On August 19, 2020, “DECREE of incorporation of various administrative units and decentralized bodies of the Ministry of Health” was published in the Mexican Official Gazette

One of the most relevant is the incorporation of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) to the Undersecretary for Prevention and Promotion of Health of the Ministry of Health.

COFEPRIS was a decentralized agency of the Ministry of Health, in charge of the control and surveillance in all aspects related to sanitary regulation (in connection to drugs, medical devices, health services, food supplements, food and beverages, cosmetics, pesticides, clinical studies, etc.), with administrative, technical and operational autonomy, as well having its own legal personality and assets.

From now on, COFEPRIS or its faculties will depend directly on the Undersecretary for Prevention and Promotion of Health.

We consider that this structural movement does not contribute to the independence and autonomy required for the regulatory authority. In addition, it is not difficult to foresee a conflict of interest, since some of the public policies for the acquisition of medicines and medical supplies are devised precisely from the Undersecretaries on which now, the most important regulatory entity in Mexico, COFEPRIS, will depend and obey directly.

In this regard, OLIVARES will continue to monitor the legal implications and changes in the proceedings and criteria derived from this administrative modification.

FOR FURTHER INFORMATION ON THE CONTENT OF THIS NEWSLETTER, PLEASE CONTACT:

Alejandro Luna Fandiño

Alejandro Luna Fandiño

Partner

Alejandro Luna joined OLIVARES in 1996 and being made partner in 2005, he has been instrumental to the firm´s IP Litigation, Regulatory and Administrative Litigation practices. He co-chairs the Life Sciences & Pharmaceutical Law industry group and coordinates the Litigation Department.
Armando Arenas

Armando Arenas

Partner

Armando Arenas joined OLIVARES in 2000 and became a partner in January 2017. He has experience working on a range of IP matters, including consulting and litigation on trademark, patent, unfair competition, trade dress protection, and misleading advertising cases before the Mexican Institute of Industrial Property (IMPI), Federal Court of Tax and Administrative Affairs (FCTA), Federal Circuit Courts (FCC) and the Supreme Court of Justice (SCJ) Regulatory Affairs and Public Acquisitions.
Daniel Sánchez

Daniel Sánchez

Partner

Daniel Sanchez joined OLIVARES in 2000 and became a partner in 2011. He is one of the leading intellectual property (IP) and administrative litigators in Mexico and is recognized by industry rankings and publications.
Gustavo A. Alcocer

Gustavo A. Alcocer

Partner

Gustavo Alcocer manages the Corporate and Commercial Law Group at OLIVARES, advising domestic and foreign businesses and the owners of those businesses on Mexican and cross-border corporate and commercial transactions.

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