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

I present the explanatory memorandum to the bill and I move:

That this bill be now read a second time.

This bill amends the Therapeutic Goods Act 1989 in a number of ways.

Firstly, it incorporates into the act provisions allowing the stockpiling and supply of medical devices to deal with emergency situations without the requirement for such devices to comply with the act.

Second, it gives effect to a range of amendments which have been in contemplation for a number of years, and which were to have been adopted as part of the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

Turning first to the medical devices amendments, these provisions are based on similar provisions allowing medicines to be stockpiled and supplied in emergency situations which were added to the act in 2002.

It is unfortunate that other amendments made to the act that same year to deal with medical devices did not include an emergency provision from the outset. But be that as it may, the government is now acting to include these provisions so that medical devices can lawfully be stockpiled in case of a future emergency and made available in an actual emergency without having to comply with the act.

In 2002 the then parliamentary secretary, in introducing the bill, explained that the amendments were necessary to strengthen the ability of the Commonwealth to plan for, and respond to, national emergencies in which there is the potential for large numbers of people to require emergency treatment. She gave as examples of such emergencies acts of bioterrorism or the emergence of a new, highly contagious disease in Australia.

Exactly the same rationale applies today.

The act presently operates very effectively to ensure that medical devices supplied in Australia to meet our daily health care needs meet very high standards of manufacture and quality control. In general, it is an offence to supply devices that have not been approved by the Therapeutic Goods Administration (the TGA).

But in an emergency the government may need to be able to supply very large volumes of devices such as face masks or injection kits. It may need to source these volumes from manufacturers who do not regularly supply goods to the Australian market, and who have not sought to have their products approved by the TGA.

The amendments in schedule 1 to this bill allow the minister to exempt devices from the requirements of the act so that they can lawfully be stockpiled and made available in an emergency.

The minister can only make such an exemption if she or he is satisfied that it is in the national interest to do so, and the minister’s powers may only be delegated to the Secretary of the Department of Health and Ageing.

The minister may impose conditions on the exemption, including limiting the people allowed to import, manufacture or supply the devices, and must notify those people of any other conditions on the exemption. Breaching a condition of exemption is a criminal offence.

The bill does not provide for parliamentary scrutiny of the exemption through disallowance. This is because a security consultant engaged by the government last year recommended that the contents of the stockpile should be classified as “confidential” to ensure that would-be bio-terrorists were not able to find out what preparations Australia had made for dealing with a possible bio-terrorist act.

For this reason the bill also amends the act so that similar exemptions applying to medicines are not to be subject to disallowance.

Turning to the deferred ANZTPA amendments, the bill deals with the “fit and proper person” test, default standards for medicines, information disclosure, and the use of restricted representations in advertising. It also makes technical amendments to all offence provisions to bring them into line with the latest policy on how these should be expressed.

The act currently requires the secretary, in deciding whether to grant or revoke a manufacturing licence or a conformity assessment certificate for a medical device, to have regard to whether the applicant, a person taking part in managing the applicant’s affairs, or a person “likely to have effective control over the applicant”, is a fit and proper person.

The test in deciding such a person is at once subjective—in that there is no limit on the matters the secretary may consider, and there is no guidance on who is a person “likely to have effective control”—and unduly harsh in that the secretary must have regard to any conviction against any law of the Commonwealth or a state or territory, no matter what the crime or when it took place.

Not only has the test been criticised by industry for these reasons, but it is also administratively problematic.

The amendments in schedule 3 of the bill replace this test with a much narrower test, requiring the secretary to have regard to breaches of the act or offences against it, together with offences involving fraud or dishonesty over the previous 10 years.

The amendments also replace the undefined concept of “effective control” with an objective definition of a “major interest holder”, defined as a one-fifth shareholder of a body corporate.

When the act was introduced it provided that unless the minister determined standards for therapeutic goods, they had to comply with the requirements of the British Pharmacopoeia. The British Pharmacopoeia thus effectively served as the default standard for therapeutic goods.

Since the act came into effect many manufacturers based in the United States or Europe have entered the Australian market. As part of the ANZFTA consultation process industry pressed for the inclusion of the US Pharmacopoeia and the European Pharmacopoeia as alternative default standards.

