Medsafe is holding us all back

Medsafe is holding us all back

Hopefully a short rant this time!

What is Medsafe?

Medsafe is New Zealand’s medication regulatory authority. Except in a few cases all the medications on sale in New Zealand, and certainly any you see on shelves or advertised, have Medsafe approval.

This is a very important role - Medsafe ensures medicines meet the quality and efficacy the manufacturers claim, is safe to use in the way the manufacturer has specified, has appropriate guidance for patients and prescribers, and has a secure distribution network.

So why is this a problem?

Medsafe is industry funded. That is, to sell a medication in New Zealand you first have to pay Medsafe for the privilege of approval, supply all the documentation that Medsafe require, and wait for Medsafe to process your application.

This process can cost from NZ$10,000 to over $100,000 depending on the category of medicine. Medsafe do not recognise any overseas approvals.

The end result is unless a manufacturer or importer can justify the cost of Medsafe approval they won’t apply for it. Medications that are perfectly usable are unavailable in New Zealand because the cost is too high. This can be seen with the current oestrogen patch shortage - two brands which are just as effective as the only approved one are being prescribed under Section 29 of the Medicines Act, but they’re unapproved because there isn’t the demand to pay for Medsafe approval.

What about Section 29?

Section 29 allows for registered doctors - not nurse practitioners, dentists, or other medical practitioners who could prescribe an approved medicine - to prescribe medicines without Medsafe approval.

However, when something is prescribed under S29 the name of the patient, prescriber, supplier, and the medicine have to be sent to the supplier, who must store this information and forward on information about the medicine supplied (but not patient details) to Medsafe.

This means any supplier of S29 medicines has to maintain a database of what they’ve supplied and who they sent it to. Which isn’t great for things like hormones…

Additionally doctors seem wary of prescribing under S29 unless they’re really familiar with the medication. I don’t know why.

How could we address this?

Make Medsafe work for the health of New Zealanders, either by funding its work or by recognising overseas authorities. We collaborate with Australia on food regulations, why not medication?

Of course these things take far too long. It was recommended that the maximum length for a prescription be increased from three months to six, and from one to three for controlled drugs. Only the latter has actually happened. At least they’ve dropped the $5 kick-in-the-teeth when you’re sick charge.


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