Wellington (Thursday, 2 November 2023) - The New Zealand Initiative’s latest report argues New Zealand could have safe and faster access to new
pharmaceuticals by relying on overseas approvals.
The report proposes the Rule of Two. Drugs approved by at least two trustworthy overseas agencies would automatically be
approved here. Medsafe could block automatic approval in extraordinary circumstances.
“The Rule of Two would hasten access to safe medicines while imposing little risk,” said Dr Eric Crampton, Chief
Economist with the Initiative and author of the research note.
The research note draws on indicative work by two teams of Canterbury students.
Drugs rejected by Medsafe tend not to be drugs that would have been approved by the Rule of Two. But drugs like
Herceptin could have been approved a decade earlier.
“Medsafe approval is not the sole barrier to new pharmaceuticals. But it is an unnecessary barrier for drugs already
safely approved elsewhere, while worsening other barriers,” said Dr Crampton.
In August, Pharmac proposed declining 24 funding applications because they saw no supplier willing to pursue Medsafe
registration. One of those drugs was recommended for Australia’s Public Benefit Scheme later that month.
Dr Crampton concluded, “America spends hundreds of millions of dollars more evaluating drugs than Pharmac’s entire
drug-buying budget. If the FDA and another trustworthy agency say a drug is safe, will Medsafe’s 60 staff often find
something they missed?”