Andrew Southcott (Boothby, Liberal Party, Shadow Parliamentary Secretary for Regional Health Services, Health and Wellbeing) Share this | Link to this | Hansard source

The parliament has been waiting for this bill, and its related legislation, for a while. Going back to 2002 the Australian Health Ministers’ Conference recommended a specific regulatory framework for tissue and biological therapies. This was developed in the context of a joint regulator with New Zealand—the proposed Australia New Zealand Therapeutic Products Authority. However, in July 2007 the enabling bill in the New Zealand parliament stalled and so the joint agency is currently suspended. However, the need for a specific regulation of biological therapies in the Australian context remains and hence we have this bill.

Biologicals cover human cell and tissue therapies. Tissue therapies would be things like skin grafts after severe burns; transplantation of heart, kidney, lungs or pancreas; bone-tendon ligament grafts to repair injuries; heart valves to replace defective valves; and corneal transplants. The cellular therapies include things like making cartilage cells—chondrocytes—for cartilage repair, eyelet cell transplantation for diabetes and mesenchymal progenitor cells for musculoskeletal defects.

Looking at the organisations that are involved in producing the human cell and tissue therapies, in December 2008 the TGA estimated the number of organisations who are undertaking work on human cell and tissue therapies. These included organisations involved in IVF and organ transplantation, and it should be pointed out that these will be covered by different regulations. The organisations that this legislation will have implications for are the 20 licensed tissue banks—one in the ACT, five in New South Wales, three in Queensland, two in South Australia, one in Tasmania, five in Victoria and three in Western Australia; these include bone banks, eye banks, heart valve banks and skin banks—and also organisations which are working in the area of cellular and tissue therapies. Of the latter organisations, there is currently one in New South Wales, one in Queensland, one in South Australia, one in Tasmania, four in Victoria and one in Western Australia. There are companies that are involved in this area: Verigen in Western Australia and the Australian Stem Cell Centre in Victoria are examples of businesses who are involved in the manufacture of human cell and tissue therapies.

When we look around the world we see that in the United States, the European Union and Canada there is specific regulation for biologicals. In the United States, the Food and Drug Administration regulates biologics specifically. Somatic cell and gene therapy, which are a much more interventionist therapy, are regulated as a medicinal, or class III medical device, product, which is much more comprehensive. In the European Union there is a specific directive on human tissues and cells being used as therapies. In Canada they regulate HCTs, other than transplant and IVF, as class IV medical devices.

The number of therapies that are going on is potentially enormous. In the United States, the FDA estimates that the number of tissue transplants went from 350,000 in 1990 to 1½ million by 2007. These would typically be bone, ligament and corneal transplants, and so on. The problem with the current regulation in Australia is the lack of clarity. There is no risk based classification. There is a lack of international harmonisation with the other countries I have mentioned. In the legislation the regulation impact statement outlined a number of approaches to regulation. Option 1 was to retain the status quo. Option 2 was to regulate all HCTs as medicines or therapeutic devices and remove the exemptions for transplant, assisted reproduction tissues and HCTs which have been prepared for a particular person. Option 3, which is the option that is being taken, is to regulate the HCTs as a discrete class of therapeutic goods—biologicals. Organs and assisted reproduction tissues are to be excluded as they already have a separate regulation which works well; to include them would be to add a further level of regulation and additional compliance cost. This is consistent with the approach in the United States, Europe and Canada.

There is a remaining issue with this legislation which has not been addressed in the parliamentary secretary’s second reading speech or in the legislation. That is the situation of medical practitioners who are removing and then re-implanting tissues so that routine medical practice is not captured by the TGA. The opposition would appreciate a response from the parliamentary secretary to this to cover how this situation will be dealt with if it is intended to deal with it by way of regulations.

In the legislation there are four classes of HCTs, each with a different level of regulation based on the level of risk. From the consultation it is apparent that stakeholders prefer option 3, which has been reflected in this bill. As I said, option 3 has regulation based on risk and clarity, has compliance costs lower than option 2, has improved consumer safety over option 1, which is the status quo, and is consistent with the experience in the United States, Europe and Canada.

