Product Liability and Regulatory Enforcement in Kenya’s Health Sector

Product liability and regulatory enforcement in Kenya’s health sector run on two tracks that a manufacturer or importer must watch at the same time. The first is regulatory enforcement by the Pharmacy and Poisons Board (PPB). The second is civil liability to an injured patient or consumer through the courts. A recall handled well on the regulatory side does not shield a company from a damages claim, and a civil settlement does not discharge its duties to the regulator. This article sets out the statutory powers on each track, what recent High Court decisions say about how PPB must use its powers, and the practical steps that reduce exposure.

PPB’s enforcement powers

Section 3A of the Pharmacy and Poisons Act (Cap. 244) lists the Board’s powers. They include formulating guidelines for regulating the manufacture, import, export, distribution, sale and use of medical products, granting or withdrawing authorisation for clinical trials, granting or withdrawing marketing authorisation, and recalling medical products from the market. The Act defines pharmacovigilance as monitoring the effects of medical drugs after they have been licensed, including identifying previously unreported adverse reactions, which is the legal home of adverse event reporting.

The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules (Legal Notice 100 of 2022) add product-level controls. Rule 11(1) allows the Board to withhold, suspend or cancel a registration where, among other grounds, the holder misrepresented information in the application, obtained the certificate fraudulently, failed to comply with the Act, the Rules or a certificate condition, the product’s formulation, composition, quality, safety or presentation has changed so that it is unsuitable for registration, or it is in the public interest to do so. Rule 11(3) requires a notice of intention on Form 5 and an opportunity to be heard first. Rule 13(2) also obliges a registration holder to report to the Board any quality and safety changes or defects that could affect patient safety in a marketed product, and any marketing or regulatory decisions made in the country of origin or another country where the product is marketed.

What the courts have said about PPB’s process

The High Court has recently scrutinised how PPB exercises these powers. In Republic v Pharmacy and Poisons Board and another; Galaxy Pharmaceuticals Ltd (Ex parte Applicant) [2026] KEHC 4863 (KLR), decided on 15 April 2026, the court quashed a notice of intention to cancel dated 26 March 2025 and a decision of 22 May 2025 cancelling the registration certificates for forty pharmaceutical products. It ordered the certificates reinstated by mandamus and the products restored to the register, and it described the Board’s refusal to give reasons as irrational and unreasonable. An earlier application over the same notice, Republic v Pharmacy and Poisons Board; Prism Life Sciences Limited (Interested Party); Galaxy Pharmaceuticals Limited (Ex parte Applicant) [2025] KEHC 12028 (KLR), was struck out as moot on 15 August 2025 because the certificates had by then been cancelled. We have not checked whether the 2026 judgment is under appeal.

The practical point for manufacturers is that the public interest ground in rule 11 does not displace fair process. A holder served with a notice of intention should respond within the time allowed, ask for the Board’s reasons in writing, and keep the record needed to challenge the decision if the Board acts without them.

Product liability under the Consumer Protection Act

The Consumer Protection Act, 2012 (Act No. 46 of 2012) gives injured consumers a separate route. Section 12 makes it an unfair practice to make a false, misleading or deceptive representation, including a representation that goods or services have performance characteristics, ingredients, benefits or qualities they do not have. Section 16 allows a consumer to rescind an agreement entered into after or while a person engaged in an unfair practice, with any remedy available in law. Under section 84 a consumer may sue in the appropriate court, a court may award exemplary or punitive damages in addition to other remedies, each person who engaged in the unfair practice is jointly and severally liable with the person who contracted with the consumer, and officers and directors of an operator are jointly and severally liable for any remedy against the operator.

Alongside the Act, common law negligence applies. A claimant must show a duty of care, a breach, and that the breach caused the injury. Causation is usually the hard part in health cases, because patients often have underlying conditions and take several medicines. Defendants typically argue intervening causes, such as a prescribing or dosing error or a patient’s failure to follow instructions, and contributory conduct, such as use outside the approved indication. We have not identified Kenyan authority adopting the learned intermediary doctrine, so a manufacturer should not assume that warnings given only to a prescriber will discharge its duty to warn.

Why the two tracks interact

The same defective batch can produce a PPB recall, a rule 11 notice and civil claims at once. A recall ordered under section 3A does not limit damages for patients harmed before it issued, and a settlement with patients does not satisfy the Board’s separate demands for reporting, recall scope and corrective action. Coordinate the regulatory response and the litigation strategy from the first day so the two do not contradict each other.

Software and digital products

Liability is not limited to physical products. A diagnostic algorithm that gives a false result, or a telemedicine platform that fails to connect a patient with care in time, can attract negligence and consumer claims, in addition to the certification regime under the Digital Health Act, 2023. We are not aware of any Kenyan exception for software. See our guide to digital health and telemedicine regulation.

Practical risk management

Keep a documented complaint and adverse event process that feeds both PPB reporting under rule 13(2) and an internal risk register. Review labelling and marketing claims against section 12 of the Consumer Protection Act, because a technically accurate but misleading claim can create liability even when the product works. Keep batch records, complaint logs and PPB correspondence well beyond the minimum retention period, since claims often arrive years after sale. Review product liability insurance against Kenya’s exposure, including exemplary damages and joint and several liability, because policies written for other markets may not contemplate them.