Schedule 4 of the bill contains a series of amendments to include these pharmacopoeias as default standards with the same standing as the British Pharmacopoeia. The amendments also remove references to the veterinary version of the British Pharmacopoei, as the act no longer regulates veterinary medicines, and makes a number of consequential amendments to remove other references to the regulation of therapeutic goods for use in animals.

The act sets out when the secretary can release information obtained under the act to other regulatory agencies or to the public. These provisions are unduly restrictive as they relate to the public release of information, and they have proved operationally difficult as they relate to providing information to other agencies.

The government has decided to broaden the public access to information under the act.

In particular, the TGA will publish a greater range of information about goods included on the Australian Register of Therapeutic Goods on its website to inform members of the public about the therapeutic goods and devices that are available in Australia, and assist them to make better informed choices and decisions about their use of therapeutic goods.

It will publish the minutes and deliberations of expert advisory committees, as well as a greater range of information considered in, and the reasons for, making particular decisions, including summaries of the evaluation of applications for the entry of prescription medicines on the register.

The amendments in schedule 5 will support this by allowing the minister to determine, by legislative instrument, classes of therapeutic goods information which may be published by the secretary. The amendments also widen the definition of information that may be released to include information held by the TGA, as well as information acquired by the TGA under the act.

Other amendments in the schedule resolve the practical difficulties with the provisions relating to the release of information to other government authorities.

The act currently regulates advertising of therapeutic goods. It includes a regime provided for the pre-approval of some categories of advertisements, together with limits and restrictions on the kinds of representations that may be made in advertisements. For example, advertisements to the public cannot refer to serious illnesses, or make claims that a cure is infallible.

While the limits and restrictions are intended to apply to all advertisements, the current structure of the act implies that they only apply to advertisements that do not require pre-approval.

The amendments in schedule 6 are intended to clarify that the limits and restrictions apply to all advertisements.

Finally, schedule 7 contains a series of purely technical amendments to align all criminal offence provisions in the act with current policy on the expression of such provisions.

The changes made by this bill do not encompass all the reforms the government intends to make to the therapeutic goods regulatory regime.

We intend to introduce further legislation next year to give effect to other changes that were foreshadowed as part of the ANZTPA process, including new frameworks for the regulation of human cellular and tissue-based therapies and homeopathic medicines.

We will also be pursuing changes to the current advertising arrangements. The Productivity Commission has recommended that the government should streamline and clarify the advertising regime for therapeutic goods. At this stage, government intends to carry out informal consultations with industry over the next few months before releasing a formal consultation document for consideration next year.

The amendments in this bill are thus the first instalment in an ongoing program of reform to the act.

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

I commend this bill to the House.

Peter Dutton (Dickson, Liberal Party, Shadow Minister for Health and Ageing) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 provides for a number of amendments to the Therapeutic Goods Act and in part implements some of the reforms proposed originally for the establishment of the Australia-New Zealand therapeutic products authority. The process to establish the Australia-New Zealand therapeutic products authority commenced with the signing of a memorandum of understanding between Australia and New Zealand in December 2003. However, the process stalled in July 2007 under the pressure of domestic political conditions in New Zealand at that time. As my colleagues have noted in the Senate, with a different political landscape in New Zealand today there is an opportunity now for the government to continue with the trans-Tasman reform process initiated by the coalition government.

This bill will amend the operations of the Therapeutic Goods Administration. The TGA has an important role in regulating therapeutic goods, such as medicines and medical devices, according to quality, safety and efficacy. However, it is important that any regulation is also efficient and efficacious. This is particularly the case for the TGA, which operates on a cost recovery basis for the listing of relevant products on the Australian Register of Therapeutic Goods. It is imperative that under any cost recovery process compliance requirements and costs do not jeopardise the listing of potentially beneficial products for the Australian community.

Specifically, the proposed changes in the bill provide for the exemption of medical devices under the act to allow for stockpiling and timely supply in emergency situations, the removal of the requirement that instruments allowing stockpiling of therapeutic goods be disallowable, a narrower fit and proper test in the granting of manufacturing licences and conformity assessment certificates, inclusion of the United States and European Pharmacopeia as default standards for therapeutic goods in addition to the existing British Pharmacopeia default, improved information disclosure by the TGA and the clarification of regulation applying to advertising.

