Ratification of the African Medicines Agency Treaty

“The African Medicines Regulatory Harmonization (AMRH) program is playing a critical role in building the foundation for AMA. Through our established continental working committees, we are developing the technical capacity for the trust and collaboration necessary to implement AMA and advance regulatory efficiency on the continent,” adds Chimwemwe.

Multi-sector stakeholder advocacy

Multi-sector advocacy by stakeholders is critical to achieving ratification. In Kenya and South Africa, NRAs and PATH worked with various stakeholders to advocate for treaty ratification up to ministerial level. The process was accelerated by cultivating internal advocates within NRAs and health ministries, as well as external advocates, including civil society groups, pharmaceutical societies and manufacturers, the media, regional economic committees and international institutions, such as the AU and the European Union. World Health Organization.

PATH held different engagement meetings with NRAs that provided them with opportunities to advocate for treaty ratification with stakeholders in Kenya and South Africa. Different methods to engage these stakeholders included meetings, training, and formal and informal discussions during conferences and convenings.

Political good will for regulatory harmonization

Strong political goodwill and prioritization by the government and health ministries in Kenya, Tanzania and South Africa helped accelerate ratification of the treaty. Political goodwill is created when powerful decision-makers with legal and financial influence understand the importance and benefits of strengthened NRAs, harmonized regulatory systems, and the role WADA plays in achieving these goals. Promotion commitments are an invaluable component.

In Kenya and South Africa, PATH developed communication packages to share information, equipping leaders with the information they needed when making decisions during the treaty ratification process. PATH is also providing Kenya with technical support on the Kenya Drugs Authority Bill legislation that will enable the establishment of a strengthened drug authority for the country and contribute to the country’s NRA reaching maturity level 3.

Funding commitment

A mandatory prerequisite for countries that have ratified the treaty is the commitment of resources to co-finance the operations of the AMA. Member states will be required to commit financial, technical and in-kind resources to support the operationalization and administration of the agency; These resources will not only strengthen clinical trials and improve manufacturing standards within each country, but will also position the continent’s regulatory bodies on a global scale.

Align national and continental regulatory frameworks

For the AMA to function effectively and efficiently, countries must align with the continent’s regulatory law, the AU Model Law for the Regulation of Medical Products, and the AMA’s healthcare policies. WADA member countries will also be required to create an enabling environment for the sustainability of the pharmaceutical industry to encourage local pharmaceutical production, in line with the Pharmaceutical Manufacturing Plan for Africa and its business plan.

Policy coherence between relevant government ministries and those involved in the pharmaceutical industry, together with the WADA, will be key to the success of local pharmaceutical production on the continent.