GAZETTE NOTICE NO. 5043

IT IS notified for general information of the public that the Cabinet Secretary for Health has constituted a committee to be known as the Independent Investigative Committee on Tissue and Organ Transplant Services (hereinafter referred to as “the Committee”). 1. The Committee shall comprise of the following: Elizabeth Bukusi (Prof.) — Chairperson, Members: Jonathan Wala Ameyo (Dr.), Ahmed Sokwala (Prof.), Prexedes Okutoyi (Dr.), Patrick Mburugu (Dr.), Noelle Atieno Orata (Dr.), Ann Kasyoka Barasa (Dr.), Diviner Kemunto Nyarera (Dr.), Wendy Kimbui (Dr.), Sara Talaso Bonaya, Charles Kandie (Dr.), Joseph Ndirangu, Larica Onam, Secretariat: Stella Kanja (Dr.), Rueben Tulei, Jedidah Effie Oduor. 2. The terms of reference of the Committee shall be to— (a) establish the existing legal and regulatory framework governing the tissue and organ transplant services in Kenya and to conduct an in-depth independent investigation into any non-compliant tissue and organ transplant services offered within health facilities in Kenya including in Mediheal Group of Hospitals ( hereinafter referred to as “ Mediheal”) and to assess the status of governance, ethical, legal and clinical practices of tissue and organ transplant services across all health facilities in Kenya; (b) review the existing policy, legal and institutional framework, standards, guidelines and protocols that govern organ and tissue transplant services in Kenya and identify any existing gaps in the framework; (c) evaluate governance and operating procedures, including transplant protocols, ethics reviews, and post-transplant monitoring and identify any existing weaknesses and gaps; (d) identify systemic weaknesses, risks of malpractice, or non- compliance with legal or ethical standards in tissue and organ transplant services; (e) determine the facilities that are duly licensed to provide transplant services in Kenya and conduct site reviews of all facilities offering tissue and organ transplant services to establish the status of compliance with the existing framework and protocols; (f) conduct an in-depth investigation into instances of malpractice or non-compliance by the facilities offering the transplant services (if any); (g) undertake a comprehensive inquiry into the allegations of illegal organ transplant and organ trafficking at Mediheal by undertaking the following— (i) obtain and review all clinical records, consent forms, and documentation for tissue and organ including renal transplant procedures conducted over the past sixty (60) months; (ii) interview renal transplant surgeons, nephrologists, anaesthetists, administrators and patients (donors and recipients); (iii) carry out an in-depth investigation into the alleged malpractices, organ trafficking or non-compliance by Mediheal; (iv) establish the legality and ethical validity of each renal donor-recipient match, including verification of donor consent and identity; (v) determine whether any instances of commercialisation, coercion, organ trafficking, or violations of the Human Tissue Act or any other applicable laws or regulations occurred; (vi) investigate and establish Mediheal’s adherence to the existing policy and legal framework including standards, guidelines and protocols on transplant services; 6:23 PM THE KENYA GAZETTE 23rd April, 2025 1784 1784 (vii) audit the hospital’s internal tissue and organ transplant governance systems, including functioning of its Renal Transplant Ethics Committee (TEC); (viii) determine if reporting lines to regulatory agencies were followed and if routine audits or site inspections were done; (ix) establish status of compliance of Mediheal as regards shipment of human tissue samples and organs out of the country and submission of relevant reports to the relevant government agencies including the Ministry of Health; (x) hold consultative meetings with relevant stakeholders and the public; (xi) access and review any previous reports relevant to its mandate; and (xii) prepare and submit a report containing recommendations on how to address the identified gaps, weaknesses, professional misconduct, criminal conduct, or any other issues identified to the Cabinet Secretary for Health. 3. In the execution of its mandate, the Committee shall— (a) regulate its own procedures with respect to the orderly conduct of its proceedings, quorum for the transaction of business and other related matters; (b) carry out or cause to be carried out such studies or research as is necessary in furtherance of its mandate; and (c) in consultation with the Cabinet Secretary for Health, co-opt any person as may be necessary to assist the Committee to discharge its mandate. 4. The Chairperson and other members of the Committee shall prior to embarking on their duties, subscribe to the Declaration set out in the Schedule. 5. The Secretariat of the Committee shall be responsible for─ (a) accurately capturing the deliberation of the Committee; (b) keeping the records of the Committee; (c) preparing the Committee’s reports; (d) undertaking research and liaising with relevant Government agencies or departments and any other institution for purposes of collecting relevant information necessary in furtherance of the Committee’s mandate; and (e) any other responsibility as assigned by the Committee. 6. The Committee shall be domiciled at the Ministry of Health. 7. The members of the Committee shall serve for a period of three months with effect from the 23rd April, 2025. Dated the 23rd April, 2025. ADEN DUALE, Cabinet Secretary for Health.