The coalition broadly supports the amendments contained within the bill, as does industry, according to available stakeholder feedback. The inclusion of the United States and European Pharmacopeia in addition to the existing British default for therapeutic goods standards is a commonsense reform, providing a degree of flexibility for organisations bringing beneficial products to market in Australia.

The reforms to the fit and proper test provide workability to what is currently too broad a test. The amendments provide practical and measurable guidance as to persons who did not meet the requirements of a fit and proper person. The provisions to improve access to information held by the TGA is important in the interests of transparency, and this will provide interested stakeholders with relevant information pertaining to the details on that Australian Register of Therapeutic Goods: summaries of evaluations of applications to register new therapeutic goods and the records of the advisory committees established under the act.

Advertising provisions in this bill clarify the existing regulations regarding advertising of therapeutic goods. It is appropriate that current regulations requiring pre-approval of advertisements in mainstream media be extended to other media. These amendments are straightforward reforms designed to enhance the operation of the TGA and are largely uncontentious. However, I bring attention to the concerns outlined by my colleagues in the Senate regarding the amendments to the current exemption provisions. These amendments remove the requirement that instruments allowing the stockpiling of therapeutic goods be disallowable. The provision is said to be based on advice that the contents of the stockpile should have a classification of confidential in the interests of national security and therefore should not be tabled in the parliament and subject to public scrutiny. Whilst the coalition considers national security of paramount importance, I do bring attention to the caution by which such exemptions to parliamentary scrutiny of ministerial decisions should be made. Nevertheless, notwithstanding these concerns, the coalition is satisfied that this bill will enhance the operations of the TGA as a fundamental institution in our healthcare system.

Whilst I am on this debate in relation to our healthcare system, I want to again return to the very important issue surrounding a patient in New South Wales by the name of Pauline Talty. I want to bring to the House’s attention today the situation of this courageous young woman, Pauline Talty. As we have spoken about in the press before and also in this House, Pauline needs a lifesaving bowel transplant operation. Seven months ago—and I repeat, seven months ago—Pauline sought funding under the Medical Treatment Overseas Program to travel to Pittsburgh for this transplant. At the time, her doctors warned that she may only have around 12 months to live. Through the very long and agonising months since, she has had to repeatedly argue her case to the federal health department, which twice denied her treatment under MTOP, dismissing the advice of numerous health experts. On 13 May—two weeks ago tomorrow—the decision was reversed. Her battle with bureaucracy ended, or so she thought. The secretary of the health department wrote to Pauline to inform her that her lifesaving surgery overseas had been approved. On that afternoon, I stood in the House and praised the government for this change of heart. I had committed to do that. It was a very long, public campaign but, nonetheless, the government in the end changed the decision and I said at the time that if they did that I would praise them, and I did. This is very important, Madam Deputy Speaker.

Janelle Saffin (Page, Australian Labor Party) Share this | Link to this | Hansard source

I call the honourable members attention to the fact that whilst I am happy to give a lot of leeway, as we do in this place, you have strayed a long way from the bill, so please finish that remark.

Peter Dutton (Dickson, Liberal Party, Shadow Minister for Health and Ageing) Share this | Link to this | Hansard source

Sure, Madam Deputy Speaker, I am just finishing on this note and I thank the government for their accommodation made to Pauline’s treatment. Two weeks might not seem a long time to any of us but consider someone in Pauline’s position; two weeks is a long time. She still feels that the red tape is trapping her and that she is being asked to be the middle person between the federal department and the hospital in Pittsburgh, from her hospital bed in Sydney. It is not good enough.

Ms Anna Burke (Chisholm, Deputy-Speaker) Share this | Link to this | Hansard source

Would the honourable member come back to the bill right now, please.

