The Moroccan Agency for Medicines and Health Products (AMMPS) has recently approved the national market release of Ozempic for the treatment of type 2 diabetes. Currently, only the expensive brand-name version of this injectable medication, which contains semaglutide, is available. The Association for Access to Treatment (ITPC-MENA) has approached the agency to advocate for the availability of affordable generic versions, emphasizing that their use should not be misappropriated. The Moroccan Agency for Medicines and Health Products (AMMPS) authorized the introduction of Ozempic to the national market earlier this November. Previously available only abroad, this injectable medication containing semaglutide is prescribed for type 2 diabetes alongside appropriate diet and physical activity. Its proper use could significantly improve quality of life in a country where diabetes affects 10.6% of adults aged 18 and over, nearly 2.7 million people. According to data cited by the Ministry of Health and Social Protection on the occasion of World Diabetes Day, and at the launch of a national campaign running from November 14 to December 15, 2025, the national survey on common risk factors for non-communicable diseases shows that 10.4% of Moroccans are «at a pre-diabetic stage, half of whom are unaware of their condition», delaying treatment and care. The ministry also underscores the significant financial burden linked to diabetes. In 2022 alone, annual expenses related to the disease exceeded 1.5 billion dirhams, according to the National Health Insurance Agency (ANAM). The arrival of Ozempic is therefore considered promising. The Association for Access to Treatment (ITPC-MENA) noted on Wednesday that «administered once a week, this treatment represents a major therapeutic advance for people living with diabetes, a chronic disease that continues to grow rapidly». Yet, the NGO warns that «behind this good news lies a major concern in Morocco's drug policy: the way clinical data exclusivity is currently applied risks delaying the arrival of much more affordable generics, effectively reserving Ozempic for a small minority who can afford it, or for a limited number of insured patients». A Data Exclusivity Rule That Limits Access According to ITPC-MENA, the issue stems from «a poorly designed clinical data exclusivity clause». Citing Article 4 of the decree governing marketing authorization (AMM), the association explains that any innovative drug obtains five years of protection over the clinical data submitted by its holder. During this period, no generic manufacturer may rely on that data to request authorization, a restriction that keeps cheaper semaglutide generics off the Moroccan market. Speaking to Yabiladi, Othmane Marrakchi, advocacy officer at ITPC-MENA, confirmed that «the problem lies in the restrictive exclusivity rule», which prevents both the importation and the local development of generics for several years. «We have alerted AMMPS about this issue, and the Agency assured us it is reviewing the decree», he added. He hopes the NGO's recommendations will be taken into account, «if not for Ozempic, then for other essential medications for costly diseases». The organization also notes that even when a drug's patent has expired, is disputed, or does not exist, Morocco cannot authorize a generic version before the five-year period ends, unless it requires the manufacturer to repeat costly and ethically questionable clinical trials. «As written, this provision exceeds international standards and restricts the flexibilities Morocco is entitled to under WTO rules to improve access to generics», ITPC-MENA stressed. Since its release abroad, Ozempic has frequently been used off-label for weight loss, leading to shortages, falsifications, and safety warnings in several countries. Some, such as France, now strictly regulate its use. In France, one pen costs €76.58, more than €300 for four doses per month. Avoiding Misuse While Ensuring Affordable Access For Marrakchi, Morocco can avoid both misuse and exclusion. He argues that the priority must be «regulation that ensures affordable access for diabetic patients», not high prices intended to deter non-diabetic use. «I believe Morocco has all the administrative, legal, human, and technical capacity needed. Developing an affordable local generic would ease the financial burden on both patients and the social security system, while strengthening health sovereignty and I believe our national laboratories are fully capable of producing it», he said. In this regard, ITPC-MENA is calling on AMMPS and the supervising ministry to revise the exclusivity clause. Its recommendations include: - Limiting data protection when a drug has already been marketed for more than 18 months abroad; - Excluding protection in cases where generics are already approved in recognized regulatory systems, or when the patent is expired or nonexistent; - Ensuring the primacy of public health by allowing explicit waivers of data exclusivity when required for public health needs, budgetary pressures, or to support local generic manufacturing.