The parliamentary secretary has indicated that by way of legislative instrument organs donated for transplantation and assisted reproduction tissues will not be classified as biologicals for regulation under the act. Organs will continue to be regulated by the Organ and Tissue Donation and Transplantation Authority and assisted reproduction tissues will continue to be regulated in the current way—that is, the status quo will remain. There is also a provision in the legislation for non-conforming biologicals to be used in exceptional circumstances when clinically necessary and when the patient or guardian consents. I have no issue with that at all.

This bill is part of the overall ongoing regulatory reform being undertaken by the Therapeutic Goods Administration. This is the fourth in a series of bills to implement that reform. It seeks to build on the other reforms agreed to by the parliament over the last year. The coalition has been broadly supportive of these measures as they have been presented to the parliament by the government. The primary purpose of this bill, as I said, is to introduce a framework for the regulation of biologicals—human cellular and tissue based therapy products. This bill specifies what they are and provides for them to be regulated separately from other therapeutic goods and medical devices.

HCTs have been primarily manufactured by not-for-profit tissue banks and major hospitals. However, with rapid advances in cell and tissue technology, there is an increasing involvement by private sector companies and clinics in the manufacture of HCT products, while medical device manufacturers may in fact in future incorporate HCTs into medical devices. Clearly, therefore, we do need an update of the Therapeutic Goods Act to reflect that these emerging technologies and HCT products can be regulated as a specific group.

The government assures that under this legislation all biologicals used within Australia will be properly assessed and regulated, providing confidence for patients who hope to benefit from the outcome of these new technologies. As I said earlier, this is a bill that was first foreshadowed by the Australian Health Ministers’ Conference in 2002. Public consultations ensued through 2003 and 2004 and the Australian Health Ministers’ Advisory Council and Australian Health Ministers’ Conference agreed to implementation of frameworks for biologicals in 2006.

Most of these reforms were agreed to in the context of the proposed Australia-New Zealand therapeutic products authority. When the New Zealand government decided not to proceed with the joint authority, the Australian government decided to implement these proposed changes in the Australian context alone.

The framework for the regulation of biologicals is established in schedule 1 of the bill. The government has said that the amendments will ensure that the regulation of biologicals is consistent with the regulation of other therapeutic goods. The bill will create four classes of biologicals from low risk—class 1—to high risk—class 4. The TGA has said that a risk based approach will be adopted, with the stringency of the regulations and other requirements increasing with the risk level of the biological. Biologicals at a low-risk level will be subject to less rigorous evaluation and regulation.

Biologicals will have to be included on the Australian Register of Therapeutic Goods and only those that are so registered, or otherwise exempted, will be able to be supplied and used within Australia. Biologicals can be exempted from the TGA regulatory framework by regulation to deal with emergency situations, to allow for special experimental uses or where substitutes are not available.

Criminal and civil penalty provisions are provided for in the bill to ensure compliance by those bodies and individuals involved in the making, supplying and use of biological materials. It is stated that all these penalties are consistent with other provisions of the Therapeutic Goods Act and can apply in the same way as penalties for the misuse of other therapeutic goods.

The parliamentary secretary has assured the parliament that the legislation will provide flexibility to deal with urgent medical circumstances and that non-conforming biologicals will be able to be made available in exceptional circumstances. The parliamentary secretary has also assured the House that the legislation will ensure that sponsors and manufacturers of biologicals will not face unnecessary requirement and that they will be able to transition smoothly and easily to the new regulatory arrangements. Importantly, organs donated for transplant and assisted reproductive tissues, such as IVF embryos, will not be classified as biologicals for regulation under the act and will continue to be regulated under existing arrangements.

In the main, the coalition notes that stakeholders are supportive of the need for these measures to regulate biologicals. Those stakeholders have, however, flagged some areas of concern. On the issue of immunity from prosecution for the Commonwealth and Commonwealth officers, the coalition notes that, while the Therapeutic Goods Act presently contains various immunity provisions, they will be repealed by these amendments. The provisions for immunity outlined in this bill provide greater breadth of the immunity conferred and to whom it is conferred upon. The coalition accepts that these provisions are consistent with other Commonwealth legislation and other regulatory agencies but notes the concern of some stakeholders that the TGA must remain responsible for its actions.

The coalition also notes that, where information is sought under the provisions of these amendments, in some circumstances the right to avoid self-incrimination is void; however, the bill balances that by providing that any information supplied will be inadmissible as evidence against that person. Again, these measures are consistent with other Commonwealth legislation.

