PATH lauds government of Kenya for fully ratifying the African Medicines Agency Treaty

September 13, 2023 by PATH

Less than two years since the establishment of the African Medicines Agency (AMA), Kenya officially deposited its ratification instruments to the African Union Commission on 16 July 2023.

This is a momentous development that sets precedent for more African countries to follow suit in the ratification process. Kenya depositing ascension instruments to the African Union Commission (AUC) and moving it to full ratification is a show of solidarity and support to regulatory harmonization initiatives in Africa and will ensure that the AMA—while becoming fully operational—contributes to increased availability of safe and efficacious medicines and medical products across the continent and boosts Africa’s manufacturing capacity for health products including drugs and vaccines.

Over the past few years, PATH provided technical assistance and advocacy for ratification of the AMA in Kenya. PATH supported the government by providing ongoing technical assistance through written documentation, presentations, and trainings for decision makers highlighting both the process and benefits of the agency to the country and continent at large. PATH engaged government stakeholders as champions for ratification and played a key role to support the government in the AMA public participation process, both by planning and convening stakeholders for their inputs.

PATH has also been a strong partner of the Africa Union Development Agency (AUDA-NEPAD), the development agency of the AU, in facilitating crucial conversations with key stakeholders across the African continent, including heads of state, ministers, and policy experts, underscoring the urgency with which the AMA treaty needs to be ratified by all 55 AU member states. For example, in November 2021, we co-convened a stakeholder consultation alongside the Southern African Development Community (SADC) Ministers of Health meeting in Lilongwe, Malawi to amass political support for the AMA. This influenced Malawi’s eventual signing of the treaty.

The AMA, whose headquarters are currently hosted in Rwanda, officially came into force on 5 November 2021 after the 15th country fully ratified the treaty. Amongst others, the agency has an impact driven mandate to increase the approval of safe and quality medical products through facilitating work sharing and other reliance pathways. The agency will support the availability of both regulatory and scientific guidance for priority and emerging diseases and for traditional medicines. The AMA is designed to harmonize the regulatory landscape and move Africa towards a single integrated block, especially with regards to the regulation of medical products; enhance standards; improve ease of movement of medical products that meet accepted international standards; promote local production; encourage innovation; and ensure efficiency and ease of innovation introduction into the African market.

The operationalization of the AMA will further strengthen intra-Africa trade through collaboration with the African Continental Free Trade Area.

The main foreseen contributions of the AMA to Kenya will include but are not limited to: addressing human capital issues and infrastructure related to harmonization of medicines and medical products regulatory framework; reviewing policies and identifying avenues for access to finance for enhancing national capacity for medicines regulation and control in Kenya; and, enabling the Kenyan pharmaceutical industry to mitigate challenges posed by the complex requirements which involve meeting product quality in conformance to Good Manufacturing Practices (GMP) standards to spur local pharmaceutical production. The need for the establishment of supportive structures for common use cannot be over emphasized, hence the necessity to be part of the African Union’s broader regulatory scheme through the AMA.

“Ratification of the AMA treaty is a very important and necessary pre-requisite for AU member states to commit resources to co-finance the operations of the agency as a top priority, building on the existing commitments from various development partners,” said Dr. Nanthalile Mugala, PATH’s Chief of Africa Region.

In addition to Kenya, PATH also applauds the 25 other AU member states that have so far ratified the AMA treaty. PATH pledges its continued technical and advocacy support to ensure more AU member states complete their AMA ratification processes, for the continent to become more capable and self-sustaining in manufacturing its own medical products and technologies.