Ursula Stephens (NSW, Australian Labor Party, Parliamentary Secretary Assisting the Prime Minister for Social Inclusion) Share 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.