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Wednesday, 22 June 2011
Page: 3489


Senator FIERRAVANTI-WELLS (New South Wales) (10:15): The Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 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 prescription medicines are evaluated by the TGA.

These processes have come about due to an internal review of the application evaluation processes by the Therapeutic Goods Administration undertaken in 2009. They 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 briefly touch on each of them.

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 listing for prescription medicines already on the Australian register in line with the application and evaluation processes 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 calendar days to 300 calendar days. This is something the opposition will be holding the government to account on.

There are a number of matters pertaining to prescription medicines that this government needs to be held to account on; not least the cabinet interference in the listing of prescription medicines on the Pharmaceutical Benefits Scheme. Only yesterday we had health minister Nicola Roxon and Prime Minister Julia Gillard again politicising the lifesaving Pharmaceutical Benefits Scheme. Unlike any previous government, the Gillard Labor government has taken it upon itself to effectively make life-and-death decisions by deferring listings of new drugs on the PBS. Medical experts decide what drugs should be subsidised for Australian patients, doctors decide what drugs will be prescribed for patients; but in Australia the Gillard cabinet decides whether those drugs will be made available.

Getting back to the bill, 500 days seems far too long for the TGA 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 and 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 significant administration costs of monitoring each application until completion and that 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 this 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? This 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.