A "Rule of Two" for faster access to safe medicines

Dr Eric Crampton
Insights Newsletter
10 November, 2023

If New Zealand required local crash testing for every new car model, dealerships would be late to stock a small number of mass-market vehicles at higher cost. It would be stupid.  

Fortunately, New Zealand regulators instead decide which foreign standards are up to scratch and require that new cars meet at least one of them.  

Access to the latest pharmaceuticals is at least as important as access to the latest car model. But consider the effects of Medsafe requirements.  

Ozempic is a wonder drug for Type II diabetes. It earned FDA approval in December 2017. Approval from Canada, Europe, and Japan quickly followed. The drug’s success even markedly improved Denmark’s GDP statistics, where Novo Nordisk is based. 

By the time Novo Nordisk sought Medsafe approval in December 2021, Ozempic had already been successfully prescribed for four years overseas. Nevertheless, Medsafe took fifteen additional months to confirm what a host of foreign drug approval agencies had already found.  

New Zealand is too small to insist on these kinds of hurdles. 

Government likes to blame foreign pharmaceutical companies for being late to apply to Medsafe. But why would any pharmaceutical company put Medsafe at the front of its queue? We are a tiny market at the far end of the world, unwilling to pay very much for medicines. Pharmaceutical companies must decide where to allocate their regulatory teams’ efforts.  

The hurdles really do seem useless. What would happen if we simply approved any pharmaceuticals already approved by at least two trustworthy foreign approval agencies – a Rule of Two? Two teams of Canterbury University students investigated that idea for us. 

They found that Medsafe does not actively protect New Zealand against risky drugs: Drugs declined by Medsafe tend not to have been approved by at least two foreign regulators. And Medsafe moves in concert with other agencies to withdraw drugs from the market if they are found risky. But Medsafe takes longer to approve drugs – sometimes more than a decade longer – than it would under our proposed Rule of Two. 

It is possible that Medsafe provides accidental protection by discouraging the submission of drugs for approval – but that blocks safe drugs too. Besides, under our Rule of Two, Medsafe would keep an emergency handbrake for exceptional cases. 

A Rule of Two would mean faster approval for safe medicines while letting Medsafe focus its limited resources where it could add real value.

Dr Eric Crampton's report, Safe to Follow: Faster Access to Medicines for Kiwis, was published on 3 November.

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