Latin America Roundup: Argentina’s president names new ANMAT director
Roundups | 09 January 2024 |
Argentina president Javier Milei has named an agency insider to head the country’s National Administration of Drugs, Foods and Medical Devices (ANMAT).
In an official communication on 26 December, Milei named Nélida Agostina Bisio as ANMAT’s new director. Bisio, a psychologist and medicines expert with the agency, replaced pharmacist Manuel Limeres, who had led ANMAT since 2020 and served a previous term as its director, from 2002 through 2008.
Some observers were concerned that Milei, an economist and self-described “anarcho-capitalist” who assumed the presidency after promising to shrink government and enact sweeping deregulation across virtually all sectors of Argentina’s economy, might move to shutter the medicines agency or drastically curtail its powers.
ANMAT is expected to see an extensive reshuffling of department heads, according to a report in pharmabiz.net. And, in keeping with Milei’s overall aim to reduce the scope and power of Argentina’s institutions, many employee contracts that ended in 2023 are expected not to be renewed.
In December, pharmabiz.net reported that the agency put an end to telework policies implemented during the COVID-19 pandemic and demanded that ANMAT employees return to the office.
Official Bulletin (Spanish)
Colombia’s designated INVIMA head withdraws; agency unions declare “institutional crisis”
Despite expectations that Germán Velásquez would soon take the helm of Colombia’s National Institute of Drug and Food Surveillance (INVIMA) as the first confirmed director under the current government, he has withdrawn from the process, leaving the agency in the hands of its latest acting director.
In a post on social media platform X last October, Colombia president Gustavo Petro named Velásquez, a health policy and intellectual property analyst with the Geneva-based think tank South Centre, and formerly with the World Health Organization, as the forthcoming head of INVIMA. Velásquez was expected to be confirmed by the end of 2023.
However, in early January, Velásquez began telling Colombian news outlets that he was no longer interested. For months, the Colombian government had taken no action on his confirmation, he said, and he would, therefore, remain with his current organization in Switzerland.
According to news outlet El Tiempo, the delays over Velásquez’s confirmation concerned a statute that would have prevented a person with a philosophy degree (PhD), as Velásquez has, from assuming the role of top regulator. The newspaper noted, however, that this could have been fixed with a resolution, allowing the confirmation to proceed.
Yenny Adriana Pereira Oviedo, a chemical engineer and quality systems manager, was named the new acting director of INVIMA – the fourth to date under the current administration.
Velásquez’s withdrawal is just the latest setback for the agency, which in recent months has faced legal actions aimed at uncovering its role in ongoing medicines shortages and furor over its long backlog in approving medicines and clinical trials. In a joint letter dated 3 January, the heads of three INVIMA trade unions criticized the current government, alleging that the delays that resulted in Velasquez’s withdrawal signaled “a clear disinterest in the public health of the country.”
The workers’ groups argued that the latest misstep had compromised Colombia’s competitiveness and “accentuated the internal crisis inside the institution.” INVIMA’s woes are principally a result of the national government’s failure to provide the “human resources and tools” needed to carry out the agency’s duties, they alleged, even after the same administration made legal changes aimed at speeding new product registrations.
“The continuous naming of acting directors has generated instability and slowed the institute’s strategic decision making, affecting its function and sowing uncertainty” both within the agency and outside it, the unions wrote.
Trade unionists’ letter (Spanish)
Mexican pharmacies sell out of Pfizer COVID vaccine
In early December, Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) gave full marketing approval to two Pfizer and Moderna COVID-19 vaccines against the Omicron XBB 1.5 variant.
By late December, the Pfizer vaccine began selling out in the pharmacy chains where it was offered at a price of approximately US$50, according to news reports. The Moderna vaccines arrived in Mexico in late December and are expected to be distributed soon.
Mexico’s president, Andrés Manuel López Obrador, told the press in December that “whoever wants to buy these medicines in pharmacies can” and that the government had no intention of limiting access to them.
López Obrador has long promoted Cuban-made vaccines based on older COVID-19 variants as the backbone of the country’s free national vaccination campaign and is lately promoting a Mexican-made vaccine called Patria, which has yet to become available. In a 4 January press conference, López Obrador cast aspersions on the Pfizer and Moderna products when asked whether they would be integrated into the public program. “In medicine, there is mercantilism and profit,” he said. “There are campaigns and horrendous things in everything related to laboratories and medicines.”
News Report (Spanish)
Brazil’s controlled substances database has been offline since 2021
Brazil’s National Health Surveillance Agency (ANVISA) has not logged information on controlled substance sales by private pharmacies since November 2021, the Brazilian Medical Association and national press reported in late December. The reason, according to an ANVISA spokesperson, is because of “instability” in the reporting database, which was established in 2014. The database exists to alert for excessive purchases of controlled substances such as opioid drugs. It also tracks purchases of antibiotics. ANVISA told press outlets that the agency is “studying the viable and necessary solutions for the reestablishment” of the database.
Brazilian Medical Association (Portuguese)
ANVISA opens comment period on digital labels
ANVISA is seeking public comment on whether scannable QR codes can enhance or replace conventional labeling for certain products. The codes can be used to present the product label and additional information, such as videos. ANVISA seeks the measure “to improve access to the label and other information through digital means, promoting a more comprehensive approach to the responsible use of medications,” the agency said in a news release issued on 13 December. The public comment period will end on 19 March.
ANVISA (Portuguese)
Honduras’s ARSA agency reports more pharmacovigilance training in 2023
Honduras’s Sanitary Regulatory Agency (ARSA) reported on 29 December that its inspection actions had increased by nearly 60% compared with 2022, for a total of 12,609 inspections last year. The agency also reported more than doubling its training activities in 2023, as well as creating new classes of licenses and launching new technical and pharmacovigilance centers.
