Reform aims to move novel products through quicker

A new team focused on assessing novel animal and plant health products will be established by year’s end, marking what one senior regulator says is a milestone in speeding up the flow of innovation into the primary sector.

Vincent Arbuckle, Deputy Director-General of New Zealand Food Safety, says the Ministry for Primary Industries (MPI) is recruiting four specialist assessors who will work only on novel and new product applications, creating a separate pathway outside the existing queue.

The move follows months of discussion over whether new products could simply be prioritised within the current system.

"We've been working with the sector on this question of how to prioritise novel products," he told the recent Animal and Plant Health (APHANZ) conference during a panel session.

"We had hoped that we could find an agreement to prioritise them and some methodology, but it's understandable why we could not get agreement on that."

The challenge was that every applicant wants a faster pathway when it benefits their own product, but few support a system that pushes their application further down the line.

After spending much of the past year workshopping alternatives with industry, MPI concluded the better option was to establish a dedicated channel for new products rather than attempt to reorder the queue.

"These are complex cases that require really deep technical ability."

The new assessment channel will be underwritten by the Crown if fee revenue does not cover its costs, allowing the unit to focus on moving innovative products through the system.

Eighteen months after the government’s Agricultural and Horticultural Products Regulatory Review, Arbuckle says suppliers can be confident progress is being made.

But he is careful not to overstate what the industry should expect in the immediate future.

"I acknowledge fully that at the moment, from an individual company's perspective, you will not yet see change," he says.

Reducing approval times will not come from simply putting more pressure on staff.

"We cannot achieve queue reduction just by whipping the team harder. You've actually got to redesign the work, the way the work is done and what work is done."

The new assessment team sits alongside several other changes designed to speed up access to products, including proposed amendments to the Agricultural Compounds and Veterinary Medicine (ACVM) Act, greater sharing of assessment work with Australia's regulator, and expanded self-assessment pathways for lower-risk product changes.

Arbuckle also points to practical improvements that could come from industry itself.

One of the biggest challenges for MPI is that product applications often arrive without warning, making it difficult to plan appropriate assessment resources.

"One of the things that would help us, from industry, would signalling of incoming and likely incoming applications by type," he said. "At the moment they just turn up."

He also says application quality varies significantly.

"There are some very slick companies that produce beautiful applications, simple and easy to deal with. That’s not always the case. So better preparation makes a big difference."

While there is strong pressure to speed up approvals, Arbuckle stresses the importance of maintaining New Zealand's reputation in export markets.

"Our trading partners are testing our products every day," he said. "What I don't want is a product that we approve or have rushed through suddenly pinged overseas and it puts into question $64 billion worth of exports."

He says regulators must find the balance between efficiency and protecting the integrity of New Zealand exports.

One positive development to emerge from industry pressure has been closer cooperation between regulators.

Concerns raised by industry have changed the way regulatory agencies work together.

"In the past, I had no contact with the Environmental Protection Agency," he said. "Suddenly, I was having regular meetings with the committee and with the chair. We've set the up the Sector Leaders Forum. So we're much more joined up as regulators."

He also credits APHANZ for helping maintain momentum and accountability.

But the drive for reform is no longer simply a response to criticism.

"We're aligned with this. It's not like this is being done to us," he said. "We actually align with the need for improvement."

And even if external pressure faded, he added, "we would still do this. We want to do it."

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