Andrew Southcott (Boothby, Liberal Party, Shadow Parliamentary Secretary for Regional Health Services, Health and Wellbeing) Share 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.

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