The Kenyatta National Hospital. Fines for breaching patient safety could reach Sh50 million and offenders may be jailed for up to ten years.On paper, the proposed patient safety law looks great. It
guarantees your safety in health facilities, and imposes up to Sh50 million in
fines on errant health facilities.
But some health workers lobbies are already opposed to it
saying it duplicates existing laws and would create loopholes for corruption.
We look at what to expect should the new Quality Healthcare
and Patient Safety Bill become law.
The Ministry of Health mooted the law mid last year and unveiled
the draft last week.
The bill is currently undergoing public participation across
the 47 counties.
If it becomes law, Kenyans will see the rise of a powerful
new body, the Quality Healthcare and Patient Safety Authority.
According to the draft, the Authority would wield vast
powers. It would not only register and license all health facilities across the
country, but also accredit them, set and monitor quality benchmarks, and even
suspend or revoke licenses.
These functions currently fall under multiple bodies such as
the Kenya Health
Professions Oversight Authority (KHPOA) and the professional councils it was
expected to coordinate, such as the Kenya Medical Practitioners and Dentists
Council (KMPDC),
the Clinical Officers Council, and the Nursing Council among others.
The proposed law sets broad standards for public and private
health facilities for the safety of patients and workers.
It empowers the authority’s officers to penalise offending
facilities with “a fine not exceeding fifty million shillings or to
imprisonment for a term not exceeding ten years, or both.”
The Bill also proposes the creation of a Healthcare Tribunal
to resolve disagreements involving patients, workers, or facilities.
“A patient is entitled to respectful, person-centered care,
including quality palliative and end-of-life care; non-discriminatory treatment
regardless of age, sex, disability, ethnicity, health status or socioeconomic
status; and tailored services for vulnerable or marginalized groups, including
women, youth, persons with disabilities and minority groups,” the Bill says.
But most of these provisions are already stipulated, though
rarely enforced, by the Health Act, 2017. For example, Section 5 of the Health
Act declares that “Every person has the right to the highest attainable
standard of health” and “Every person shall have the right to be treated with
dignity, respect and have their privacy respected.”
Section 7 specifies that “Every person has the right to
emergency medical treatment,” including pre-hospital care and stabilising
treatment. Any facility that fails to provide this, while able, commits an
offence punishable by a fine not exceeding Sh3 million.
The new Bill repeatedly restates these same rights, word for
word, despite being intended as a step forward.
According to Peterson Wachira, chairman of the Health Sector
Caucus Kenya, that raises a question: if
the Health Act already secures these protections, why build a new tower instead
of reinforcing the one standing?
“We observe that more than 80 per cent of contents in
Quality of Healthcare and Patient Safety Bill 2025 are already provided for in
other legislations and policies within the ministry including; Health Act 2017,
National Policy on Patient Safety, Health Worker Safety and Quality of Care,
Public Health Act, Clinical Officers Act, Medical Practitioners and Dentists
Act, Nurses Act, Kenya Quality Model of Health (KQMH) policy, Medical
Laboratory Technicians and Technologists Act, Nutrition and Dieticians Act,
PHOTC Act, Pharmacy and Poisons Act, among others,” he said.
Another critical function under the Health Act 2017 law appears to be
duplicated. Sections 45 and 48 establish the Kenya Health Professions Oversight
Authority (KHPOA) as the body responsible for regulating health professions.
“The functions of the Authority (KHPOA) shall be to monitor
the performance by health regulatory bodies; ensure the maintenance of
professional standards; ensure the development and compliance with policies,
guidelines and standards related to health professionals; facilitate resolution
of disputes among regulatory bodies; coordinate joint inspections; and promote
and ensure continuous professional development in collaboration with relevant
regulatory bodies,” Section 48 of the Health Act says.
Wachira says Justice Wesley Korir in September 2022 directed for amendment of
Health Act 2017. He says this provides a shorter and cost-effective route for
its improvement, if need be, without reproducing and duplicating laws that
provide for health.
The new Bill even goes further: it would strip regulatory
authorities of their power to set scopes of practice – defining what doctors,
nurses, clinical officers and other professionals may do – and transfer that
authority to the Director General of Health.
Section 19(1) of the Bill suggests: “A health facility shall
adhere to the scope of practice for the healthcare providers employed or
contracted in health facilities as prescribed by the Cabinet Secretary on the
recommendation of the Director-General.”
Professional bodies in their memorandum protest saying this
is taking control away from specialists and placing it in the hands of
political appointees.
“Transfer of mandate
on development of scopes of practice from regulatory bodies to Director General
is retrogressive and will negatively affect quality of health,” Wachira said.
“Councils and boards are better placed to continue with this
function since they have a diversity of members representing various fields
including trainers, regulators, legal practitioners and practitioners in the
relevant field, which provides a better and informed forum for development of
progressive Scopes of Practice.”
At issue is also timing and cost. The Bill comes as Kenya
struggles to pay health staff, maintain facilities, and invest in digital
systems.
The Cabinet recently resolved to merge or dissolve
unnecessary agencies to ease budget pressures. “Yet here we are, preparing to
launch another national health agency with fresh staff, offices, and
administration, all while the roles it would fill are already guaranteed under
existing law,” health workers
said in a statement.
Rather than creating a new body, union leaders and lawyers
argue that the government should amend the 2017 Act to make KHPOA fully
operational, inclusive, and powerful enough to protect patients and oversee
standards.
The task then would be to fill in the missing pieces (hire
staff, deepen inspections, improve infrastructure) not compete with another
agency.
However, some observers see merit in the bill’s attention to
telemedicine, data privacy, digital platforms, and even medical
aesthetics—areas previously neglected in law. Joash N.R., a clinical officer
and health tech strategist,
said:
“If you work in healthcare (especially in sales, tech, or
innovation), you know telehealth has been growing but it’s also been vibing in
the grey area. No clear rules. No accountability. No structure for how we
handle virtual consultations, data privacy, or even digital prescriptions. This
Bill changes that.”
He added: “It recognizes telemedicine as part of Kenya’s formal healthcare structure.”
Public Health PS Mary Muthoni defends the Bill and the new
authority it creates, saying the country needs a strong regulatory body to
oversee health service providers and protect patients from unsafe practices.
“Patients are too often exposed to substandard conditions,
with services offered in poorly built facilities and by unqualified staff,” she
said.
“The Quality of Health and Patient Safety Bill will be a
game changer. It aims to restore dignity and safety within Kenya’s healthcare
system.”
The ministry said it will give Kenyans across all 47
counties an opportunity to review, adopt, or recommend changes during a series
of public forums, ensuring it reflects the needs and priorities of both
patients and providers.
The PS also called on the public and healthcare stakeholders
to actively contribute during the ongoing public participation process.
“We want Kenyans to understand what this bill means and to
help shape it. Quality healthcare is a right, not a privilege, and this
legislation is one way of making that right a reality,” Muthoni added.