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Article in press 
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Department of Pharmacy Practice and Administration, School of Pharmacy and Health Professions, The University of Maryland Eastern Shore, Princess Anne, MD 21853, USA
Abstract
Trade agreements are an overlooked area of research and policy analysis that affect market access, pricing and reimbursement decisions by pharmaceutical manufacturers, and research and development decisions in the long term. TheTrans-Pacific Partnership (TPP) is the most recent multi-national agreement under considerations that may have profound implications in developed and developing countries in the Pacific Rim. As in the case of other trade arrangements, the TPPnegotiations are not transparent, but a major leak of the most recent draft has been published in WikiLeaks. The leaked document has raised a number of concerns about intellectual property rights (IPR) and regulatory data protection (RDP) that have implications for public health and economic policy throughout the region. In particular, IPR and RDP go beyond the minimum standards set under the World Trade Organization (WTO) and may affect drug access negatively by delaying generic drug and biosimilar product availability and by raising prices by removing national regulations dealing with drug pricing and reimbursement. Of particular concern is the establishment of a litigation process where multi-national companies can sue individual countries before a panel of private attorneys who are appointed by the World Bank or United Nations. This paper addresses these concerns along with a commentary on the likelihood of occurring and the need for future research. © 2016 Elsevier Inc.
Author keywords
Global pharmaceutical industry; Innovation; Intellectual property; Regulatory data protection; Trade policy; Trans-Pacificpartnership
ISSN: 15517411Source Type: Journal Original language: English
DOI: 10.1016/j.sapharm.2015.11.012Document Type: Article in Press
Publisher: Elsevier Inc.
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Freeman, R.A.; Department of Pharmacy Practice and Administration, School of Pharmacy and Health Professions, The University of Maryland Eastern Shore, Princess Anne, MD 21853, USA, ; email:raf@freemangroupllc.com
© Copyright 2016 Elsevier B.V., All rights reserved.
© Copyright 2016 Elsevier B.V., All rights reserved.
