Global Pharmaceutical Linkage Regulations: A Consortium Framework

Global Pharmaceutical Linkage Regulations: A Consortium Framework

Dr. Ron Bouchard is an Associate Professor in the Faculties of Law and Medicine at the University of Manitoba.

I am pleased to announce a new collaborative consortium of eleven intellectual property law and health policy scholars, economists, and practicing lawyers in nine countries. The group is called the Consortium Study of Global Pharmaceutical Linkage (CsGPL or Consortium).

The Consortium is spread across nations with mature linkage regulations (US: Dan Cahoy; Canada: Ron Bouchard; Aidan Hollis; Joel Lexchin), nascent regulations (Australia: Tom Faunce; China: Paul Jones), those without regulations but with certain practices that may operate to parallel linkage (EU: Bengt Domeij; Graham Dutfield) and those where both the existence and scope of linkage regulations are currently the subject of intense public scrutiny and litigation (India: Feroz Ali Khader; Mexico: Juan Louis Serrano; South Korea: Heesob Nam).

The Consortium includes individuals with past and present litigation experience with pharmaceutical linkage regulations on both sides of the brand-generic divide, and includes scholars appointed in Faculties of Law, Medicine, Health, and Economics as well as practicing lawyers working in law firms and Non-Governmental Organizations on pharmaceutical matters. The Consortium is fortunate to be supported in its work by a Key Decision Maker Advisory Board composed of senior members of government in health, industry and intellectual property portfolios and the judiciary working on matters relating to pharmaceutical linkage regulations.

In its work thus far, the Consortium understands that the study of structure-function relationships in living systems, both at the micro and macro level, has served science especially well over the last century. Indeed, the rapid spread of pharmaceutical linkage worldwide offers a unique and time sensitive opportunity to carry out empirical work on the system as it evolves outward from its original focus in the U.S. As a result, a major goal of the Consortium’s work on global pharmaceutical linkage will be to investigate the structural and functional aspects of different systems of linkage regulations, and their relationship on the one hand to drug availability costs, and expenditures, and incentives for innovation and protection of intellectual property rights on the other.

A second major goal of our work is to produce and use empirical knowledge relating to different global linkage regimes to assist key decision-makers and knowledge users in domestic and global governments and legal systems working with linkage in their efforts to stimulate the production of new and innovative drugs while at the same time lowering public health costs and increasing access to essential medicines.

The first paper from the Consortium has now been accepted for publication. The full cite is: Bouchard, R.A. Cahoy, D., Domeij, B., Dutfield, G., Faunce, T., Hollis, A., Jones, P., Ali Khader, F., Lexchin, J., Nam, H., & Serrano, J.L. "Global Pharmaceutical Linkage Regulations: A Consortium Framework." Minnesota Journal of Law, Science & Technology 12(2): 1-30. 2011.

The article can be found online at:



I also have a new book coming out on pharmaceutical linkage. The book, entitled Patently Innovative. How Pharmaceutical Firms Use Emerging Patent Law to Extend Monopolies on Blockbuster Drugs, (Biohealthcare Publishing (Oxford) Limited, Oxford UK), is to be published in the summer of 2011.

A preview of the book can be found online at: