Illegal removal and transplantation of human organs could attract fines of up to Sh50 million and a prison sentence of up to 10 years under a new Bill before Parliament.
The Kenya Blood, Cells, Tissues and Organs Bill 2026 seeks to tighten oversight of blood and transplant services while setting strict penalties for people and facilities that operate outside the law.
The proposed legislation, sponsored by Seme MP James Nyikal, who chairs the National Assembly Health Committee, would create the Kenya Blood and Transplant Authority (KBTA).
The Authority would take charge of regulating and coordinating blood donation and transfusion, together with the donation and transplantation of human cells, tissues and organs.
It would advise the Cabinet Secretary and county governments on policies affecting the sector, enforce standards, offer technical support and check whether institutions comply with established policies and practices.
The Authority would also coordinate the entire blood donation process, from public education and donor recruitment to counselling, screening, collection, testing, processing, storage, transportation and distribution.
In transplant services, it would oversee the management of donors and recipients, testing, matching and allocation, as well as the retrieval, processing, storage and distribution of cells, tissues and organs.
Facilities to face certification rules
The proposed law would require transfusion and transplant facilities, retrieval centres, blood banks, cell and tissue banks, laboratories, distributors and sample referral courier providers to be registered and certified.
A facility that provides transfusion or transplant services without the required certification would face a fine of up to Sh500,000, a prison term of up to two years, or both.
KBTA would also be given inspection and investigation powers, including the ability to handle complaints, demand documents and issue directions.
It could work with law enforcement officers to search premises suspected of involvement in illegal blood collection, organ retrieval, trafficking, tissue banking or transplantation.
“An authorised officer or inspector may, at any time and with or without a warrant, enter, inspect and search any premises or facility where the authorised officer or inspector has reasonable cause to believe that the premises or facility trades in human organs, cells and tissues; is carrying out trafficking in human cells, tissues and organs; or obtains financial gain or a comparable advantage from the medical and scientific use of the human body and its parts," the Bill reads in part.
The Bill proposes a fine of between Sh20 million and Sh50 million, a jail term of up to 10 years, or both for anyone who carries out a transplant involving cells, tissues or organs from a living donor without obtaining prior authorisation.
The sale, trafficking and commercial dealing of human organs, cells and tissues would also be prohibited.
A person convicted of such offences could be fined up to Sh50 million or jailed for as long as 25 years, or receive both penalties. The same punishment would apply to unauthorised retrieval of organs intended for transplantation.
However, the proposed law would allow compensation to living donors for legitimate expenses, lost earnings and other related costs. Such payments would have to be declared to the Authority.
The use of force or coercion to obtain a donation would also be prohibited.
Blood donation to remain voluntary
The legislation proposes a national blood and transplant reference laboratory to handle specialised testing, quality checks, standardisation, validation and technical guidance.
Regional cells and tissue centres, regional and satellite blood centres and other blood establishments would also be established under the proposed framework.
Blood donation would remain voluntary and without payment, except in special circumstances where innovative approaches may be allowed.
Before donating, a person would be required to give written and informed consent. Donors would also have a right to information about their health, testing, possible adverse events and the results of tests conducted.
All donated blood would undergo mandatory testing and would be treated as a national resource.
Only registered and certified establishments would be permitted to process blood and blood components, which would then be supplied to certified transfusing facilities.
"A designated transfusing facility shall conduct the transfusion of blood, blood components and blood products as provided under this Act. A health care professional or health care provider shall not conduct, cause to be conducted or aid in conducting, by themselves or through any other person, any activity relating to transfusion at a place other than a transfusing facility certified under this Act," reads the Bill.
"A transfusing facility which contravenes this provision commits an offence and shall be liable, upon conviction, to a fine not exceeding five hundred thousand shillings or imprisonment for a term not exceeding two years, or to both."
New rules for organ allocation
The Bill would establish a national waiting list for recipients seeking cells, tissues and organs.
Allocation would have to be fair and transparent, with citizenship or residency status allowed as a consideration. Political affiliation, race, ethnicity, sex, religion and financial status would not be allowed to influence allocation.
Living and deceased donors would also be subject to conditions requiring informed consent, screening and approval before organs or tissues are retrieved.
The Bill stipulates that "Brain death would have to be confirmed by two independent teams eight hours apart."
Organs could only be retrieved from unclaimed bodies after six months and following the publication of a public notice.
The proposed Authority would oversee licensing and complaints, while a Blood and Transplant Appeals Tribunal would be created to deal with appeals.
County governments would be tasked with putting the policies into effect, encouraging donation, providing safe transfusion services and offering follow-up care.
The proposed framework also covers quality control, protection of donor and recipient information, and monitoring and reporting of adverse events.
If passed into law, the Bill would repeal relevant sections of the Health Act and Human Tissue Act and replace them with a single framework covering blood, cell, tissue and organ donation and transplantation.