As of 11 September, it has been legal to advertise Jynneos, the monkeypox vaccine, to communities at risk for monkeypox. It’s also been legal, since then, to provide the vaccine without a lengthy consultation with a G.P.
Unfortunately, it’s all just a bit late.
On 12 September, Health New Zealand reported five monkeypox cases linked to the Winter Pride Festival in Queenstown.
The reason why Jynneos authorisation is just a bit late is just a bit stupid. Surely we can do better than this.
The global monkeypox outbreak started in 2022. It has been obvious for two years that monkeypox spreads rapidly via sexual contact. Men who have sex with men, and others who have sex with men who have sex with men, are at highest risk.
Fortunately, a vaccine has long been at the ready.
Jynneos was approved by the European Medicines Agency and by Canada in 2013 for smallpox. Canada authorised it for monkeypox in 2020; the EMA recommended it for monkeypox in 2022. There, it goes by the trade name Imvamune.
The American Food and Drug Administration approved it in 2019 and provided Emergency Use Authorisation for use in monkeypox in 2022.
New Zealand’s first case was in 2022.
The manufacturer did not apply for New Zealand approval until 2023.
Defenders of New Zealand’s indefensible regulatory system typically blame the manufacturer in such circumstances. But Medsafe is known to be slow, with cumbersome application processes. In a global outbreak, manufacturers should not be blamed for failing to prioritise small countries with terrible processes at the far end of the world.
We should instead blame the terrible processes that stop safe and effective medicines from reaching the people that need them.
In the middle of a global Monkeypox outbreak, Medsafe took about eighteen months to approve a vaccine that had already been approved by larger and better-resourced regulators.
Medsafe provisional approval came four years after Canada had authorised it for monkeypox.
It is always, of course, possible to argue that the New Zealand government should massively increase Medsafe’s budget so it can be as fast as the FDA. When I last checked, the FDA’s drug evaluation budget exceeded Pharmac’s drug-buying budget. And replicating work already done by many others overseas seems a worse use of money than buying medicines.
It is possible to access medicines that have not been evaluated by Medsafe. Section 29 of the Medicines Act allows it.
But it isn’t easy.
First, you have to know that you ought to have the medicine. Your GP might be less familiar with medicines that are not yet here approved. And you would have to know to go to talk with your GP about it in the first place.
Fortunately, New Zealand allows direct-to-consumer advertising of pharmaceuticals – not all countries do. While that advertising has its detractors, it is very good at one very important job: letting people know that particular medicines exist.
Unfortunately, no vaccine supplier is going to pay to advertise in a market where the vaccine is not yet approved.
Public awareness campaigns may instead be needed – like the targeted campaigns that helped raise awareness for other diseases where very specific communities are at risk.
Unfortunately, it is illegal to advertise unapproved medicines.
As the Post reported, “The mpox vaccine has been under a special provision in the Medicines Act since 2023, but it was unapproved so could not be promoted and could only be given after a detailed consultation with the patient.”
Medsafe’s website is very clear about the implications of New Zealand legislation.
It is illegal to advertise unapproved medicines, regardless of whether they are proven safe and effective overseas to the satisfaction of many other trustworthy countries’ regulators.
It is also illegal to advertise unapproved uses of approved medicines, regardless of whether other countries are already finding that medicine critically important in an emergency.
Finding out that a vaccine is available then gets a bit more difficult than it ought to be. Normally, governments consider it a good idea to spend money to increase public awareness about this kind of thing. Instead, New Zealand forbids anyone from doing so until Medsafe has triple-checked the work already undertaken by overseas experts, regardless of how many people are harmed by the delay.
Section 29 of the Medicines Act allows GPs to prescribe unapproved medicines. But it isn’t simple for GPs.
And while other vaccines can be provided by your pharmacist or by nurses at community outreach clinics, unapproved medicines cannot be. They can only be administered by prescription, and only medical practitioners are allowed to prescribe them.
And there’s another fun part. Patients being prescribed an unapproved medicine must be informed that details about the prescription, including their name, will be recorded and may be sent through to Medsafe.
None of this makes any kind of sense.
And it makes even less sense when the coalition agreements between National and ACT, and between National and New Zealand First, promised that drugs already approved by at least two overseas agencies would be automatically approved here – without having any of this monkey-business.
It isn’t crazy to maintain restrictions on use of experimental unapproved medicines.
But New Zealand’s Section 29 processes, and Medsafe’s drug approval processes, are far too restrictive for medicines that at least two trustworthy overseas regulators have already found to be safe.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was first published HERE
The reason why Jynneos authorisation is just a bit late is just a bit stupid. Surely we can do better than this.
The global monkeypox outbreak started in 2022. It has been obvious for two years that monkeypox spreads rapidly via sexual contact. Men who have sex with men, and others who have sex with men who have sex with men, are at highest risk.
Fortunately, a vaccine has long been at the ready.
Jynneos was approved by the European Medicines Agency and by Canada in 2013 for smallpox. Canada authorised it for monkeypox in 2020; the EMA recommended it for monkeypox in 2022. There, it goes by the trade name Imvamune.
