The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) in June 2012 issued guidelines regarding confidential information filed when registering a marketing authorization (sanitary registry) for human-bound medicines (Official Letter No. CAS / 01/OR/896/2012).
In accordance with these guidelines, authorities must deem information that meets certain requirements, outlined below, as confidential and subject to protection against unfair use and disclosure to third parties when filing a marketing authorization registry for pharmochemical medicines. This information must be kept confidential for a term of five years following the date of issuance of the corresponding marketing authorization (in addition to the period between the filing of the request and the issuance of the marketing authorization).
Likewise, the guidelines establish that it shall only be possible to resolve requests for generic medicines that intend to include confidential information once the above-mentioned five-year period has elapsed. Thus, it may only be possible to issue marketing authorizations for generic medicines when the requesting party obtains the chemical product through a procedure other than that considered as confidential for another product.
In order to have the proper protection for such information, the requesting entity must evidence that the information considered confidential meets any of the following criteria: (i) is necessary for the issuance of the corresponding marketing authorization ; (ii) refers to data regarding experiments or other kinds of non-disclosed information occurring prior to its filing with the proper authorities ; (iii) refers to pharmochemicals that use new chemical compounds ; (iv) constitutes information necessary to determine the safety and efficiency of such products ; and (v) consists of information which was obtained through considerable effort.
These guidelines have not been published in the Federal Official Gazette. However COFEPRIS will consider them compulsory as of the date that they were published on its website.
Even if the issuance of these guidelines grants an additional degree of comfort in connection with the secrecy and confidentiality of the information filed with COFEPRIS, the guidelines mirror the general provisions regarding confidential information and documentation already enacted in other laws, such as the Industrial Property Law and Regulations.
Likewise, these guidelines are based only upon the North American Free Trade Agreement (NAFTA) and not other provisions and international agreements executed by Mexico, which could eventually limit the protection of such data and information in cases related to countries other than those forming part of NAFTA.
In our view, there should be no distinction in the confidentiality of information filed with COFEPRIS when there is an applicable legal provision deeming it as such.
José Alberto Campos-Vargas
Mexico City, Mexico
Mexico City, Mexico