Media Extract: BURDEN OF PROOF IS ON MEDSAFE TO JUSTIFY ITS EXISTENCE

Media Extract: BURDEN OF PROOF IS ON MEDSAFE TO JUSTIFY ITS EXISTENCE

by Dr. Eric Crampton | The NZ Initiative

Dr. Eric Crampton, in a recent article in The Dominion Post, gave his views on the agency Medsafe and questioned it’s real purpose. The key point was that the way it is structured, it causes delays, which can be life threatening for patients. Some excerpts of this critical view are given here. Full article can be read in the link below.

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.

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.

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 pediatric 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.

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?

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.

Courtesy: The NZ Initiative

Read full article: https://www.nzinitiative.org.nz/reports-and-media/opinion/new-opinion140/