The Kenya Blood, Cells, Tissues and Organs Bill, 2026
Status Timeline
Proposed
Active now
Public Review
Pending
Debate
Pending
Executive
Pending
Final
Pending
Establishment of the Kenya Blood and Transplant Authority
The Bill establishes a centralized Kenya Blood and Transplant Authority (Clause 6) managed by a Board that includes a chairperson appointed by the President and healthcare professionals. The Authority is tasked with:
- Coordinating donor recruitment and blood collection.
- Maintaining a National Waiting List for cells, tissues, and organ recipients.
- Ensuring the ethical, fair, and equitable allocation of organs.
Mandatory Certification for Medical Facilities
To perform transplant-related services, facilities must receive formal certification from the Authority:
- Transfusing Facilities (Clause 25), Transplant Facilities (Clause 26), and Retrieval Facilities (Clause 27) must apply for and maintain valid certificates.
- Conducting these operations in an uncertified facility is an offence carrying a fine of up to KSh 500,000, imprisonment for up to two years, or both.
Severe Penalties for Commercial Organ Trade
The Bill imposes strict prohibitions on the commercialization of human parts (Clause 103):
- It bans buying, selling, or offering monetary rewards/compensation for human organs, cells, or tissues.
- Violating these provisions carries a fine not exceeding KSh 50 million, imprisonment for a term of up to 25 years, or both.
Strict Written Consent Rules for Transfusions and Transplants
Informed written consent is legally required before any procedure can occur:
- Transfusion without consent (Clause 101) is punishable by a fine between KSh 500,000 and KSh 1 million, or up to two years in prison.
- Transplanting without consent (Clause 102(1)) is punishable by a fine between KSh 5 million and KSh 10 million, or five to ten years in prison.
Bill No.
No. 18 of 2026
Gazette No.
Supplement No. 88 of 2026
Sponsor
James Wambura Nyikal
Background
The Kenya Blood, Cells, Tissues and Organs Bill, 2026, aims to establish a centralized regulatory framework to govern the collection, processing, storage, and medical use of human blood and transplant materials. Currently, these activities are fragmented across different institutions. The Bill seeks to guarantee safe, high-quality, and ethical access to transfusions and transplants, while suppressing black-market organ harvesting and commercial trafficking.
Key Amendments
- Health Act (Cap. 241): The Bill repeals Sections 80, 81, 82, 83, 84, and 85 of the Health Act to hand over the regulation of blood and human organs to the newly formed Authority.
- Human Tissue Act (Cap. 252): The Bill repeals the Human Tissue Act of 2012 in its entirety to avoid statutory overlaps.
New Obligations
- Facility Licensing: Blood banks, transfusing facilities, transplant facilities, retrieval facilities, sample referral couriers, and distributors must register with and obtain certificates from the Authority.
- Mandatory Testing and Traceability: Under Clause 45, all donated blood must undergo mandatory testing. Transfusing facilities must keep thorough records to ensure the full traceability of every blood unit from donor to recipient (Clause 47).
- National Waiting List: Under Clause 56, the Authority must maintain a fair, transparent, and non-discriminatory National Waiting List for organ recipients.
- Donor Consent Validity: Living donations are only valid if the donor is at least 18 years old, of sound mind, and has signed a dated written consent form in the presence of two independent witnesses (Clause 78).
Penalties
- Commercial Organ Dealings: Selling, buying, or acting as an intermediary in commercial organ transactions carries a fine of up to KSh 50 million or imprisonment of up to 25 years (Clause 103).
- Unconsented Organ Retrieval: Removing organs or tissues from a living donor without explicit, lawful consent carries a fine between KSh 20 million and KSh 50 million, or imprisonment for 5 to 10 years (Clause 102(2)).
- Obstruction of Inspectors: Anyone who obstructs authorized inspectors investigating facilities faces a fine of up to KSh 10 million, a prison term of up to 3 years, or both (Clause 94).
- Facility Non-Compliance: Operating an uncertified transfusing, retrieval, or transplant facility carries a fine of up to KSh 500,000, imprisonment of up to 2 years, or both.
Transitional Provisions
- Private Blood Centres: Existing private blood collection and processing facilities are required to register and comply with the licensing terms of the Act within six months of its commencement (Clause 118).
- Institutional Succession: The newly established Kenya Blood and Transplant Authority will formally succeed the Department of the National Blood Transfusion, Tissue and Human Organ Transplant Services currently run by the Ministry of Health (Clause 119(2)).
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