Problems with access to medicines without ANZPTA

RMI Media Release

28 March 2007

Problems with access to medicines if ANZPTA is not agreed to.

A Parliamentary Select Committee was told today that New Zealanders need to be confident that all therapeutic products on the market are safe to use, are of good quality and do what they say they will do.

“New Zealanders need to be protected from the inappropriate use of potentially harmful substances and they need to be protected against the harm caused by products that don’t work,” Dr Pippa MacKay, the chair of the Researched Medicines Industry Association (RMI) said.

The RMI strongly supports the establishment of the proposed New Zealand Australia Therapeutic Products Authority (ANZTPA) that will ensure an appropriate level of regulation, relative to the level of risk. This will mean consumers can have confidence in all therapeutic products on the market in New Zealand.

The RMI Chief Executive, Lesley Clarke, told the committee that Government needs to consider what will happen if ANZTPA does not proceed. “The current New Zealand regulator is not delivering. Evaluation of new prescription medicines takes too long, three or more years, compared with only 15 months in Australia.

“Putting more money into Medsafe will not necessarily resolve the situation as there will still be challenges in meeting capacity and expertise requirements. Further, the cost of propping up Medsafe will be borne by industry.”

“The New Zealand market is so small that high evaluation fees, plus the long wait for a one-in-four chance of funding by PHARMAC may mean many pharmaceuticals will simply not be offered to the New Zealand market, and therefore will not be available to the patients who need them” Lesley Clarke told the committee.

“Access to medicines is important and regulatory approval is the first step in the process. The current system isn’t working, doing nothing is not an option and if the joint agency does not proceed - what is Plan B?” She asked the committee.

ENDS

© Scoop Media