The Kenya Medical Research Institute Bill, 2025

SPECIALISSUE

Kenya Gazette Supplement No.72 (National Assembly Bills No.20)

REPUBLIC OFKENYA

KENYA GAZETTESUPPLEMENT

NATIONALASSEMBLYBILLS,2025

NAIROBI,29thMay,2025

CONTENT

| Bill for Introduction into the National Assembly- | PAGE | |-----------------------------------------------------|--------| | The Kenya Medical Research Institute Bill,2025 | 469 |

THEKENYAMEDICALRESEARCHINSTITUTE BILL,2025

ARRANGEMENTOFCLAUSES

Clause

PARTI-PRELIMINARIES

1. Short title. 2. 2. 3. Interpretation. 4. 3. 5. Objects of the Act. 4. Guiding Principles.

PARTI-THEKENYAMEDICALRESEARCH

INSTITUTE

5. Establishment of the Institute. 6. Headquartersof the Institute 3. 7. 4. Functions of the Institute 8. Powers of the Institute 9. TheBoard ofDirectors of the Institute. 7. 10. 8. Qualification for appointment as Chairperson or Member of the Board. 11. Term of office. 10. 12.Vacation of office. 11. 13.Committees of the Board. 12. 14.Conduct of the business and affairs of the Board. 13. 15.Delegation by the Board. 14. 16.Director-General of the Institute. 15. 17.Removal from office of the Director-General. 16. 18.Corporation Secretary. 17. 19.Staff of theInstitute. 18. 20.Remuneration. 19. 21.Protection from personal liability. 20. 22.Common seal.

PARTII-CONDUCT OFRESEARCHFOR HUMANHEALTHANDINNOVATION

• 23.Research areas.
• 24.Research priorities and agenda.
• 25.Initiation of research.
• 26.Scientific Steering Committee.
• 27.Training and professional development of human health research scientists.
• 28.Communication and participation.
• 29.Inter-disciplinary collaboration.
• 30.Ethical considerations.

31. Establishment of the Scientific and Ethics Review

• Unit.
• 32.Membership to the Scientific and Ethics Review
• Unitcommittees.
• 33.Code of conduct for members.
• 34.Community engagement in research.
• 35.Data collection.
• 36.Quality assurance in research.

37. Management of research data. 38. Data management,analysis and dissemination.

• 39.Monitoring and evaluation.

PARTIV-CLINICALTRIALS

• 40.Conduct of clinical trials.
• 41.Clinical trial research in public health emergencies.

PARTV-TRADITIONALANDALTERNATIVE

MEDICINE

42. Responsibility of government in traditional and 2. alternative medicine. 3. 43.Assessment of quality,efficacy,and safety. 4. 44.Support for development. 5. 45.Capacity building for practitioners.

• 46.Offencesrelated to traditional medicinal products.
• 47.Management of traditional and alternative medicine knowledge.

PARTVI-TRAINING AND CAPACITY BUILDING

• 48.Capacity building in matters of human health.
• 49.Training by the Institute.

50. Specialized post-graduate degrees,diplomas and

• certificates
• 51.Scholarships.
• 52.Admission for training by the Institute.

PARTVII-RESEARCH INFRASTRUCTURE

• 53.Establishment of research centres.
• 54.Biobanks.
• 55.Exportation and importation of biological materials.
• 56.Designation of biobanks.
• 57.Research data banks.
• 58.Access to health research data banks.
• 59.Establishment of botanical gardens.
• 60.Establishment of animal houses and insectaries.

61. Establishment of research clinics.

PARTVII-INTELLECTUALPROPERTY

• 62.Rights to vest in the Institute.
• 63.Withholding intellectual property information.
• 64.Registration of intellectual property.
• 65.Ownership ofintellectual property.
• 66.Commercialization of intellectual property.
• 67.Benefits.

PART IX-FINANCIALPROVISIONS

68. Funds of the Institute. 2. 69.Investment of funds

• 70.Financial year.
• 71.Annual estimates.

72. Accounts and audit.

• 73.Annual report.

PARTX-DELEGATEDLEGISLATION

74. Regulations.

PARTXI-GENERALPROVISIONS

• 75.Risk management.
• 76.Integration of legal frameworks.
• 77.Experts.
• 78.Duty to protect personal data held by the Institute

79. Disclosure of information held by theInstitute.

• 80.Confidentiality.

81. Exemptions. 82. Offences. 83. General penalty

• Relationship with the National Commission for

84. Science Technology and Innovation.

PART XII-REPEALANDTRANSITIONAL PROVISIONS

• 85.Interpretation of part.
• 86.Reference to the formerInstitute.
• 87.Agreements, contracts and other binding instruments.
• 88.Assets and liabilities.
• 89.Directions,orders,etc.of the former Institute
• 90.Annual estimates of the former Institute

91. Legal proceedings.

• 92.Board of the former Institute.
• 93.Staff of the formerInstitute.
• 94.Disciplinary proceedings

• 95.Pension.
• 96.Repealof L.N.35/2021.
• 97.Amendment of Cap.511. SCHEDULE-CONDUCT OFBUSINESS AND

AFFAIRSOFTHEBOARD

THEKENYAMEDICALRESEARCHINSTITUTE BILL,2025

A Bill for

AN ACT of Parliament to make provision for the establishment,powers and functions of the Kenya Medical Research Institute; to provide for the effective conduct,co-ordination and promotion of research for human health in Kenya and for connected purposes

ENACTEDby theParliamentofKenya asfollows-

PARTI-PRELIMINARIES

• 1.This Act may be cited as the Kenya Medical Short title. Research Institute Act,2025.
• 2.In this Act,unless the context otherwise Interpretation. requires-

"alternative medicine" means complementary medicine and includes a broad set ofhealth care practices that are notpart ofKenya's tradition and are not integrated into the dominant health care system;

means specialized institutions sor repository that collect, store and manage biological

"biobanks" materials;

"biological material"means living organisms or any substance derived from living organisms including human tissues,blood,genetic material,cells,microorganisms, toxins and other materials for use in scientific and medical research;

"biospecimens" means any material derived from a human or animal body for research,diagnostic or therapeutic purposes including blood,tissue,urine,saliva and genetic material;

"Boardmeans the Board of Directors of the Institute established under section 9;

"Cabinet Secretary"means the Cabinet Secretary responsibleformattersrelating tohealth;

"clinical trialmeans a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes;

"Commission"means the commission for University

"Director-General means the person appointed under section 16;

Education Established under section 4 of Universities Act;

"human heaith"means a state of complete physical,

mental,aud social well-being and not merely the absence of disease or infirmity:

"incubaticncentres" means atransitoryand facilitative platform that gives innovators technical assistance,irastructure,access to inventors and investors and networing that may encourage and scale-up inventions;

"informed consent"means a process of obtaining permission before conducting a health care prevention ona

person;

"Institute"means the Kenya Medical Research Institute established under section 5;

process,machine,composition of matter,life form,rticle ofmanufacture,software,copyrighted werk and know-how and information associated with the above.it includss but is not restricted to such things as new or improved devices, circuit layouts, chemical compounds,drugs,genetically engineered biological organisms,data sets,databases, software or unique and innovative uses of existing inventions,and

"intellectual property" mean any new or useful

"public health emergency"means the occurrence or imminent threat of an illness or health condition caused by bioterrorism,epidemic or pandemic disease or an infectious agent or toxin that causes substantial risks to humans by causing a significant number of human fatalities or permanent or long-term disability;

"research for human health"includes systematic investigation,experimentation,exploration, examination and evaluation for purposes of decision-policydevelopment,policy-development and practice in human

health and includes clinical trials;and Cap,210.

"traditional medicine"includes the knowledge,skills andpractices based on the theories,beliefs and experiences used in the maintenance of health and in the prevention, diagnosis,improvement or treatment of physical and

indigenous to different cultures,whether explicable ornot, mental illness.

• 3.The objects of this Act shall be to-
• (a) establish the Kenya Medical Research Institute;
• (b) establish mechanisms for the conduct,coordination,promotion and regulation ofresearch for human health in Kenya;and
• (c)provide for the protection and improvement of human health and quality of life through research and development,capacity building,innovation and service delivery.
• 4.(l) The Institute shall,in the performance of its functions,be guided by-
• (a)values and principles enshrined in Articles 6(3), 10,27(4),28and 43(1)(a)of the Constitution;
• (b) thevalues and principles ofpublic service set out
• in Article232(1)of the Constitution;and
• (c)the principles of leadership and integrity set out under Chapter Sixof the Constitution.
• (2)Withoutprejudice to the generality of subsection (1),a person involved in the implementation of this Act shallhaveregard to—
• (a)research excellence and integrity;
• (b)respect,ethics and professional standards;
• (c)honesty and transparency;
• (d) openness and accountability;and
• (e)commitmentin service to the people

PARTII-THEKENYAMEDICALRESEARCH

INSTITUTE

• 5.(l) There is established the Kenya Medical Establishmentof the Institute.
• Research Institute.

Objects of the Act.

Guiding Principles.

• (2) The Institute shall be a body corporate with perpetual succession and a common seal and shall,in its corporate name,be capable of-

2. (a) suing and being sued; 3. (b) taking,purchasing or otherwise acquiring, holding,charging and disposing of movable and immovableproperty; 4. (c) borrowing and lending money; 5. (d)entering into contracts;and 6. (e) doing or performing all other things or acts necessary for theproper performance of its functions under this Act,which may lawfully be doneorperformedbyabodycorporate. 7. 6.(l) The headquarters of the Institute shall be in Nairobi. 8. (2)Notwithstanding subsection (1),the Institute shall ensure reasonable access of its services in all parts of the Republicinaccordance with Article 6(3) of the Constitution and may establish such centres as it considers necessary for the proper discharge ofits functions. 9. 7.(1) The functions of the Institute shall be to- 10. (a) conduct research for human health; 11. (b)identify and make recommendations to the 12. Cabinet Secretary on priorities for research for human health; 13. (c)establish and maintain infrastructure and systems 14. forresearch forhuman health; 15. (d) build capacity for research for human health; 16. (e)undertake scientific and technological invention and innovation for human health and service 17. delivery; 18. (f)establish incubation centres forinvention, innovation andproduct developmentforhealth; 19. clinical,laboratory and 20. (g)provide specialized diagnostic servicesforhuman health; 21. (h)provide technical and advisory support to 22. government and otherrelevant agencieson matters

Headquarters of the Institute.

Functions of the

Institute.

related to research for human health including the collection,storage,use,transfer or sharing of biological materials, disease surveillance, pandemic preparedness,outbreaks and emergency response;

• (i) collect, store,use, transfer or share biological materials for research for human health;
• provide a scientific and ethics review mechanism on research for human health to ensure integrity and compliance with statutory requirements and regulations;and
• (k) perform such other functions as may be prescribed by any other law or as necessary for the promotion of the objects of thisAct.
• 8.(l) The Institute shall have all the powers necessary for the proper performance of its functions under this Act and any other written law.
• (2) Without prejudice to the generality of subsection (1),the Institute shall have the power to-
• (a)manage,control and administer the assets of the Institute in such manner and for such purpose as best promotes the objects for which the Institute is established in accordance with the Public Procurement and Assets Disposal Act;
• (b) open such bank accounts for the funds of the Institute as may be necessary;
• (c) determine the provisions to be made for capital
• and recurrent expenditure and for the reserves of the Institute;
• (d) subject to approval of the Cabinet Secretary for National Treasury,invest any surplus funds of the Institute notimmediatelyrequiredfor the purposes
• of this Act,as it may determine;
• (e)receive gifts,grants,donations or endowments made to the Institute or any other monies in respect of the Institute and make legitimate disbursements therefrom in accordance with the provisions of this Act;

Powers of the Institute,

Cap.412C.

• (f)levy fees for the services rendered by the Institute as may be determined from time to time by the
• Board;
• (g)enter into association, collaboration or partnerships with such other bodies or organizations,within or outside Kenya,as it may consider desirable or appropriate andin furtherance of the purposes for which the Institute is established;
• (h) create,develop,apply for and hold rights in intellectual property,and enter into agreements or arrangements for the commercial exploitation of
• such rights or otherwise as may be appropriate;
• obtain and maintain experimental laboratory plants and animals s including organisms for research purposes;
• establish research centres and departments as may be considered necessary for the performance of its functions under this Act;
• k) obtain and maintain research biological and data repositories and the attendant infrastructure;and
• D undertake any activity necessary performance of any of its functions.
• for the
• 9.(l) The Institute shall be managed by a Board of Directors which shall consist of-
• (a)a non-executive chairperson appointed by the President;
• (b) the Principal Secretary in the Ministry responsible for matters relating to health or a representative
• designated in writing;
• (c)the Principal Secretary in the Ministry responsible for matters relating finance or a representative
• designated in writing;
• (d) theAttorney-General designated in writing;
• or a representative
• (e) the Principal Secretary in the Ministry responsible
• for matters relating to higher learning or a representative designated in writing;

The Board of Directors of the

Institute.

• (f) four members,not being public officers,two of
• whom shall be scientists with knowledge and expertise in research for human health,appointed by the Cabinet Secretary;and
• (g)the Director-General who shall be an ex officio
• memberof theBoard.
• (2)The Cabinet Secretary shall,in appointing persons
• as members of the Board under subsection I(f).ensure that the appointments afford equal opportunity to men and women,the youth,persons with disabilities,minorities and marginalizedgroups and ensureregional balance.
• (3) The appointment of the chairperson and members under subsection l(f) shall beby notice in the Gazette,
• 10.(l) A person shall qualify for appointment as the chairperson of theBoard,where theperson-
• (a)holds a postgraduate degree in biomedical sciences or other health-related field from a
• university recognized in Kenya;
• (b)has professional knowledge and experience of at least fifteen years in biomedical science or other
• health-related field;
• (c) has served in a senior management level for a
• period of at least ten years;and
• (d)meets the requirements of Chapter Six of the
• Constitution.
• (2) A person shall qualify for appointment as a member of the Board under section 9(i) (f,where the person-
• (a) holds a degree in biomedical sciences or medicine from a university recognized inKenya;
• (b) has professional knowledge and experience of at least ten years;and
• (c)meets the requirements of Chapter Six of the
• Constitution.
• (3)A person shall not qualify for appointment as a chairperson or a member of the Board,where the person-

Qualification for appointment as Chairperson or Memberof the Board.

• (a) is an undischarged bankrupt;
• (b) is declared to be of unsound mind;
• (c)has been convicted of a criminal offence and sentenced to a termofimprisonmentexceedingsix months:or
• (d) hasbeen removed from office for contravening the provisions of the Constitution or any otherwritten
• law.
• 11.(l) The chairperson and members appointed under section 9(1)(f) shall hold office for a term of threeyears and shall be eligible for re-appointment for one further term of three years.
• (2)The membersappointedunder section 9(1)(b),(c), (d)and (e) shall hold office during their tenure of office unlessremoved from officeby the appointingauthority.
• 12.A person shall cease to be a chairperson or member of the Board,where thatperson-
• (a)isunable toperform the functions of the officeby reason ofprolonged physical or mental illness;
• (b)isotherwise unableorunfit to discharge his or her duties;
• (c) is adjudged bankrupt;
• (d) is convicted of a criminal offence and sentenced to imprisonmentforatermexceedingsixmonths;
• (e)is absent from three consecutive meetings of the
• Board without lawful cause;
• (f)resigns by notice in writing to the appointing
• authority;
• (g) dies;or
• (h) is removed from office in accordance with the provisions of the Constitution.
• 13.(l) The Boardmay establish Committees for the effectiveperformance of itsfunctions under this Act.
• (2) The Board may co-opt into the membership of a committee established under subsection (l),any person whose knowledge and expertise may be necessary for the

Term ofoffice.

Vacation ofoffice.

Committees of the

Board.

effective performance of the functions of the Institute in accordance with the Government directives issued from time to time.

• (3)A person co-opted into a Committee under and participate in its deliberations,but shall not vote at
• subsection (2),may attend the meetings of the Committee such meetings.
• 14.(l) The Board shall conduct its business and affairs in accordance with the provisions of the First Schedule.
• (2) Without prejudice to the provisions of subsection
• (1),the Board may regulate its own procedure.
• 15.The Board may,by resolution either generally or in any particular case, delegate to any committee of the Board or to any member,officer,employee or agent of the Board the exerciseof any of the powers or theperformance of any of the functions or duties of the Board under this Act.
• 16.(1) The Board shall,through an open,transparent and competitive recruitment process,appoint a suitably qualified person to be the Director-General of the Institute.
• (2) A person shall qualify for appointment as the Director-General of the Institute,where theperson-
• (a)holds a Doctor of Philosophy degree (PhD) in biomedical sciences or its equivalent,from a
• university recognized in Kenya;
• (b) has had at least ten years post-qualification professional experience,five of which shall be in matters of-
• (i)
• policy formulation;
• policy-oriented research and analysis;
• (ii) leadership:and
• (iv)
• management of human resource or finance: and
• (c) has served in a senior management level for a
• period of at least ten years;and
• (d) meets the requirements of Chapter Six of the
• Constitution.

