Proposal for changes to the process of including new diseases in newborn screening in Norway

On June 26, 2024, the Norwegian Directorate of Health published its proposal to change the process of including new diseases (or removing existing ones) in newborn screening. The key objective is making the process more dynamic, which requires regulatory and administrative amendments.

The key proposed changes are the following:

• The reference group for the newborn screening will receive a more explicit mandate to assess the knowledge base and provide professional support and recommendations on whether the disease should be included in the screening program;
• Applications for the inclusion (or removal) of diseases to the screening program must be submitted through regional health authorities (RHA); 
• The newborn screening will continue to be a national service according to specialist health services regulations;
• Changes are proposed in the regulations for genetic testing;
• The timelines for various stages of the process are to be set.

No changes are planned for the criteria that the Directorate of Health uses to assess applications for introducing new diseases in the screening or removing existing diseases, as well as for evidence requirements.

See the full details in Norwegian here.

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