What’s the point of Medsafe?

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Ultimate Geek

#3156835 7-Nov-2023 07:42

johno1234: Drop Medsafe and transfer the funding to Pharmac. Now you are saving lives.

Medsafe is partially funded by collecting fees from the pharmaceutical industry.
It also runs a pretty small ship of about 60 staff at two sites, administrative functions, product approval and standard setting based at the head office in Wellington.
Investigation and Border Control functions are based in Auckland.

Medsafe appears to have two core functions:

Pre-marketing approval must be obtained for new and changed medicines. New medicines cannot be marketed in New Zealand without the consent of the Minister of Health. Medicines to which changes have been made cannot be marketed without the consent of the Director-General of Health. Data that satisfactorily establish the quality, safety and efficacy of the product, for the purposes for which it is to be used, must be submitted for evaluation before consent can be granted.

Post-marketing surveillance monitors the safety of medicines and medical devices in use. Products shown to be unsafe are removed from use, and prescribers are advised about new safety information for products. Post-marketing surveillance is achieved through activities such as:

monitoring adverse reactions to medicines used in New Zealand and monitoring the international literature and other information sources;
testing marketed medicines against product quality standards;
handling complaints and investigations; and
auditing and licensing medicine manufacturers.

So if you got rid of MedSafe you would have to trust whoever is the Minister of Health at the time to do the approvals....
Personally I would like some professional bureaucracy here in our own backyard, rather than let AU or the US tell us what medicine or drugs we could have.... I would trust the EU tho.

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afe66

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#3157033 7-Nov-2023 15:35

Medsafe also liase with CARM which are the pharmac vigilance group looking for adverse events.
Or we could just trust the drug companies to do this.

There were attempts to try to merge au and nz systems which fell over for politics.... Funny that

farcus

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#3157067 7-Nov-2023 16:56

mattwnz:

It is not whether such an organisation is needed, it is whether it could be merged with Australia's equivalent, to potentially have more resources and better economies of scale, and avoid duplication. That potentially saves both money and time.

froma purely selfish perspective I'm not sure I would agree with this.
As an insulin pump user, an enormously useful software / firmware update was approved in NZ (as it was in Europe) a year or two before AU.

Handle9

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#3157456 9-Nov-2023 05:02

Interesting opinion piece from Eric Crampton, on similar lines of the original post in the thread. Given the highly opaque nature of the NZ Initiative funding it's worth taking with a grain of salt but it's also worth considering.

What it doesn't touch on is how Medsafe funds it's compliance side of the organization if the approval fees are removed. I guess there would need to be some sort of compliance fee for medcines.

https://www.newsroom.co.nz/pro/how-a-rule-of-two-could-remove-our-barrier-to-better-drug-access

johno1234

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#3157484 9-Nov-2023 08:02

Handle9:

Interesting opinion piece from Eric Crampton, on similar lines of the original post in the thread. Given the highly opaque nature of the NZ Initiative funding it's worth taking with a grain of salt but it's also worth considering.

What it doesn't touch on is how Medsafe funds it's compliance side of the organization if the approval fees are removed. I guess there would need to be some sort of compliance fee for medcines.

https://www.newsroom.co.nz/pro/how-a-rule-of-two-could-remove-our-barrier-to-better-drug-access

I like Crampton's thinking on this one. This approach could allow the 90% of straight forward cases to go straight through, and the freed up resources at Medsafe could be applied to the tricky cases for a faster process.

Geektastic

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#3157490 9-Nov-2023 08:30

MikeB4:
mattwnz:
It is not whether such an organisation is needed, it is whether it could be merged with Australia's equivalent, to potentially have more resources and better economies of scale, and avoid duplication. That potentially saves both money and time.

The idea of "budget" medical safety is ludicrous.

Not remotely.

There is no unlimited supply of money, is there?

Geektastic

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#3157491 9-Nov-2023 08:33

Handle9:
Interesting opinion piece from Eric Crampton, on similar lines of the original post in the thread. Given the highly opaque nature of the NZ Initiative funding it's worth taking with a grain of salt but it's also worth considering.

What it doesn't touch on is how Medsafe funds it's compliance side of the organization if the approval fees are removed. I guess there would need to be some sort of compliance fee for medcines.

https://www.newsroom.co.nz/pro/how-a-rule-of-two-could-remove-our-barrier-to-better-drug-access

He’s a generally sensible chap and his thinking here is indeed more or less identical to what I was thinking when I wrote the post.

Geektastic

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#3157492 9-Nov-2023 08:40

frankv:
We are in fact somewhat different from Europe and Australia in terms of our mix of origins and therefore genetics. Whilst a drug or vaccine may be "safe enough" for Europeans and those descended mostly from Europeans, it may not be "safe enough" for Pacific Islanders (or vice versa). The safety of a medicine for Pacific Islanders is unlikely to be investigated by European or America agencies. "Safe enough" is relative, depending on the harm done to affected individuals and the number of those individuals, and the benefit to the individuals and society. It's also ethical, as in "Are we willing to cause the deaths of 2 or 3 in return for saving hundreds?" but also "Are we willing to cause the deaths of 2 or 3 Pacific Islanders in return for saving hundreds of mostly Europeans?"

How many ethnicities do you think there are within Europe?