Conductof business and affairs of the Board.

Delegation by the Boarel.

Director-General of the Institute.

• (3)A person shall not qualify for appointment as the Director-General of the Institute,where the person-
• (a)is an undischarged bankrupt;
• (b) is declared to be ofunsound mind;
• (c)has been convicted of a criminal offence and sentenced to a term ofimprisonment exceeding six
• months;or
• (d) has been removed from office for contravening the provisions Gf the Constitution or any other written
• law.
• (4) Te Director-General shall serve on such terms
• and conditions as the Board may determine.
• (5)TheDirector-General shall hold office for a period of three years and shall be eligible for re-appointment for one further term of threeyears.
• (6) The Director-General shall,in the performanceof the functions and duties of the office,be responsible to the
• Board.
• (7) The Director-General shall-
• (a) be the Chief Executive Officer of the Institute;
• (b) be the accounting officer of the Institute;
• (c)be responsible for-
• (i)implementing the decisions of the Board;
• (i)the day-to-day administration and management of the affairs of the Institute; pue
• (ii)co-ordination and supervision of the staff of the Institute;and
• (d)perform any other lawful duties as may be assigned by the Board and the law.
• 17.(l) The Director-General may be removed from office by the Board in accordance with the terms and
• condition of service,for-
• (a) inability to perform the functions of the office arising out ofphysical or mental infirmity;

Removal from office of the Director-General.

• (b)gross misconduct or misbehaviour;
• (c)incompetence or neglect of duty;
• (d) conviction for a criminal offence with a sentence
• to imprisonmentfora term exceeding sixmonths;
• (e)violation of the Constitution or any other written
• law:or
• (f any other grounds specified in the terms and
• conditions ofservice of theDirector-General.
• (2) Where the question of the removal of theDirector-
• General under subsection (l) arises,the Board shall act in accordancewith theprinciples offair administrativeaction prescribed underArticle 47of the Constitution and theFair Administrative Action Act.
• 18.(1) The Board shall,through an open,transparent and competitive recruitment process,appoint a suitably qualified person to be the Corporation Secretary of the Institute on such terms as the Board may,upon the advice of the Salaries and Remuneration Commission,determine.
• (2)A person shall qualify for appointment as the CorporationSecretary if thatperson-
• (a)holds a bachelor's degree in law from a university
• recognized in Kenya;
• (b) is an Advocate of the High Court of Kenya;
• (c)is a Certified Public Secretary;
• (d) is a member in good standing of the Institute of Certified PublicSecretaries ofKenya;
• (e)has at least five years'experience as a corporation
• secretary or a similargovernancerole:and
• (f)meets the requirements of Chapter Six of the
• Constitution.
• (3)The Corporation Secretary shall be the Secretary to the Board and shall-
• (a)in consultation with the Chairperson of the Board, issue noticesformeetings of theBoard;
• (b) keep,in custody,the records of the deliberations,
• decisions and resolutions of the Board;

Cap.7L

Corporation Secretary,

• (c) transmit decisions and resolutions of the Board to the Director-General for execution, implementation and other relevant action;
• (d)provide guidance to the Board on their duties and responsibilities on matters relating to governance;
• and
• (e)perform such other duties as the Board may direct.
• 19.(l) The Board shall,through a competitive and staff as may be necessary for the proper discharge of its functions under this Act,upon such terms and conditions of service as theBoard may determineupon the adviceof the Salaries and Remuneration Commission.
• (2) The Board shall,in the appointment of staff,
• ensure-
• (a)equalization of opportunities for the youth and personswith disability;
• (b) that not more than two thirdsof its staff are of the same gender:and
• (c) that the appointment of staff reflects the ethnic and regional diversity of the people ofKenya.
• 20.The chairperson,members of the Board and staff of the Institute shall be paid such remuneration,fees. allowances and such other reimbursements as may be approved by the Cabinet Secretary upon the advice of the Salaries and Remuneration Commission.
• 21.(1) No matter or thing done by a member of the Board or an officer,employee or agent of the Institute shall,where the matter or thing was done in good faith in the execution of the functions or powers of the Institute render the member,officer,employee or agent personally liableforany action,claim or demandwhatsoever.
• (2) Notwithstanding subsection (1),nothing in this section shall exempt a member of the Board,officer, employee or agent of the Institute from individual responsibilityfor unlawful or criminal actcommitted by the member of the Board,officer,employee or agent of the
• Institute.

Staff of the Instiute.

Remuneration.

Protection from personal liability

• 22.(l) There shall be a common seal of the Institute which shall be kept in the custody of the Corporation Secretary and shall not be used except on the direction of the Board.
• (2) The affixing of the common seal of the Institute
• shall be authenticated by the signatures of the Chairperson and the Director-General and any document required by law to be made under seal and all decisionsof the Board may be authenticated by the signatures of the Chairperson and the Director-General.
• (3)The Board shall,in the absence of either the Chairperson or the Director-General,in any particular matter,nominate one member to authenticate the seal of the Institute on behalf of either the Chairperson or the Director-General.
• (4) The common seal of the Institute when affixed to a document and duly authenticated,shall be judicially and officially noticed,and unless the contrary is proved,any necessary order by the Institute under this section shall be presumed to havebeen duly given.

PARTIII-CONDUCT OF RESEARCHFOR

HUMANHEALTHANDINNOVATION

• 23.(1) The Institute shall conduct research related to Research areas. human health including-
• (a)public health research;
• (b)biomedical research;
• (c) traditional and alternative medicine research;and
• (d) clinical,applied and social science research.
• (2) The research specified under subsection (l) may
• (a) program based;
• (b) investigator initiated;
• (c)collaborative or team based;or
• to addressnational priorities.
• 24.(l)The Institute shall formulate a national human
• Research priorities health research priority for purposes ofidentifying health and agenda.
• be-

Common seal.

• research programmes and priorities in accordance with the
• national and international health research priorities.
• (2) The Institute shall,through a consultative process with the relevant stakeholders including the Ministry, regional and international health research organizations, other research partners and collaborators,formulate a research agenda.
• 25.(1) The Institute may initiate research through-
• (a) an investigator initiated initiative;
• (b)a program based initiative;
• (c) collaboration with local and international partners;
• the relevant regulatory frameworks;
• (d) a contract with various legal entities governed by
• (e) secondary research in accordance with the relevant
• policies,guidelines and laws;or
• any other initiative as the Board may from time to
• time determine.
• (2) The modalities of initiating and conducting the
• research shall be prescribed by Regulations.
• 26.(1) There shall be established a Scientific Steering Committee which shall be responsible for-
• (a)providing strategic scientific leadership;and
• (b)the overall management of research in the
• Institute.
• (2) The Scientific Steering Committee shall comprise
• of heads of directorates,programmes,research centres and scientific units at the Institute.
• (3)The Scientific Steering Committee,for purposes of
• discharging its mandate,shall -
• (a) develop a comprehensive research agenda aligned with the national health priorities;
• (b) foster acultureof innovation and inter-
• disciplinary collaboration to drive high-impact research;
• (c)periodically review and update the research priorities to ensure relevance and responsiveness
• to emerging health challenges;

Initiation of research.

Scientific Steering

Committee.

• (d) develop and implement a strategic fundingplan to diversifyresearch funding sources;
• (e) identify sources for external research grants and partnerships for the implementation of the areas identified as theInstitute's researchpriorities;
• (f)establish structures to facilitate engagement of the scientific community in budgeting and financial managementpractices for optimization ofresource allocation and utilization for science;
• (g)engage in oversight and monitoring of human resource to ensure a skilled and motivated scientific workforce;and
• (h)mobilize financial resources with all relevant stakeholders.
• 27.The Scientific Steering Committee shall,for purposes of training and professional development of
• scientists,-
• (a)establish a comprehensive training and mentorship program to enhance the skills and knowledge of human health research scientists;
• (b) encourage participation in the national and
• international scientific conferences,workshops and exchanges;
• (c)foster collaboration with academic institutions, and
• industry or otherresearch organizations toprovide opportunities for advanced training specialization;and
• (d) promote a culture of continuous learning, knowledge sharing and innovation within the
• Institute.
• 28.The Scientific Steering Committee shall,for the purposes of ensuring communication and participation in discharging its functions,-
• (a)implement a structured communication system within the Institute that encourages feedback and collaboration amongst stakeholders;and
• (b) foster a cultureof inclusivity to ensure that diverse perspectives and expertise contribute to the decision-makingprocesses.

