SECTOR
Health & Pharmaceuticals
OLM Law Advocates advises health and pharmaceutical clients in Kenya on regulation, licensing, compliance and commercial agreements.
DISCUSS YOUR MATTER →Legal services for healthcare providers, pharmaceutical companies and medical device manufacturers.
Healthcare and pharmaceutical lawyers for hospitals, clinics, pharmaceutical manufacturers and distributors, and medical-device companies in Kenya. We navigate Pharmacy and Poisons Board licensing, Kenya Medical Practitioners and Dentists Council requirements, clinical-trials regulation, health-data protection, medical-negligence defence, and employment structuring for clinical and non-clinical staff.
Relevant expertise: Corporate & Commercial; Data Protection & Privacy; Employment & Labour; Dispute Resolution & ADR; Competition & Antitrust
How we help. We act for hospitals, clinics, pharmaceutical manufacturers and distributors, and medical-device companies on Pharmacy and Poisons Board licensing, Kenya Medical Practitioners and Dentists Council requirements, clinical-trials regulation and ethics approvals, health-data protection under the Data Protection Act, medical-negligence defence, supply and distribution agreements, and employment structuring for clinical and non-clinical staff.
Why OLM for health and pharmaceuticals. Healthcare sits at the crossroads of heavy regulation, sensitive personal data and high-stakes liability. Our combined regulatory, data-protection, employment and dispute-resolution capability lets a provider manage licensing, patient-data compliance and negligence risk through one accountable team.
Frequently Asked Questions
What licences does a pharmaceutical business need in Kenya? Manufacturing, importation and distribution of pharmaceuticals require registration and licensing with the Pharmacy and Poisons Board, alongside product registration. We handle the licensing and the supporting commercial agreements.
How is patient data regulated in Kenya? Health data is sensitive personal data under the Data Protection Act 2019 and requires explicit consent for processing, strict security measures, and ODPC registration. We build health-data compliance programmes tailored to clinical settings.
What are the rules on clinical trials in Kenya? Clinical trials require approval from the Kenya Medical Research Institute (KEMRI) Ethics Review Committee and the Pharmacy and Poisons Board, and must comply with Good Clinical Practice guidelines. We advise on the regulatory pathway and documentation.
