Pharmac’s role in medical devices decided within a year

eHealthNews.nz: National Systems & Strategy

Pharmac’s role in medical devices decided within a year

Monday, 24 June 2024

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NEWS - eHealthNews.nz editor Rebecca McBeth

Contracting for medical devices will either be “all in or all out” of Pharmac within a year, says David Seymour, associate minister of health (Pharmac).

Speaking at the Medical Technology Association of NZ (MTANZ) Conference on June 24, Seymour said a decision was needed in order to give clarity to the sector.

He said the Government will provide that clarity within the next year about whether contracting for medical devices will sit with Pharmac, as currently some procurement is done by Pharmac and some by Health New Zealand Te Whatu Ora.

“I am pushing as hard as possible to get to a stage within a year where you are either all in on devices and doing it well, or you are all out,” he said.

Pharmac was given responsibility for managing hospital medical devices in 2012, however a review of the agency in 2022 found the agency was “ill-placed” to coordinate the complex medical devices supply chain.

The review recommended that cataloguing and contracting of devices move to Health NZ, however the previous government rejected this proposal, at least until after the Therapeutic Products Bill was enacted.

The Therapeutic Products Act (TPA), passed in 2023, introduced a new regulator and market authorisation regime for medical devices, including software as a medical device (SaMD).

The new government is now repealing the Act and consultation on replacement legislation will take place this year.

“It will be taken away before it ever comes into force, and that will lead us back to where the previous government started, with a considerable regulatory challenge,” Seymour said.

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He told attendees the government has not yet got it right both on the regulatory front and purchasing front, but said regulating devices and therapeutics is very challenging, because of the spectrum of things covered.

He told the conference that new regulation must be fit for purpose and ensure that the benefits of the regulation will exceed the costs.

“It is critical that we make sure that our regulatory environment does not overstep the mark” does not disaggregate us from the rest of the world,” he said.

Seymour also acknowledged that Pharmac needs to change.

“I am challenging them to change their culture: to go from being quite adversarial to seeing clinicians and vendors and patients as partners, where you can collaborate and work together towards a better outcome,” he said.

MP Todd Stephenson recognised the frustration of industry and providers in having to work through procurements for medical devices with two different agencies.

“We do not want providers having to go to different organisations to do the procurement, so it needs to be clear, but within a year's time, it is going to be one way or the other.”

He said the government is working on a new “appropriate regulatory framework”, but does not have that much time to put in place something to replace the TPA.

Stephenson talked about the importance of global harmonisation and the “rule of two” whereby if a drug has been approved by two jurisdictions that New Zealand recognises then it should be approved here within 30 days, and applying that also to devices.

“We cannot put unnecessary burdens on industry when they are getting their devices regulated,” Stephenson said.

He said Pharmac was set up more than 30 years ago when no one could have imagined the kinds of medical technologies available today, so the organisation needs to “evolve and adapt”.

The question remained over the role of Pharmac in procuring medical devices but the clear signal is that it could be the best place for these to sit.

Former National MP and chair of the Pharmac board Paula Bennett told the MTANZ audience that she brings change to the organisation.

She said there is a window of opportunity over the next 18 months to make a case for social investment in medical technologies that bring wider value to people’s lives, society and the economy.

“We have got social investment coming up and the means for us to show a model of where we can improve New Zealanders’ lives by getting access to medical devices and medicines earlier,” she told the conference.

Picture: David Seymour, associate minister of health (Pharmac)