Peter Dutton (Dickson, Liberal Party, Shadow Minister for Health and Ageing) Share this | Link to this | Hansard source

Indeed I will. That is why I call tonight on the health minister to intervene in this particular case, because it is unacceptable that the bureaucratic process is still bogging down this particular issue. This government has this bill, which is an important bill, before the House tonight, and the government has the support of the coalition in relation to this bill. We have a health system in this country which is in crisis. The point that I make, by way of example through Pauline’s case, in relation to this very important debate, is that this government gave a commitment to this dying young woman that they would cut the bureaucratic process, but they have not. So the call, again, for this government is to make sure that they put aside the bureaucratic nonsense and provide a better outcome for Pauline Talty.

Ms Anna Burke (Chisholm, Deputy-Speaker) Share this | Link to this | Hansard source

Would the honourable member for Dickson please return to the bill, and if the honourable member has forgotten the title I will help him. It is the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009]. Thank you.

Peter Dutton (Dickson, Liberal Party, Shadow Minister for Health and Ageing) Share this | Link to this | Hansard source

We can all read, Madam Deputy Speaker, and we can all see the travesty that has taken place in relation to Pauline Talty. I have made my point in relation to Pauline Talty—

Ms Anna Burke (Chisholm, Deputy-Speaker) Share this | Link to this | Hansard source

You have indeed!

Peter Dutton (Dickson, Liberal Party, Shadow Minister for Health and Ageing) Share this | Link to this | Hansard source

and I will be making it on many occasions subsequent to this if the government does not act promptly so that this debate can be had and this woman can get on with her life. That is the call we make to the government tonight.

In relation to the bill, there are some areas of concern. Those areas have been flagged in the Senate, and we have made the government aware of them tonight. In terms of the general thrust of this bill and the way in which it has been presented by the government, the coalition support the bill. As the alternative government of this country, we will continue to hold this government to account to make sure we have better patient outcomes in this country and to make sure that the government does not continue to put extra pressure on the public hospital system, which is already at—and in some cases beyond—breaking point. We renew that commitment to the Australian people tonight.

James Bidgood (Dawson, Australian Labor Party) Share this | Link to this | Hansard source

I rise to speak in favour of the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008. As a previous owner of two medical centres that service the healthcare needs of 40,000 people in the electorate of Dawson, I welcome this bill. I have seen firsthand the benefit of medical science working hand-in-hand with complementary medicines and alternative therapies—’complementary’ being the key word. This bill provides for medicines to be approved if they meet specific criteria, or disapproved if they do not. I welcome this because I often come across previous patients, and also people who come in for consultations at my office, who ask for amendments such as this. I know that this bill will be welcomed by many people, particularly in my electorate, who I have seen benefit from different types of therapeutic goods.

Schedule 1 of the bill provides for medicines to be suspended from the register—and, as we know, medical devices can already be suspended. Schedule 2 requires manufacturing licences to cover single manufacturing sites, except in limited circumstances provided for in guidelines, and enables variations to licences and transfer of licences between licence holders. Schedule 3 enhances monitoring powers to enable samples to be taken of any therapeutic good or any thing related to a therapeutic good on premises and to enable video and other recordings to be taken in addition to still photographs and sketches. Schedule 4 establishes a framework for the regulation of homoeopathic and anthroposophic medicines to commence in July 2011 with supporting regulations to be made to commence at that time. I am particularly interested in schedule 4. Currently, many of these homoeopathic and anthroposophic medicines are exempt from the requirement under the act that they 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, implements the 2003 recommendation by the Expert Committee on Complementary Medicines in the Health System that these products be regulated. This means that we will have conditions that recognise what truly does work, and we will avoid snake oil type therapeutic goods which clearly do not work. This enables these determinations to be made.

Schedule 5 of the bill enables the minister to determine lists of permitted and prohibited ingredients for inclusion in listed medicines. Schedule 6 makes minor technical amendments to references to orders published in the Gazette and to disallowable instruments to reflect that they are legislative instruments for the purposes of the Legislative Instruments Act 2003. Finally, schedule 6 makes other amendments to improve and clarify the operation of the act, including simplifying arrangements for setting conditions on medicines and confirming that decisions of the secretary may be made by a computer program.

The act presently enables medical devices to be suspended from the Australian Register of Therapeutic Goods, known as the register, when there are safety concerns with those goods. However, there are presently no similar provisions for medicines; therefore, if there are safety concerns with a medicine, the only option available to the secretary is to cancel its registration or listing. After addressing the reason for the cancellation, the sponsor must then reapply and pay the related application and assessment fees to re-register or relist the medicine. This is costly and inefficient. This bill provides that medicines can be suspended instead, when there are safety concerns that may be addressed within the period of the suspension.

