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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:
(i) 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;
(ii) 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
(iii) 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.
Lead agency:
Ministry of Health
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.
Website:
Australia New Zealand Therapeutic Products Authority more [external link]
Particular interest to Maori and other groups:
The preparation and supply of medicine by practitioners, such as Chinese medicine practitioners and traditional Maori 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 Maori interest groups in June 2002 and 1600 submissions were received in New Zealand. 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.
Legislation required:
Yes. 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 and the New Zealand and Australian Governments have expressed their shared commitment to strengthening Trans-Tasman economic integration through a range of initiatives. In that context, they signalled that work would be done on therapeutic product standards between the two countries.
Contact:
Susan Martindale
Team Leader
Business Development and Support
Medsafe
Ministry of Health
susan.martindale@moh.govt.nz
Ph (04) 496 2092
Fax (04) 496 2229
New Zealand is a party to the FCTC. A protocol to the FCTC is under development. This protocol relates to the illicit trade of tobacco products and negotiations commenced February 2008.
Lead agency:
Ministry of Health
Status:
Multilateral. New Zealand is a party to the FCTC and has been fully compliant with the binding obligations since pictorial warnings on tobacco packages came into effect in February 2008.
Two Intergovernmental Negotiating Body (INB) sessions have occurred to discuss the elaboration of a protocol on illicit trade. The Second Conference of the Parties of the FCTC held in Bangkok 30 June – 6 July 2007 agreed to establish an INB to commence elaboration of a protocol on illicit trade. The INB met first in February 2008 and then in October 2008 where it considered a ‘Chairs text’.
The third session of the INB is scheduled to be held in Geneva from 28 June to 5 July 2009.
Website:
WHO Framework Convention on Tobacco Control more [external link]
Particular interest to Maori and other groups:
Maori smoking rates are much higher than those of other ethnic groups, and smoking is a significant contributor to Maori/non-Maori health inequalities. Maori are a priority group for tobacco control initiatives, including smoking cessation services International efforts to reduce access to and use of tobacco will assist New Zealand to reduce its smoking rates. New Zealand hosted a workshop on tobacco and indigenous people in October 2007. Tobacco Control NGOs, including New Zealand-based ones, played an important role in the negotiation of the FCTC, and continue to do so in monitoring its implementation.
Legislation required:
Possibly, this will depend on the requirements of the final text and also whether New Zealand decides to ratify the protocol.
Contact:
Dr Ashley Bloomfield
Chief Advisor
Public Health Directorate
Ministry of Health
Ph (04) 816 3938
Fax (04) 816 2191