Training and professional development of

human health research scientists.

Communication and participation.

• 29.The Scientific Steering Committee shall,for the purposes of inter-disciplinary collaboration-
• (a) facilitate cross-disciplinary collaboration within the Institute and with external partners to encourage knowledge sharing,innovation and the integration of different scientificperspectives;and
• (b)foster an environment that values teamwork and promotes interdisciplinary research approaches to addresscomplex health challenges effectively.
• 30.(1) The Institute shall uphold ethical standards and
• shall conduct research that is-
• (a) scientifically valid;
• (b) socially valuable;and
• (c)protects the rights and welfare of research participants.
• (2) The Institute shall,in conducting research,be guided by principles including-
• (a)respectforresearch participants including upholding data privacy principles in accordance with the Data Protection Act;
• (b)maximization of benefits and minimization of potential harms or risks to research participants
• and communities;
• (c) fairness and equitability toresearch participants;
• (d)scientificvalidity in conducting research;
• (e) independent review to ensure the research meets
• ethical standards;
• (f) respect for vulnerable research participants and
• communities;
• (g) community engagement;and
• (h) transparency and accountability in the research processes,methods,findings and dissemination.
• (3) Without prejudice to the generality of subsection (2),the Institute shall in the case of-
• (a)human participants ensure-

Inter-disciplinary collaboration.

Ethical considerations.

Cap.411C.

• (i respect of persons and communities through provision for the making of informed consent whether voluntary or informed participation;
• minimize research risks by ensuring that research procedures do no harm;
• (ii) maximize the benefit of research to research
• participants or the community;and
• (b)animal subjects ensure-
• (i) methods to minimize pain and distress are specified;
• where applicable,a strong justification is made for not using proper drugs to alleviate pain and distress;and
• (ii) where applicable,the method of euthanasia is specified.
• (4)A research scientist shall,in conducting research,
• comply with the institutional,national and international regulations and treaties.
• 31.(1) There is established the Scientific and Ethics Review Unit within the Institute in accordance with the
• Science,Technology and Innovation Act.
• (2) The Scientific and Ethics Review Unit shall comprise of multidisciplinary committees whose membership shall be drawn from within the Institute and other stakeholders as provided for under the Science,
• Technology and Innovation Act.
• (3)The Institute shall, in consultation with the Cap.5l1.
• Scientific and Ethical Review Unit-
• (a) develop,review and implement policies, regulations,standards and procedures for scientific
• conduct and research ethics;
• (b)ensure adherence to and compliance with set international and local standards for scientific conduct and research ethics;
• (c)ensure that all research proposals adhere to scientific and ethical principles that are fundamental to the conduct ofresearch involving human participants;

Establishment of the Scientific and EthicsReview Unit. Cap.511,

• (d) review and approve research proposals submitted to the Scientific and Ethics Review Unit;
• monitor approved on-going research protocols to ensure adherence to scientific and ethical principles;
• provide and facilitate training in research methodology and ethics towards building capacity for researchers and committee members;
• (g)review and approve material transfer agreements for use and transfer of biological material;and
• (h) ensure adherence to animal use policies,ethics and regulations in the use of animals for research.
• 32.(l) The members of the Scientific and Ethics Review Unit Committees shall be appointed by the Director-General.
• (2)Each Committee of the Unit shall comprise at least
• eight members and a maximum of twenty members with varying expertise and possessing the professional competence necessary to promote comprehensive scientific and ethical review ofresearch initiatives at the Institute.
• (3) The core membership of each Committee of the
• Unit shall include ata minimum-
• (a) at least two clinicians:
• (b)at least two non-clinician scientists;
• (c)at least one legal expert;
• (d)at least one theologian,sociologist or ethicist;
• (e)at least one biostatistician or epidemiologist;
• (f)at least one community representative;and
• (g)a representative of a national referral and teaching hospital or a public university ethics review committee.
• (4)The appointment of additional members to the
• Scientific and Ethics Review Unit Committees-
• (a) shall reflect the other specialties required;and
• (b)may give consideration to community representation.

Membership to the Scientific and Ethics Review Unit committees.

• 33.The Institute shall formulate a Code of Conduct
• forresearch for human health.
• 34.The Institute shall,where the conduct of research
• involves the community,engage the community.
• 35.(1) A researcher shall collect data for purposes of obtainingknowledgeor information required to answer an
• identified research issue.
• (2) Data shall be collected from-
• (a)literature;
• (b)humans;
• (c)animals;
• (d) organisms;
• (e)plants;or
• (f)any other human health research-related materials.
• (3) The sources of data collected under subsection (2)
• shall include-
• (a)primary data categories collectedthrough experiment, questionnaire, observation or interview;or
• (b) secondary data categories collected through literature survey,official and unofficial reports or
• library resources.
• (4) The researcher shall,in processing data collected, adhere to therelevantlaws and guidelines.
• 36.(l) The Institute shall formulate comprehensive quality assurance plans specific to research studies,where applicable,for ensuring the integrity,reliability and validityofresearch outcomes.
• (2) The internal quality assurance shall include regular monitoring,reviewand auditofresearch activities.
• (3) The external quality assurance shall be conducted agencies or accreditation bodies.
• (4) The Institute shall from time to time engage peer review expertpanels to provide guidance on bestpractice
• onmattersofresearchforhumanhealth.

Code of conduct for members.

Community engagement in

research.

Data

collection.

Quality assurance in research

• 37.The Institute shall,in managing research data,
• (a) collect and store human health research digital and non-digital data in accordance with the relevant
• laws;
• (b) organize and document data to ensure traceability and facilitate subsequent analysis and interpretation;
• (c)ensure data validation and quality assurance to mitigate errors for accuracy and completeness;and
• (d)restrict access to authorized persons with strict protocols in place to safeguard against unauthorized access or disclosure.
• 38.(l) The Institute shall ensure suitable management and analysis of data and interpretation of research findings for reporting and dissemination.
• (2) The Institute shall disseminate research findings through-
• (a) knowledge management strategy implementation;
• (b) stakeholder engagement and feedback;
• (c)open access initiatives;
• (d) publication inpeer-reviewed journals:and
• (e) stakeholder feedback and engagement.
• (3) The relevant government agencies shall apply research findings in developing their policies where applicable.
• 39.The Institute shall ensure that research development andi implementation processes make provision for monitoring and evaluation mechanisms.

PART IV-CLINICAL TRIALS

• 40.The Institute shall-
• (a) facilitate research and continuous discovery of medicines and products,including alternative medicines and herbal products;
• (b)offer technical expertise in the conduct of clinical
• trials;

Management of

research data.

Data management, analysis and dissemination.

Monitoring and

evaluation.

Conduct of clinical trials.

• (c) ensure the safety and well-being of research participants involved in clinical trials;
• (d)uphold the integrity of data generated during clinical research;
• (e) enhance the capabilities and competencies of healthcare professionals and research scientists in clinical trials and clinical trial management; and
• conduct of clinical trialsinKenya.
• (f) provide technical advice on the regulation of the
• 41.(l) The Institute shall,in case of a public health emergency undertake such research or innovation or drug re-purposing that is necessary to address the public health emergency and prepare for future crisis.
• (2) The Institute shall,in undertaking the research, innovation or drug re-purposing under subsection (1), ensure that-
• (a) the research does not hinder the response to an
• emergency or theprovision ofproperhealthcare;
• (b)research
• hparticipants are fairly selected and informed consent obtained;
• (c) studies are designed to produce reliable results despite challenging conditions;
• (d) the health needs of affected communities are
• prioritized;and
• (e) the affected communities are prioritized in
• dissemination of research findings.

PARTV-TRADITIONALANDALTERNATIVE

MEDICINE

• 42.The Government of Kenya shall-
• (a)recognize and integrate traditional and alternative medicine in a manner that complements the
• conventional healthcare system;
• (b) safeguardpublic health by ensuring that traditional and alternative medicinal products and practices meet stringent quality,safety,and efficacy standards;

Clinical trial research in public health

emergencies.

Responsibility of govermnment in traditional and alternative medicine.

