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The Globalisation of the Pharmaceutical Industry The Globalisation of the Pharmaceutical Industry PHARMACEUTICALS POLICY AND LAW Pharmaceuticals Policy and Law Volume 18 Earlier published in this series Vol.1. J.L. Valverde and G. Fracchia (Eds), Focus on Pharmaceutical Research Vol.2. J.L. Valverde (Ed), The Problem of Herbal Medicines Legal Status Vol.3. J.L. Valverde (Ed), The European Regulation on Orphan Medicinal Products Vol.4. J.L. Valverde (Ed), Information Society in Pharmaceuticals Vol.5. C. Huttin (Ed), Challenges for Pharmaceutical Policies in the 21st Century Vol.6. J.L. Valverde and P. Weissenberg (Eds), The Challenges of the New EU Pharmaceutical Legislation Vol.7. J.L. Valverde (Ed), Blood, Plasma and Plasma Proteins: A Unique Contribution to Modern Healthcare Vol.8. J.L. Valverde (Ed), Responsibilities in the Efficient Use of Medicinal Products Vol.9(1,2). J.L. Valverde (Ed), 2050: A Changing Europe. Demographic Crisis and Baby Friend Policies Vol.9(3,4). J.L. Valverde (Ed), Key Issues in Pharmaceuticals Law Vol.10. J.L. Valverde and D. Watters (Eds), Focus on Immunodeficiencies Vol.11(1,2). J.L. Valverde and A. Ceci (Eds), The EU Paediatric Regulation Vol.11(3). J.L. Valverde (Ed), Health Fraud and Other Trends in the EU Vol.11(4). J.L. Valverde (Ed), Rare Diseases: Focus on Plasma Related Disorders Vol.12(1,2). J.L. Valverde and A. Ceci (Eds), Innovative Medicine: The Science and the Regulatory Framework Vol.12(3,4). J.L. Valverde (Ed), New Developments of Pharmaceutical Law in the EU Vol.13(1,2). J.L. Valverde (Ed), Challenges for the Pharmaceuticals Policy in the EU Vol.14(1). J.L. Valverde and J. Lyle Bootman (Eds), The Value of Pharmaceuticals Vol.14(2–4). J.L. Valverde (Ed), Advances in Pharmaceutical Legislation Vol.15(1,2). J.L. Valverde (Ed), Advances in Pharmaceutical Legislation Vol.15(3,4). J.L. Valverde, M. Oehlrich and A. Daemmrich (Eds), Legal and Political Competitiveness for Pharmaceuticals Vol.16(1,2). J.L. Valverde and U.M. Gassner (Eds), Pharmaceutical Innovation and Non-patent Protection Vol. 16(3,4) J.L. Valverde, J.P. Real and S. Palma (Eds), Pharmaceuticals in Latin America Vol. 17(1,2) J.L. Valverde and A. Ramos-Cormenzana (Eds), The Common Technical Document and the Harmonisation of Medicinal Products Vol. 17(3,4) J.L. Valverde and C. Bottari (Eds), Clinical Trials: Aspects of Substance and Application Issues The Globalisation of the Pharmaceutical Industry Pharmaceuticals Policy and Law Volume 18, 2016 Editors J.L. Valverde Chair Jean Monnet, Granada, Spain Eduardo Pisani International Federation of Pharmaceutical Manufacturers and Associations, Switzerland Amsterdam • Washington, DC • Tokyo © 2016 Network of Centres for Study of Pharmaceutical Law. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the Network of Centres for Study of Pharmaceutical Law. No responsibility is assumed by the Publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or other- wise, or from any use or operation of any methods, products, instructions or ideas contained in the mate- rial herein. Although all advertising material is expected to conform to ethical standards, inclusion in this publication does not constitute a guarantee or endorsement of the quality or value of such product or of the claims made of it by its manufacturer. Publisher IOS Press Nieuwe Hemweg 6B 1013 BG Amsterdam The Netherlands fax: +31 20 687 0019 e-mail: [email protected] Distributor in the UK and Ireland Distributor in the USA and Canada Gazelle Books IOS Press, Inc. Services Ltd. 4502 Rachael Manor Drive White Cross Mills Fairfax, VA 22032 Hightown USA Lancaster LA1 4XS fax: +1 703 323 3668 United Kingdom e-mail: [email protected] fax: +44 1524 63232 e-mail: [email protected] Legal Notice The publisher is not responsible for the use which might be made of the following information. Printed in the Netherlands PHARMACEUTICALS POLICY AND LAW Volume 18(1–4), 2016 CONTENTS Editorial 1 Introduction 5 J.L. Valverde The globalization of medicines as a challenge for governments 19 M.A. Desai Compulsory licensing: Procedural requirements under the TRIPS agreement 31 C.R. Gawel Patent protection as a key driver for pharmaceutical innovation 45 M. Aitken Understanding the pharmaceutical value chain 55 N. Neufeld Breaking New Ground: The WTO Agreement on Trade Facilitation 67 C. Lourenco, N. Orphanos and C. Parker The International Council for Harmonisation: Positioning for the future with its recent reform and over 25 years of harmonisation work 79 Towards African Regulatory Harmonization Processes – Accelerating Patient Access to Medicines J.M. Mwangi Towards African Medicines Regulatory Harmonization: The case of the East African Community 91 O. Lahlou Accelerating patient access to medicines in the Economic Community of West African States, the Southern African Development Community and the organization for the coordination of the fight against endemic