Launch of New Portal for IMPI-COFEPRIS Linkage System in Mexico

The presentation on March 30th of the portal for the IMPI-COFEPRIS linkage system is a notable event for several reasons. Firstly, and most importantly, it brings transparency and efficiency to a system that has been in place for over 20 years without achieving its objectives to date. If we were to simplify the purpose of the mechanism to the maximum, we would say it is the lock that prevents granting sanitary permits for generic drugs when they could violate a patent. The reason is simple: it would be inconsistent for the health authority (COFEPRIS) to grant a permit to market a drug when the IMPI has already granted a patent for the same product, and its validity has not yet expired. This, which in this basic hypothesis might seem not to cause confusion, in practice has become the subject of all kinds of challenges, to the point of making the system unworkable. The complaints from those seeking to launch generics upon a patent's expiration are that the nebulous nature of the system leads to refusals by the IMPI (to COFEPRIS's inquiries), often based on improper interpretations of the scope of that patent, or of subsequent applications that continue to protect the active substance in various forms and combinations. On the side of patent rights holders, who are presumably the protected parties, the complaint stems from not having a say in a deliberative process that results in the authorization of a drug that infringes their rights. As often happens, the spaces opened by regulatory uncertainty are usually filled with endless litigation. In any case, the lack of clarity has direct consequences for the system, which passes the bill to consumers by not having timely availability of medications—whether patented or generics—and forcing them to make defensive decisions due to regulatory ambiguity. The portal being presented seeks precisely to provide transparency and certainty in the sanitary authorization process, respecting the rights of patent holders, but based on public and accessible information, moving away from hermetic procedures that did not allow one to know what was happening inside the 'black box' of both authorities. By enabling a rapid and precise ruling on whether the launch of a generic would infringe a patent, it can thus define the date on which it will receive its sanitary permit, allowing all parties to have certainty and maintain the necessary supply in both public and private markets. For any generic, the decision to produce and sell also goes through multiple regulatory and commercial filters that require significant preparation and investment, so being able to define the path is crucial to fulfilling the objective. If the portal launched in coordination by IMPI and COFEPRIS functions as planned, it will have ended with a knot that for many years choked the linkage issue in Mexico. The question then will be: why did it take 23 years to solve something that two authorities with vision and intention resolved in a few months?