Andrew Southcott (Boothby, Liberal Party, Shadow Parliamentary Secretary for Primary Healthcare) Share this | Link to this | Hansard source

In speaking on the Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011, I would like to make it clear from the outset that the opposition will not be opposing this bill. The bill contains three different elements and makes changes to the Therapeutic Goods Act 1989. These are further changes to the legislation to implement the streamlined processes with regard to the way in which prescription medicines are evaluated by the TGA. These streamlined processes have come about due to an internal review of the application and evaluation processes by the Therapeutic Goods Administration, undertaken in 2009. The streamlined processes apply to both the registration of new prescription medicines and any applications to make changes to already existing entries of prescription medicines on the Australian Register of Therapeutic Goods.

The original legislative changes to implement these processes were made and passed by this parliament in a similar bill last year. The bill before us today contains further changes in this process. As I said earlier, there are three main amendments that this bill will make, and I would like to speak briefly to each one.

The first amendment, on the streamlined submission process, deals with the way applications are made to deal with a prescription medicine's entry on the Australian Register of Therapeutic Goods when that application involves evaluation of clinical, preclinical or bioequivalence data. Before the streamlined application processes were implemented, applications for evaluation were accepted under the expectation that further data, research and information would be provided throughout the application process. This led to significant delays, with a time lag between the TGA getting back to applicants and applicants getting back to the TGA. The information will now be required upfront, at the beginning of the application, to remove any delays resulting from an application having to provide extra documentation throughout the evaluation process. This amendment will bring the application and evaluation process for changes for listings for prescription medicines already on the Australian Register of Therapeutic Goods in line with the application and evaluation process for new listings that were implemented under the TGA bill last year.

The implementation of these changes is, I am informed, expected to reduce the length of the evaluation process from approximately 500 to 300 calendar days. That is something the opposition will be holding the government to account on. Five hundred days seems far too long to deal with this application process. The coalition welcomes any sensible amendment that reduces the length of time it takes to move prescription medicines through the evaluation phase and onto the public market.

The second amendment in the bill relates to the way evaluation fees are collected by the TGA for applications requiring the evaluation of clinical, preclinical or bioequivalence data associated with the prescription medicine. As it currently stands, there are prescribed time lines for evaluation of prescription medications under the therapeutic goods regulations. When an evaluation is not completed by the TGA within these prescribed time lines, the evaluation fee payable by the applicant is reduced by 25 per cent. This is currently administered by payment of three-quarters of the evaluation fee initially on application and the remaining one-quarter of the evaluation fee on completion of the evaluation by the TGA within the prescribed time. The new process under these amendments would require the full evaluation fee to be collected by the TGA upon the application for evaluation being lodged and for 25 per cent of that fee to be refunded if the evaluation is not completed within the prescribed time limit.

The TGA has said that this leads to the significant administrative cost of monitoring each application until completion, and the added burden of invoicing applicants twice is not warranted given that the TGA completes most of the applications on time. The Parliamentary Secretary for Health and Ageing, in the second reading speech, stated that additional administrative costs are passed on to industry, as the TGA operates on a full cost recovery basis. Given that the TGA operates on a full cost recovery basis, where there are reduced administrative costs, will there be some alleviation on industry, some rebate for industry, some way of reducing the costs that are passed on to industry? That is something I would like the government to address.

The third and final amendment, for want of a better description, seems like a housekeeping amendment. It deals with the operation of a ministerial power to make determinations that impose standard conditions on the registration and listing of therapeutic goods on the register. The standard conditions set by the minister apply not only to the new registration or listings after the legislative instrument comes into effect but also on a retrospective basis to therapeutic goods on the register. In what seems like an oversight, the 2009 bill did not have any provision to ensure that the old standard conditions set by the minister ceased to apply when new standard conditions are imposed. This third amendment included in the bill before us rectifies this apparent oversight. The opposition will not be opposing this legislation.

Shayne Neumann (Blair, Australian Labor Party) Share this | Link to 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.

Jane Prentice (Ryan, Liberal Party) Share this | Link to this | Hansard source

The Therapeutic Goods Administration is responsible for regulating therapeutic goods in Australia, including medicines, gene technology and blood products. In short, it is responsible for the regulation of all the medical products we use, from bandaids to vaccines. Given the importance of these products to society, it is critical that the Therapeutic Goods Administration be an efficient body so that individuals can gain access to the sometimes life-saving drugs they need and medical companies in Australia can continue to develop new drugs and products without the hindrance and uncertainty that can be caused if the TGA takes too long to process applications.

My electorate of Ryan is home to some of Australia's top medical research centres. As we all know, Professor Ian Frazer developed his cervical cancer vaccine at the University of Queensland and is currently working on other groundbreaking projects to continue to improve our health and raise standards of living. Concurrently, the Australian Institute for Bioengineering and Nanotechnology at the University of Queensland is developing a way of administering vaccines, through nanotechnology, straight into the bloodstream without the use of needles. The technology is a patch about the size of a fingernail that simply needs to be pressed against the skin, eliminating the need for a trained nurse to give the injection and a temperature controlled environment for transport. Just imagine it: where we had a padded box with only six to 10 syringes we could now have hundreds of these vaccination patches. Imagine the benefits such technology could deliver to the world.

