Mexico Edges Towards International Regulatory Standards

Reforms to Mexico's drug regulatory framework, while slow in coming, have yielded several key results in recent years. Changes to the country's General Health Law approved in the last few months have finally established bioequivalency requirements for all generic drug products. It is hoped that the measure will force so-called "similares" off the market.

According to some studies, illicit copy products account for 60% of Mexico's annual drug unit sales. Mexican legislators have now decided to oblige all drugmakers to register their products with health authorities, in a move that will be welcomed by the research-based sector.

The topic of drug market reform has proved divisive in Mexico, with the country's social security agency clashing with the health ministry over licensing for cheap medicines. On the other hand, a cross-party group of reform-minded legislators are also pushing for a tightening of the Health Law's Article 208, which currently classifies drug copying as an "administrative" crime carrying only a light sentence.

The most significant recent change to drug market regulation has undoubtedly been September 2003's revision to Mexico's patent law, which established that marketing approval for a drug cannot be given without a recognised patent. Previously, no certificate was required, allowing copied drugs to have legal market status. The research-based industry, for its part, appears cautiously satisfied with progress thus far. Significantly, US industry association PhRMA has notably decided not to lobby for the country's inclusion on the Office of the US Trade Representative's (USTR) 2004 Special 301 Report on Intellectual Property.