governments, and position both countries well on the international stage. It would also have resolved the issues with the Medicines Act and the temporary exemption for therapeutic products under the Trans-Tasman Mutual Recognition Arrangement (which has now become a permanent exemption). Until 2007 a large amount of work was done to bring the ANZTPA initiative to fruition. Legislation was introduced in New Zealand (and released as an exposure draft in Australia) but could not be passed as there was a lack of political support. The lack of support largely reflected concern about the inclusion of complementary medicines within the scope of the joint scheme. (New Zealand has now developed a separate regime for these products in the form of the Natural Health Products Bill.) As a consequence the two governments put ANZTPA on hold. In 2011 the Prime Ministers of New Zealand and Australia recommitted to ANZTPA and work recommenced. A few years later, however, following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding, the Prime Ministers of Australia and New Zealand announced in November 2014 to cease efforts on this major project. Government expectations On 17 November 2014 Cabinet noted that the Minister of Health would signal the next steps to upgrade New Zealand’s regulation of therapeutic products. This involves “a new and comprehensive regulatory regime which will replace the Medicines Act … 1981 and its Regulations” [CAB Min (14) 36/22 refers]. A Therapeutic Products Bill to repeal and replace the Medicines Act 1981 has priority 6 on the Government’s Legislation Programme [CAB Min (15) 5/7 refers]. Objectives The new regime is being designed to meet the needs of the health and disability support sector now and into the future, and to give effect to Government’s expectations for regulatory systems (including international alignment or conformity as appropriate). More specifically, the regime is being designed to: meet expectations of risk management and assurance of safety result in efficient and cost effective regulation be flexible, durable, up-to-date, and easy to use ensure high-quality, robust and accountable decision-making foster sustainable regulatory capacity support New Zealand and economic objectives be trusted and respected support consumer access and individual responsibility for care. These objectives will require: an enabling legislative framework that can be readily maintained and updated regulatory requirements that are consistent with cost-effective risk management and accepted international practice a regulator with capacity, independence, flexibility, and accountability.
governments, and position both countries well on the international stage. It would also have resolved the issues with the Medicines Act and the temporary exemption for therapeutic products under the Trans-Tasman Mutual Recognition Arrangement (which has now become a permanent exemption). Until 2007 a large amount of work was done to bring the ANZTPA initiative to fruition. Legislation was introduced in New Zealand (and released as an exposure draft in Australia) but could not be passed as there was a lack of political support. The lack of support largely reflected concern about the inclusion of complementary medicines within the scope of the joint scheme. (New Zealand has now developed a separate regime for these products in the form of the Natural Health Products Bill.) As a consequence the two governments put ANZTPA on hold. In 2011 the Prime Ministers of New Zealand and Australia recommitted to ANZTPA and work recommenced. A few years later, however, following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding, the Prime Ministers of Australia and New Zealand announced in November 2014 to cease efforts on this major project. Government expectations On 17 November 2014 Cabinet noted that the Minister of Health would signal the next steps to upgrade New Zealand’s regulation of therapeutic products. This involves “a new and comprehensive regulatory regime … which will replace the Medicines Act 1981 and its Regulations” [CAB Min (14) 36/22 refers]. A Therapeutic Products Bill to repeal and replace the Medicines Act 1981 has priority 6 on the Government’s Legislation Programme [CAB Min (15) 5/7 refers]. Objectives The new regime is being designed to meet the needs of the health and disability support sector now and into the future, and to give effect to Government’s expectations for regulatory systems (including international alignment or conformity as appropriate). More specifically, the regime is being designed to: meet expectations of risk management and assurance of safety result in efficient and cost effective regulation be flexible, durable, up-to-date, and easy to use ensure high-quality, robust and accountable decision-making foster sustainable regulatory capacity support New Zealand and economic objectives be trusted and respected support consumer access and individual responsibility for care. These objectives will require: an enabling legislative framework that can be readily maintained and updated regulatory requirements that are consistent with cost-effective risk management and accepted international practice a regulator with capacity, independence, flexibility, and accountability.
regulatory-impact-statement-therapeutic-products-regulation.doc.docx