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IS-2446 E

Summary of The Norwegian Strategy for Personalised Medicine in Healthcare 2017-2021

Publication title:

Summary of The Norwegian Strategy for Personalised Medicine in Healthcare

Published:

9/2016

Publication number:

IS-2146 E

Published by: Contact us: Post adress: Visiting adress:

Helsedirektoratet [email protected] Pb. 7000 St Olavs plass, 0130 Oslo Universitetsgata 2, Oslo Phone from abroad: +47 24 16 30 00 www.helsedirektoratet.no https://helsedirektoratet.no/legemidler/persontilpassetmedisin

PREFACE

In the field of personalised medicine, prevention, diagnostics, treatment, and follow-up are adapted to the biological characteristics of the individual. The use of personalised medicine is set to transform the health service. The aim is to offer patients more precise and targeted diagnostics and treatment, while treatment without effect is avoided. There are already examples where this approach is used, e.g. within rare diagnoses and cancer. Technological advances present new opportunities in diagnostics and treatment, and personalised medicine is thus a field where clinical practice and research are closely linked. Personalised medicine is an important area for innovation and commercial development. Personalised medicine requires advanced equipment, a multidisciplinary approach and a high level of expertise. Through the strategy, we aim to build firm foundations for the future of the public health service. The primary healthcare service should be involved in this development. The strategy will contribute to consistent, high-quality services. The key recommendations include: development of expertise, a coordinated national development of the field, development of ICT systems and registries. Health care providers, patient organisations, industry and commerce will play important roles in the follow-up of the strategy. Large-scale genetic analyses, which has recently been introduced in clinical practice, is one of the main issues of the strategy. Such analyses generate large quantities of sensitive medical information and data. Genome analyses may provide major opportunities for patients, but will also raise a number of challenges that are particularly linked to the fact that genetic data is extremely sensitive. Therefore, developments must take place within a robust and ethically sound framework that ensures data security and protection of privacy. The strategy must be viewed as an initial step, which will be followed up with concrete action plans. There is no specific funding for this strategy. Thus, funding for the initiatives must be proposed through ordinary budget processes. The established principles for priority setting in healthcare will apply to personalised medicine. The strategy was developed in close collaboration with patient organisations and the healthcare sector. The Directorate of Health would like to thank all contributors, including participants of the various working groups as well as those responding during the public consultation process. We are looking forward to working with the different stakeholders to implement this strategy in the healthcare services.

Director General of Health 2

TABLE OF CONTENTS TABLE OF CONTENTS

PREFACE

2

TABLE OF CONTENTS

3

1. BACKGROUND

4

1.1 About the strategy

4

1.2 Scope

4

2. VISION, AIMS AND PRINCIPLES

5

2.1 Strategic aims

5

2.2 Guiding principles

6

3. STRATEGIC AREAS AND SUMMARY OF RECOMMENDATIONS

7

A.

Expertise and information

7

B.

Quality and academic and clinical development

8

C.

Health registries

8

D.

Information and