There is also some concern about costs and cost recovery practices of the TGA in the context that any action that drives up costs could have an impact on the availability of particular therapies and their costs to the patient. Stakeholders believe that in this area, where rapid changes and advances are being made, there is great need for flexibility on the part of both the TGA and the government. Given that there will be a delayed commencement date for the amendments contained in this bill to allow for further consultation on various matters, the coalition would urge the government to heed some of the concerns outlined and to take up these matters with stakeholders during that consultation process. The coalition does not oppose the bill.

Brett Raguse (Forde, Australian Labor Party) Share this | Link to this | Hansard source

I rise today to speak about the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 and the Therapeutic Goods (Charges) Amendment Bill 2009. The Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 is the fourth in a series of bills to implement reforms to the regulation of therapeutic goods in Australia through amendments to the Therapeutic Goods Act 1989. The legislation reflects the government’s commitment to maintaining the position of Australia’s Therapeutic Goods Administration, the TGA, as a leading global regulator of therapeutic goods and to continue to strengthen and enhance this well-deserved position. It builds upon the other therapeutic goods reform bills approved by parliament over the past year, to further strengthen and improve Australia’s therapeutic goods regulatory framework. This legislation includes a new regulatory framework for cellular and tissue based therapy products, known as biologicals, so that these products can be regulated as a specific therapeutic goods group.

Implementation of the biologicals framework was agreed to in 2006 by the Australian Health Ministers’ Conference and was among other improvements that were to have been adopted as part of legislation underpinning the proposed Australia-New Zealand therapeutic products authority, ANZTPA. The Rudd government is committed to moving forward to implement these improvements. We have delivered on that commitment, with the majority of improvements now implemented through the reform bills that were passed by the parliament last year, in this current bill and in another just introduced amendment that is before the House today.

Schedule 1 of the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 will implement a new framework for the regulation of biologicals and will bring Australia’s regulation of these products into line with other leading therapeutic goods regulators around the world including, importantly, the United States, Canada and the European Union. Biologicals include things such as skin tissue for use in grafts following burns, and bone for grafting. It is envisaged that a legislative instrument will be made under the biologicals framework to declare that organs donated for transplantation and assisted reproductive tissues such as IVF embryos will not be classified as biologicals for regulation under the act. Instead, organs will continue to regulated by the Australian Organ and Tissue Donation and Transplantation Authority established by this government and assisted reproductive tissues will continue to be regulated under current arrangements.

The new framework will enable the overarching regulatory principles that apply to all other therapeutic goods to be adapted and applied to biologicals by including a new part in the act. The principal benefit of the new biologicals part is its ability to apply different levels of premarket and postmarket regulation requirements based on the relative risk of each biological. It will also ensure that all biologicals used in Australia are properly assessed and regulated, as currently many are exempted and do not fit neatly under the medicines or medical devices frameworks. To enable this to occur, classes of biologicals will be set out in regulations to be made under this bill. The lowest class will include biologicals that are at a relatively low-risk level, while other classes will apply to biologicals of incrementally higher risk levels. For example, those biologicals that have been extensively manipulated or are intended to be used for a purpose that is not their usual or original purpose would fall under the highest risk class. The rigour of the application and assessment process and postmarket monitoring for biologicals will be aligned to these risk based classes so that higher risk biologicals will be required to provide a higher level of information to confirm their safety, quality and efficacy.

This approach means that sponsors of biologicals in lower risk classes are not required to comply with unnecessary requirements that are relevant only to the higher risk biologicals. Only those biologicals that are approved and included in the Australian Register of Therapeutic Goods or otherwise given an exemption under this new part will be able to be imported, exported, supplied or used in Australia. This is consistent with all other therapeutic pubic goods, such as medicines. The new part will also apply criminal offence and civil penalty provisions to dealings with biologicals in the same way as they apply to other therapeutic goods. Were this not the case, the act would be inconsistent in its application and sponsors of biologicals or other therapeutic goods might have an incentive to frame the claims in relation to the nature of their product so that it would come under the more lenient offence and civil penalty provisions.

