Kenya Tissue and Transplant Authority Order

This Order is officially titled the Kenya Tissue and Transplant Authority Order.

AI-assisted research synopsis — verify against the official legal text below.

Jurisdiction: Kenya
Instrument: Notice
Citation: Legal Notice 142 of 2022
Version: Undated source snapshot
Language: en

Source attribution: Source: Kenya Law

Statute overview

About this statute

This Order is officially titled the Kenya Tissue and Transplant Authority Order. Defines the terms "Authority", "Board", "Cabinet Secretary" and "Chief Executive Officer" for the Order. Creates the Kenya Tissue and Transplant Authority as a state corporation. The Kenya Tissue and Transplant Authority must ensure safe and ethical access to human cells, tissues and organs and protect donor and recipient safety and biosafety by establishing and maintaining compliant systems. The Authority has a range of functions including regulation of transplant services, licensing and registration of facilities and providers, maintaining registries, establishing allocation mechanisms, overseeing standards, providing support services, emergency preparedness, public mobilization, international collaboration, research, advising government, and other functions as determined by the Board with Cabinet Secretary approval.

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Provisions of Kenya Tissue and Transplant Authority Order

Showing 23 of 23

Part I

PRELIMINARY

1
PRELIMINARY - 1. Citation

AI-assisted research summary: This Order is officially titled the Kenya Tissue and Transplant Authority Order.

Section 1. Citation Section This Order may be cited as the Kenya Tissue and Transplant Authority Order.
2
PRELIMINARY - 2. Interpretation

AI-assisted research summary: Defines the terms "Authority", "Board", "Cabinet Secretary" and "Chief Executive Officer" for the Order.

Section 2. Interpretation Section In this Order, unless the context otherwise requires— "Authority" means the Kenya Tissue and Transplant Authority established by paragraph 3; "Board" means the Board of Directors of the Kenya Tissue and Transplant Authority constituted in accordance with paragraph 6; "Cabinet Secretary" means the Cabinet Secretary for the time being responsible for health; and "Chief Executive Officer" means the person appointed in accordance with paragraph 11.

Part II

ESTABLISHMENT OF THE KENYA TISSUE AND TRANSPLANT AUTHORITY

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ESTABLISHMENT OF THE KENYA TISSUE AND TRANSPLANT AUTHORITY - 3. Establishment of the Kenya Tissue and Transplant Authority

AI-assisted research summary: Creates the Kenya Tissue and Transplant Authority as a state corporation.

Section 3. Establishment of the Kenya Tissue and Transplant Authority Section 3(1) There is established a state corporation to be known as the Kenya Tissue and Transplant Authority. Section 3(2)(a) suing and being sued; Section 3(2)(b) taking, purchasing or otherwise acquiring, holding, charging or disposing of movable and immovable property; Section 3(2)(c) receiving, investing, borrowing and lending money; and Section 3(2)(d) doing or performing all other things or acts, including entering into contracts for the proper performance of its functions under this Order, which may be lawfully done or performed by a body corporate. Section 3(3) The Kenya Tissue and Transplant Authority shall be the successor to the Department of the National Blood Transfusion, Tissue and Human Organ Transplant Services existing at the Ministry of Health at the commencement of this Order.
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ESTABLISHMENT OF THE KENYA TISSUE AND TRANSPLANT AUTHORITY - 4. Objective of the Authority

AI-assisted research summary: The Kenya Tissue and Transplant Authority must ensure safe and ethical access to human cells, tissues and organs and protect donor and recipient safety and biosafety by establishing and maintaining compliant systems.

Section 4. Objective of the Authority Section The objective of the Kenya Tissue and Transplant Authority shall be to ensure access to safe and ethical use of human cells, tissues and organs and 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.
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ESTABLISHMENT OF THE KENYA TISSUE AND TRANSPLANT AUTHORITY - 5. Functions of the Authority

AI-assisted research summary: The Authority has a range of functions including regulation of transplant services, licensing and registration of facilities and providers, maintaining registries, establishing allocation mechanisms, overseeing standards, providing support services, emergency preparedness, public mobilization, international collaboration, research, advising government, and other functions as determined by the Board with Cabinet Secretary approval.

