Latin America Roundup: Mexico’s top regulator to depart this fall

Alejandro Svarch Pérez, head of Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS), will leave the agency before October to lead IMSS-Bienestar, the branch of Mexico’s Social Security Institute that provides free healthcare and medication to some 50 million Mexicans without other forms of coverage.

The announcement was made by Mexico’s incoming president, Claudia Sheinbaum, who will take office on 1 October.

Svarch Pérez, a 35-year-old physician, had already held various public health leadership positions in México when he took the helm of COFEPRIS in 2021. Later that year, Mexico became the second Latin American country after Brazil to join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Svarch Pérez has been credited with implementing anti-corruption and digitalization strategies and has aggressively promoted regional regulatory harmonization initiatives aimed at assuring better public access to medicines and helping Latin American health systems become more resilient both to future pandemics and global market forces.

Svarch Pérez had also championed the creation of a pan-Latin American medicines agency, a project that has largely stalled, though one offshoot of the effort was the establishment of a regional school for health regulation in Mexico. Under his leadership, COFEPRIS has worked closely with companies on regulatory certainty, sped up some of its processes – though long delays are still common – and promoted domestic clinical trials. The agency has yet to name Svarch Pérez’s replacement.

Announcement (Spanish)

Brazil eases rules for mpox vaccines

The Brazil Health Regulatory Agency (ANVISA) said 22 August that it had reissued a rule simplifying registration and importation of medicines and vaccines for the prevention or treatment of mpox disease. In addition, it said that Brazil is attempting to develop its own mpox vaccines.

The first measure comes in response to the World Health Organization’s 14 August declaration that the spread of novel mpox variants in Africa constitutes a Public Health Emergency of International Concern (PHEIC).

Medicines and vaccines purchased by Brazil’s health ministry will be exempt from usual processes on a provisional basis if the products have been approved for the same indications by trusted regulatory agencies outside Brazil, ANVISA said. The trusted agencies include the World Health Organization and the European Medicines Agency, as well as the national authorities of Canada, Japan, the US, and UK.

“With the approval of the regulation, ANVISA aims to simplify documentation and speed up the import process, in order to facilitate the Brazilian population’s access to medicines or vaccines,” the agency said.

A day after the WHO emergency was declared, ANVISA announced it had formed an emergency committee to monitor the mpox threat. Of the approximately 700 cases of mpox reported to date in Brazil, none have been determined to be caused by the new variant, known as clade 1b, that is circulating in the Democratic Republic of Congo and has been detected in several other countries in Africa, as well as in Sweden and Thailand.

On 20 August Brazil’s government news agency reported that the Federal University of Minas Gerais, in Bello Horizante, Brazil, was working on a domestically produced mpox vaccine, an initiative that began two years ago with the help of the US National Institutes of Health.

On 26 August, ANVISA reported that it was investigating an imported mpox case in a Brazilian airport, but this was later deemed more likely to be chickenpox.

ANVISA statement (Portuguese)

Mexico, PAHO host harmonization meeting

The 11^th Pan-American Conference on Harmonization of Pharmaceutical Regulations (CPARF) took place 21-23 August in Mexico City.

At the meeting, sponsored by the Pan-American Health Organization (PAHO), regulators from the Americas discussed regulatory reliance, a concept some view as less about reducing burdens on industry than creating regulatory mechanisms to protect against emerging disease threats and keep public health systems stocked with affordable, quality medications.

At the meeting, the first to be held in person since the COVID-19 pandemic, Svarch Pérez, the outgoing head of COFEPRIS, said that the members of the CPARF network needed to focus on making decisions based on the highest quality scientific evidence. A “trusted regulatory space,” he said, would offer “broader and faster possibilities of access to supplies authorized by other health authorities.” The region’s national health systems and industry should share the goal, he said, of prioritizing “the protection and attention of real health needs.”

Francisco Rossi, the head of Colombia’s National Institute for Food and Health Surveillance (INVIMA), used the meeting’s opening plenary session to argue for an activist role for Latin American regulators, rejecting the concept of regulation as purely technical. Rossi, an outspoken critic of the global pharmaceutical industry, complained of a reliance structure in which low-income countries are encouraged to ratify decisions by regulators in high-income countries as “a colonial inheritance,” resulting in pressure to approve costly or unnecessary medications. Regulators should be involved in decisions about pricing, Rossi argued.

At the same plenary session, Michelle Rodriguez, director of the U.S. Food and Drug Administration’s Latin America Office, told the conference that the agency was listening to the concerns of the Latin American regulators, agreeing that “we need a common language on reliance” and “more trust among regulators.” Pushing back against the concept of reliance as a one-way street, Rodriguez noted that a higher degree of reliance would also help regional manufacturers get their products into international markets. In the next pandemic, she said, “we are going to need products from wherever we can get them.”

COFEPRIS statement (English)

Central American regulators meet in Mexico

In the days prior to the CPARF meeting, COFEPRIS, along with Mexico’s development agency, AMEXID, hosted regulators from all seven Central American countries, plus Mexico, Colombia and the Dominican Republic, for workshops on improving training and technical expertise for regulatory agency employees. At the meeting, part of a collaboration effort begun in 2022 in response to the region’s difficulties during the COVID-19 pandemic, participants discussed marketing authorizations, inspections, laboratories, devices, and surveillance, the Mexican agency said 14 August.

COFEPRIS statement (Spanish)

Honduras, Argentina agencies sign MOU

During the CPARF meeting, Honduras’s Health Regulation Agency (ARSA) and Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) signed a memorandum of understanding to further information exchange, training, and best practices, ANMAT said 22 August.

ANMAT statement (Spanish)

Latin America Roundup: Mexico’s top regulator to depart this fall

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