A feature of the changes for biologicals is the ability to deal flexibly with urgent medical circumstances. Unlike medicines which may be readily mass produced, biologicals are produced from cells and tissues. As a result, the amount able to be produced and available on hand at any one time may vary. Also, there will always be minor differences between biologicals of the same product—for example, bone tissue from one donor will obviously not be exactly the same as bone tissue derived from another donor. The new part will require that all biologicals must meet certain standards and be manufactured according to good manufacturing processes and practice. However, there may be exceptional circumstances where a patient is critically ill and urgently requires a biological for treatment but none that conform to the requirements are available and no other approved therapeutic good is appropriate. This part will also provide that non-conforming biologicals can be used in such circumstances if, stringently, the patient’s doctor believes it is clinically necessary and the patient or their guardian consents. The decision to use non-conforming biologicals in exceptional circumstances would be made, as it is now, on a case-by-case basis by the doctor and the patient or their guardian.

It is important that this bill reflects the limited but critically important role for exceptional release. The bill provides that details for exceptional release will be set out in regulations. The requirements will be similar to those for access to unapproved medicines under category A of the current Special Access Scheme where patients are critically ill and no other approved therapeutic good is appropriate. Implementing the new arrangement proves the government is committed to making sure that sponsors and manufacturers of these products will be able to transition smoothly and easily to the regulatory arrangements so that the supply of biologicals to those who need them will not be affected.

As part of this commitment, the government has undertaken extensive consultation with the industry over the last 18 months, including explaining the proposed framework to sponsors and manufacturers, and setting out the steps they will need to take to comply with the framework. To further support the transition, the amendments in this bill establishing a framework will not commence until a date to be proclaimed within 12 months. This will ensure that the remaining consultation work on supporting details, such as the product-specific standards, can be finalised and in place to commence at the same time.

Schedule 1 also includes specific transitional provisions for any applications for inclusion of biologicals in the register as medicines or devices that are under consideration by the TGA at the time the new biological arrangements commence. Those biologicals will continue to be assessed as either medicines or devices, depending on which group they are currently regulated under. Where an application is approved, the biological will then be included in the register and moved to that part for biologicals. This will prevent applicants needing to make a new application or having the application assessment process being restarted or protracted as a result of the application being transferred for consideration by the biological assessment area. However, input into these applications is routinely provided by the biologicals assessors to ensure they meet the necessary standards. The existing arrangements in relation to advertising of therapeutic goods, review of decisions and other general provisions in the act will be applied to biologicals in the same way that they are for other therapeutic goods.

Through the cognate bill, associated amendments will also be made to the Therapeutic Goods (Charges) Act 1989 to enable annual charges to be payable by sponsors to maintain the inclusion of their biological in the register. These charges apply to all therapeutic goods and reflect the work of the TGA to monitor products on an ongoing basis. The biologicals industry sector has waited for a long time for this new framework and has begun readying itself to implement the new arrangements.

Schedule 2 of this bill replaces a number of currently somewhat inconsistent provisions that indemnify the minister, the secretary and others acting as required under the act with a single provision. The schedule does this by including a new section in the act to provide that the Commonwealth, the minister, the secretary, the national manager of the TGA and others empowered or authorised to do certain things under the act can do so without fear that civil legal action can be taken against them for doing so, as long as they do not act in bad faith. This is consistent with Commonwealth legislation for a number of other regulatory agencies such as the Australian Prudential Regulation Authority Act 1998 and others.

In other amendments under schedule 3 of the bill there will be provision for greater flexibility to recall specific batches of therapeutic goods where there are safety, quality, efficacy, presentation or performance concerns about any affected batches. Currently, in some cases where there are safety, quality, efficacy, presentation or performance concerns, the entire entry for a good must be suspended or cancelled in order to enable the recall of batches to occur. This approach is unnecessary and excessive in some circumstances where only a small number of batches are affected.

Consistent with the provisions included in the previous amendments, enabling information to be sought from a person who previously held a conformity assessment certificate for a medical device, schedule 4 of this bill enables information to be sought from people who previously had a medicine included in the register. Schedule 5 clarifies that unpaid annual charges are a debt due to the Commonwealth, to ensure that they are able to be recovered, as the TGA operates on a full cost recovery basis through the work it undertakes.

Finally, schedule 6 of the bill includes a number of minor amendments. These include providing that, where a person asks to vary the conditions of registration or listing for a medicine, the application for this must be accompanied by the relevant fee, to enable the TGA to assess and respond to the request. This will principally support postmarket monitoring of those medicines that are required to have an approved risk management plan as a condition of their registration and where the sponsor may wish to make a change to the agreed plan.