Section 5. Functions of the Authority Section 5(1)(a) regulate all services relating to human cells, tissue and organ transplant in accordance with the Health Act (Cap. 241); Section 5(1)(b) register and license facilities and establishments dealing with human cells, tissues and organs and transplant services; Section 5(1)(c) maintain a registry of transplant service providers, donors and recipients; Section 5(1)(d) establish an equitable mechanism for matching and allocation of cells, tissue and organs; Section 5(1)(e) oversee the implementation of policies, guidelines, procedures and standards relating to human tissues and organs; Section 5(1)(f) provide support services for transfusion and transplant systems including testing, grouping, typing, banking, processing, distribution, manufacturing and quality control; Section 5(1)(g) develop a national emergency response mechanism including maintenance of strategic reserves for human tissues and organs; Section 5(1)(h) mobilize, educate and sensitize the members of the public to foster voluntary donations of cells, tissues and organs; Section 5(1)(i) collaborate, within agreed reciprocal arrangements, with other established organ exchange organizations in other countries, for the exchange of tissue and organs, where appropriate; Section 5(1)(j) conduct, and collaborate with other stakeholders, in conducting research on human cells, tissues and organs and related services; Section 5(1)(k) advise the Cabinet Secretary, National and County Governments and all the stakeholders on ethical, legal and clinical issues related to services for human cells, tissue and organ transplant; and Section 5(1)(l) such other functions as the Board, with the approval of the Cabinet Secretary, may determine. Section 5(2)(a) establish and maintain linkages with the relevant regulatory and service bodies on matters related to cells, tissues and human organ medical services; Section 5(2)(b) make and enforce directions to ensure compliance with this Order and with the conditions of licences thereof; Section 5(2)(c) 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; Section 5(2)(d) summon of any person who is in possession of any information relating to violation of the provisions of this Order; Section 5(2)(e) enter, search and inspect any place suspected to be indulging in unauthorised removal, procurement or transplantation of human cells, organs or tissues; or Section 5(2)(f) 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.

Part III

BOARD OF DIRECTORS OF THE AUTHORITY

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BOARD OF DIRECTORS OF THE AUTHORITY - 10. Delegation by the Board

AI-assisted research summary: The Board may, by written resolution (generally or for a particular case), delegate to any committee of the Board the management of the Authority, the exercise of any powers, or the performance of any functions of the Board under this Order or any other written law.

Section 10. Delegation by the Board Section The Board may by resolution, in writing, either generally or for a particular case, delegate to any committee of the Board, the management of the Authority, the exercise of any of the powers or the performance of any of the functions of the Board under this Order or any other written law.
11
BOARD OF DIRECTORS OF THE AUTHORITY - 11. Chief Executive Officer

AI-assisted research summary: The Board must appoint a suitably qualified person as Chief Executive Officer through competitive recruitment and with Cabinet Secretary approval; the CEO is responsible for day-to-day operations under Board supervision.

Section 11. Chief Executive Officer Section 11(1) The Board shall through a competitive recruitment process, and subject to approval by the Cabinet Secretary, appoint a suitably qualified person to be the Chief Executive Officer of the Authority. Section 11(2)(a) is a Kenyan Citizen; Section 11(2)(b) has at least an advanced degree from a university recognized in Kenya; Section 11(2)(c) has at least ten years' experience at a senior management level with skills related to health systems, haematology, laboratory service, transplant medicine, pathology, finance, management, economics, law or any other relevant field; and Section 11(2)(d) satisfies the requirements of Chapter Six of the Constitution. Section 11(3) The Chief Executive Officer shall be responsible for the day-to-day operations and administration of the Authority, under the general direction and supervision of the Board.
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BOARD OF DIRECTORS OF THE AUTHORITY - 12. Corporation Secretary

AI-assisted research summary: The Board must competitively recruit a person qualified under the law governing public secretaries in Kenya to serve as the Corporation Secretary of the Authority; the Corporation Secretary must act as Secretary to the Board and arrange meetings and keep the records of the Board.