• (c)promote the conservation of medicinal plant
• biodiversity and the sustainable use of resources, acknowledging the intrinsic value of traditional knowledge in health preservation;and
• (d) foster biodiversity conservation as a critical component of sustainable healthcare.
• 43.(1) The Institute shall,upon reference,in collaboration with relevant agencies conduct comprehensive assessments of traditional and alternative medicinal products to determine their guality,efficacy and safety forpurposes of safeguarding public health.
• (2) The Institute,in conducting the assessments in subsection (l)-
• (a) shall focus on utilizing Kenya's biodiversity and in particular,indigenous flora for the discovery of novel medicinal properties;
• (b) shall employ a variety of scientific methodologies
• including biochemical,pharmacological and toxicological evaluations;
• (c)may conduct preclinical and clinical trials to assess the safety and efficacy of traditional and alternative medicinal products;and
• (d) shall oversight the standardization and validation of traditional and alternative medicinal products.
• (3) The Institute shall support the relevant regulatory bodies to establish and enforce quality assurance standards and conduct market surveillance to ensure-
• (a) that traditional and alternative medicinal products
• safe,efficacious and of high quality; and
• (b) the proper labeling,advertising and marketing of traditional and alternative medicinal products to prevent misleading representation.
• 44.(1) The Institute shall-
• (a) identify high-potential healthcare products derived from traditional and natural sources and support
• their development into scalable prototypes;

Assessment of quality.efficacy, and safety.

Support for development.

• (b)authenticate natural medicinal productsand promote sustainable conservation of their sources; and
• (c)provide traditional medicine practitioners and
• herbal product developers with the necessary support and guidance.
• (2) The Institute may,in the discharge of the duties in subsection (l),establish a framework for the identification and support ofhealthcareproducts derived from traditional and natural sources with significant potential for contribution to the health sector.
• (3)The framework in subsection(2) shall-
• (a)make provision for the criteria for the evaluation of healthcare products based on their safety, efficacy.sustainability and capacity to address unmet healthcare needs;
• (b)require the Institute to lead research initiatives for the investigation of extracts, fractions and compoundsderivedfrom naturalproductsfortheir potential therapeutic applications in disease management:and
• (c)facilitate the developmentof healthcareproducts into scalable prototypes through providing the necessary technical, scientific and regulatory assistance.
• 45.(1) The Institute shall develop programs aimed at building the capacity of traditional and alternative medicine practitioners,herbal product developers and healthcare professionals to-
• (a)ensure the safeand effective use of traditional and
• alternative medicines;
• (b)recommend theintegration ofvalidated traditional and alternative medicinepractices into thenational healthcare system:and
• (c)promote preservation and transmission of
• traditionalmedical knowledge.

Capacity building for practitioners.

• 46.(1) A person commits an offence in relation to traditional medicinal products if that person engages in-
• (a)knowingly addingconventional medicines or other
• unauthorized substances;
• (b)making false,misleading or deceptive claims about ingredients,benefits or risks in print, electronicmedia or on billboards;
• (c)selling or promoting products demonstrable therapeutic benefit;
• lacking
• (d)making claims about curative,preventive or diagnostic properties without credible scientific evidence or established traditional knowledge;
• (e) selling or distributing products with an unknown orinadequate toxicological assessment;or
• manufacturing,preparing or selling products under unsanitary or poor-quality conditions

and shall on conviction,be liable to a fine not exceeding three million shillings,or to imprisonment fora term not exceeding threeyearsor to both.

• 47.(l) The Institute shall establish and maintain a comprehensive national database for the codification and preservationof traditional and alternative medical knowledge.
• (2)The database shall be a repository of scientifically validated knowledge.practices and formulationsof traditional and alternativemedicine.

PARTVI-TRAININGAND CAPACITYBUILDING

• 48.The Institute shall build capacity in matters of
• human health through-
• (a)research:and
• (b) training in research for human health and health sciences.
• 49.(l) The Institute shall provide-
• (a)post-graduate training in specialized human health research including the conduct of clinical trials, health sciences, pharmaceutical sciences,

Offencesrelatedto traditional medicinal products.

Management of traditional and alternative medicine knowledge.

Capacity building in matters of human health.

Training by the Institute

• biomedical sciences,public health and nutritional sciences,social and behavioural sciences, traditional and alternative sciences;and
• (b) specialized short course training programmes in health sciences and research methods in accordance with the functions of the Institute and the training or capacity needs for the country or the region.
• (2) The training programmes in subsection (1) may be
• provided in collaboration with other accredited institutions ofhigher learning or research.
• (3) The training programmes shall be aligned to the
• standard frame provided by the Commission.
• (4)A new or revised training programme shall be
• submitted to the Commission for evaluation and approval in accordance with the Universities Act.
• (5) The Institute shall determine the-
• (a) curriculum of the training programmes;
• (b) training manuals;
• (c) training programmes and course units for each
• training programme;and
• (d) academic calendar including the duration of each course of study and the conduct ofexaminations.
• 50.(1) The Institute may,subject to accreditation by the Commission and the award of a Charter under the Universities Act,award-
• (a) specialized postgraduate degrees, diplomas, certificates or other awards asmay beprovided for in the statutes developed pursuant to section 23(1) of the Universities Act;and
• (b) honorary postgraduate degrees or any other academic recognition upon a person who has rendered distinguished service to the advancement of any branch oflearning or who has otherwise rendered service in any field of human health endeavour worthy of such a degree or academic recognition as provided for in the statutes developed pursuant to section 23(l) of the Universities Act.

Cap.210.

Specialized postgraduate degrees, diplomas and certificates Cap.210.

Cap.210.

Cap.210.

Cap.210.

• (2)A specialized degree including an honorary degree or any other award conferred under subsection (l) may be cancelled or withdrawn by the Institute in the manner set out in the statutes developed pursuant to section 23(1)of the Universities Act.
• 51.The Institute may,subject to accreditation by the Commission and the award of a Charter under the Universities Act,award scholarships, fellowships, bursaries,prizes and such other awards as may be provided for in the statutes developed pursuant to section 23(1) of the Universities Act.
• 52.(l) The Institute shall establish a criteria for the
• admission of qualifiedpersons to the training programmes offered by the Institute.
• (2)A person shall not qualify for admission to the training programme offered by the Institute,unless that person has met the admission requirements set by the
• Institute for that trainingprogramme.
• (3) A person who wishes to be admitted to a training
• programme offered by the Institute shall apply in the prescribed form and pay theprescribed application fees.
• (4)The Institute shall 1consider an application submitted under subsection (3) and ifit is satisfied that the applicant meets the admission criteria,admit the applicant
• to the trainingprogramme.

PARTVII-RESEARCHINFRASTRUCTURE

• 53.(1) The Board may establish such research centres and infrastructure as it may consider necessary for the effective discharge of the mandate of theInstitute.
• (2) The research centres shall be hubs of research, invention,innovation,collaboration and knowledge management.
• 54.(1) The Institute shall establish biobanks for the
• collection,storage and management of biological materials.
• (2)Despite subsection (1),the Institute may,by notice in the Gazette, designate any research institution, site or
• health establishment as a biobank.
• (3)A biobank may-

Schodarships.

Cap.210.

Cap.210.

Admission for

training by the Institute.

Establishment of

research centres,

Biobanks.

• (a)receive biological materials for storagepurposes;
• (b) store aliquots of biological materials for such
• period as may beprescribed;and
• (c) dispose of biological materials in accordance with
• the prescribed Regulations.
• (4)The Institute shall,in establishing the biobanks,
• (a)put in place processes and procedures for the operation ofbiobanks;
• (b)ensure adherence to ethical,regulatory and quality standards for responsible management and use of biological materials and associated data for research,healthcare and publichealth;
• (c) develop and implement guidelines or procedures for all aspectsofbiological materials management
• including-
• (i) collection procedures including informed
• consent processes and documentation;
• (ii) processing techniques to ensure sample integrity and quality control;
• (iii) storage conditions including temperature monitoring and security measures;and
• (iv) distribution protocols for access to biological materials and associated data by authorized
• users;
• (d)restrict access tobiological materials to authorized
• users;and
• (e) implement data management systems to ensure
• secure storage,retrieval and sharing of clinical and metadata.
• 55.(1) A person shall not export or import biological materials without theprior written approval of theInstitute
• as provided under subsection (2).
• (2) The Institute may,on the recommendation of the Board,permit the export or import of biological materials where the applicant satisfies the requirements set out by the Institute in the export or import agreement or in the
• relevant laws and regulations.

Exportation and importation of biological materials.

