Maxine McKew (Bennelong, Australian Labor Party, Parliamentary Secretary for Early Childhood Education and Child Care) Share this | Hansard source

In summing up, as mentioned in the second reading speech, the Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 amends the Therapeutic Goods Act 1989 in a number of ways. Firstly, it incorporates into the act provisions allowing medicines to be suspended from the Australian Register of Therapeutic Goods where there are safety concerns but where it is expected that these can be corrected in a short period of time. The suspension provisions are based on similar provisions allowing medical devices to be suspended which were added to the act in 2002. For the duration of the suspension, the medicine cannot be supplied. If the concerns about the medicine’s safety extend to batches that may have already been supplied to the public, these will be able to be recalled under the new provisions. Currently, where there are safety concerns with the medicine, the only option available is to cancel the medicine from the register and then, once the safety concerns have been addressed, the sponsor must apply to have the medicine relisted or to re-register and pay the relevant fees. This clearly is inefficient and costly. The amendments in schedule 1 will address this.

The second set of changes relate to manufacturing licences. Presently, a licence can be issued to cover more than one site, and the name of the licence holder, the manufacturing steps approved to be undertaken and the sites covered are not specified on the licence. Further, licences cannot be varied or transferred to another manufacturer. Schedule 2 will address these issues by providing that licences can only cover one site except in limited circumstances, which are to be set out in guidelines. Such circumstances would include where two sites are located adjacent to each other and are jointly involved in the manufacture of the same therapeutic good. The amendments in this schedule will also require that manufacturing licences specify the details of the licence holder and what is approved by the licence. This schedule will also enable licence holders to apply to vary their manufacturing licence and will provide for regulations to be made setting out a process for transferring a licence to another manufacturer.

The bill also enhances existing monitoring powers in the act for authorised officers to enter and inspect premises and to take samples to assess the safety and quality of therapeutic goods and the processes in manufacturing and dealing with these goods. The powers currently do not enable samples to be taken of related material such as ingredients used in manufacturing medicine, although the quality of these ingredients is directly related to the quality of the final product. The powers are also limited to inspecting those therapeutic goods expected to be on the premises—for example, those that the site is licensed to manufacture, although other potentially unauthorised therapeutic goods may be found on premises. Currently, the act does not enable authorised officers to take samples of these other goods. So the amendments in this schedule address these problems to ensure monitoring for safety and quality can occur in full at all sites handling therapeutic goods. Further to this, the amendments will update the references in the act to replace references to still images or sketches with references to still or moving images or recordings, to allow, for example, video recording of manufacturing equipment in operation.

Schedule 4 of the bill includes a new framework for the regulation of homoeopathic and anthroposophic medicines. Currently, many of these medicines are exempt from the requirements of the act to be included in the register and meet manufacturing requirements. The bill now provides a framework for the regulation of these medicines and, in doing so, it implements the 2003 recommendations of the Expert Committee on Complementary Medicines in the Health System that these products be regulated.

The framework in the bill will provide for standards to be set by reference to the relevant pharmacopoeia. The new framework will commence in July 2011 to allow time for this industry sector to prepare to comply with the requirements and to ensure further consultation can occur to inform the necessary changes to the regulations to give effect to the details of the framework.

Schedule 5 of the bill enables the minister to determine in a legislative instrument the ingredients that are permitted and those that are prohibited from being included in listed medicines. Applications to list a new medicine for supply in Australia must certify that the medicine contains only permitted ingredients and no prohibited ingredients while the secretary, in considering an application to list a medicine for export, must have regard to its compliance with the lists.

A person can apply for an ingredient to be included in the permitted ingredients list and the minister must consider the application. All decisions regarding the ingredients to be included on the lists will be made by the minister based upon advice from the TGA, the Therapeutic Goods Administration, and its expert advisory committees.

Schedule 6 makes amendments to references in the act to orders published in the Gazette and to disallowable instruments to clarify that these are legislative instruments for the purposes of the Legislative Instruments Act 2003.

Finally, schedule 7 makes a number of miscellaneous amendments to improve and clarify the operation of the act. Most significantly, this schedule provides for new, more transparent arrangements for the setting of conditions on therapeutic goods. The amendments will enable the minister to determine by legislative instrument the standard conditions that are to apply to categories of medicines. Alongside these standard conditions the secretary will continue to be able to set specific conditions on particular medicines included in the register.

The amendments also establish in the act two specific conditions that will be applicable to all registered and listed medicines. These are to require that medicines not be exported or supplied after the expiry date for the medicine and that medicines cannot be advertised for any purpose other than that which was accepted for the registration or listing of the medicine.

The final schedule also clarifies that decisions of the secretary, such as for applications to list medicines and low-level medical devices, can be made by computer software. The secretary will retain the power to substitute a decision of her own within 60 days of the computer program decision.

The bill also strengthens safety and quality scrutiny for listed medicines manufactured overseas. Although the act requires sponsors seeking listing of a medicine that is manufactured overseas to receive confirmation from the secretary that the manufacturing processes are acceptable, similar certification requirements have not been required for medicines whose manufacturer has been moved from a previously approved Australian or overseas manufacturer to an overseas manufacturer.

Although sponsors of these medicines must advise the TGA of the manufacturing move once it has occurred, and the TGA then reviews the quality of the overseas manufacturer, prior certification is not currently required under the act. So the amendments in schedule 7 will address this discrepancy and require that, as a condition of listing medicines that are manufactured overseas, the sponsor must receive certification from the secretary that the manufacturing and quality control procedures are acceptable before the medicine’s manufacturer can be moved. This will ensure that the quality and safety of those medicines are maintained.

The government intends to make further amendments to the regulatory regime for therapeutic goods later in the year. In particular, the changes will provide for a new framework for the regulation of human cellular and tissue based therapy products, also known as biologicals, which have to be implemented under the joint Australia New Zealand Therapeutic Products Authority. New arrangements for the separate scheduling of medicines and poisons will also be introduced.

Finally, Australia has been well served by the TGA, and it is important that the regulatory regime that the TGA implements is kept up to date so that the authority and the industry it regulates can operate as efficiently as possible and so that, most importantly, Australian consumers can continue to have timely access to safe and effective therapeutic goods.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

Ordered that this bill be reported to the House without amendment.

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