The bill, which has already undergone initial consultations across all member states, aims to create a unified legal framework for healthcare services and medical products within the East African Community.
KIGALI, Rwanda – Hon. Francine Rutazana, a Rwandan representative in the East African Legislative Assembly (EALA), has tabled a landmark bill designed to harmonize healthcare laws across the eight East African Community (EAC) partner states, including regulations governing medical products originating from outside the region.
The draft legislation has already been the subject of preliminary consultations across all member states, with stakeholder meetings held from August 17–21, 2026. In each country, a wide range of stakeholders—including pharmaceutical manufacturers, regulatory bodies, medical oversight agencies, universities, and pharmaceutical traders—have convened to gather input for the proposed law.
These contributions will be submitted to the EALA for consolidation, followed by further legislative steps until the bill is ratified and signed by the heads of member states.
A Unified Regulatory Framework
Speaking after two days of consultations in Rwanda on August 20–21, 2026, Deputy Rutazana expressed optimism about the bill’s potential. She stated that the legislation, introduced in the name of Rwanda, would synchronize the operations of health institutions across the EAC, establishing standardized procedures.
She cited the example of Food and Drugs Authorities (FDAs) within the region. Currently, some partner states have well-established regulatory bodies while others are still developing them. A unified law would enable the creation of a cohesive oversight system, eliminating discrepancies.
“The bill will also help pharmaceutical manufacturers and medical equipment suppliers across the EAC meet uniform quality standards,” she said. “Manufacturers need a common platform because inconsistencies in product quality can hinder cross-border trade. This law will align quality standards with benchmarks, ensuring that a factory operating in one country can easily sell its products in others without undergoing redundant inspections as is currently the case.”
Boosting the Regional Pharmaceutical Market
Rutazana further emphasized that the law would strengthen the regional pharmaceutical market. “When medicines produced within the region are needed, there will be no need to import them from abroad. They can be purchased locally, which will save East Africans from the high costs associated with imported medicines,” she explained.
If all goes according to schedule, the bill is expected to be finalized at the EALA level by December 2026. It will then be submitted to the heads of state in 2027. Once signed, the law will enter into force immediately within the EAC.
Closing Legal Gaps and Enhancing Oversight
Mr. Mwesigye John Patrick, Director of the EAC Regional Centre of Excellence for Vaccines, Immunization, and Health Supply Chain Management (EAC RCE-VIHSCM), told IGIHE that the bill would address several critical gaps in the current system.
He noted that current health collaboration within the EAC relies on guidelines of varying scopes and enforceability, which are not as binding as formal legislation. “This law will strengthen existing guidelines and provide a legal foundation that supersedes them, ensuring there is a legally enforceable instrument to address issues like substandard medicines,” he explained. “Currently, if a problem arises, there may be no law protecting either the buyer or the seller.”
Once enacted, the law would establish a common framework for approving medicines for entry into EAC member states, whether manufactured locally or imported. It would also simplify procedures for pharmaceutical industries to compete effectively on the global market.
Strengthening Manufacturing and Supply
According to Mwesigye, individual regulatory bodies will continue to oversee domestic manufacturers to ensure quality. “This will facilitate the distribution of products locally, like here in Rwanda through Rwanda Medical Supply, as well as across borders without barriers,” he said.
The harmonized oversight would also enable coordinated decision-making to recall unsafe medicines from the market across all EAC states, including products originating from outside the region if defects are identified.
Currently, the EAC region is home to 119 pharmaceutical manufacturing plants producing human medicines. These include 7 in Rwanda, 30 in Kenya, 2 in Burundi, 34 in the Democratic Republic of the Congo (DRC), 15 in Tanzania, 38 in Uganda, 1 in Somalia, and none in South Sudan. While these factories supply approximately 30% of the medicines used within the EAC, the percentage varies significantly by country, with some relying on imports for nearly all their needs. Another 50 plants are reportedly in the pipeline.
Despite this progress, the figures highlight the region’s continued reliance on imports, as many manufacturers produce only a limited range of products—sometimes as few as 20 types, compared to the thousands needed.
“These established factories and those being set up are already responding to the guidelines that have been put in place, which has attracted more investors to the EAC,” Mwesigye noted. “Once we have a harmonized law, it will be an even greater incentive.”
The African Union has set a goal of producing 60% of the continent’s vaccines locally by 2040, a significant leap from the current rate of less than 1%. Strengthening investment and collaboration in pharmaceutical manufacturing is seen as a cornerstone of achieving this target.
