COFEPRIS: An Innovation Barrier?

COFEPRIS is investing in its transformation, focusing on digitization and transparency. However, there is still much to be done. Bureaucratic processes are still highly complicated, hampering innovation in the industry, agree experts.

COFEPRIS monitors health risks linked to the use and consumption of goods and services, health supplies, exposure to environmental and labor factors, health emergencies and the provision of health services. Although it aims to be a reliable and effective authority for protection against health risks, some health industry actors find COFEPRIS to be inefficient and an obstacle to innovation. “The industry has reported important delays. There are several studies from various associations in Mexico that show that COFEPRIS is lagging behind and has been a bottleneck in accessing innovation,” said Mario Muñiz, General Manager of the North Latin American Region for  IQVIA.

Technological advancements are also disrupting the regulatory environment, which has to maintain a balance between consumer protection and the development of the industry, while addressing the potential unintended consequences of innovation, states Deloitte. This ends up affecting the industry as it prevents the country from fully exploiting its technological capabilities. “Worldwide, about US$20 billion are invested in clinical studies and US$500 million could be invested in Mexico if COFEPRIS transformed its processes,” Patrick Devlyn, President of the Health Commission for CCE, told MBN. 

Even when COFEPRIS does approve a new product, there is reluctance from the general industry to adopt these new alternatives without further validation from foreign bodies, which has raised doubts regarding the commission’s reliability. “Some Mexican hospitals have told us that they will not adopt our technology unless it is FDA-approved, which is baffling and sad at the same time. Evidently, some leaders in the Mexican healthcare industry mistrust their own institutions,” said Teofilo Tijerina, CEO of Hera Diagnostics. 

COFEPRIS’ lack of efficiency prevents patients from accessing innovative medicines and treatments. Despite it being unable to tackle its workload properly, the commission has faced cuts in resources after becoming part of the Deputy Ministry of Prevention and Health Promotion, which is questioning COFEPRIS’ purpose, according to IMCO.

What Needs to Be Done?

To become a facilitator, rather than an inhibitor for development, COFEPRIS needs to accelerate its protocols. Actors in the health industry have urged COFEPRIS to deploy actions to increase legal certainty to promote innovation and attract foreign investment to Mexico. Experts also consider that more efforts should be made to achieve the homologation of standards between COFEPRIS and the FDA, which would allow the Mexican institution to attract further innovation projects. It has also been recommended for COFEPRIS to become more like foreign regulatory institutions, such as the European Medicines Agency, to act as a surveillance organ that speeds up administrative transactions, highlights IMCO. 

To meet the market’s demands, COFEPRIS is modifying its services to offer better assistance. The institution has bet on digitization and has created the Procedure Digitalization Platform (DIGIPRiS) to help users carry out procedures related to personal consumption. DIGIPRiS aims to manage paperwork, allowing users to monitor their service or procedure from admission to conclusion, while integrating electronic files and databases, as reported by MBN. Over 33,000 procedures have already been done through this platform, according to the government. Moreover, it was recently announced that the advertisement notice, COFEPRIS’s most requested procedure, can now be done through DIGIPRiS. Over 200 successful procedures of this kind have been reported.