Wednesday 8 November 2023

A Rule of Two for new drug approvals

Requiring Medsafe to automatically approve any drug that had already been approved by at least two trustworthy overseas regulators would sharply hasten new drug approvals without adding particular risk. 

Giving Medsafe an emergency handbrake for use in exceptional circumstances, subject to ongoing review to make sure they were using it appropriately, would reduce what minimal risk might otherwise result. 

I call it a Rule of Two. 

It's my column in Newsroom this week, and a report we put out on Thursday last week

The FDA spends hundreds of millions of dollars more on drug approvals than Pharmac spends buying drugs. It is exceedingly unlikely that Medsafe would ever find anything that the FDA missed. It is even more exceedingly unlikely that they'd catch something that both the FDA and the European Medicines Agency had missed. Or the EMA and Australia. Or the FDA and Canada. Or Canada and the UK. 

Medsafe has about 60 staff. Take this job off them and let them focus on areas where they might add real value. 

It isn't just that Medsafe pulls stunts like taking fifteen months to approve Ozempic after it had already been approved by everybody else and after it had already been on the market overseas for four freaking years. It's that Novo Nordisk didn't bother to even apply here until December 2021, because what's the point? Medsafe is too much hassle relative to the size of our market. They haven't submitted Wegovy for approval here yet, for obvious reasons. 

The full delay isn't the fifteen months Medsafe spent evaluating. The full delay is the over five years from the drug's second overseas approval until its approval here. 

Government here, and especially during Covid, loved blaming pharmaceutical companies for not getting their paperwork into Medsafe early. 

It would be like requiring Ferrari to send six of their latest and most expensive models to NZ for destructive crash testing, rather than relying on overseas approvals, and then blaming Ferrari for that there are zero Ferraris on the market in New Zealand. In that case it would be the stupid rule that would be the problem, not Ferrari. It's crazy that we seem able to (sensibly) rely on foreign approvals for cars but not for medicines. I'd think relying on just one would be fine, but a Rule of Two would be sufficiently better than what we have that that's fine too. 

Our report draws on the work of a couple of teams of Canterbury econ students who checked whether Medsafe approval ever really actively protects Kiwis. Turns out there's basically no cases where Medsafe long-term declined drugs that would have been approved by a Rule of Two, and Medsafe withdrawals of drugs from the market tends to follow foreign leads anyway. 

So. Set a Rule of Two. 

Policy doesn't have to be stupid. 

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