Health Act

This Act may be cited as the Health Act.

This section provides definitions of terms used in the Act (for example: "abortion", "alternative medicine", "Authority", "Board", "breastfeeding", "Cabinet Secretary", and many others).

Establish a national health system encompassing public and private institutions and providers of health services at national and county levels to progressively and equitably facilitate the highest attainable standard of health services.

Responsibility to develop policies, laws and other measures necessary to protect, promote, improve and maintain the health and well-being of every person.

Section 5 gives every person rights to the highest attainable standard of health (including promotive, preventive, curative, palliative and rehabilitative services) and to be treated with dignity, respect and privacy; it also requires the national government, in consultation with county governments, to provide funds to county governments to implement subsection (3).

Provides for the types, availability and cost (if any) of health services.

Information about a user is confidential except when disclosed by court order, with the user's informed consent for health research and policy planning, or when nondisclosure poses a serious public health threat; proposed disclosures under the public-health-threat exception are subject to regulations published by the Cabinet Secretary of health.

Section 12 sets out rights of healthcare providers (including non-discrimination, a safe working environment, refusal to treat abusive users except in emergencies, and the right to take salaried posts), obligations to provide care and emergency treatment and to inform users of their health status, and empowers facility heads to impose conditions on services taking account of a provider's health status.

Users must adhere to the rules of a health facility when receiving treatment or using the health services provided by the establishment.

Any person may file a complaint about treatment at a health facility and have it investigated; governments must set and publish complaint procedures; facilities must display and communicate the procedure; facility heads (or designees) must handle complaints; complainants must be informed in writing within three months; the Authority must act if complaints are not resolved.

The national government has multiple duties to develop health policy, ensure rights to health, mobilize resources, collaborate internationally, and other functions to progressively realize the right to health.

Establishes the Office of the Director-General for health; sets recruitment process and appointment authorities; lists qualifications and tenure.

The Director-General must be the technical advisor to the Government on all matters relating to health within the health sector.

Section title: "Section 18. Directorates Section medical services;"

Establishes the county health system and the office of County Director of health and lists the qualifications and duties of the County Director of health.

County governments must implement the national health policy and standards as laid down by the national government Ministry responsible for health.

The National Health System must work in a manner that respects the distinct levels of government and the principles of cooperation and coordination set out in this Act and related legislation.

Section 6 establishes rights to reproductive health information and access to services for men and women of reproductive age and a right of parents to appropriate health-care services through pregnancy, childbirth and the postpartum period.

Everyone has the right to emergency medical treatment. Medical institutions that have the ability must provide such treatment; failing to do so is an offence and may attract a fine not exceeding three million shillings.

Healthcare providers must, where possible, inform users about the information listed in subsection (1) in a language and manner the user understands; providers may require formal confirmation if a user refuses treatment; 'user' and 'healthcare provider' are defined.

Healthcare providers must take all reasonable steps to obtain the user's informed consent.

The national and county governments must ensure progressively equitable distribution across the country of publicly owned health institutions (hospitals, health centers, pharmacies, clinics and laboratories) needed for promotive, preventive and rehabilitative health services.

The national and county governments may enter into public-private partnerships to establish and deepen health service provision, subject to section 65 and other laws on public-private partnerships.

Applies to any public health institution classified as a national referral facility under this Act.

The technical classification of levels of healthcare is set out in the First Schedule, but subsection (1) does not apply to health facilities managed by a county government at the commencement of the Act.

Establishes a Health Sector Inter-Governmental Consultative Forum and identifies membership including the Director-General for health (or designate) and County Directors of health (or designates).

The Forum is to develop criteria and a framework for determining matters requiring inter-governmental consultation.

The Forum must meet at least twice a year.

The Forum must regulate the conduct and regulation of its business and affairs.

Protects the rights of any individual suffering from a mental disorder or condition.

Establishes the Council, lists its membership (including a Chairperson appointed by the Cabinet Secretary and the Chief Executive Officer as ex officio secretary) and grants the Council corporate powers such as suing and being sued and holding property.

The Council functions include posting interns to National Government and County Government facilities.

The Council has the power to control, supervise and administer the Council's assets in a manner and for purposes that best promote the Council's purposes.

The Public Service Commission must recruit a Chief Executive Officer through an open and transparent process; the Council shall appoint the CEO; the CEO serves a five-year term (eligible for one reappointment subject to satisfactory performance) and is responsible for day-to-day operations.

Section 34(1) says the conduct and regulation of the Council's business and affairs shall be as provided in the Second Schedule; Section 34(2) says the Council may regulate its own procedure except as provided in the Second Schedule.

