One item stood out, at least for me. Both agreements promised a Rule of Two: Medicines already approved by at least two trusted overseas regulators would automatically be approved in New Zealand as well.
It was welcome, rational, and simple.
Few New Zealanders spending a summer in Europe, Canada, or the UK would refuse a doctor’s prescription if they discovered that New Zealand’s Medsafe had not yet evaluated the recommended medicine.
Lots of other countries have reputable and reliable approval agencies. Relying on their judgement, especially if two of them agreed, would not just save money. It would save precious time.
We would not have to wait for pharmaceutical companies to get around to asking Medsafe for permission, or for Medsafe to double-check work that had already been done by better-resourced agencies overseas.
Let’s take a simple illustration.
Last September, Medsafe authorised Jynneos – a vaccine against Monkeypox that has been approved overseas for years. Medsafe’s authorisation meant that the vaccine could finally be advertised; it previously could not. And accessing unapproved medicines is difficult.
Monkeypox spreads readily via sexual contact.
It would have been sensible to advertise and promote the vaccine well before Queenstown’s Winter Pride Festival and let nurses and pharmacists administer it. But that is illegal without Medsafe approval, regardless of how many other countries have approved it.
Medsafe’s approval came too late. One day after Medsafe approval, five cases were reported from the festival.
The coalition agreements promised a simple solution. Medicines approved by at least two trustworthy overseas regulators would automatically be approved here as well.
And then the bureaucracy helped draft the framework.
And, somewhere along the way, things went terribly wrong.
The legislation reported back from Select Committee provides modest improvements to the status quo. But nothing like what was promised in both coalition agreements.
Medicines that have been fully approved by at least two trusted regulators will have a faster path to Medsafe authorisation, rather than automatic authorisation.
There can be years between a medicine being approved overseas and anyone asking Medsafe to approve it here. New Zealand is a small market in a big world. If we are lucky, faster processes will encourage companies to apply here a bit earlier. But we may not be lucky. Medicines that are not put up for approval will not be evaluated. Kiwis who could have benefitted from those medicines will suffer needlessly.
The faster pathway is only available for medicines fully approved overseas. But medicines developed quickly in response to a pandemic often receive emergency use authorisation, with full approval coming later. When time is of particular importance, the most important medicines will not have access to the faster pathway.
The legislation will strengthen access to unapproved medicines – it is an improvement on the status quo. More medical practitioners, including pharmacists and nurse-practitioners, will be able to prescribe medicines that have not been approved here yet, and they will face less paperwork.
Unfortunately, Emergency Medical Technicians are not counted in that group. Work published in the New Zealand Medical Journal warned that EMTs can need to rely on substitute medicines – sometimes ahead of Medsafe certification – if a locally-approved medicine has run short. It is unreasonable to expect EMTs to track down someone who can sign the necessary paperwork before administering medicine in an emergency.
And the prohibition on advertising unapproved medicines will remain a barrier. Your pharmacist may be able to provide an unapproved medicine if it is suitable for you and if you ask for it. But how would you know what to ask for?
It is particularly disappointing when compared to what was promised in the coalition agreements.
The government promised a transformation in the approvals process, allowing automatic reliance on overseas authorisation.
The bureaucracy turned it into a minor tweak on the existing system.
Somewhere, someone decided that medicines already considered safe in Canada, the UK, Europe or the US could not just be automatically approved here, and that we would have to wait until someone saw fit to ask Medsafe’s permission.
The pace of new medicine development will increase substantially. Artificial intelligence is helping to identify new and promising compounds. We are on the cusp of a world of wonders.
Companies developing these wonders will race to get their new medicines approved in major overseas markets. If their regulatory affairs teams handling drug approvals have to decide between sending paperwork for last year’s new medicine to New Zealand, or for this year’s new medicine to the Europeans, the larger market will win.
New Zealand risks remaining an afterthought, regardless of a faster verification pathway.
The legislation is an improvement over the status quo. But it is not the Rule of Two we were looking for.
Click the following links for Eric Crampton’s 2023 report, Safe to Follow: Faster Access to Medicines for Kiwis, and his submission on the Medicines Act Amendment Bill, are available on the Initiative’s website.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was sourced HERE
Lots of other countries have reputable and reliable approval agencies. Relying on their judgement, especially if two of them agreed, would not just save money. It would save precious time.
