Latin America Roundup: COFEPRIS says generic lab monopoly lasted two decades, affected access to medicines

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) offered further details on a recently uncovered corruption ring, which enabled one lab evaluating generic medicines to receive vastly more business than its competitors, thanks to interventions by COFEPRIS functionaries.

In a news conference on 16 July, agency head Alejandro Svarch Pérez revealed that the scheme – in which COFEPRIS regulators reduced the regulatory burden on one company and increased it for its competitors – had been ongoing since 2004. This “silent but very harmful” ring took a long investigative effort to uncover, Svarch Pérez said. It “significantly stalled investigation into, and as a result the production of, our generic medications” and had caused prices to be vastly higher than they should have been, affecting access.

On 22 June, COFEPRIS issued an update on the anticorruption strategies it has carried out over the past two years. These include greater camera surveillance in regional offices, allowing for the systematic recording and monitoring of functionaries, and anti-corruption courses attended by thousands of COFEPRIS personnel.

COFEPRIS press conference (Spanish)

PAHO hosts regulatory workshops in Guatemala

The Pan-American Health Organization (PAHO) hosted regulators from Latin American agencies from 9-12 July in Antigua, Guatemala, to discuss the World Health Organization’s Global Benchmarking Tool, the standardized methodology by which WHO evaluates national regulatory authorities worldwide. Regulators from Colombia, Mexico, Argentina, Brazil, Chile, and Cuba participated.

Part of the aim of the conference, PAHO said, was to aid these agencies in becoming WHO-listed authorities, or WLAs. The WLA designation indicates that an agency is operating at an advanced level of performance by global standards, according to WHO.

During the meeting, COFEPRIS officials met with PAHO representatives to discuss the new Regional Health Regulation School, a Mexico-led initiative that seeks to improve regulatory training across the Americas, the agency said in a statement 16 July. Regulators with Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) also sent out notice that they had participated in the PAHO workshops in Guatemala.

In August, COFEPRIS will host a PAHO-sponsored meeting on harmonization that will be attended by regulators across the Americas.

PAHO

COFEPRIS opens public comment period on new device standards and terms

On 26 June, Mexico’s COFEPRIS announced that it had opened a comment period on a new scheme for device regulation that would adopt internationally used terms and tighten reporting requirements in a bid to improve standards. Mexico’s device industry has experienced steady growth in recent years, and the draft rule, as proposed, “allows for the unification of application criteria at a national level harmonized in international guidelines,” according to its preamble. The proposed rule defines each regulatory term and acronym in detail, and also establishes new surveillance protocols for devices. For example, under the new rule, marketing authorization holders, distributors and sellers of medical devices would have to immediately notify Mexico’s health sectary of any adverse events reported to them. The 60-day public comment period will end in late September.

COFEPRIS (Spanish)

El Salvador set to launch new regulatory agency

After a series of delays and some adjustments to the scope of its mandate, El Salvador’s new Superintendency of Health Regulation (SRS) will open on 7 August.

The new entity will regulate medicines, nutritional supplements, medical devices, medical equipment, and “other health technologies,” as well as tobacco, alcohol, and chemical products, according to a notice issued 18 July by the outgoing National Directorate of Medicines (DNM).

The DNM has been issuing frequent updates to users on how the change will affect them. Procedures pending with the DNM will not be affected, it says, except that the SRS will issue the final decisions. The DNM continues to advise on imminent changes to payment systems and computer platforms.

The new agency was created by an act of El Salvador’s legislature in November 2023 and comprises two divisions: regulatory, which will manage licensing and renewals, and surveillance, which will handle compliance and pharmacovigilance. Its advisory board members will serve five-year terms that can legally be extended to 10 years, according to the government website elsalvador.com, and its headquarters will be in the San Salvador suburb of Santa Tecla.

Elsalvador.com (Spanish)

Colombia: INVIMA chief describes “structural problems” behind shortages

Francisco Rossi, the director of Colombia’s National Institute of Food and Drug Surveillance (INVIMA), acknowledged in a news conference 24 July that about 12 medicines continue to be unavailable in the country, not due to a backlog of procedures at INVIMA but to “scarcity of primary materials, regulations, supply chains, and commercial issues.”

Rossi commented that while many problems have been corrected in the months since he assumed the agency’s directorship, others “still require effort, both national and international,” to solve.

Reiterating his own frequent criticisms of industry practices, Rossi added that certain medicines “are no longer interesting from a commercial point of view even though they continue to be useful from a … public health point of view, which is something that has to be discussed with the industry because in a market economy, [pharmaceutical manufacturers] will privilege products that are more profitable.”

The Colombian government must design policies that encourage the production of priority medicines, Rossi said, and noted that INVIMA is better able to track medicines at risk of shortage under a new rapid reporting system.

Infobae (Spanish)

Latin America Roundup: COFEPRIS says generic lab monopoly lasted two decades, affected access to medicines

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