ARSA (Spanish)
In an official communication on 26 December, Milei named Nélida Agostina Bisio as ANMAT’s new director. Bisio, a psychologist and medicines expert with the agency, replaced pharmacist Manuel Limeres, who had led ANMAT since 2020 and served a previous term as its director, from 2002 through 2008.
Some observers were concerned that Milei, an economist and self-described “anarcho-capitalist” who assumed the presidency after promising to shrink government and enact sweeping deregulation across virtually all sectors of Argentina’s economy, might move to shutter the medicines agency or drastically curtail its powers.
ANMAT is expected to see an extensive reshuffling of department heads, according to a report in pharmabiz.net. And, in keeping with Milei’s overall aim to reduce the scope and power of Argentina’s institutions, many employee contracts that ended in 2023 are expected not to be renewed.
In December, pharmabiz.net reported that the agency put an end to telework policies implemented during the COVID-19 pandemic and demanded that ANMAT employees return to the office.
Official Bulletin (Spanish)
Colombia’s designated INVIMA head withdraws; agency unions declare “institutional crisis”
Despite expectations that Germán Velásquez would soon take the helm of Colombia’s National Institute of Drug and Food Surveillance (INVIMA) as the first confirmed director under the current government, he has withdrawn from the process, leaving the agency in the hands of its latest acting director.
In a post on social media platform X last October, Colombia president Gustavo Petro named Velásquez, a health policy and intellectual property analyst with the Geneva-based think tank South Centre, and formerly with the World Health Organization, as the forthcoming head of INVIMA. Velásquez was expected to be confirmed by the end of 2023.
However, in early January, Velásquez began telling Colombian news outlets that he was no longer interested. For months, the Colombian government had taken no action on his confirmation, he said, and he would, therefore, remain with his current organization in Switzerland.
According to news outlet El Tiempo, the delays over Velásquez’s confirmation concerned a statute that would have prevented a person with a philosophy degree (PhD), as Velásquez has, from assuming the role of top regulator. The newspaper noted, however, that this could have been fixed with a resolution, allowing the confirmation to proceed.
Yenny Adriana Pereira Oviedo, a chemical engineer and quality systems manager, was named the new acting director of INVIMA – the fourth to date under the current administration.
Velásquez’s withdrawal is just the latest setback for the agency, which in recent months has faced legal actions aimed at uncovering its role in ongoing medicines shortages and furor over its long backlog in approving medicines and clinical trials. In a joint letter dated 3 January, the heads of three INVIMA trade unions criticized the current government, alleging that the delays that resulted in Velasquez’s withdrawal signaled “a clear disinterest in the public health of the country.”
The workers’ groups argued that the latest misstep had compromised Colombia’s competitiveness and “accentuated the internal crisis inside the institution.” INVIMA’s woes are principally a result of the national government’s failure to provide the “human resources and tools” needed to carry out the agency’s duties, they alleged, even after the same administration made legal changes aimed at speeding new product registrations.
“The continuous naming of acting directors has generated instability and slowed the institute’s strategic decision making, affecting its function and sowing uncertainty” both within the agency and outside it, the unions wrote.
Trade unionists’ letter (Spanish)
Mexican pharmacies sell out of Pfizer COVID vaccine
In early December, Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) gave full marketing approval to two Pfizer and Moderna COVID-19 vaccines against the Omicron XBB 1.5 variant.
By late December, the Pfizer vaccine began selling out in the pharmacy chains where it was offered at a price of approximately US$50, according to news reports. The Moderna vaccines arrived in Mexico in late December and are expected to be distributed soon.
Mexico’s president, Andrés Manuel López Obrador, told the press in December that “whoever wants to buy these medicines in pharmacies can” and that the government had no intention of limiting access to them.
López Obrador has long promoted Cuban-made vaccines based on older COVID-19 variants as the backbone of the country’s free national vaccination campaign and is lately promoting a Mexican-made vaccine called Patria, which has yet to become available. In a 4 January press conference, López Obrador cast aspersions on the Pfizer and Moderna products when asked whether they would be integrated into the public program. “In medicine, there is mercantilism and profit,” he said. “There are campaigns and horrendous things in everything related to laboratories and medicines.”
News Report (Spanish)
Brazil’s controlled substances database has been offline since 2021
Brazil’s National Health Surveillance Agency (ANVISA) has not logged information on controlled substance sales by private pharmacies since November 2021, the Brazilian Medical Association and national press reported in late December. The reason, according to an ANVISA spokesperson, is because of “instability” in the reporting database, which was established in 2014. The database exists to alert for excessive purchases of controlled substances such as opioid drugs. It also tracks purchases of antibiotics. ANVISA told press outlets that the agency is “studying the viable and necessary solutions for the reestablishment” of the database.
Brazilian Medical Association (Portuguese)
ANVISA opens comment period on digital labels
ANVISA is seeking public comment on whether scannable QR codes can enhance or replace conventional labeling for certain products. The codes can be used to present the product label and additional information, such as videos. ANVISA seeks the measure “to improve access to the label and other information through digital means, promoting a more comprehensive approach to the responsible use of medications,” the agency said in a news release issued on 13 December. The public comment period will end on 19 March.
ANVISA (Portuguese)
Honduras’s ARSA agency reports more pharmacovigilance training in 2023
Honduras’s Sanitary Regulatory Agency (ARSA) reported on 29 December that its inspection actions had increased by nearly 60% compared with 2022, for a total of 12,609 inspections last year. The agency also reported more than doubling its training activities in 2023, as well as creating new classes of licenses and launching new technical and pharmacovigilance centers.
ARSA (Spanish)
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