A duty to have regard to something is not a duty to use it. It can be satisfied by reading the overseas assessment, noting it, and then doing the local assessment much as before.
It is not the first time that promises of greater reliance on overseas regulators have been watered down in legislation. But as the pace of innovation abroad accelerates, it will be harder to keep up without relying on others’ work.
Regulatory regimes charged with making sure new products are safe need to balance two types of risk.
The first is obvious. If a regulator certifies as safe something that isn’t, people who trust in that certification will be harmed. The second is less obvious but just as important. If a regulator spends too much time assessing a new product, delays in accessing safe products will also harm people.
Changes in regulatory processes typically mean getting more of one kind of harm in exchange for less of the other. Ideally, they would move toward having just the right amount of stringency, where either loosening or tightening the rules would be a bad idea.
There is a way of avoiding that trade-off, if an agency could somehow just become better at assessing new products. That kind of efficiency improvement is difficult but not impossible to achieve.
New Zealand has just over five million people. The EU has about 450 million. The US has 340 million. Japan has 120 million. The UK, South Korea, Canada, and Australia all have tens of millions more people than we do, and all have regulators who assess the same sorts of things that our regulators assess.
A country of five million people that ignored the assessments of overseas regulators would almost inevitably do a worse job of things. It could not marshal the required expertise. Its regulators would take longer to come up with an answer and would be less likely to provide the right answer.
Rather than deciding which products are safe, New Zealand could decide which overseas regulators are safe. New Zealand regulators could be instructed to rely on the assessments of trusted overseas regulators unless an identified New Zealand-specific risk justified a different treatment. Our regulators could then focus on things that other countries’ regulators might not have checked, rather than duplicating work already done elsewhere.
New Zealand’s regulators are not fans of that kind of approach. Or, at least, the regulatory system has struggled to turn it into legislation that reflects initial intent.
The incoming Coalition government promised automatic approval of medicines authorised by at least two other trusted regulators. The legislation that resulted might allow faster processing of some medicines approved abroad, if anyone were willing to put those medicines through Medsafe’s faster-track approval process. If pharmaceutical companies do not apply to the new fast-track, it will not help. And it cannot help in any future pandemic, as emergency-use medicines are not allowed to use this pathway.
The same thing seems to be happening again with agricultural and horticultural products.
Those products were, perhaps surprisingly, always going to be a bit trickier than medicines for people. A person’s a person, no matter where from. So, a medicine safe and effective in Canada will almost certainly also be safe and effective here, so long as it is imported safely. So will medicines and vaccines for companion animals like domestic dogs and cats.
But some agricultural and horticultural products approved by regulators New Zealand might trust may not fit EU residue limits or import requirements. Even trace residues can matter if they jeopardise market access. Canterbury’s thin alluvial soils combined with high water tables bring different risks for some agricultural chemicals than thick soils over deep aquifers. Any reasonable reliance regime would have to account for those differences.
But let’s look at where things started and how they’re now going.
In June 2024, Hon Penny Simmonds, Hon David Seymour and Hon Andrew Hoggard issued a press release welcoming a Ministry for Regulation review on the approval processes for those products. They noted it can take nine years and “wrangling government agencies” for approval.
By September 2024, the releases shifted in tone slightly. Risks to overseas market access started being noted.
That kind of risk could be handled in a regulatory reliance regime. New Zealand’s regulators could be required to consider approvals by trusted overseas regulators. They could also be allowed to reject or restrict products that had risks specific to New Zealand, or that imposed risks to export-market access including residue limits, phytosanitary requirements, or importing-country conditions.
The Ministry for Regulation encouraged this kind of approach. Its eventual report suggested reliance on overseas approval, but maintaining a watch for locally specific risks. They wrote, “This recommendation could improve efficiency and proportionality by focusing resource on risks of most relevance to New Zealand.”
To put it another way, a country of five million does not need to have its regulators reassess all the information already assessed by other countries’ regulators. But it does need to watch for any risks that are particularly important here and that wouldn’t have the same importance elsewhere.
