By political reporter Melissa Clarke
More than a decade of work towards a trans-Tasman scheme to regulate medicines and other bio-medical products has been quietly scrapped by the Federal Government.
Although the medical sector had wanted a single regulatory system, it has not complained about the Australian and New Zealand governments walking away from the drawn-out negotiations.
Instead, the industry is hopeful Australia will adopt a system of accepting European or American certifications of medicines.
The cross-border negotiations to establish the Australia-New Zealand Therapeutic Products Agency (ANZTPA) had been ongoing since 1999.
Labor’s assistant health spokesman, Stephen Jones, said he could not understand why the Government had walked away from the work that had been done.
“In rejecting it, throwing things in the bin now, what you’re doing is wasting resources that have already been spent on it,” he said.
“A lot of good work had been done. It should have been a pretty simple matter to kick this one into touch.”
ANZTPA would have taken over the role of Australia’s Therapeutic Goods Administration (TGA) and its Kiwi counterpart, Medsafe.
Benefits not worth time, money already devoted
AusBiotech chief executive Anna Lavelle said the industry had backed the push for a joint regulatory agency.
“The idea of having harmonisation with New Zealand was a fine idea,” she said.
“But I think, as has been evidenced by the protracted negotiations, it’s not as straightforward as people had hoped.”
Dr Lavelle said the benefits were not worth the amount of time and money the TGA was devoting to the process.
“The TGA is very resource strapped and we would prefer them to be using their resources for their statutory remit, which is the regulatory process in Australia,” she said.
Health Minister Peter Dutton declined to comment.
His joint statement with New Zealand’s health minister did not outline why negotiations were abandoned, but said the TGA and Medsafe would continue to cooperate.
US, European certification may be accepted
Some in the sector say New Zealand was unhappy when the Australian Government announced it would conduct a review into medicines and medical devices.
That review will look at the possibility of accepting American or European certification of drugs and other products.
The pharmaceutical industry is keen to see that pursued, according to Medicines Australia chief executive Tim James.
“We do need to ask ourselves here in Australia, how much are we prepared to put faith or trust in overseas regulators?” he said.
“We would like to see a lot of faith and trust put in overseas regulators, but equally we’re not saying that we should submit fully to overseas regulators.”
Mr Jones thinks both approaches are possible.
“People point to the European system and say that closer alignment should be looked at between Australia and the Europeans, but I think we should be able to do both things at once,” he said.