Latin America Roundup: Proposed Peru agency overhaul sparks concern

A new bill that would overhaul Peru’s medicines agency would increase its financial dependence on the state and do nothing to improve its technical capacity, according to a report in the Peruvian health news outlet Salud con Lupa.

The bill, introduced in Peru’s legislature 24 April and signed by the country’s president, cabinet chief, and health minister, seeks to replace Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) with an entity called the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (APEMED).

The effort dates back to 2023, according to the news outlet, and stems from concerns within DIGEMID about the agency’s financial stability and autonomy.

However, Salud con Lupa, which spoke with several health analysts, found that the new bill does not address these concerns, and might worsen some existing problems within the agency. Its wording “eliminates the possibility of APEMED being financed through its own income” from fines and user fees, as was originally proposed, the outlet found. Without such provisions, the new entity will be stymied by its government-assigned budget, and suffer the same “lack of personnel, scarce resources and limited enforcement capacity” that DIGEMID, established in 1990, currently does.

The bill does not increase technical training standards for its regulatory professionals, as outside experts have demanded, nor mandate that the country’s top regulator be well recognized in the regulatory field, the report concluded. In addition, the new agency would not have the independent authority to purchase or construct new facilities. DIGEMID currently rents its offices.

The bill is slated for urgent legislative review after a recent debacle in which seven people died, and hundreds were sickened, after receiving locally made IV saline solutions with too-high concentrations of salt. The most recent death occurred on 18 April, according to media reports, in a 26-year-old man who had received treatment with the solutions in March. Calls for agency overhaul ensued, and DIGEMID’s director was replaced twice.

Salud con Lupa (Spanish)

Mexican firm suspended for falsifying regulatory documents

Officials with Mexico’s anti-corruption office announced on 29 April that they had identified 16 drug companies with irregularities in their filings with the Federal Commission for Protection Against Health Risks (COFEPRIS). In one case, the violations were serious enough to result in an immediate suspension of the company’s activities, while a case involving a different, unnamed firm was turned over to prosecutors.

Biomics Lab México, a maker of genetic tests, was suspended indefinitely, according to the anticorruption office. The second, unnamed firm is being investigated for falsifying documents. The irregularities are related to medicine pricing and coding, not safety or efficacy. They were uncovered during the government’s due diligence related to a “mega-purchase” of medicines for Mexico’s public health system.

The mega-purchase was announced in October 2024. With procurement well underway and hundreds of millions of products already delivered, it was canceled in April over mounting concerns about fraud, and a new purchasing plan is now being developed, according to the government. “[W]e are working with the Ministry of Health and COFEPRIS to establish clear and simple procedures, thus preventing any abuse, irregularity, or inconvenience during the process,” the anticorruption office said in a 29 April news release.

Statement (Spanish)

Argentina health ministry meets with RFK Jr. and team

Argentina’s health minister, Mario Lugones, along with other top health officials, took part in a virtual meeting with US Health and Human Services Secretary Robert F. Kennedy Jr. and his advisors on 22 April, the Argentinian Health Ministry said in a news release.

Topics discussed at the meeting included concerns about drug pricing, access to treatment, and “drugs reaching the market with increasing speed before there is sufficient clinical evidence,” according to the 23 April statement.

Two veteran HHS officials with the agency’s Americas office, Nelson Arboleda and Mackenzie Klein, were present at the meeting, as well as Bethany Kozma. Kozma, who served as a USAID official during President Donald Trump’s first term, was described as representing HHS’s Office of Global Affairs.

The current presidents of Argentina and the United States have found common cause in embracing controversial health-related positions. Both have publicly disparaged the World Health Organization over its response to the COVID-19 pandemic, and announced plans to withdraw their countries from it. In February of this year, Argentina president Javier Milei declared a ban on hormonal treatments for transgender youth.

Statement (Spanish)

Honduran regulator demands better cooperation; protests erupt at headquarters

Regulators with Honduras’s medicines agency, including its director, traveled to Cuba in late April to promote regional efforts to boost medicines production, according to an official statement issued 22 April.

At a health conference hosted by the Cuban government and the Pan-American Health Organization, Dorian Salinas, the head of Honduras’s Health Regulatory Agency (ARSA), argued for broader cooperation across sectors of her government to help local industry develop and produce quality products, a key goal of ARSA.

“This is not the sole responsibility of the regulatory body; it requires the participation of public finance, the legislative branch, the tax agency, and all institutions that understand the importance of our industry having the capacity to produce generic and essential medicines for the region,” Salinas was quoted in the release as saying.

Weeks later, ARSA offices were beset by a spate of politically charged protests against Salinas and the agency, accusing the director of not hiring adherents of the country’s current ruling political party, according to a 5 May report in the Honduran news site El Heraldo.

Statement (Spanish)

Brazil, Paraguay regulators meet

Following the terms of a cooperation agreement signed in March 2024, regulators with the Brazil Health Regulatory Agency (ANVISA) met with their counterparts in Paraguay’s National Directorate of Health Surveillance (DINAVISA), the Paraguayan agency said in news release.

DINAVISA director Jorge Iliou Silvero, and Rômison Rodrigues Mota, who serves on ANVISA’s collegiate board of directors, both took part in the 25 April meeting in Brasilia, in which “marked an advance in the strengthening of the accord between the institutions,” DINAVISA said. Discussions covered Good Manufacturing Practices for medicines, participation in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the WHO’s Global Benchmarking Tool (GBT).

Statement (Spanish)

Latin America Roundup: Proposed Peru agency overhaul sparks concern

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