New regulations risk breaking a health system already at breaking point

Cushla Smyth is CEO of the Medical Technology Association.

OPINION: New Zealanders better get ready to wait a whole lot longer for a decent chance at accessing lifesaving medical technology, if additional changes aren’t made to the Therapeutic Products Bill before it passes into law.

As the CEO of MTANZ, the Medical Technology Association of New Zealand, I support the health reforms in Aotearoa New Zealand. Widespread change was needed to increase access to quality healthcare. Reducing the number of district health boards was a sensible step in the right direction.

We know how incredibly important it is to work collaboratively, to ensure patients have access to the best possible treatment in a timely and efficient manner.

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So, it makes no sense that industry concerns over the Therapeutic Products Bill have largely been ignored.

In particular, MTANZ made a recommendation to the government to change the legislation to avoid the medical device supply issues currently being experienced in Europe after changes to the EU regulatory system.

The bill, as it currently stands, throws out years of progress, and collaboration across comparable countries, that has meant New Zealanders have had timely access to medical devices.

What’s more, the government has shown a willingness to make changes to the bill to address rongoā Māori and natural health products, which should be extended to medical devices.

Over 60,000 medical devices are registered on the Australian Register of Therapeutic Goods, varying from latex gloves to high tech robotics. They have, until now, been deemed as safe to use in New Zealand because of this registration.

This has been the case for over 20 years. Under the new legislation, all products used in New Zealand will need to be assessed and approved by the new regulator regardless of stringent overseas approval.

Access to these medical devices is critical to maintain a world-class health system and ensure New Zealanders in need can get on with their lives post-treatment.

Yet despite these facts, the Therapeutic Products Bill in its current form, will require a new regulator to assess hundreds of thousands of medical devices already safely in use New Zealand, before being used in New Zealand. Currently, little clarification is offered about how, and when, that regulator will achieve this.

The ‘transitional framework’ proposed by the bill provides sponsors of medical devices a 2-to-5-year period in which to obtain market authorisation for their products.

That market authorisation is wholly dependent on the new regulator being resourced with the skills, capability and capacity to assess the applications in a timely way: hardly setting the regulator up for success. Rather, the task seems almost impossible when applications will number hundreds of thousands.

So why, when the health reforms are beginning to show some benefit, would these serious industry concerns be ignored?

Why, when the health system is at breaking point with staff shortages and burnout, would further burden be placed upon the system.

As an industry leader, I call on the government to take industry concerns into serious consideration so that patients in Aotearoa New Zealand can have confidence in the health system – provide automatic approval to products that already have an authority from trusted overseas regulators.

I’ll end this where I began.

Which is to say that, without additional change to the Therapeutic Products Bill, New Zealanders better get ready to wait a whole lot longer to access medical innovation.

Because, quite frankly, the government have ignored industry concerns and the regulatory overreach is about to make things a whole lot harder than they have to be.