Latin America Roundup: Paraguay merges medicines and food agencies

Paraguay’s president on 31 October signed a law that joins its medicines and foods safety agencies.

The National Directorate of Health Surveillance (DINAVISA) has absorbed the functions of the former National Institute of Food and Nutrition (INANA). The aim of the merger, President Santiago Peña told Paraguayan news outlets, is to avoid redundancies, to increase efficiency, and to improve the government’s ability to respond to public health challenges, as well as to reduce costs.

The merger of two Paraguayan agencies follows a similar move in El Salvador, which this fall joined its medicines and food agencies by creating a new, larger entity.

Statement (Spanish)

COFEPRIS to remain under health secretariat

Despite some legislators calling for it to become an autonomous agency better insulated from political pressures, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) will remain under the authority of the country’s health agency, which is being reorganized under the government of President Claudia Sheinbaum.

A statement published 31 October in Mexico’s official government register lists the agency as among those reporting to Mexico’s health secretariat, led by David Kershenobich.

Though COFEPRIS was founded in 2001 as a “decentralized,” or semi-autonomous, entity under Mexico’s health secretariat, its independence was reduced when, in 2020, it was placed under its direct authority. Since then, some lawmakers have criticized decisions by COFEPRIS, particularly those related to approvals of Covid vaccines, as politically influenced, and proposed reforms that would not merely restore the agency’s former to its former level of autonomy but increase it and change its financing to a self-funded model.

Agreement

Four Latin American agencies join IMDRF

The national regulatory agencies of Peru, Costa Rica, the Dominican Republic, and Paraguay are among the newest affiliate members of the International Medical Device Regulators Forum.

In a statement issued 4 October, the IMDRF reported on the outcome of its September 2024 meeting in Seattle, WA, which included accepting these countries as new affiliate members.

The IMDRF promotes harmonization of standards for medical devices across regions and globally. Like the World Health Organization, with which it works closely, it has a tiered membership structure. Among Latin American regulators, only The Brazil Health Regulatory Agency (ANVISA) has earned a seat on its management committee, along with the US Food and Drug Administration and others.

Peru, Costa Rica, the Dominican Republic and Paraguay join a growing roster of Latin American regulators in IMDRF’s affiliate tier, which already included the agencies of Chile, Cuba, El Salvador and Mexico. Agencies in this category can attend certain meetings and working groups of the IMDRF and may incorporate IMDRF documents into their regulatory frameworks.

In a 22 October statement, officials with Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) asserted that the agency’s affiliate member status will give Peruvians “faster access to innovative medical devices” and “equal conditions for our national [device] industry, which will now be able to compete face to face” in international markets.

In the same statement, Peru health minister César Vasquez was lauded the designation as “a historic milestone for public health in Peru.”

DIGEMID has recently sought to draw attention to its performance and to the pace of its pharmaceutical approvals, noting in October that it had reduced its backlog of approvals and other procedures by more than 90% in the past year.

Statement

Chile, India sign cooperation agreement

Chile’s Institute of Public Health (ISP) has signed an agreement with India’s health ministry to promote cooperation related to manufacturing, best practices, and pharmacovigilance, the Chilean agency said on 21 October.

The pharmacovigilance portion includes provisions, which are not detailed in the statement, for when a pharmaceutical product or device manufactured in either country is found to have problems, the agency said.

Close coordination on medicines between Chile and India dates back more than a decade. As early as 2012, Indian trade delegations visited ISP officials, aiming to smooth the import and approval of more Indian-made generics. In recent years a number of India-made products have been subject to safety alerts or recalls in Chile, including, in October, a brand of oral contraceptives.

Statement (Spanish)

INVIMA director says agency deliberately shuns high-cost drugs

Francisco Rossi, the director of Colombia’s National Institute of Food and Drug Surveillance (INVIMA) made headlines for seeming to acknowledge that his agency was not approving drugs for rare diseases due to cost.

Speaking at a conference in Bogotá on 30 October, Rossi commented that he was frequently asked “why INVIMA takes so long to approve new medications, to approve innovations, and the answer is always very complex. But we always start by saying – and I don’t miss the opportunity to repeat it – ‘because they are very expensive.’”

With prices so high, Rossie continued, such medicines become products “not destined for developing countries – this is not the market for these products. And what’s more, these are markets in which [companies] are able to do clinical trials to identify new indications, new diseases, new niches – but their prices make them an impossibility for us,” he said. Rossi added – seemingly misunderstanding the US healthcare system – that private insurers pay for high-cost medicines in the United States, in contrast to Colombia.

Rossi’s comments generated controversy among patient advocacy groups. “The INVIMA director said three things that cross an ethical line into cynicism,” Denis Silva, spokesman for the advocacy group Pacientes Colombia, told the newspaper El Colombiano. “First, that INVIMA deliberately delays authorizations based on cost; second, the medicines for rare and orphan diseases should not be paid with public resources, and third, that public resources should not be used for innovations.”

Before being formally named INVIMA director this year, Rossi was a deputy director of INVIMA for several months in 2022 and 2023. In March 2023, he was forced to step down following comments that suggested he and then-health minister Carolina Corcho had opted to turn away shipments of foreign-made generics in order to try and bolster Colombia’s domestic pharmaceutical industry. Those comments came amid persistent nationwide shortages of essential medications.

El Colombiano (Spanish)

ANVISA tweaks trial codes for advanced therapies

Brazil’s ANVISA agency said on 21 October that it had created a new coding scheme for clinical trials involving experimental advanced therapies, a change prompted by the recent adoption of a sweeping new law regulating research in human subjects. The updated scheme aims to simplify codes and thereby hasten decisions by the agency.

On 29 October, in response to a different new law, ANVISA announced a list of companies currently authorized to manufacture, import and/or market personalized medical devices in the risk III or IV drug class. For entities wanting to get on that list, the agency updated on needed steps.

Statement 1, 2 (Portuguese)

Latin America Roundup: Paraguay merges medicines and food agencies

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