Latin America Roundup: Zúñiga named new head of COFEPRIS

Armida Zúñiga Estrada, a veteran regulator with Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS), has been selected by Mexican president Claudia Sheinbaum to lead the agency.

A pharmacist and biologist, Zúñiga Estrada was not among the rumored top picks for the job, which has come to be seen as increasingly important by Mexico’s political and business classes. Recently the conservative National Action Party (PAN) disseminated across its media outlets a list of qualities it hoped a new COFEPRIS head should have, among them at least 8 years of regulatory experience. PAN legislators are also seeking reforms that would increase the agency’s autonomy, alleging that its past decisions over COVID-19 vaccines had been influenced by presidential politics.

Zúñiga Estrada counts a decade of years of service at COFEPRIS under two previous presidential administrations; Sheinbaum’s will be her third. She was previously the head of the agency’s analytical division, which oversees a network of laboratories and directs safety and efficacy testing of pharmaceutical products and medical supplies.

Read more in El Economista (Spanish)

Latin American patients slow to access new drugs: report

Patients in Latin America wait nearly five years, on average, to gain access to novel therapies, according to the latest report by the pharmaceutical trade group FIFARMA.
The group’s 2024 Waiting to Access Innovative Therapies (WAIT) report, published 9 October, looked at wait times for 365 molecules following their approvals in the United States or Europe over the past decade. The countries covered in this year’s report were Argentina, Brazil, Chile, Colombia, Costa Rica, the Dominican Republic, Ecuador, Mexico, Panama, and Peru.

Wait times from EU or US approval to local approval averaged 33 months across the included countries, FIFARMA found, and from approval to access an average of 2 years. The Dominican Republic and Brazil saw the fastest times to approval, at 22 and 23 months, respectively. Costa Rica saw the fastest time between local regulatory approval and listing on the national formulary, at 3 months.

This is the third year in a row that FIFARMA has reported on wait times in Latin America. The new report carefully stratifies, with information specific to each country, the degree and type of access to drugs. It details whether patients can purchase new medicines on the open market, receive them for free through public health systems, and/or obtain them by other means (such as judicial petitions). It also looks at specific categories of medication, including neurology, oncology, immunology, and central nervous system medications, as well as orphan drugs.

Andre Ballalai of IQVIA, the pharmaceutical research and consulting firm that conducted the report for FIFARMA, said in a video presentation that Colombia saw the highest level of access to new oncology drugs among all the countries studied, while Brazil saw the lowest, with only 4% deemed to have full availability – meaning broad, national reimbursement through public channels. Brazil’s wait times to approval for cancer drugs was relatively short, but access to those agents lagged, Ballalai explained. Colombia saw the opposite scenario, he said, with drugs taking longer to approve but meaningful access occurring faster afterward. In no country that the study looked at were oncology drugs the fastest medication class to become available.

Long wait times and limited access to novel therapies are nothing new in Latin America; indeed, times remain similar to those described in FIFARMA’s 2023 report, with the vast majority of molecules seeing no changes in approval or availability over the past year.

The study authors made note of a discordance between an increasing number of new molecules receiving approval in the US or EU and the Latin American regulators’ pace in evaluating them. However, some 13% of molecules did see improvements in their degree of availability from 2023 to 2024, they noted. “This shows that paths to availability exist, however, it is a challenge to navigate them, with many molecules remaining static,” the report found.

Report

Brazil court rules on high-cost medications

Brazil’s Federal Supreme Court has reached an agreement with state courts on reimbursement for high-cost medicines that have been approved by the Brazilian Health Regulatory Agency (ANVISA) but are not covered in the public health system.

The agreement, signed 17 October, stipulates that cases in which patients demand to be treated with very high-cost medicines (approximately US $52,000 or more), must be heard by federal courts.

Cases involving non-covered but approved treatments that are somewhat lower in cost (between approximately $1750 and $52,000) can be heard by state courts. Even where cases are decided by the states, reimbursement for such treatments fall mostly on the Brazilian government, according to a report in the public media outlet Agência Brasil, with 65% of the value of non-cancer treatments, and 80% of the value of cancer treatments, to be paid for with federal funds.

At the signing, Justice Luís Roberto Barroso stated that the agreement was important because “the judicialization of health has emerged as one of the Brazilian judiciary’s most significant challenges, [and] likely one of the most complex, as it presents issues that lack straightforward legal or morally affordable solutions.”

Report (Portuguese)

Honduras announces solicitation process for new pharmaceutical lab

The Honduran government says it plans to create a new pharmaceutical laboratory, which will be run by and serve the national Health Regulation Agency (ARSA), in the town of Quimistán, Santa Bárbara, according to an official statement issued 14 October. Its budget and projected opening date are unknown.

Mary Vallecillo, a scientific advisor to the Honduran president who was quoted in the statement, said that the lab complex will facilitate local production of medicines, and perform genetic analyses and diagnostics not yet available in the country.

ASRA director Dorian Salinas told a Honduran news outlet that the lab would have “advanced technology to guarantee compliance with the highest quality standards in the control of health products,” and called the project a “milestone” for Honduras.

Statement (Spanish)

Latin America Roundup: Zúñiga named new head of COFEPRIS

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