Clinical Trials in Kenya: Regulatory Approval and Ethical Requirements

Clinical trials in Kenya are regulated through several overlapping laws, and a sponsor that treats them as a single approval will usually lose time. A trial of a pharmaceutical product needs authorisation under the Pharmacy and Poisons Act, ethics review, and often a research licence under the Science, Technology and Innovation Act, and it must also respect Kenya’s data protection rules. This guide explains what each statute says and where sponsors should confirm the detail before they start.

Clinical trials in Kenya: the governing laws

The Pharmacy and Poisons Board (the Board) regulates trials of pharmaceutical products under the Pharmacy and Poisons Act (Cap. 244). Section 25A of that Act, headed “Clinical trials”, is the central provision. The Act defines a clinical trial as any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, to discover or verify their effects, identify adverse reactions, or study their absorption, distribution, metabolism and excretion in order to establish efficacy and safety.

Research licensing is a separate layer. The Science, Technology and Innovation Act, 2013 requires a licence from the National Commission for Science, Technology and Innovation (NACOSTI) for scientific research in Kenya, subject to exceptions. Health research is also addressed in Part XIV of the Health Act, 2017, which establishes the National Health Research Committee as a technical committee that recommends national research for health policy and priorities.

Board authorisation under section 25A

Section 25A(1) provides that a pharmaceutical product shall not be used for a clinical trial unless the Board grants approval, with the approval of the relevant ethics body. Under section 25A(2), anyone who intends to start a trial must apply to the Board in the prescribed form, accompanied by the study protocol in the prescribed format and the prescribed fee.

Three further requirements deserve attention:

• The protocol must include a post-trial access programme, so that participants can obtain investigational medicinal substances before the Board grants marketing authorisation (section 25A(3)).
• The person granted approval must put in place a robust quality assurance system to protect data integrity and the safety and well-being of participants (section 25A(5)).
• The Board must inspect clinical trials to ensure compliance with the prescribed requirements (section 25A(6)).

The Board must also prescribe guidelines for accelerated evaluation of applications during emergencies, epidemics and outbreaks (section 25A(4)). Sponsors should obtain the Board’s current guidelines and forms, because the Act leaves the application format, fee and review procedure to be prescribed.

Ethics review

For clinical trials in Kenya, because section 25A(1) ties Board approval to the approval of the relevant ethics body, no sponsor should assume it can obtain Board authorisation without ethics clearance. The Act does not set out in terms whether the two applications must be made one after the other or may run side by side. Sponsors should therefore ask the Board and the chosen ethics committee how they expect to receive submissions and plan the timetable around that answer.

Ethics committees assess the scientific and ethical soundness of a protocol, including the informed consent process and the treatment of vulnerable participants. The form of consent documents, the handling of minors and adults who cannot consent, and any community engagement expected are set by the committee’s own requirements and by the national research ethics guidelines, not by the statutes covered here. Sponsors should read the committee’s current instructions before drafting participant materials.

NACOSTI research licensing

Section 12(1) of the Science, Technology and Innovation Act provides that, subject to any other law, a person shall not undertake scientific research in Kenya without a licence. Section 12(2) disapplies that requirement for a person conducting scientific research within a university or academic research institution programme, and the Cabinet Secretary may, on the Commission’s recommendation, exempt other research by Gazette notice (section 12(4)). A person who contravenes section 12 commits an offence and is liable on conviction to a fine of up to five million shillings, imprisonment for up to four years, or both (section 15). Licence holders must follow the procedures, standards, code of ethics and guidelines prescribed by regulations (section 14).

An industry-sponsored trial run by a company or contract research organisation will generally fall outside the university exemption, so sponsors should confirm with NACOSTI at the outset whether a licence is required and whether any exemption applies. The two regimes operate side by side.

Trial agreements, insurance and indemnity

The statutes above do not prescribe the commercial terms of a trial, so the clinical trial agreement carries much of the legal risk. Sponsors typically contract separately with each site institution and investigator on the supply of investigational product, payment of site costs, publication rights and responsibility for participant injury. The agreement should state clearly whether the sponsor’s indemnity covers only injuries caused directly by the investigational product or also injuries arising from trial procedures, and should require insurance that matches the indemnity. Settling this in the contract is far cheaper than arguing about it after an incident.

Data protection in clinical research

The Data Protection Act, 2019 defines “sensitive personal data” to include data revealing a person’s health status, so participants’ trial data falls in that category. Sponsors and investigators who process it are data controllers or processors and must meet the Act’s requirements on lawful processing, security and consent. Part VI of the Act regulates the transfer of personal data outside Kenya, which matters whenever trial data goes to a sponsor’s home country. Section 48 allows a transfer only where conditions are met, including proof to the Data Commissioner of appropriate safeguards. Our guide to data protection compliance in Kenya explains the wider obligations.