Latin America Roundup: COFEPRIS to prioritize review of mass-purchased medicines

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has thrown its weight behind a new national drug procurement scheme, saying it will prioritize the review of products mass-purchased for public-health channels.

Under the new model, unveiled by President Claudia Sheinbaum in late October, Mexico will make its largest consolidated drug and medical supplies purchase ever, with a budget reported to be US $6.4 billion for the first year.

Much of the impetus behind the effort is averting the drug shortages that have plagued Mexico in recent years, leading to protests. Large drug purchases by the previous government, and a previous procurement arrangement with a United Nations agency, all suffered from logistical failures and transparency issues that this government says it has taken steps to avert.

Already, the key institutions in Mexico’s public healthcare system have weighed in with their requests for medicines and supplies, and the public comment period has ended. The next step, to be completed by yearend, is the public tender and awarding of contracts, with delivery expected to start in March 2025.

In a statement issued 5 November COFEPRIS, now led by agency veteran Armida Zúñiga, said that the agency was participating in “the entire consolidated purchasing process,” starting by identifying currently registered products among those to be procured. While non-approved products may be requested by institutions, none will make it into public-health channels without COFEPRIS review.

Once the purchase is complete, COFEPRIS “will attend to the import permits for the designated products and will provide priority attention to regulatory issues that may arise,” the agency said, adding that its work would “strengthen the coverage of the universal vaccination program,” replace obsolete equipment in hospitals and clinics, and help guarantee the availability of free medications through public health channels.

Statement (Spanish)

Central American regulators meet in Mexico

On 15 November, COFEPRIS reported that it had hosted a five-day meeting for regional regulators interested in harmonizing their countries’ pharmacovigilance strategies.

The meeting was attended by regulators from Mexico, El Salvador, Panama, Costa Rica, Honduras, the Dominican Republic, and Belize as well as officials with the Pan-American Health Organization (PAHO). Workshops and talks focused on “good information management practices, experiences in drug coding, and risk analysis that allow for timely decision-making,” according to a summary of the meeting published by the health news outlet ConsultorSalud. Reporting protocols for adverse effects and medication errors were also among topics covered.

Under its current leadership, COFEPRIS appears to be maintaining a strategy of active regional outreach similar to that championed by its previous director, Alejandro Svarch Pérez.

Statement (Spanish)

INVIMA clarifies director’s controversial statements on orphan drugs

In late October Francisco Rossi, the director of Colombia’s National Institute for Drug and Health Surveillance (INVIMA), implied in public comments that the agency deliberately stalled approvals of high-cost drugs for rare diseases, sparking an outcry among patient advocates and calls for Rossi’s resignation.

On 7 November, INVIMA published a detailed statement decrying “disinformation” about its position on these medications. “INVIMA does not delay or reject innovations because they are expensive, but because the approval mechanisms are not as reliable as desired,” the agency said, noting that in the United States and Europe, fast-track approvals are made possible by strong pharmacovigilance mechanisms that are lacking in less-developed countries.

INVIMA cited the cases of two fast-tracked, yet ultimately flawed treatments: PTC therapeutics Translarna (ataluren) for Duchenne muscular dystrophy and AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib), which is used in certain blood cancers. The Colombian system spent about US $5 million on Ataluren before postmarketing studies failed to confirm clinical benefit, and the European Medicines Agency did not renew its approval. And while ibrutinib was widely used for lymphoma in Colombia, INVIMA said, in 2023 the US Food and Drug Administration requested that the manufacturer withdraw its lymphoma indications over failure to confirm efficacy in the postmarketing period.

“Global experience does not suggest that all innovations coming from [other] countries are good, nor that the way they were approved can be extrapolated to our realities,” the agency said.

Statement (Spanish)

Uruguay urges solutions to ‘judicialization’ of high-cost treatments

Speaking to her counterparts from Chile, Bolivia, Argentina, Paraguay and Brazil, Uruguay’s health minister, Karina Rando, advocated for more international dialogue on the use of lawsuits seeking access to medical treatments and pharmaceuticals, a common practice across Latin America.

Rando was speaking to health ministers in MERCOSUR, a group whose members include the countries in South America’s Southern Cone as well as Venezuela. PAHO officials also attended the meeting.

So-called judicialization of healthcare “is a problem that puts the region’s health systems under pressure due to the financial impact and the limitations it generates to guarantee effective therapies,” Rando said in the meeting, and stressed the need to seek solutions that promote fair access to treatments and reduce judicialization.

Statement (Spanish)

ANVISA creates AI tool for impurities

The Brazilian Health Regulatory Agency (ANVISA) said on 8 November that it had developed an AI tool that would “optimize the analysis of qualification studies on the limits of impurities and degradation products” in medicines.

The tool, ANVISA said, would allow for “faster identification of impurities” by allowing them to be compared to levels in products previously analyzed by the agency. In addition, the agency said, “the tool will enable the grouping and systemization of data on impurities, offering information in a more structured way to assist ANVISA’s decision-making.”

Statement (Portuguese)

Costa Rican regulators meet with FDA on device harmonization

Officials with Costa Rica’s health ministry met with FDA representatives to discuss implementing guidelines set by the International Medical Device Regulators Forum, which Costa Rica joined in October as an affiliate member.

The collaboration “underscores Costa Rica’s commitment to continually improve its processes as a regulatory authority,” the ministry said in a statement issued 8 November, and increases the country’s capability to respond to future health emergencies.

“With the technical support of the FDA, Costa Rica is positioned to advance in the modernization of its regulatory system,” prioritizing efficiency and productivity through “cutting-edge” regulatory approaches, the ministry said.

Statement (Spanish)

Latin America Roundup: COFEPRIS to prioritize review of mass-purchased medicines

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