Thursday, 13 May 2010
Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009; Therapeutic Goods (Charges) Amendment Bill 2009
I rise today to speak on the Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 and the Therapeutic Goods (Charges) Amendment Bill 2009. The purpose of the first bill is to introduce a framework for the regulation of biologicals by the Therapeutic Goods Administration. Biologicals are human cellular and tissue based therapy products that contain or are derived from human cells or tissues—for example, skin grafts used to treat severe burns. This legislation will have implications for the 20 licensed tissue banks nationally, including bone banks, eye banks, heart valve banks and skin banks, and also organisations which are working in the area of cellular and tissue therapies. The regulatory impact statement outlined a number of approaches to regulation: option 1 was to retain the status quo; option 2 was to regulate all human cellular and tissue therapies as medicines or therapeutic devices and remove the exemptions for transplant, assisted reproduction tissues, and human cellular and tissue therapies which had been prepared for a particular person; and option 3, which is the option that is being taken, is to regulate human cellular and tissue therapies as a discrete class of therapeutic goods, namely, biologicals.
In the legislation there are four classes of human cellular and tissue therapies, 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 is reflected in this bill. 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 experience in the United States, Europe and Canada. 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.
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 implementing that reform. It seeks to build on other reforms agreed to by the parliament over the last year. The coalition has been broadly supportive of these measures. Human cellular and tissue therapies have been primarily manufactured by not-for-profit tissue banks and major hospitals. However, with rapid advances in cellular and tissue technology there is an increasing involvement by private sector companies and clinics in the manufacture of human cellular and tissue products, while medical device manufacturers may in future incorporate human cells and tissues into medical devices. Clearly, therefore, we do not need an update of the Therapeutic Goods Act to reflect that these emerging technologies and human cellular and tissue 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 technologies. Biologicals will 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 in Australia. Biologicals can be exempted from the Therapeutic Goods Administration regulatory framework by regulation to deal with emergency situations, to allow for special experimental users 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, supply and use of biologicals. 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 second bill complements the amendments proposed in the first bill and will ensure consistency with the approach on annual charges for biologicals taken towards all therapeutic goods. The coalition does not oppose these bills.