By AMOS MUOKI 

For medical professionals, the availability of human organs and tissues is an invaluable asset. The ability to study a heart with a rare abnormality or to bank genetic material for disease research saves lives and propels scientific discovery. However, the pursuit of these noble objectives does not grant physicians a “free pass” in harvesting bodily materials. To remove an organ from a deceased body without permission is to treat that body with contempt and degradation.

At the heart of Kenya’s legal framework on organ and tissue donation is a single, powerful notion: consent. Whether for research, treatment, or education, bodily material can only be retained or used with the individual’s permission. This principle respects diverse views including religious beliefs that demand a body be buried whole and ensures that the desire to benefit science does not override fundamental respect for the human body.

Primary Regulatory Framework

Kenya’s legal framework for organ donation is built on three main instruments: the Human Tissue Act (Cap 252), the Health Act (Cap 241), and the Kenya Policy on Donation, Transfusion and Transplant of Human Derived Medical Products, 2022.

The Human Tissue Act (Cap 252 Laws of Kenya)

The first key instrument is the Human Tissue Act (Cap 252), which deals exclusively with organ harvesting from deceased donors. The Act, enacted in 1968 and amended subsequently, provides a legislative framework for whole body donation and the taking, storage, and use of human organs and tissue.

Under section 2, a person during their final illness may, in writing or orally in the presence of two or more witnesses, request that their body or a specified part be used after death for therapeutic purposes, medical education, or research.

If such consent exists, the person lawfully in possession of the deceased’s body (typically the hospital administrator or a designated officer) may authorise removal of the specified part.Where the deceased did not expressly consent, the person in lawful possession may still authorize harvesting unless the deceased had objected during life or any surviving spouse or relative objects.

In case of family conflict, the surviving spouse’s opinion prevails a provision that has been criticized for potentially marginalizing other close relatives, including adult children or parents. Even for unclaimed bodies, consent is required. If no relative steps forward, an officer appointed by the deceased in their lifetime may authorize harvesting. In practice, however, most unclaimed bodies in Kenyan public mortuaries are not harvested due to the difficulty of tracing such an appointed officer.

The provisions under Section 3(1) permits only a licensed medical practitioner to harvest a deceased person’s body part, and the doctor must first satisfy themselves that the person is actually dead. Notably, the Act does not specify the standard for determining death (e.g., brain death vs. cardiopulmonary death), creating a potential legal grey area.

The Health Act (Cap 241)

The second key instrument is the Health Act (Cap 241) , particularly Part XI, which provides a broader regulatory framework for harvesting human organs, blood, tissues, and gametes from both living and deceased donors.

Section 80 permits harvesting of tissue or gametes for transplantation only in a duly licensed health facility and on the written authority of the person in charge of that facility. The authorizing medical professional is prohibited from leading the transplantation procedure they have authorized, a conflict-of-interest safeguard designed to ensure independent clinical judgment.

Section 81 requires a person wishing to donate their body or tissue upon death to express that request in a will, in a signed document witnessed by two competent witnesses, or orally in the presence of at least two competent witnesses.

The donor must nominate a beneficiary institution; failing which the donation is null and void. This requirement is stricter than the Human Tissue Act, which does not mandate institutional nomination, and has been criticised for potentially invalidating otherwise valid donations.

Where a person did not consent or object during life, section 80(2) entitles the spouse, elder child, parent, guardian, or eldest brother or sister (in that order of priority) to donate the deceased’s body or tissue.

Enforcement is practically difficult, as approaching grieving relatives soon after death can appear callous and insensitive. Many Kenyan hospitals report that families refuse consent due to cultural beliefs, religious objections (particularly among Muslim and certain Christian communities), or distrust of the medical system.

Section 82 sets out the permissible purposes for donation: training health science students, conducting health research, advancing health sciences, administering treatment, or producing therapeutic or diagnostic substances.

Section 85 establishes the National Blood Service based on voluntary non-remunerated donations. As of 2023, the Service collects approximately 180,000 units of blood annually, falling short of the national need estimated at over 400,000 units, though this shortfall relates to blood products rather than solid organs.

Kenya Policy on Donation, Transfusion and Transplant of Human Derived Medical Products, 2022

This Policy prescribes the practice standards and sets the regulatory framework for organ and tissue donation by living donors and Paragraph 2.2.1 notes that in practice, transplantation services are coordinated through the Ministry of Health.

