Requiring Medsafe approval for pharmaceuticals already approved by at least two trustworthy overseas regulators makes little sense.
Foreign pharmaceutical approval agencies are well-resourced. They also tend to be cautious about approving drugs.
Under the Initiative’s proposed Rule of Two, drugs would automatically be approved in New Zealand if they had been approved by at least two trustworthy overseas approval agencies, unless Medsafe had extraordinary concerns about a particular medicine. But drugs so-approved would be reviewed if withdrawn from foreign markets.
“The Rule of Two would hasten access to safe medicines while imposing little risk,”
This research note draws on indicative work by two teams of Canterbury students.
Drugs rejected by Medsafe were unlikely to have been approved by two trustworthy overseas agencies. But the Rule of Two would have seen safe drugs approved between one and twelve years earlier than Medsafe. And Medsafe tended to move in tandem with overseas agencies in withdrawing drugs from the market, rather than moving more quickly.
“Medsafe approval is not the sole or even the primary barrier to access to new pharmaceuticals. But it is an unnecessary barrier for drugs already safely approved elsewhere, while worsening other barriers,”
In August, Pharmac proposed to decline 24 different pharmaceuticals’ 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.
“America spends about half a billion dollars more per year evaluating drugs than New Zealand spends on buying them through Pharmac. If the FDA and another trustworthy agency say a drug is safe, is it likely Medsafe’s 60 staff will find something they missed?”