Australia, NZ Ditch Proposed Joint Therapeutic Products Agency

A proposed Joint Therapeutic Products Agency between Australia and New Zealand has been ditched by both governments.

Peter Dutton and Jonathan Coleman, ministers of health of Australia and New Zealand, respectively, said the Australia New Zealand Therapeutic Products Agency, or ANZTPA, will no longer push through because a cost-benefit analysis had shown the merger will be impractical for both countries. The ANZTPA was greenlighted in 2011 and was expected to replace by 2016 Australia's Therapeutic Products Agency and New Zealand's Medsafe.

Despite the discontinuation, the two countries vowed to "continue to cooperate on the regulation of therapeutic products where there are benefits for consumers, businesses and regulators." In a factsheet, the ANZTPA has been described as an agency that will "safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries."

Had it pushed through, the ANZTPA will be the one to regulate complementary medicines, over-the-counter medicines, prescription medicines, medical devices, blood and blood products, tissues and cellular therapies. A single trans-Tasman regulatory system would have provided not only health benefits for consumers, but also reduced regulatory costs for industry and greater efficiency for governments.

The agreement for the creation of the ANZTPA was first reached in 2003. But reviews and assessments continued to hamper its progress. New Zealand was unable to pass enabling legislation. Then in 2007, negotiations between the countries were suspended. Funding for ANZTPA will initially be shouldered by both countries. Over time, the cost of regulation will be integrated into the cost recovery arrangements with the industry.

With the discontinuation, Australia's Therapeutic Goods Administration and New Zealand's Medicines and Medical Devices Safety Authority will continue to carry out trans-Tasman regulatory harmonization efforts. "Each country will now proceed with its own domestic therapeutics regulatory reform program but they remain open to future cooperation activities," portal pharmaletter.com said.

"New Zealand and Australia will continue to cooperate in areas which will deliver mutual benefits to consumers, businesses and regulators - including developing a new information sharing arrangement, and formalising mutual recognition of good manufacturing practice audits," the New Zealand government said in a statement.