Currently, there are six operational kidney transplant centres (at Kenyatta National Hospital, Moi Teaching and Referral Hospital, and four private facilities) and cornea transplant facilities (primarily at Kikuyu Eye Hospital and Lions Eye Hospital).

The Policy recognises that human organ and tissue transplantation services are not linked with donation, banking, and allocation services. Unlawful biomedical research and tissue harvesting remain prevalent due to insufficient inspection capacity. The Ministry of Health’s inspectorate, as of 2024, consists of fewer than ten officers responsible for over 1,000 registered health facilities, making routine inspections infeasible.

Paragraph 2.2.4 acknowledges that Kenya has no scheme for organ matching and allocation based on well-defined criteria.

There is no registry of donors, recipients, providers, transplant facilities, organ banks, or post-transplant traceability for living donors. This lack of traceability means that living donors—particularly those from low-income backgrounds—cannot be monitored for long-term health complications, such as kidney failure in remaining kidneys.

Most importantly, paragraph 1.3, principle 5 states that biological materials from living persons must be taken only with the donor’s prior informed and voluntary consent.

For deceased persons, it is imperative to verify that the individual had provided prior consent or had not expressed objections, as mandated by national law.

International Standards: The Declaration of Istanbul (2008)

The Declaration of Istanbul on Organ Trafficking and Transplant Tourism sets broad international standards that Kenya aligns with, particularly through Section 80 of the Health Act.The Treaty defines organ trafficking as the recruitment, transport, transfer, harbouring, or receipt of living or deceased persons or their organs through force, fraud, coercion, abuse of power, or payments to a third party for the purpose of exploitation. It defines organ commercialization as any policy or practice in which an organ is treated as a commodity, including being bought, sold, or used for material gain.

The Treaty enjoins member states to end the victimisation of the world’s poor including illiterate and impoverished persons, undocumented immigrants, refugees, and prisoners as the source of organs for the rich.

Constitutional Challenge: The Kenya Tissue and Transplant Authority

In a significant development, Legal Notice No. 142 of 2022 established the Kenya Tissue and Transplant Authority as a State Corporation. Its mandate was to ensure access to safe and ethical use of human cells, tissues, and organs; to register and license facilities; and to maintain a registry of transplant service providers, donors, and recipients.

However, in the case of Council of County Governors versus Kenya Tissue and Transplant Authority & Others [2023] KEHC 21046 (KLR) , Justice L.N. Mugambi delivered a judgment on 30th June 2023 declaring the Gazette Notice unconstitutional.The reason was that the tissue and organ transplantation is a concurrent function of National and County Governments under the Fourth Schedule of the Constitution. Vesting this mandate exclusively in a National Government agency (a State Corporation) without consensus from the Council of Governors violated the objects of devolution concerning health functions. This ruling leaves a critical gap in institutional oversight, returning the regulatory responsibility to the concurrent, and potentially less coordinated, authority of both levels of government.

Practical Realities: Living Donors and the Absence of a Deceased Donor Programme

Kenya performs approximately 50–80 kidney transplants annually, the vast majority from living related donors (spouses, parents, siblings, or children). Living unrelated donations (e.g., friends or altruistic strangers) are legally permissible but rare, subject to rigorous ethical review. Deceased donor kidney transplantation is virtually non-existent in Kenya. This is not due to legal prohibition the Human Tissue Act expressly permits it but due to the absence of a deceased donor procurement infrastructure: no organ procurement organisation, no trained transplant coordinators, no national rapid-referral system, and no public awareness campaigns to encourage donor registration.

Conclusion

Kenya possesses a detailed, consent-driven legal framework for organ and tissue donation, with strong prohibitions against commercialization and clear rules for both living and deceased donors. Statutes like the Human Tissue Act and the Health Act prioritize voluntary consent, family involvement, and medical professionalism.

However, significant practical challenges remain: the absence of a national donor-recipient registry, a lack of matching and allocation criteria, insufficient inspection capacity to combat unlawful harvesting, the constitutional invalidation of the proposed central authority, and the near-total absence of a deceased donor transplant programme.

Until these gaps are addressed particularly the creation of a constitutional, coordinated regulatory body and the establishment of practical procurement infrastructure the noble objectives of organ donation and transplantation will struggle to be realised safely, ethically, and equitably in Kenya. For the thousands of patients awaiting transplants, legal provisions on paper are no substitute for functioning systems on the ground.

The writer is legal commentator on constitutional and human rights issues, the article is intended for public education and does not constitute legal advice.