Richard Colbeck (Tasmania, Liberal Party, Shadow Parliamentary Secretary for Health) Share this | Link to this | Hansard source

The Senate is considering the Therapeutic Goods Legislation Amendment (Annual Charges) Bill 2008. The bill amends the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989 in relation to the imposition and collection of annual charges and also the exemption from paying a charge. The Therapeutic Goods Administration, or TGA, conducts a range of activities in order to ensure that medicines and medical devices available here in Australia meet acceptable standards and to ensure that Australians have access within reasonable time to therapeutic advances. In doing so, the TGA has responsibility for compiling and maintaining the Australian Register of Therapeutic Goods, or ARTG, where medicines must be either registered or listed, and where medical devices are included. As of 23 May 2008, there were approximately 54,000 products on the register and accordingly I am sure that we can certainly appreciate the volume of work that is undertaken by the TGA to maintain such an extensive and necessary register. I must emphasise again that this work is completed with the aim of protecting Australian consumers while also demanding high standards within medicinal and therapeutic innovation and advancement.

Under the current legislation, annual fee payments are set as the date of entry of production in the ARTG or the date that the manufacturing licence was granted and then the anniversary of that date annually. One part of the proposed amendment will change this to legislate for a uniform date—1 October—for all annual payments. It is proposed that this change to the payment schedule will result in much greater administrative efficiency for the TGA, though I do note the Bills Digest, and in turn the Therapeutic Goods Administration’s own website, indicates that this legislative change simply brings the legislation into line with what is current administrative practice for the TGA. Currently the Therapeutic Goods (Charges) Act and the Therapeutic Goods Act contain provisions for a reduction or waiver of annual charges. This bill repeals the provisions from the Therapeutic Goods (Charges) Act and inserts them into the Therapeutic Goods Act for the purposes of consistency and readability. The power for annual charges to be reduced or completely waived for goods or devices which now have low volume and low value ensures that sponsors are not discouraged from registering or listing goods and devices that can bring benefit and relief to consumers but which, for certain reasons, face challenges in the commercial world.

Despite the clear merit of the exemption and waiver provision, I do welcome the amendments to this bill, which are aimed at improving the scrutiny, accountability and transparency associated with such applications. I note the concerns raised by the Australian National Audit Office in its financial statement audit report for 2006-07 for the Department of Health and Ageing in relation to the lack of third-party confirmation. Under the amendment there will now be the ability to request additional information from applicants seeking an exemption and from those already granted an exemption. There will also be the ability to cancel exemptions and require payment of the annual charge. These provisions will ensure the exemption mechanism is not abused by unscrupulous applicants while at the same time ensuring that the TGA obtains all charges to which it is entitled. With those remarks, I advise that the opposition will be supporting the bill.

Ursula Stephens (NSW, Australian Labor Party, Parliamentary Secretary Assisting the Prime Minister for Social Inclusion) Share this | Link to this | Hansard source

I thank Senator Colbeck for his remarks, his contribution to the debate and his indication that the opposition is supporting this legislation. The Therapeutic Goods Legislation Amendment (Annual Charges) Bill 2008, as we have heard, amends the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989 to provide administrative efficiency for both the TGA and its stakeholders in the way annual charges are imposed and collected and to provide more transparency and accountability in the granting of exemptions from liability to pay annual charges because of the low-value turnover of the therapeutic goods.

The bill makes a number of changes to the existing regime relating to the imposition and collection of annual charges by allowing for the setting of a uniform date for the payment of annual charges. These amendments will, for example, allow sponsors of therapeutic goods that are entered in the Australian Register of Therapeutic Goods to pay all annual charges on one particular date instead of on different dates within the financial year that are based on the anniversary dates of the entry of those goods. The bill introduces changes to the current exemption from liability to pay annual charges because of the low-value turnover of the therapeutic goods. The changes include requiring persons applying for, or who have already been granted, an exemption to provide evidence certified by an approved person to support their eligibility for such an exemption. The bill also provides for the making of regulations that will set out additional details on the processing, granting and cancellation of the exemption. These amendments will therefore provide greater clarity, transparency and accountability in the processing and the granting of an exemption.

The bill also makes other technical and consequential amendments and includes a clarification that an annual charge can actually be set at a nil amount. On that basis, I commend the legislation to the Senate.

Question agreed to.

Bill read a second time.