Argentina - New Law on Protection of Confidential Information

Ladas & Parry

Argentina has adopted a new law, which came into effect in January 1997, to provide for the protection of confidential information. The law broadly follows the provisions of Article 39 of the GATT-TRIPs Agreement. The new law provides protection for information which is secret, in that it "has been treated as such", and which has commercial value, against unauthorized publication or use in a manner contrary to "honest trade practices". It thus appears that the law will only apply if the owner of the information has taken some steps to maintain its confidentiality. Under the law actions can be brought against those who have improperly obtained such information or who are in the process of disclosing such information. Implementing regulations which may clarify what is required to bring an action are, however, still awaited.

The law also has special provisions relating to disclosure of information to health authorities in order to obtain marketing approval for new pharmaceutical products. On their face these provisions provide that the act of obtaining health authority approval of a "similar product" to one already approved in Argentina or in one of fifteen other countries is not of itself a violation of the new law. This appears to open the door to possible use, by generic drug manufacturers, at least indirectly, of data generated by drug innovators. This aspect of the new law has been criticized by the United States pharmaceutical industry as providing insufficient protection against use of data generated by the innovator of a new drug by a subsequent copier of that drug and has led the United States to propose a withdrawl of Generalized System of Preferences (GSP) benefits for a number of Argentine exports to the United States.