Morocco is preparing to overhaul the regulatory framework governing marketing authorizations (AMM) for pharmaceutical products, with implications that could reshape the market for generic medicines and ease the financial burden on patients and social insurance funds. The reform is linked to an examination of bill 27.26, which amends the country’s pharmaceutical code and opens the way for revision of the 2015 decree regulating AMMs.
At the heart of the debate are two mechanisms widely viewed as structural obstacles to the timely arrival of generic drugs. The first concerns data exclusivity: under article 4 of the current decree, no third party may rely on a patent-holder’s clinical data for five years from the date of its first Moroccan authorization. In practice, international pharmaceutical laboratories tend to file their Moroccan AMM applications close to patent expiry, thereby securing an additional five-year window of exclusivity after the patent lapses — extending commercial protection well beyond its intended scope.
The case of Ozempic, the type 2 diabetes treatment, illustrates the stakes. Its international patent was due to expire in 2026, but its Moroccan registration only came through in 2025, leaving the country an estimated four additional years without access to more affordable equivalents. A pen of Ozempic costs around €76 in Europe — over €300 per month for a standard regimen — while a generic equivalent retails at roughly €5 in Bangladesh. Countries including Brazil, Argentina, Chile, and Jordan have already revised comparable data-exclusivity provisions in their own frameworks. Meanwhile, AMM approval timelines in Morocco average three years, against a regulatory target of nine to twelve months, causing Moroccan generic manufacturers to reach African markets years after their Indian competitors.
A second obstacle concerns temporary use authorizations (ATU), originally conceived to provide patient access to treatments before formal registration. Some operators are reported to favor this mechanism for prolonged periods rather than filing full AMM dossiers, citing insufficient market size. Drugs marketed under ATU escape the standard AMM price-fixing regime — with prices set by reference to the country of origin — creating an additional structural barrier to generic market entry.
Morocco’s Drug and Pharmaceutical Products Agency has convened a series of consultations with sector professionals on the proposed reforms. The precise content of the forthcoming revised decree remains unclear, and the agency had not responded publicly to queries at the time of reporting.
