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Wednesday, 27 August 2008
Page: 6305


Ms HALL (9:34 AM) —As the previous speaker stated, the Therapeutic Goods Legislation Amendment (Annual Charges) Bill 2008 is a noncontroversial piece of legislation, and we would expect the opposition to support it because it makes for better operation of the Therapeutic Goods Act. This bill amends the Therapeutic Goods Act 1989 to make a number of changes to the existing regime for the imposition and collection of annual charges. It also provides transparency and clarity in the granting of exemptions from liability to pay annual charges due to low turnover of therapeutic goods and it makes other technical and consequential changes.

I think it is really important to mention the need for transparency and clarity. The previous government did not always have that as one of its goals, but one of our goals has always been to ensure that transparency exists. The Therapeutic Goods Act requires that a therapeutic good must be registered, listed or included on the Australian Register of Therapeutic Goods before it can be lawfully imported into, manufactured in, supplied in or exported from Australia. The Therapeutic Goods Act generally requires a person to obtain a manufacturing licence to manufacture goods in Australia. An annual charge is payable in respect of the registration, listing or inclusion of therapeutic goods on the register and in respect of manufacturing licences under the Therapeutic Goods Act. Annual charges are considered to be taxes and, as such, are imposed by a separate taxing act.

The new requirements provided in this legislation will come into effect on 1 July next year. As you can see, the government is giving adequate time for the legislation to pass through the House and go through all stages before it comes into effect. It is not a last minute approach to the introduction of the legislation. The government takes all legislation very seriously.

It is important to note that there are currently around 50,000 registrations, listings and inclusions in the register that are liable for annual charges every year. In addition, a significant number of new entries are made each and every year. The TGA is unable to predict the dates when entries are to be made in the register for a particular therapeutic good and consequently issue the invoice for the annual charges prior to the entry. Therefore, it is a difficult task for the TGA to issue a separate invoice for each entry and seek payment for the annual charge on the date of regulatory approval in the first financial year and on the anniversary in subsequent years. Some sponsors have a significant number of registered, listed or included goods on the register, and payment of the annual charges for these sponsors would also be a difficult task if they had to pay for individual goods on the basis of commencement dates and subsequent anniversaries. Therefore, the bill includes amendments for the fixing of a uniform date for the payment of annual charges. This makes for the smooth running of the register.

Sponsors with low turnovers of therapeutic goods are currently entitled to an exemption from the liability to pay annual charges in relation to those goods. Under the current provisions, the TGA does not have the power to seek evidence verifying the eligibility of a person applying for, or who has been granted, the exemption from paying the annual fee. The Australian National Audit Office has raised some concerns about the lack of the TGA’s ability to review the eligibility of sponsors applying for or who have been granted exemptions.

Amendments are also required to ensure that the Therapeutic Goods Act 1989 supports regulations prescribing all the necessary requirements relating to the lodgement. The amendments in this bill address those concerns and will provide greater clarity, transparency and accountability in the processing and granting of this exemption. That is the issue that I think is very important—that this transparency, clarity and accountability will exist. It will get rid of the grey areas and ensure that the TG Act and the register operate in the way that they are meant to.