New Zealand has pulled out of plans to set up with Australia a joint drugs regulatory agency after the government admitted that it had failed to get sufficient support in Parliament to proceed.
Legislation to establish the Australia/New Zealand Therapeutic Goods
Agency (ANZTPA) is being shelved because “the government does not
have the numbers in Parliament to put in place a sensible, acceptable
compromise that would satisfy all parties at this time,” said New
Zealand State Services Minister Annette King. The Australian
government had agreed that suspending negotiations on the joint
authority “is a sensible course of action,” she added.
Back in December 2003, the two nations signed their original
agreement to replace Australia’s Therapeutic Goods Administration
and the New Zealand Medicines and Medical Devices Safety
Authority (Medsafe) with a single agency to regulate therapeutic
products, including medical devices and prescription, over-the-
counter and complementary medicines, in both countries.
The new Agency was planned to be up and running in 2005, and then by
mid-2006, but it has been dogged by controversy because of the
inclusion of complementary medicines in its remit, as these products
are not currently scrutinised by Medsafe. A massive opposition
campaign in New Zealand claimed that, under the new agency, herbal
remedies, dietary supplements and other complementary products would
be regulated by “Australian-dominated legislation” and that the cost
of meeting the new regulations would lead to the disappearance of 60%
of all products from the market, with the prices of those remaining
having to rise unacceptably.
Government attacked for wasting time and money
New Zealand’s opposition parties have broadly welcomed the bill’s
shelving, but have sharply attacked the Labour government for wasting
time and money on it. “Labour never listened to the legitimate concerns the complementary medicines industry, and other political parties, had about this bill,” said New Zealand National Party health spokesman Tony Ryall, while Peter Dunne, head of United Future New Zealand added: “Why the government decided in the first place to go ahead with the legislation and gave commitments to Australia that it could pass such a bill before it did any checking that it would have the Parliamentary numbers has always been beyond me. United Future supported the Bill's introduction only to allow its consideration by a select committee, but we had made it clear to them as long ago as last August that we did not support the mandatory
inclusion of complementary health products and natural medicines.”
And Green Party spokeswoman Sue Kedgley said of the Minister: “Had
she listened to the Health Select Committee four years ago, instead
of crashing on regardless, she would have saved millions of dollars
of taxpayers’ money. Serious questions need to be asked about the
huge waste of resources that has gone into pursuing this piece of
legislation. The Government has already spent at least seven million
dollars of taxpayers money on the agency.”
However, New Zealand’s Researched Medicines Industry Association
condemned “the intense, misleading and emotive lobbying” and “Third
World politicking” about complementaries which, it said, had ignored
the needs of seriously ill New Zealanders who need prescription
medicines.
“Do you know what you’ve done?” RMI chair Pippa MacKay asked Members
of Parliament. Medsafe “does not have the capacity to process
applications to register new medicines within a reasonable timeframe.
It currently takes an average of three years for a medicine to be
evaluated - more than twice as long as in Australia,” said Dr MacKay,
adding: “This unacceptable delay, along with last year's 800%
increase in fees, has meant that there have been only four
applications for the registration of new medicines since August last
year.”
NZ-ers 'missing out on new medicines'
The bill would have resolved existing medicines registration problems, but New Zealanders now risk missing out on new medicines available in the rest of the developed world, warned Dr MacKay. "It is a shame that those same people demand that food be regulated for safety reasons, yet somehow naively expect that the labels on complementary medicines
from unknown sources should be believed. The needs and interests of
the majority have been overridden by a tiny self-interested minority,” she added.
Medsafe’s official statements on the ANZTPA had acknowledged that New
Zealand's current regulatory framework for therapeutic products is
outdated and out of line with international best practice and that
its regulatory capacity is not sustainable even in the short-to mid-
term. “Establishing a new Authority with Australia has advantages for
both countries in terms of efficiency, making the most of scarce
technical expertise, sharing resources and reducing overall costs,”
it said.
