Europeanization and Globalization 2 Nada Bodiroga-Vukobrat Daniel Rukavina Krešimir Pavelić Gerald G. Sander Editors Personalized Medicine A New Medical and Social Challenge Europeanization and Globalization Volume 2 Series editors Nada Bodiroga-Vukobrat Rijeka, Croatia Sinisˇa Rodin Luxembourg, Luxembourg Gerald G. Sander Ludwigsburg, Germany More information about this series at http://www.springer.com/series/13467 Nada Bodiroga-Vukobrat • Daniel Rukavina • Kresˇimir Pavelic´ • Gerald G. Sander Editors Personalized Medicine A New Medical and Social Challenge Editors Nada Bodiroga-Vukobrat Daniel Rukavina Jean Monnet Department of Croatian Academy of Sciences and Arts European Public Law Rijeka University of Rijeka Croatia Rijeka Croatia Kresˇimir Pavelic´ Gerald G. Sander Department of Biotechnology University of Applied Sciences ¨ University of Rijeka Hochschule fu€r Offentliche Verwaltung Rijeka und Finanzen Ludwigsburg Croatia Ludwigsburg Germany ISSN 2366-0953 ISSN 2366-0961 (electronic) Europeanization and Globalization ISBN 978-3-319-39347-6 ISBN 978-3-319-39349-0 (eBook) DOI 10.1007/978-3-319-39349-0 Library of Congress Control Number: 2016956105 © Springer International Publishing Switzerland 2016 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG Switzerland Preface When we use the term personalized medicine, it implies the systematic use of information about the individual patient with the goal of choosing optimal preven- tion and/or welfare therapy. The main focus of personalized medicine in current medical treatment is to generate innovative treatments and drugs while reducing negative side effects. Recent achievements in life science have created novel opportunities to monitor and assess the progression of each individual patient’s condition. The merit of these new capabilities lies mainly in the development and application of high-throughput technologies that provide global insights into the genomic-proteomic profile of diseases. New accomplishments in high-throughput technologies such as transcriptomics that provides an entire insight into gene activity in an organism, proteomics that gathers knowledge on global protein pro- files, or metabolomics that provides information on metabolite status, will dramat- ically change molecular medicine and life science. At the same time, it should be noted that genes and proteins cannot explain everything. One needs to consider other complex elements, including molecular pathways, protein structure, second- ary protein modifications, epigenetics, and many others. New methods to provide some novel insights into biological mechanisms could include lipidomics, glycomics, metabolomics, nutrinomics, and even complex structural genomics methodologies and approaches. The use of these methods in medicine may allow an individualized service for each patient and boost the progression in medicine from the traditional focus on discovering new drugs to a new and more preemptive approach. This change will bring about substantial social shifts that will change socio-humanistic relationships and raise a whole series of important questions: moral-ethical, legal, and socio-economic. These issues will result from current challenges in medicine and humanity that are both faced with multiple processes of globalization and fast changes in society. Some of the current issues relate to new severe and fast-spreading infectious diseases, changes in the “behavior pattern” of certain diseases, demographic change resulting from an aging population, and fast and dramatic climate changes. v vi Preface This book offers comprehensive coverage of the various aspects of personalized medicine as an original approach to classifying, understanding, treating, and preventing disease based on individual biological differences. In the introductory section, it defines personalized medicine as a way toward new medical practices and addresses the question: what can personalized medicine offer citizens, medical professionals and reimbursement bodies, and stakeholders? Subsequent chapters discuss the technological aspects of personalized medicine: data collection, com- prehensive integration and handling of data, together with key enabling factors in developing the requisite technological support for personalized medicine. Lastly, the book explores the main issues shaping the implementation and development of personalized medicine—education, stakeholder participation, infrastructure, a revised approach to the classification of disease and medical tests, regulatory frameworks, and new reimbursement models—together with ethical, legal, and social issues. Ultimately, the book calls for interdisciplinarity and a radical change in the way we approach the health and well-being of individuals. Target groups are medical doctors and researchers in the field of biomedicine, as well as experts from social sciences dealing with legal, economic, and social aspects of health system issues in general. The primary beneficiaries