Latin America Roundup: Chile comptroller faults regulators for lax enforcement

A recent report by Chile’s comptroller’s office details a series of irregularities in monitoring and withdrawal of medical products from the market by Chile’s Institute of Public Health (ISP) between 2020 and 2023.

Two episodes were highlighted in the 11 September report: the recall of two types of defective cochlear implants made by one device manufacturer, and the recall of liquid medical products, mostly saline solutions, contaminated with Burkholderia cepacia complex bacteria. The contaminated products, most of which came from a single manufacturer, are believed to be responsible for 80 deaths and 600 cases of serious illness in Chile.

The report, solicited by the Chilean senator and physician Juan Luis Castro González, found that the ISP did not adequately enforce withdrawal of the defective or contaminated products in the time frame stipulated by law, nor did it insist on the comprehensive follow-up reports from manufacturers as the law also requires.

The report also implicated a separate government agency, which is responsible for the procurement and tracking of medicines used in Chile’s public health system, as well as several hospitals, as contributing to the crisis. With the cochlear implants, which are used in severely hearing-impaired patients, one hospital waited nearly a year before evaluating people who had received the recalled products, the report found.

Statement, report (Spanish)

Brazil creates new advisory body for trials

The Brazilian Health Regulatory Agency (ANVISA) announced on 13 September that it had created a “technical chamber for clinical research in medicines and medical devices” that will offer advice to ANVISA’s clinical trials divisions. The main purpose of the new entity, dubbed CATEPEC, is to support, streamline, and improve the regulatory process, the agency said. Its members have not yet been selected.

Part of the new body’s mandate is to be interdisciplinary, bringing different voices and perspectives into the regulatory sphere. In a notice issued concurrently with the announcement, ANVISA said it is looking for people affiliated with research institutions with backgrounds in drug or device research, health technology assessment, safety evaluation, and data protection as well as representatives from medical societies across a broad range of specialties.

Statement (Portuguese)

Mexico adds modification requests to its digital platform

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) last week announced that its digital platforms are now able to accommodate requests for modifications of existing marketing authorizations. The agency’s DIGIPRIS platform, designed as both an anti-corruption initiative and a way to speed regulatory processes, has to date handled half a million procedures, including extensions of marketing authorizations and advertising notices, COFEPRIS said. In announcing the new function of its platform, the agency invited representatives from 17 pharmaceutical manufacturers.

Statement (Spanish)

Dominican Republic to roll out digitalization by year’s end

The director of the Dominican Republic’s General Directorate of Medicines, Food and Health Products (DIGEMAPS) said on 10 September that the agency’s new digital platform would be unveiled – at least for priority product categories -- by the end of 2024, according to a report in Diario Libre. DIGEMAPS director Leandro Villanueva told news outlets present at a national health conference that the agency’s digitalization strategy has been in development since 2021. Villanueva, whose background is in finance and risk management, said that wait times for authorizations would decrease dramatically as a result of the program, to as little as 24 hours for products previously approved by the US Food and Drug Administration or the European Medicines Agency.

Diario Libre (Spanish)

Falsified cancer drugs spark alarm in Mexico

While alerts about falsified drugs are common across Mexico and Latin America, most tend to concern products available through retail pharmacies. On 13 September Mexico’s COFEPRIS agency advised about falsification of three cancer drugs used in clinical settings: Roche’s Mabthera (rituximab), the chemotherapy agent fludarabine (marketed by Sanofi’s Beneflur (fludarabine), and Merck’s Keytruda (pembrolizumab). In a statement, COFEPRIS described several lots of these products deemed by their manufacturers to be counterfeit or otherwise suspect and asked anyone encountering them to notify the agency.

Statement (Spanish)

El Salvador agency to double technical staff

El Salvador’s Superintendency of Health Regulation (SRS), the new agency that replaced the National Directorate of Medicines (DNM) when it opened in August, will employ more than twice the number of regulatory technicians as its predecessor, according to documents published in the Salvadoran newspaper La Prensa Grafica, with 614 employees in the “technical” category, compared with 253 at DNM. It will also see the number of administrators reduced, from more than 117 at DNM to just 44. Salaries are also higher than at the DNM, with the lowest-paid SRS employees receiving between US $700 and $750 per month, approximately $200 more per month than at the DNM. The number of employees with salaries above $2,300 a month will increase from 24 to 67.

The agency’s revenues, like those of the DNM, are expected to come exclusively from user fees. The SRS had a budget of $7.2 million from August through December, nearly all of which is expected to be recouped from fees.

La Prensa Gráfica (Spanish)

New Disclosure Rules for Brazilian Doctors

A new federal rule published earlier this month, and which takes effect March 2025, obliges Brazilian physicians to disclose their relationships with pharmaceutical and device companies to their regional offices of the Brazilian Medical Association, the country’s main professional group for doctors. The association is charged with making the information available to the public by way of its websites.

Industry relationships that must be reported include employment by device or drug companies or their intermediaries; paid services to these industries; clinical research sponsored by industry; holding of stocks and other financial interests; receipt of free samples of products; and promotional or speaking engagements. The rule prohibits doctors from accepting any benefits related to devices, medicines or other products not registered with ANVISA.

In recent years, Brazilian legislators have floated national transparency bills that would have require a government agency, like ANVISA, to manage and disseminate information on physician-industry relationships. But these have not gone forward. Currently only one Brazilian state, Minas Gerais, imposes stringent reporting requirements on doctors and publishes that information.

The new federal rule, according to an analysis published by the Brazilian law firm Licks Attorneys, “delegates the responsibility for disclosure” to the Brazilian Medical Association in each state.

Analysis by Licks Attorneys

Latin America Roundup: Chile comptroller faults regulators for lax enforcement

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