As RSV season arrives again, we must count the cost of waiting for medicines
Monday, 22 June 2026
Dylan Mordaunt is a medical doctor and health economist. He has led research on the approval processes for new medicines in small markets.
OPINION: Every winter, babies arrive in paediatric wards working too hard to breathe. Some need oxygen. Some need fluids through a tube or drip. A smaller number need intensive care. Most recover. But, their families remember the fear. Clinicians remember the pressure on crowded wards. They also know something important has changed: some of this illness may now be preventable.
Respiratory syncytial virus, or RSV, is one of the commonest causes of viral lung infection (such as bronchiolitis, pneumonitis and bronchopneumonia) in infants. For decades, treatment was mostly supportive: oxygen, hydration, time and careful watching. Prevention existed for only a narrow group of very high-risk babies, usually through palivizumab, a monthly antibody injection that is expensive and logistically difficult.
Now there are newer options. Nirsevimab, sold overseas as Beyfortus, is not a vaccine. It is a long-acting monoclonal antibody: a dose of ready-made protection that can cover an infant through an RSV season. Abrysvo is different: a maternal RSV vaccine given in pregnancy so protective antibodies cross the placenta to the baby.
The United States moved in 2023. Its Food and Drug Administration (FDA) approved nirsevimab in July that year. US advisers recommended it for infants entering their first RSV season and for some high-risk children entering a second season. The FDA also approved Abrysvo for use in pregnancy in August 2023.
New Zealand should not automatically copy the United States, if there is a reason not to. Our RSV burden, prices, workforce, delivery system and competing health priorities matter. Pharmac’s role is to negotiate hard to maximise use of the public dollar. MedSafe’s role is to protect safety and quality. Sometimes the hold-up is a supplier, not a regulator.
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But overseas approval and recommendation change the question. Once trusted regulators have reviewed the evidence, what extra local work genuinely adds value? What should be checked here? And when does local process become avoidable delay? More specifically, in its entire history, has MedSafe made any pre-approval recommendations that are specific to New Zealand or New Zealand communities? As far as I can tell, the answer is no.
The public record puts New Zealand in an uncomfortable middle ground. Pharmac’s immunisation advisory committee considered nirsevimab in November 2025 and recommended it be listed with high priority for all infants at birth or in their first RSV season, and for high-risk children entering a second season.
Yet the June 2026 pharmaceutical schedule still lists palivizumab under special authority criteria, not nirsevimab or Beyfortus. Abrysvo and another long-acting antibody, clesrovimab, were on Pharmac’s May 2026 advisory agenda. The current coalition government has made a show of funding cancer therapies. Are vulnerable infants less important?
That shows the system is working through the issue. It also shows why families and clinicians are frustrated. For a baby facing this winter, “under assessment” is not protection. As a paediatrician and health-policy researcher, I see both.
Cost matters. No health system can fund every promising product at any price. Cost-effectiveness for RSV prevention will depend on the negotiated price, uptake, delivery model, seasonality and whether protection is targeted or universal. But RSV costs are not confined to a pharmaceutical budget line. They include emergency departments, hospital beds, intensive care, caregiver time off work and strain on whānau.
They also include inequity. Pharmac’s advisers noted major inequity for Māori, Pacific peoples and children living in the highest-deprivation areas. If access is slow, confusing or dependent on private means and clinician persistence, the children who already carry the highest burden may wait longest.
Medicines regulation usually thinks hard about one kind of mistake: saying yes too soon. That caution is important. A medicine may be less effective than hoped, more harmful than trials first showed, or poor value for money. Pregnancy vaccines, in particular, require careful scrutiny.
But there is another mistake: waiting too long. If a product is effective, safe enough and good value when implemented well, delay is not neutral. It means preventable illness, preventable hospitalisations and winter pressure on a system already stretched. A false approval can harm people. So can a false delay.
New Zealand’s unapproved-medicines pathways, including section 29 of the Medicines Act, are useful safety valves for individual patients. They are not a substitute for a national prevention strategy. A population-level seasonal intervention cannot sensibly depend on ad hoc access, private means and paperwork.
The Therapeutic Products Act has been repealed. In the interim, New Zealand continues to rely on the Medicines Act 1981, which the Government itself has described as outdated. That creates a rare opportunity to redesign the system around modern realities.
In my recent comparative research on medicines reliance and accelerated access in small markets, I found countries like New Zealand do not have to choose between sovereignty and speed. The better question is where domestic effort is best spent. Small regulators can rely more intelligently on trusted overseas assessments while preserving local decisions on labelling, prescribing conditions, equity, price, implementation and post-market safety.
That means moving from “wait and review” to “trust and manage”. This is effectively what New Zealand has always done. What I am proposing is to stop pretending MedSafe adds much value at the initial assessment, and shifts investment of regulatory resource into post-approval monitoring (known as pharmacovigilance).
This aligns well with the evolving concept of clinical governance, which surfaces early safety signals from the clinic, roadside and ward, to the board, enabling rapid responses when safety signals first occur. If we had a system like this, what might it have meant for issues like pelvic mesh?
For RSV and similar high-impact interventions, MedSafe and Pharmac assessment should run in parallel where possible. Public dashboards should show where products are up to, who has the next action, and why decisions are waiting. Trusted overseas approvals should trigger rapid verification unless there is a clear New Zealand-specific reason for deeper review. Savings in regulatory effort should be reinvested in pharmacovigilance, real-world effectiveness monitoring, adverse-event reporting and auditing of unapproved-medicine use.
Faster assessment is not a blank cheque for manufacturers. Regulators should still say no when evidence is weak. Pharmac should still say no when the price is wrong.
There is credible high-quality economic evidence that RSV prevention can be cost-effective in the right populations and at the right price, but the conclusion is highly sensitive to programme design, product price, seasonality, and which benefits New Zealand chooses to count.
But caution should count all the risks. A baby on oxygen does not care whether the bottleneck was regulatory approval, funding assessment, procurement, supply, or a company’s launch strategy. The family experiences only one fact: protection was not available.
New Zealand needs a medicines system that can say no when no is the right answer. It also needs one that can recognise when waiting has become a risk of its own.