Kenya plans local manufacturing of ARVs
To fight HIV effectively, Kenya needs a steady supply of essential commodities, including antiretroviral drugs (ARVs).
Kenya has set eyes on manufacturing HIV antiretroviral (ARV) drugs for both local and global consumption, pending approval from regulatory bodies.
Director General for Health, Patrick Amoth, says the country is seeking more avenues for funding that will support the venture.
The move follows US President Donald Trump's recent edict of a 90-day pause in US-funded foreign assistance, which could impact critical programmes such as the President's Emergency Plan for AIDS Relief (PEPFAR).
The intiative currently provides 37 per cent of Kenya's HIV programme funding. "We have a local manufacturing plant for ARV's but we need approvals to work with the regulatory bodies so that we can also be able to manufacture not only for one country but globally," said Dr Amoth.
“Even as we build on existing capacities, local manufacturing of essential medicines, including ARVs, remains a priority.
"Achieving Maturity Level 3 stability is crucial for our country to enhance the exportation of locally manufactured health products and technologies,” said Health Cabinet Secretary Dr Deborah Barasa, on X.
Health Cabinet Secretary Debra Barasa addresses journalists in Mombasa on Tuesday. She says the ministry is crafting a response to the aid freeze announced by the US.
The stakes are high for Kenya's 1.3 million people living with HIV.
According to the National Syndemic Disease Control Council, as of 2024, this includes nearly 890,000 females and 487,000 males, with over 71,000 children under 14. Currently, 97 per cent of registered HIV-positive individuals receive antiretroviral therapy, with 94 per cent achieving viral suppression.
The country's dependence on external funding remains significant.
During 2021-2022, approximately 63.5 per cent of Kenya's HIV programme funding came from foreign sources, with PEPFAR being the largest contributor.
This isn't Kenya's first attempt at local ARV production.
In 2019, the government announced plans for a manufacturing plant aimed at treating 300,000 people and reducing the country's annual HIV medication budget from Sh38 billion. Although the ministry did not say how much local manufacturing would save the taxpayer, it said this would reduce reliance on imports.
The facility was also meant to produce malaria and tuberculosis drugs, with plans to export to 23 African States. However, the current status of this initiative remains unclear, with ministry officials unavailable for comment.
Rocky road
Recent research suggests significant challenges ahead.
A 2023 study by The Kenya Legal and Ethical Issues Network on HIV and Aids found that despite available expertise and lessons learned from Covid-19, the environment for sustainable local ARV production faces multiple obstacles.
The study identified several key barriers, including weak policy and regulatory frameworks, inadequate infrastructure, limited financial resources, insufficient political support and challenges in maintaining WHO manufacturing standards.
“The landscape for a sustainable, resilient local production of ARVs in Kenya is not promising at the moment, despite the availability of know-how, skills and lessons learnt from Covid-19 pandemic,” the study said.
Previous attempts at local production via partnerships with European manufacturers GlaxoSmithKline and Boehringer faced sustainability challenges, particularly in maintaining global norms while sourcing Active Pharmaceutical Ingredients from Indian suppliers.
“The lives of people living with HIV is largely dependent on existing ARV supply value chain currently pegged on 90 per cent imported and donor supported procurement and supply management mechanism. This is not sustainable in the event of global changes in the current supply paradigm,” says the study.
“There had been relentless and concerted efforts among local manufacturers and civil society organisations in support of this initiative, but political will has been lacking or lukewarm within government and its agencies.
"The government seems to be working at cross purposes from a policy, legislative, and regulatory perspective, which continues to make it prohibitive for local manufacturers to participate in a level playing field with importers and foreign manufacturers,” says the study.
Warning
Researchers from the Kenya Medical Research Institute warn that without proper contingency measures, the country risks losing ground on its HIV/AIDS targets.
Kenya aims to achieve the "95-95-95" goals by 2030: ensuring 95 per cent of people living with HIV know their status, 95 per cent of those diagnosed receive treatment, and 95 per cent of those treated achieve viral suppression.
The various bodies expected to be involved in ensuring the local manufacturing meets the required standards include the World Health Organisation, Pharmacy and Poisons Board Kenya, and the Kenya Medical Practitioners, Pharmacists and Dentists Council.
