Africa Pharma Brief: New Agency Hopes to Improve Africa’s Pharma Market

An efficient pharmaceutical regulatory framework can be part of a support system that catalyzes growth in a region’s clinical trials, minimizes trade in counterfeit, substandard and falsified medical products and hence protect patients from harm.

For the African continent, the strive to achieve an efficient regulatory framework of its pharmaceutical industry has seen countries that are members of the Africa Union (AU) sign the Treaty for the formation of African Medicine Agency (AMA, that is being modeled more like the European Medicines Agency though with a few variations.

AMA, which was first mooted by African Heads of State and Government in 2017 followed by the adoption of the Treaty for its establishment in early 2019, hopes to support Africa wean itself from the current low and weak medicine production and also to effectively address the thriving trade in counterfeit and substandard pharmaceutical products in addition to streamlining the medicine imports’ trade.

At least 18 AU Member-States, have signed to support the formation of AMA although it requires at least 15 countries to deposit tools of instrument of ratification at the AU Commission in Addis Ababa, Ethiopia before the Agency is fully launched. So far five have deposited the tools of instrument of ratification.

When AMA if finally launched, it would incorporate roles currently played by the African Medicines Harmonization and the African Vaccines Regulatory Forum, combined under the new Agency that is expected to “serve as the continental regulatory body that will provide regulatory leadership.” (1)

The agency would “ensure that there are harmonized and strengthened regulatory systems, which govern the regulation of medicines and medical supplies products on the African continent.” (1)

AMA, the AU says, “will regulate the access to safe, effective, good quality and affordable essential medicines and health technologies.” (1)

Among the priority areas awaiting implementation by AMA include the coordination of existing “regulatory systems, strengthen and harmonize efforts of the African Union Commission, Regional Economic Communities and the Regional Health Organizations and member states.”

Actually, the World Health Organization (WHO) had previously recognized the fast “changing landscape of biomedical research and product testing” in Africa and supported the creation “of a regulatory platform whose objective is to promote human resource capacity, best practices, common technical requirements and the efficiency and transparency of regulatory processes.” (2)

It is with this realization of the need for a regulatory forum that in 2006 the Organization created the African Vaccine Regulatory Forum (AVAREF) “as an informal capacity-building platform aimed at improving the regulatory oversight of interventional clinical trials being conducted in Africa.” The AVAREF role will be taken up by AMA, once it becomes operational.

AMA will not only strengthen Africa’s regulatory and ethics reviews but also support fast-tracking of vaccines of high health value such as the ones against Ebola, which infected 3,470 people during its 10th outbreak in Democratic Republic of Congo in August this year and has since killed at least 2,287 of patients. (3)

The formation of AMA comes at a time when African governments realize the potential of the continent to become a formidable global pharmaceutical market if only a combination of factors that have been identified as hurdles to the expansion the capacity of the continent to increase its share of the global medicine market share are addressed.

Currently, Africa’s share of the global pharmaceutical market is estimated at less than 2% despite the continent carrying nearly 75% of the world’s HIV/AIDS cases and accounting for up to 90% of the global malaria deaths. (4)

AMA is expected to build on the 2007 AU-endorsed Pharmaceutical Manufacturing Plan for Africa, a continental roadmap on how the continent would ensure increased availability of safe, high quality and efficacious medical products in Africa. (1)

When fully operational, AMA will “coordinate on-going regulatory systems, strengthen and harmonize efforts of the African Union-recognized regional economic communities, regional health organization and Member States.”

Furthermore, through AMA, the African governments hope to address existing hurdles in the fast approval of clinical trials, marketing authorization for new products and the importation of quality, safe and efficacious pharmaceutical products.

REFERENCES

1.     https://au.int/en/pressreleases/20200205/african-medicine-agency-ama-treaty

2.     https://www.afro.who.int/health-topics/immunization/avaref

3.     https://reliefweb.int/report/democratic-republic-congo/drc-ebola-outbreaks-crisis-update-november-2020

4.     https://www.afdb.org/fr/news-and-events/revitalizing-africas-pharmaceutical-industry-13289

About the Author:

With great honor and pleasure, PharmaSources.com has now invited Shem Oirere as one of the writers. He graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.