As 2022 unfolds with many promising aspirations for Africa, the African Medicines Agency’s (AMA) operationalisation will certainly be one to keep an eye on.
The treaty establishing the agency became on November 5 2021 after the signing, ratification and submission of the legal instrument by the 15th Member State—Cameroon. By February 2 this year, 28 countries had signed the treaty while 19 had ratified it.
With over half of the African States signing up, more countries are set to follow.
The agency seeks to coordinate ongoing regulatory initiatives and systems and enhance the capacity of State parties as well as the regional economic communities to regulate medical products and technologies in the continent.
Africa’s physical and virtual pharmaceutical market has for long been preyed on by counterfeiters and nonconformists who have consistently flooded the market with falsified and substandard medicines.
Such products tend to circulate where there is inadequate regulation and governance framework, manifesting itself through unethical practices by manufacturers, wholesalers, distributors, retailers, healthcare workers and quack herbalists, among others. Similarly, substandard medical products tend to reach patients when there are limited tools and technical capacity to enforce quality standards in manufacturing, supply and distribution.
These conditions have contributed to the widespread sale and consumption of unsafe and inefficacious medical products on the continent.
The World Health Organisation (WHO) records that between 2013 and 2017, Africa accounted for 42 percent of global seizures of falsified and substandard medicines. During the same period, the continent’s burden of the sale of falsified and substandard medical products stood at over 30 percent.
In certain regions, the sale of particular falsified medicines exceeded the gross domestic product (GFP) of some African economies.
In 2016, potentially dangerous and illicit medicines worth $59 million were confiscated during an Action Against Counterfeit and Illicit Medicines’ operation in Africa.
The outcome of this menace has been dire and burdened the African economies on all fronts, encumbering economic and social progress besides greatly affecting the healthcare systems and treatment outcomes.
Firstly, individuals, especially in the informal economy that accounts for over 80 percent of the African economy, continue to spend on inefficacious and unsafe medicines. Fake antimalarial medicines alone cost patients and health care systems about $38.5 million annually.
This further shrinks the already meager disposable income of these individuals, making it difficult to end poverty
Secondly, governments lose revenue through unpaid taxes while spending a fortune to combat the sale of unsafe and ineffective medical products.
Thirdly, legitimate pharmaceutical firms face declining revenues due to unfair competition for the market. Therefore, they downsize and eventually shut down.
Socially, the falsified and substandard medicines further erode Africa’s human capital and productivity which is critical for its economic growth and development.
According to the WHO, counterfeit drug trade in Africa accounts for about 100 000 deaths per year.
Lastly, the reported scandalous sales of false and substandard medicines continue to destroy citizens’ trust in their healthcare system. This has resulted in seeking medical attention from traditional or unqualified professionals.
However, laudable efforts have been made at the continent level to counter the sale and consumption of FS medical products.
These include continental policy frameworks such as the Pharmaceutical Manufacturing Plan for Africa (that aims to catalyse local production of quality and affordable pharmaceutical products), the African Medicines Regulatory Harmonisation Initiative and the Lome Initiative that seeks to criminalise the trafficking of falsified and substandard drugs in the continent.
The AMA comes in as the continent’s independent agency with full mandate to enhance the capacity of African countries and regional bodies to regulate medical products and technologies.
It will enhance the competence of good manufacturing practices inspectors in pharmaceuticals as well as coordinate and build on the on going regulatory initiatives and systems. In close collaboration with the African Continental Free Trade Area, the agency will further coordinate and enhance the initiation and monitoring of primary medical supplies in the supply chain.