When it comes to medicines, New Zealand has chosen the second path. Rather than recognising authorisations provided by better-resourced overseas drug approval agencies, New Zealand requires local approval for new medicines.
New Zealand’s local medicine approvals agency, Medsafe, takes too long to check over the workings for medicines that have already been checked over and approved elsewhere. But the bigger problem is that drug companies are very slow to apply for Medsafe authorisation, if they apply at all.
Australia’s market is large enough to be worth the while of international pharmaceutical companies. New Zealand’s is often too small to be worth the hassle Medsafe imposes. When pharmaceutical companies’ regulatory teams decide where to focus their efforts, New Zealand can miss out.
If a company thinks that New Zealand’s government drug-buying agency, Pharmac, will fund a medicine, Medsafe application can be worthwhile. If they do not, and especially if the medicine targets a relatively rare disorder, there is little point in applying. The potential market is too small to be worth the effort.
The consequences are obvious.
Abrysvo, a vaccine administered to pregnant women to protect their infants from Respiratory Syncytial Virus (RSV), is both authorised and funded in Australia. Kiwi women helped test the medicine during clinical trials. But nobody has applied for Medsafe authorisation. So it is not available here, despite high infant RSV hospitalisation rates.
Nirsevimab, a treatment for infants with RSV, was approved in Australia in November 2023. A Medsafe application was lodged in May 2025. Medsafe reports that “additional evaluation” began on 12 June 2026. Sick infants whose mothers could not legally be vaccinated will have to wait.
Wegovy was FDA-approved in June 2021. Novo Nordisk applied to Medsafe in May 2024, three years after its US approval. Medsafe then took almost a year to confirm what every other regulator had found.
Medsafe provisionally approved Jynneos, the Monkeypox vaccine, on 11 September 2024. Long approved for smallpox, it was authorised for Mpox in Canada in 2020, and in Europe and the US in 2022. New Zealand’s approval came a bit late, though. On 12 September, five cases linked to Queenstown’s Winter Pride Festival were reported. In a more sensible system, vaccination before the Festival would have been encouraged. Ours instead made it nearly impossible.
The incoming National-led government promised to solve the problem. National’s coalition agreement with the ACT Party said that medicines approved by two trusted countries would automatically be approved for use here.
Automatic approval would mean nobody would have to wait until a company applied to Medsafe. If the Europeans and the Canadians found a drug is safe, it would automatically be authorised here too.
Let’s provide a bit of context.
America’s Food and Drug Administration budgeted $2.5 billion for its human drugs programme in 2026. That’s about $4.3 billion New Zealand dollars for evaluating new products.
New Zealand’s drug buying agency, Pharmac, which also decides which medicines to fund, was allocated $1.76 billion.
So the FDA spends more than twice as much evaluating new medicines as the New Zealand government spends buying medicines.
The FDA is not the only regulator out there. Kiwis should have few qualms about using medicines prescribed while on holiday in places like Canada, the UK, Europe, Singapore, Switzerland, or Australia. Medsafe is unlikely to find problems that others have missed. We could simply recognise their authorisations.
The final legislation is not what was promised.
The government set a new fast-track Medsafe approval pathway for medicines that had been fully approved by two trusted regulators. Crucially, though, application will still be required.
The new pathway has yet to open. Hopefully, the promise of fewer hassles will encourage applications. But even if it works well, it will still prove useless in an emergency. Medicines and vaccines developed quickly during the pandemic generally received emergency use authorisation rather than full approval, and those medicines cannot use the fast track.
Precisely the scenario in which speed matters most is the one in which speed will not be allowed.
The pace of medical advance is accelerating. In just the past couple of months, new drugs have promised to double survival time in late-stage pancreatic cancer and to massively increase survival rates for metastatic lung cancers. mRNA cancer vaccines are in the works. And Retratrutide, now in Phase Three trials, looks even more effective than Wegovy.
Even with a faster-track pathway, Medsafe will have a hard time keeping up if it must reassess every other regulator’s work. Kiwis will fall farther behind an accelerating frontier, and have shorter, less healthy lives, because of a domestic insistence that nothing can be good enough unless a New Zealand regulator confirms that it is good enough.
