Evolution of data exclusivity
Mexico, along with the United States and Canada, was one of the
first countries to sign data protection provisions in a free trade
agreement. The North American Free Trade Agreement (NAFTA) included
obligations related to the protection of data submitted before
regulatory agencies well before the Agreement on Trade-Related
Aspects of IP Rights (TRIPs).
Paragraphs 5 to 7 of Article 1711 of NAFTA contain specific
provisions with regard to data submitted to entities in charge of
granting market approvals for pharmaceutical and agrochemical
products, with the main obligation imposed on the contracting
states to prevent unfair commercial use of such information. NAFTA
has always been considered a more specific standard for the
protection of clinical data than TRIPs, as it provides for a
minimum standard of five years of protection from the date that
market authorisation was granted.
