From mid-2020 through 2022, New Zealand women helped test whether vaccinating pregnant women against Respiratory Syncytial Virus (RSV) could protect their newborns.
Abrysvo has been authorised by regulators in the US, the UK, Canada, Australia, Argentina, Japan, Switzerland, Singapore, Hong Kong, and the EU. European authorisation covers some thirty countries. Many approvals came in 2023 and 2024.
But not here.
It’s emblematic of a much larger problem. Small countries that do not want to fall farther behind an accelerating world need to learn to rely on other countries’ regulatory authorisations.
Let’s start with RSV and work our way up from there.
RSV is a common childhood respiratory virus. Health New Zealand says that most children will have been exposed to it by the age of two, and that reinfection is common. Earlier Auckland surveillance work implied roughly 2% of infants are hospitalised with RSV in their first year.
Since the MATISSE vaccine trial, post-authorisation work has reinforced the vaccine’s efficacy. A large English real-world study of nearly 290,000 infants found maternal vaccination reduced RSV hospitalisation by over 81% when given at least two weeks before birth, rising to almost 85% protection when given at least four weeks before birth.
The vaccine is sufficiently effective to draw public funding in countries including Argentina, Australia, the UK, and many European countries; it is offered to pregnant women in more countries.
Regulators and immunisation authorities in peer countries have judged it safe and effective enough to approve, recommend, and in many cases publicly fund for pregnant women. But if you are pregnant and want it here, you will likely find you cannot get it, even if you are willing to pay for it yourself.
The reason is frustrating.
No matter how safe and effective a vaccine or medicine has proven overseas, nobody in New Zealand can access it in the ordinary way unless one of two things happens. Either Medsafe authorises it, or a doctor is prepared to use the Medicines Act’s Section 29 unapproved-medicine pathway for a named patient.
In theory, Section 29 can help. In practice, it is a poor substitute for approval. Abrysvo is not approved, so it is not part of New Zealand’s routine maternal immunisation advice. Most pregnant women will not know it exists. GPs will not be familiar with it. And without predictable demand, wholesalers and pharmacies have little reason to arrange cold-chain import channels for a rarely prescribed vaccine.
The result is circular. Because it is not approved, it is rarely prescribed. Because it is rarely prescribed, there is little reason for anyone to make supply easy.
Medsafe maintains a database of applications for authorisation and of approved products. Abrysvo was broadly approved internationally in 2023 and 2024. As of 27 April 2026, Medsafe’s database notes no application for Abrysvo.
Medsafe will not start thinking about Abrysvo until someone applies for authorisation.
Without either authorisation or sufficient local demand to make Section 29 processes feasible, pregnant women are simply out of luck. Their infants will face a much higher risk of catching RSV and winding up in hospital. Each hospitalisation costs the public health system about $5000 on average, while bringing risk of longer-term consequences for the hospitalised child.
Pregnant women are, in practice, blocked from spending their own money to help protect their infants and to help reduce burdens on the public health system.
As institutional design, this is, bluntly, incredibly stupid.
It can be tempting to blame Pfizer for not having applied for New Zealand authorisation. But New Zealand often is just not worth the time and effort for drug companies’ regulatory affairs teams if demand is expected to be low.
The problem isn’t mainly the roughly $100,000 application fee for novel medicines. It’s the time and effort that pharmaceutical companies would spend on New Zealand’s paperwork and dealing with Medsafe. An hour spent dealing with Medsafe for a market of five million people is an hour not spent with regulators whose decisions cover tens or hundreds of millions of people.
Abrysvo is not an outlier. It can take years for drug companies to get around to applying for Medsafe authorisation for medicines broadly approved abroad. We are not worth the hassle. It isn’t a ‘them’ problem. It is an ‘us’ problem. Keeping these kinds of rules does not protect us against ‘Big Pharma’. It just hurts anyone who could have benefitted from earlier access to medicines already proven safe and effective overseas.
The same problem is worse for rare disorders. Rare multiplied by small means a tiny New Zealand market. If a medicine might draw only a handful of prescriptions, why would a company spend scarce regulatory time seeking New Zealand approval?
The government intends its new, faster authorisation pathway for medicines approved by at least two trusted overseas regulators to be operational by the middle of this year. Under that pathway, a sponsor will still need to apply for Medsafe authorisation. But the process is meant to be simpler, with greater reliance on decisions already made abroad.
Hopefully, that pathway will be simple enough that New Zealand will be worth the lowered hassle. And, hopefully, Pfizer, Abrysvo’s manufacturer, is simply waiting for that pathway to open before making application here.
But if the new pathway is not sufficiently attractive, and medicines commonly approved abroad do not make it into New Zealand’s application queue, the government should reconsider how the system operates.
The coalition agreements that formed the government promised something closer to automatic approval for medicines approved by at least two trusted overseas regulators. What is being implemented is a sponsor-led verification pathway. What was promised was closer to unilateral recognition.
The lesson applies more broadly than medicines.
It is hard for a country of about five million people to replicate the regulatory processes of larger countries. And there is no need to do it, at least not as default. Unilateral recognition of trusted overseas regulators’ decisions would make it faster and easier for new products and services to reach the New Zealand market.
The pace of innovation abroad is only going to increase. If New Zealand’s regulatory processes stand still, Kiwis will fall farther behind.
Dr Eric Crampton is Chief Economist with the New Zealand Initiative and Adjunct Senior Fellow with the Department of Economics and Finance at the University of Canterbury.
His report, Safe to Follow: Faster Access to Medicines for Kiwis, which drew on work undertaken at the Canterbury’s Department of Economics and Finance, was published in 2023.
To read the article on the Newsroom website, click here.