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Implementation of precision medicine in healthcare—A European perspective

Stenzinger, Albrecht ; Moltzen, Ejner K. ; Winkler, Eva ; Molnar-Gabor, Fruzsina ; Malek, Nisar ; Costescu, Alexandru ; Jensen, Brigitte Nybo ; Nowak, Frédérique ; Pinto, Carmine and Ottersen, Ole Petter , et al. (2023) In Journal of Internal Medicine 294(4). p.437-454
Abstract

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... (More)

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.

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@article{6c916092-0a8d-4d41-9a12-13efe01ec319,
  abstract     = {{<p>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.</p>}},
  author       = {{Stenzinger, Albrecht and Moltzen, Ejner K. and Winkler, Eva and Molnar-Gabor, Fruzsina and Malek, Nisar and Costescu, Alexandru and Jensen, Brigitte Nybo and Nowak, Frédérique and Pinto, Carmine and Ottersen, Ole Petter and Schirmacher, Peter and Nordborg, Jenni and Seufferlein, Thomas and Fröhling, Stefan and Edsjö, Anders and Garcia-Foncillas, Jesus and Normanno, Nicola and Lundgren, Bettina and Friedman, Mikaela and Bolanos, Natacha and Tatton-Brown, Katrina and Hill, Sue and Rosenquist, Richard}},
  issn         = {{0954-6820}},
  keywords     = {{clinical trials; education and training; ethicolegal aspects; governance; patient advocacy; personalized medicine; precision medicine; real-world evidence}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{437--454}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Journal of Internal Medicine}},
  title        = {{Implementation of precision medicine in healthcare—A European perspective}},
  url          = {{http://dx.doi.org/10.1111/joim.13698}},
  doi          = {{10.1111/joim.13698}},
  volume       = {{294}},
  year         = {{2023}},
}