Latin America Roundup: Argentina medicines agency to undergo systematic review

The mission and operations of Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) will be subject to systematic review and possibly curtailed, Argentina’s government says.

The review was initiated through a resolution issued on 4 June by the nation’s health ministry. It occurs under the auspices of a sweeping 2024 law giving the country’s executive branch, led by President Javier Milei, broad emergency powers to restructure the government and reduce its scope.

According to a 5 June statement by the ministry, the ANMAT review was inspired by meetings in May with US health authorities, including Secretary of Health and Human Services Robert F. Kennedy Jr. The goal is “to reduce unnecessary bureaucracies and promote a more agile and results-oriented” agency, the health ministry said. A three-person committee appointed by the ministry will conduct the review.

Argentina’s cancer, agricultural safety, technology, and aviation agencies also face similar review processes, according to media reports.

Statement (Spanish)

Uruguay’s proposed medicines agency is named

Uruguay has settled on a name for its nascent national regulatory agency. A detailed proposal for an Agency for the Evaluation, Regulation, and Surveillance of Health Technologies (AUVISA) has been formally submitted to country’s health minister, Cristina Lustenberg, by academic pharmacologists at the country’s leading public university who have been tasked with the agency’s planning.

The future agency, according to a 15 June report in Uruguay’s Diario La R, “will operate under the leadership of the health ministry, but independently, without political or financial interference” and will absorb the functions of the country’s existing quality control laboratories for medicines, which are currently supported by the government’s general fund.

AUVISA projected to become self-sustaining after an initial investment by the state, supported by user fees and taxes on exports and sales. Among its key goals is to facilitate the export of locally manufactured medical products by aligning regulatory standards with those of purchasing countries. A further goal is to help create a national vaccines institute with production for domestic use and exportation, the report said.

The 40-page proposal has not been released by the government, though a copy was published online on 14 June by El País, which noted that AUVISA’s annual budget for salaries, as laid out in the proposal, would be USD $13 million per year for 250 employees. This figure attracted criticism from the project’s opponents, who have characterized the proposed agency as costly and redundant.

Uruguay is one of a handful of Latin American countries lacking a dedicated medicines agency. A previous government’s effort to launch one in 2020 failed, according to El País.

Unregistered HPV vaccine sparks alert in Mexico

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) issued an alert to health professionals and the public on 4 June about unregistered vaccines against human papilloma virus (HPV) circulating in the country.

The agency reported the lot numbers of the suspect products. It urged clinics to suspend use of any product not labeled in Spanish and advised the public not to seek vaccination with HPV vaccine marketed by Merck Sharp and Dohme as Gardasil, until further notice.

The alert came after information received from Gardasil’s distributor in Mexico. The agency did not make clear whether the suspect lots – labeled in English – were falsified or merely diverted into the country from other intended markets. A public health expert in the Mexican state of San Luis Potosí told the local news outlet El Exprés that the suspect vaccines were almost certainly falsified and that some had already been offered to private clinics.

The alert represents the second time in less than two years that COFEPRIS has warned about lots of diverted or falsified vaccine labeled as Gardasil. In August 2023, a similarly worded alert was issued.

Falsified and unauthorized medicines are extremely common across Latin America and can make their way into clinics. Just this this month a large underground laboratory was discovered in Peru, according to media reports, with more than five tons of unauthorized medical products confiscated, including many labeled as common antibiotics and anti-inflammatory drugs.

Also in June, regulatory authorities in Ecuador confiscated nearly 5,000 medical devices stored in a private hospital. The devices, including surgical screws and plates, were unregistered and likely also bootlegged. Regulators with Ecuador’s National Agency for Health Regulation, Control and Surveillance (ARSCA) said that they had received a tip about the products through an agency phone app.

COFEPRIS (Spanish)

Colombia extols public production of chloroquine

The office of Colombia President Gustavo Petro on 13 June announced that the essential medication chloroquine, used in the treatment and prevention of malaria, has been manufactured in the country for the first time thanks to a novel collaboration agreement, announced in 2023, between the government and a public university.

The national production of chloroquine at a public manufacturing plant “implies a reduction in our dependence on international markets as we strengthen scientific capacity, industrial technology and regulatory [capacity],” the president’s office said in a statement.

The product, comprising 150 mg tablets, will be marketed under the auspices of the University of Antioquia, in Medellín, which oversees the only public plant authorized by the country’s medicines agency, the National Institute for Food and Drug Surveillance (INVIMA). Currently the university plant can only manufacture solid, nonsterile tablets, and is focusing on producing a limited profile of generic anti-parasitic medications.

The new chloroquine product has yet to be registered with INVIMA, but the university projects that, once it is, 1.3 million of the tablets will be produced by the public plant per year. Colombia is a malaria endemic country with approximately 70,000 cases reported annually.

Statement (Spanish)

Latin America Roundup: Argentina medicines agency to undergo systematic review

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