Latin America Roundup: Longtime pharma critic named head of Colombia’s INVIMA

Colombian president Gustavo Petro on 28 October named Germán Velásquez to head its National Food and Drug Surveillance Institute (INVIMA), an agency that endured 14 months with only acting directors amid mounting numbers of registrations in limbo and widespread shortages of essential medications.

Velásquez, 75, holds a doctorate in health economics from Sorbonne University, in Paris, and spent two decades at World Health Organization, including as its director of Public Health, Innovation and Intellectual Property. After leaving WHO in 2010, he became a health policy adviser for South Centre, a Geneva-based intergovernmental organization representing 54 developing countries.
A longtime critic of the global pharmaceutical industry, Velásquez has spent decades advocating for binding international treaties under WHO that would result in affordable medicines for citizens of developing countries.
During the COVID-19 pandemic, Velásquez demanded that the WHO revive a tabled initiative for a global IP treaty, calling current research and development models “fragmented, inefficient, expensive, and full of overlaps and waste of resources,” and unable “to provide the global solution that the COVID-19 crisis requires.” A new model “based on health rather than commercial interests” is possible under the WHO constitution, he argued in a July 2020 policy brief published by South Centre.
Velásquez’s appointment to INVIMA “has already sparked all types of tension in pharmaceutical circles,” according to a report in El País (in Spanish). His strained relationship with industry is not new. In 2001, while on a work trip with WHO, he was attacked with a knife in Rio de Janiero and, two days later, assaulted in Miami in incidents that Velazquez characterized as acts of intimidation related to his policy positions.
Velásquez’s appointment comes as INVIMA faces judicial action in Colombia over its role in ongoing medication shortages. On 31 October, a court in Bogota demanded that the agency present a written plan, within 10 days, detailing how it intended to resolve shortages of priority drugs, “define strategies to facilitate access to raw materials for the manufacture of medicines,” and speed resolution of some 27,000 active registration requests for medicines, according to Colombian news reports.
El País (Spanish)

COVID vaccines spark confusion, debate in Mexico

On 24 October, Mexican president Andrés Manuel López Obrador received a dose of the Cuban-manufactured COVID-19 vaccine Abdala, dismissing questions about its efficacy as the products of “disinformation” and “bad faith.”

Days later, on 28 October, Mexico’s Health Secretariat announced that the country had received 2.8 million additional doses of the Cuban vaccine to be used in Mexico’s 2023-2024 national vaccination campaign. A newer Mexico-made vaccine, called Patria, will be ready for use this month, López Obrador said.

Neither of these products has been shown efficacious against the Omicron XBB variants currently circulating in Mexico, nor has the Russian-made Sputnik vaccine that, like Abdala, remains under emergency use authorization by Mexico’s Federal Commission for the Protection Against health Risks (COFEPRIS). Complicating matters further, health authorities have extended the legal shelf life of some lots of Abdala by 18 months.

COFEPRIS moved forward last month with applications for Pfizer’s Comiarty and Moderna’s Spikevax, two vaccines effective against the Omicron XBB 1.5 variant, to receive non-emergency marketing authorization in Mexico, which would allow people to purchase them on the open market. In an update issued 3 November, COFEPRIS reiterated its “total commitment to transparency” on those applications and said they were advancing.

However, experts question whether the vaccines will be approved this year or become available through public channels during the 2023-2024 campaign.

Opposition politicians have cried foul, demanding that COFEPRIS speed authorization of the Pfizer and Moderna products and that the government use make use of available health budgets to buy them. In a 24 October press conference, legislator Éctor Jaime Ramírez decried the administration of “useless and expired vaccines” in the public program as “total negligence.”

COFEPRIS statement (Spanish)

El Salvador launches regional hub for PPE evaluation

El Salvador has launched a Central America regional hub to evaluate personal protective equipment, including masks, gloves and protective clothing, produced in Central American and Caribbean countries and intended for sale in the region, according to a 25 October statement from the Pan-American Health Organization (PAHO).

The Quality Control Laboratory (LCC), which operates under El Salvador’s National Directorate of Medicines (DNM), has received equipment worth $725,000 from funds donated by the US, along with technical support from PAHO, the statement said.

A parallel initiative is being developed under PAHO at Colombia’s INVIMA agency, to serve PPE producers and markets in South America.

“The shortage of gloves, masks and other personal protection elements that we suffered at the beginning of the pandemic cannot be repeated,” said PAHO Director Jarbas Barbosa in the press statement. “PAHO quickly recognized the enormous external dependence of the region on these products and decided to undertake this project in order to strengthen our regulatory systems from a regional perspective,” he added.

Last month, El Salvador hosted representatives from 19 regulatory agencies in Latin America and the Caribbean for a PAHO-sponsored meeting on harmonizing regulations on medical devices. In the future, the El Salvador and Colombia PPE labs could take part in evaluations for PAHO’s Regional Revolving Funds program, which helps countries in the Americas to access vaccines, essential medicines, and public health supplies at affordable prices, the organization said.

PAHO statement

Latin America Roundup: Longtime pharma critic named head of Colombia’s INVIMA

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