FromFri, 25 June 2004
Hon Annette King - Speech to MIANZ Annual Conference: The benefits of a Trans-Tasman Therapeutic Products Joint Agency
MIANZ has been active in calling for stronger regulation of medical devices, and in particular a pre-market approval
mechanism, for many years. I am pleased that the Government has been able to respond to those calls by moving to
introduce a regulatory scheme that will bring New Zealand into line with the rest of the developed world.
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Thank you very much for inviting me to speak at your annual conference. I know you've been treated to a selection of
interesting, knowledgeable speakers already today so I hope I can uphold the high standards!
I am very pleased to be able to join you in your silver jubilee year as you celebrate the important contribution that
medical technology makes to the health of New Zealanders. As the saying goes, times change, and it is interesting to
reflect on the pace of change over the last quarter-century.
Twenty-five years ago we didn't have the technology to perform keyhole surgery, and a gall bladder operation required a
large surgical incision and a hospital stay of several days. In contrast, these days we take laparoscopic surgery using
sophisticated cameras and video monitors for granted. Such advances in surgical techniques have resulted in improved
outcomes and lower relative costs.
Significant advances have been made in medical technologies in the last 25 years too. From gene therapy to tissue
engineering and the application of nanotechnology in the prevention and treatment of disease, technological advances
have resulted in exciting improvements in the delivery of healthcare in the 21st Century. We have seen advances in
medical device technology, pharmaceuticals, surgical techniques and transplantation procedures make a considerable
contribution to improving the health status of New Zealanders.
As you may or may not know, in my former life I was a dental therapist so naturally dental healthcare has always been a
subject close to my heart. I'm sure many of you will remember those terrifying trips to the "murder house," but nowadays
there's no sign of the old dental clinic drill that used to instil such fear into everybody. It has been replaced by the
high-tech, high-speed, low-pain models we now take for granted. The development of dental restorative treatments that
look better and last longer is just one example of the impact of nanotechnology in dentistry.
While there is no doubt that the emergence of new technologies has provided clinicians and their patients with
significant advances in health care, the availability of these new technologies has also presented challenges. Yet it is
not a problem unique to New Zealand. Healthcare providers the world over struggle with the same issue: how to prioritise
in order to work within the constraints of limited funding?
I know Stephen McKernan has just talked to you about the challenges facing District Health Boards. In an era where
ever-increasing demands are being placed on New Zealand's healthcare resources, DHBs face the need to monitor current
demand and forecast future demand for technology as they make purchasing and management decisions.
Purchasers must weigh the benefits against the costs to determine where the taxpayer dollar will be most effectively
spent. Continual reassessment is needed to monitor the ongoing need for existing technologies and the emerging need for
new ones. This task is made easier and more efficient if reliable, unbiased information about product safety and quality
is readily accessible. This is one of the significant benefits that enhanced regulation of medical devices can deliver.
MIANZ has been active in calling for stronger regulation of medical devices, and in particular a pre-market approval
mechanism, for many years. I am pleased that the Government has been able to respond to those calls by moving to
introduce a regulatory scheme that will bring New Zealand into line with the rest of the developed world.
I share your concern about the potential for New Zealand to become a dumping ground for sub-standard products that would
not be acceptable in countries that have a modern regulatory system. I want to assure you that I am taking positive
action to address that concern.
Like you, I want to see a risk-based system of regulation that is based on a globally harmonised approach. We all want
to see a level playing field that keeps the cowboys out, but at the same time is adaptable and responsive to the
regulatory challenges created by innovations at the cutting edge of technology. That is what I expect to see delivered
through the joint regulatory scheme with Australia. As you know, the joint scheme will be based on the framework
recommended by the Global Harmonisation Taskforce, or GHTF.
For the health care provider, the benefits of a regulated medical device market will be significant. Currently New
Zealand is out of step with the rest of the developed world because, with the exception of a few specific product types,
there is no requirement for devices to meet minimum standards of safety, quality and performance and no pre-market
assessment of higher-risk products.
Furthermore, there is no comprehensive post-market monitoring system to detect product failures or adverse events. We
are only now, through the transitional WAND (Web-Assisted Notification of Devices) database, starting to compile a
product register that will ensure we have the information needed to efficiently and effectively manage the recall of
defective or unsafe products.
In this regulatory vacuum it has been necessary for our hospitals to perform a quasi-regulatory role by self-checking
the safety and performance credentials of products offered for supply. Once the joint scheme is operative, it will be
possible for purchasers to rely on the regulatory approval as an assurance that the product meets the required safety
and performance standard as they do now with pharmaceuticals.
The proposed regulatory scheme, consistent with the GHTF framework, will be based on a set of essential principles
relating to quality, safety and performance, vigilance requirements and the use of international standards. The new
regulations are based on the manufacturers' "intended use" of the medical device and allow for new technologies.