• (3)A person who contravenes this section commits an offence and is liable,on conviction,to a fine not exceeding two million shillings or to imprisonment for a period not exceedingfiveyears,or toboth.
• (4) The Cabinet Secretary may prescribe Regulations togive effect to this section.
• 56.(l) Where the Institute designates a research institution,site or health establishment as a biobank in accordance with section 54,the Institute shall issue a permit in the prescribed manner.
• (2) Every biobank shall comply with the requirements of therelevant laws.
• (3)Aperson whokeepsbiological materialswithout a permit issued under this Act,commits an offence and is liable,on conviction,to a fine not exceeding two million shillings or to imprisonment fora term notexceeding five years,or to both.
• 57.(1)The Institute shall-
• (a) establish research data banks;
• (b) store human research data in the research data bank for availability and accessibility;and
• (store human research data in a secure form with
• restricted access in accordance with the relevant laws.
• (2) An authorized person shall-
• (a) take reasonable measures to ensure that no person collects,uses, discloses,retains or disposes of research data unless it is in accordance with the law;and
• (b) be responsible for any sensitive data that is collected,used,disclosed,retained or disposed of by the authorized person's agents.
• (3)For purposes of this section-

"authorized person" means the research scientist responsible for the ethical design and conduct of a research

study.

Designation of biobanks.

Research data banks.

• 58.(l) The Institute may access research data banks
• or any information collected by research scientist for human health.
• (2) The Cabinet Secretary may,in consultation with the Board,make Regulations for ensuring that data banks for internally and externally funded health research are kept in a central research repository.
• 59.(1) The Institute may establish botanical gardens for purposes of human health research and capacity
• building.
• (2) The Cabinet Secretary,in consultation with the Board,may prescribe Regulations to give effect to this section.
• 60.(1) The Institute may establish animal houses or insectaries for the purposes of conducting research for human health and capacity building.
• (2) An animal house established under this Act shall comply with the applicable laws.
• (3) The Cabinet Secretary may prescribe Regulations
• to give effect to this section.
• 61.(1) The Institute may establish research clinics for
• the conduct ofresearch for human health.
• (2) Despite subsection (1),the Institute may designate any research institution,site or health establishment as a
• research clinic.

PARTVILI-INTELLECTUALPROPERTY

• 62.(1) The rights to an invention or innovation made by the Institute shall vest in the Institute unless there is an agreement to the contrary.
• (2) The Institute may apply for a patent in respect of any invention or innovation contemplated in subsection (1) and shall, for the purposes of the Copyright Act and the Industrial Property Act,be regarded as the assignee of the inventor or innovator of the invention or innovation where an inventor or innovator contributed to that invention or
• innovation.
• 63.Any information on intellectual property thatmay not berequired to be included in any statement of corporate

Access to health research data

banks.

Establishment of botanical gardens.

Establishment of animalhouses and insectaries.

Establishment of research clinics.

Rights to vest in the Institute.

Withholding intellectual intent,annual report or financial statements by the Institute may be properly withheld and may be released upon request in accordance with the provisions of the Access to Information Act.

• 64.(l) The Institute shall establish a mechanism for the notification of inventions,discoveries or technical developments.
• (2)The mechanism in subsection (1) shall,in collaboration with the relevant government agencies, provide for the protection of intellectual property rights of an invention,discovery or technical development.
• (3) Despite the provisions of subsection (2),the Institute shall at all timesreserve therightnot to protect or
• commercialize intellectual property where-
• (a) the intellectual property is not in the best interests of the Institute,inventor,innovator or the public;
• or
• (b) there are no reasonable prospects of commercial success.
• (4) The Institute shall,in collaboration with the
• relevant institutions,establish and maintain a database on innovations.
• 65.(1) All rights and obligations relating to an invention shall belong exclusively to the Institute or the sponsoring entity as the case maybe,subject to the Institute or sponsoring entity being fully responsible for any and all expenses in the generation of the innovation or invention, fees,and any other charges resulting from the application for,granting or maintenance of intellectual property rights.
• (2) Where an intellectual property right held by the Institute or sponsoring entity is not being worked or has not been licensed within two years from the date of the notification of the invention,the inventor may apply to succeed the intellectual property right or for a licence to work that intellectual property right on terms to be mutually agreed by the inventor and the Institute or sponsoring entity as the case may be.
• (3) All rights and obligations relating to any invention
• produced by an employee or associate of the Institute or

property information.

Cap.7M

Registration of intellectual property.

Ownership of intellectual property.

sponsoring entity without making significant use of the time and resources of the Institute or sponsoring entity,and not subject to any agreement expressly stating otherwise, shall belong exclusively to the inventoror innovator.

• (4) Despite the provisions of this section,ownership ofapatent shall be forfeited to therelevantnational body where the-
• (a)forfeiture is necessary in the interests of the security of the country;or
• (b) scientific innovation,invention,or patent is of
• strategic importance to the country in accordance with therelevant laws.
• 66.(l) The Institute or sponsoring entity as the case
• may be,shall have the sole discretion regarding the commercialization ofintellectualpropertyowned by it and shall ensure that reasonable efforts are made to keep the inventors or innovators informed,and where appropriate involved in thecommercializationof the intellectual property towhich they contributed.
• (2)Thedecision on themodeofcommercializationof intellectual property under subsection (1) shall rest with the
• owner of the intellectual property.
• (3)The mode of commercialization of intellectual property may include-
• (a) licensing;
• (b)assignment or sale;
• () formation of a commercialization entity or joint venture;or
• (d) donation orroyalty free access on humanitarian or
• othergrounds.
• 67.(l) Where an intellectual property right reaches
• the stage of commercialization,a share of royalties accruing to the inventor orinnovator shall beforwarded to the inventor or innovator in accordance with minimum requirementsset outin therelevant laws.
• (2) Where financial benefits are derived from the transfer or licensing of intellectual property rights,any direct costs incurred including expenses relating to the

Cominercialization of intellecrual property

Benefits.

generation of the invention,fees,and any other charges resulting from the application for,granting or maintenance of the intellectual property rights and in marketing the invention or innovation shall first be recovered by the owner of the intellectual property.

• (3)Awardsforintellectual property beneficiariesshall
• continue to bepaid to-
• (a) an innovator or inventor where the inventor has left the employment of theInstitute or sponsoring entity as the case may be:and
• (b) the estate of the innovator or inventor where the
• inventor is dead.
• (4)Aninnovatororinventor or estateoftheinnovator or inventor shall,for purposes of subsection (3),notify the Institute or sponsoring entity of any changes in contact details.
• (5) Where an invention makes significant use of knowledge or resources that may be related directly to a particular community or area,theInstituteor the sponsoring entity shall take the necessary action to ensure that any transfer or licensing of intellectual property rights to a person or entity is in the best interests of that
• community orarea.

PARTIX-FINANCIALPROVISIONS

• 68.(1)The funds of the Institute shall comprise of
• (a)moniesallocated byParliament for the purposes of
• the Institute;
• (b)moniesas may accrue to or vest in the Institute in the course of the exercise of its powers or the performance of itsfunctions under this Act;
• (c)monies from feespaid to the Institute inrespect of the services offered by it;
• (d)moniesasmaybepayable to the Institutepursuant to this Act or any otherwritten law;
• (e) gifts,grants,donations or endowments as may be given to the Institute:and
• (f)monies from any other lawful source provided for
• the Institute.

Fundsof the

Institute.

• (2) All the funds donated,lent or issued to the Institute under this Act shall be accounted for and appropriated in accordance with the Public Finance Management Act.

2. 69.(l) All monies in the Institute which are not immediatelyrequired to be appliedfor thepurposes of this 3. Act shall be invested- 4. (a)in such investment in a reputable bank on the advice of the Central Bank of Kenya,being an investment in which trust funds,or part thereof, are authorized by law to be invested;and 5. (b) in government securities as may be approved by 6. the National Treasury. 7. (2)All investments made under this section shall be 8. held in the name of the Institute. 9. 70.The financial year of the Institute shall be the 10. period of twelve monthsendingon the thirtieth day of June in each year. 11. 71.(1) The Institute shall,within three months after the end of the financial year,cause to beprepared estimates ofits revenue and expenditure for thatfinancial year.

• (2) The annual estimates shall make provision for all estimated expenditure of theInstitutefor the financial year

13. concerned,and in particular shall provide for the- 14. (a) payment of salaries,allowances and other charges inrespect of the staff of theInstitute: 15. (b)paymentof allowances and any other emoluments 16. to the members of theBoard; 17. (c)payment of pensions,gratuities and other charges inrespect ofretirementbenefitswhich arepayable out of the funds of the Institute; 18. (d) proper maintenance of buildings and grounds of 19. the Institute; 20. (e)acquisition,maintenance,repair and replacement of the equipmentand othermovable property of 21. the Institute;or 22. creation of such reserve funds to meet future or contingent liabilities in respect of retirement

Cap.412A.

