Bill Shorten (Maribyrnong, Australian Labor Party, Parliamentary Secretary for Disabilities and Children's Services) Share this | Link to this | Hansard source

I move:

That this bill be now read a second time.

This bill makes a number of amendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989 relating to the collection and imposition of annual charges and the implementation of exemptions from a liability to pay annual charges because of low-value turnover of therapeutic goods.

Generally, therapeutic goods are required to be registered, listed or included on the Australian Register of Therapeutic Goods before they can be lawfully imported into, manufactured in, supplied in or exported from Australia. The Therapeutic Goods Act usually requires a person to obtain a manufacturing licence in order to manufacture therapeutic goods in Australia. Annual charges are payable for maintaining entries in the register and for manufacturing licences issued under the Therapeutic Goods Act.

The current provisions fix the dates for payment of annual charges on the commencement of the registration, on the listing or inclusion of a medical device in the register or on the commencement of the issuing of a manufacturing licence. In subsequent years, the annual charges are payable on these anniversary dates. In general, these due dates can only be amended with the consent of the relevant sponsor or the manufacturer of therapeutic goods.

Currently there are around 50,000 registrations, listings and inclusions in the register that are liable for an annual charge. In addition, a significant number of new entries are made in the register every year. It is therefore an arduous task for the Therapeutic Goods Administration, the TGA, to issue a separate invoice for each register entry and to seek payment of the annual charge on the date of regulatory approval in the first financial year and on the anniversary date in the subsequent years.

The bill therefore proposes amendments to include the fixing of a uniform date for the payment of annual charges for all financial years after the year in which the initial charge is paid. For newly entered goods in the register, the bill allows some flexibility for working out the payment dates in accordance with the regulations, instead of on the commencement dates for the entry of goods in the register. Some of these changes have already been implemented administratively, such as setting the date for payment of annual charges for goods already entered in the register as 1 October of the relevant financial year, and therefore would not affect stakeholders adversely. These changes will provide administrative efficiency for both the TGA and stakeholders.

Sponsors with low-value turnover of therapeutic goods are currently entitled to an exemption from the liability to pay annual charges in relation to those goods. Some concerns have been raised in relation to the transparency of the exemption. The Australian National Audit Office also recently raised some concerns on the lack of ability of the TGA to review the eligibility of sponsors applying for, or who have been granted, exemptions. Under the current provisions, the TGA does not have power to seek evidence verifying the eligibility of persons applying for, or who have been granted, the exemption for paying annual charges for low turnover of therapeutic goods.

The amendments set out in the bill are proposed to address those concerns and will provide for greater clarity, transparency and accountability in the processing and the granting of this exemption. New provisions allow the making of regulations to require a statement by an approved person supporting claims for the exemption, and provide powers to obtain additional information from the applicant or the person who has already been granted an exemption.

In addition to other technical and consequential amendments, the bill also makes it clear that an annual charge can be set at nil amounts. The amendments set out in the bill are proposed to commence on 1 July 2009.

I commend the bill to the House.

Debate (on motion by Mr Randall) adjourned.