COFEPRIS Loses Its Decentralized Status

An announcement made on the Nation's Official Gazette informed the Ministry of Health’s decision to attach COFEPRIS and CONAMER to the Deputy Ministry of Prevention and Health Promotion, headed by Hugo López-Gatell. This reorganization happened after Minister of Health Jorge Alcocer dissolved the Deputy Ministry of Integration and Development of the Health Sector to which these former autonomous dependencies and other 11 instances belonged.

The Federal Commission for Protection Against Sanitary Risks (COFEPRIS) monitors the production, commercialization, import, export and marketing of medications, medical devices, pesticides, fertilizers, chemicals and makeup. The commission was created 19 years ago as a strategic response to regulatory measures on products that make up around 10 percent of Mexico’s GDP.  Numbers explain its importance as it regulates 44 cents of each peso spent by households in Mexico on food, beverages and tobacco; health care items and personal care items.

COFEPRIS has won international recognition for its regulatory requirements and for its overall work on ensuring safety of products delivered to Mexican society. It was in 2011 that the commission was recognized for its work. “After various evaluations, COFEPRIS obtained the certification as an international and functional reference regulatory agency for drugs and vaccines,” said the then Commissioner Mikel Arriola.

COFEPRIS’ impact on healthcare and on patients can be easily reflected on how, according to the data collected by the Peña Nieto’s administration, the commission helped increase access to care through the approval of 540 generic versions of previously patented medicines, which allowed a price reduction of up to 70 percent in said drugs. Generics make up around 90 percent of the medicines in Mexico and are an inclusive way to access medicine due to their low prices, which can be 80 percent lower than patented medicine.

How long does COFEPRIS take to approve a product? Depends on the product, but for the pharmaceutical industry, “when a new cancer drug is approved by the FDA, it takes COFEPRIS 56 months in average to approve it for use in Mexico,” said Cristobal Thompson, Executive Director of AMIIF, to MBN. “Canadians take two and a half years, while the average for the OECD is 18 months.”

“COFEPRIS’ regulations should not be seen as a barrier as they are necessary to guarantee the safety and quality of medical devices used in Mexico. The challenge to introducing medical devices into the Mexican public sector comes from the different processes undertaken by each institution to approve a product,” said to MBN Roger Brownrigg, General Manager of Johnson & Johnson. After COFEPRIS has approved the product, the General Health Council has to give its approval and then it is followed by another year at IMSS, ISSSTE or any other public institution.

Will this panorama remain the same? With the overall changes that President López Obrador has brought to Mexico, COFEPRIS has changed too. This and the COVID-19 outbreak have impacted the commission. According to Yoloxóchitl Macías, Health Area Manager at ANCE, the government’s fight against corruption has also reflected on COFEPRIS. “At ANCE, we want to play by the rules and offer a strong service that is solely based on our expertise. Fortunately, it seems that this kind of behavior is diminishing and many companies are glad to hear you do not have contacts inside COFEPRIS. They do not want to be in a situation where there could be an accusation of corruption,” Macías told MBN.

Before COVID-19, COFEPRIS approval times and regulations were stabilizing after the change in administration, according to Melissa Rosales, Director General of RM Pharma. “Healthcare companies are just thankful that our regulatory environment is stable because uncertainty is what we do not want from regulators. If COFEPRIS maintains its three-month approval period, we can call it a win,” she said in an interview with MBN.

According to a comment Cecilia Bravo, President of ANAFAM made during an interview with MBN, in the area of raw materials the pharmaceutical sector did have a few issues in a number of cases during the COVID-19 outbreak. Some countries restricted the export of certain supplies and this was a problem when the supplier was bound to a specific SKU here in Mexico. “In these cases, we asked the sanitary authority to authorize imports from a different supplier. These suppliers need to meet certain conditions. However, in the case of generics you have different options. COFEPRIS provided some support on the issue but only to a certain extent.”

COFEPRIS had to grant some permissions to supply the Mexican market with health and sanitization products. However, there are still companies waiting for a quick approval. “Amunet is waiting for COFEPRIS’ approval of our COVID-19 test, while at the same time, the agency is quickly authorizing foreign tests. This is discouraging because we are not new to COFEPRIS,” Fernando Ruiz, Founder and CEO of Amunet, told MBN.

Is this the ideal time for such a change? COVID-19 is still strong in Mexico, meaning that COFEPRIS will be swamped in approvals for medical devices and medicines. Moreover, the country is entering a medicine supply contract with the UN in which COFEPRIS will have to participate. Additionally, a COVID-19 vaccine is expected to be ready soon, which will need the attention of regulatory entities for its approval and distribution authorization. Lastly, Mexico is about to fully implement a new food and beverages labeling standard, which also needs COFEPRIS’ supervision.