Additive bio- manufacturing: 3D printing for medical recovery and human enhancement STUDY Science and Technology Options Assessment EPRS | European Parliamentary Research Service Scientific Foresight Unit (STOA) PE 614.571 Additive bio-manufacturing: 3D printing for medical recovery and human enhancement Study IP/G/STOA/FWC/2013-001/LOT5/C2 July 2018 Abstract Additive bio-manufacturing (bio-AM) is defined here as the use of 3D printing for medical purposes or non-therapeutic “human enhancement”, whether they involve the production of biological material or not. It includes any application for rehabilitating, supporting or augmenting biological functionality. The impacts of bio- AM are uncertain, and it is not clear which actions may be required to foster responsible development of the technology. This study responds to these gaps in our knowledge by describing the state of the art and future development prospects, analysing their wide-ranging impacts - including social, ethical and economic aspects - and identifying key policy challenges along with options to respond to them. Key challenges are to avoid an incoherent, piecemeal adaptation of regulatory frameworks, to support responsible development that improves citizens’ lives, and to foster public participation and citizen-driven innovation. The European RRI approach could provide a useful platform for responding to these challenges, emphasising inclusiveness and co-creation by a wide variety of stakeholder groups, including public participation. PE 614.571 3 STOA - Science and Technology Options Assessment The STOA project ‘Additive bio-manufacturing: 3D printing for medical recovery and human enhancement’ was requested by the European Parliament's Science and Technology Options Assessment (STOA) Panel. It was carried out by the European Technology Assessment Group (ETAG), led by the Institute for Technology Assessment and Systems Analysis at Karlsruhe Institute of Technology (KIT/ITAS) and including the Institute of Technology Assessment of the Austrian Academy of Sciences (ITA/OEAW), the Rathenau Institute, the Danish Board of Technology (DBT) Foundation and France-based Responsible Technology (RT). It was managed by the Scientific Foresight Unit (STOA) within the Directorate-General for Parliamentary Research Services (DG EPRS) of the European Parliament. AUTHORS Arianna Ferrari, Martina Baumann, Christopher Coenen, Daniel Frank, Leonhard Hennen, António Moniz (KIT/ITAS); Helge Torgersen, Jan Torgersen (ITA/OEAW); Lisa van Bodegom, Freija van Duijne, Ingrid Geesink, Barend van der Meulen (Rathenau Institute); Emilio Mordini (RT); Karen Riisgaard, Rasmus Øjvind Nielsen (DBT Foundation). Scenario illustrations by LUC - le Laboratoire d'Usages Collaboratifs - luc-lab.com STOA ADMINISTRATOR RESPONSIBLE Phillip Boucher, Scientific Foresight Unit (STOA) Directorate for Impact Assessment and European Added Value Directorate-General for Parliamentary Research Services European Parliament, Rue Wiertz 60, B-1047 Brussels E-mail: [email protected] Acknowledgements We are extremely grateful to the individuals and organisations that made important contributions to the study, including: Dario Tamburrano (MEP), Nuno Araújo, Eduard Arzt, José Barata, Thomas Bayer, Torsten Bell, Wouter Boon, Martin Malthe Borch, Alice Conquand, Carlos Cuevas-Garcia, Mark Cutkowsky, Aránzazu del Campo, Peter Dubruel, Maria Farsari, Peter Gruber, Øyvind Halaas, Michael Hasenpusch, John (J.A.) Jansen, Miet Janssen, Ali Khademhodseini, Polina Kotlarenko, Phoebe Li, Alberto Magarelli, Giorgio Magistrelli, Vladimir Mironov, Lorenzo Moroni, Iris Otto, Enno Park, Wendy Phillips, Radu Racasan, Heinz Redl, Lale Rodgarkia-Dara, Melike Şahinol, Erica Seidita, Angela Simone, Jürgen Stampfl, Coline Thomas, Aneta Tyszkiewicz, Franz Varga, Hildebrando Vasconcelos, Niki Vermeulen, Ellen Willemsen and Yu Shrike Zhang. LINGUISTIC VERSION Original: EN ABOUT THE PUBLISHER To contact STOA or to subscribe to its newsletter please write to: [email protected] This document is available on the Internet at: http://www.europarl.europa.eu/stoa/ Manuscript completed in July 2018 Brussels, © European Union, 2018 DISCLAIMER This document is prepared for, and addressed to, the Members and staff of the European Parliament as background material to assist them in their parliamentary work. The content of the document is the sole responsibility of its author(s) and any opinions expressed herein should not be taken to represent an official position of the Parliament. Reproduction and translation for non-commercial purposes are authorised, provided the source is acknowledged and the European Parliament is given prior notice and sent a copy. PE 614.571 ISBN 978-92-846-3148-3 doi: 10.2861/923327 QA-01-18-636-EN-N 4 Additive bio-manufacturing: 3D printing for medical recovery and human enhancement Table of contents EXECUTIVE SUMMARY .................................................................................................................................. 6 1 INTRODUCTION ...................................................................................................................................... 9 2 ADDITIVE BIO-MANUFACTURING................................................................................................. 10 2.1 TECHNIQUES ................................................................................................................................... 14 2.2 APPLICATION AREAS ................................................................................................................... 19 3 SOCIO-TECHNICAL IMAGINARIES ................................................................................................ 43 3.1 CULTURAL IMAGINARIES OF 3D PRINTING ......................................................................... 44 3.2 DISCUSSION ..................................................................................................................................... 49 4 STEEPED ASPECTS ................................................................................................................................ 52 4.1 ETHICAL ASPECTS ......................................................................................................................... 52 4.2 SOCIAL ASPECTS ............................................................................................................................ 54 4.3 ECONOMIC ASPECTS .................................................................................................................... 56 4.4 DEMOGRAPHIC ASPECTS ............................................................................................................ 58 4.5 ENVIRONMENTAL ASPECTS ...................................................................................................... 58 5 FOCUS ON THREE APPLICATION AREAS ..................................................................................... 60 5.1 ORTHOTICS AND PROSTHETICS ............................................................................................... 60 5.2 DENTISTRY....................................................................................................................................... 61 5.3 TISSUE AND ORGAN PRINTING ................................................................................................ 63 6 360° ENVISIONING WORKSHOP ...................................................................................................... 66 6.1 METHODOLOGY ............................................................................................................................ 66 6.2 FINDINGS ......................................................................................................................................... 66 6.3 TOWARDS SCENARIOS ................................................................................................................. 71 7 SCENARIO WORKSHOP ...................................................................................................................... 73 7.1 METHODOLOGY ............................................................................................................................ 73 7.2 SCENARIOS ...................................................................................................................................... 74 7.3 FINDINGS ......................................................................................................................................... 86 8 ANALYSIS OF POLICY ISSUES ........................................................................................................... 88 8.1 REGULATION .................................................................................................................................. 88 8.2 DISTRIBUTION OF BENEFITS ...................................................................................................... 95 8.3 PUBLIC PARTICIPATION AND CITIZEN-DRIVEN INNOVATION ..................................... 98 9 POLICY OPTIONS................................................................................................................................. 100 9.1 CHALLENGES ................................................................................................................................ 100 9.2 OPTIONS ......................................................................................................................................... 102 10 REFERENCES ........................................................................................................................................