In May 2026, the Pharmacy and Poisons Board (“PPB”) warned against a counterfeit batch of Phesgo, a prescription medicine used to treat certain forms of HER2-positive breast cancer. The affected product falsely purported to originate from Roche. The PPB reported that the batch number did not correspond to an authentic Roche batch and that the vial contained a white powder rather than the ready to use liquid formulation. This incident highlights the broader challenge posed by counterfeit pharmaceutical products in Kenya, where products that misrepresent their identity threaten patient safety, undermine confidence in legitimate pharmaceutical brands and expose businesses to legal risks.
The alert raises an important question for pharmaceutical businesses: what happens when a falsified medicine enters the supply chain? For importers, distributors, pharmacies and healthcare providers, the consequences may extend to regulatory action, criminal liability and civil claims, depending on their involvement and the circumstances. This article examines the relevant legal obligations and what businesses should do to manage these risks.
1. The regulatory obligations under the Pharmacy and Poisons Act
The Pharmacy and Poisons Act (Cap. 244) regulates the handling and distribution of pharmaceutical products. Section 50A(e) makes it an offence to manufacture, import, export, compound, store, promote or distribute medicinal substances that have been labeled, packaged or promoted in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding its source, character, value, quality, composition, potency, merit or safety.
Liability depends on the conduct and evidence against the person or business concerned. Section 51 prescribes a fine not exceeding KShs 1 million, imprisonment for up to 2 years or both.
For pharmaceutical businesses, compliance requires more than holding the appropriate licences. Importers, distributors and pharmacies should be able to verify their suppliers, establish the provenance of products and trace the movement of stock. These records may prove critical when the authenticity of a batch is challenged.
2. Counterfeit medicines and intellectual-property enforcement
The Anti-Counterfeit Act, 2008 provides a further avenue for action against falsified medicines. The definition of counterfeiting in the Act covers the deliberate and fraudulent mislabeling of medicine as to its identity or source, whether or not the product contains the correct ingredients.
Section 32 prohibits specified dealings in counterfeit goods, including their possession or control in the course of trade, manufacture, sale, distribution and importation.
Where falsified medicine misuses a pharmaceutical manufacturer's name or protected trademark, the affected brand owner may pursue enforcement through the Anti-Counterfeit Authority and consider other applicable intellectual-property remedies.
For pharmaceutical companies, this makes brand protection an important part of supply-chain risk management. Suspected counterfeiting should be addressed through appropriate regulatory and enforcement channels, supported by evidence identifying the product, its branding and its source.
3. Consumer protection and potential civil liability
Article 46 of the Constitution of Kenya, 2010 protects consumers’ rights to goods and services of reasonable quality, information necessary to obtain full benefit from goods and services, and compensation for loss or injury arising from defective goods or services.
The Consumer Protection Act, 2012 reinforces these protections. Section 5 implies a warranty that goods supplied under a consumer agreement are of reasonably merchantable quality, while section 12 prohibits false, misleading or deceptive representations concerning goods and services.
The Competition Act, 2010 also addresses liability for unsuitable or defective goods in specified circumstances. Section 64 provides for compensation where defective goods cause loss or injury. Under section 65, a supplier who fails to identify the manufacturer or upstream supplier within 30 days of a written request may be deemed the manufacturer for purposes of a compensation action. For suppliers handling counterfeit or falsified medicines, these provisions highlight the importance of traceability and verifiable sourcing, particularly where a defective product causes harm and its true manufacturer cannot be identified.
For businesses, these provisions reinforce the importance of effective procurement controls, accurate records and documented responses to suspected product defects. They also make clear why supply agreements should address product authenticity, warranties, recalls and responsibility for losses arising from non-compliant products.
4. Responding to a suspected falsified medicine
Where a pharmaceutical product is suspected to be counterfeit, businesses should take prompt steps to comply with the applicable regulatory requirements. The Pharmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules, 2022 and the PPB’s Guidelines for Recall and Withdrawal of Health Products and Technologies provide the regulatory framework for addressing affected products. The appropriate response should include:
a) Isolate affected stock: Suspend further sale and distribution of the suspected product and comply with any applicable PPB recall or withdrawal directions.
b) Notify the relevant authorities: Report the suspected falsified medicine to the PPB and cooperate with the manufacturer and affected recipients, as appropriate.
c) Preserve evidence: Retain product samples, packaging, invoices, import records, delivery notes and supplier correspondence to support investigations and potential legal proceedings.
d) Trace the supply chain: Establish the product’s source, quantities received and distributed and the recipients supplied.
e) Assess legal exposure: Review applicable statutory obligations, contractual remedies, insurance requirements and potential claims against responsible suppliers or other parties.
Businesses should also consider incorporating product-authenticity warranties, traceability requirements, recall procedures, indemnities and record-access provisions into their procurement and distribution agreements. These measures can strengthen compliance, facilitate investigations and support recovery where contractual breaches or other actionable wrongdoing are established.
5. How CM Advocates LLP can assist
CM Advocates LLP advises businesses on intellectual-property protection, regulatory obligations and disputes arising from falsified or non-compliant products. We assist clients in assessing their legal exposure, protecting their commercial interests and responding to suspected counterfeiting and product-related disputes. Our Intellectual Property, Brands and Commercialisation Unit assists with:
a) Intellectual-property protection and enforcement against suspected counterfeit products;
b) Legal reviews of pharmaceutical procurement, importation and distribution arrangements;
c) Drafting and review of supply agreements, including authenticity warranties, recall obligations and indemnities;
d) Advice on regulatory investigations, product recalls and related legal obligations;
e) Assessment of contractual liability and recovery against suppliers; and
f) Intellectual-property litigation, commercial disputes and claims arising from defective or falsified products.
For enquiries, please contact the contributor below or reach out to our Intellectual Property, Brands and Commercialisation team at ipbc@cmadvocates.com.
Contributors:
Mercy Chore
Associate Advocate
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