Patent system harmonization obligations found within international trade agreements have been subject to intense scrutiny over the past two decades due to the potential negative implications for public health in developing countries. In 1994, NAFTA became the first trade agreement to include patent system harmonization obligations. Mexico as a signatory to NAFTA was the first developing country to adopt the patent system of developed countries via patent system harmonization. This makes Mexico a particularly relevant and appropriately mature case study on the subject. The central research question I address is “Whether NAFTA patent system harmonization promotes access to medicines in Mexico, while incentivizing pharmaceutical R&D? An affirmative answer to this question is the argument that has been espoused by the U.S. Government and backed by the multi-national research-based pharmaceutical industry. This is a position, however, that has lacked confirmatory evidence.

My doctoral dissertation undertook a comparative legal analysis, a scoping study, and qualitative research to address this question. A key finding is that international trade agreements should be drafted with optimal pharmaceutical patent protection standards in mind. Further, patent system harmonization results in a net health benefit that can be maximized through the provision of feedback evidence todecision-makers in order to develop responsive laws and policy. Evidence was provided through qualitative research that the compulsory license, as the primary safeguard in the promotion of access, is an inadequate downstream mechanism.

Through this research I developed a proposal that: if we reform the granting of patent terms from a fixed 20-year life period to a flexible and adjustable term determined through an assessment of health and economic conditions that exist during any given time period, we will improve both global equity in access to medicines and reduce economic inefficiencies in our current model for pharmaceutical R&D, while maintaining adequate incentives to conduct pharmaceutical R&D. The proposed reform is akin to the use of interest rates as an economic growth and stabilization tool in monetary policy. It would require government patent/heath offices to analyze current global conditions in pharmaceutical access and R&D, and accordingly adjust the number of years of patent protection awarded. This novel contribution to the academic literature informs Canadian, Mexican, and other developing country decision makers on how to design appropriate policy for the benefit of public health.


Presenter: Benjamin Charles Warren
Ph.D. Candidate, LL.M., J.D., B.Comm