The proposed
Quality Healthcare and Patient Safety Bill, 2025, sets out to reform how
healthcare is regulated in Kenya, promising safer care and greater
accountability. The proposed law aims to enhance patient safety, standardise
healthcare delivery and advance universal health coverage under the Bottom-Up
Economic Transformation Agenda.
While the full text of the Bill is not publicly available in the provided sources, recent posts on X (formerly Twitter) and related web information highlight key aspects and potential flaws or concerns.
But beneath its objectives lies a complex maze of overlapping procedures, uncertain feasibility and likely cost implications for both healthcare providers and patients. Rather than closing existing regulatory gaps, the Bill may widen them by creating a heavy administrative superstructure that duplicates functions already managed by established regulatory agencies.
A central feature of the proposed law is the establishment of a new authority tasked with registering, licensing, inspecting, accrediting and rating health facilities.
These functions, however, are already actively handled by regulators such as the Kenya Medical Practitioners and Dentists Council, the Pharmacy and Poisons Board, the Medical Laboratory Technicians and Technologists Board and the Kenya Health Professions Oversight Authority.
These institutions operate under statutory mandates, with professional oversight mechanisms backed by enforceable rules. Strengthening their coordination and capacity would offer a more efficient path forward than setting up a new agency from scratch.
Alternatively, we should ask if it is possible we house all regulators as opposed to adding another one.
We must also ask. Given the current calls for austerity and the existing burden on taxpayers, is it truly prudent to establish another tax-funded agency?
There are also teething issues when it comes to licensing as seen in provisions in Part IV of the proposed law.
For instance, Section 50(2) requires an inspection to be undertaken before a license is issued. While inspections are critical to public safety, the feasibility of carrying out nationwide pre-licensing checks, within annual renewal timelines, is highly questionable.
Under the proposed law, health facilities will be required to include particulars of a digital health solution certified by the Digital Health Agency. While the integration of digital tools into care is welcome, conditioning licensure on this certification introduces a new cost centre and layer of bureaucracy, tied to an agency whose visibility and operational capacity remain unclear. This is likely to delay approvals and increase financial pressure, particularly for health facilities.
It is also not clear how much compliance to the DHA will cost.
Even more
puzzling is the multi-step compliance structure the Bill introduces. A facility
will be required to register, obtain a licence and then separately pursue
accreditation, followed by a quality scoring and rating process. All of this
occurs under the same authority. Why should a facility undergo four separate
evaluations to legally operate? Each stage implies new compliance requirements,
assessments and likely fees, without clearly demonstrating added value. This
complex process risks discouraging investment in the sector.
Further,
Section 69 introduces a performance rating and recognition certificate based on
the level of the facility. If licensing and accreditation already confirm a
facility’s suitability to operate, what does this additional layer offer? Does
it imply that initial standards are minimal, with real quality measured later?
Or is it simply another form of classification that adds little practical
benefit?
And yet, it must be noted, that this is merely an examination of one part of the proposed legislation. If what is seen in this section is anything to go by, one can only imagine the scale of bureaucracy, cost implications and procedural complexity embedded in the rest of the Bill.
What emerges is not a streamlined system for enhancing healthcare quality, but a complicated regime of overlapping mandates, regulatory hoops and financial burdens. Kenya already has institutions that have conducted impactful inspections, licensing and enforcement actions under existing laws. Rather than replacing such efforts, reform should modernise and support them through better funding, digitisation and clearer accountability structures.
Yes, there is room for improvement in our healthcare oversight system. But this Bill proposes to do so by layering multiple new obligations onto the same providers without addressing root problems like system fragmentation, enforcement gaps, or professional shortages. Effective reform should simplify processes and not complicate them.
The Bill risks replacing known imperfections with a sprawling, untested system that could make the regulatory space more fragmented and costly. Kenya deserves better. Strengthening what already works is not only more cost-effective; it’s a smarter, faster path to true healthcare quality.
The writer is a resident of Kandara, Murang’a, works in the healthcare sector, [email protected]
