Structure-Function Analysis of Global Pharmaceutical Linkage Regulations

66 Pages Posted: 21 Feb 2015

See all articles by Ron Bouchard

Ron Bouchard

University of Manitoba - Faculty of Law (deceased)

Daniel R. Cahoy

Pennsylvania State University - Mary Jean and Frank P. Smeal College of Business Administration

Bengt Domeij

Uppsala University - Faculty of Law

Graham Dutfield

University of Leeds

Tom Faunce

Unaffiliated Authors

Aidan Hollis

University of Calgary - Department of Economics

Paul Jones

Independent

Feroz Ali

National Law School of India University

Joel Lexchin

York University

Heesob Nam

Independent

Juan Luis Serrano

Olivares & Cia

Date Written: February 20, 2015

Abstract

Linkage regulations tie generic drug approval and, thus, access to essential medications to existing drug patents through potentially long and costly litigation. The linkage regime is in the process of rapidly spreading worldwide through international free trade agreements. Even so, very little is known about how the regulations work in developed nations let alone how they impact public health systems across international borders. The authors constitute a network of eleven health policy experts and practicing lawyers in nine countries including those with mature linkage regulations, those with new regulations, those without regulations but with practices that parallel linkage, and those where regulations are currently subject to intense public debate and litigation.

Keywords: Global Pharmaceutical Linkage, Structure Function Relationship, Hatch-Waxman Act, NOC Regulations, TRIPS Plus, WTO

JEL Classification: O31, O34

Suggested Citation

Bouchard, Ron and Cahoy, Daniel R. and Domeij, Bengt and Dutfield, Graham and Faunce, Tom and Hollis, Aidan and Jones, Paul and Ali, Feroz and Lexchin, Joel and Nam, Heesob and Serrano, Juan Luis, Structure-Function Analysis of Global Pharmaceutical Linkage Regulations (February 20, 2015). Minnesota Journal of Law, Science & Technology, Vol. 12, No. 2, 2011, Available at SSRN: https://ssrn.com/abstract=2567637 or http://dx.doi.org/10.2139/ssrn.2567637

Ron Bouchard

University of Manitoba - Faculty of Law (deceased)

Daniel R. Cahoy

Pennsylvania State University - Mary Jean and Frank P. Smeal College of Business Administration ( email )

310 Business Building
University Park, PA 16802
United States
814-865-6205 (Phone)
814-865-6284 (Fax)

Bengt Domeij

Uppsala University - Faculty of Law ( email )

Faculty of Law Box 512
Uppsala, SE-751 20
Sweden
+46 709 90 40 48 (Phone)

HOME PAGE: http://www.jur.uu.se

Graham Dutfield

University of Leeds ( email )

School of Law
Liberty Building
Leeds, LS2 9JT
United Kingdom
0113 343 1606 (Phone)

HOME PAGE: http://leeds.academia.edu/GrahamDutfield

Tom Faunce

Unaffiliated Authors

United States

Aidan Hollis

University of Calgary - Department of Economics ( email )

2500 University Drive, NW
Calgary, Alberta T2N 1N4
Canada
403-220-5861 (Phone)
403-220-5262 (Fax)

Paul Jones

Independent ( email )

Feroz Ali (Contact Author)

National Law School of India University ( email )

Nagarbhavi, PO Box 72
Bangalore, Karnataka 560072
India

Joel Lexchin

York University ( email )

4700 Keele Street
Toronto, Ontario M3J 1P3
Canada
+416-736-2100 x 22119 (Phone)
+416-736-5227 (Fax)

Heesob Nam

Independent ( email )

Juan Luis Serrano

Olivares & Cia

Pedro Luis Ogazon 17
Col. San Angel, D.F. 01000
Mexico

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