Latin America Roundup: Mexico’s COFEPRIS uncovers collusion scheme involving third-party lab

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) says that it has unveiled “historic collusion” within its ranks, marking the second time in 18 months that it has discovered a pattern of corruption and taken action to resolve it.

This time, the agency said in a statement issued 8 July, the corruption involved third-party companies authorized by COFEPRIS to carry out activities necessary to regulation. These companies own labs that test drugs and verify that products are bioequivalent.

COFEPRIS said that it had identified at least one firm that got away with less rigorous evaluations by the agency, while similar entities faced “unjustified over-regulation.” The favored company came to monopolize testing activities at the expense of its competitors.

The determination of corruption came after an internal review, COFEPRIS said, that revealed discrepancies in how these entities were evaluated and how regulators interpreted requirements for each.

Neither COFEPRIS nor Mexican news outlets named the company that was favored, nor did it say how it had dealt with the individuals responsible for the favoritism. The agency said only that it would take immediate action to correct norms “related to auxiliary companies in health regulation” and work with the entities harmed.

In recent years COFEPRIS has drawn attention to its anti-corruption efforts, such as the DIGIPRIS digital platform that allowed it to do away with third parties who had previously helped shepherd drugs and devices through the regulatory process, and whom the agency regarded as a key source of corruption.

In February 2023, the agency announced that it had fired 11 employees involved in a corruption ring that had been active for over a decade. That ring had leaked proposed rule changes, destroyed agency hard drives, and shared information with representatives of regulated entities, among other offenses. The ring was detected, the agency said, thanks to an intelligence-sharing effort between COFEPRIS and Mexico’s navy that was established in 2022 to weed out corruption.

In January 2024, COFEPRIS took the unusual step of declaring itself free of corruption, and announced that 43 of its people – among them high-level functionaries -- had been fired following anti-corruption probes. It also revealed that it had installed more than 1,000 cameras in its offices across the country to detect suspicious activity by employees.

Statement (Spanish)

COFEPRIS reactivates scientific committee

Mexico’s COFEPRIS agency said on 5 July that its scientific advisory committee had convened again for the first time in twenty years.

The agency said the committee’s functions are to provide it with technical advice; weigh in on guidance, health policies, institutional issues and regulatory management; provide scientific information regarding possible risks to the population; and propose research topics and develop criteria that can be used to prioritize public health problems.

Although the agency said that the committee had been dormant for decades, documents on COFEPRIS’s website indicate that the committee at least had a published agenda in 2015 and 2017. At that time the committee was said to comprise representatives from a long list of institutions, including universities, government ministries, and agencies.

The agency said in its news release that the members of the reconvened committee include Mexico’s Health Secretary Jorge Alcocer Varela, COFEPRIS head Alejandro Svarch Pérez, and Miriam Loera Rosales, head of evidence and risk management for COFEPRIS, as well as other unnamed scientific and technical experts from government and academia.

The new committee aims to guarantee more transparency and a solid scientific basis for decision-making, according to notes in its latest agenda, which was published in May. On its schedule for July are meetings related to a new user guide to the common technical document, or CTD; guidelines on nitrosamine impurities in drugs; and a question-and-answer guide on good manufacturing practices for pharmaceuticals.

Statement (Spanish)

Brazil revises its SOP for medicines

The Brazilian Health Agency (ANVISA) published on 11 July its new standard operating procedure for medicines that seeks to reduce the back-and-forth between the agency and companies seeking registrations and renewals of drugs.

The comprehensive SOP stratifies procedures by the risk class of product and allows lower-risk categories to proceed with fewer requirements. The agency said in a news release that it expects to see an approximately 30% reduction in required documentation and communications between regulated parties and the agency.

Document (Portuguese)

Dominican Republic says approvals now take two weeks

Regulators in the Dominican Republic say that the processing time for a new drug approval or renewal has been reduced to an average of 2 weeks, down from more than 300 days, thanks to reforms initiated in 2021.

In a statement issued 10 July, the government said a series of 2021 rule changes, collectively dubbed “Zero Bureaucracy,” have allowed officials with the country’s General Directorate of Medicines, Food and Health Products (DIGEMAPS) to become vastly more efficient, in part by granting medicines approved by the US Food and Drug Administration or the European Medicines Agency virtually automatic approval in the country.

Statement (Spanish)

Chile tables bill aimed at combating illegal medicine sales

On 4 July, during a meeting of Chile’s Senate Health Committee, Chilean Health Minister Ximena Aguilera told legislators that a bill meant to ban the irregular sale of medications and stiffen penalties for offenders should be effectively tabled, according to BioBioChile.

The proposed bill, which had been deemed urgent, would impose fines and jail time on people selling pharmaceuticals outside legal channels. In Chile, the designation of a bill as urgent means it must be debated within weeks of being introduced.

The reclassification of the bill from urgent to non-urgent meant that it would not likely be debated or voted on anytime soon. The Aguilera did not offer senators any reasons for the decision to reclassify the measure, leaving observers puzzled. Chile’s Public Health Institute (ISP) had been the key driver of the proposed legislation.

One senator, Juan Luis Castro, expressed frustration with the government’s move and demanded that the bill be re-classed as urgent. Illegal traffic and falsification of medicines “is extremely serious,” Castro told senators, and “has tripled in recent years,” making stronger legislation a necessity. In April, when the stiff penalties were first proposed, Chilean health officials told legislators that illegal medication sales had grown by tenfold and that robbery of trucks carrying medicines had increased fourfold.

BioBioChile (Spanish)

Latin America Roundup: Mexico’s COFEPRIS uncovers collusion scheme involving third-party lab

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