are therefore from these groups of professional experts, but the presented content may attract the widest possible readership as it deals with the issue of paradigm change in one of the major society pillars—the health system. We express our thanks to the University of Rijeka for their helpful support that was essential for this enterprise. This publication is supported by the Croatian Science Foundation project No. 5709 “Perspectives of maintaining the social state: towards the transformation of social security systems for individuals in personalized medicine” and the University of Rijeka project No. 13.08.1.2.03 “Social security and market competition.” Finally, we owe our sincere gratitude to the Springer Verlag for recognizing the value of our efforts and for its continuous support to our scientific endeavors. Rijeka, Croatia Nada Bodiroga-Vukobrat Rijeka, Croatia Daniel Rukavina Rijeka, Croatia Kresˇimir Pavelic´ Ludwigsburg, Germany Gerald G. Sander 10 March 2016 Contents Personalized Medicine: The Path to New Medicine . . . . . . . . . . . . . . . . 1 Kresˇimir Pavelic´, Sandra Kraljevic´ Pavelic´, and Mirela Sedic´ Legal Aspects of Personalized Medicine . . . . . . . . . . . . . . . . . . . . . . . . . 21 Ulrich Becker Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Nada Bodiroga-Vukobrat and Hana Horak Embryonic Stem Cell Patents and Personalized Medicine in the European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Jasmina Mutabžija Personalised Medicine and Public Health . . . . . . . . . . . . . . . . . . . . . . . 81 Vladimir Mic´ovic´, Iva Sorta-Bilajac Turina, and Ðulija Malatestinic´ Personalized Medicine and Technology Transfer . . . . . . . . . . . . . . . . . . 95 Petra Karanikic Economic Evaluations of Personalized Health Technologies: An Overview of Emerging Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Ana Bobinac and Maja Vehovec Computational Methods for Integration of Biological Data . . . . . . . . . . 137 Vladimir Gligorijevic´ and Natasˇa Pržulj The Role of Proteomics in Personalized Medicine . . . . . . . . . . . . . . . . . 179 Djuro Josic´ and Urosˇ Andjelkovic´ The Role of Radiology in Personalized Medicine . . . . . . . . . . . . . . . . . . 219 D. Miletic´, P. Valkovic´-Zujic´, and R. Antulov vii viii Contents Implantation of Toric Intraocular Lenses: Personalized Surgery on the Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231 Iva Dekaris, Nikica Gabric´, Ante Barisˇic´, and Alma Bisˇcˇevic´ Personalized Medicine of Central Nervous System Diseases and Disorders: Looking Toward the Future . . . . . . . . . . . . . . . . . . . . . . 241 Miranda Mladinic´ Pejatovic´ and Srđan Anzic´ Personalized Medicine in Gastroenterology . . . . . . . . . . . . . . . . . . . . . . 257 ˇ Davor Stimac and Neven Franjic´ Personalized Medicine in Clinical Pharmacology . . . . . . . . . . . . . . . . . . 265 Dinko Vitezic´, Nada Božina, Jasenka Mrsˇic´-Pelcˇic´, Viktorija Erdeljic´ Turk, and Igor Francetic´ Personalized Medicine: The Path to New Medicine Kresˇimir Pavelic´, Sandra Kraljevic´ Pavelic´, and Mirela Sedic´ Abstract Personalised medicine is a new paradigm that represents a shift from current simplified consideration of the patient as a member of the population sharing common fate of disease towards the view that each patient is a unique individual. Every person has specific genomic/proteomic and metabolic signature that could account for specific clinical features of disease, response to treatment and disease severity. Therefore, disease and the treatment itself should be considered individually. Due to a number of reasons for introduction of new paradigm in medicine, implementation of personalised medicine is envisaged in several con- secutive steps where projections of the levels of technology, medicine and integra- tion need to be coordinated. 1 Introduction Modern medicine faces great challenges, including rapid social changes resulting from globalization, emerging new infectious diseases that spread quickly, alter- ations in clinical patterns of some diseases (e.g., drug-resistant tuberculosis), and abrupt climate and demographic changes (i.e., aging). These are only some of the issues that traditional medicine is likely to cope with great difficulties. Professor Kresˇimir Pavelic´, M.D. Ph.D., Head of Laboratory for High-Throughput Analytics, University Centre for High-Throughput Technologies, Department of Biotechnology, University of Rijeka, Rijeka, Croatia. Professor Sandra Kraljevic´ Pavelic´, Ph.D., University Centre for High-Throughput Technologies, Department of Biotechnology, University of Rijeka, Rijeka, Croatia. Assistant Professor Mirela Sedic´, Ph.D., University Centre for High-Throughput Technologies, Department of Biotechnology, University of Rijeka, Rijeka, Croatia. K. Pavelic´, M.D., Ph.D. (*) Laboratory for High-Throughput Analytics, Department of Biotechnology, University Centre for High-Throughput Technologies, University of Rijeka, Rijeka, Croatia e-mail: