Implementation of precision medicine in healthcare—A European perspective

Author:

Stenzinger Albrecht12ORCID,Moltzen Ejner K.3,Winkler Eva4,Molnar‐Gabor Fruzsina5,Malek Nisar26,Costescu Alexandru7,Jensen Brigitte Nybo8,Nowak Frédérique9,Pinto Carmine10,Ottersen Ole Petter11,Schirmacher Peter12,Nordborg Jenni12,Seufferlein Thomas13,Fröhling Stefan1415,Edsjö Anders161718,Garcia‐Foncillas Jesus19,Normanno Nicola20,Lundgren Bettina8,Friedman Mikaela1821,Bolanos Natacha22,Tatton‐Brown Katrina232425,Hill Sue26,Rosenquist Richard182127ORCID

Affiliation:

1. Institute of Pathology Heidelberg University Hospital Heidelberg Germany

2. Centers for Personalized Medicine (ZPM) Germany

3. Innovation Fund Denmark International Consortium for Personalised Medicine (IC PerMed) Aarhus Denmark

4. Section of Translational Medical Ethics National Center for Tumour Diseases University Hospital Heidelberg Heidelberg Germany

5. Faculty of Law Heidelberg University Heidelberg Germany

6. Department for Internal Medicine University Hospital Tübingen Tübingen Germany

7. European Commission DG Research and Innovation Brussels Belgium

8. Danish National Genome Center Copenhagen Denmark

9. Health Technologies Institute Inserm Paris France

10. Medical Oncology Comprehensive Cancer Centre, AUSL‐IRCCS di Reggio Emilia Reggio Emilia Italy

11. Karolinska Institutet Stockholm Sweden

12. Lif – The Research‐Based Pharmaceutical Industry Stockholm Sweden

13. Department of Internal Medicine I Ulm University Hospital Ulm Germany

14. Division of Translational Medical Oncology German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT) Heidelberg Germany

15. German Cancer Consortium (DKTK) Heidelberg Germany

16. Department of Clinical Genetics Pathology and Molecular Diagnostics Office for Medical Services, Region Skåne Lund Sweden

17. Division of Pathology Department of Clinical Sciences Lund University Lund Sweden

18. Genomic Medicine Sweden (GMS) Sweden

19. Department of Oncology and Cancer Institute Fundacion Jimenez Diaz University Hospital Autonomous University Madrid Spain

20. Cell Biology and Biotherapy Unit Istituto Nazionale Tumori – IRCCS – Fondazione G. Pascale Napoli Italy

21. Department of Molecular Medicine and Surgery Karolinska Institutet Stockholm Sweden

22. Lymphoma Coalition Madrid Spain

23. National Genomics Education NHS England London UK

24. St George's University Hospitals NHS Foundation Trust London UK

25. St George's University of London London UK

26. Office of Chief Scientific Officer and the Genomics Unit NHS England London UK

27. Clinical Genetics Karolinska University Hospital Stockholm Sweden

Abstract

AbstractThe technical development of high‐throughput sequencing technologies and the parallel development of targeted therapies in the last decade have enabled a transition from traditional medicine to personalized treatment and care. In this way, by using comprehensive genomic testing, more effective treatments with fewer side effects are provided to each patient—that is, precision or personalized medicine (PM). In several European countries—such as in England, France, Denmark, and Spain—the governments have adopted national strategies and taken “top‐down” decisions to invest in national infrastructure for PM. In other countries—such as Sweden, Germany, and Italy with regionally organized healthcare systems—the profession has instead taken “bottom‐up” initiatives to build competence networks and infrastructure to enable equal access to PM. In this review, we summarize key learnings at the European level on the implementation process to establish sustainable governance and organization for PM at the regional, national, and EU/international levels. We also discuss critical ethical and legal aspects of implementing PM, and the importance of access to real‐world data and performing clinical trials for evidence generation, as well as the need for improved reimbursement models, increased cross‐disciplinary education and patient involvement. In summary, PM represents a paradigm shift, and modernization of healthcare and all relevant stakeholders—that is, healthcare, academia, policymakers, industry, and patients—must be involved in this system transformation to create a sustainable, non‐siloed ecosystem for precision healthcare that benefits our patients and society at large.

Funder

Novo Nordisk Fonden

Science for Life Laboratory

Agence Nationale de la Recherche

Publisher

Wiley

Subject

Internal Medicine

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