EAC Bill to harmonize medical regulation, strengthens local medical supply

The General-Purpose Committee of the East African Legislative Assembly (EALA), today, held a public hearing in Nairobi on the East African Community Medical Products Bill, 2024.

The Bill, when adopted, aims to fast-track harmonization of the regulation, production, and distribution of medical products across the region.

The proposed Bill, introduced to the EALA Assembly in October 2024, seeks to establish a common framework for regulating medical products in EAC Partner States, while improving access to essential, safe, quality, and affordable medicines.

Speaking during the Public Hearing, EALA Legislator, David Ole Sankok, Chair of the Kenya Sub-Committee of the General-Purpose Committee, said the proposed legislation would strengthen coordination among national medicines regulators and promote products manufactured within the EAC.

He said harmonised regulatory systems would enable locally manufactured medical products to compete more effectively in regional and international markets, while facilitating their movement across partner States.

“The Proposed Bill seeks to improve access to essential, safe, quality, and affordable medicines,” Sankok said.

He clarified that the Bill proposes measures to promote good manufacturing practices and quality standards, strengthen information sharing among Partner States and facilitate mutual recognition of procedures for the registration, evaluation, and inspection of medicines.

“Medicine produced within the Community shall be manufactured in accordance with the compendium of good manufacturing practices approved by a Council,” reads the Statement.

The Legislator said the regulation would strengthen regional cooperation in combating substandard and counterfeit medical products, while supporting local pharmaceutical manufacturing and regional medical-products value chains.

“The Bill is to facilitate access to essential medicines in the Community; to promote medical products manufactured in the Community, to promote good manufacturing practices and quality standards in producing medical products, to promote preference for medical products produced in the Community during public procurement and for related matters,” reads part of the document.

The Bill builds on earlier regional efforts, particularly the 2019 version, and incorporates observations from partner states gathered during public hearings held in April 2022.

It is anchored in Article 118 of the EAC Treaty, which provides for the harmonization of drug registration procedures.

The proposed law aligns with the African Union Model Law on Medical Products Regulation and draws from regional and continental frameworks, including the EAC Common Market Protocol, the EAC Industrial Policy and the African Continental Free Trade Area (AfCFTA).

The measure is intended to create a larger and more predictable market for manufacturers operating within the region while encouraging investment in pharmaceutical production.

He said the Bill would grant preference to medical products manufactured within the Community in public procurement while encouraging good manufacturing practices and fostering information exchange at the regional level.

Sankok stressed the importance of the Bill, calling for investment in local manufacturing to reduce overreliance on imported medicines and medical supplies, citing the COVID-19 pandemic, which exposed the vulnerability of member states.

“We have been taught by what happened during Corona time, during lockdown,” he said, arguing that African countries experienced delays in accessing vaccines during the pandemic.

He said the EAC is rich in expertise, technology, and resources, adding that the experience underscored the need for Partner States to strengthen domestic and regional manufacturing capacity while leveraging digital technology.

EALA lawmaker added that the Bill seeks to encourage investment in local production of medical products while at the same time supporting employment, generating tax revenue, and creating markets for locally available raw materials and energy.

He said East Africa has significant resources that could support a stronger medical manufacturing industry, including raw materials, human capital, and energy potential.

Ole Sankok pointed to East African professionals working in pharmaceutical and related industries outside the region, saying their expertise could contribute to building the sector at home.

Sankok said the EAC market, which he estimated at about 350 million people, could provide an incentive for international manufacturers to establish production facilities within the region. “Those Asian giants that manufacture medicine will really have to come and manufacture within our market,” he said, adding: “We have everything that it takes to have industries.”

Beyond manufacturing, Sankok said the Bill seeks to address regulatory differences that cause delay in access to quality medical products.

He said if adopted and implemented, it is expected to establish a harmonised framework for the registration and regulation of medicines across EAC Partner States.

He said it proposes improved infrastructure and systems for storage, distribution, and cold-chain management of medical products, including vaccines requiring controlled temperatures.

He added that the legislation will provide a better human-resource capacity, research and development, and technological innovation in the medical-products sector, with the aim of improving the competitiveness of EAC-produced medicines and other products.

He said the ongoing public participation across the EAC’s eight Partner States brings together government agencies, regulators, legal experts, health-sector stakeholders, and traditional medicine practitioners to identify regulatory challenges and propose ways to harmonize standards and procedures across the region.

Sankok said they will also be giving views on improving access, affordability, safety, and quality of medical products; strengthening local pharmaceutical value chains; and tackling substandard and falsified medicines.

He said the traditional medicine practitioners are included in the exercise to help the Committee consider how traditional medical knowledge can be incorporated into the regional framework.

The process is aimed at ensuring the legislation is practical and workable across the EAC while improving access to essential medicines and strengthening local manufacturing and regulations.

By Ian Chepkuto