The African Medicines Agency And Medicines Regulation: Progress, Challenges, And Recommendations

• By: OKAFOR, Olanike Olawumi (Pharmacy Council Of Nigeria)
• Co-author(s): Mr. Adeniyi Abdulwahab
  Dr Ukamaka Okafor (Pharmacy Council Of Nigeria, Nigeria)
  Mr. Damilola Adesuyi
  Dr Adriana Miranda
  Miss Rashidat Yusuf
  Mrs Olanike Olawumi Ajayi (Pharmacy Council Of Nigeria, Nigeria)
  Professor Don Eliseo Lucero-Prisno
  
• Abstract:

  Title: The African Medicines Agency and Medicines Regulation: Progress, Challenges, and Recommendations
  
  Background information: Africa, the second most populated continent, struggles to meet the health needs of its growing population and remains the only global region with the highest rates of mortality and the shortest average lifespan. The United Nations Economic Commission for Africa (UNECA) reported that Africa imports approximately 94% of its medicinal and pharmaceutical products. This implies that most patients have no access to locally manufactured drugs and may be unable to afford imported ones, many of which are either fake, substandard, or counterfeits. In response to this and other arising issues in the pharmaceutical sector, the African Medicines Agency (AMA) was formed; as a specialised agency of the African Union (AU) intended to facilitate the harmonisation of medicines and medical products regulation throughout Africa. Following a similar model to that of the European Medicines Agency (EMA), the AMA is intended to address the inefficiencies of the National Medicines Regulatory Agencies (NMRAs), which is essential in ensuring medical products' quality, safety, and efficacy in the continent. The AMA is expected to absorb and supervise roles currently performed by other regional bodies such as the African Vaccines Regulatory Forum (AVAREF) and the African Medicines Regulatory Harmonization (AMRH) initiatives.
  
  Purpose: This study examines the key milestones in the establishment of the African Medicines Agency, the factors that have enabled AMA, the challenges faced by AU member states in ratifying the AMA treaty, the role of each member state in the operationalization of the AMA and its anticipated benefits.
  Method: We conducted a review of data sources that explored the progress and challenges of the African Medicines Agency and Medicines Regulation in Africa. Further, we drew lessons from existing continental initiatives such as EMA and South-east Asia Regulatory Network (SEARN) and areas of applicability to AMA. The retrieved data were discussed narratively to address the aim of the study.
  Results: The implementation of AMA is largely hindered by poor political commitment in some member states, corruption, differences in risk-benefits interpretation amongst the member states, differences in organizational structure, weak legal/regulatory frameworks, inadequate financial mechanisms, and inadequate political and policy leadership. Despite these challenges, the treaty has recorded remarkable successes which include the appointment of a Special Envoy, the selection of its headquarters, and the signing of the treaty by 33 member states.
  Conclusion: The value of AMA in achieving optimal health outcomes and its other benefits cannot be overemphasized. Therefore, all member states should adopt the best procedures in signing and ratifying the treaty, and implementing associated commitments.