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The Globalisation of the Pharmaceutical Industry

The Globalisation of the Pharmaceutical IndustryPHARMACEUTICALS POLICY AND LAWP harmaceuticals Policy and LawVolume 18 Earlier published in this Valverde and G. Fracchia (Eds), Focus on Pharmaceutical Valverde (Ed), The Problem of Herbal Medicines Legal Valverde (Ed), The European Regulation on Orphan medicinal Valverde (Ed), Information Society in C. Huttin (Ed), Challenges for Pharmaceutical Policies in the 21st Valverde and P. Weissenberg (Eds), The Challenges of the New EU Pharmaceutical Valverde (Ed), Blood, Plasma and Plasma Proteins: A Unique Contribution to Modern Valverde (Ed), Responsibilities in the Efficient Use of medicinal (1,2).

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.

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Transcription of The Globalisation of the Pharmaceutical Industry

1 The Globalisation of the Pharmaceutical IndustryPHARMACEUTICALS POLICY AND LAWP harmaceuticals Policy and LawVolume 18 Earlier published in this Valverde and G. Fracchia (Eds), Focus on Pharmaceutical Valverde (Ed), The Problem of Herbal Medicines Legal Valverde (Ed), The European Regulation on Orphan medicinal Valverde (Ed), Information Society in C. Huttin (Ed), Challenges for Pharmaceutical Policies in the 21st Valverde and P. Weissenberg (Eds), The Challenges of the New EU Pharmaceutical Valverde (Ed), Blood, Plasma and Plasma Proteins: A Unique Contribution to Modern Valverde (Ed), Responsibilities in the Efficient Use of medicinal (1,2).

2 Valverde (Ed), 2050: A Changing Europe. Demographic Crisis and Baby Friend (3,4). Valverde (Ed), Key Issues in Pharmaceuticals Valverde and D. Watters (Eds), Focus on (1,2). Valverde and A. Ceci (Eds), The EU Paediatric (3). Valverde (Ed), Health Fraud and Other Trends in the (4). Valverde (Ed), Rare Diseases: Focus on Plasma Related (1,2). Valverde and A. Ceci (Eds), Innovative Medicine: The Science and the Regulatory (3,4). Valverde (Ed), New Developments of Pharmaceutical Law in the (1,2). Valverde (Ed), Challenges for the Pharmaceuticals Policy in the (1). Valverde and J. Lyle Bootman (Eds), The Value of Pharmaceuticals (2 4).

3 Valverde (Ed), Advances in Pharmaceutical (1,2). Valverde (Ed), Advances in Pharmaceutical (3,4). Valverde, M. Oehlrich and A. Daemmrich (Eds), Legal and Political Competitiveness for (1,2). Valverde and Gassner (Eds), Pharmaceutical Innovation and Non-patent ProtectionVol. 16(3,4) Valverde, Real and S. Palma (Eds), Pharmaceuticals in Latin America Vol. 17(1,2) Valverde and A. Ramos-Cormenzana (Eds), The Common Technical Document and the Harmonisation of medicinal ProductsVol. 17(3,4) Valverde and C. Bottari (Eds), Clinical Trials: Aspects of Substance and Application Issues The Globalisation of the Pharmaceutical IndustryPharmaceuticals Policy and LawVolume 18, ValverdeChair Jean Monnet, Granada, SpainEduardo PisaniInternational Federation of Pharmaceutical Manufacturers and Associations, SwitzerlandAmsterdam Washington, DC Tokyo 2016 Network of Centres for Study of Pharmaceutical Law.

4 All rights 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.

5 PublisherIOS Press Nieuwe Hemweg 6B1013 BG AmsterdamThe Netherlandsfax: +31 20 687 0019e-mail: in the UK and Ireland Gazelle Books Services Ltd. White Cross Mills Hightown Lancaster LA1 4XS United Kingdom fax: +44 1524 63232e-mail: in the USA and CanadaIOS Press, Rachael Manor DriveFairfax, VA 22032 USAfax: +1 703 323 3668e-mail: NoticeThe publisher is not responsible for the use which might be made of the following in the NetherlandsPHARMACEUTICALS POLICY AND LAWV olume 18(1 4), 2016 CONTENTSE ditorial 1 Introduction ValverdeThe globalization of medicines as a challenge for governments DesaiCompulsory licensing.

6 Procedural requirements under the TRIPS agreement GawelPatent protection as a key driver for Pharmaceutical innovation 45M. AitkenUnderstanding the Pharmaceutical value chain 55N. NeufeldBreaking New Ground: The WTO Agreement on Trade Facilitation 67C. Lourenco, N. Orphanos and C. ParkerThe 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 MwangiTowards African Medicines Regulatory Harmonization: The case of the East African Community 91O. LahlouAccelerating 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 99M.

7 Caturla Go iAccelerating regulatory approvals through the World Health Organization collaborative registration procedures 109G. Grampp, Kozak and T. SchreitmuellerPolicy considerations for originator and similar biotherapeutic products R nninger and GarbeImport testing turned into an unnecessary limitation of patient access to medicines as risks are managed effectively Trujillo and De GuzmanPharmacovigilance: "Vigilantia initiative" 157R. Mages and KubicCounterfeit medicines: Threat to patient health and safety 163E. Utt and C. WellsThe global response to the threat of antimicrobial resistance and the impor-tant role of vaccines 179B.

8 Shaw and P. WhitneyEthics and compliance in global Pharmaceutical Industry marketing and promotion: The role of the IFPMA and self-regulation 199 Author Index Volume 18 (2016) 207vi ContentsPharmaceuticals Policy and Law 18 (2016) 1 41 DOI PressEditorial The innovation and access to landscapeJose Luis Valverdea, and Eduardo PisanibaChair Jean Monnet of EU Law, Granada, SpainbInternational Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva,SwitzerlandThe 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 , it is a high-technologysector that invents and develops life-saving and life-enhancing medicines, reinvesting more ofits net sales back into innovative researchthan any other Industry ( on average) [1].

9 As evidence of the above, despite the complexity andunpredictability of the in-novation process, the Industry has developed more than 550 medicines in the last15 years for some of the world s most critical and emerging health needs, includingoncology, cardiovascular disease, and diabetes [2,3]. During the past 5 years, 182novel drugs to treat major public health concerns have been approved by the USFood and Drug Administration (FDA), with 45 approved in 2015 alone [4]. Industrycontinues to be instrumental in exploratory research, as well as translating researchinto patient-ready life-saving and life-enhancing medicines to those in need [5].

10 The new medicines and vaccines springing from the work of scientists overdecades created a legacy from which every one of us benefits today. Effectivemedicines and vaccines do more than prevent and treat diseases, and patients are notthe only ones who are helped by new developments. When new medicines improvea population s health, also the economy benefits from a healthier the right medicines is just one step in improving public health. A sharedgoal in the global health community, including the Industry , is to ensure the world spatients receive the medicines they need tolive longer and healthier lives. Expandingaccess to health care and to medicines can be complex and challenging, particularlyin low- and middle-income countries, and requires a structured, collaborative effortthat ensures health systems use resources effectively and efficiently.


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