Abstract
Objectives
The introduction of Personalised Medicine (PM) into healthcare systems could benefit from a clearer understanding of the distinct national and regional frameworks around the world. Recent engagement by international regulators on maximising the use of real-world evidence (RWE) has highlighted the scope for improving the exploitation of the treasure-trove of health data that is currently largely neglected in many countries. The European Alliance for Personalised Medicine (EAPM) led an international study aimed at identifying the current status of conditions.
Methods
A literature review examined how far such frameworks exist, with a view to identifying conducive factors – and crucial gaps. This extensive review of key factors across 22 countries and 5 regions revealed a wide variety of attitudes, approaches, provisions and conditions, and permitted the construction of a comprehensive overview of the current status of PM. Based on seven key pillars identified from the literature review and expert panels, the data was quantified, and on the basis of further analysis, an index was developed to allow comparison country by country and region by region.
Results
The results show that United States of America is leading according to overall outcome whereas Kenya scored the least in the overall outcome.
Conclusions
Still, common approaches exist that could help accelerate take-up of opportunities even in the less prosperous parts of the world.
Funding source: PROMISE-Personalized Medicine Inquiry-Based Education Co-funded by the Erasmus+ Programme of the European Union, Grant Agreement No. 2019-1-HR01-KA203-061010.
Award Identifier / Grant number: 2019-1-HR01-KA203-061010.
Acknowledgments
Denis Horgan developed the concept, orientation, and overall narrative for this manuscript. A special thanks goes to Jaya Singh, Sanya Sethi, Anupriya Paul and Jonathan A. Lal for their contribution in data analysis and presenting the results. We would like to thank the members of the European Alliance for Personalised Medicine (EAPM), and the representatives of the European Commission and Member States for their kind input. All co-authors of this manuscript participated on roundtables organized by EAPM. We thank them all for their valuable and kind inputs. The organized panel was facilitated by sponsorship from Novartis, Astra Zeneca, MSD, Merck.
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Research funding: This research received a grant from PROMISE-Personalized Medicine Inquiry-Based Education Co-funded by the Erasmus+ Programme of the European Union, Grant Agreement No. 2019-1-HR01-KA203-061010.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: D.H. and M.K. are employees of the European Alliance for Personalised Medicine, which receives funding from both the public and private sectors. France Dube is an employee of Astra Zeneca. Amber Johns is a consultant to the ICGC ARGO project.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
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