Latin America Roundup: COFEPRIS hosts FDA delegation with focus on devices, platforms

Regulatory Focus is pleased to announce a new biweekly Latin America Roundup focused on regulatory issues in Latin America and the Caribbean. If you have any tips or stories we missed, please send them to [email protected].

Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) hosted a meeting in February with officials from the US FDA, including Katherine Serrano, the agency’s Latin America director. The focus of the meeting was increasing collaboration on device regulation, according to COFEPRIS.

The Mexican agency, led by Alejando Svarch Pérez, said in a statement that it aims to “align regulatory frameworks and participate in the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP),” and also highlighted to the FDA officials the success of its digital platform DIGIPRiS, which, since its launch last year, has fielded some 52,000 requests, including for modifications and extensions of sanitary registrations and certificates of free sale, in an effort to lighten bureaucratic backlogs and paperwork as well as reduce opportunities for corruption.

These and other categories of requests are now handled through the platform, which has reduced the lag on some decisions, the agency told US FDA officials. For example, evaluation time for first extension for a pharmaceutical product is now 76 days, down from 356.

COFEPRIS

COFEPRIS report promises more streamlining and regulatory certainty

Early this year COFEPRIS outlined in a comprehensive white paper its broad regulatory aims for 2023 and beyond, stating that its overwhelming objective is “to provide regulatory certainty to companies in the pharmaceutical sector in order to offer medical innovations and productive development to the Mexican market.”

In 2021, Mexico became a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The country’s proximity to the United States, skilled labor force and access to regional and domestic markets all give it the potential to “become an enabling environment for scientific innovation in health,” the officials wrote, while conceding that its current regulatory framework “does not create the ideal conditions to allow the effective entry (from the clinical phase to obtaining marketing authorizations) of new innovative treatments, biosimilars or interchangeable generics.” Current policy aims to “reduce entry barriers to the Mexican market,” and “eliminate technical obstructions to trade that have been generated by our country’s regulations,” the agency said.

COFEPRIS said that it would produce a report on regulatory improvements and compliance in the first quarter of 2023. The report will provide more clarity on bioequivalence and biosimilarity studies, among other areas.

Report

Psychiatric drug shortages, a lab shutdown, and a corruption scandal

The same white paper also described COFEPRIS’s aim to help guarantee Mexico’s domestic supply of medicines, which has been plagued by shortages in recent years, some of them linked to sweeping changes in procurement and distribution under current President Andrés Manuel López Obrador. A four-year agreement between the López Obrador government and the United Nations Office for Project Services, aimed at solving procurement issues, was dissolved early amid ongoing medicine shortages in Mexico.

COFEPRIS has seen no shortage of domestic controversy in recent weeks. In mid-February the agency announced the firing of 11 of its functionaries for “presumed collusion with the regulated sector.” The fired individuals were involved in the regulation of pesticides, the agency said.

On February 23 COFEPRIS announced that it had discovered “critical deficiencies in the traceability of psychotropic and narcotic drugs, which shows the irregular handling of substances subject to strict sanitary control” at Mexico’s largest psychiatric drug manufacturer, Psicofarma, forcing it to suspend operations. The move will likely aggravate a severe shortage of psychiatric medications in both the private and public sector that physician groups, including the Mexican Psychiatric Association and the Mexican Society of Pediatric Neurology have in recent weeks decried publicly in letters and formal statements.

Maribel Ramírez Coronel, a healthcare sector columnist for the Mexican business newspaper El Economista, told Focus that while COFEPRIS’s vigilance with Psicofarma was to be lauded, the agency has contributed in some ways to the ongoing psychiatric drug shortage, thanks to the slow progress of certain types of requests through its system.

The agency’s new digital platform speeded some procedures, “but these are the most basic ones,” Ramírez said. Import permits and registrations for active pharmaceutical ingredients, which lagged after the pandemic with many Mexican labs seeking new suppliers outside China, remain slow, she said. “There’s still a lot of lag in import permits and new authorizations. The regulator should be prioritizing the processes that alleviate the shortage.”

ANVISA’s autonomy challenged by Congress

After the swearing in Brazilian’s President Luiz Inácio Lula da Silva earlier this year, a voting block in Brazil’s congress made a surprise attempt to curb the powers of several powerful and highly autonomous agencies, including its medicines agency, ANVISA. The proposed legislation would make ANVISA, a rulemaking institution that previously answered only to the executive branch, into a non-rulemaking body tasked with implementing rules drafted by an outside council whose members would have to be approved by the legislative branch.

The proposed change was met with an immediate uproar from Brazilian industry groups and even its union of pharmaceutical workers, with more than 30 entities signing a manifesto to express opposition to the move and support for ANVISA, which “maintains, still, mutual cooperation agreements with the main world regulatory agencies in the health area,” including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the letter writers argued. “This recognition strengthens national sovereignty and facilitates the insertion of our products in the world market.”

The manifesto appears to have put a chill for now on the drive to legislative oversight of an agency whose independence has long been valued and trusted by the Brazilian populace, Benny Spiewak, an attorney and regulatory affairs expert based in São Paolo, told Focus. However, he said “there is at least a 5% chance that this change could still happen” in March.

Spiewak said that ANVISA had become “collateral damage” of a broader legislative push to curb the power of certain highly autonomous agencies. During the COVID-19 pandemic, it survived multiple attempts to meddle in its vaccine decisions by Brazil’s former president, Jair Bolsonaro, as the country witnessed public battles reminiscent of those between the Trump Administration and public health officials, including Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases (NIAID). Brazilians appreciate that ANVISA bureaucrats “fought Bolsonaro on vaccines, they stood their ground, they have the population’s back and the industry’s back,” said Spiewak, who predicts that the current left-leaning government will see fewer clashes with the agency if it remains under the executive branch.

Manifesto (Portuguese)

More telemedicine platforms approved by ANVISA

In February, two digital health platforms were listed with ANVISA. The orthodontics platform Grin comprises an app and two scope devices for cell phones. Grin, a New York-based company, describes its product as a “digital orthodontic platform that provides remote oral healthcare solutions in partnership with trusted local doctors.” Brazil is home to more than 30,000 orthodontists. Lithuanian firm Oxipit AI also said its ChestEye application was cleared for use by ANVISA. The firm describes its technology as a medical imaging tool that analyzes radiologist reports and medical images using artificial intelligence.”

Spiewak said the recent uptick in telemedicine platforms is only likely to accelerate in Brazil, and in Latin America more broadly, as these can be enormously attractive in low-resource settings. “Digitalized e-systems that allow you to do more with less are something that we’ve been seeing grow expect to see grow for at least for the next 5 years. A doctor in São Paolo can consult with someone in the Amazon using their cell phone,” he said.

Under current law, only Brazilian healthcare professionals residing in the country may consult with patients using these platforms. But Spiewak said there is increasing pressure from foreign companies to change this. “A doctor from Colorado with the best state of the art technology can address someone’s concern in Brazil,” he said. “In the coming year we may well see a broadening of the license requirements to expand to Brazilian healthcare professionals living outside Brazil. And at some point, perhaps in the next three to five years, Spiewak predicted that “not just non-resident Brazilians but maybe actual foreigners” will be using the same platforms.

Grin, Oxipit AI

Latin America Roundup: COFEPRIS hosts FDA delegation with focus on devices, platforms

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