Higher Costs A Possibility With ANZTPA Regulations
E spicom View : The Medical Technology Association of New Zealand (MTANZ) has long been advocates of the proposed ANZTPA regulations, but has recently explicitly viewed its concerns about increased bureaucracy of the regulations in its current form and a possible rise in costs, which it intimates will ultimately be passed on to the customer or end-user. MTANZ represents a small but growing band of manufacturers that mainly specialise in niche, high-tech devices largely geared for export.
The Medical Technology Association of New Zealand (MTANZ) is not in favour of the Australia New Zealand Therapeutic Products Agency (ANZTPA) in its current proposed form, saying it could lead to increased healthcare costs and reduced access to innovative medical devices for consumers and health boards.
The MTANZ said whilst it supported the need for medical devices in New Zealand to meet internationally recognised standards for safety and performance, it did not support the potentially unlimited cost of running the new joint regulatory agency being fully funded by industry, and the agency duplicating pre-market approval or clearance, for what it views as no additional benefit.
"MTANZ has been advocating internationally for a globally harmonised regulatory system so that companies do not have to meet multiple, and potentially conflicting, requirements or have to re-register devices in each country," said MTANZ chief executive Faye Sumner said in a statement in November 2013.
"While there will undoubtedly be benefits for companies who operate across both markets, we have some concerns for our New Zealand manufacturers and NZ-owned domestic companies, and most especially for New Zealand consumers and taxpayers who will ultimately bear the increased costs of compliance. We are looking to the joint regulator to demonstrate significant cost and compliance efficiencies in the new regulatory scheme."
Currently, there are no compliance costs for offering a medical device for sale in New Zealand. Companies have to notify their devices with the Government's regulatory body, Medsafe, before placing the device on the local market. MTANZ proposes that the emphasis should be on improving post-market surveillance and utilising globally-accepted medical device market clearances to maintain public health and safety.
In a discussion document, ANZTPA - A Proposed Regulatory Framework For Medical Devices, released in November 2013, MTANZ has proposed five principles to guarantee timely access to safe medical technology while supporting industry innovation:
•A regulatory scheme based on international best practice
•A regulatory scheme that recognises third-party conformity assessment for all classes of medical devices
•A regulatory scheme with a fee structure that is limited to efficiency costs only and fairly reflects the market size
•A regulatory scheme that has a major focus on post-market vigilance and surveillance
•A regulatory scheme that fosters and supports innovation and does not severely lengthen time to market.
Ms Sumner said NZ-manufactured devices are already audited to recognised international standards to enter offshore markets and the MTANZ wants to be assured that the ANZTPA process will not subject them to further costs and time for no tangible benefit.
Overview Of The ANZTPA
In December 2003, the Australian and New Zealand governments signed a treaty to form a single therapeutic agency for the regulation of therapeutic products, including medical devices, OTC, prescription and complementary medicines. This was to be named the Australia New Zealand Therapeutic Products Authority (ANZTPA).
The bi-national agency was to replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). While the basic principles were easy to establish, the details of the proposed merger have proved complex, leading to more than one slip on the legislative timetable. Progress appeared to be made, however, with legislation being presented in New Zealand in December 2006, and in Australia in April 2007.
In June 2011, the Prime Ministers of Australia and New Zealand reaffirmed their commitment to the establishment of the ANZTPA to administer a joint regulatory scheme for therapeutic products. This reaffirmation acknowledged that the New Zealand Government will introduce a separate scheme to regulate certain natural health products in the New Zealand market.
The Prime Ministers have agreed that a three stage approach over a period of up to five years will be adopted to progressively achieve this goal by mid-2016. The three stages involve the two countries' regulators, the TGA and Medsafe.
In December 2013, the TGA and Medsafe announced they completed a series of joint projects that promises to deliver improved access to information about therapeutic products in both countries, as well as enhanced cooperation between the regulators ahead of the proposed ANZTPA.
The TGA and Medsafe have now commenced a further programme of harmonisation work that will be undertaken over the next two and a half years, which includes 14 activities across six regulatory areas. This new phase of joint work will progressively increase aspects of regulatory alignment between TGA and Medsafe that will facilitate business planning and align aspects of regulatory practice for the transition to ANZTPA. It will involve consultation with stakeholders as these activities are progressed.
For medical devices, the targets would be:
•The publication of guidance on the requirements for the submission and assessment of manufacturers' evidence on the TGA, Medsafe and ANZTPA websites, by December 2014.
•To identify the extent of product overlap in the Australian and New Zealand markets for medical devices in Class III and Active Implantable Medical Devices and the impacts for transition, by February 2015.
|New Zealand Medical Device Market, 2008-2018|
Market Set To Grow By Around 5% Per Annum To 2018
The New Zealand medical device market is expected to post steady, if unspectacular, growth in the next few years. As a highly-developed market, New Zealand cannot be expected to achieve the sort of growth rates seen elsewhere in the Asia/Pacific region, and it must be said that the government's longstanding tough approach to cost control will reduce the scope for growth too.
On the other hand, the market is currently growing faster than many other mature markets. BMI Espicom estimates the CAGR for 2013-2018 to be 4.8%. This will take the market to US$989.1mn by 2018, equal to US$208 per capita. The orthopaedic market is expected to be the best sector for growth, driven by the rising availability of new technologies and an ageing population.