This globally harmonised approach to regulation will allow New Zealand manufacturers and healthcare providers to keep
pace with international best practice and maintain a reputation for the production and use of high quality medical
devices.
It will also provide a platform to enable New Zealand and Australia to enter into mutual recognition arrangements that
help to minimise regulatory costs by avoiding unnecessary duplication of work.
I know Stewart Jessamine has already discussed this with you in his presentation earlier today.
On a positive note, I want to focus now on the benefits of joining forces with Australia to create a world first - a
joint regulatory scheme and joint agency to administer both pre-market and post-market regulatory requirements for
therapeutic products.
The main benefits of this scheme will be the assurance to both industry and consumers, through the pre-market approval
system, that medical devices on the market meet standards consistent with international best practice. Both industry and
healthcare providers will also benefit from the post-marketing surveillance system, which will give greater assurance
regarding the safety and quality of medical devices in use.
The creation of a comprehensive product register of medical devices will also mean that recall of defective products can
be carried out more safely and efficiently.
In creating a single market for products the joint regulatory scheme will facilitate trade, both in the trans-Tasman
context and in the wider international arena. It will also strengthen the capacity to meet the challenges of regulating
the new wave of innovative technologies - capacity that would be very difficult to build and maintain for New Zealand
alone. The flow-on effect of that increased capacity will be more rapid access to new products.
>From day to day I hear and see a lot of misinformed comment about the joint agency and how it will work in practice.
My political opponents talk of an Australian take-over and of an unaccountable regulator.
I want to stress that those assertions are far from the truth. These same detractors say we should not form a
partnership with Australia but instead go it alone, ignoring the fact that this would impose higher costs on industry.
I want to explain why I am absolutely confident that we are entering into a joint partnership arrangement, not a
take-over. Firstly, in terms of the superstructure of the agency - the Ministerial Council and the Board - New Zealand
and Australia have an equal voice. There are only two Ministers on the Council -- myself and the Australian Federal
Minister for Health and Ageing. It's a 50-50 arrangement.
The five members of the board are appointed on the agreement of both Ministers on the Council. These matters and the
role of the Board are all spelt out in the treaty, and can only be changed by agreement of both Governments. The whole
scheme has been very carefully designed to ensure that in respect of all material matters, neither country can
unilaterally influence its operation. Hence the decision to create a trans-Tasman instrument called Ministerial Council
Rules.
These rules will spell out the detail of the scheme -- not only in relation to how medicines and medical devices will be
regulated, but also the detail of accountability and governance matters.
This approach guarantees us an equal voice in setting the rules. It also ensures that a common rule book will continue
to apply over time by guarding against the divergence that might be expected to occur if such detail was in the
implementing bills that have to progress through both Parliaments.
Of course Parliamentary oversight is still retained because the Ministerial Council Rules will be subject to
disallowance by either Parliament, and if this happens they will be disallowed in both countries.
A guiding principle in the design of the scheme has been that the agency should be no less accountable than comparable
organisations are at present in New Zealand and Australia. This means, for example, that the agency will be required to
table an annual report in both Parliaments, and that decisions will be subject to merits review and to judicial review.
Both the Official Information Act and the Australian Freedom of Information Act will apply to the Agency, meaning
individuals may request information under either statute. The Auditor-General and the Ombudsman will have oversight of
the agency; the so-called "Whistle-blowers Act" will apply; and the list goes on and on.
Another common misconception about the Agency is that its staff will be Australian public servants. I can tell you this
is not so! Employment arrangements for staff will be set out in Ministerial Council Rules. Obviously it would be
inappropriate for agency staff to be either New Zealand or Australian public servants since they will be serving
stakeholders in both countries. There will be a fully functional office in Wellington. Medical device companies will be
able to interact with Agency staff in New Zealand when they need advice or regulatory action. In the lead-up to
implementation, Medsafe will be taking steps to build capacity and expertise in device regulation so the Wellington
office can handle industry queries from day one.
My expectations of the joint agency are quite simple. It must administer a world-class regulatory scheme to protect
public safety. It must do so professionally, transparently and cost-effectively and be accountable to the Parliaments,
industry and public of both Australia and New Zealand.
In my role as a member of the Interim Ministerial Council I will be working hard with my fellow Council member,
Australian Minister Trish Worth, during the implementation phase to make the decisions that are needed to set that
course.
After discussions with MIANZ leadership today, I have asked the Ministry of Health to establish a working group of
officials and representatives of the association to work through details as it affects the medical devices industry in
the joint regulator.
Thank you again for the chance to address your conference. I hope it proves to be a thought-provoking day.
ENDS