Investment of funds.

Financial year.

Annual estimates.

• benefits,insurance or replacement of buildings or equipment,or in respect of such other matters as the Institute may consider appropriate.
• (3) The annual estimates shall be approved by the
• Institute before the commencement of the financial year to which they relate and after the approval,the annual estimates shall not be increased without prior consent of theBoard.
• (4) No expenditure shall be incurred for the purposes
• of the Institute except in accordance with the annual estimates approved under subsection (3).
• 72.(1) The Board shall cause to be kept all proper books and records of accounts of the income,expenditure, assets and liabilities of the Institute.
• (2)Within three months at the end of each financial year,the Board shall submit to the Auditor-General, the accounts of theInstitute together with-
• (a)a statement of income and expenditure of the Institute during the year,and
• (b)a statement of the assets and liabilities of the
• Institute on the last day of that year.
• (3) The accounts of the Institute shall be audited and
• reported upon in accordance with the provisions of the PublicFinance Management Act and thePublicAudit Act.
• 73.(1) The Board shall,within three months after the end of each financial year,prepare and submit to the Cabinet Secretary a report on the operations of the Institute for the immediately precedingyear.
• (2) The Cabinet Secretary shall,within three months ofsubmission of the report under subsection (1),transmit the report toParliament.

PARTX-DELEGATEDLEGISLATION

• 74.(l) The Cabinet Secretary shall,in consultation with theBoard of Directors,make regulations for the better carrying into effect the functions of the Act.
• (2) Without prejudice to the generality of subsection (1),the regulations made under this section may provide

Accountsand andit.

Cap.412A. Cap.412B.

Annualreport.

Regulations.

• (a) the fees to be charged under this Act;
• (b) the forms to be used in connection with this Act;
• (c) the establishment and management of biobanks;
• (d) the establishment and management of incubation
• centres;
• (e) the scientific and ethics review mechanism;
• (f) the collection,storage,use and transfer of biological materials;
• (g)maintenance ofrepositoriesof research for human
• health data;
• (h) the criteria for the admission of qualified persons tothe training programmes offered by the
• Institute;
• i) the categories of examinations and the manner in which suchexaminations shall be administered;
• any other matter thatmay be related to the conduct
• ofresearch forhuman health.
• (3)For the purpose of Article 94(6)of the Constitution-
• (a) the purpose and objective of the delegation under this section is to enable the Cabinet Secretary to make regulationsforbetter carrying into effect the provisions of this Act:and
• (b)the authority of the Cabinet Secretary to make regulations under this Act is limited to bringing into effect theprovisions of thisActandfulfilment
• of the objectives specified under this section.
• (4)The principles and standards applicable to the
• delegatedpowerreferred to under this Act are those set out in-
• (a) the Statutory Instruments Act;
• (b) the Interpretation and General Provisions Act;
• (c) the general rules of international law as specified
• underArticle 2(5)of the Constitution;and
• (d)any treaty and conventionratified byKenya under
• Article 2(6)of the Constitution.

Cap.2A.

Cap.2.

PARTXI-GENERALPROVISIONS

• 75.The Institute shall undertake risk management through identification and documentation of risks their impact occurrence and specify measures formitigation and monitoroutcomes.
• 76.The Institute shall in executing its mandate be guided bypoliciesand legislation including-
• (a) the Data Protection Act and policy;
• (b)the Digital HealthAct and policy;
• (c)the ICTpolicy;and
• (d) the Computer Misuse and Cybercrime Act;
• 77.The Board may engage on behalf of the Institute,
• the service of such experts in respect of any of the functions of theInstitute in connection with which they are considered to have special competence.
• 78.The members of the Board,officers,staff or
• agents of theInstitute have a duty to safeguard thepersonal dataofapersonheldby theInstitutein accordancewith the provisions of Article 31 (c)and (d)of the Constitution,the DataProtectionActandanyotherrelevantlaw.
• 79.(l) The Institute shall ensure that the right of
• access to information guaranteed under Article 35 of the Constitution is guaranteed subject to the limitations provided under Article 24 of the Constitutionand to the nature and extent specified under subsections(2)and(3).
• (2) An officer,member of staff,or agent of the Institute shall not disclose information acquired in the course of his or her duties under the Act except,with the written consent of the Director-General.
• (3) The Institute shall not disclose any information that would in the opinion of the Institute compromise the integrity of research for human health,patent and other related rights.
• 80.The Institute shall keep information acquired for purposes of the performance of the functions of Institute confidential and shall disclose such information only to the extent that it considers necessary fortheproper performance of the functions of the Institute.

Risk management

Integration of legal frameworks Cap.411C. No.15of2023.

Cap.79C,

Experts.

Duty to protect personal data held

by the Institute.

Cap.411C.

Disclosure of information held

by the Institute.

Confidentiality.

81. The Institute may, subject to the Public Finance Management Actand any other relevant law,be exempted from such taxes, duties,fees,levy,cess or other charges pertaining to laboratory and clinical equipment and supplies,specialized research software,research vehicles, educational materials, technical assistance grants and renewable energy technologies as the Cabinet Secretary responsible for matters relating to the National Treasury may,by notice in the Gazette. 2. 82.(1)Aperson who- 3. (a)refuses or fails,without reasonable cause to comply with a request to furnish the Institute with any information or to produce any documents or records;or 4. (b) in furnishing such information under paragraph (a),makes a statement which he knows to be false, commits an offence and shall be liable,on conviction,to a fine not exceeding five hundred thousand shillings or to imprisonment for a term not exceeding three years,or to both. 5. (2)A person whoreceivesinformation in 6. contravention of the provisions of this Act shall not disclose orpublish theinformation so received. 7. (3)Aperson who contravenes subsection (2)commits an offence and shall be liable,on conviction,to a fine not exceeding five hundred thousand shillings or to imprisonment for a term not exceeding three years,or to both such fine and imprisonment. 8. 83.A person who contravenes the provisions of this Act,commits an offence and shall be liable,on conviction, toa fine not exceeding five million shillings or to imprisonment for a term not exceeding three years,or to both. 9. 84.The Institute shall,in performing its functions, cooperate with the National Commission for Science Technology and Innovation and shall,in relation to the National Commission for Science Technology and 10. Innovation- 11. (a) be responsible for research for human health;

Exemptions. Cap.412A,

Offences.

General penalty.

Relationship with the National Commission for Science Technology and Innovation.

• (b)review and approve research proposals in human health in accordance with this Act.

PART XII-REPEAL AND TRANSITIONAL PROVISIONS

• 85.In this Part,"former institute"means the Kenya Medical Research Institute established under the Kenya
• Medical Research Institute Order,2021.
• 86.Any reference in any written law or in any document or instrument to the former Institute shall,on and after the commencement of this Act,be construed to be a reference to the Institute.
• 87.(l) Every agreement,deed, bond or other
• instrument to which the former Institute was a party or which concerned the former Institute and whether or not of such a nature that the rights, liabilities and obligations thereunder could be assigned,shall have effect as if the Institute were a party thereto or affected thereby instead of the former Institute and as if for every reference,whether express or implied,therein to the former Institute were substituted in respect of anything to be done on or after the commencement of this Act.
• (2) Any agreement,contract,project,memorandum of understanding or any other binding instrument entered into under or in respect of the former Institute before the commencement of this Act shall continue to hold and be implemented by the Institute.
• 88.(l) All funds,assets and other property,both movable and immovable,which immediately before the commencement of this Act were yested in,acquired under, held for and on behalf of the former Institute shall,by virtue of this section and without further assurance,vest in the Institute.
• (2) All rights,obligations,powers and liabilities which immediately before the commencementof this Act were vested in,imposed on or enforceable against the former Institute shall be vested in,imposed on or enforceable against the Institute
• (3) Every officer having the power or duty to effect or amend any entry in a register relating to property,or to

Interpretation of part, L.N.35/2021.

Reference to the former Institute.

Agreements, contracts and other binding instruments.

Assets and

liabilities.

issue or to amend any certificate or other document effecting or evidencing title to property,shall,without paymentofa fee or other charge and upon requestmade by or on behalf of the Institute,do all such things as are by lawnecessarytogivefinal effect to the transfer ofproperty referred to under subsection(1).

