The Protection Of Clinical Data In Mexico Still A Pending Issue

In Mexico, a couple of decades ago, the protection of clinical data was a little-known legal figure, in addition to having been disregarded for many years, although Mexico had already acquired certain international obligations to attend to and recognize this right, which mainly prevents unfair competition and illicit enrichment.

There is still an absence of domestic regulation in Mexico regarding such important protection and a form of attraction and access to new, safe and effective products, as well as the incentive for the development of new and more clinical studies, both for novel products, as well as new formulations, presentations, and indications. After more than 25 years of Mexico's flagrant disregard of the obligations of international treaties to recognize the figure, both in TRIPS and NAFTA, it is time for Mexico to adopt this figure in its domestic legislation and thus avoid the uncertainty and judicialization of the figure.