A person's organs could only be donated after their death if they had given consent while alive, while bodies left unclaimed in mortuaries for six months could become eligible for organ and tissue recovery under a proposed law seeking to tighten Kenya's transplant rules.
The Kenya Blood, Cells, Tissues and Organs Bill, 2026, also sets strict procedures for confirming brain death and approving organ recipients, even as county governments and state agencies push for changes to how the new regulatory authority will operate.
Under the proposed legislation, hospitals will be prohibited from removing organs from deceased people unless they had agreed to donate them before their death.
The Bill also seeks to prevent conflicts of interest during organ donation by separating the responsibilities of medical practitioners who declare a person dead from those involved in recovering organs and treating recipients.
A doctor who confirms a person's death will not be allowed to participate in removing their organs or providing medical care to the person receiving the donation.
In addition, an independent transplant committee must approve the donation and determine who qualifies to receive the organ.
The legislation further requires brain death to be confirmed by two separate medical teams, with the assessments conducted eight hours apart.
However, the proposed law provides a different procedure for bodies that remain unclaimed in mortuaries for prolonged periods.
Under its provisions, the proposed Kenya Blood and Transplant Authority may authorise the removal of organs, cells and tissues from a body that has remained unclaimed for six months.
Such permission cannot be granted where there are reasons to believe that a relative is likely to come forward to claim the deceased.
The authority will also be required to inform the public of its intention to grant permission through advertisements in newspapers with wide circulation.
The proposals are contained in legislation published on April 2, which seeks to establish a new institution to regulate blood donation, transfusion services and organ transplantation in the country.
However, the proposed law is already facing pressure from government agencies and county governments, which want Parliament to revise several provisions touching on institutional powers, criminal penalties and the management of healthcare services.
The Council of Governors is among the stakeholders seeking substantial changes, arguing that county governments should retain responsibility for operating blood banks, tissue services and transplant programmes in their hospitals.
The council wants counties to continue managing these facilities with financial support from the national government, instead of having their responsibilities reduced to implementing policies issued by the proposed authority.
It is also seeking representation on the authority's board to ensure county governments participate in decisions affecting services delivered through their health facilities.
The proposed authority would take over responsibilities currently handled by the blood and transplant department within the Ministry of Health.
Its mandate would include regulating blood collection and transfusion, overseeing organ transplantation, certifying hospitals offering the services and establishing regional and satellite blood centres.
It would also control the importation and exportation of blood, while private blood centres would be required to apply for licences within six months.
One of the council's main objections concerns Clause 24, which sets out the responsibilities of county governments.
The provision requires counties to comply with national policies, encourage voluntary blood donation and ensure safe blood transfusion services.
However, the governors argue that these duties do not adequately reflect the role counties play in providing healthcare and managing medical facilities.
They want the clause amended to expressly state that counties shall establish and operate blood transfusion services, blood banks, tissue services, human milk banks and organ transplant services within their own health facilities, in accordance with standards set by the law.
The council is also seeking a review of the enforcement powers proposed under Clauses 25 and 26, which require hospitals to obtain certification from the authority before providing blood transfusion and organ transplant services.
As currently drafted, hospitals that operate without the required certification risk a fine of up to Sh500,000, imprisonment for up to two years, or both.
The Council of Governors wants the authority to have powers to suspend a hospital's certificate if it breaches the requirements, but only where such action is necessary to protect public health or patient safety.
It is further proposing the removal of imprisonment as a punishment for hospitals that violate the certification rules.
The Bill's explanatory note states that the provisions are intended to address unlawful and unregulated blood transfusion and organ transplantation.
However, the proposed legislation provides much heavier penalties for serious offences involving human organs.
Anyone found removing organs without authorisation could face a fine of up to Sh50 million, imprisonment for up to 25 years, or both.
Meanwhile, the Office of the Attorney General has identified several gaps in the proposed legislation, particularly concerning the establishment and management of the new authority.
One of its concerns is the lack of transitional provisions explaining how the authority's board will conduct its affairs as the institution is being established.
Although the Bill states that the board should operate under a governance framework, the office says it does not clearly identify the law under which the framework should be developed.
It wants Parliament to review the provision and introduce clear guidelines governing the board's operations and administrative responsibilities during the transition period.
The Attorney General's office has also raised concerns over unclear requirements for certifying facilities that will be allowed to carry out organ transplants, calling for the provisions to be reviewed.
The Director of Public Prosecutions, Renson Ingonga, has separately asked MPs to strengthen the proposed law to ensure offences created under it can be properly investigated and prosecuted.
Through a representative, his office told the Health Committee that it handles cases involving crimes related to blood, cells, tissues, human milk and organs, including trafficking, illegal removal and unlawful sale.
The DPP wants the proposed authority's enforcement responsibilities clearly defined to avoid interference with the independence of his office.
He has also called for the legislation to be aligned with existing criminal laws or to clearly distinguish the offences created under the new law from those already covered by other statutes.
His office warned that overlapping or conflicting offences could complicate investigations and prosecutions, making it harder to hold offenders accountable.
It wants Parliament to provide clear descriptions of criminal offences and the penalties attached to each, while specifying which institutions are responsible for investigating cases, determining guilt and imposing punishment.
The proposals are intended to prevent disputes over the respective responsibilities of the new authority, prosecutors and the courts.
The Pharmacy and Poisons Board has also asked MPs to narrow the proposed authority's mandate to prevent it from taking over functions already assigned to the board under the Pharmacy and Poisons Act.
The board's Chief Executive Officer, Dr Ahmed Mohamed, through a representative, told the committee that some provisions could create an overlap in the regulation of medicines manufactured from blood, medical devices and diagnostic test kits.
The board wants the new authority to concentrate on donated blood, blood components intended for transfusion, blood banks and transfusion services.
It argues that its existing oversight of blood-derived medicines, medical devices and diagnostic test kits should remain under its mandate rather than being transferred to the proposed institution.
Stakeholders have also questioned the wording of provisions dealing with the illegal sale of human organs, saying the Bill does not clearly establish who should be held responsible for the offence.
They want Parliament to clarify the provisions to ensure that individuals involved in the unlawful trade can be properly identified and prosecuted.
The submissions before the Health Committee have brought attention to disagreements over the powers of the proposed authority, the responsibilities of county governments and the enforcement of offences under the new law.