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Thursday, 12 May 2011
Page: 3936


Mrs PRENTICE (Ryan) (11:15): 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.