Executive summary

All patient care is, to some degree, personalised. The more specific discipline of personalised medicine is typically characterised by the use of large-scale analytical tools to identify biological characteristics in an individual as a basis for prevention or treatment.

The vision of the Norwegian Government is that personalised medicine should be an integral part of prevention, diagnostics, treatment and follow-up in the health care services, with the objective of improving health and coping skills throughout life. The strategy for personalised medicine from the Norwegian Government for the period of 2023–2030 is based on the Norwegian Strategy for Personalised Medicine in Healthcare (2017–2021) from the Norwegian Directorate of Health and its follow-up through associated activities.

Three strategic goals are established to facilitate the achievement of the vision:

• 1. Equality in access to personalised medicine, with close integration of patient care, research and other types of systematic generation of knowledge.

This strategic goal responds to inequalities in access to personalised medicine, and the fact that personalised medicine challenges the legal and organisational distinction between research and routine clinical practice. There is a need to enhance knowledge on personalised medicine throughout the patient journey, including preventive measures, diagnostics, treatment and follow-up. The primary health care services must be equipped to benefit from the opportunities presented by personalised medicine.

• 2. Health care services that possess the relevant competence to meet individual needs related to personalised prevention, diagnostics, treatment and follow-up.

This strategic goal shall ensure sufficient knowledge and skills related to personalised medicine for citizens and health care providers. Areas of emphasis include health literacy, lifelong learning, multidisciplinarity and teamwork, integration of research and capacity building.

• 3. Safe and efficient use, analysis, sharing and storage of large-scale health data needed for personalised medicine applications in healthcare, service development and research within a framework that secures the integrity of the individual and data privacy.

This strategic goal shall meet the challenges associated with the information systems and data management in the field of personalised medicine, particularly with regard to physical infrastructure and organisation of services related to storage, sharing and high-performance computing of large-scale health data. In addition it adresses the practical and regulatory challenges related to the primary and secondary use of health data in the interface between research and clinical procedures with relevant and rapidly developing software.

The Strategy sets the overall direction and expectations going forward. In addition, it identifies specific actions to facilitate the ongoing work and achieve the Governments’ vision. Dependencies to other ongoing processes are indicated where relevant.

The Strategy takes the perspective of clinical pathways as its point of departure, and describes opportunities for personalised prevention, diagnostics, treatment and follow-up, including in primary care. Personalised medicine may enhance the specificity of possible treatments, with an associated reduction of side effects. However, the field still exhibits uncertainties with regard to cost-effectiveness and overall benefits. Personalised medicine is relevant for diverse medical specialties and a broad spectrum of technologies. Therefore, the current strategy includes all relevant medical specialties and technological modalities. The first strategy had an emphasis on three focus areas, i.e. cancer, infectious diseases, and rare genetic disorders. Experiences from these areas will provide ongoing guidance for other fields. Established networks and collaborative initiatives, such as the National genome centre, will be continued and further developed. The implementation of personalised medicine in the health care services must be done in accordance with current principles for priority-setting in health care, and in a manner that maintains sustainability of services, as well as personal integrity and privacy.

Research is a key activity in personalised medicine, and in certain areas, the bulk of applied services occurs in a research setting. There is a need for more knowledge on the outcomes of personalised medicine applications with regards to efficacy, safety and health economics. Personalised medicine is also valuable for innovation and development of the health industry.

There is great potential and a strong basis for development and implementation of personalised medicine in Norway. We have a robust public health care service with a uniform organisation, a national system for the assessment and introduction of health techonologies and established fora for collaboration. Norway has distinguished research and innovation environments, and models have been developed for public-private cooperation related to personalised medicine, health data management and clinical trials. Norway has excellent health registries, biobanks and population surveys that may serve as a basis for research, innovation and knowledge development, as well as well-established screening programmes that may allow for preventive initiatives.