African Medicines Agency Dedication Needs More Than Words – Global Issues

To date, 19 countries have already ratified the convention. However, this number remains well below 55 AU member states and excludes some of the power centers in the region such as South Africa, Nigeria, Kenya, Ethiopia and Senegal. Credit: Charles Mpaka/IPS
  • Opinion by Johnpaul Omollo, Taonga Chilalika (nairobi/johannesburg
  • Inter Press Service

In November 2021, after 15 countries signed and ratified the AMA treaty, the AMA became a specialized agency of the African Union (AU). To date, 19 countries – Algeria, Benin, Burkina Faso, Cameroon, Chad, Egypt, Gabon, Ghana, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone, Tunisia, Uganda and Zimbabwe – have signed the treaty.

However, this number remains well below 55 AU member states and excludes some of the power centers in the region such as South Africa, Nigeria, Kenya, Ethiopia and Senegal.

Over the next five years, African healthcare, especially local pharmaceutical production, will be a major economic driver for the region – expected to account for about two percent of the global pharmaceutical market by 2022.

By harmonizing the regulations for health products, Africa will become a more attractive market for the pharmaceutical sector, both for research and development and for the introduction of innovations.

These harmonization efforts will further enhance trade in support of the African Continental Free Trade Area (AfCFTA), deepening African integration and enabling the development of markets for health products and technologies? Most importantly, the agency coordinates joint assessments and inspections for a select group of products and coordinates capacity building.

The next two years will be pivotal in setting up the agency, including selecting a host country, appointing the Director General, recruiting staff and setting up offices for AMA. Countries that have not yet ratified will have no say in these important decisions that will strengthen the drug regulation in the region.

This has been a long journey. The agency is derived from the African Medicines Regulatory Harmonization (AMRH) initiative launched in 2012 led by the African Union Development Agency (AUDA-NEPAD) to address the challenges facing drug regulation in Africa.

These challenges include weak legal frameworks, duplication and slow drug registration processes and subsequent lengthy approval decisions, limited technical capacity and weak supply chain control. As COVID-19 has shown, these challenges pose both a public health risk and an economic risk to the continent.

To improve the fragmented regulatory system for the registration of medical products in Africa, the vision is to gradually move from a country-oriented approach, where 55 countries operate independently, to a regional cooperation, where five Regional Economic Communities support one agency.

AMA will review regional policies and identify new sources of funding to increase national capacity to regulate drugs, as well as attempt to simplify the complex requirements of regional and global standards and guidelines.

Member States should also be aware of the extensive operationalization process needed to set up the Agency’s administrative and technical workflows. For example, as part of the administrative workflow, they must select a host country, appoint a Director General, recruit staff, furnish office space, and register the treaty with the UN Secretary General.

We must act quickly to ensure that the entire continent is on board. By now, every AU member state should have approved and ratified the AMA by signing, ratifying and depositing its instruments with the AU Commission.

Member States should allocate resources as a top priority to co-finance the agency’s activities, building on the already existing commitment of more than €100 million by the Bill & Melinda Gates Foundation and the European Union.

With a vision to prepare Africa to facilitate the production of 60 percent of the vaccines needed on the continent by 2040, the creation of AMA is a cry for countries and regulators. We urgently need to put in place the tools needed to achieve the optimal operationalization of the Agency by the end of 2022.

We applaud the 19 Member States that have ratified the AMA. We urge these states to be champions by promoting the benefits of the agency across the continent to encourage and motivate the rest to get on board and ratify the Africa Medicines Agency.

Johnpaul Omollo is a Senior Advocacy and Policy Officer at PATH in Kenya. Follow him on Twitter @JPmcOmollo

Taonga Chililika is a Senior Advocacy and Policy Associate at PATH in South Africa. Follow her on Twitter @TaongaChilalika.

© Inter Press Service (2022) — All rights reservedOriginal source: Inter Press Service

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