The Ministry’s report also noted the previous Labour government also tried to bring in greater reliance on international regulators’ assessments for these products. But watering-down during legislative drafting resulted in no clear way of even using information from overseas regulators in most cases.
In February 2025, Cabinet accepted the recommendation to use “international regulators’ assessments to save time.” The press release cited expected benefits of $272 million over 20 years from a halving of approval times.
The May 2025 Cabinet work said the coming new regime would enable recognition of international regulator assessments and would “require the Director-General [of the Ministry for Primary Industries] to use an appropriate, available recognised international regulator assessment” when considering products. And tightening of the “significant effects” test to New Zealand-specific effects would “allow the EPA assessment to focus on aspects unique to New Zealand only.”
It is now one year later. The two amendment bills have now been introduced. A promised regulatory reliance pathway has turned into a requirement that local regulators “have regard to” overseas assessments.
As far as legislative instructions go, this is the weakest possible sauce. All manner of outcomes are consistent with ‘having regard to’ those assessments. The Director-General could read other regulators’ assessments and decide to double-check all their work, to focus solely on New Zealand-specific risks, or to do anything in between.
It is certainly very different from the May 2025 Cabinet work that would have required the Director-General to use those overseas assessments.
A stronger framework would require local regulators to rely on overseas assessments unless they identified a relevant and material New Zealand-specific trade-access, biosecurity, or environmental risk. It would couple that requirement with oversight.
Every refusal to rely on a recognised overseas assessment should have to identify the specific New Zealand risk, explain why conditions could not manage it, and be reported publicly. If the same grounds are repeatedly used to block products without evidence of real local risk, Parliament or Ministers should be able to narrow those grounds. If the regulator identified actual risks and mitigated them appropriately, its diligence could be celebrated. If it instead unduly delayed safe products with little risk, its discretion could be narrowed.
The next few years promise a pace of AI-fuelled innovation none of us have experienced. Small regulators in small countries will not be able to keep up.
Merely ‘having regard to’ overseas approvals will mean falling farther behind a rapidly moving frontier.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was first published HERE
Regulatory regimes charged with making sure new products are safe need to balance two types of risk.
The first is obvious. If a regulator certifies as safe something that isn’t, people who trust in that certification will be harmed. The second is less obvious but just as important. If a regulator spends too much time assessing a new product, delays in accessing safe products will also harm people.
Changes in regulatory processes typically mean getting more of one kind of harm in exchange for less of the other. Ideally, they would move toward having just the right amount of stringency, where either loosening or tightening the rules would be a bad idea.
There is a way of avoiding that trade-off, if an agency could somehow just become better at assessing new products. That kind of efficiency improvement is difficult but not impossible to achieve.
New Zealand has just over five million people. The EU has about 450 million. The US has 340 million. Japan has 120 million. The UK, South Korea, Canada, and Australia all have tens of millions more people than we do, and all have regulators who assess the same sorts of things that our regulators assess.
A country of five million people that ignored the assessments of overseas regulators would almost inevitably do a worse job of things. It could not marshal the required expertise. Its regulators would take longer to come up with an answer and would be less likely to provide the right answer.
Rather than deciding which products are safe, New Zealand could decide which overseas regulators are safe. New Zealand regulators could be instructed to rely on the assessments of trusted overseas regulators unless an identified New Zealand-specific risk justified a different treatment. Our regulators could then focus on things that other countries’ regulators might not have checked, rather than duplicating work already done elsewhere.
New Zealand’s regulators are not fans of that kind of approach. Or, at least, the regulatory system has struggled to turn it into legislation that reflects initial intent.
The incoming Coalition government promised automatic approval of medicines authorised by at least two other trusted regulators. The legislation that resulted might allow faster processing of some medicines approved abroad, if anyone were willing to put those medicines through Medsafe’s faster-track approval process. If pharmaceutical companies do not apply to the new fast-track, it will not help. And it cannot help in any future pandemic, as emergency-use medicines are not allowed to use this pathway.
