- The treaty for the establishment of African Medicines Agency entered into force on 5 November 2021.
- AMA will improve access to safe, quality and efficacious medical products and enhance access to the African Continental Free Trade Area.
Foreign Affairs Cabinet Secretary Rachael Omamo has sought Parliament’s approval of Kenya’s move to be a signatory of the African Medicines Agency (AMA).
In a memorandum to the National Assembly, Omamo wants members to consider and approve Kenya’s ratification of the African Union Treaty for the establishment of AMA.
She wants the House to direct her office to prepare and deposit the relevant instruments to the Depository, the Chairperson of the African Union Commission.
The ratification process was approved by the Cabinet during its meeting held on May 12, 2022.
Omamo said the signing and ratification of the treaty by Kenya will demonstrate Kenya’s commitment to the continent’s collective action to the improved regulation of medicines, medical products and technologies.
“Ratification will bring out positive consequences both to the country and member States,” she said.
The CS, in the memorandum dated May 30, 2022, said AMA will provide guidance and enhance efforts towards harmonisation of medical products regulation.
She added that AMA will improve access to safe, quality and efficacious medical products and enhance access to the African Continental Free Trade Area.
Weak regulatory systems have resulted in the circulation of substandard and falsified medical products in many African countries, posing risk to public health, harming patients and undermining confidence in healthcare delivery systems.
Twenty-six member states have signed the treaty while 17 countries have ratified the agreement for the establishment of the AMA and deposited the legal instrument of ratification to the commission.
The treaty for the establishment of AMA entered into force on 5 November 2021.
The Assembly of Heads of States and Government, at its 32nd ordinary session, resolved to establish the African Medicines Agency, placing an emphasis on investment in regulatory capacity strengthening.
The agency is dedicated to improving access to quality, safe and efficacious medical products in Africa.
The AMA Treaty was adopted by the AU Assembly on 11 February 2019 and a minimum of 15 member states were needed to ratify the AMA Treaty in their national parliaments, for AMA to come into force.
AMA seeks to support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA).
It will further play a critical role in catalysing trade in support of the Africa Continental Free Trade Area (AfCFTA).
It will evaluate medical products for the treatment of priority diseases as determined by the African Union.
It will also regularly inspect, coordinate and share information about products that are authorised for marketing.
By developing common standards and regulations, AMA will also be responsible for harmonising legislation.