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Agreement between the Government of New Zealand and the Government of Australia for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products
Treaty Type:
Bilateral/Plurilateral
Common Name:
ANZTPA
Responsible Department:
Health
Administering Department:
Treaty Summary:
This agreement provides for the establishment of a joint therapeutic products regulatory authority and regulatory scheme for prescription and non-prescription medicines, complementary medicines, medical devices, blood and tissue/cellular products. The authority would be responsible for ensuring the quality, safety, efficacy and timely availability of therapeutic products manufactured or supplied in Australia and/or New Zealand or exported from Australia or New Zealand to a third country.
The primary objective of the Parties in concluding this agreement was to safeguard public health and safety in Australia and New Zealand by establishing and maintaining a joint scheme consistent with international best practice for the regulation of the quality, safety, and efficacy or performance of therapeutic products, and of their manufacture, supply, import, export and promotion.
The other objectives of the Parties in concluding this agreement are:
- to establish a world-class regulatory authority to be responsible for the effective and efficient administration of the scheme and to be accountable to both Parties;
- to establish a Ministerial Council to oversee the implementation of the scheme and the operation of the Authority and to perform certain functions to give effect to the scheme; and
- to avoid barriers to trade except where such barriers are necessary to safeguard public health or safety, or to fulfil other legitimate objectives consistent with the Parties’ international obligations.
NZ Adherence Status:
In Progress
Negotiation Status:
Bilateral. The treaty was signed on 10 December 2003 and presented to the House on 30 March 2004. The treaty was referred to the Health Committee for the Parliamentary treaty examination process. The Health Committee issued its report on the treaty examination on 18 June 2004. The Government response to the report of the Health Committee was tabled in Parliament on 14 September 2004. The treaty can be ratified once legislation is passed. Negotiations on this treaty are currently on hold.
Organisation:
Is Signed By NZ:
Yes
Signature Date:
10/12/2003
Ratified or Signed:
No
Requires Ratification:
Yes
NZ Territorial Applications:
None
Information about required Legislation:
The Therapeutic Products Bill was introduced in December 2006 and referred to the Government Administration Committee. On 16 July 2007, the then State Services Minister Annette King announced the postponement of negotiations with Australia. The legislation remains on the Parliamentary Order Paper.
On 20 June 2011 the Prime Ministers of New Zealand and Australia announced that the New Zealand and Australian Governments had agreed to proceed with a joint scheme for the regulation of therapeutic goods (for example, medicines, medical devices, and biologicals). New Zealand is introducing a separate scheme to regulate natural health products in the New Zealand Market.
A three-phase and staged approach over a period of up to five years will be adopted to progressively achieve the establishment of ANZTPA.
Impacts on Maori:
The preparation and supply of medicine by practitioners, such as Chinese medicine practitioners and traditional Māori healers, will not be subject to regulation under the joint scheme. The proposed scheme has been the subject of consultation with stakeholders. A discussion paper was released to stakeholders, including Māori interest groups in June 2002 and 1600 submissions were received in New Zealand.
Impacts on Stakeholders:
A series of consultations with pharmaceutical, medical device and complementary medicine stakeholders and with other interested parties including consumer groups was also held in 2001. Consultation took place throughout 2006 and 2007.
Link To Legislation:
Treaty Text Link:
Contact Information:
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