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#3157498 9-Nov-2023 08:56

Geektastic:
frankv:

We are in fact somewhat different from Europe and Australia in terms of our mix of origins and therefore genetics. Whilst a drug or vaccine may be "safe enough" for Europeans and those descended mostly from Europeans, it may not be "safe enough" for Pacific Islanders (or vice versa). The safety of a medicine for Pacific Islanders is unlikely to be investigated by European or America agencies. "Safe enough" is relative, depending on the harm done to affected individuals and the number of those individuals, and the benefit to the individuals and society. It's also ethical, as in "Are we willing to cause the deaths of 2 or 3 in return for saving hundreds?" but also "Are we willing to cause the deaths of 2 or 3 Pacific Islanders in return for saving hundreds of mostly Europeans?"

How many ethnicities do you think there are within Europe?

I'm sure there's dozens if not hundreds. But not enough Samoans to be much of a consideration in Public Health.

johno1234

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#3157505 9-Nov-2023 09:07

frankv:

I'm sure there's dozens if not hundreds. But not enough Samoans to be much of a consideration in Public Health.

Have there really been medicines that are beneficial for some ethnicities but dangerous to others? If so has the incidence been of such scale as this could not have been controlled by careful prescription? We have many medicines that are fatal to some people (for example allergies) that are manageable. We don't block them because they cause harm to some people. These medicines are improving and saving lives.

gzt

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#3157788 9-Nov-2023 20:14

You might not block them but you would expect them to be released with the correct advice wouldn't you?

Handle9

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#3157793 9-Nov-2023 20:19

frankv:

Geektastic:

How many ethnicities do you think there are within Europe?

I'm sure there's dozens if not hundreds. But not enough Samoans to be much of a consideration in Public Health.

I could well be wrong but I don't think there would be many drug companies conducting clinical trials in NZ to target specific ethnicities. They will likely just be submitting their existing clinical data for evaluation.

I'd be interested to see otherwise if I'm wrong.

MikeB4

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#3157843 10-Nov-2023 07:41

Four years back I was on a drug trial for a new Biologic. This trial include specific need to include Maori and Pacifica participants.

frankv

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#3157916 10-Nov-2023 09:30

johno1234:

Have there really been medicines that are beneficial for some ethnicities but dangerous to others? If so has the incidence been of such scale as this could not have been controlled by careful prescription? We have many medicines that are fatal to some people (for example allergies) that are manageable. We don't block them because they cause harm to some people. These medicines are improving and saving lives.

https://humgenomics.biomedcentral.com/articles/10.1186/s40246-023-00461-z

Inter-individual variability in drug response that leads to either adverse drug reactions (ADRs) or low drug efficacy is commonly observed in clinical practice and poses significant burden to patient health and health care system. Insufficient drug efficacy and drug-related toxicity occur in up to 50% of the clinical treatments and ADRs accounts for 6–9% of all hospital admission, of which up to 40% are life threatening [1,2,3]. Importantly, it is estimated that 20–30% of the variability in drug response can be explained by genetic polymorphisms that are primarily localized in genes involved in drug absorption, distribution, metabolism and excretion (ADME), as well as in drug target genes and immune-related genes [4].

NB We're talking genetics rather than ethnicity which is as much a cultural as inherited thing.

From the above, clearly some medicines are beneficial for some genotypes but ineffective or require higher or lower doses for others. And what may be an appropriate dose for one person would be dangerous for another. So I think the answer to your first question is yes.

It's not really possible to estimate how _many_ life-threatening ADRs are due to genetics. Presumably drug ineffectiveness could also be life-threatening, but perhaps wouldn't be categorized as an ADR.

The problem with "careful prescription" is that the prescriber needs to somehow know what drugs affect what genotypes in what way, which is where Medsafe comes into it. The prescriber would guess, based on (say) Samoan ethnicity (name, appearance, clothing, language), that the person was Polynesian. That still doesn't guarantee they have the particular gene that causes the problem, but it raises the risk. So the prescriber might look for a medicine not identified as being ineffective/dangerous for some Polynesians.

It's not about blocking medicines... it's about identifying medicines that are safe/unsafe for some group of people.

ezbee

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#3157944 10-Nov-2023 10:37

Seems a conflation of Medsafe with Pharmac in article that was supposed to be complaint about Medsafe.

Pharmac Funding is the real issue.

Funding is the issue, and it might give pause to think that we just elected a 'money saving' Government.
So money will have to be saved somewhere else first, after the bit given back as tax cuts is taken out.

Latest...

Pharmac asked to reconsider funding RSV drug for at-risk babies
https://www.stuff.co.nz/national/health/301005975/pharmac-asked-to-reconsider-funding-rsv-drug-for-atrisk-babies

""
In announcing its decision on 31 October, Pharmac said funding for the drug over the last two winters had come out of ring-fenced funding for the Covid-19 response, which was separate from the Combined Pharmaceutical Budget (CPB).

"We acknowledge that palivizumab reduces hospitalization rates for at-risk babies. Our clinical advisors have recommended it be funded with a high priority. However, there's limited evidence that it reduces the number of deaths from RSV."
""
Pharmac would like to fund palivizumab, but due to its "current budgetary constraints", it was not able to do so for the upcoming RSV season.
""

Interestingly though "reduces hospitalization rates" surely does theoretically save money,
but thats money in someone else's budget, not in Pharmac's so.
However Hospitals are short of money to start with so that saving gets absorbed in the working on non existent waiting list, cleaning mold out of a ward or something.
So it would not be there to give Pharmac, so answer is the same.
Pharmac will have to take money from one drug to fund another that has a public profile.
Over 60's are also a risk group for RSV

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