medical device. D. Take into account any other information that the committees consider may be material in their deliberations. Recommendation Thirty: The Panel recommends that the Advisory The Commonwealth rejects Recommendation Thirty as the Committee on Medicines Scheduling (ACMS) become a sub-committee of the roles of medicine consideration for TGA registration and for Advisory Committee on Medicines and make recommendations to that scheduling are quite different. This recommendation was not committee about the: supported by stakeholders. As part of the Smaller Government the Commonwealth proposes to rationalise the number Agenda, 1. Scheduling of medicines; and of TGA advisory committees from eleven to seven, of which 2. Inclusion of medicinal substances in Appendix H of the Poisons the Advisory Committee on Medicines Scheduling will be Standard. retained as a standalone committee. This is due to its important role in advising the TGA on the scheduling of medicinal substances and ensuring that state and territory governments have strong input into scheduling decisions (as state law actually implements a scheduling decision). The Panel recommends that the Australian The Commonwealth of Recommendation Recommendation Thirty-One: supports the intent Government give consideration to organisational structures that will facilitate Thirty-One, and notes recent organisational changes within the improved integration of: Department of Health to address process alignment and implement collaborative mechanisms. 1. Pre-market regulation of medicines and medical devices with health technology assessment of these products for subsidy and other purposes; and 2. Post-market monitoring of medicines and medical devices for safety, efficacy and costeffectiveness. Recommendation Thirty-Two: The Panel recommends that the Australian The Commonwealth defers consideration of Recommendation Government review and enhance the with a view to Thirty-Two. The Department of Health and associated agencies NRA’s funding model, providing either a dedicated annual appropriation or other appropriate are scheduled to undergo a in Portfolio Charging Review budgetary arrangements on an or routine capacity basis, to enable it 201718. A review of the funding arrangements ‘as-needs’ regulator’s to more effectively fulfil its mandate to act in the public interest and to ensure should not be conducted in isolation. Deferring consideration that genuine and systemic improvements to its capacity, expertise and under the will ensure funding Portfolio Charging Review
medical device. D. Take into account any other information that the committees consider may be material in their deliberations. Recommendation Thirty: The Panel recommends that the Advisory Committee on Medicines Scheduling (ACMS) become a sub-committee of the Advisory Committee on Medicines and make recommendations to that committee about the: 1. Scheduling of medicines; and 2. Inclusion of medicinal substances in Appendix H of the Poisons Standard. The Commonwealth rejects Recommendation Thirty as the roles of medicine consideration for TGA registration and for scheduling are quite different. This recommendation was not supported by stakeholders. As part of the Smaller Government Agenda, the Commonwealth proposes to rationalise the number of TGA advisory committees from eleven to seven, of which the Advisory Committee on Medicines Scheduling will be retained as a standalone committee. This is due to its important role in advising the TGA on the scheduling of medicinal substances and ensuring that state and territory governments have strong input into scheduling decisions (as state law actually implements a scheduling decision). Recommendation Thirty-One: The Panel recommends that the Australian Government give consideration to organisational structures that will facilitate improved integration of: 1. Pre-market regulation of medicines and medical devices with health technology assessment of these products for subsidy and other purposes; and 2. Post-market monitoring of medicines and medical devices for safety, efficacy and costeffectiveness. The Commonwealth supports the intent of Recommendation Thirty-One, and notes recent organisational changes within the Department of Health to address process alignment and implement collaborative mechanisms. Recommendation Thirty-Two: The Panel recommends that the Australian Government review and enhance the NRA’s funding model, with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and The Commonwealth defers consideration of Recommendation Thirty-Two. The Department of Health and associated agencies are scheduled to undergo a Portfolio Charging Review in 201718. A review of the regulator’s funding arrangements should not be conducted in isolation. Deferring consideration under the Portfolio Charging Review will ensure funding
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