The bill provides that manufacturing licences are to cover one site per licence, except in limited circumstances to be identified in guidelines, such as when two sites are adjacent to one another and jointly manufacture the same therapeutic good. Licence holders will also be able to apply to vary their licence, and the regulations will set out arrangements to enable the transfer of licences. Presently, many homeopathic and anthroposophic medicines are exempt from requirements under the act to be listed or to comply with quality manufacturing requirements. The bill implements a recommendation from 2003 of the expert committee on complementary medicine to regulate these products in the health system. The amendments will commence in July 2011 to provide time for further consultation with the industry sector to inform supporting regulations.

The regulations currently provide for permitted ingredients in listed medicines; however, the arrangements for amending this list and seeking to include new ingredients are not as clear as they might be. This bill clarifies this by empowering the minister to determine the list by legislative instrument, setting out permitted and prohibited ingredients and amounts of ingredients for listed medicines.

This bill also implements a number of minor amendments to clarify and improve the operation of the act. These amendments are, firstly, to clarify the arrangements for setting conditions on medicines and empowering the minister to determine standard conditions to apply to categories of medicines, with the secretary continuing to be able to set specific conditions on certain medicines; secondly, to clarify that computer programs are able to be used to make decisions for the secretary, with the secretary retaining the ability to replace those decisions; thirdly, to enable applicants to apply for a previous request to have an application to list or register a medicine that was treated as cancelled revoked so as to enable the application for the medicine to be considered; and, fourthly, to strengthen overseas manufacturing quality requirements for medicines by requiring that, before the manufacture of a medicine can be moved to an overseas manufacturer, certification must be received from the secretary that the manufacturing and quality control procedures for the proposed overseas manufacturer are acceptable.

This bill makes a number of minor technical amendments to references to orders and disallowable instruments to reflect that these are legislative instruments for the purpose of the Legislative Instruments Act 2003.

Finally, further amendments are planned for later in the year to establish a new framework for the regulation of human cellular and tissue based therapy products, biologicals, and new arrangements for the separate scheduling of medicines and poisons to reflect recommendations from the 2001 Galbally review and decisions from the Council of Australian Governments. I wholeheartedly commend this bill to the House.

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 on behalf of the Minister for Health and Ageing, I would like to thank the members who have contributed to this debate. This bill amends the Therapeutic Goods Act 1989 in a number of ways. Firstly, it incorporates into the act provisions allowing the stockpiling and supply of medical devices to deal with emergency situations. These provisions are based on similar provisions allowing medicines to be stockpiled and supplied in emergency situations which were added to the act in 2002. The amendments in schedule 1 to this bill allow the minister to exempt devices from the requirements of the act so that they can lawfully be stockpiled and made available in an emergency. These exemptions are not subject to parliamentary scrutiny. This follows advice, received by the then government in 2007, which recommended that the contents of the stockpile should be classified as confidential to ensure that would-be bioterrorists were not able to find out what preparations Australia had made for dealing with possible bioterrorist acts. For this reason, the bill also amends the act so that similar exemptions applying to medicines are not subject to disallowance. This bill also gives effect to a range of amendments which have been in contemplation for a number of years and which were to have been adopted as part of the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

The bill deals with the ‘fit and proper person’ test, default standards for medicines, information disclosure and the use of restricted representations in advertising. It also makes technical amendments to all offence provisions, to bring them into line with the latest policy on how these should be expressed, and these have been canvassed in the second reading speech. So the changes made by this bill do not encompass all of the reforms that the government intends to make to the therapeutic goods regulatory regime. The amendments in this bill are but the first instalment in an ongoing program of reform to the act. Australia has been well served by the TGA in the past, and it is important that the regulatory regime that the authority implements is kept up to date, so that the TGA and the industry it regulates can operate as efficiently as possible and so that Australian consumers can continue to have timely access to safe and effective therapeutic goods. I commend this bill to the House.

Question agreed to.

Bill read a second time.

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