The Council may, by resolution generally or in any particular case, delegate to a committee or to any member, officer, employee or agent the exercise of its powers or the performance of its functions or duties under the Act.

The Chairperson and the members (other than ex officio members) must hold office for a term of five years and may be reappointed once.

The Council may competitively appoint suitably qualified staff when necessary for efficient performance of its functions.

Council staff must serve under terms of service determined by the Council; the Council may determine those terms on recommendation of the Salaries and Remuneration Commission.

Members of the Council and persons working under its instructions are not personally liable for acts or omissions done in good faith while performing Council functions; the Council remains liable to pay compensation for injuries or property loss caused by exercise of powers or failure of works.

The Council's funds are "such funds as may be appropriated by the Parliament."

The Council's financial year is the twelve-month period ending on 30 June each year.

The Council must prepare and approve annual revenue and expenditure estimates before each financial year, submit them to the Cabinet Secretary for approval, and must not increase the estimates without the Cabinet Secretary's consent.

The Council must keep proper books and records of its income, expenditure, assets and liabilities.

The Council may invest its funds in specified securities, subject to approval by the Cabinet Secretary responsible for finance; the National Treasury may approve other securities.

An Authority called the Kenya Health Professions Oversight Authority is established.

Section 46 sets out the Authority's Board composition, requires the Cabinet Secretary to appoint a Chairperson who is a health professional, provides that the Authority is supported by a Secretariat headed by the Chief Executive Officer (appointed by the Authority through a competitive process and serving as an ex officio member and secretary), vests the Authority's powers in the advisory Board, and requires the Authority to conduct its business in accordance with the Second Schedule.

The Board has power to control, supervise and administer the assets of the Authority.

The Authority must maintain a duplicate register of health professionals; promote and regulate inter-professional liaison between statutory regulatory bodies; coordinate joint inspections; receive and facilitate resolution of complaints from patients, aggrieved parties and regulatory bodies; monitor execution of regulatory mandates; arbitrate disputes between statutory regulatory bodies; and ensure standards for health professionals are not compromised.

The Public Service Commission must recruit a Chief Executive Officer through an open and transparent process; the Authority appoints the Chief Executive Officer; the Chief Executive Officer must serve for five years (eligible for one re-appointment subject to satisfactory performance), must be responsible to the Board for day-to-day operations, and a person with any direct or indirect interest in the health sector must not be appointed.

Section 50(1) makes the Board’s conduct and regulation of its business and affairs subject to the Third Schedule; Section 50(2) permits the Authority to regulate its own procedure except as provided in the Third Schedule.

The Authority may delegate, by resolution, its powers, functions or duties to a committee, member, officer, employee or agent.

The Board may competitively appoint suitably qualified staff as may be necessary for the efficient performance of the functions of the Board.

The staff of the Board must serve the Board on terms of service determined by the Board on recommendation of the Salaries and Remuneration Commission.

Members of the Board, officers, employees, agents and persons acting under their direction are not liable for acts or things done in good faith to execute the Authority's functions, powers or duties; however, the Board remains liable to pay compensation for injury, damage to property or interests caused by exercise of powers or by failure of works.

The Authority's funds are "such funds as may be appropriated by Parliament."

The financial year of the Authority is the period of twelve months ending on the thirtieth day of June in every year.

The Board must prepare annual estimates of the Authority's revenue and expenditure at least three months before each financial year; the Board must approve and submit these estimates to the Cabinet Secretary, and after approval the Authority must not increase them without the Cabinet Secretary's consent.

The Board may invest any of the Authority's funds in securities permitted for trustees or in other securities approved by the National Treasury, subject to approval by the Cabinet Secretary responsible for finance.

The Board must cause proper books and records to be kept of the Authority's income, expenditure, assets and liabilities; the Authority's accounts must be audited and reported upon in accordance with the Public Audit Act (Cap. 412B).

Respective regulatory bodies must inspect, monitor and evaluate performance standards in the health sector, provided this does not conflict with the Authority's functions or other written law.

Health professionals who want to form a professional regulatory body must follow criteria set by the Cabinet Secretary in consultation with the Authority.

A single regulatory body for health products and health technologies shall be established by an Act of Parliament.

The regulatory body has functions including licensing health products and technologies, licensing manufacturers and distributors, testing and inspecting facilities, controlling clinical trials, overseeing advertising, surveillance and disposal, and regulating contractors and physical security.

