Introduction

Africa’s population is projected at 1.2 billion, and although significantly rural, is projected to be the fastest urbanizing population. Africa has a high disease burden of communicable and non communicable disease that contributes to a signicant market for the pharmaceutical industry.It’s estimated that the annual earnings from substandard and/or counterfeit drugs were over US$30 billion, according to the World Health Organization, 2017 report of fake drugs trade. Counterfeit, fake and substandard drugs are a public health risk contributing significantly to morbidity and mortality.

The establishment of the African Continental Free Trade Area(AfCFTA), which will make Africa the largest integrated trading area in the world, allowing access without tariffs to a market of over 1.2 billion potential consumers and by extension creating an African Economic Community by 2028, will have significant importance to public health and safety. Regulation shall be critical to guaranteeing the protection of the 1.2 billion African market from fake, substandard, and counterfeit products and services.

On the more positive side and within the context of the 4th Industrial revolution, the progressive industrialization of Africa, and the possibility of transforming raw materials into products, including into medicines, medical devices and technologies; the scaling up of intra Africa Trade and mobility and the free movement of technical expertise; increased cooperation and partnerships between AU recognized Regional Economic Communities (RECs) shall advance the implementation of the Pharmaceutical Manufacturing Plan of Africa.

It is for the reasons given above that the establishment of a Continental Agency that contribute to the improved regulation of medicines, medical products and technologies is equally timely and critical.
The Africa Medicine Agency(AMA)

In 2014, in Luanda, Angola, between the 14th to the 17th of April, the 1st African Ministers of Health meeting jointly and requested member states to;

a. Prioritize investment for regulatory capacity development;

b. Pursue the efforts towards convergence and harmonization of medical products regulation in RECs;

c. Allocate adequate resources for AMA

In 2019, due to the fact that, weak regulatory systems have resulted in the circulation of substandard and falsified (SF) medical products in many African Union Member States; posing risk to public health, harming patients and undermining confidence in healthcare delivery systems; the Assembly of Heads of State and Government, at its 32nd ordinary session decision Assembly/AU/Dec.735(XXXII) reaffirmed the Executive Council 34th ordinary session decision EX.CL/1141(XXXIV) to establish the African Medicines Agency placing an emphasis on investment in regulatory capacity strengthening.

The AMA Treaty

The African Medicines Agency is to be established by Treaty. The African Medicines Agency is a Specialized Agency of the African Union with its own rules, membership and resources to enhance the capacity of State Parties and Regional Economic Communities (RECs), to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent. The Treaty shall enter into Force 30 days after the deposit of the 15th instrument of ratification and ascension.
Member states who are members of the Conference of the Party to the Treaty, shall be invited to put in an offer to host the Agency. Following an assessment of each countries bid to host, the report shall be presented to the Assembly of Heads of State and Government for a decision on the hosting of the Agency.

The main purpose of AMA shall be

i. To coordinate on-going regulatory systems,

ii. To Strength and harmonize efforts of the African Union-recognized RECs, RHOs and Member States,

iii. To provide regulatory guidance,

iii. To Complement and enhance collaboration and contribute to improving patients’ access to quality, safe and efficacious medical products and health technologies on the continent.

The AMA Treaty has taken into consideration key AU Decisions, Declarations and Policy Frameworks: including The 55th Decision of the African Union (AU) {Assembly /AU/Dec.55 (IV)} taking during the Abuja Summit 2005 requested the AU Commission to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of the New Partnership for Africa’s Development (NEPAD), now African Union Development Agency (AUDA) aimed to improve access to good quality, safe and efficacious medical products and health technologies for the African population and the 19th ordinary session decision of the Assembly - {Assembly AU/Dec.442 (XIX)}, Pillar II also requested the AU Roadmap 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.

The Africa Medicines Agency shall also build on the strengthened capacity of medical products regulation in Africa and the harmonization of regulatory systems, within the context of the African Medicines Regulatory Harmonization (AMRH) Initiative.

To date, 11 member states, namely; Algeria, Benin, Chad, Ghana, Madagascar, Mali, Morocco, Rwanda, Saharawi Arab Democratic Republic, Senegal and Tunisia are amongst the first countries to sign the Treaty, and only Rwanda, has deposited its instrument of ratification at the office of the Chairperson of the Africa Union Commission.

Foot note:

All AU member states are encouraged to sign AMA by either their Ministers of Foreign Affairs or can designate in writing their Ambassador accredited to the Africa Union to sign at the African Union Commission, Addis Ababa, Ethiopia. Following signature, member states are encouraged to ratify the Treaty, as soon as, possible.

Further information can be obtained from the Department of Social Affairs:

DepartmentofSocialAffairs@africa-union.org and from; Dr. Margaret Agama-Anyetei, Head of Division for Health, Nutrition and Population; Social Affairs Department; AU Commission; Tel: +251115162211; E-mail: Agama-AnyeteiM@africa-union.org
Media inquiry Contacts:

Ms. Esther Azaa Tankou, Head of Information Division, Tel: +251911361185, E-mail: yamboue@yahoo.com

For further information contact

Directorate of Information and Communication | African Union Commission I E-mail: dic@africa-union.org I Web Site: www.au.int I Addis Ababa | Ethiopia

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