Crampton: Coalition’s ‘Rule of Two’ for medicine approval has been gutted

Summarised by Centrist

Dr Eric Crampton says the government’s new fast-track medicine approval law fails to deliver on its coalition promise, calling it a hollowed-out version of the “Rule of Two” that New Zealanders were told to expect. 

In an opinion piece for Newsroom, the New Zealand Initiative economist argues that the new regime still delays New Zealanders’ access to potentially life-saving treatments.

The original commitment, repeated in both the National–NZ First and National–ACT agreements, was: “Require Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.” 

Crampton supported this idea. “If a drug has already been approved by two competent agencies, requiring Medsafe approval does not do much to improve safety,” he writes. “Medsafe’s main contribution is delay.”

But the legislation introduced this month, Crampton says, requires drugs to be fully approved overseas, not provisionally, meaning the fast-track would be useless in an emergency like a pandemic. 

It still depends on pharmaceutical companies submitting full applications to Medsafe, something they are often unwilling to do in a small market like New Zealand. “Our problem,” says Crampton, “is that New Zealand is a tiny and relatively poor backwater with little real willingness to pay for new medicines.”

A better system, he says, would grant automatic provisional approval based on two trusted overseas agencies, with Medsafe able to intervene only in exceptional cases.

Read more over at Newsroom (paywalled)

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