Legislation under section 62 must provide that marketing approval is granted only by a technically competent body after appropriate assessment shows the product meets generally recognized standards; approval may be subject to conditions on promotion and advertising.

People, firms or institutions must not carry out the activities listed in section 63(1) unless they hold a valid licence from the single regulatory body; licence-holders must display the licence conspicuously and produce it for inspection when required by an officer of that body.

After due assessment, it is found to achieve the therapeutic or the intended effect it claims to possess or which may reasonably be attributed to it.

Section 67 governs procurement of health products and technologies: procurement must follow the Public Procurement and Disposal Act and inter-governmental arrangements; Kenya Medical Supplies Authority must include therapeutic feeds and nutritional formulations among products it procures, may act as first call for county referral procurement and must endeavour to establish county branches; the national government must provide guidelines for procurement, distribution and management across the national health system.

Section 68 lists public and environmental health interventions and priorities, including disease prevention, promotion of healthy lifestyles, safe food supply and nutrition, public health education, effective family planning and sexual and reproductive health services, maternal and child health including neonatal care, elimination of female genital mutilation, maternal nutrition and micronutrient supplementation, reduction of disease burden from poor environmental hygiene and pollution, control of waterborne/food-borne/vector diseases and climate change effects, reduction of healthcare-acquired infections, strengthening national and county capacity against diseases of international concern, and building community capacity to address public health challenges.

Ensuring and promoting the provision of quarantine, especially in ports, borders and frontiers health services.

All employers must provide workplace lactation stations with specified facilities and prevent promotion of infant formula within them; lactation stations must not be located in rest rooms.

Employers must give nursing employees paid break intervals (in addition to meal breaks) for breastfeeding or expressing milk, including time to and from the lactation station, not exceeding one hour per eight-hour period.

The national government department of health must formulate policies to guide traditional and alternative medicine practice; the county executive department for health must ensure implementation of those policies.

The regulatory body must maintain a national and county-level register; must set minimum standards of practice for traditional and alternative medicine in consultation with the National government department for health; and must be responsible for registration, licensing and standards compliance of practice in traditional and alternative medicine.

The regulatory body must institute documentation and mapping measures for traditional and alternative medicine practice; county executive departments for health must facilitate that mapping.

The national government department for health must develop policies to standardize traditional and alternative medicine practice, in consultation with key stakeholders.

Charges for practising traditional medicine must be approved by the Authority in consultation with statutory bodies.

The national government department of health must develop policy guidelines and a referral system from traditional and alternative medicine practitioners to conventional health facilities; it may prescribe related regulations which county departments shall implement.

Transplants must occur in duly authorized health facilities; specified medical practitioners (the practitioner in charge or those authorized) or, where none, an authorized practitioner designated by the person in charge, or the person from whom tissue/gametes are removed (in the prescribed manner), may authorize; the medical practitioner who grants authorization under subsection (1)(b) shall not be the lead participant in that transplant; criteria and procedural measures for approval of organ transplant facilities are stated; charging a fee for a human organ or otherwise contravening this section is an offence punishable by a fine not exceeding ten million shillings or imprisonment for up to ten years or both.

Certain persons may donate a deceased person's body or tissue; a person who makes a donation must nominate a donee; the Cabinet Secretary may donate if next-of-kin cannot be located and may only allow use of donated tissue after prescribed steps to locate next-of-kin have been taken.

Permitted purposes for donation: training of students in health sciences; health research; advancement of health sciences; therapeutic purposes (including use of tissue in any living person); and production of therapeutic, diagnostic or prophylactic substances.

A donor may revoke a donation (before the relevant organ is transplanted into the donee), either in the same manner it was made or, for donations by will or document, by intentionally destroying that will or document.

Specifies who may consent to or authorize a post mortem: prior personal consent, specified relatives in order, necessity to determine cause of death, and medical practitioners authorized to give written authorization.

Establishes the Kenya National Blood Transfusion Service, charges the Service with developing a national voluntary non‑remunerated blood donation service and with establishing settings and mechanisms to superintend, regulate and provide blood transfusion services; contravention is an offence punishable by fine or imprisonment.

Section 86 sets out health finance functions including developing mechanisms for an integrated national health insurance system (social health protection and health technology assessment); establishing oversight mechanisms to regulate all health insurance providers; developing policies and strategies to realize universal health coverage; determining cost-sharing mechanisms in consultation with county authorities; defining public financing of health-care framework including annual allocations for reimbursing providers responding to disasters and emergencies; ensuring pharmaceutical and non-pharmaceutical products correspond to Kenya Medical Supplies Authority market prices; defining a standard health package financed through prepayment mechanisms; and providing frameworks for collaboration with finance, planning and other departments to secure healthcare for vulnerable groups, optimize private health services usage, and harmonize planning, financing and monitoring within the health sector.

