Hon Annette King

Minister of Health, Minister for Racing

5 July 2001 Speech Notes

Address to the New Zealand Medical Industry Association

Good afternoon and a particular hello to our friends from Australia joining us today. I won't make any jokes about rugby, because you will be hearing plenty of those while you are here. In respect of another code, however, one thing I will say is that if Alfie Langer were a medical device, I'd patent him tomorrow.

Thank you for your invitation to speak with you today. In fact, I think I invited myself when I called on Faye a few weeks ago.

I always enjoy getting out of my Wellington office and having face-to-face contact with as many people in the sector as I can. I find it very useful being able to exchange ideas and find out about the latest developments in each area of expertise.

I know you want me to talk to you a little about the concept of District Health Boards, and I will do so, but I also want to take time to talk about the establishment of a register for medical devices and equipment. I am sure this is of even more interest to everyone here today.

I want to begin by saying that I have enjoyed working with your Association on the concept of a register and also wish to acknowledge your industry’s constructive role in the recent consultative paper. The Association has been tireless in its support for a register and I hope you are looking forward to this vision coming to fruition.

It is refreshing to be involved in a major change supported by the people it affects most. This is a rare event in politics and makes my job a lot easier because it means I don’t have to use time and resources to try to persuade everyone to come on board.

I am advised that Medsafe has also valued the good working relationship with your organisation and looks forward to this continuing during the implementation phase. The continuing support and involvement of the industry will be crucial to the success of the register.

I strongly support the concept of a medical device register for several reasons. Firstly, it is consistent with international efforts at harmonisation. I am advised it will mirror the process used by the Australian Therapeutic and Goods Administration, which is in turn based on the essential principles model drawn from the work of the global harmonisation taskforce and European directives.

I also support the establishment of a register because of the additional safeguards it will provide. I am convinced a register will reduce the potential for complications and errors caused by substandard equipment. Just as importantly, it will provide reassurance for government and the public alike. It will enable people to have faith that medical devices and equipment are contributing to improving the health of all New Zealanders.

Faulty equipment or poorly maintained devices are directly responsible for very few adverse events. As you know, most medical mishaps are the result of a mix of procedural and systems failures, fatigue, poor judgement or simple bad luck.

However, medical devices and equipment are a relatively easily part of the jigsaw to improve and the consequences of things going wrong are very significant to the people and institutions concerned.

I am sure you are all aware of past instances where devices and equipment have been implicated in errors and patient recalls. These mishaps proved very expensive to the hospitals concerned. They involved up-front costs for investigating what had occurred and following-up with affected patients, and diverted resources from, and caused disruption to, other services. Most importantly these also undermined public trust in the system.

I am determined to do everything I can to reduce the chances of any repeats of these unfortunate experiences. I believe working in partnership with your industry on the development and establishment of a register has an important contribution to make toward this goal.

Errors and patient recalls are regrettable at any time, but even more so during a period of extreme pressure on health funding and eroding trust in the health system.

It is not surprising if events like the Gisborne inquiry and other recent issues undermine the public’s confidence in health professionals and the system as a whole. I am determined to ensure New Zealanders regain trust in their health system and all measures, no matter how small and seemingly insignificant, are vital to achieving this goal.

The same principles that are behind the establishment of a register are also driving a range of other government initiatives including the Health Professionals Competency Assurance Bill (HPCA bill) and Health and Disability Services (Safety) Bill (HDSS bill).

These bills also seek to establish a more flexible statutory framework focused on consumer safety and to provide greater consistency and transparency in place of the complexity and prescriptive approach of existing legislation.

The HPCA Bill will establish a new framework for registering authorities to decide on the detailed requirements for registration. The HDSS Bill will establish new rules for licensing and registration of hospitals, rest homes and residential disability care services.

I am aware that your association has supported similar goals for a number of years and that is one of the main reasons you have supported the concept of a register. I am also aware you are concerned about the costs associated with the establishment of a register.

The new system will unavoidably involve a small up-front registration fee. However, the Ministry of Health is determined to keep this as low as possible by basing it on a cost recovery basis.

This will be a small price to pay for public safety and the certainty created by the new system that will be in the long-term interests of the industry and the public.

The new system must also be based around a partnership between government and the industry, which acknowledges that improvements will stem from a combination of regulation and better product support.

I want to see the new register put in place alongside an increased emphasis on training and product support and follow-up.

The industry has a certain responsibility to assist providers to ensure their staff have the knowledge and expertise to correctly operate and maintain medical equipment. If this does not take place the potential of these devices will not be fully exploited and the associated health benefit will not be maximised.

Many of the recent mishaps involving medical equipment and devices may have been prevented with further training and better follow-up. This is even more important as devices and equipment become more complicated.

Having made a few remarks about the register I now want to move on to the changes the Government has made to the health and disability sector as a whole and how these are laying the groundwork for improvements to the health of all New Zealanders.

The changes are being driven by the need to provide both a credible and affordable public health system in response to the challenge of increases in the cost of healthcare.

There are many causes of this increase, demographic causes such as ageing populations, technological causes such as advances in surgical techniques and pharmaceuticals, and society's changing expectations in association with these trends.

This has significant consequences in a publicly-funded system like New Zealand's because it results in pressures for large increases in government spending.

The Government’s response has been to change the framework of the health system to make choices about prioritisation much clearer and to ensure spending decisions are made in a more transparent and strategic manner rather than behind the scenes in response to immediate circumstances.

The Government’s vision is based on a non-commercial, collaborative and accountable system that reduces health inequalities. This is to be achieved by:

- promoting a population health approach

- focusing public health funding on reducing inequalities

- improving coordination between different agencies

- empowering the community to adopt local solutions to local problems, and

- addressing the wider socio-economic issues impacting on health

Allowing for flexibility, innovation and integration of services is the primary way of reducing inequalities. In practical terms this means allowing community groups and other non-traditional providers a greater role in the system. If an organisation is shown to provide effective services, they should be encouraged rather than discouraged because they lack enough credentials on their letterhead.

The Government’s faith and trust in the resourcefulness of our community is also illustrated in the establishment of district health boards (DHBs). The DHBs are the principle means to introduce greater community involvement in health decision-making will ensure people can reclaim ownership of their health system for the first time in over a decade.

DHBs were introduced under the New Zealand Public Health and Disability Act late last year and came into formal existence on the 1st of January this year. A transitional phase will last until elections for DHB members in October. Seven members of each board will be elected by local voters to ensure local views are represented in deciding district health priorities.

Over time, we will be moving to a system of devolved funding to DHBs, on a population basis. This will mean a fairer allocation to regions, as it will ensure that the relative level of funding reflects the health needs of each DHB population. It will devolve decisions about health priorities to a local level.

The second major plank of the changes is the New Zealand Health Strategy that highlights thirteen population health objectives for the Ministry of Health and DHBs to focus on for action in the short and medium term. Toolkits and detailed action-orientated strategies for specific issues have been developed in conjunction with these objectives, and will be implemented through performance and funding agreements with DHBs and providers.

I want to again thank you for your invitation to speak today. I also reiterate my support for the concept of a register for medical devices and equipment and acknowledge your members’ support for this concept over several years.

Like all areas in the health and disability sector it is also important to acknowledge that Government cannot achieve things alone. Instead, the solutions lie in maintaining an effective working partnership with experts in the field.

There is every reason to expect this will occur because of the good working relationship that already exists between the Ministry and your organisation. I wish you well for your AGM and for your important work over the coming months.

ENDS

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