AMATA statement at the 78th World Health Assembly (Agenda item: 13.5)

The International Alliance of Patients’ Organizations, on behalf of the African Medicines Agency Treaty Alliance – AMATA, commends the WHO and Member States for sustained attention to the urgent public health threat posed by substandard and falsified medical products, which continue to endanger lives, particularly in low- and middle-income countries.

Across the world, strong and coordinated regulatory systems have been instrumental in addressing this challenge. In Europe, the Americas, and parts of Asia, well-established regional regulatory agencies have played a key role in ensuring that patients have timely access to quality, safe, and effective medicines. These systems have enabled: rapid detection and recall of dangerous products, shared information across borders, streamlined approvals of essential medicines, and strong deterrents against criminal networks trafficking falsified drugs.

These experiences offer a clear lesson: strong regulatory frameworks save lives and build public trust.

In Africa, the African Medicines Agency (AMA) offers the opportunity to deliver similar benefits tailored to the continent’s unique needs and contexts. Once fully operational, AMA can be a cornerstone of Africa’s efforts to combat substandard and falsified products by: harmonising regulatory standards, enhancing oversight of medicines entering African markets, strengthening cross-border collaboration, and ensuring that no country is left behind in building capacity to fight substandard and falsified products.

Together with AMATA, and as part of the #AfricanMedsAgencyNOW campaign, we call on all African Member States yet to ratify the AMA Treaty to do so urgently. We also urge international partners, including WHO, to support the implementation of the Agency as a strategic partner in the global effort against substandard and falsified medical products to ensure patients have timely access to safe, effective, and quality  medicines.  

Together with AMATA, we stand ready to support this mission, in partnership with Member States, WHO, and the wider global health community.

Thank you.