The National Treasury must facilitate county treasuries opening and maintaining bank accounts to operationalize disbursements of conditional grants, donations and other monies designated for health, in accordance with the Constitution and the Public Finance Management Act (Cap. 412A).

The Cabinet Secretary must develop and regulate private health services; public and private health services and facilities must complement each other to provide comprehensive and accessible healthcare.

Private entities may operate hospitals, clinics, laboratories and other health-sector institutions, subject to licensing; standards and licence conditions are defined in regulations issued by the Cabinet Secretary.

Qualified private health workers are entitled to practice in Kenya but must be licensed by the appropriate regulatory bodies.

Licensees must allow inspections at any time by the Authority and regulatory bodies and must provide emergency services on request or when required; institutions and private health workers are entitled to compensation under similar terms.

The Cabinet Secretary and the County Governors are entitled to enter into partnership agreements with private-sector companies to develop health services or facilities; counties or individual facilities may also enter into such agreements, subject to the Public Private Partnerships Act (Cap. 430) and where appropriate.

Parliament must enact legislation to give full effect to the provisions of this Part.

At least thirty per cent of the National Research Fund must be allocated for health research.

Non-governmental and international organizations may, with Committee approval and notwithstanding national government responsibility under section 92, cooperate with research institutions (including KEMRI, universities and health institutions) to provide support for promotion and conduct of health research.

The Cabinet Secretary must establish a National Health Research Committee (a technical committee). The Committee's membership shall be as provided under section 94 and shall consist of not more than eleven members appointed by the Cabinet Secretary.

The Chairperson must be a distinguished health researcher and renowned in a health discipline.

Chairperson serves five years (renewable once); members serve three years (renewable once). Both may resign by letter to the Cabinet Secretary.

The Committee must make recommendations on national research-for-health policy and priorities, consider specified factors when doing so, carry out and prioritise research activities (including determining extent and ensuring focus on priorities), establish frameworks and resources (including a national research database and National Research Fund allocation), and execute its functions through the head of the Ministry directorate responsible for research and development who shall be its secretary.

The Kenya Medical Research Institute must review its programmes to align with population health interests and the national health research programme; the Committee must collaborate with other research organisations to recommend the national health policy.

The Committee may regulate its own procedure, except as may be provided in the Fourth Schedule.

The Committee must set standards for ethical clearance on health research approvals.

E—Health is a recognized mode of health service.

Administration of health information banks including interoperability framework, data interchange and security.

The Ministry of Health must facilitate a comprehensive integrated national health information system; the Cabinet Secretary may prescribe data categories, formats and compilers (in consultation with the Director General); healthcare providers who fail to comply with subsection (3)(a) commit an offence punishable by up to six months imprisonment or a fine of 500,000 shillings or both; county governments are not precluded from making county-level health information laws.

The Cabinet Secretary responsible for health has primary responsibility for this Act; the respective levels of government and other government agencies must collaborate, consult and enter into agreements to carry out the Act, and the respective levels of government must collaborate on implementation, regulation development and, where necessary, adapting legislation.

Section 107 requires collaboration between the state department responsible for education, science, technology and innovation and the Commission for Higher Education on national policy for training institutions; the Cabinet Secretary must issue guidelines on post-basic training; and regulatory bodies must ensure training meets standards and quality.

Section 108: Fields of collaboration; Section health workers welfare;

Section 109(1) provides that, except where the Act says otherwise, rights and obligations of the Government that existed immediately before the effective date shall continue as rights and obligations of the national and county governments as assigned under this Act; Section 109(2) states that all law in force immediately before the effective date continues and must be construed to conform with this Act.

Public officers appointed by the Public Service Commission before this Act who were serving under national and county government are deemed seconded to the county with their existing terms of service; certain officers must discharge duties for the relevant national or county functions; and The Authority must facilitate redeployment, transfers and secondment in consultation with listed bodies.

If someone is convicted of an offence under the Act for which no penalty is provided, they are liable to a fine not exceeding two million shillings or to imprisonment for three months, or both; if a corporate body commits such an offence the directors, secretary or manager are deemed to have committed it unless they prove lack of consent and due diligence; similarly partners are deemed to have committed an offence by a partner unless they prove lack of consent and due diligence.

Requires payment of fees to access services in a public health facility.