Latin America Roundup: Brazil law restores five-year limit on free study drugs

For more than a decade, Brazil’s clinical trials laws have been unusually generous to trial participants, stipulating that they continue to be provided with free study drugs indefinitely if they are shown to be effective. However, a sweeping clinical trials reform, which came into effect in August 2024, specified certain conditions under which a trial sponsor could stop providing free study medications (RELATED: Brazil’s clinical trials law strengthens participant protections, Regulatory Focus, 11 June 2024).

Conditions include when the drug becomes available in Brazil’s public health system and when it has been approved and on the market in Brazil for five years. In a move heavily criticized by industry, Brazil’s president vetoed the five-year provision at the time of the law’s passage. On 17 June, Brazil’s congress overrode that veto, and the law’s original language will now apply.

“With this change, the Brazilian market is expected to become more attractive for conducting clinical trials,” wrote analysts with the Brazil-based law firm Licks Attorneys on 23 June in Lexology. The analysts also predicted that judicial disputes would emerge from trials launched during the 10 months the veto was in place.

Analysis

ANVISA tightens prescribing rules on GLP-1s

As of 23 June, GLP-1 agonist drugs, a class of agents used in the treatment of type 2 diabetes and obesity, are subject to the same tightened prescription rules as antibiotics and other medications that have the potential for off-label use and overuse.

In an open letter published this February, Brazilian endocrinology and diabetes associations urged the Brazil Health Regulatory Agency (ANVISA) to curb the prescribing of these agents. Two months later, ANVISA announced that it planned to implement new restrictions, citing high rates of semaglutide, liraglutide, and other GLP-1 drugs being used outside approved indications.

According to a report in the Brazilian news outlet Diário da Manhã, ANVISA’s pharmacovigilance system found that 32% of adverse events reported for these drugs occurred with off-label use. Pancreatitis cases comprised nearly 6% of adverse events seen with off-label use in Brazil.

Patients must present now two copies of their GLP-1 prescriptions to pharmacists. One copy must be retained by the dispensing pharmacy, as is currently the case with antibiotics in Brazil, and prescriptions remain valid for only 90 days.

ANVISA statement

Medical devices a focus of BRICS forum

Representatives of BRICS nations met with Brazilian device manufacturers and regulators at a 13 June meeting in Brasilia hosted by ANVISA to discuss regulatory reliance objectives in the device sector, according to a report in the Brazilian business media outlet Editora Roncarti.

Representatives of the device industry group ABRAIDI, who attended the meeting, summarized for participants the current state of Brazil’s device market, now valued at $15 billion per year. According to ABRAIDI, some 45% of all devices in Brazil are imported, mainly from the US and Europe. Sergio Madiera, ABRAIDI technical director, told Editora Roncarti in an interview that Brazil could also consider importing “low-risk, high-consumption products” from Asian members of BRICS, while cautioning that these countries “are not yet in a position to offer high-technology medical devices, with the exception, perhaps, of China.”

Madiera also drew attention to ANVISA’s current challenges, including “progressively deficient staffing” that threatened to stymie its recent advances in deregulation, reliance initiatives, and other areas. Brazil, Russia, India, China, Indonesia, Egypt, Iran, the United Arab Emirates, and South Africa are the current members of BRICS, which seeks to promote cooperation among Global South countries. Another 10 nations, most recently Vietnam, have joined the group as partner countries, allowing them to participate in meetings but not vote.

Report (Portuguese)

Device group credits COFEPRIS for thriving production in Mexico

Smoother and faster regulatory processes have helped boost medical device production in Mexico, the head of the country’s device trade group, AMID, told the Mexican news outlet La Silla Roja. João Carapeto, who is also the director of diagnostics for Roche in Mexico, said that thanks in part to processing improvements at the Federal Commission for the Protection Against Health Risks (COFEPRIS), Mexico now counts US$15 billion in annual device output, with much of that being exported to the US. Estimates of Mexico’s device production vary, with one recent analysis valuing it at $12 billion annually.

Article

Mexico’s medicines procurement plan favors firms with more “physical” investment

Mexico’s next consolidated public purchase of medicines for the public health system, slated to start in 2026, includes include a requirement that suppliers have “physical investment in Mexico in any part of the value chain,” whether manufacturing, warehousing, research, or innovation, according to a 12 June report in Lexology by attorneys from the law firm Basham, Ringe y Correa. Importantly, the level of physical investment “will be treated as an objective criterion for awarding technical and economic points in procurement procedures,” the Basham attorneys wrote. As part of the plan, COFEPRIS “has been instructed to expedite key processes, including [health] registrations, import permits for raw materials, and export certificates” for the products purchased.

Report

Venezuela unveils new digital platform

Venezuela’s Autonomous Health Control Service (SACS) is seeking to speed authorization requests and other processes through an updated online platform, according to a 28 June report in the Venezuelan media outlet 2001 Live. Through the Automated Information System for Health Control (SIACv2), accessible through the regulatory agency’s website, users can “execute a wide range of functions,” including soliciting permits for healthcare businesses and electronic certificates of free sale for medicines. Users can also check the status of processes, upload documents, and pay user fees through the platform.

Report (Spanish)

PAHO lends support to Uruguay agency effort

Uruguay’s ongoing push to create an autonomous medicines agency has received support from the Pan American Health Organization, which took part in a recent meeting that included representatives of about 80 entities from across Uruguay’s health world, according to a 20 June statement from the office of Uruguay’s president. In a press conference, health minister Cristina Lustenberg, the effort’s champion, made clear that a primary goal of an independent agency is to make medicines and procedures more accessible and affordable to the population. Lustenberg cited several of what she called “inadmissible” current prices for procedures and medications in Uruguay. PAHO actively supports regional efforts to improve regulatory capacity across Latin America and the Caribbean. In mid-June, the organization hosted the 16th annual meeting of RedETSA, a collaborative network of 38 regulatory authorities, in Buenos Aires.

Statement (Spanish)

Latin America Roundup: Brazil law restores five-year limit on free study drugs

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