Latin America Roundup: Argentina president announces intent to withdraw from WHO

Following the example set by US President Donald Trump in January and using similar incendiary rhetoric about COVID-19 pandemic lockdowns, Argentinian President Javier Milei has announced that Argentina plans to withdraw from the World Health Organization (WHO).

The president’s announcement was made on social media 5 February without corresponding legislation or a formal declaration of emergency, as Argentine law demands. In a post on X, Milei slammed WHO as the “ideologues” behind the widespread quarantines, which he called “a crime against humanity.”

Milei’s statements were reportedly made without consultation with Argentina’s medical societies, public-health entities, or even its health minister, Mario Lugones, who described the proposed withdrawal in a news conference as “a decision made by the president.” Former national public health officials and current heads of regional health agencies warned of serious consequences stemming from ending epidemiological information-sharing and other forms of collaboration with WHO and the Pan-American Health Agency, an entity that serves as WHO’s regional office for the Americas. In social media posts, Lugones argued that Argentina received no direct funding from WHO and that its cooperation agreements with PAHO would remain standing, even as Argentina moved forward with a WHO withdrawal.

Argentina became a member of WHO in 1948. It currently acquires about 80% of the vaccines used in its national immunization program through PAHO’s Regional Revolving Fund and relies heavily on PAHO’s Strategic Fund to purchase lower-cost medicines and supplies for its public health system. Several of Argentina’s epidemiology and health research centers are active collaborators with WHO and PAHO. As of 30 January, Argentina was scheduled to pay WHO dues of approximately $8 million for 2024-2025.

PAHO and WHO have actively helped shape Argentina’s regulatory climate. In 2009 Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT) became PAHO’s first listed national regulatory authority of regional reference, a designation that indicates a high level of functioning, following a comprehensive audit.

PAHO has long lent extensive technical support to regulators through regular meetings and workshops, facilitated regulatory report-sharing with other regional agencies, and helped shape good manufacturing practices guidance for Argentina’s pharmaceutical industry. PAHO has also worked on drug and device harmonization initiatives with ANMAT. Recently, PAHO and ANMAT announced a novel collaboration to manufacture a Pfizer pneumococcal vaccine in Argentina.

COFEPRIS names deputy commissioners

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has named four new deputy commissioners, all of them experienced regulators or public health professionals, to manage different functions at the agency.

In a statement issued 31 January, COFEPRIS said that Rafael Hernández Medina, a key architect of Mexico’s regulatory harmonization efforts and for more than two decades helped edit the country’s pharmacopeia, will now oversee authorizations and approvals. Health promotion will be headed by Isabel Amalia González Flores, who has extensive experience in government and has collaborated with international organizations on the advancement of regulatory frameworks. Imelda Rocío Guzmán Cervantes, a 15 -year veteran of the agency’s laboratory division, will oversee technical analysis, while risk management will be administered by María Esther Díaz Carrillo, who previously worked for Mexico’s health secretariat on issues of food export regulations. All the deputy commissioners became active on 1 February.

Under Commissioner Armida Zúñiga Estrada, COFEPRIS has sought to consolidate its expertise, project professionalism, and conduct outreach to industry.

At a recent business conference in Mexico City, Sergio Iván Valdés-Ferrer, director of investigation at Mexico’s health secretariat, told attendees that COFEPRIS seeks to reduce approval times for new products to 40 days, “So that the industry gains credibility and [more investment] in Mexico,” according to a 2 February report in the business news outlet Milenio. Recalling the slow-walked approval processes of Pfizer COVID-19 vaccines under the previous government, “We don’t want this to happen again,” Valdés-Ferrer commented, acknowledging that to achieve such an ambitious reduction in approval times would require COFEPRIS to hire more evaluators. This may be a tall order, as COFEPRIS has seen its budgets slashed by 15% in 2025, according to press reports.

The Mexican pharmaceutical industry appears to welcome COFEPRIS’s new leadership. In early February, after a joint meeting with the agency, representatives of the trade association AMIIF praised Zúñiga Estrada and applauded her lineup of new deputy commissioners, according to media reports.

Statement (Spanish)

ANVISA issues first monitoring reports on gene, cell therapies

The Brazil Health Regulatory Agency (ANVISA) has published the first public reports from its monitoring program for advanced therapies approved for use in the country. In a 27 January statement, the agency said that the reports had been prepared in partnership with their license holders and cover all advanced therapy products registered with ANVISA since 2020, and which count more than a year on the Brazilian market.

Advanced therapies comprise a special regulatory category in Brazil and include cell therapy products, tissue engineering products, and gene therapies developed for serious and rare diseases. As clinical trial data may be less robust than for conventional treatments, they require continuous safety and efficacy monitoring in the post-approval period. Among Latin American countries, only Brazil has a fully developed regulatory and reporting framework for advanced therapies, with Argentina catching up.

The first therapies covered in this round of reports include three gene therapies and three cell therapies.

Paying for advanced therapies is a special challenge in Brazil, where courts are often forced to intervene. On 2 February, ANVISA announced the opening of a public comment period on pricing criteria for advanced therapies, and invited “health professionals, patients, pharmaceutical industry representatives, researchers, government entities and all other interested parties” to weigh in via its website until 28 March.

Statement (Portuguese)

Latin America Roundup: Argentina president announces intent to withdraw from WHO

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