Morocco revises drug pricing rules and introduces mechanism to prevent shortages

The reform introduces new rules for originator drugs, generics, and biosimilars, tightens control over price revisions, and allows for price reduction agreements for high-cost medications. A key aspect of the new decree is the inclusion of exceptional measures to ensure the national market's supply during health emergencies, severe shortages, or risk of stock depletion. The decree applies to both locally manufactured and imported human-use drugs with marketing authorization, conditional authorization, emergency use authorization, or specific authorization.

It also specifies the method for converting the ex-factory price of imported drugs into dirhams, based on the average exchange rates from Bank Al-Maghrib over the three months preceding the price setting, adding 2.5% for approach costs and customs duties. The new framework also refines how ex-factory prices are determined when an originator drug's price is unavailable in comparison countries and outlines calculations for changes in packaging size or dosage. Originator drug prices will be reviewed every three years, with different mechanisms for drugs above and below 300 dirhams, based on reference country prices.

Generics and biosimilars will also see more precise regulation, with their prices revised in line with originator drug reductions, capped at 15%. A significant addition is Ar