Section 12. Corporation Secretary Section 12(1) The Board shall competitively recruit a person qualified, in terms of the law governing the practice of public secretaries in Kenya, to serve as the Corporation Secretary of the Authority. Section 12(2) The Corporation Secretary shall be the Secretary to the Board and shall be responsible for arranging the business and meetings of the Board, the keeping of records of the Board’s meetings, the keeping of the records of the proceedings of the Board, and perform such other duties as the Board may direct.
13
BOARD OF DIRECTORS OF THE AUTHORITY - 13. Staff

AI-assisted research summary: The Authority may employ officers, staff or agents it considers necessary for its functions, under terms the Board may determine in consultation with the Cabinet Secretary and on the advice of the Salaries and Remuneration Commission.

Section 13. Staff Section The Authority may employ such other officers, staff or agents as it considers necessary for the discharge of its functions and duties under this Order, upon such terms and conditions as the Board may determine, in consultation with the Cabinet Secretary and on the advice of the Salaries and Remuneration Commission.
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BOARD OF DIRECTORS OF THE AUTHORITY - 6. Board of the Authority

AI-assisted research summary: Lists Board membership and some appointment responsibilities, permits the Board to co-opt experts temporarily, and makes the CEO an ex officio member.

Section 6. Board of the Authority Section 6(1)(a) a non-executive Chairperson appointed by the President; Section 6(1)(b) the Principal Secretary in the Ministry for the time being responsible for finance, or his or her representative, appointed in writing; Section 6(1)(c) the Principal Secretary in the Ministry for the time being responsible for health, or his or her representative, appointed in writing; Section 6(1)(d) the Attorney-General or his representative, appointed in writing; Section 6(1)(e) one person, not being a governor, nominated by the Council of Governors; Section 6(1)(f) 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; and Section 6(1)(g) the chief executive officer who shall be an ex officio member of the Board. Section 6(2) The persons to be appointed under subsection (1)(a) and (g) shall be selected through conventional board resourcing procedures including through applications, referrals and knowledge of the market and industry actors. Section 6(3) The appointments under subparagraphs (1)(a) and (g) shall be by notice in the Gazette . Section 6(4) The Board may co-opt any other person with necessary expertise and on temporary basis as it considers necessary to assist the Board in discharging its duties and responsibilities.
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BOARD OF DIRECTORS OF THE AUTHORITY - 7. Tenure and vacation

AI-assisted research summary: The Chairperson and Board members appointed under paragraph 6(1)(g) hold office for three years, renewable once; members may vacate office for the listed grounds including resignation by written notice to the appointing authority, incapacity, unexcused absence at three consecutive meetings, bankruptcy/composition, or imprisonment of six months or more.

Section 7. Tenure and vacation Section 7(1) The Chairperson and members of the Board appointed under paragraph 6(1)(g) shall hold office for a term of three years which may be renewed only once for a further term of three years. Section 7(2)(a) resigns from office, by a notice, in writing, addressed to the appointing authority; Section 7(2)(b) is incapacitated by prolonged physical or mental illness or is otherwise unable to discharge the functions of a member of the Board; Section 7(2)(c) is absent from three consecutive meetings of the Board without good cause and prior apology; Section 7(2)(d) is adjudged bankrupt or enters into a composition scheme or arrangement with his creditors; Section 7(2)(e) is sentenced by a court to imprisonment for a term of six months or more.
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BOARD OF DIRECTORS OF THE AUTHORITY - 8. Functions of the Board

AI-assisted research summary: The Board must manage and administer the Authority and perform listed functions such as administering property and funds, receiving and approving money, advising the Cabinet Secretary on transplant policy, and carrying out other necessary functions including revenue-raising ventures.

