Latin America Roundup: Brazil approves skinny labeling

Officials with the Brazil Health Regulatory Agency (ANVISA) on 6 December voted to permit the removal of patented indications from generic drug labels, in a practice known as skinny labeling. The exemption to a 2009 drug labeling rule will soon allow labels for reference and generic products to differ. Generic labels that omit patented indications must disclose having done so, according to the updated rule, with language stating that “information referring to the patent-protected indications of the drug has been suppressed.”

ANVISA has debated whether to allow skinny labeling for at least a year. During the 6 December deliberations, Director, André Barra Torres expressed that the agency supported the exemption as a way to improve access to healthcare, not to challenge the rights of patent holders or encourage off-label prescribing, according to reports by patent lawyers in Brazil. Nonetheless, the exemption “represents a drastic change in the ANVISA’s official stand on skinny labeling and could significantly impact the enforcement of ‘use’ patents in Brazil,” lawyers with the Rio de Janeiro-based firm Licks Attorneys wrote in a post on Lexology, a global legal intelligence platform.

Lexology

Colombia strikes vaccine manufacturing deal with China’s Sinovac

On 5 December Claudia López, the mayor of Bogotá, Colombia, announced from Beijing an agreement with Chinese vaccine maker Sinovac to create what she described as the country’s first human vaccine manufacturing plant. The deal, which creates a new entity called BogotáBio, will aid “recovery of our health sovereignty of the city and country” and help Colombia to be better prepared for future pandemics, López said in a statement.

A $100 million Sinovac plant was originally slated to be built in Chile. However, negotiations between the Chinese firm and Chilean officials fell through in 2022, with conflicting reports as to the cause of Sinovac’s withdrawal. In a December 7 statement from Sinovac, its chief executive, Weidong Yin, commented that the new Colombian facility would serve not only Colombia “but also will contribute to disease prevention and control across the Latin American region.”

Vaccines against varicella, hepatitis, influenza and polio are expected to be manufactured at the BogotáBio plant, according to a 15 December report in the business journal La Republica, which obtained an interview with Helen Yang, chief business officer at Sinovac. The news outlet also reported that BogotáBio would cost $300 million, triple the investment that had been projected for Chile.

Colombia was among the first countries to authorize Sinovac’s COVID-19 vaccine, granting it emergency use approval in 2021. While the BogotáBio may end up manufacturing the first human vaccines in Colombia, a separate Colombian firm, VaxThera, owned by the large health insurer Sura, is also developing capacity, with construction on its manufacturing facility expected to be completed this month. The stated aim of VaxThera, established in 2021, is also to improve the country’s health sovereignty following the COVID-19 pandemic. The company says it will produce vaccines against dengue, chikungunya, yellow fever, influenza and zika.

Sinovac statement

Mexico grants full marketing approval to two COVID-19 vaccines

After months of heated rhetoric, uncertainty and delays, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) announced 7 December that it had simultaneously granted full marketing approval to Pfizer’s Comirnaty and Moderna’s Spikevax, two vaccines developed against the XBB 1.5 Omicron strains of the SARS-CoV-2 virus. The approvals represent the first time since the start of the pandemic that COVID-19 vaccines have been evaluated for commercial sale in Mexico, rather than emergency use.
The Pfizer products have arrived in the country, according to news reports, while the Moderna products are expected before year end. The prices of the vaccines, which are not likely to be included in Mexico’s public vaccination campaign for 2023 and 2024, are not yet known, and the agency cautioned that any vaccines outside the auspices of the government program be received only under “strict recommendation” by medical professionals.

COFEPRIS statement (Spanish)

Brazil, Mexico seek to speed approvals for clinical trials

On 29 November, Brazil’s legislature approved a sweeping bill outlining how clinical research is to be conducted in the country, detailing participants’ rights and sponsors’ obligations. According to a summary analysis by attorneys with the DLA Piper law firm, the bill also provides for a major restructuring of Brazil’s ethics and review committees, bringing them closer in line to US and European models and shortening agency deadlines for analysis and approvals. The tighter regulatory deadlines outlined in the new bill, the attorneys wrote, should promote “a considerable increase and acceleration in the conduct of clinical research in Brazilian territory, benefiting not only patients but the entire health sector.”

Latin American countries, despite having many qualities that make them attractive for clinical research, are plagued by slow approval times for trials. On 6 December, Mexico’s COFEPRIS announced that it had dispensed with physical paperwork and in-person meetings related to proposed clinical research in human subjects. Its digital trials platform “optimizes the evaluation times of procedures” to minimize delays, and “allows the processing of requests for new protocols and changes to those already authorized,” the agency said.

COFEPRIS statement

New top regulator in Ecuador

Physician Daniel Sánchez Procel, an infectious disease specialist who has served as a hospital director and in different public health roles in recent years, was named the new head of Ecuador’s Regulatory, Surveillance and Control National Agency (ARSCA) on 6 December. Dr. Sánchez previously worked for the agency as a technical coordinator for vigilance. He replaces attorney Ana Karina Ramírez, who had led the agency since May 2021.

ARSCA statement (Spanish)

Latin America Roundup: Brazil approves skinny labeling

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