Robert Oakeshott (Lyne, Independent) Share this | Link to this | Hansard source

The purpose of the Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 is to amend the Therapeutic Goods Act. Certainly I am not opposing this legislation. In fact, I think it is timely and well overdue for a number of reasons. The amendment allows certain goods on the register to be suspended in certain circumstances—and I will come back to that. It amends the manufacturing licences. It amends monitoring powers to allow the taking of samples of therapeutic goods—and I will also come back to that. It amends arrangements for complementary medicines. It enables the making of lists of permitted and prohibited ingredients in listed medicines, clarifies arrangements for conditions of listing goods and makes some technical corrections to references to reflect changes in terminology.

I make just three very brief points. The first is that I hope this bill reflects some growing interest from the government in the growing desire of community members to explore a range of options in regard to treatment of their own health and wellness. I am noticing at home that, whilst there is certainly a commitment to traditional Western medicines, there is a growing interest and desire to complement those Western techniques with a whole variety of options for personal treatment regarding wellness. Whether they are Eastern medicines, the various complementary medicines or the homeopathic options, a whole range of desires and considerations are becoming more and more prominent. For the government to respond to that—and I hope this bill is part of a response to that—I think is a positive thing in reflecting the needs and wants of the broader community.

I hope this bill also starts to capture the hawking of the snake oil—for want of a better term—that we see far too often in communities such as mine. I am sure that every local member has experienced various products coming into their local communities being sold in various pyramid schemes. One person wins substantially out of the marketing and selling of that product, claiming that it is going to improve the health and wellbeing of everyone in that community, and within a year they are out of town. They might have got a new car, and a lot of people are left with a lot of debt in the community for the longer term. We have experienced that on the mid-North Coast on several occasions. Hopefully, if this bill is reflecting the government wanting to start to capture, monitor and control that process in a better way, and really define the boundaries of what is acceptable and what is not acceptable as a product on the market, then good work has been done by the government in putting this bill forward.

Thirdly, and probably at the sexier end of the spectrum, in the hawking of product and snake oil, there has been standout debate about various billboards in various communities as to what products can and cannot deliver. Once again, I hope this bill starts to shape some of those debates in a more controlled, managed and sensible way. It might also help in some community advertising standards being reached which reflect the wants and needs of the community better and reflect the wants and needs of government better. There are some pretty confronting billboards. I am no prude, but I think we can do better than having snake oil promoted on billboards, regardless of the product, challenging community standards in the way things are marketed in the marketplace.

I support the bill. I think I am the only speaker on this side, so we can assume the opposition generally supports this bill. I certainly hope this bill, by being put before the House, does the work that is desired and I hope it does what it is trying to achieve.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

In my contribution on the Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 I would like to start where the previous member, the member for Lyne, finished on the matter of billboards—and I think I know the billboards that he is referring to. They relate to the treatment of impotence. The House of Representatives Standing Committee on Health and Ageing will actually be looking at the claims surrounding that issue in a short and sharp inquiry that is going to take place in the very near future. I thought the member might be interested to know that because it has been an issue of great concern to a number of members on that committee. The committee has had a presentation given to it. I have actually written to the New South Wales Minister for Health, who has advised me that the Health Care Complaints Commission conducted an inquiry into the matter in 1998 and it is currently with the Office of Fair Trading in New South Wales. As the member rightly pointed out, we need a whole-of-Australia approach to the issue, not just in New South Wales. I thought I would just put that on the record as a matter of interest. Madam Deputy Speaker, I apologise for straying from the legislation that we are debating today, but I feel that to be vitally important. In effect, it does refer to this legislation because, like the previous speaker, I hope that it is captured by this legislation.

The bill amends the Therapeutic Goods Act 1989 to provide for medicines to be suspended from the register. It amends manufacturing licence arrangements and enables variation and transfer of licenses. It enhances monitoring powers, establishes a framework for the regulation of homoeopathic medicines and enables the minister to determine lists of permitted and prohibited ingredients. It clarifies that instruments in the act come under the Legislative Instruments Act 2003 and it makes other amendments to improve and clarify the operation of the act. Currently medicines are treated differently from therapeutic goods. Therapeutic goods can be suspended from the list, but this legislation enables medicines to be suspended. As I mentioned, medical devices can be suspended already. This bill amends the manufacturing licences, enables variation and transfer of licences and enhances monitoring.

The previous speaker mentioned an issue that relates to homeopathic and alternative medicines. Back in 2003 there was a very newsworthy investigation into some of the practices. At that time there was a rethink about the way these goods were handled. This legislation has been prepared in consultation with the industry, but I hope it will pick up on some of those goods being sold with claims that misrepresent what they can and cannot do. I have had quite a bit of contact with people within my community on this. The member for Paterson, who I see has joined me, may have had some contact with people in the Hunter, too, in relation to some of the treatments and remedies that have been promoted within our community.

This legislation, I believe, will put in place some control and will enable the suspension of those medications which promoted as being able to treat a certain illness or deliver some remedy that they in fact cannot. It is also important to note that at the moment it is very, very difficult to have medicines removed from the list. This legislation will enable that to happen very quickly. It will streamline the process and overall it will ensure that goods—both homeopathic medicines and medicines generally—that are presented for sale within our communities are safe and deliver what it is said they will deliver. As has been noted by all speakers on this legislation, it is non-controversial. There would not be a member in this parliament who would not support it, and I have great pleasure in supporting it. I was pleased to be able to provide that extra information on impotence treatments.

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