The 26-day notice: how a compounding wind-down works in Denmark

A request to reinstate the dulaglutide shortage listing in Denmark has been declined. The regulator’s published reasoning is that reported supply now meets forecast demand at the presentation level, which is a narrower test than the one the applicants argued for.

The determination rests on manufacturer-reported supply against forecast demand at the level of individual presentations rather than the molecule as a whole. That distinction matters: a market can be adequately supplied in aggregate while a specific dose strength remains constrained, and the notice acknowledges as much without treating it as grounds for continued listing.

Patients are the constituency with the least notice and the fewest options. A person stabilised on a compounded preparation who is told to transition to an approved product faces a different dose presentation, a different device, a different price and, frequently, a prior-authorisation process that takes longer than the wind-down period allows.

Peter Malinowski, former state board of pharmacy inspector, was blunter about the commercial position. "If your model depended on a shortage list, your model was a bet on scarcity. That is a legitimate bet and it has now lost."

We have asked the regulator whether the audit sample will be published in aggregate. The department will report the answer.