A small and nimble country would recognise that products good enough for our overseas friends are probably good enough for us too. New Zealand has chosen a different path and may learn to regret it.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was first published HERE
Australia’s market is large enough to be worth the while of international pharmaceutical companies. New Zealand’s is often too small to be worth the hassle Medsafe imposes. When pharmaceutical companies’ regulatory teams decide where to focus their efforts, New Zealand can miss out.
If a company thinks that New Zealand’s government drug-buying agency, Pharmac, will fund a medicine, Medsafe application can be worthwhile. If they do not, and especially if the medicine targets a relatively rare disorder, there is little point in applying. The potential market is too small to be worth the effort.
The consequences are obvious.
Abrysvo, a vaccine administered to pregnant women to protect their infants from Respiratory Syncytial Virus (RSV), is both authorised and funded in Australia. Kiwi women helped test the medicine during clinical trials. But nobody has applied for Medsafe authorisation. So it is not available here, despite high infant RSV hospitalisation rates.
Nirsevimab, a treatment for infants with RSV, was approved in Australia in November 2023. A Medsafe application was lodged in May 2025. Medsafe reports that “additional evaluation” began on 12 June 2026. Sick infants whose mothers could not legally be vaccinated will have to wait.
Wegovy was FDA-approved in June 2021. Novo Nordisk applied to Medsafe in May 2024, three years after its US approval. Medsafe then took almost a year to confirm what every other regulator had found.
Medsafe provisionally approved Jynneos, the Monkeypox vaccine, on 11 September 2024. Long approved for smallpox, it was authorised for Mpox in Canada in 2020, and in Europe and the US in 2022. New Zealand’s approval came a bit late, though. On 12 September, five cases linked to Queenstown’s Winter Pride Festival were reported. In a more sensible system, vaccination before the Festival would have been encouraged. Ours instead made it nearly impossible.
The incoming National-led government promised to solve the problem. National’s coalition agreement with the ACT Party said that medicines approved by two trusted countries would automatically be approved for use here.
Automatic approval would mean nobody would have to wait until a company applied to Medsafe. If the Europeans and the Canadians found a drug is safe, it would automatically be authorised here too.
Let’s provide a bit of context.
America’s Food and Drug Administration budgeted $2.5 billion for its human drugs programme in 2026. That’s about $4.3 billion New Zealand dollars for evaluating new products.
New Zealand’s drug buying agency, Pharmac, which also decides which medicines to fund, was allocated $1.76 billion.
So the FDA spends more than twice as much evaluating new medicines as the New Zealand government spends buying medicines.
The FDA is not the only regulator out there. Kiwis should have few qualms about using medicines prescribed while on holiday in places like Canada, the UK, Europe, Singapore, Switzerland, or Australia. Medsafe is unlikely to find problems that others have missed. We could simply recognise their authorisations.
The final legislation is not what was promised.
The government set a new fast-track Medsafe approval pathway for medicines that had been fully approved by two trusted regulators. Crucially, though, application will still be required.
The new pathway has yet to open. Hopefully, the promise of fewer hassles will encourage applications. But even if it works well, it will still prove useless in an emergency. Medicines and vaccines developed quickly during the pandemic generally received emergency use authorisation rather than full approval, and those medicines cannot use the fast track.
Precisely the scenario in which speed matters most is the one in which speed will not be allowed.
The pace of medical advance is accelerating. In just the past couple of months, new drugs have promised to double survival time in late-stage pancreatic cancer and to massively increase survival rates for metastatic lung cancers. mRNA cancer vaccines are in the works. And Retratrutide, now in Phase Three trials, looks even more effective than Wegovy.
Even with a faster-track pathway, Medsafe will have a hard time keeping up if it must reassess every other regulator’s work. Kiwis will fall farther behind an accelerating frontier, and have shorter, less healthy lives, because of a domestic insistence that nothing can be good enough unless a New Zealand regulator confirms that it is good enough.
A small and nimble country would recognise that products good enough for our overseas friends are probably good enough for us too. New Zealand has chosen a different path and may learn to regret it.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was first published HERE
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