This schedule will also clarify what is meant by ‘new information’ in regard to reviews of decisions made under the act. So that now includes any information that a sponsor had at the time of the original decision but which was not provided to that decision maker. The amendments in this schedule support the minister or their delegate being provided with all pertinent information on which to make a decision, and remove a loophole that enabled such information to be withheld from that decision maker and lodged later for consideration by the Administrative Appeals Tribunal. Further improvements to the therapeutic goods regulatory regime introduced to parliament today will further round out improvements which we had as a government implemented throughout 2009.

I would like to make some comments—and to put at rest the mind of the member for Boothby—about the ability of the TGA to use discretion and to have flexibility in some of those processes. I would like to relate an anecdote about some pragmatic approaches that were recently taken by the TGA with its administrative allies—in this case, Medicare—in having appropriate flexibility to make regulatory changes while still being stringent as to the use of certain medicines and medical products. Late last year I was approached by two Gold Coast City councillors, Councillor Donna Gates and Councillor Jan Grew, about major concerns for their communities over the effects of diabetes on eyesight and that a certain medication, Avastin—used for retinal vein occlusions and severe diabetic retinopathy—due to a classification of use, was not being provided for certain ophthalmic procedures or for other uses in cardiac cases and other uses.

After representations to our minister, and departmental discussions through the TGA, I am pleased to report to this House that the critical needs of diabetic patients have been recognised. The appropriate changes were made to secure the use of Avastin—and, by the way, at a much lower cost to the government—not only to provide critical sight-saving injections but at a much lower cost to taxpayers—in fact, at about a 20th of the cost. This, of course, affects the whole of Australia. This is, as I said, an example of the stringent but flexible approach that is appropriate when you are looking at some of the regulation.

I would like to read an email from a retinal surgeon about this very issue. It goes:

Dear Brett

Please see attached re reversal of the TGA/HIC’s decision re item number 42740 as it relates to intravitreal injection of numerous important sight saving injections (E.g. Avastin for retinal vein occlusions and severe diabetic retinopathy, Triamcinolone for inflammation, antibiotics for serious intraocular infections …

May I personally thank you for the great efforts that you have brought to bear with respect to this welcome decision.

My patients have literally lived through a very dark era in the history of eye health care in Australia and the reversal of the November 2008 decision by TGA/HIC is very welcome.

This had caused huge heartache for many and they are all glad that this era has passed.

Once again, many thanks for your help with this issue.

That is an example of that flexibility. I know that on both sides of the House we would be pleased at least to have legislation and a framework that allows certain decisions, particularly in the case of critical medical need, to be addressed in that way. So credit goes also to Councillors Gates and Grew from the Gold Coast City Council for bringing this issue forward for their community.

This bill provides a substantial raft of improvements for all people, for Beenleigh and for all the seats in that South-East Queensland region. As the member for Moncrieff well knows, we do work very well together in the Gold Coast region and I see myself as the government member representing that whole region of South-East Queensland. I thank the member for his interjections and his support for the work we do collectively. I know the member for Moncrieff would have been frustrated in those 12 years under the previous government at the lack of ability of the previous government to support South-East Queensland. I am glad to see him here in the chamber today supporting what I am doing as the federal member for Forde and working for the Gold Coast region.

On a serious note, it is clear that these councillors from the Gold Coast City Council brought forward an issue that has surfaced not only their community, which is my community, but every community in Australia. It is so important that governments, irrespective of their political flavour, understand the need for legislation and procedure that allows for these decisions that at the end of the day are very important for and critical to medical outcomes.

In conclusion, this bill provides a substantial raft of improvements to the act and the regulation of therapeutic goods in Australia. Together with the wider regulatory reforms implemented last year, this bill will reinforce Australia’s international position as a leading therapeutic goods regulator. I therefore commend this bill to the House.

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

It gives me great pleasure to rise and speak on the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 and the Therapeutic Goods (Charges) Amendment Bill 2009 that we have before us in the parliament today. As all members would know, the Rudd government is the government of health reform, be it in the total overhaul of the nation’s health system by the establishment of the National Health and Hospitals Network, be it in addressing the chronic work shortages that were addressed in The blame game report of the House of Representatives Standing Committee on Health and Ageing which was commissioned by the previous government or be it in amending the Therapeutic Goods Act 1989 in the way it is being amended here today. The primary purpose of this amendment to the Therapeutic Goods Act is to introduce a framework for the regulation of biologicals which is consistent with the regulation of therapeutic goods and medical devices under the Therapeutic Goods Act 1989. This bill is part of the overall regulatory reform to the act undertaken by the Therapeutic Goods Administration, the TGA. We believe that this is important legislation that positions the Therapeutic Goods Act to benefit the people of Australia. This is the fourth bill that is being considered by the parliament.

