Mark Butler (Port Adelaide, Australian Labor Party, Parliamentary Secretary for Health) Share 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.

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