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 Dr. Abdullah Makame, the Chairperson of the General-Purpose Committee, 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.
“We were caught-off guard when the COVID-19 pandemic struck,” Dr Makame noted, adding that the crisis exposed East Africa to fully dependent on imported medical products, that could potentially be manufactured locally.
Speaking during a Public Hearing on the proposed Bill, Dr Makame, said the Bill was both essential and timely, clarifying that the EAC is seeking to establish a harmonised regional framework for the regulation, production, movement and access to medical products under the proposed legislation.
Introduced in EALA in October 2024, the Bill seeks to improve cooperation and access to safe, quality, and affordable medicines across the region.
He said the Legislation was intended to harmonise the management, production, and distribution of medical products, while supporting regional industrialisation and reducing overdependence on supplies from outside Africa.
“We wanted to harmonise the management, movement, and production of medical products to strengthen policies, regulatory systems, and Good Manufacturing Practices for human and animal medicines,” Dr. Makame said.
According to Dr. Makame, better regional pharmaceutical management and production would contribute to a healthier population and workforce.
The Bill seeks to harmonise medicine regulations across Partner States through cooperation and joint safety assessments.
Dr. Makame said the current challenge is that medicines registered in one Partner State, may remain confined to that country, even when they meet internationally recognised standards.
The proposed system would allow regulators to work together and establish mutual recognition, enabling products that meet agreed standards to move more easily across the region.
“If that product, which is registered in any part of the EAC, meets the standards which are set, and these are global standards, then it can move across the board and across the region,” he said, adding that the approach could also help expand markets for manufacturers and encourage greater investment in pharmaceutical production within East Africa.
The Bill would give national medicines regulators responsibility for overseeing medical products, from production and import to sale and use, as well as advertising, inspections, and removal of unsafe or counterfeit medicines.
The Legislation further provides for the sharing of information and intelligence between national medicines regulatory authorities concerning medical products that may pose risks to the public.
Dr. Makame said regional information sharing would help regulators and enforcement agencies identify and close loopholes through which illegal products enter East African markets.
“We want to ensure that the regulators and other enforcers of the law share information, they share intelligence, and they also agree on how they are going to seal the loopholes whereby these illegal products are coming into our market,” he said.
He acknowledged that completely eliminating illicit medicines would be difficult, but said the objective was to establish stronger regional vigilance and make East Africa safer from fake medical products.
Under the proposed Legislation, the EAC Council, on the recommendation of the Essential Medicines Sectoral Council responsible for health, would determine and publish a regional list of essential medicines.
The list would comprise medicines considered by the Council to be the most effective and safe for addressing the most important health needs of the community.
Partner States would then be required to ensure that people within their territories have access to medicines included on the community’s essential medicines list.
The Bill also provides for joint evaluations and inspections, as well as agreements between Partner States to facilitate access to essential medicines.
The proposed framework would require Partner States to report suspected adverse reactions to medicines and alert the EAC Secretary General when products are recalled, removed, deregistered or deemed a health risk.
The Secretary General would then publish relevant information across the community and take appropriate measures to warn the public about the products circulating in the market.
The Council would additionally be required to issue measures to combat the production, circulation, and use of substandard and counterfeit medical products.
He argued that East Africa should move from being predominantly a consumer and importer of medical products to becoming a producer capable of supplying its own population and competing in external markets.
According to Dr. Makame, the increased production could eventually generate surpluses for export, create employment, and contribute to economic development.
Following the public hearings, the final Bill will be harmonised and circulated to Partner States before being endorsed and assented to become law.
By Ian Chepkuto
