Healthcare Regulation in Kenya: Licensing and the Health Act 2017

Healthcare regulation in Kenya is spread across several statutes rather than found in one code. The Health Act, 2017 sets the framework for the health system, while licensing of facilities and practitioners sits mainly in the professional statutes, and financing of care now runs through the Social Health Insurance Act, 2023. A facility or investor needs to read all three layers together.

Healthcare regulation in Kenya: licensing a health institution

Section 89(1) of the Health Act permits private entities to operate hospitals, clinics, laboratories and other health sector institutions, subject to licensing by the appropriate regulatory bodies. Section 89(2) leaves the standards and licence conditions to regulations made by the Cabinet Secretary. The Act therefore points to other laws for the licensing mechanics, and it is a mistake to look for the whole answer in the Health Act.

For health institutions, the Medical Practitioners and Dentists Act supplies the mechanics. Under section 15, the Kenya Medical Practitioners and Dentists Council registers a health institution as an approved health institution and issues a licence authorising use of premises as a health institution. The licence must specify the nature of services the institution may provide, and it must be displayed in a conspicuous place (section 15(7) and (8)). An application for the licence is due on or before 30 October of each practising year (section 15(5)), and the Council may decline to renew, cancel or revoke it if the institution is operated in breach of the Act or its regulations (section 15(9)).

Section 91 of the Health Act adds duties for licensed institutions. They must permit and facilitate inspection at any time by the Kenya Health Professions Oversight Authority and by regulatory bodies, and they must provide emergency services in their field of expertise without regard to the prospect of direct financial reward. That Authority, established by section 45, maintains a duplicate register of health professionals, coordinates joint inspections with regulatory bodies, and facilitates resolution of complaints (section 48).

Professional registration and the cost of getting it wrong

Healthcare regulation in Kenya is cadre-specific. Each cadre has its own statute and regulator. The Medical Practitioners and Dentists Act deals with doctors and dentists. The Nurses and Midwives Act establishes the Nursing Council of Kenya. The Pharmacy and Poisons Act deals with pharmacists and pharmaceutical technologists and requires business premises to be registered with the Board (section 23).

The offences bite on both practitioners and facilities. Under section 22 of the Medical Practitioners and Dentists Act, a person who practises or professes to practise medicine or dentistry without being registered or licensed commits an offence punishable by a fine of up to five million shillings, imprisonment of up to five years, or both. On the nursing side, section 22(1) of the Nurses and Midwives Act makes it an offence for any person to employ another as a nurse in a health institution if that person is not registered, enrolled or licensed, punishable by a fine of up to five hundred thousand shillings, imprisonment of up to two years, or both. Section 22(2) lets the Council authorise entry to check the status of nurses, the condition of premises and the standard of nursing care.

Practitioner licences under the Medical Practitioners and Dentists Act are renewed under section 14, which asks for an application at least thirty days before expiry. A facility should keep a register of every clinical employee’s licence expiry date and check it monthly.

From NHIF to the Social Health Authority

The Social Health Insurance Act, 2023 repealed the National Health Insurance Fund Act, 1998 (section 54). It establishes the Social Health Authority (section 4) and three funds: the Primary Healthcare Fund, whose object is to purchase primary healthcare services from health facilities (section 20); the Social Health Insurance Fund (section 25); and the Emergency, Chronic and Critical Illness Fund (section 28).

The Act leaves contribution rates to be prescribed. Regulation 17(1) of the Social Health Insurance Regulations, 2024 sets the monthly statutory deduction for salaried households at 2.75% of gross salary or wage, payable by the ninth day of each month, and regulation 17(2) provides that the amount payable shall never be less than KES 300 per month.

For a facility, section 33 is the provision that matters commercially. The Authority pays out of the Funds only to healthcare providers and facilities that are empanelled and contracted under the Act. A facility seeking empanelment applies to the body responsible for accreditation for quality of care, and the Authority may contract the empanelled providers within thirty days of publication of the list (section 33(2) and (3)). A facility aggrieved by a decision on accreditation may appeal to the Dispute Resolution Tribunal within thirty days (section 33(5)). Licensing alone does not mean a facility will be paid by the Authority.

Claims are processed by the Claims Management Office within the Authority (section 35), which reviews and validates claims, issues pre-authorisations and sets up systems for detecting fraud. A facility’s claims documentation should therefore be treated as a compliance function. Section 43 allows a person aggrieved by a decision made under the Act to appeal within one month to the Dispute Resolution Tribunal, with a further appeal to the High Court within twenty-one days of the Tribunal’s order.

Patient consent

Section 9(1) of the Health Act provides that no specified health service may be provided to a patient without the patient’s informed consent, subject to listed exceptions, including emergencies, consent by a person mandated in writing or authorised by law or a court order, and consent by next of kin where the patient cannot consent. Section 9(2) requires a healthcare provider to take all reasonable steps to obtain informed consent. Section 9 does not itself prescribe a written form, so a provider should adopt a documented consent process as a matter of good practice and evidence.

Investment and partnership with government

Investment in healthcare regulation in Kenya is open to partnership with government. Section 92 of the Health Act allows the Cabinet Secretary and county governors to enter into partnership agreements with private sector companies to develop services or facilities for public health, subject to the Public Private Partnerships Act. Counties or individual facilities may do the same. Investors in larger projects should plan for the procurement process under that Act from the outset.

Frequently asked questions

This article is general information on Kenyan law as at its publication date, not legal advice. Reading it does not create an advocate and client relationship.