Background
Population-based cancer registries are essential for effective cancer surveillance, evidence-informed policy formulation, and monitoring of cancer control interventions. In low- and middle-income countries, the performance and sustainability of cancer registries depend not only on technical capacity but also on enabling legal and institutional frameworks. In Kenya, the establishment of the National Cancer Registry (NaCaRe-KE) under the leadership of the National Cancer Institute of Kenya (NCI-K) represents a major milestone in strengthening national cancer surveillance. However, the extent to which existing legal and institutional arrangements effectively support cancer registration within a devolved health system remains insufficiently documented.
 
Objectives
This study aimed to assess the adequacy of Kenya’s legal and policy framework for cancer registration, examine institutional roles and coordination mechanisms supporting cancer surveillance, and analyze the translation of legal mandates into operational practice at national and county levels, in alignment with global cancer registry standards.
 
Methods
A qualitative policy and implementation analysis was conducted through a structured review of national laws, policies, and regulatory instruments relevant to cancer registration, surveillance, data protection, and data sharing. Key documents reviewed included the Cancer Prevention and Control Act, national health information system policies, national cancer control strategies, and data protection legislation. This was complemented by key informant interviews with national and county-level stakeholders involved in cancer control, health information systems, and cancer registration. Data were analyzed thematically using a policy implementation framework to assess coherence between legal mandates, institutional arrangements, and operational practice, and to examine alignment with international guidance from the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC).
 
Results
Kenya demonstrates a strong and coherent legal and policy foundation for cancer registration and surveillance. The Cancer Prevention and Control Act establishes cancer surveillance as a national mandate and designates NCI-K as the lead coordinating institution for cancer control and cancer registration. National health information system policies recognize cancer as a reportable condition within routine health reporting structures, facilitating integration of cancer registration into the national digital health architecture. The Data Protection Act provides a clear framework for lawful processing, confidentiality, and regulated data sharing for public health purposes. These instruments are broadly aligned with WHO and IARC-GICR standards on legal authority, institutional accountability, and protection of individual privacy. Nevertheless, important implementation gaps persist. Enforcement of compulsory cancer reporting remains inconsistent, particularly across private and faith-based health facilities. Operationalization of roles between national and county governments is uneven, resulting in variable county-level engagement, resourcing, and ownership. In addition, limited operational guidance on data sharing has contributed to cautious or fragmented data exchange, affecting data completeness and timeliness.
 
Conclusions
Kenya has established a solid legal and institutional foundation for cancer registration that aligns well with global cancer surveillance standards. Strengthening regulatory guidance, sensitizing implementors and policy formulators, intergovernmental coordination, and accountability mechanisms is essential to translate legal mandates into effective and sustainable cancer registration practice.