We would not have to wait for pharmaceutical companies to get around to asking Medsafe for permission, or for Medsafe to double-check work that had already been done by better-resourced agencies overseas.
Let’s take a simple illustration.
Last September, Medsafe authorised Jynneos – a vaccine against Monkeypox that has been approved overseas for years. Medsafe’s authorisation meant that the vaccine could finally be advertised; it previously could not. And accessing unapproved medicines is difficult.
Monkeypox spreads readily via sexual contact.
It would have been sensible to advertise and promote the vaccine well before Queenstown’s Winter Pride Festival and let nurses and pharmacists administer it. But that is illegal without Medsafe approval, regardless of how many other countries have approved it.
Medsafe’s approval came too late. One day after Medsafe approval, five cases were reported from the festival.
The coalition agreements promised a simple solution. Medicines approved by at least two trustworthy overseas regulators would automatically be approved here as well.
And then the bureaucracy helped draft the framework.
And, somewhere along the way, things went terribly wrong.
The legislation reported back from Select Committee provides modest improvements to the status quo. But nothing like what was promised in both coalition agreements.
Medicines that have been fully approved by at least two trusted regulators will have a faster path to Medsafe authorisation, rather than automatic authorisation.
There can be years between a medicine being approved overseas and anyone asking Medsafe to approve it here. New Zealand is a small market in a big world. If we are lucky, faster processes will encourage companies to apply here a bit earlier. But we may not be lucky. Medicines that are not put up for approval will not be evaluated. Kiwis who could have benefitted from those medicines will suffer needlessly.
The faster pathway is only available for medicines fully approved overseas. But medicines developed quickly in response to a pandemic often receive emergency use authorisation, with full approval coming later. When time is of particular importance, the most important medicines will not have access to the faster pathway.
The legislation will strengthen access to unapproved medicines – it is an improvement on the status quo. More medical practitioners, including pharmacists and nurse-practitioners, will be able to prescribe medicines that have not been approved here yet, and they will face less paperwork.
Unfortunately, Emergency Medical Technicians are not counted in that group. Work published in the New Zealand Medical Journal warned that EMTs can need to rely on substitute medicines – sometimes ahead of Medsafe certification – if a locally-approved medicine has run short. It is unreasonable to expect EMTs to track down someone who can sign the necessary paperwork before administering medicine in an emergency.
And the prohibition on advertising unapproved medicines will remain a barrier. Your pharmacist may be able to provide an unapproved medicine if it is suitable for you and if you ask for it. But how would you know what to ask for?
It is particularly disappointing when compared to what was promised in the coalition agreements.
The government promised a transformation in the approvals process, allowing automatic reliance on overseas authorisation.
The bureaucracy turned it into a minor tweak on the existing system.
Somewhere, someone decided that medicines already considered safe in Canada, the UK, Europe or the US could not just be automatically approved here, and that we would have to wait until someone saw fit to ask Medsafe’s permission.
The pace of new medicine development will increase substantially. Artificial intelligence is helping to identify new and promising compounds. We are on the cusp of a world of wonders.
Companies developing these wonders will race to get their new medicines approved in major overseas markets. If their regulatory affairs teams handling drug approvals have to decide between sending paperwork for last year’s new medicine to New Zealand, or for this year’s new medicine to the Europeans, the larger market will win.
New Zealand risks remaining an afterthought, regardless of a faster verification pathway.
The legislation is an improvement over the status quo. But it is not the Rule of Two we were looking for.
Click the following links for Eric Crampton’s 2023 report, Safe to Follow: Faster Access to Medicines for Kiwis, and his submission on the Medicines Act Amendment Bill, are available on the Initiative’s website.
Dr Eric Crampton is Chief Economist at the New Zealand Initiative. This article was sourced HERE
2 comments:
In a word rent seekers.
This has nothing to do with the medicines, it is all to do with jobs. Medsafe has a cosy little empire, run by who knows how many people. They will run from top managers down to clerical staff. Why on earth would the bureaucracy ever shaft any of their own? Pass the legislation and one clerk could replace the entire group. No way. Was never going to happen.
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