It is therefore important that the body that regulates medical products in Australia does not slow down the delivery process of these technologies. For this reason, the coalition will not be opposing this bill, as it aims to finish what was started by the 2009 internal review of the TGA, which concluded that many efficiency measures could be introduced to streamline application and evaluation processes. Whilst most of these changes were effected under the Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010, the further changes today include not only applications for new prescription medicines to the TGA but also amendments being sought to drugs that are already on the TGA's approved list. Before these changes were implemented, applications for new and existing prescription medicines were made with the expectation that information could be requested and provided for throughout the application time frame—that is, not all of the information the TGA required for approval was initially provided. This meant that there was a great deal of going back and forth between the medical companies and the TGA—a fairly inefficient process. However, under the changes made last year, all required information must be provided upon application or the TGA will simply not accept it. This helped to streamline the process, reducing the time it took for approval from 500 to 300 calendar days. This of course was beneficial to the TGA through a reduction of time spent on bureaucratic measures, as well as the medical companies, who now have their product approved in a more timely manner, allowing them faster market access. Most importantly, it is good for the individual, who can now benefit from new technology sooner.

The proposed changes under this bill extend this requirement of upfront information to existing prescription medicines that are seeking an amendment to be approved by the TGA. This is a measure that the coalition does not oppose, as it brings all applications in line with each other, regardless of whether they are for a new or existing drug, as well as bringing the aforementioned benefits of an efficient application process to any amendments medical companies seek for their product. The coalition welcomes these sensible changes, which increase public access to medical products.

In addition to the streamlined information provisions the bill before us presents, it also proposes changes to how application fees are paid to the TGA. The TGA currently operates to a time limit of 255 business days, or 500 calendar days, in which applications are processed. Should the TGA fail to meet this time line, the medical company is offered a 25 per cent reduction in the application fee. This is currently administered by requiring 75 per cent of the fee to be payable upon application. As long as the application is processed within the time frame, the further 25 per cent is collected at the end of the process. However, this is resulting in increased red tape, as the TGA must administer two invoices to medical companies and all of the paperwork such a system requires. This is unwarranted as, since its establishment in 1992, with approximately 500 applications per month, the TGA has only exceeded the 255 business day time limit with 15 products. This figure is small enough to make such a payment scheme unnecessary.

In light of this, the bill proposes that the full application fee be paid upfront and should the TGA exceed the time limit it will refund 25 per cent of this fee. This eliminates double invoicing, further streamlining the process and reducing the administrative burden. This is important, as the TGA operates under full cost recovery conditions, so these additional costs are being passed on to the industry. Given that these measures will reduce the cost, I would expect to see the TGA now pass on the reduction to the industry.

The final measure this bill proposes is simply administrative, to ensure that the ministerial standards charges passed under the previous legislation are made retrospective so that prescription medicines are subject to the new standards the minister sets. This addresses an apparent oversight of such a provision in the previous legislation.

It is important that the TGA is as efficient as it can possibly be whilst providing responsible processing of applications for new and existing medical products. The coalition welcomes sensible measures to improve the TGA's efficiency, as it improves access for the public to medical products as well as supporting medical companies in relation to new technologies.

Ms Catherine King (Ballarat, Australian Labor Party, Parliamentary Secretary for Health and Ageing) Share this | Link to this | Hansard source

I would first like to thank members for their contributions to the debate on the Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011. I thank the member for Ryan, who is still here in the chamber and is obviously a great advocate for some of the research that is happening in her own electorate, the member for Boothby and also the member for Blair. The member for Boothby, in his contribution, raised questions around the measures in this bill. These measures will create some efficiencies and we are obviously hoping that those efficiencies will be passed on to industry. As to whether the potential savings will be passed on to industry, I can advise that the Therapeutic Goods Administration consults with industry annually about their fees and charges, and obviously the measures contained in this bill will form part of that annual consultation process. The member for Boothby also highlighted that the coalition will be watching for the efficiencies that these measures put in place. I am pretty sure that industry are watching that as well; they are in my ear, and that of the TGA, pretty quickly as those sorts of things start to make their way through the system.

The amendments in this bill are designed to improve processes for the evaluation of prescription medicines, the collection of evaluation fees payable for prescription medicines and the imposition of standard conditions on registered and listed therapeutic goods by way of a legislative instrument. New streamlined procedures for processing applications involving the evaluation of prescription medicines are being adopted by the TGA to significantly shorten the time taken to complete evaluations from 500 calendar days to 300.

To enable the TGA to meet the shortened time frame, an amendment has been included to require companies applying to make changes to the entry of their prescription medicines on the Australian Register of Therapeutic Goods where the changes involve an evaluation of clinical, preclinical or bioequivalence data to include adequate information in an approved form before the application is taken to be effective. Adequate data lodged at the appropriate time is necessary to allow an evaluation to be completed by the TGA in a timely fashion. Applications not accompanied by the required information in an approved form and accompanied by the application fee will not be evaluated. The full amount of evaluation fees payable for the registration of prescription medicines will now be required to be paid when applications are accepted for evaluation. The practice of sponsors paying the final quarter of the full evaluation fee, owing only after the completion of the evaluation by the TGA within the prescribed deadlines, will be replaced with a system of refunds at a quarter of the full evaluation fee paid if the TGA fails to complete an evaluation on time.

The bill also contains amendments to ensure that, where new standard conditions are for the first time imposed by means of a legislative instrument on registered or listed therapeutic goods already included in the register, any standard conditions in place in relation to those goods can be removed at the same time. This will avoid an overlap between the old standard conditions and the new standard conditions imposed by the instrument. Standard conditions imposed by the minister will generally apply to registered and listed therapeutic goods irrespective of when they were included in the register. However, an amendment will enable the minister to impose conditions only on goods that are entered in the register after an estimate has been made. This amendment will provide additional flexibility to ensure that changes in conditions do not apply to existing entries where it is not appropriate that they do so. These measures will help ensure that TGA processes keep up with the changing environment in which it undertakes its regulatory functions.

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 the bill be reported to the House without amendment.