After the Parliament amended the health legislation on 12 December 2023, to restructure the central health administration, the resulting organizational changes came into force on 1 January 2024 (see Figure 2.1).
Figure 2.1. Overview of the health system following the 2023 amendments
Source: Authors
As the reform aimed at clarifying the roles and responsibilities of the state agencies subordinate to the Ministry of Health and Care Services, it also intended to make the threefold division of roles (that is, governmental tasks, supervisory activities, and knowledge production) clearer and more consistent.
Hence, the role of the Directorate of Health as an authority agency is reinforced, while the role of the Institute of Public Health (NIPH) as a knowledge agency is enhanced. Furthermore, the Directorate of eHealth (NDE) was partially merged with both the Directorate of Health and the NIPH. Finally, the Medical Agency has been transformed into a directorate, now known as the Norwegian Medical Products Agency (NOMA).
The new Directorate of Health was remodelled with a reinforced governmental authority, including an expanded role in analyzing and advising on public health within care services. Its activities encompass interpreting regulations, formal authority tasks within infection control and environmental medicine, government and implementation functions, and responsibility over registers’ analysis and statistics within both the field of health and care services and broader field of public health. As it merged with some functions of the NDE, the Directorate of Health gained responsibility for the digitalization of the health and care services sector.
NIPH’s role as a knowledge centre was strengthened in several areas, including the transfer of the Health Data Department and Health Data Service from the former NDE; and the transfer of the management of the Norwegian Patient Registry (NPR), the Municipal Patient and User Registry (KPR), and the Egg and Sperm Donor Registry (including the Mother and Donor Code Registry) from the Directorate of Health and of the Cancer Registry from the Oslo University Hospital (OUS).
NOMA, the new directorate for Medical Products, was assigned additional responsibilities, notably in the areas of supply chain security, emergency preparedness, procurement, and public financing of medical products. The new agency will now play a more active role in managing emergency stockpiles. These changes will require closer dialogue with stakeholders and strengthened international cooperation, particularly with the European Medicines Agency (EMA) and the European Commission’s Health Emergency Preparedness and Response Authority Directorate-General (DG HERA). Additionally, NOMA became responsible for cost-benefit assessments of all medical products, including vaccines and medical devices, a function transferred from NIPH. Furthermore, the medical products agency gained expanded responsibility on market insight and vaccine procurement, which involves establishing a specialist group within procurement processes for medicines and vaccines that are financed by the Norwegian National Insurance Scheme (Folketrygden), vaccines for vaccination programs, and medicines for the emergency stockpile in Norway.