Nairobi: The proposed East African Community Medical Products Bill, 2024, will go a long way in enhancing the implementation of the East African Community (EAC) Customs Union and the Community’s industrialisation Policy and Strategy.
According to Kenya News Agency, Dr. Abdullah Makame, the Chairperson of the General-Purpose Committee (EALA), stated that the region had the capacity to manufacture some of the products it needed but lacked adequately coordinated systems and policies to ensure that those products could be produced and moved efficiently across Partner States. Dr. Makame reflected on the region’s unpreparedness during the COVID-19 pandemic, highlighting the reliance on imported medical products that could potentially be manufactured locally.
During a Public Hearing on the proposed Bill, Dr. Makame emphasized the necessity and timeliness of the Bill, clarifying that the EAC is aiming to create a harmonised regional framework for the regulation, production, movement, and access to medical products. Introduced in the East African Legislative Assembly (EALA) in October 2024, the Bill seeks to enhance cooperation and access to safe, quality, and affordable medicines across the region.
The legislation aims to harmonise the management, production, and distribution of medical products, supporting regional industrialisation and reducing dependence on external suppliers. Dr. Makame noted that the Bill intends to strengthen policies, regulatory systems, and Good Manufacturing Practices for both human and animal medicines.
Dr. Makame highlighted that better regional pharmaceutical management and production could lead to a healthier population and workforce. The Bill seeks to harmonise medicine regulations across Partner States through cooperation and joint safety assessments, addressing the issue of medicines registered in one state remaining confined despite meeting international standards.
The proposed system would enable regulators to collaborate and establish mutual recognition, allowing products that meet agreed standards to move more easily across the region. Dr. Makame mentioned that such an approach could expand markets for manufacturers and encourage investment in pharmaceutical production within East Africa.
The Bill assigns national medicines regulators the responsibility of overseeing medical products from production and import to sale and use, including advertising, inspections, and the removal of unsafe or counterfeit medicines. The legislation also calls for sharing information and intelligence between national medicines regulatory authorities regarding potentially risky medical products.
Dr. Makame acknowledged the challenge of completely eliminating illicit medicines but stressed the objective of establishing stronger regional vigilance to protect East Africa from counterfeit medical products. The proposed legislation includes the EAC Council’s role in determining a regional list of essential medicines to address critical health needs.
Partner States would be responsible for ensuring access to these essential medicines within their territories. The Bill provides for joint evaluations, inspections, and agreements to facilitate access to essential medicines, requiring Partner States to report adverse reactions and alert the EAC Secretary General when products pose health risks.
The Secretary General would disseminate relevant information and take measures to warn the public about risky products. Additionally, the Council would be tasked with combating the production, circulation, and use of substandard and counterfeit medical products. Dr. Makame argued for East Africa’s transition from being predominantly a consumer and importer to becoming a producer, with the potential to generate export surpluses, create employment, and foster economic development.
Following public hearings, the final Bill will be harmonised and circulated to Partner States before being endorsed and assented to become law.
