Questions & answers about consultation and governance and accountability arrangements
October 2006
What is the legal standing of the Agreement or Treaty?
The Agreement or Treaty, which was signed between New Zealand and Australia in December 2003, gave a commitment that both countries would proceed with the work to set up a joint Authority and regulatory scheme. The Treaty sets out the accountability and management structures which guarantee each country an equal voice in the development and running of the new regulatory scheme. In signing the Treaty, New Zealand and Australia have committed to the development of the legislation needed to implement the new scheme. The Treaty will not be ratified until the implementing legislation is passed into law in both countries.
Was the Agreement or Treaty entered into without consultation?
A consultative approach has occurred and continues to occur at every stage in the development of the new scheme, with stakeholders being given every opportunity to provide comment and feedback on the proposals. The Treaty is the result of years of collaboration between the Therapeutic Goods Administration and Medsafe and extensive consultation with stakeholders in both countries. In 2003, the Governments of Australia and New Zealand made the decision to proceed with the Authority and signalled their commitment through the signing of the Treaty.
Consultation on establishing a trans Tasman therapeutic products authority, including consultation with Māori, started in 2002 and is continuing. There has, and will continue to be, consultation with Māori stakeholders as part of the overall consultation undertaken as part of the development of the new scheme. A hui was held in Rotorua on 10 July 2006 with Māori traditional healers and those with a special interest in the traditional medical system, Rongoa Māori. The hui aimed to provide information about the proposed regulatory scheme for prescription and over-the-counter medicines, complementary medicines and medical devices.
Who will be the members of the Ministerial Council?
The Authority will be overseen by a two-member Ministerial Council comprising the New Zealand Minister of Health and the Australian Health Minister. Each Minister will have an equal voice in the running of the Authority.
What happens if there is a delay with the legislation in one or other country?
The Authority will not be established until the implementing legislation has been passed in both countries. There will be two separate but closely aligned Bills introduced into the New Zealand and Australian Parliaments to implement the scheme. The Bills are required to bring the Treaty into force, to establish the Authority and to allow the regulatory arrangements to be made.
What is the timeframe for establishing the new scheme?
Late 2007 is the target date for when the Authority is expected to go live, however, this is subject to the passage of legislation in both countries.
URL: http://www.anztpa.org/about/qaarrange.htm