The future of Canadian health care is being shaped by biotechnology. New technologies are providing patients with earlier diagnoses and superior treatment options. At the same time, developers of these technologies are seeking ways to maximize financial and strategic returns on their investments, and intellectual property is a primary vehicle for doing so. This has created new kinds of regulatory challenges for public officials and the biomedical technology industry. (1)
Innovation in the biomedical field has already triggered intellectual property related issues concerning the legal use and patentability of human genes, licensing and pricing of patented medicines, clinical trial data protection, and many more matters. Canadian policy makers now face the difficult task of shaping economic incentives for innovative research and product development while maintaining mechanisms to ensure public access to these health products and services. Moreover, a successful intellectual property regime must work within the broader regulatory context, especially in the health care field. In order to promote access to health technologies, law and policy makers must venture beyond traditional objectives of intellectual property and consider the multitude of other social, economic and political factors at play.
Tania Bubela and colleagues (2) recently identified and discussed the need for policy coherence in addressing the persisting challenges at the intersection of intellectual property and health. This article adds to the ongoing dialogue by exploring the complex set of relationships that exist between intellectual property and other biomedical law and policy issues in the specific context of Canada's federal structure. While its primary focus is on the regulation and governance of intellectual property issues, the central thrust of our argument is that these intellectual property laws, policies, and practices cannot be isolated or divorced from broader regulatory issues. Intellectual property is deeply integrated in the network governance of biomedical technological innovation. Understanding intellectual property issues in this context has major legal implications, especially related to the constitutional division of powers, and, therefore, also has real practical and public policy significance.
The article has three parts. The first deconstructs and challenges assumptions about federal jurisdiction over intellectual property in the biomedical field by exploring the scope of Parliament's constitutional jurisdiction over patents and examining how the provinces also have a jurisdictional claim over the regulation of patented medicines and health technologies.
The second part investigates a series of case studies on issues of assisted human reproduction, gene patents and diagnostic testing, pharmaceutical pricing and intergovernmental relations, data exclusivity and intergovernmental relations, and finally, subsequent entry (generic) biologics. The conclusions that can be drawn from these case studies include: (i) intellectual property related jurisdictional overlap does exist in key areas of biomedical technology; (ii) a flawed and possibly unconstitutional federal regulatory framework will result if the provinces are not included in intellectual property decision making; (iii) the intersection of domestic and international intellectual property affairs further complicates federal-provincial relations in this field; and (iv) there is a need and opportunity for a cooperative intergovernmental approach in addressing federalism related to intellectual property.
The third part of this paper elaborates on this final conclusion by addressing possible strategies to manage complex relationships, in the context of Canadian federalism, for better regulation and governance of biomedical technology innovation.
II. Canadian Federalism and Biomedical Innovation