The same thing seems to be happening again with agricultural and horticultural products.
Those products were, perhaps surprisingly, always going to be a bit trickier than medicines for people. A person’s a person, no matter where from. So, a medicine safe and effective in Canada will almost certainly also be safe and effective here, so long as it is imported safely. So will medicines and vaccines for companion animals like domestic dogs and cats.
But some agricultural and horticultural products approved by regulators New Zealand might trust may not fit EU residue limits or import requirements. Even trace residues can matter if they jeopardise market access. Canterbury’s thin alluvial soils combined with high water tables bring different risks for some agricultural chemicals than thick soils over deep aquifers. Any reasonable reliance regime would have to account for those differences.
But let’s look at where things started and how they’re now going.
In June 2024, Hon Penny Simmonds, Hon David Seymour and Hon Andrew Hoggard issued a press release welcoming a Ministry for Regulation review on the approval processes for those products. They noted it can take nine years and “wrangling government agencies” for approval.
By September 2024, the releases shifted in tone slightly. Risks to overseas market access started being noted.
That kind of risk could be handled in a regulatory reliance regime. New Zealand’s regulators could be required to consider approvals by trusted overseas regulators. They could also be allowed to reject or restrict products that had risks specific to New Zealand, or that imposed risks to export-market access including residue limits, phytosanitary requirements, or importing-country conditions.
The Ministry for Regulation encouraged this kind of approach. Its eventual report suggested reliance on overseas approval, but maintaining a watch for locally specific risks. They wrote, “This recommendation could improve efficiency and proportionality by focusing resource on risks of most relevance to New Zealand.”
To put it another way, a country of five million does not need to have its regulators reassess all the information already assessed by other countries’ regulators. But it does need to watch for any risks that are particularly important here and that wouldn’t have the same importance elsewhere.
The Ministry’s report also noted the previous Labour government also tried to bring in greater reliance on international regulators’ assessments for these products. But watering-down during legislative drafting resulted in no clear way of even using information from overseas regulators in most cases.
In February 2025, Cabinet accepted the recommendation to use “international regulators’ assessments to save time.” The press release cited expected benefits of $272 million over 20 years from a halving of approval times.
The May 2025 Cabinet work said the coming new regime would enable recognition of international regulator assessments and would “require the Director-General [of the Ministry for Primary Industries] to use an appropriate, available recognised international regulator assessment” when considering products. And tightening of the “significant effects” test to New Zealand-specific effects would “allow the EPA assessment to focus on aspects unique to New Zealand only.”
It is now one year later. The two amendment bills have now been introduced. A promised regulatory reliance pathway has turned into a requirement that local regulators “have regard to” overseas assessments.
As far as legislative instructions go, this is the weakest possible sauce. All manner of outcomes are consistent with ‘having regard to’ those assessments. The Director-General could read other regulators’ assessments and decide to double-check all their work, to focus solely on New Zealand-specific risks, or to do anything in between.
It is certainly very different from the May 2025 Cabinet work that would have required the Director-General to use those overseas assessments.
A stronger framework would require local regulators to rely on overseas assessments unless they identified a relevant and material New Zealand-specific trade-access, biosecurity, or environmental risk. It would couple that requirement with oversight.
Every refusal to rely on a recognised overseas assessment should have to identify the specific New Zealand risk, explain why conditions could not manage it, and be reported publicly. If the same grounds are repeatedly used to block products without evidence of real local risk, Parliament or Ministers should be able to narrow those grounds. If the regulator identified actual risks and mitigated them appropriately, its diligence could be celebrated. If it instead unduly delayed safe products with little risk, its discretion could be narrowed.
The next few years promise a pace of AI-fuelled innovation none of us have experienced. Small regulators in small countries will not be able to keep up.
Merely ‘having regard to’ overseas approvals will mean falling farther behind a rapidly moving frontier.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was first published HERE
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