Come the next pandemic, we are going to be in the same stupid mess that we were in during the last one.
Trusted pharmaceutical regulators overseas, like those in Australia, Canada, Europe, and the UK, will have given provisional approvals for vaccines that are safe.
And Kiwis will have to wait, despite two coalition agreements promising it would not happen again.
Both the National - NZ First and the National - ACT agreement included the following commitment:
“Require Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.”
A Rule of Two for medicines approval. If at least two trusted agencies have approved the drug, it would automatically be approved here.
Drug approval regimes always need to balance two risks. Approving everything without checking anything would mean no delays but potential risk of drugs that are not safe. Spending twenty years and a billion dollars testing each new medicine before release would mean little risk of bad drugs being released, but a lot of unnecessary misery, illness, and death for those who could have been helped by a drug that was delayed.
If a drug has already been approved by two competent agencies, requiring Medsafe approval does not do much to improve safety.
The European Medicines Agency has about nine hundred staff and draws on over forty authorities from across EU member states. The UK’s Medicines and Healthcare products Regulatory Agency has over a thousand staff. Medsafe has about sixty. It is unlikely to find anything that others have missed.
Medsafe’s main contribution is delay.
Automatic approval would not mean the drug would be funded – that would be a careful and separate decision for Pharmac to make.
But Medsafe delays affect those decisions.
In August 2023, Pharmac published a proposal to decline funding applications for 27 different medicines. In 24 of the 27 cases, Pharmac’s stated reason for declining to progress funding applications was simply “We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration.”
Obviously, the problem isn’t just that Medafe is slow, though it is very slow. The problem is also that New Zealand is a tiny and relatively poor backwater with little real willingness to pay for new medicines. No supplier being willing to pursue Medsafe registration is our problem, not theirs.
Drug companies are slow to get drugs into New Zealand’s approval process. Their regulatory teams will typically target their largest potential markets first, then work their way down the list. In the odd case where they think Pharmac might fund a medicine quickly, Medsafe might be a higher priority. Otherwise, we are very much at the back of the queue.
And for drugs targeting rare disorders, New Zealand may never make the queue at all. A disorder striking one person in a million, in a country of five million people, means a potential market of five people. Requiring Medsafe approval for those medicines is like requiring Lamborghinis proven safe overseas to undergo local crash-testing. But nobody would smash a million dollar car in hope of maybe being able to sell a single one in a small market. We sensibly rely on overseas approval for cars. We ought to for medicines.
The version of the Rule of Two that I had suggested, and the version written into both coalition agreements, solved that problem.
In my version, Medsafe would have a short period in which to pull an emergency handbrake. If Medsafe had extraordinary reason to believe a drug proven safe elsewhere would not be safe here, they could insist on local checks. If Medsafe then protected us against drugs withdrawn from markets overseas, we could thank them. If they instead just provided delay, the government could remove the handbrake.
The version in the Coalition agreements had no handbrake. Just a thirty-day clock from the date a drug was approved by the second trusted overseas agency.
In either case, nobody would have to wait for a pharmaceutical company to get around to submitting a drug for Medsafe approval. It would be automatically approved. Importers could then simply bring in approved drugs from the relevant overseas markets, so long as the imported medicine matched what was approved abroad.
Drugs already approved by two trusted overseas regulators will have access to a new fast-track verification process (in addition to the existing pathway for drugs elsewhere-approved).
Only fully-approved medicines will have access to the new pathway, so it will not help us in any future pandemic. A better system would have provided provisional approval for medicines provisionally-approved by trusted regulators overseas.
New Zealand will have to wait for pharmaceutical companies to submit their drugs for Medsafe approval through the fast-track process. During Covid, nobody was in a hurry to get treatments into Medsafe’s approval process; when asked, Medsafe simply blamed companies for not applying. Perhaps a faster track will attract more applicants.
But how fast will that track really be?
The Coalition agreements promised thirty days from the date a drug was approved by a second overseas agency.
The Bill promises thirty working day approval after Medsafe acceptance of an application. Acceptance may be some time after receipt if Medsafe needs to confirm that the drug is eligible for the pathway. Medsafe requires unredacted assessment reports from both approving countries’ agencies. If the pharmaceutical companies have not been provided with a copy of the unredacted report from the overseas regulators, the path will not be available.
And, in any case, the Bill’s Regulatory Impact Statement makes clear that Medsafe can stop the 30-day clock at will. It need only ask the applicant for more information. The clock does not run while waiting for the requested information.
In short, it looks like Medsafe officials ran circles around the Minister and his staff to avoid producing legislation meeting the clear intent of the coalition agreements.
There is a way to access unapproved medicines, despite Medsafe. Section 29 of the Medicines Act allows doctors to prescribe overseas-approved medicines.
But the section is restrictive. Paramedics, for example, are not authorised to dispense unapproved medicines independently. As Dylan Mordaunt explains in the New Zealand Medical Journal, that can be a substantial barrier “forcing paramedics to choose between adhering to the law and providing optimal patient care.”
And the section was useless in facilitating access to Covid vaccines that had been approved overseas months before they were submitted for Medsafe approval.
Submissions on the Bill close 19 May.
I will be pointing out that this is not the Rule of Two that they promised us.
To read the full article on the Newsroom website, click here.