• 89.A direction,notice,order,permit,authorization,
• licence or any other document that was granted,issued or made under the repealed Order, and that was valid immediately before thecominginto force of this Act,shall be given effect as if granted,issued or made under this Act.
• 90.The annual estimates of the former Institute for the financialyear in which this Act comes into operation shall be deemed to be the annual estimates oftheInstitute for the remainder of thatfinancialyear:

Provided that such estimates may be varied by the Institute in such manner as the Cabinet Secretary may approve.

• 91.All actions, suits or legal proceedings by or
• against the former Institute subsisting immediately before the commencement of this Act shall be carried out on, prosecuted by,or against the Institute,and no such suits, actions or legal proceedings shall abate or be affected by the coming into operation of this Act.
• 92.A person who immediately before the commencement of this Actwas a chairperson or a member ofthe Board of the former Institute shall,upon commencement of this Act,remain in office for the remainderof the term of that person.
• 93.(1)Aperson who,immediately before the commencement of this Act was an officer,employee or member of staff of the former Institute,not being then under notice of dismissal or resignation shall,on the commencement of this Act,be deemed to be an employee of theInstitute on the same terms and conditions.
• 94.(1) Where on the commencement of this Act any
• disciplinary proceedingsagainst any officer or member of staff of the former Institute are in the course of being heard,or have been heard or investigated by the former Institute but no order or decision has been made thereon,

Directions,orders, etc.of the former Institute.

Annual estimates

of the former Institute.

Legal proceedings.

Board of the former Institute

Staffoftheformer Institute

Disciplinary proceedings.

• the Institute shall carry on and complete the hearing or investigation and make an order orrender a decision,as the case may be.
• (2)Where on the commencement of this Act,any such officer or member of staff of the former Instituteis interdicted orsuspended,the Institute shall deal with such officer or member of staff in such manner as it deems appropriatehavingregard to the offence committed by that officer or member of staff,including the completion of disciplinary proceedings that have been commenced against that officer ormember ofstaff.
• (3)Where on the commencement of this Act,any penalty,other than dismissal,has been imposed on any officerormember ofstaffofthe formerInstitutepursuant to disciplinary proceedingsand the penalty has notbeen,or remains to be,served by such officer or member of staff that officer or member of staff shall upon transfer to the Institute,serve or continue to serve such penalty to its full asif it had been imposed by the Institute,where applicable.
• (4)Despite the generality of subsection (1) and (2), the provisions on discipline in the human resource instruments of the former Institute shall apply until the conclusion of the disciplinaryprocess.
• 95.(1)Amember of staff of the former Institute who becomesamemberofstaffof theInstitute shall continue to begovernedbyt the existing Government pension arrangements or any other statutory voluntary pension scheme.
• (2)Any person whose services are transferred to the Institute,on the commencement of this Act,and who being a member of any statutory voluntary pension scheme or provident fund,shall for the purposes of this Act,continue to be governed by the same regulations under those schemes or funds,as if the person had not been so transferred,and for the purposes of the regulations governing those schemes or funds,service with the Institute shall be deemed to be service in the former Institute.
• (3) The Board may,by order,make provisions with respect to pension or provident fund benefits of the

Pension.

members of staff of the Institute and with respect to the pension scheme and provident fund of the former Institute.

• (4) This section shall apply to the staff of the former Institute with necessary modifications.

96. Subject to the provisions of this Part, the Kenya Medical Research Institute Order,2021 is repealed. 3. 97.The Fourth Schedule to the Science,Technology

RepealofL.N. 35/2021.

• Amendmentof and Innovation Act is amended by deleting paragraph 5. Cap.511,

SCHEDULE

(s.14(1))

CONDUCT OFBUSINESSANDAFFAIRSOFTHE

BOARD

• 1.(l) The Board shall meet not less than four times in every financial year and not more than four months shall elapse between the date of one meeting and the date of the next meeting.
• (2) The chairperson may call a special meeting of the Board at any time the chairperson deems fit for expedient transaction of the business of the Board.
• (3) The notice for a meeting of the Board shall be given in writing to each member of the Board at least fourteen days before the day of the meeting.
• (4) In the case of a special,or extra-ordinary meeting, a notice of less than fourteen days'notice shall be considered sufficient.
• (5) Notwithstanding the provisions of subparagraph (2),the chairperson may,upon requisition in writing by at least two thirds of the members,convene a special meeting of the Board at any time for the transaction of the business oftheBoard.
• (6) The notice to be given under subparagraph (2) and (3)shall state-
• (a) the venue and time of the meeting;and
• (b) the agenda with sufficient details of business to be
• discussed at the meeting.
• (7) The chairperson shall preside at every meeting of the Board at which the chairperson is present but in the chairperson's absence, the members present shall elect from among themselves a chairperson who shall,with respect to that meeting and the business transacted thereat, have all the powers of the chairperson.
• (8) Unless a unanimous decision is reached,a decision on any matter before the Board shall be by the concurrence of amajority of all the members present and voting at the
• meeting.
• (9) The Board may,with approval of the Cabinet Secretary,co-opt or invite any number of persons to act as

Meetings.

MEMORANDUMOFOBJECTSANDREASONS

The Kenya Medical Research Institute as currently established vide a Legal Order has an inadequate legal framework. The Bill therefore regulation,conduct,promotion and co-ordination research for human

The principal object of this Bill is to make provision for the establishment,powers and functions of the Kenya Medical Research Institute. The Bill also makes provision for the effective conduct, coordination andpromotion ofresearch forhuman health in the country.

health.

Part I(clause 1 to 4) provides for preliminary matters including the short title, the objects and guiding principles of the proposed Bill.It further provides various definitions such as research for human health,

incubation centres and human health among others.

Part ll(clause 5 to 22) provides for the establishment of the Kenyan Medical Research Institute,its functions,powers;the composition of the Board ofDirectors of the Institute,their term ofoffice and qualifications for appointment.It further provides for the appointment of a DirectorGeneral who shall be the accounting officer and Chief Executive Officer of the Institute and the functions of the Director-General.It also provides for the manner of appointmentof staff of the Institute.

and communitiesamong other things.

Part Ill (clause 23-39) provides for the conduct of research for human health.It sets out the scope,methodology and ethical considerations in the conduct of research that involves humans,animals

Part IV (clause 40-41) provides for the conduct of clinical trials by the Institute within the scope of research for human health particularly

during public health emergencies.

Part V (clause 42-47) provides for the conduct of research in traditional and alternative medicine as a way of encourage the use and integration of traditional and alternative medicinal products in the

healthcare system in the country.

Part VI (clause 48-52) provides gives the Institute the responsibility of building capacity in matters of human health through research and training in research for human health and health sciences. The Institute, subject to subject to accreditation by the Commission for University Education and the award of a Charter under the Universities Act, Cap.210 will be able to offer specialized post-graduate degrees, diplomas and

certificates and short courses on matters related to health sciences.

Part Vll (clause 53-61) provides for research infrastructure

including biobanks,botanical gardens and research centres among others which shall be used as hubs of research, invention,innovation, collaboration and knowledge management in matters of human health.

Part VIll (clause 62-67) provides for the management of intellectual property arising out of inventions or innovations made by the Institute or arising out of the performance of the functions of the Institute.

Part Ix (clause 68-73) provides the sources of funds of the Institute, the audit of these funds as well as the annual report by the Board on the utilization of its funds and the activities undertaken in a given financial year.

Part X (clause 74) provides for the delegation of power to the Cabinet Secretary in the Ministry responsible for health to make regulations for the better carrying into effectof the functions of the Act in consultation with theBoard ofDirectors of the Institute.

Part XI (clause 75-84) provides for the general provisions such as offences and matters of risk management and confidentiality in the conduct of research, disclosure of information,protection ofpersonal data

erelationship between the Institute and National Commission for e Technology and Innovation.

Part X (clause 85-97) provides for the repeal and transitional provisions as the Kenya Medical Research Institute Order,2021 is being repealed.

The Schedule of the Bill provides for the conduct of the business and

affairs of the Board.

Statement on the delegation of legislative powers and limitation

offundamental rightsand freedoms

The Bill delegates legislative powers to the Cabinet Secretary but it

doesnot limit fundamental rights and freedoms.

Statement on whether the Bill concerhs County Governments

The Bill does not concern county governments in terms of Article 110(1)(a)of the Constitution.

Statement that the Bill is not a money Bill within the meaning of

Article 1i4of the Constitution

This Bill is a money Bill within the meaning of Article 114 of the

Constitution.

Dated the20th May,2025.