On July 20, 2016, the Mexican Antitrust Commission (known by its Spanish acronym, COFECE) announced that it will conduct a study regarding competition concerns over pharmaceutical products with lapsed patents. This is the first time such a study has been undertaken in Mexico.
The press release said that the Commission chose to conduct this market assessment due to the relevance of these products to the national economy and public health.
COFECE noted that, according to 2015 national statistics, the pharmaceutical industry represented 2.7% of the Gross National Income, and 2015 government purchases of pharmaceutical products reached more than MXN 50 billion (around USD 2.6 billion).
The Commission will first analyze the rationale behind the fact that, according to the announcement, there are approximately 350 products listed in the National Formulary with sole suppliers, although around 63% of these products have lapsed patents.
COFECE emphasized that this analysis should not be considered in any way as a prejudgment of potential misconducts. It pointed out that this assessment aims to provide Mexican Regulatory Agencies with recommendations on how to encourage competition and correct inefficiencies.
OLIVARES believes that the COFECE official communication in this regard contains several flaws and confuses concepts in order to justify the study. For example, the Commission provides data concerning out-of-pocket expenses of the private sector to explain its reasoning for reviewing public acquisitions of medical products; however, these are separate realms governed by various factors and rules and are not necessarily related.
Partners and Associates of our law firm, through the various industry Associations in which we participate, will follow up with COFECE on this study which demands further analysis with respect to the intersection of regulations over healthcare products, patent rights, and competition.
This newsletter is intended only as a general discussion of the addressed issues, and should not be regarded as legal advice.
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