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Precision Medicine Editorial Precision Medicine in Europe – Forging a Common Vision Jose M Martin-Moreno 1,2 1. Professor, Department of Preventive Medicine and Public Health of the Medical School and INCLIVA Clinical Hospital Biomedical Research Institute, University of Valencia, Spain; 2. Senior Associate, Johns Hopkins Bloomberg School of Public Health, Baltimore, US Abstract The prospect of achieving truly personalised medicine (or precision medicine) has raised patients’ hopes and piqued researchers’ curiosity, prompting the development of new -omics fields and attracting interest from the health technology industry. However, to ensure that new advances are incorporated equitably without diverting scarce resources from essential services and underserved populations, European institutions must forge a common policy that balances investments with returns and competition with coordination. Keywords Precision medicine, genomic sequencing, health technology assessments Disclosure: Jose M Martin-Moreno has no conflicts of interest to declare. No funding was received in the publication of this article. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 13 March 2015 Accepted: 19 March 2015 Citation: European Oncology & Haematology, 2015;11(1):32–3 Correspondence: Jose M Martin-Moreno, Department of Preventive Medicine and Public Health of the Medical School and INCLIVA Clinical Hospital Biomedical Research Institute, University of Valencia, Valencia 46010, Spain. E: jose.martin-moreno@uv.es Genomic sequencing has been compared to piecing together a giant biological jigsaw puzzle. It is an arduous, slow process, somewhat prone to error and fraught with technical, practical and ethical complications that make its widespread implementation very challenging for the time being, even in the most advanced healthcare systems. Yet genomic sequencing is simple compared with the broader healthcare aim to which it contributes: personalised medicine, the ability to precisely tailor therapies to the genetic profile of patients and their diseases, thereby increasing efficacy, improving patient outcomes and quality of life and ultimately reducing treatment costs. This distant endpoint holds so much promise that it is tempting to call for large public and public–private investments, akin to the $215  million that President Obama requested of the US Congress in his 2016 budget. 1 The unwritten rules of globalised one-upmanship would also have Europe match or even surpass the investments of its competitors in scientific innovation to consecrate its place in the vanguard of biomedical and -omics research. However, before the vision of personalised medicine can be fully realised, a host of complex obstacles must be overcome – painstakingly, deliberately and incrementally. European health systems would perhaps be best served by an in-depth situation analysis and a long-term strategy that sets out system goals rooted in equity, patience and proportionality. Many health system stakeholders, including the European Society of Medical Oncology (ESMO), have speculated on the future of personalised cancer care. 2–4 The particular relevance of these therapies to oncology is undeniable (as we have seen with new targeted therapies for metastatic breast cancer, 5 myeloid leukaemia, 6 melanoma 7 ) and others, but the oncology community should not underestimate the challenges facing the field, least of all the immense costs and technical demands 32 in collecting, storing and processing the amount of data needed for functional biobanks. The need for researchers to access these data on a large scale raises problems related to equity and distribution of cost burden, as well as privacy and intellectual property. To overcome the technological hurdles, we may need to wait for the development of a whole new field of study – healthcare knowledge engineering – that today is in its infancy. 8 The regulatory landscape must also be transformed: although market approval for pharmaceuticals is centralised through the European Medicines Agency (EMA), the companion diagnostics are only partially and heterogeneously regulated at a national level, undermining the consistency, comparability and quality of precision diagnostics. Health technology assessments will also undergo a shift in paradigm, for large up-front investments must be weighed against benefits that will be seen only in the long term. In professional training, the sheer speed of progress in the -omics field makes medical curricula obsolete almost as quickly as they are developed; specific to oncology, we know that the genetic profiles of tumours vary widely and evolve over time, creating a possible need for multiple, invasive biopsies among cancer patients, with no assurance or even hope of immediate clinical benefits. These considerable challenges will be overcome only with time, and progress will be largely incremental, dependent on the gradual maturation of the discipline, emerging technological and computational advances and a sustainable stream of wisely directed research investments. In consideration of the potential epidemiological value of consolidated international biobanks, European countries would be wise to work together. But in light of the high initial costs, it is unrealistic – even perverse – to expect the low- and middle-income countries in the east and the south to use scarce resources for this purpose. One widely held conviction, which crystallised in the ESMO Emerging Countries Committee during the 2014 ESMO Conference in Madrid, was that Tou c h ME d ica l ME d ia