Section 8. Functions of the Board Section 8(1) The Board shall be responsible for the management and administration of the Authority. Section 8(2)(a) administer the property and funds of the Authority in such a manner and for such purposes as will, in the opinion of the Board, promote its best interests; Section 8(2)(b) receive on behalf of the Authority grants in aid, gifts, donations, fees, subscriptions or other moneys and approve disbursement; Section 8(2)(c) advise the Cabinet Secretary on policy matters relating to tissue and human organ transplant; Section 8(2)(d) do or perform all other necessary functions or activities of a Kenya Tissue and Transplant Authority, including undertaking of any ventures for the purposes of raising revenues for the purposes of funding its activities wholly or in part.
9
BOARD OF DIRECTORS OF THE AUTHORITY - 9. Powers of the Board.

AI-assisted research summary: The Board has all powers to manage and administer the Authority and may, among other specific powers, open bank accounts; receive grants, gifts, donations or endowments and disburse them; acquire land or assets; invest funds not immediately required; determine fees; enter agreements or partnerships; and, with written prior approval of the Cabinet Secretary, carry out other activities to promote the Authority's objects and purposes.

Section 9. Powers of the Board. Section 9(1) The Board shall have all the powers necessary to manage and administer the Authority in a manner that shall enable the realization of the objects and purposes for which the Authority is established. Section 9(2)(a) open a bank account(s) for the funds of the Authority into which all moneys received by the Authority shall be paid in the first instance and out of which all payments made by the Authority shall be made; Section 9(2)(b) receive any grants, gifts, donations or endowment and make legitimate disbursements therefrom; Section 9(2)(c) acquire such land or assets as are necessary for the proper performance of the functions of the Authority; Section 9(2)(d) invest any funds of the Authority not immediately required for performance of the objects and purposes for which the Authority is established; Section 9(2)(e) determine fees for services rendered by the Authority from time to time; Section 9(2)(f) enter into any agreement or partnership with any public sector agencies and other parties for the operation of facilities, equipment or services of the Authority as necessary, in furtherance of the discharge of the functions of the Authority; and Section 9(2)(g) with the written prior approval of the Cabinet Secretary, carry out any other activity that in the opinion of the Board will promote and facilitate the realization of the objects and purposes of the Authority.

Part IV

FINANCIAL PROVISIONS

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FINANCIAL PROVISIONS - 14. Funds of the Authority

AI-assisted research summary: Funds of the Authority are monies appropriated by Parliament for the purposes of the Authority.

Section 14. Funds of the Authority Section monies appropriated by Parliament for the purposes of the Authority;
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FINANCIAL PROVISIONS - 15. Financial Year

AI-assisted research summary: The financial year of the Kenya Tissue and Transplant Authority is the twelve‑month period ending on the thirtieth day of June each year.

Section 15. Financial Year Section The financial year of the Kenya Tissue and Transplant Authority shall be the period of twelve months ending on the thirtieth day of June in each year.
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FINANCIAL PROVISIONS - 16. Annual estimates

AI-assisted research summary: The Kenya Tissue and Transplant Authority must prepare annual estimates in accordance with the Public Finance Management Act (Cap. 412A).

Section 16. Annual estimates Section The annual estimates of the Kenya Tissue and Transplant Authority shall be prepared in accordance with the Public Finance Management Act (Cap. 412A)
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FINANCIAL PROVISIONS - 17. Accounts and audit

AI-assisted research summary: The Board must keep proper audit books and records of accounts for the Kenya Tissue and Transplant Authority; the Authority's accounts must be audited and reported in accordance with the Public Finance Management Act (Cap. 412A) and the Public Audit Act (Cap. 412B).

