The Kenya Medical Research Institute Bill, 2025
Status Timeline
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Public Review
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Debate
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Executive
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Final
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KSh 3 Million Fine for Deceptive Traditional Medicine Claims
Clause 46 establishes new criminal offenses related to traditional medicinal products. A person commits an offense and faces a fine of up to KSh 3 million, imprisonment for up to three years, or both, for:
- Knowingly adding conventional medicines or unauthorized substances to traditional products.
- Making false, misleading, or deceptive claims about ingredients, benefits, or risks in advertisements.
- Manufacturing, preparing, or selling products under unsanitary or poor-quality conditions.
Written Approval Required to Import or Export Biological Materials
Clauses 54 and 55 introduce a strict licensing and regulatory framework for biobanks and biological materials:
- Exporting or importing biological materials without prior written approval from the Institute is prohibited.
- Contravention carries a fine of up to KSh 2 million, imprisonment for up to five years, or both.
- Unlicensed possession of biological materials carries a similar penalty of up to KSh 2 million or imprisonment up to five years.
New Scientific and Ethics Review Unit to Vet Research Proposals
Clause 31 establishes the Scientific and Ethics Review Unit within the Institute. This unit is mandated to:
- Develop and implement scientific and ethical standards.
- Review and approve all research proposals to ensure adherence to ethical principles.
- Monitor ongoing research protocols to ensure compliance.
KSh 5 Million General Penalty for Contravention of the Act
Clause 83 establishes a heavy general penalty of up to KSh 5 million, imprisonment for up to three years, or both, for any person who contravenes any provision of the Act where no specific penalty is provided.
Bill No.
National Assembly Bills No. 20 of 2025
Gazette No.
Supplement No. 72
Sponsor
James Nyikal
Background
Currently established under the Kenya Medical Research Institute Order, 2021 (L.N. 35/2021), KEMRI operates under a limited legal framework. The Kenya Medical Research Institute Bill, 2025 seeks to transition KEMRI into a statutory body corporate with expanded regulatory, ethical oversight, and commercialization powers.
Key Amendments
- Repeal of L.N. 35/2021: The Bill formally repeals the Kenya Medical Research Institute Order, 2021 (Clause 96).
- Amendment of Cap. 511: The Bill amends the Science, Technology and Innovation Act (Cap. 511) by deleting paragraph 5 of the Fourth Schedule (Clause 97).
New Obligations
- Research and Consent Obligations: Under Clause 30, the Institute and researchers must ensure all human participant research obtains informed consent and respects data privacy in accordance with the Data Protection Act (Cap. 411C).
- Database for Traditional Medicine: Clause 47 requires the Institute to establish and maintain a comprehensive national database for the codification, preservation, and scientific validation of traditional and alternative medical knowledge.
- IP Ownership and Commercialization: Clause 65 vests all rights and obligations relating to an invention exclusively in the Institute or the sponsoring entity. If an intellectual property right is not worked or licensed within two years, the inventor may apply to the Institute to license it on mutually agreed terms.
Penalties
- General Offences (Clause 82): Refusing to furnish the Institute with requested information, or providing false information, is punishable by a fine up to KSh 500,000, imprisonment for up to three years, or both.
- Traditional Medicine Violations (Clause 46): Adulterating traditional medicine with conventional drugs or making deceptive medicinal claims carries a fine up to KSh 3 million and/or imprisonment up to three years.
- Biobanking Violations (Clauses 55 & 56): Exporting/importing biological materials without KEMRI's written approval, or operating an unauthorized biobank, is punishable by a fine up to KSh 2 million, imprisonment up to five years, or both.
- General Penalty (Clause 83): Any other contraventions of the Act carry a general penalty of up to KSh 5 million or imprisonment up to three years.
Transitional Provisions
- Transfer of Assets and Liabilities: Under Clause 88, all funds, assets, liabilities, and agreements of the former Institute are transferred to and vested in the new Institute.
- Staff and Board Transition: Existing Board members and staff under the former Institute continue in office under the new statutory body (Clauses 92 & 93).
- Disciplinary and Legal Proceedings: Clause 94 provides that any ongoing disciplinary proceedings against staff of the former Institute will be completed by the new Institute.
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