Burden of proof is on Medsafe to justify its existence

Dr Eric Crampton
The Dominion Post
29 November, 2021

It isn’t that a New Zealand drug approval agency is a bad idea per se. It’s rather that the one we have might not be worth having.

Drug approval processes worldwide are costly, both in time and in money. It is important to be sure new drugs are safe. It is also important that health insurers and governments purchasing drugs know those drugs are effective.

But an approval agency that simply rubber-stamped every application it received would risk approving a lot of unsafe drugs.

And some people would be hurt or die as consequence.

But you could also imagine an agency that took half a century to approve any application. No drug would be approved unless the agency could determine, with certainty, that no adverse effects were encountered for decades after taking a drug.

Nobody outside of clinical trials would ever be hurt by a bad drug, but a lot of people would suffer and die from the conditions that those drugs could have treated.

Taking too long to approve treatment for a dangerous disease can also be an exceptionally risky choice. Especially in a pandemic.

A good drug approval agency, in principle, must balance those risks. Precautionary considerations cut in both directions.

In practice, things can be different.

If an unsafe drug is released, deaths make headlines. They attract protests. And the official who approved the drug may be sacked. But if a drug takes years longer to be released than it should, most of the people harmed will not even know it. The treatment simply is not available.

Economist Alex Tabarrok argues that the political costs of different types of errors weigh heavily for drug approval agencies, leading them to err on the side of hurting people through approval processes that are too costly and take too long. Empirical work has been consistent with Tabarrok’s hypothesis.

But the simplest confirmation of Tabarrok’s hypothesis requires no complex statistical tools. Drugs proven safe and effective for one purpose can readily be prescribed for any other purpose so long as doctors and funders think it appropriate. Making approval conditional on efficacy then only adds delay.

All of that suggests drug approval agencies worldwide should ease back on their approval processes.

Now imagine that Medsafe had never existed. New Zealand could rely on approvals provided by trusted regulators elsewhere.

If at least two of Australia, Canada, the United States, the UK, Singapore, the European Union, Israel, Switzerland or Japan approved a drug, it would automatically be approved here too. There are a lot of approval agencies out there. New Zealand would never be slower than the second-slowest trusted agency.

Why replicate the efforts of better resourced agencies elsewhere who are already on the task?

There could be a good reason.

If international regulators err on the side of being too slow, a New Zealand agency could be faster and nimbler than others. Where other agencies harm their publics by taking too long to approve drugs, ours could avoid such errors.

That does not seem to be the role Medsafe plays.

Instead, Medsafe adds further delay on top of delays seen abroad.

Delayed approvals put us at the back of procurement queues for effective Covid treatments that will be in high demand. Those treatments keep patients out of scarce intensive care beds. Delays will matter.

Pfizer’s paediatric Covid vaccine was approved in America weeks ago. Millions of doses have since been administered. Canada started vaccinating kids last week. Europe approved it last week. And all seems to be going well.

Meanwhile, One News reports that MedSafe may take a long Christmas holiday before finalising approval here, even though Covid will soon be widespread.  "Medsafe later clarified that it would continue to assess the data over the summer, but the organization seems to see little need for urgency." 

At this point, the burden of proof should be on Medsafe to justify its continued existence.

What value do they provide that justifies the delay that they impose?

Does anyone really believe that New Zealand’s regulators will find a flaw that the Americans, the Canadians, and the Europeans missed – a flaw big enough to justify putting us months behind others? Even though the American Food & Drug Administration’s annual budget, all on its own, is over NZD$8 billion?

Medsafe could be replaced by a rule.

Any vaccine, drug, or treatment approved by at least two trusted agencies, whether fully or as emergency use authorisation, would receive matching approval here.

Or, if the government did not want to abolish Medsafe, it could require that, within two working days, Medsafe approve any drug approved by two trusted agencies.

And parents wanting the safest choice for their kids would not need to be planning summer vaccination flights abroad.

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