The American Food and Drug Administration approved it in 2019 and provided Emergency Use Authorisation for use in monkeypox in 2022.
New Zealand’s first case was in 2022.
The manufacturer did not apply for New Zealand approval until 2023.
Defenders of New Zealand’s indefensible regulatory system typically blame the manufacturer in such circumstances. But Medsafe is known to be slow, with cumbersome application processes. In a global outbreak, manufacturers should not be blamed for failing to prioritise small countries with terrible processes at the far end of the world.
We should instead blame the terrible processes that stop safe and effective medicines from reaching the people that need them.
In the middle of a global Monkeypox outbreak, Medsafe took about eighteen months to approve a vaccine that had already been approved by larger and better-resourced regulators.
Medsafe provisional approval came four years after Canada had authorised it for monkeypox.
It is always, of course, possible to argue that the New Zealand government should massively increase Medsafe’s budget so it can be as fast as the FDA. When I last checked, the FDA’s drug evaluation budget exceeded Pharmac’s drug-buying budget. And replicating work already done by many others overseas seems a worse use of money than buying medicines.
It is possible to access medicines that have not been evaluated by Medsafe. Section 29 of the Medicines Act allows it.
But it isn’t easy.
First, you have to know that you ought to have the medicine. Your GP might be less familiar with medicines that are not yet here approved. And you would have to know to go to talk with your GP about it in the first place.
Fortunately, New Zealand allows direct-to-consumer advertising of pharmaceuticals – not all countries do. While that advertising has its detractors, it is very good at one very important job: letting people know that particular medicines exist.
Unfortunately, no vaccine supplier is going to pay to advertise in a market where the vaccine is not yet approved.
Public awareness campaigns may instead be needed – like the targeted campaigns that helped raise awareness for other diseases where very specific communities are at risk.
Unfortunately, it is illegal to advertise unapproved medicines.
As the Post reported, “The mpox vaccine has been under a special provision in the Medicines Act since 2023, but it was unapproved so could not be promoted and could only be given after a detailed consultation with the patient.”
Medsafe’s website is very clear about the implications of New Zealand legislation.
It is illegal to advertise unapproved medicines, regardless of whether they are proven safe and effective overseas to the satisfaction of many other trustworthy countries’ regulators.
It is also illegal to advertise unapproved uses of approved medicines, regardless of whether other countries are already finding that medicine critically important in an emergency.
Finding out that a vaccine is available then gets a bit more difficult than it ought to be. Normally, governments consider it a good idea to spend money to increase public awareness about this kind of thing. Instead, New Zealand forbids anyone from doing so until Medsafe has triple-checked the work already undertaken by overseas experts, regardless of how many people are harmed by the delay.
Section 29 of the Medicines Act allows GPs to prescribe unapproved medicines. But it isn’t simple for GPs.
And while other vaccines can be provided by your pharmacist or by nurses at community outreach clinics, unapproved medicines cannot be. They can only be administered by prescription, and only medical practitioners are allowed to prescribe them.
And there’s another fun part. Patients being prescribed an unapproved medicine must be informed that details about the prescription, including their name, will be recorded and may be sent through to Medsafe.
None of this makes any kind of sense.
And it makes even less sense when the coalition agreements between National and ACT, and between National and New Zealand First, promised that drugs already approved by at least two overseas agencies would be automatically approved here – without having any of this monkey-business.
It isn’t crazy to maintain restrictions on use of experimental unapproved medicines.
But New Zealand’s Section 29 processes, and Medsafe’s drug approval processes, are far too restrictive for medicines that at least two trustworthy overseas regulators have already found to be safe.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was first published HERE
5 comments:
Great more toxins to pump into the body. After COVID who believes any one?
What a very long article on a very non-issue.
Eric is quite right - Medsafe and Pharmac would be more effective if they approached medicine approval in a more business like way.
As soon as the possibility of a disease like MPox is confirmed, Medsafe should be evaluating potential treatments and vaccines, and approving those as quickly as possible, even if no public funding is available (ie allow people to self fund).
Section 29 is a joke - there are so many section 29 medicines being prescribed by doctors every day unknowingly (because the subsidised registered brand is unavailable) that I’m sure patients are not being told. And how do you explain Section 29 to someone? The medicine is not registered in NZ but is available and has been approved because there is no alternative. Sometimes, it’s the same medicine in Australian packaging, and that packaging hasn’t been approved here. That makes little sense to most people, and really just amounts to bureaucracy. The whole system needs a common sense tidy up
Monkeypox, another fictious illness discovered using "experiments" that failed to follow the scientific method. Junk pseudoscience leads to poor outcomes for all. The author should really check out the Monkeypox Mania Symposium.
Is Eric softening up the public for foreign approval of medicines and medical countermeasures without any local regulation? The acceptance of the approval of foreign regulators such as the FDA and European Medicines Agency was one of the NZ First policy platforms.
It is a terrible idea when you understand the kill box legislation in place in the USA unconvered by Paralegal and Researcher Katherine Watts at the baliwicknews substack. Foreign regulatory authorities cannot be trusted when they are granted immunity from prosecution for the consequences of their actions under the legislation.
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