Australia and New Zealand to form Joint Body for Regulating Therapeutic Goods
Tuesday 15th November 2011
Australia and New Zealand are to join forces to form the Australia New Zealand Therapeutic Products Agency (ANZTPA), which will regulate medicines, medical devices and medical interventions (such as cellular therapy). The new Trans-Tasman agency should provide greater health benefits for consumers, reduce regulatory costs for industry and improve efficiency for both governments.
Currently medicines and medical devices are regulated in New Zealand by Medsafe and by the Therapeutic Goods Agency (TGA) in Australia. In Australia, the TGA must approve medicines and medical devices sold in Australia. In New Zealand, however, Medsafe must only be notified of new medical devices going on sale: medical devices are not subject to a full approval process as in Australia. Once the ANZTPA is established, full approval will be required for medical devices in New Zealand as well as Australia.
In 2003, a treaty was signed by the Australian and New Zealand governments which envisaged a common regulatory framework for all therapeutic goods. However, the joint scheme did not proceed because New Zealand was not able to pass the required legislation. In June 2011, Prime Ministers John Key and Julia Gillard announced that the joint scheme would now proceed, although New Zealand will establish its own system for the regulation of natural health products.
In July 2011, Medsafe and the TGA began sharing resources, expertise and information in the first step of a five-year, three-stage plan to establish the ANZTPA. Products will still need to meet the regulations of each country until a common regulatory scheme is put in place. To this end, the Medicines Amendment Bill was introduced into Parliament on 13 October 2011.
The Bill removes strict and detailed approval requirements from the Medicines Act 1981 and allows new requirements to be prescribed by the Medicines Regulations 1984. While this allows for greater flexibility in updating approval requirements, there are concerns regarding lack of consultation with the public and industry, and that standards of approval will be dictated from across the Tasman – the ANZTPA will be based in Canberra.
The first reading of the Bill will have to wait until the next Parliament is in session in 2012, assuming it is amongst those bills carried over by the incoming government after the election.
This article was written by Claire McInnes. Claire is a patent attorney based in our Wellington office.