after the instrument comes into effect as there may be occasions when this is appropriate. The measures in this bill are all about improving processes. They are important for Australians and important to people in my electorate of Blair. They are about streamlining existing systems to ensure greater efficiencies. This, we believe, is in the best interests of not just our nation but the health system generally.

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