Kenya’s endeavour to ensure access to safe and ethical use of human cells, tissues and organs is set to be actualised with the establishment of the Kenya tissue and transplant authority by president Uhuru Kenyatta.

The authority, which was established through a special gazette notice dated august 1st, will be a successor to the Department of the National Blood Transfusion, Tissue and Human Organ Transplant Services. It will be required to ensure the safety, biosafety and wellbeing of donors and recipients in medical services relating to human derived medical products through the establishment and maintenance of systems that comply with safety and legal requirements.

The authority will be tasked with regulating all services relating to human cells, tissue and organ transplant in accordance with the Health Act, 2017, register and license facilities and establishments dealing with human cells, tissues and organs and transplant services, maintain a registry of transplant service providers, donors and recipients as well as establish an equitable mechanism for matching and allocation of cells, tissue and organs.

It will also oversee the implementation of policies, guidelines, procedures and standards relating to human tissues and organs, provide support services for transfusion and transplant systems including testing, grouping, typing, banking, processing, distribution, manufacturing and quality control, develop a national emergency response mechanism including maintenance of strategic reserves for human tissues and organs, mobilize, educate and sensitize members of the public to foster voluntary donations of cells, tissues and organs and collaborate with other established organ exchange organizations in other countries, for the exchange of tissue and organs.

Other functions include conducting and collaborating with other stakeholders in conducting research on human cells, tissues and organs and related services, advising health Cabinet Secretary, National and County Governments and all stakeholders on ethical, legal and clinical issues related to services for human cells, tissue and organ transplant and such other functions as the Board, with the approval of the Cabinet Secretary, may determine.

In discharging its mandate, the authority has been given powers to establish and maintain linkages with relevant regulatory and service bodies on matters related to cells, tissues and human organ medical services, make and enforce directions to ensure compliance, inspect hospitals periodically for examination of the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed. It may also summon any person who is in possession of any information relating to violations, enter, search and inspect any place suspected to be indulging in unauthorised removal, procurement or transplantation of human cells, organs or tissues or order the production of any document or material object suspected to be used in relation to unauthorised removal, procurement or transplantation of human cells, organs or tissues.

The authority will have a board consisting of a non-executive Chairperson appointed by the President, the Principal Secretary in the Ministry of health responsible for finance, or his or her representative, appointed in writing, the Attorney-General or his representative, appointed in writing, one person, not being a governor, nominated by the Council of Governors, three other members, not being public officers, appointed by the Cabinet Secretary by virtue of gender, disability, regional balance and their knowledge and experience in matters relating to haematology, pathology, transplant medicine, finance, management, economics, law or any other relevant field. The chief executive officer will be an ex-officio member of the Board.

The formation of the authority comes amid increased investments in modern blood processing, storing, testing equipment, access to safe organs and transplantation services and distribution mechanisms across the Country. In order to institutionalize and safeguard the gains made, Kenya has developed the Kenya Policy on Donations, Transfusion and Transplant of Human derived medical products, the first integrated policy on blood, cells, tissues and organs in Eastern, Central and Southern Africa.

To address the challenge of obsolete equipment and resources in the management blood, cells, tissues and organs, the ministry of health has invested in digitizing health by leveraging technology with the recent launch of the Kenya Blood Banking Information System– Damu-KE. The system ensures efficiency and security of related products and in building capacity for the health system to respond to critical needs. The system has been deployed to all Regional Blood Transfusion Centres and to county-based satellites and is operational in the National referral hospitals.

As part of the medium-term Plan 4, the ministry of health has prioritised the development of a Kenya Blood and Organ Centre. The Centre will host a strategic blood products reserve bank to eliminate shortages during emergencies with a nationally coordinated deployment mechanism. It will include an organs and stem-cell bank for a repository of available products and therefore facilitate implementation of an organ compatibility matching and allocation scheme.

In an effort to safeguard quality of related products, the first Blood and Organs Reference Laboratory will be established to serve Eastern and Central Africa besides investing in training human resource with capacity for specialized transfusion and transplant medicine and research.