By Juan Serrano --
The Federal Commission for Protection Against Sanitary Risks (COFEPRIS) is the Mexican equivalent of the U.S. Food and Drug Administration (FDA). For the past three years this Commission was headed by Miguel Angel Toscano, who had previously held a position at the Ministry of Economy. Mr. Toscano's exit from COFEPRIS has been announced by several news outlets, and his replacement is Mikel Arriola, an attorney who was previously working as the head of tax legislation at the "Secretaria de Hacienda" (the Ministry of Treasury).
The appointment of a commissioner lacking technical background is noteworthy, especially considering the process of approval of biologic drugs. For starters, this change will probably cause a further delay in the issuance of specific regulations, as the project announced last year is still under review. The latest development regarding the regulations is an analysis performed by the Federal Antitrust Commission (COFECO) recommending the removal of two items in the regulation, specifically:
• The prohibition of substitution of innovator drugs for biocomparable ones, unless the physician specifically allows it in the corresponding prescription.
The main arguments by the COFECO for the removal of this provision, are that it will limit consumer access, and that substitution has been allowed in other jurisdictions such as the U.S.
• The requirement included in the regulations stating that when a drug (either an innovator or a biocomparable) will be manufactured in Mexico, clinical trials will have to be performed within the country.
This requirement is considered by COFECO as an unnecessary market barrier, and that a better option would be to establish minimum standards in order to approve drugs based on clinical trials performed abroad. The report by COFECO (in Spanish) can be found here.
Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs. He can be contacted at [email protected].
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