Friday 13 September 2024

Monkeypox and Medsafe

In a sane world, medicines and vaccines already approved by trustworthy overseas regulators would automatically be able to be used in New Zealand as well.

New Zealand is not sane. But neither is anywhere else really on that standard. Other places are just faster than NZ in getting things approved, with more practicable pathways for expedited review. 

If a medicine is unapproved, it can still be accessed under restrictive provisions of the Medicines Act. Medsafe summarises it here

Those restrictions include bans on advertising and marketing. 


Monkeypox has been an obvious risk for some time. Jynneos was approved by the EMA in 2013 for smallpox and was recommended for monkeypox in 2022. It was approved by the FDA in 2019, and given emergency use authorisation for monkeypox in 2022. The "Emergency" in the EUA was the monkeypox outbreak. 

Nobody applied for Medsafe authorisation until 2023.



Medsafe took over a year to approve it, despite its already having been approved in Canada, the US and Europe at the point at which application was made.

It was available in New Zealand through Section 29. However, you can't advertise unapproved medicines. 

 
Radio New Zealand notes that greatest transmission risk is concentrated among men who have sex with men, and those who have sex with men who have sex with men. 

The outbreak from the Queenstown Pride Festival now counts five in total. 

It sure would have been great if it hadn't been illegal to advertise the vaccine earlier and to make it real easy for folks to get the vaccine.   

Or if Medsafe had been required to automatically approve medicines already approved by two others - which would have had it authorised in New Zealand in 2022.

We are ruled by Vogons.

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