June 27, 2019
Patients could bear the impact of changes to NZ medical device regulation system
Patients could bear the impact of proposed changes to New Zealand’s medical device regulation system for little benefit,
warns the Medical Technology Association of New Zealand
, the only national industry body representing medical technology companies in NZ.
“The proposed Therapeutic Products Bill and the ongoing centralised procurement process by PHARMAC could have the joint
effect of increasing costs of medical devices and procedures while potentially reducing choice for the clinician and
delaying access to life-saving, innovative medical technology,” says MTANZ CEO Faye Sumner, CNZM.
Ms Sumner says these topics will be extensively discussed at the MTANZ Health Tech Conference
in Auckland from July 2 to 3.
“Patients may be assured that medical devices used in New Zealand currently meet the highest quality standards both in
New Zealand and internationally.
“All devices entering NZ are currently notified to Government regulator, Medsafe, but this will become a more complex
registration process with associated cost, under the proposed NZ Therapeutic Products legislation replacing the
Medicines Act 1981,” says Ms Sumner.
“We are working closely with Medsafe in relation to new requirements and legislation to ensure that the 400,000 medical
devices being placed on the NZ market meet the highest international standards (ISO) for safety and performance.”
At the same time, PHARMAC is taking control of the procurement of medical devices supplied to the DHBs.
Ms Sumner says her industry believes the proposed PHARMAC cost-based procurement system is not best suited to the
procurement of medical devices.
“We propose a value-based procurement system that ensures clinicians have the autonomy and authority to acquire the
right device for the right procedure. It is about treating a patient with the best possible device rather than the
cheapest possible device.
“Our industry is very concerned at the multiplying effect of both significant changes being introduced in parallel and
the potential disruption to the supply chain which could lead to the reduced availability of medical device products in
the New Zealand market.
“Ultimately, the impact of both these changes will be felt by the patient.
“Our industry constantly strives to improve our technologies and care delivery. Medical devices are the foundation of
modern healthcare treatment, providing healthcare professionals the tools they rely on to improve patient care.”