New medicines are slow to be authorised for the New Zealand market.

Even if a medicine has already been approved by many other trustworthy overseas regulators like those in Canada, the UK, Australia, and the EU, Medsafe can take a very long time to evaluate a medicine.

But pharmaceutical companies are not quick to get their medicines into our approval process. New Zealand is a tiny market. We are not at the top of anyone’s priority list. Medsafe will not assess a medicine without an application.

Consider RSV – the respiratory virus whose name is utterly unpronounceable when it isn’t an acronym. It is highly contagious. Pregnant women, infants, and some young children are more at risk from it – at least according to the Immunisation Advisory Centre.

Vaccination against RSV is available for New Zealand’s elderly. But while forty other countries allow access to Abrysvo, a vaccine administered to pregnant women to protect their infants, Medsafe’s database shows no evidence that its manufacturer has applied for New Zealand approval.

New Zealand researchers helped with the clinical trials that proved its safety and effectiveness. But the vaccine is not available here. Simply being good enough for forty other countries and tested here isn’t sufficient.

The Coalition agreements that formed the current government promised a solution. The new government would “Require Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.”

Submissions on the legislation intended to achieve that result close today.

Unfortunately, the legislation will not solve the problem.

The proposed legislation does not provide automatic approval of medicines proven safe and effective elsewhere.

It instead proposes a new ‘verification’ pathway for some new medicines that have been approved by at least two trusted overseas authorities. It promises faster evaluation, but with a few conditions.

Drugs provisionally approved elsewhere under an emergency use authorisation would not be eligible for the pathway. Covid vaccines and treatments that earned rapid emergency approval abroad and helped save lives would not be eligible. So the system will fail in emergencies when it is most urgently needed.

And Medsafe can stop the clock on any verification process by asking for more information. Even if a drug has already been approved by forty other countries, if Medsafe wants to further delay access here, it can simply demand more paperwork. 

Most importantly, the system still counts on pharmaceutical companies to make the first move. Perhaps a faster and simpler pathway will encourage some manufacturers to apply more quickly for Medsafe approval. But we should not be optimistic.

Drug companies time release into different markets deliberately. Their regulatory teams will want to prioritise the largest and most lucrative markets first and then work their way down the list. New Zealand will remain a small market with limited willingness to pay for new medicines. So companies will still have little reason to submit a low-margin older generic drugs for Medsafe approval.

Worse, President Trump has threatened to ban drug companies from charging more in the United States than they charge elsewhere. Similar rules within Europe resulted in drug companies delaying the rollout of new medicines in poorer European markets by up to a year.

If authorising a drug for the New Zealand market requires charging Americans no more than Pharmac might pay, don’t expect anyone to be in a hurry to apply for New Zealand authorisation.

The world sits on the edge of an age of wonders in new medical discoveries. Researchers collaborate with artificial intelligence tools tuned to discover promising compounds. The pace will increase. Medsafe will have a harder time keeping up. And the proposed verification pathway will not do much to ease the burden.

Economist Alex Tabarrok describes the “invisible graveyard” filled with people who could have been helped by safe and effective medicines that have been unduly delayed. As the pace of innovation overseas accelerates, relying on overseas approvals becomes more important.

The proposed legislation simply does not solve the problem.

There are two potential solutions.

The legislation could shift from a verification pathway to the automatic approval envisioned in the coalition agreements. Drugs approved by at least two trustworthy regulators would automatically also be approved here.

Medsafe could be provided with an emergency handbrake for medicines it thought needed particular attention here before authorisation. If it abused the handbrake, the handbrake could be removed.

Alternatively, the pathway that already exists in Section 29 of the Medicines Act for unapproved medicines could be strengthened.

If a medicine has been approved by at least two trusted overseas authorities, it could have a simplified import process through Section 29, with a broader range of clinicians authorised to administer those medicines.

The legislation as drafted fails to solve an important problem. But it can be improved. It should be.

To read the full article on The Post website, click here.