04 May 2007
As you would know, an exposure draft of the Therapeutic Products Bill 2007 ("Bill") governing the regulation of therapeutic products under the new Australia New Zealand Therapeutic Products Authority ("ANZTPA") was released for public consultation and comment on 2 April 2007. This is the first of a package of Bills to be released, to give effect to the Agreement between the Australian and New Zealand Governments for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products ("the Agreement").
The New Zealand version of the Bill, the Therapeutic Products and Medicines Bill 2006 ("the NZ Bill"), was introduced into the New Zealand Parliament on 5 December 2006 and was read for the first time in December 2006. The NZ Bill was then referred to a New Zealand Select Committee, which will report on it in June 2007.
Subject to the New Zealand Select Committee's report, the outcome of the consultation on the Australian Bill and the alignment of the two Bills, the Australian Government has indicated that it intends to introduce the Australian Bill and its counterparts into the Australian Parliament as soon as possible. In any case, tabling of the New Zealand Bill before its Parliament and the release of an exposure draft of the Australian Bill shows that the joint regulatory scheme is one step closer to being established.
Overview of the Bill
Although the Bill introduces some changes to the legislative scheme set out in the Therapeutic Goods Act 1989 (Cth) ("TG Act"), the draft Bill largely mirrors the current regulatory regime in Australia. The purpose of the Bill is to give effect to the joint regulatory Scheme in Australian law. The Scheme will be administered by ANZTPA, which will regulate the quality, safety and efficacy of prescription medicines, over-the-counter medicines, complementary medicines, medical devices, and some other products (including some sunscreens, blood and blood products, and cellular/tissue therapies).
Significantly, the Bill will establish a Ministerial Council, made up of the Health Ministers of Australia and New Zealand. The Ministerial Council Rules provide for the Council to perform the functions of overseeing the joint regulatory Scheme and ANZTPA.
The Australian and New Zealand Bills are drafted to ensure, as far as possible, identical outcomes in a seamless regulatory scheme. This is consistent with the trans-Tasman governance of the Ministerial Council and of ANZTPA. However, there will be some exceptions between the two countries, such as regulation concerning the direct-to-consumer advertising. Differences in regulation between the two countries are inevitable, given the inherent difficulties in merging two quite disparate regulatory schemes.
There are also key differences which depart from the current Australian regulatory process as legislated by the TG Act. In particular, there are differences in the proposed merits review of regulatory decisions made by ANZTPA, and there are significant changes to the penalty provisions under ANZTPA. We have outlined some of the key provisions of the Bill in our summary document. To view the summary document, please click here.
Next steps
While noting that this Bill substantively provides for the regulation of therapeutic products under the trans-Tasman Scheme, there are also two other Bills which will be released for exposure separately. One Bill will deal with the transitional arrangements and make consequential amendments to other legislation, while the other Bill will deal with charges and taxes on Australian licence holders to comply with section 55 of the Australian Constitution. These two Bills will combine with the Therapeutic Products Bill 2007 to give effect to the Agreement. There is considerable speculation as to the impact of these two Bills on the obligations of sponsors. In particular, there is widespread concern that fees under the new Scheme will increase and sponsors are anticipating that they will be faced with significant administrative burden in transitioning their products to the new Scheme.
We will update you further when exposure drafts of these two Bills have been released.
