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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:
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 [external link]
Particular interest to Māori and other groups:
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. 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 NewZealand 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
Principal Advisor Regulation
Regulatory Analysis & Delivery
Medsafe
Ministry of Health
Email: susan.martindale@moh.govt.nz
Ph: (04) 819 6892
Fax: (04) 819 6806
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. NewZealand 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.The Second Conference of the Parties (COP) 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.
Four Intergovernmental Negotiating Body (INB) sessions have occurred to discuss the elaboration of a protocol on illicit trade in tobacco. The INB held its first session in Geneva in February 2008, followed by its second session in October 2008. The third session of the INB took place in June 2009 and the fourth in March 2010.
The COP reviewed the progress made at its fourth session in Uruguay in 2010. The Conference decided that negotiations on a protocol should continue at a final session of the INB to be held in 2012, and that an informal working group, composed of, representatives of regional groups of parties, will work in 2011 to facilitate negotiations at the final session of the INB.
Website:
WHO Framework Convention on Tobacco Control [external link]
Particular interest to Māori and other groups:
Māori smoking rates are much higher than those of other ethnic groups, and smoking is a significant contributor to Māori/non-Māori health inequalities. Māori 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 2006. 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:
Brendon Baker
Senior Policy Analyst
Sector Capability and Implemetation Directorate
Ministry of Health
Email: brendon_baker@moh.govt.nz
Ph: (04) 816 3930
Fax: (04) 816 2191
