More muscle: new data protection guidelines in Mexico

Clinical data is protected in Mexico under Article 1711 of the North American Free Trade Agreement (NAFTA) (in force since January 1, 1994), and Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (in force since January 1, 1995). However, there is no consensus as to whether NAFTA embraces the concept of data exclusivity.

Legal framework

After NAFTA entered into force, the Mexican Congress amended the Industrial Property Law by adding Article 86 bis, which states: “The information required by special laws to determine the safety and efficacy of pharmaceutical and agricultural products that make use of new chemical components shall be protected under the terms of the international agreements to which Mexico is a ratifying party.”

Data protection is also regulated by Article 167 bis of the Health Care Product Raw Materials Regulations, which states:

“…The information referred to in Articles 167 and 167 bis of this Accord which are of a confidential or classified nature, under the provisions of the international agreements to which Mexico is a ratifying party and other applicable legislation, will be protected against disclosure to other parties.”

Finally, on June 18, 2012, the Federal Commission for Protection Against Health Risks (COFEPRIS) published Guidelines for the Protection of Confidential Data Regarding Drugs Containing Pharmaceutical Chemicals as New Chemical Entities. The publication of the guidelines coincided with an announcement during the G20 meeting in Los Cabos that Mexico would participate in negotiations regarding the Trans-Pacific Partnership Agreement (TPP).

Scope of the new guidelines

The preamble to the guidelines affirms the need to implement proper measures to guarantee the protection of clinical data for pharmaceutical chemical products, pursuant to the legal framework noted above. However, the guidelines do not explicitly state whether the protection conferred includes any type of data exclusivity.

The guidelines further provide as follows:

Paragraph 1

COFEPRIS will protect from unfair disclosure any confidential or governmentally reserved information filed with an application for sanitary registration. The following must be submitted with an application, pursuant to Article 167 of the regulations: