Mexico reduces the autonomy and independence of the Regulatory Authority (COFEPRIS)
August 21, 2020
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.