Wednesday 4 October 2023


If a drug or medical device has already gone through the regulatory gauntlet at the FDA and Australia, or in the UK and Canada, or the EU and Taiwan, or Switzerland and Singapore, does it seem all that likely that Medsafe's going to find anything that everyone else missed?

Sure, Medsafe has 'expedited' processes for drugs already approved elsewhere. But those processes still impose cost - particularly time cost on pharmaceutical companies' regulatory affairs teams. 

And five million middling-income people at the far end of the world just don't hit the priority queue.

Alex Tabarrok talks about the FDA's invisible graveyard: all the people it has killed by being too slow to approve safe and effective drugs. How should we think about New Zealand's, when New Zealand insists on running a separate process for drugs already approved elsewhere?

In August, Pharmac dropped a pile of drugs from funding evaluation. Why? In twenty-four cases, Pharmac said, "We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration."

The government here likes to say the problem is the pharmaceutical companies, and that Medsafe would be happy to process their applications if only they'd apply. The real problem is that we have this process at all for drugs already approved elsewhere.

ACT yesterday announced that it would require Medsafe to automatically approve any drug or device already approved by at least two other trustworthy regulators, unless Medsafe had extraordinary reason not to approve it. 

ACT says if a drug or medical device has been approved by any two reputable foreign regulatory bodies (such as Australia, United States, United Kingdom), it should be automatically approved in NZ as well within one week unless Medsafe can show extraordinary reason why it shouldn’t be. 

This simple change would significantly improve access to medicines that have already been subject to rigorous testing and analysis through other regulatory regimes.

The Strategy would include a working list of international regulatory regimes that have comparable or more robust systems compared with New Zealand. It will also include an analysis of areas where international analysis might not be directly relevant to the New Zealand population: for example, if there are significant differences in population makeup that would distort medical efficacy.

National's policy isn't far from that.

4.2 Faster approvals for new medicine

New Zealand’s slow approval process for medicines means Kiwis wait much longer than people in other countries to access potentially life-saving treatments. While it is essential that medicines and other treatments are subject to stringent scrutiny to ensure they are safe, there is no reason why New Zealanders should have to wait for our domestic medicines regulatory body, Medsafe, to conduct its own cumbersome process from scratch, when countries with health systems we trust have already gone through this exercise.

National will

  • Legislate to require Medsafe to make decisions on approval for registration for all medicines within a maximum 255 days, to align with Australia,
  • Require Medsafe to implement even faster approvals processes for any medicines for use in New Zealand that have already been approved by at least two regulatory bodies that we currently recognise, including Australia, the EU, Singapore, the UK, Switzerland and the US.

I've long wanted this kind of policy. And there's some hope that the general congruence of the two parties' policies could mean it gets done in the event of a National-ACT coalition.


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