Washington’s push for most-favoured-nation drug pricing is reshaping how global pharmaceutical manufacturers think about pricing everywhere, including in markets like Kenya where prices were never controlled to begin with. Kenya’s own access-to-medicines debate is really two separate conversations that get conflated: what the government can legally do about drug prices, and what it has actually chosen to do so far. The two are not the same thing.
Kenya Has No Binding Price Controls
Kenya’s private pharmaceutical market operates on what a 2022 peer-reviewed review in Risk Management and Healthcare Policy described as an informal, non-binding societal price mark-up that is not anchored in any legislation. There is no statute setting maximum medicine prices. Government influence on pricing runs indirectly, through KEMSA’s public procurement and the Social Health Authority’s reimbursement schedules, rather than through direct price-setting. SHA itself is a recent creation: the Social Health Insurance Act, No. 16 of 2023, assented to on 19 October 2023, established it to replace NHIF, and the Ministry of Health confirmed SHA’s formal launch on 1 October 2024. Kenya also maintains an Essential Medicines List, last updated in 2023, which functions as a clinical and procurement reference rather than a price schedule. The access gap this creates is real and documented: the same 2022 review found essential medicine availability at roughly 44 percent in public facilities against 72.4 percent in private ones, using 2018/19 data, illustrating that Kenya’s medicines access problem has historically been more about supply and financing than about price control as such.
The US Pricing Pressure Kenya Cannot Ignore
Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” signed 12 May 2025, directed US manufacturers toward MFN pricing targets, with a follow-on order on 2 April 2026 tying import tariffs directly to a manufacturer’s compliance. The Centers for Medicare and Medicaid Services has advanced this through the GLOBE and GUARD payment models, with a comment period that closed 23 February 2026, and the GENEROUS model for Medicaid, announced 6 November 2025. The mechanism that matters for Kenya is indirect but real: manufacturers facing compressed margins in their largest market often respond by tightening differential pricing elsewhere, including in markets like Kenya where volumes are lower and negotiating leverage is weaker. The WHO’s recurring Fair Pricing Forum exists precisely to give lower-income markets a coordinated voice in that conversation, but Kenya’s position in it depends on active government and industry engagement, not automatic protection.
The Legal Tools Kenya Already Has
Kenya is not without leverage of its own. Section 58(2) of the Industrial Property Act, 2001 establishes international exhaustion of patent rights, meaning goods lawfully placed on the market anywhere can generally be parallel imported into Kenya without infringing the Kenyan patent, an important safety valve if a manufacturer prices a medicine sharply higher in Kenya than in comparable markets. Sections 72 and 80 of the same Act provide compulsory licensing and government-use mechanisms for genuine public-interest situations, the same provisions discussed in the context of TRIPS flexibilities generally, though as noted elsewhere Kenya has no recorded history of actually using them for pharmaceuticals. One notable absence: the Competition Authority of Kenya’s published market inquiries do not currently include a pharmaceutical-sector inquiry, unlike sectors such as banking, fertiliser, or digital credit that have been reviewed. Whether that reflects an assessment that the market does not need scrutiny, or simply that it has not yet been prioritised, is not something this article can resolve from public materials alone.
A Concrete Access Pressure Point
HIV treatment access illustrates how funding disruption, not patent law, has been the more immediate threat to access in Kenya recently. UNAIDS documented the impact of the 2025 pause in US foreign aid on Kenya’s HIV treatment programmes, and Kenya’s Ministry of Health issued its own statement on strengthening continuity of HIV treatment amid global funding changes. This is a useful corrective to a debate that sometimes focuses entirely on patent flexibilities and pricing mechanisms: for many Kenyan patients, financing continuity has mattered more than the underlying list price of the medicine itself. The legal tools discussed above, parallel importation and compulsory licensing, address a different problem than a sudden gap in donor-funded procurement, and Kenya’s access strategy needs to account for both, since neither a favourable patent ruling nor a parallel import shipment fixes a funding shortfall at the point of care.
How We Can Help
Clay & Associates Advocates advises pharmaceutical companies, distributors, and healthcare organisations on regulatory compliance, procurement, and market access strategy in Kenya. Our companion piece on African Medicines Agency ratification covers the continental regulatory harmonisation dimension of this landscape. Contact our Life Sciences & Healthcare practice to discuss pricing, procurement, or access strategy for the Kenyan market.
Sources: Toroitich, Dunford, Armitage and Tanna, “Patients Access to Medicines: A Critical Review of the Healthcare System in Kenya,” Risk Management and Healthcare Policy, 2022; Social Health Insurance Act, No. 16 of 2023; Ministry of Health, SHA launch announcement, 1 October 2024; Executive Order 14297, 12 May 2025; Centers for Medicare and Medicaid Services, GENEROUS model announcement, 6 November 2025; Industrial Property Act, No. 3 of 2001, sections 58(2), 72, and 80; UNAIDS, PEPFAR funding pause impact on Kenya, February 2025.
Frequently asked questions
Does Kenya control the prices of medicines by law?
No. Kenya has no statutory price controls on medicines. Government influence on pricing works indirectly through public procurement by KEMSA and reimbursement decisions by the Social Health Authority.
How does US drug pricing policy affect prices in Kenya?
Indirectly. As manufacturers face pricing pressure in the US under most-favoured-nation policy, they may tighten differential pricing in other markets, including Kenya, though this is a market response rather than a legal requirement affecting Kenya directly.
Can a Kenyan importer bring in medicines purchased more cheaply abroad?
Generally yes. Section 58(2) of the Industrial Property Act establishes international exhaustion of patent rights, which supports parallel importation of genuine goods lawfully sold elsewhere.
Has Kenya’s competition regulator investigated pharmaceutical pricing?
Not as of this writing. The Competition Authority of Kenya’s published market inquiries do not currently include a pharmaceutical-sector review, unlike several other sectors it has examined.