Section 17. Accounts and audit Section 17(1) The Board shall cause to be kept all proper audit books and records of accounts of the income, expenditure, assets and liabilities of the Kenya Tissue and Transplant Authority. Section 17(2) The accounts of the Kenya Tissue and Transplant Authority shall be audited and reported upon in accordance with the Public Finance Management Act (Cap. 412A) and the Public Audit Act (Cap. 412B).

Part V

MISCELLANEOUS PROVISIONS

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MISCELLANEOUS PROVISIONS - 18. Protection from personal liability

AI-assisted research summary: Persons acting for the Authority in good faith while executing this Order are not personally liable for actions, claims or demands arising from those matters.

Section 18. Protection from personal liability Section No matter or thing done by the Board, Chairperson, any Board member, or any officer, employee or agent of the Authority shall, if the matter or thing is done in good faith and for the purposes of executing any provisions of this Order, render the Board, Chairperson, Board member, or any officer, employee or agent of the Authority or any person acting under the direction of those persons personally liable for any action, claim or demand arising from the same.
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MISCELLANEOUS PROVISIONS - 19. Liability for damages

AI-assisted research summary: The Authority is still liable to pay compensation or damages to any person for injury to that person or their interests caused by exercising powers under this Order or by failure (wholly or partially) of any works.

Section 19. Liability for damages Section The provisions of this Order shall not relieve the Authority of the liability to pay compensation or damages to any person for any injury to that person or his interests caused by the exercise of any power conferred by this Order or by failure, whether wholly or partially, of any works.
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MISCELLANEOUS PROVISIONS - 20. Policies

AI-assisted research summary: Policies section concerning the procedure for the appointment of all members of staff or officers of the Authority.

Section 20. Policies Section with respect to the procedure for the appointment of all members of staff or officers of the Authority;
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MISCELLANEOUS PROVISIONS - 21. Annual report

AI-assisted research summary: Annual report: the accounts of the Kenya Tissue and Transplant Authority and statements referred to under paragraph 15.

Section 21. Annual report Section the accounts of the Kenya Tissue and Transplant Authority and statements referred to under paragraph 15;
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MISCELLANEOUS PROVISIONS - 22. Transition of staff

AI-assisted research summary: Employees who immediately before commencement served in the Ministry of Health's Kenya National Blood Transfusion, Tissue and Human Organ Transplant Services shall serve as staff of the Authority; those employees will be assessed for placement by Board criteria; and upon publication they may choose to serve in the Authority or be redeployed in the Public Service.

Section 22. Transition of staff Section 22(1) A person who immediately before the commencement of this Order was an employee of the Government serving in the Ministry of Health in the Department of Kenya National Blood Transfusion, Tissue and Human Organ Transplant Services shall at the commencement of this Order serve as a member of staff of the Authority. Section 22(2) The employees under subparagraph (1) shall be assessed using the criteria determined by the Board, for appropriate placement in the organizational structure of the Authority. Section 22(3) Despite subparagraph (1), all employees of the Government who were serving in the Ministry of Health in the Department of Kenya National Blood Transfusion, Tissue and Human Organ Transplant Services shall upon publication of this Order be given an option to elect to serve in the Authority or be redeployed in the Public Service.
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MISCELLANEOUS PROVISIONS - 23. Transition of Assets.

AI-assisted research summary: Property acquired by the Government for use in the Ministry of Health's Kenya National Blood Transfusion, Tissue and Human Organ Transplant Services becomes property of the Authority, subject to existing rights and arrangements at the commencement of the Order.

Section 23. Transition of Assets. Section All property acquired by the Government for use of the in the Ministry of Health in the Department of Kenya National Blood Transfusion, Tissue and Human Organ Transplant Services shall be subject to the rights, liabilities, obligations, agreements and other arrangements existing at the commencement of this Order become property of the Authority.

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