diseases 99 M. Caturla Goñi Accelerating regulatory approvals through the World Health Organization collaborative registration procedures 109 G. Grampp, R.W. Kozak and T. Schreitmueller Policy considerations for originator and similar biotherapeutic products 121 S.K. Rönninger and J.H.O. Garbe Import testing turned into an unnecessary limitation of patient access to medicines as risks are managed effectively 141 J.C. Trujillo and M.A. De Guzman Pharmacovigilance: "Vigilantia initiative" 157 vi Contents R. Mages and T.T. Kubic Counterfeit medicines: Threat to patient health and safety 163 E. Utt and C. Wells The global response to the threat of antimicrobial resistance and the impor- tant role of vaccines 179 B. Shaw and P. Whitney Ethics and compliance in global pharmaceutical industry marketing and promotion: The role of the IFPMA and self-regulation 199 Author Index Volume 18 (2016) 207 Pharmaceuticals Policy and Law 18 (2016) 1–4 1 DOI 10.3233/PPL-160427 IOS Press Editorial – The innovation and access to landscape Jose Luis Valverdea,∗ and Eduardo Pisanib aChair Jean Monnet of EU Law, Granada, Spain bInternational Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland The biopharmaceutical industry is playing a vital role in both innovation and ac- cess to medicine through intensive research and development (R&D), partnerships, patient access programs, and through contributions to good governance. Firstly, it is a high-technology sector that invents and develops life-saving and life- enhancing medicines, reinvesting more of its net sales back into innovative research than any other industry (14.4% on average) [1]. As evidence of the above, despite the complexity and unpredictability of the in- novation process, the industry has developed more than 550 medicines in the last 15 years for some of the world’s most critical and emerging health needs, including oncology, cardiovascular disease, and diabetes [2,3]. During the past 5 years, 182 novel drugs to treat major public health concerns have been approved by the US Food and Drug Administration (FDA), with 45 approved in 2015 alone [4]. Industry continues to be instrumental in exploratory research, as well as translating research into patient-ready life-saving and life-enhancing medicines to those in need [5]. The new medicines and vaccines springing from the work of scientists over decades created a legacy from which every one of us benefits today. Effective medicines and vaccines do more than prevent and treat diseases, and patients are not the only ones who are helped by new developments. When new medicines improve a population’s health, also the economy benefits from a healthier workforce. Having the right medicines is just one step in improving public health. A shared goal in the global health community, including the industry, is to ensure the world’s patients receive the medicines they need to live longer and healthier lives. Expanding access to health care and to medicines can be complex and challenging, particularly in low- and middle-income countries, and requires a structured, collaborative effort that ensures health systems use resources effectively and efficiently. Ensuring that patients receive the correct medication, at the appropriate time and from a convenient location, requires a complex ‘value chain’ [6]. There are many gaps in health care systems that have an unequal impact on populations. ∗Corresponding author: Jose Luis Valverde, Chair Jean Monnet of EU Law, Granada, Spain. E-mail: [email protected]. 1389-2827/16/$35.00 c 2016 – Network of Centres for Study of Pharmaceutical Law. All rights reserved 2 J.L. Valverde and E. Pisani / Editorial – The innovation and access to landscape It should be recognized that a holistic approach to access to medicines should be adopted and enforced by the competent international and domestic health authori- ties. National procurement and supply systems for medicines are often inefficient, or poorly calibrated to meet current needs. As a result, scarce resources are wasted, the introduction of vital new medicines is delayed and stock-outs may occur, presenting a significant barrier to health. Strong regulatory systems are needed to ensure that people around the world have timely access to quality medicines and vaccines that are both effective and safe. To- day, only 20% of the World Health Organization’s Member States have well devel- oped pharmaceutical regulatory systems, due to considerable human and financial resources that such systems entail. In a globalized world, however, the regulatory landscape needs to evolve continuously to address old and new challenges. The safe and effective supply of medicines will become an increasingly important global pri- ority in the 21st century [7]: providing effective protection against falsified medicines is to be considered a shared goal, in the interests of individuals and communities all over the world.
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