As we have previously explained in our Guide and Article, COFEPRIS is the regulatory arm of the Ministry of Health in Mexico which regulates the manufacturing, importation, marketing, and other activities related with health supplies including medical devices.
Up to August 19, 2020 according to the Health Law, COFEPRIS was a separated administrative commission but part of the Ministry of Health, with technical, administrative and operative autonomy.
However, some changes were performed in the Mexican laws that changed this scheme. In this article we summarize those amendments and its possible consequences.
In August 19, 2020 an official agreement was published. In this agreement the internal structure of the Ministry of Health is changed. These changes include the modification of COFEPRIS from being hierarchically dependent from the Ministry of Health to a lower level. Specifically, as a Direction that depends on the Sub secretary of Prevention and Health Promotion. As a reference, the head of this entity is Hugo López Gatell, public servant that have been in charge of handling the COVID-19 pandemic in Mexico.
In addition of this amendment, it is expected that the Mexican Congress will modify the Health law to legitimize these changes and make the laws coherent. Up to date Lawmakers have not declared regarding this issue.
The above-mentioned changes means that COFEPRIS will lose its autonomy from the Government, unlike most regulatory agencies from other countries. The Federal Commissioner who was the head of COFEPRIS will disappear, now all decisions will be taken directly by Hugo López Gatell.
Specialized analysts have noticed that this modification will negatively impact the health care industry. They expect an increase in bureaucratic procedures and decreased quality, efficacy and professionalism in the function of the COFEPRIS.
According to experts, these changes represent a drawback to the times before the creation of the COFEPRIS in 2001, when the regulatory procedures were deficient. It is important to mention that these observations do not represent the opinion of Veraque regarding this topic. However, we noticed consistency in this judgment.
Companies and professionals in the sector must monitor the changes mentioned above and those that may arise in the coming months.