On the eve of the AUS, the International Alliance for Patient Organizations (IAPO) joined by other 50 organizations representing hundreds of thousands of patients, product development partnerships, youth groups, researchers and industry leaders, issued a statement urging Heads of State and Governments, to ratify the African Medicines Agency (AMA) Treaty as a matter of priority.

The AMA Treaty was adopted by the 32^nd ordinary session of the African Union Assembly held in Addis Ababa, Ethiopia on 11 February 2019, two years on, the same remains ratified. Although political support abounds, legal commitment from more countries remains to be secured for the continent-wide regulatory agency to become a reality. The Treaty has so far been signed by 19 countries, but only 8 out of the necessary 15 have ratified it.

On the margins of the 33^rd AUS, the Republic of Guinea, Republic of Seychelles and Republic of Niger signed the Treaty for the establishment of AMA to raise the signatories’ number for the Treaty to 14 countries, read the February 09^th 2020, African Union statement, titled- Three AU Member States signed the Treaty for the establishment of AMA.

As of then, 14 member states, namely: Algeria, Benin, Chad, Ghana, Guinea, Madagascar, Mali, Morocco, Niger, Rwanda, Saharawi Arab Democratic Republic, Senegal, Seychelles, and Tunisia were among the first countries to sign the Treaty, and only Rwanda, had deposited its instrument of ratification at the office of the Chairperson of the Africa Union Commission.

This clarion call is to ensure that patients are placed at the center of medicines regulatory harmonization processes. This is a reminder that further delaying the establishment of AMA undermines timely access to effective, quality and safe medicines and vaccines for all patients across Africa.

The COVID-19 pandemic has highlighted the importance of regulatory harmonization in the context of public health emergencies current or subsequent and the need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner.

It is of paramount importance to establish a continental regulatory body to reduce the complexity of regulatory frameworks and hence to enable all patients in Africa to have timely access to quality medicines that are safe and effective. This new agency is an integral part of the WHO Global Patient Safety Plan 2020-2030.

AMA presents an opportunity for an enabling environment to effectively regulate the whole supply chain for health products as well as leverage African regulatory assets and capacities to improve access to essential medicines and health products that are safe, effective, affordable, and quality-assured.

The first call for the ratification of the AMA treaty in 2017 by IAPO was made at their African Congress in Entebbe, Uganda via The Entebbe Statement. Granted that the African Union (AU) proposal to establish an African Medicines Agency, patients need to be recognized as partners and be meaningfully engaged.

Considering the need for patients to be placed at the epicenter of medicines regulatory harmonization processes and in line with IAPO’s goal of shaping law, policy and practice for well regulated and safe patient-centered health care, we invite you to support and widely share our statement calling for the ratification of the AMA Treaty.

The AMA Treaty factors in key AU Decisions, Declarations and Policy Frameworks including:

1. The 55th Decision of the AU (Assembly /AU/Dec.55 (IV)) taken at Abuja Summit of 2005. This requested the AU Commission to develop a Pharmaceutical Manufacturing Plan for Africa within the framework of the New Partnership for Africa’s Development (NEPAD), now African Union Development Agency (AUDA). This aimed at improving access to good quality, safe and efficacious medical products and health technologies for the African population; and

    

2. The 19th ordinary session decision of the Assembly (Assembly AU/Dec.442 (XIX). Pillar II requested the AU Road map on Shared Responsibility and Global Solidarity for AIDS, Tuberculosis and Malaria response in Africa on access to medicines aiming to accelerate and strengthen regional medicines regulatory harmonization initiatives and lay the foundation for a single African regulatory agency.

With Uganda’s ratification AMA’s establishment shall: Coordinate on-going regulatory systems; Strength and harmonize efforts of the African Union-recognized Regional Economic Communities (RECs), Provide regulatory guidance; and Complement and enhance collaboration and contribute to improving patients’ access to quality, safe and efficacious medical products and health technologies on the African continent.