In addition to the Therapeutic Goods Act amendment that we are debating today, the Rudd government has undertaken a large number of reforms to our health system. The first I touch on is the National Health and Hospitals Network reform that was announced by the Prime Minister at the National Press Club two weeks ago. It replaces eight separate health systems with the National Health and Hospitals Network combining all the hospitals and all GP and related services. It dedicates one-third of the GST revenue that currently goes to the states and territories so that the Commonwealth can make major financial changes to meet the needs of the Australian people. It is going to put in place small local hospital networks which will benefit the people of Australia.

This legislation is the result of the Rudd government listening to the people of Australia. They are acting on the recommendations made in The Blame Game report after the inquiry on health funding. There were some significant and substantial recommendations made in that report but, unfortunately, they were not acted upon. The Rudd government has embraced that report and taken it a step further. The government has responded to The blame game report. The National Health and Hospitals Network is an answer to the report commissioned by this parliament which was never acted upon when the opposition was in government. I believe it was the current Leader of the Opposition, who was the Minister for Health and Ageing at the time, who decided that he would ignore the recommendations of the report. This system will deliver 60 per cent of funding responsibilities for public hospitals. It will take over full responsibility for GP and related services provided outside hospitals and it will pay local hospital networks directly for each service.

Coming from an electorate like Shortland, I know the difficulties that have been experienced because of the chronic workforce shortage that existed and was allowed to escalate under the previous government. For 10 years in this parliament I have raised the issue of the workforce shortage with a series of health ministers, including the current Leader of the Opposition when he was the minister for health. No matter how often I spoke in the House and no matter how often I wrote to the then minister for health, my words were ignored. There was no response. There was no humanity shown by the previous government in addressing these issues that were so important to the Australian people and to the people in the Shortland electorate. When the opposition was in government I stood in this House and shared with members how people in the Shortland electorate would have to wait three weeks to get an appointment with their doctor. I have said in this House that a person was either dead or better by the time they could obtain an appointment with their doctor.

Chapter 4 of The blame game highlights that there is a critical workforce shortage. It makes recommendations, it identifies all the issues and it emphasises how important it is to address workforce issues in relation to GPs, allied health professionals and nurses. Unfortunately, for 12 long years nothing was done—and it has been said to me that it was going to happen in the 13th year! This week we have had some fantastic announcements that will go a long way to addressing the chronic shortage of doctors. The only thing I am upset about is that that shortage will not be able to be addressed tomorrow. It takes time to train new doctors. Whereas the previous government was reluctant to invest in the health of the Australian people, the Rudd government has shown it is fully supportive of ensuring that each and every Australian can obtain the health care they need. This week the Rudd government has announced $622 million to train a record number of new doctors, which will be welcomed in the electorate of Shortland and throughout Australia; $339 million to increase GP training places to record levels; $148 million to ensure that more junior doctors can experience a career in general practice—and I know that the doctors in the Shortland electorate will be very supportive of helping those doctors gain that experience and training; and $145 million to train more specialist doctors.

In addition to the issues that have been outlined, this bill implements a new framework for the regulation of biologicals; provides that civil legal proceedings cannot lie against Commonwealth staff members and others carrying out functions under the act; increases the flexibility of arrangements for the recall of goods to enable recalls of goods where there are concerns about safety; and enables information to be sought and clarified on unpaid charges. In addition to the amendments made in this bill, the Rudd government has an outstanding record in the area of health with its introduction of training and the health reform agenda. I recommend the bill to the House.

Mark Butler (Port Adelaide, Australian Labor Party, Parliamentary Secretary for Health) Share this | Link to this | Hansard source

in reply—I thank members for their contributions to this debate, particularly the member for Shortland. As I mentioned in my second reading speech, the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 amends the Therapeutics Goods Act 1999 in a number of ways. Firstly, and most importantly, it implements a new framework for the regulation of human cellular and tissue based therapy products, known as biologicals. Biologicals include such products as skin tissue for burn grafts and bone grafting. I discussed this in depth in my speech introducing the bill into the House, so I will just give a brief overview of the new arrangements.

