TY - JOUR
T1 - Implementation of precision medicine in healthcare—A European perspective
AU - Stenzinger, Albrecht
AU - Moltzen, Ejner K.
AU - Winkler, Eva
AU - Molnar-Gabor, Fruzsina
AU - Malek, Nisar
AU - Costescu, Alexandru
AU - Jensen, Brigitte Nybo
AU - Nowak, Frédérique
AU - Pinto, Carmine
AU - Ottersen, Ole Petter
AU - Schirmacher, Peter
AU - Nordborg, Jenni
AU - Seufferlein, Thomas
AU - Fröhling, Stefan
AU - Edsjö, Anders
AU - Garcia-Foncillas, Jesus
AU - Normanno, Nicola
AU - Lundgren, Bettina
AU - Friedman, Mikaela
AU - Bolanos, Natacha
AU - Tatton-Brown, Katrina
AU - Hill, Sue
AU - Rosenquist, Richard
PY - 2023
Y1 - 2023
N2 - The 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.
AB - The 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.
KW - clinical trials
KW - education and training
KW - ethicolegal aspects
KW - governance
KW - patient advocacy
KW - personalized medicine
KW - precision medicine
KW - real-world evidence
U2 - 10.1111/joim.13698
DO - 10.1111/joim.13698
M3 - Review article
C2 - 37455247
AN - SCOPUS:85165699544
SN - 0954-6820
VL - 294
SP - 437
EP - 454
JO - Journal of Internal Medicine
JF - Journal of Internal Medicine
IS - 4
ER -