President William Ruto's administration has proposed radical
changes to how the health sector will be run and regulated.
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.
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.