Australia’s current regulatory arrangements are not well suited to regulating biologicals because they were developed for medicines and devices, which are quite different from biologicals, not least because of the variability inherent in biologicals. This means that many biologicals are currently required to be regulated as either a medicine or a device. As a result, biologicals are unable to be regulated based on their varying risk level. For example, unmanipulated skin tissue which is to be used for skin grafting poses a lower risk than highly processed cells that are to be used for a purpose that is not the same as their original use. Schedule 1 of the bill addresses this by providing that biologicals be regulated as a distinct group of therapeutic goods. It also enables these products to be placed into classes depending on their level of risk. The higher the class of biological, the higher the regulatory requirements that will need to be met to ensure the biological is safe, effective and of a high quality. This is as it should be.

Regulating biologicals as a distinct group will also bring Australia into line with other leading therapeutic goods regulatory agencies around the world, including the USA, Canada and the EU. The bill also adapts and applies to biologicals the broad overarching regulatory principles that apply to other therapeutic goods. The offence and civil penalty provisions are consistent with those for other therapeutic goods. They need to be; otherwise, there is potential that sponsors will characterise their therapeutic good as a medicine, device or biological, depending on which would provide the most lenient penalties. Therefore it is essential that the bar be set at the same level for all therapeutic goods.

A key feature of the new part 3-2A for biologicals to be inserted into the Therapeutic Goods Act by this bill is a provision to enable the exceptional release of biologicals that do not meet the standards where there are no conforming biologicals or approved therapeutic goods available or that would be appropriate where a patient is critically ill and requires urgent treatment. The regulations will set out rigorous requirements that must be met before the biological can be used under exceptional release, and will require that the patient or their guardian be fully informed and give consent. Exceptional release is not a new practice; it has been used by doctors in Australia previously—such as during the Bali bombings in 2002 to treat badly burned patients when sufficient conforming skin tissue for grafts was not available. The bill better regulates this practice to ensure the safety of patients. The new arrangements for biologicals will be implemented over a period of three years. The biologicals industry is aware of this and has been awaiting these changes for some years now.

Other amendments in the bill include consolidating the existing immunity provisions in the act into a single provision to ensure that civil legal action cannot be taken against a person acting under the act unless they do so in bad faith; enabling specific batches of therapeutic goods to be recalled without the need first to suspend or cancel the entire entry of the good in the register if there are concerns about the safety, quality, efficacy, performance or presentation, but only for limited batches; enabling information to be sought from past sponsors of medicines; providing that unpaid annual charges to keep a therapeutic good on the register are debts due to the Commonwealth to enable these to be recovered; and other minor amendments.

The member for Boothby raised a couple of questions in relation to this bill which I will take a few moments to respond to. Firstly, the member for Boothby raised some questions about biologicals custom-made by doctors for their patients and the degree to which, if at all, this bill would impact on that. I can advise the House that, as with other therapeutic goods, medical practitioners will continue to be able to exercise their clinical judgment and custom make biologicals for their patients on an individual patient basis.

As noted by the opposition, regulations will be developed for this bill and these will provide details for implementation of the biologicals framework. Among these regulations will be exemptions for medical practitioners from biological regulatory requirements. Consultation on these draft regulations will occur and the input of medical practitioners obviously will be welcome.

The second point raised by the member for Boothby concerns patients’ own biologicals which, I am advised, are called autologous biologicals. The second issue raised by the opposition was that of use of a patient’s own cells or tissues for reimplantation—known, as I said, as autologous biologicals. These autologous biologicals will not be regulated under the framework introduced under this bill. This practice is currently not regulated by the TGA under the act and this exemption will continue under the new biologicals framework implemented by this bill.

As indicated in the second reading speech, the changes made by this bill do not encompass all the reforms the government intends to make to the therapeutic goods regulatory regime. The amendments in this bill are the fourth instalment in an ongoing program of reform to the act. Australia has been served well by the TGA in the past and it is important that the regulatory regime the TGA administers 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.

Before concluding, I table a minor correction to the explanatory memorandum for these bills. Page 4 of the document has been updated by removing the reference to specific companies and organisations as being involved in the manufacture of HCTs. I commend the bill to the House.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.