Industries / Life Sciences & Healthcare
Life Sciences & Healthcare
Kenya's healthcare sector is undergoing transformation. UHC implementation, expanding private provision, pharmaceutical manufacturing growth, and increasing clinical research create opportunity and legal complexity.
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Overview
Kenya's healthcare sector is undergoing transformation. UHC implementation, expanding private provision, pharmaceutical manufacturing growth, and increasing clinical research create opportunity and legal complexity.
We advise healthcare providers, pharma and biotech companies, medical device suppliers, and healthtech businesses on regulatory compliance, corporate structuring, IP, employment, data protection, and disputes.
What we do
12 service lines. Select one to see what it covers.
Life Sciences & HealthcarePharmaceutical and Medical Device Registration
We guide manufacturers, importers, and distributors through product and premises registration with the Pharmacy and Poisons Board under the Pharmacy and Poisons Act, Cap 244, covering medicines, medical devices, and in vitro diagnostics alike. This keeps a health product's two separate approval tracks moving together instead of stalling at the one an applicant forgot to plan for.
Life Sciences & HealthcareClinical Trials and Research Compliance
We structure sponsor-site clinical trial agreements and guide sponsors and contract research organisations through the multi-body approval process spanning ethics review, Pharmacy and Poisons Board authorisation, and NACOSTI licensing. This keeps a trial's legal and regulatory tracks aligned before the first patient is enrolled.
Life Sciences & HealthcareHealthcare Mergers and Acquisitions
We run legal due diligence for buyers acquiring hospital groups, diagnostics chains, and device or pharmaceutical distributors, covering competition law clearance, licence transferability, and the healthcare-specific risks a standard commercial due diligence process misses. This protects a buyer from inheriting compliance gaps along with the business.
Life Sciences & HealthcareDigital Health and Telemedicine Regulation
We advise telemedicine platforms and health-tech companies on compliance with the Digital Health Act, 2023, and the Pharmacy and Poisons Board's emerging framework for medical device software, including AI-enabled diagnostic and monitoring tools. This gives a digital health product a compliance footing built for both of the regimes now converging on it.
Life Sciences & HealthcareLife Sciences Investment and Exit Strategy
We advise investors and portfolio companies on venture financing, and on structuring exits through trade sales, secondary sales, or a listing on the Nairobi Securities Exchange's Growth Board. This gives an investor a realistic, legally sound route to liquidity mapped out well before an exit is needed.
Life Sciences & HealthcareTechnology Transfer and Licensing Agreements
We structure technology transfer and licensing agreements for pharmaceutical, diagnostic, and biotech know-how moving into or out of Kenya, including registration of the underlying licence with the Kenya Industrial Property Institute. This protects both parties' rights in the technology while satisfying Kenya's own registration requirements.
Life Sciences & HealthcareManufacturing and Supply Agreements
We draft manufacturing and supply agreements between marketing authorisation holders and local manufacturers, and advise on the Special Economic Zone and Export Processing Zone incentives available to pharmaceutical manufacturing investment. This lets a manufacturer structure production and incentives together rather than as separate afterthoughts.
Life Sciences & HealthcareHealth Insurance and SHA Transition
We advise health insurers and insurtech platforms on their obligations following the shift from the National Hospital Insurance Fund to the Social Health Authority and its Social Health Insurance Fund. This keeps a provider's claims and product design aligned with a public health financing system still settling into its new form.
Life Sciences & HealthcarePatent Prosecution and IP Due Diligence
We prosecute patents at the Kenya Industrial Property Institute for diagnostic methods, drug formulations, and device mechanisms, and run IP due diligence for investors and acquirers whose target's value sits mostly in patents and trade secrets. This gives a life sciences business protection for its inventions and confidence in what it is actually buying.
Life Sciences & HealthcareRegulatory Enforcement and Product Recalls
We advise manufacturers and importers on the parallel regulatory enforcement and civil liability tracks that follow a product safety issue, from a Pharmacy and Poisons Board-led recall to a resulting damages claim. This lets a business manage both tracks at once instead of assuming a clean regulatory recall closes out its legal exposure.
Life Sciences & HealthcareMedical Negligence Defence
We represent healthcare providers, including hospitals and individual practitioners, in medical negligence claims alleging a failure to meet the required standard of care. This gives a provider an experienced defence as patients become more aware of, and more willing to pursue, their legal rights.
Life Sciences & HealthcareCross-Border Market Entry for Pharmaceutical Companies
We advise foreign pharmaceutical and health-tech companies on entity choice, foreign ownership restrictions, and the sequencing of regulatory approvals needed to enter the Kenyan market. Getting that sequence right is the difference between a market entry that proceeds on schedule and one that stalls at the first regulator.
Most matters cross two or three of these.
Describe the situation in your own words. We will tell you what it actually involves, which services it touches, and what it will cost, before you commit to anything.
Why clients instruct us for life sciences & healthcare
Four commitments specific to this practice.
The regulatory web, navigated whole
Pharmacy and Poisons Board, the Anti-Counterfeit Authority and health data obligations, which overlap rather than divide cleanly.
Pharmaceutical IP, including what Kenya lacks
We advise on patent strategy in a jurisdiction with no data exclusivity regime, where ordinary Industrial Property Act rules decide outcomes.
Clinical research and health data
Trial agreements and DPA 2019 compliance for sensitive personal data.
Device and product market entry
Registration work for manufacturers and distributors entering the Kenyan market.
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Tell us what you are working on. You will get a clear view of what the matter involves and what it costs before you commit to anything.
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- &Scope, approach and fee confirmed in writing before work begins
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