President William Ruto's administration has proposed radical
changes to how the health sector will be run and regulated.
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The Quality Healthcare and Patient Safety Bill, 2025, which is currently undergoing public participation, proposes stringent new rules for the registration of health facilities, licensing of medical personnel and regulation of pharmacies.
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Majority leader Kimani Ichung'wah said the proposed law aims to standardise quality and enhance patient safety across the country.
The Bill establishes the Quality Healthcare and Patient Safety Authority, a powerful new body which will oversee the health sector.
The proposed authority will be responsible for registering, licensing and accrediting all health facilities.
It will superintend the accreditation of national referral hospitals to rural clinics and mobile medical units.
It will also enforce compliance with national standards, conduct inspections and have the power to suspend or revoke licenses for non-compliance.
Under the proposed law, all health facilities must obtain approval from the proposed authority before construction or operation.
They must then apply for registration and an annual license, with the authority conducting inspections to ensure compliance with infrastructure, staffing and safety standards.
There are heavy penalties for facilities that fail to meet the said requirements, including fines of up to Sh50 million or imprisonment for up to 10 years for convicted persons.
The Bill also introduces a mandatory accreditation system based on quality benchmarks. Health facilities will be assessed on criteria such as clinical outcomes, patient satisfaction and adherence to evidence-based guidelines.
Those that meet the standards will receive performance ratings and recognition certificates, while non-compliant facilities may face warnings, fines or closure.
A key focus of the Bill, which has been formally introduced in Parliament, is the protection of patient rights.
It explicitly guarantees patients the right to safe and accessible health facilities, qualified healthcare professionals, timely and effective care.
The Bill further compels hospitals to provide patients with comprehensive information to enable informed decision-making.
If enacted, health facilities would be required to develop and display a patient rights charter in prominent locations.
Facilities would also be required to establish mechanisms for patients to lodge complaints without fear of reprisal.
The Bill also emphasises dignity and equity for patients and prohibits discrimination based on age, sex, disability, ethnicity, health status, or socioeconomic status. It mandates tailored services for vulnerable groups, including women, youth, persons with disabilities and minority communities.
In what could enhance transparency and accountability, the Bill requires health facilities to integrate with national digital health systems.
The aim is to enable real-time reporting of adverse events, patient safety incidents and other quality metrics.
Facilities must also maintain detailed records of healthcare services and inspection outcomes, which will be subject to review by the authority.
The Bill places new obligations on healthcare professionals, requiring them to be duly qualified and licensed by their respective regulatory bodies.
Health facilities would be under compulsion to verify the credentials of all staff and provide periodic training on patient safety and clinical guidelines.
Additionally, the Bill posits that all healthcare professionals and facilities maintain professional indemnity insurance to cover claims arising from acts or omissions in the course of providing care.
PHARM REGULATIONS
Pharmacies and other health facilities dispensing medicines will face stricter oversight in the new dispensation.
The Bill requires them to comply with standards for the safe use, storage, and administration of health products and technologies.
Pharmacies would also be compelled to report adverse reactions to regulatory bodies and provide patient education on the safe use of medications.
The Bill establishes a Health Care Tribunal to hear and determine disputes between patients, healthcare providers and regulatory bodies.
The tribunal will have the power to grant injunctions, penalties and damages. It will also handle appeals for decisions made by the authority, providing a mechanism for redress without one having to seek redress at the courts.
Existing health facilities will have a one-year grace period to comply with the new requirements.
The Bill also proposes amendments to other health-related laws, including the Health Act, the Pharmacy and Poisons Act, the Mental Health Act, and various professional regulatory acts, to align them with the proposed legal framework.
While the Bill has been praised for its approach to patient rights and potential to improve healthcare quality, it has also faced criticism.
Pundits hold that it creates a centralised regulatory structure that may duplicate the functions of existing bodies.
Dr David Odhiambo, a public policy analyst, said this in a review published on Linked-In.
"One of the most problematic features of the proposed Bill is the establishment of a new regulatory body." He said the Bill would impact heavily on operations of the Kenya Medical and Dentists Council, Pharmacy and Poisons Board, and the Nursing Council.
"These agencies already have legal mandates to license healthcare professionals and facilities, enforce compliance and set practice standards," Odhiambo said.
He observed that, "Rather than harmonising these roles, the Bill introduces regulatory duplication that will confuse responsibilities, encourage turf wars, and waste public resources."
INSTANT ANALYSIS
The Bill is set to undergo public participation in the Parliament apepobal process. Once finalised, and if passed, it will represent the most significant reform of the country's healthcare sector.
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