Pharmaceutical regulation in 15 European …

1 Pharmaceutical regulation in 15 European countriesReviewVol. 18 No. 5 2016 Health Systems in TransitionDimitra Panteli Francis Arickx Irina Cleemput Guillaume Dedet Helene Eckhardt Emer Fogarty Sophie Gerkens Cornelia Henschke Jennifer Hislop Claudio Jommi Daphne Kaitelidou Pawel Kawalec Ilmo Keskim ki Madelon Kroneman Julio Lopez Bastida Pedro Pita Barros Joakim Ramsberg Peter Schneider Susan Spillane Sabine Vogler Lauri Vuorenkoski Helle Wallach Kildemoes Olivier Wouters Reinhard BusseDimitra Panteli (editor) and Reinhard Busse (Series editor)

2 Were responsible for this HiTEditorial BoardSeries editorsReinhard Busse, Berlin University of Technology, GermanyJosep Figueras, European Observatory on Health Systems and PoliciesMartin McKee, London School of Hygiene & Tropical Medicine, United KingdomElias Mossialos, London School of Economics and Political Science, United KingdomEllen Nolte, European Observatory on Health Systems and PoliciesEwout van Ginneken, Berlin University of Technology, GermanySeries coordinatorGabriele Pastorino, European Observatory on Health Systems and PoliciesEditorial teamJonathan Cylus, European Observatory on Health Systems and PoliciesCristina Hern ndez-Quevedo, European Observatory on Health Systems and PoliciesMarina Karanikolos, European Observatory on Health Systems and PoliciesAnna Maresso, European Observatory on Health Systems and PoliciesDavid McDaid, European Observatory on Health Systems and PoliciesSherry Merkur, European Observatory on Health Systems and PoliciesDimitra Panteli, Berlin University of Technology.

3 GermanyWilm Quentin, Berlin University of Technology, GermanyBernd Rechel, European Observatory on Health Systems and PoliciesErica Richardson, European Observatory on Health Systems and PoliciesAnna Sagan, European Observatory on Health Systems and PoliciesAnne Spranger, Berlin University of Technology, GermanyInternational advisory boardTit Albreht, Institute of Public Health, SloveniaCarlos Alvarez-Dardet D az, University of Alicante, SpainRifat Atun, Harvard University, United StatesArmin Fidler, Management Center InnsbruckColleen Flood, University of Toronto, CanadaP ter Ga l, Semmelweis University, HungaryUnto H kkinen, National Institute for Health and Welfare, FinlandWilliam Hsiao, Harvard University, United StatesAllan Krasnik, University of Copenhagen, DenmarkJoseph Kutzin, World Health OrganizationSoonman Kwon, Seoul National University, Republic of KoreaJohn Lavis, McMaster University, CanadaVivien Lin, La Trobe University, AustraliaGreg Marchildon, University of Regina, CanadaAlan Maynard, University of York.

4 United KingdomNata Menabde, World Health OrganizationCharles Normand, University of Dublin, IrelandRobin Osborn, The Commonwealth Fund, United StatesDominique Polton, National Health Insurance Fund for Salaried Staff (CNAMTS), FranceSophia Schlette, Federal Statutory Health Insurance Physicians Association, GermanyIgor Sheiman, Higher School of Economics, Russian FederationPeter C. Smith, Imperial College, United KingdomWynand van de Ven, Erasmus University, The NetherlandsWitold Zatonski, Marie Sklodowska-Curie Memorial Cancer Centre, PolandHealth Systems in TransitionDimitra Panteli, Francis Arickx, Irina Cleemput, Guillaume Dedet, Helene Eckhardt, Emer Fogarty, Sophie Gerkens, Cornelia Henschke, Jennifer Hislop, Claudio Jommi, Daphne Kaitelidou, Pawel Kawalec, Ilmo Keskim ki, Madelon Kroneman, Julio Lopez Bastida, Pedro Pita Barros, Joakim Ramsberg, Peter Schneider, Susan Spillane, Sabine Vogler.

5 Lauri Vuorenkoski, Helle Wallach Kildemoes, Olivier Wouters, Reinhard BusseReview2016 Pharmaceutical regulation in 15 European countriesThe European Observatory on Health Systems and Policies is a partnership, hosted by the WHO Regional Office for Europe, which includes the Governments of Austria, Belgium, Finland, Ireland, Norway, Slovenia, Sweden, Switzerland, the United Kingdom and the Veneto Region of Italy; the European Commission; the World Bank; UNCAM (French National Union of Health Insurance Funds); the London School of Economics and Political Science; and the London School of Hygiene & Tropical Medicine.

6 The European Observatory has a secretariat in Brussels and it has hubs in London (at LSE and LSHTM) and at the Technical University of :DELIVERY OF HEALTH CAREEVALUATION STUDIESFINANCING, HEALTHHEALTH CARE REFORMHEALTH SYSTEM PLANS organization and administrationPHARMACEUTICALS World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).All rights reserved. The European Observatory on Health Systems and Policies welcomes requests for permission to reproduce or translate its publications, in part or in address requests about the publication to.

7 Publications, WHO Regional Office for Europe, UN City, Marmorvej 51, DK-2100 Copenhagen , DenmarkAlternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office web site ( )The views expressed by authors or editors do not necessarily represent the decisions or the stated policies of the European Observatory on Health Systems and Policies or any of its designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the European Observatory on Health Systems and Policies or any of its partners concerning the legal status of any country, territory, city or area or of its authorities.

8 Or concerning the delimitation of its frontiers or boundaries. Where the designation country or area appears in the headings of tables, it covers countries , territories, cities, or areas. Dotted lines on maps represent approximate border lines for which there may not yet be full mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the European Observatory on Health Systems and Policies in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital European Observatory on Health Systems and Policies does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its and bound in the United citation.

9 Panteli D, Arickx F, Cleemput I, Dedet G, Eckhardt H, Fogarty E, Gerkens S, Henschke C, Hislop J, Jommi C, Kaitelidou D, Kawalec P, Keskim ki I, Kroneman M, Lopez Bastida J, Pita Barros P, Ramsberg J, Schneider P, Spillane S, Vogler S, Vuorenkoski L, Wallach Kildemoes H, Wouters O, Busse R. Pharmaceutical regulation in 15 European countries : Review. Health Systems in Transition, 2016; 18(5):1 and HiT summaries are available on the Observatory s web site ( ).ISSN 1817-6119 Vol. 18 No. 5 ContentsContentsPreface vAcknowledgements viiList of abbreviations ixList of tables and figures xiAbstract

10 XiiiExecutive summary xv1 Introduction 12 The context of Pharmaceutical care expenditure and consumption data Expendit u re .. Consumption ..123 The link between marketi