A Complementary Tension: The Intersectional Issue of Gene Patents in Health in Canada

Abstract

Who has no right to use your genes? It could be you. Human genetics and genomics research is costly and in it there is potential for commercial gain. In the decades of human gene-based research and development, much of the debate over the commercialization of genetic materials has occurred under the protective rubric of patent law and according to utilitarian rationales that justify the granting of exclusive rights that ostensibly will make the world a better place. However, questions arise regarding the effectiveness of patents in promoting health and well-being, given the lack of evidence supporting their exclusive rights exchange for disclosure. Patent policy may set out to combine the health improvement and economic growth objectives of innovation, but these two goals do not always align. The Canadian debate on human gene patents, illustrated by cases like Myriad Genetics’ BRCA patents and the Children’s Hospital of Eastern Ontario’s struggles over Transgenomic’s LQTS patents, highlights tensions between public and private interests. While exclusive patent rights have raised concerns about access to genetic tests, significant patent system reform in Canada may not be the solution. Instead, a comprehensive genetics policy approach is needed, alongside enhanced governmental expertise to ensure open and equitable access to gene-based technologies; it is again time for governments to reamass in-house expertise at the policy-evidence interface regarding genetics and genomics to mitigate a growing vulnerability in governance and oversight in these advancing areas of science, technology and biomedicine. Collaborative efforts among stakeholders in science, health, and industry are crucial for policy coherence, better inter-institutional cooperation, and better leadership. This study conducted in-depth interviews with 26 stakeholders from various sectors, complemented by case and doctrinal analysis of human gene patent-related litigation.