Latin America Roundup: Mexico, Colombia and Cuba press for Pan-American regulatory body

Regulatory Focus is pleased to announce a new biweekly Latin America Roundup focused on regulatory issues in Latin America and the Caribbean. If you have any tips or stories we missed, please send them to news@raps.org.
 
A frequent post-pandemic theme among Latin American agencies has been coordination and harmonization among regional regulators.
 
Earlier this year the Mexican government formally backed the creation of a Latin American Medicines Agency, a pan-Latin America body modeled after the European Medicines Agency, that would “lead to health self-sufficiency and guarantee access to quality, safe and effective medicines for the region.” Mexico Foreign Secretary Marcelo Ebrard cited the pandemic as a rationale for the effort, noting that “we do not want to forget the lessons of the pandemic ... we risk facing something similar again at any moment.”
 
The push toward a regional super-agency is being spearheaded by Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS), with strong support from Colombia’s National Institute of Food and Drug Monitoring (INVIMA), and the Community of Latin American and Caribbean States (CELAC).
 
In February, the Colombian agency said in a statement that while regulatory harmonization efforts have traditionally been led by developed countries, “growing concern has arisen in developing countries that regulations and standards do not necessarily reflect health protection considerations and may create barriers to competition, increasing the scientific and technological gap.”
 
INVIMA also announced a late February meeting with Cuban officials to discuss the proposed agency, after which recently named agency director Francisco Rossi called “one of the most interesting and concrete integration projects and basically aims to make drug regulation common to the entire Latin American region and adapt to our needs. We have taken a very important step with the visit of the Minister of Foreign Trade and the Cuban ambassador, who expressed the total commitment of their government and health authorities to promote this initiative.”
 
Before becoming INVIMA’s new director this year under Colombian President Gustavo Petro, Rossi, an epidemiologist and drug policy expert, was a founder of IFARMA, a Colombian non-governmental organization that advocates for increased access to medicines in Colombia and Latin America. Rossi is a longtime critic of industry and of patent protections and pricing schemes that would limit access to medicines. His appointment as Colombia’s top regulator marks a departure from the more industry friendly and US-centric positions of past Colombian governments.
 
The governments of several other countries have voiced support for a Latin American Medicines Agency, including Bolivia, Cuba, Dominica, the Dominican Republic, Ecuador, El Salvador, Honduras, and Jamaica. Neither Brazil nor Argentina has expressed interest in joining.
 
Mexico statement (English), Colombian statement 1, 2 (Spanish)
 
PAHO says better surveillance, vaccinations needed after three years of COVID
 
On 9 March, officials with the Pan American Health Organization (PAHO) held a press conference to update on the regional impact of the COVID-19 pandemic three years since its start. The conference focused on lessons that can be brought to bear on future pandemics for Latin America and the Caribbean, a region that saw delayed access to vaccines and, the organization reported, 43% of worldwide COVID-19 deaths over the past three years. 
 
PAHO Director Jarbas Barbosa, of Brazil, who assumed his post in February, repeatedly cited the need for coordination and data-sharing among the region’s national health agencies, especially in the areas of surveillance, data monitoring and vaccines. “Our countries also have a very important opportunity to participate in the global debate in how to develop some changes in the International Health Regulations,” Dr. Barbosa said, which will be finalized by World Health Organization members in 2024 and will likely include stronger guarantees of access to vaccines and treatments for lower-and-middle-income countries.
 
Barbosa highlighted the need to reduce the region’s reliance on medical product imports. Since the pandemic, he said, PAHO officials have stressed strengthening vaccine development and manufacturing in the region and supported its regulatory agencies to assure faster, accurate assessments of vaccines and treatments unaffected by political pressure.
 
He also noted that PAHO has backed two ongoing mRNA vaccine development projects, one in Argentina and another in Brazil. “This is a platform that can be used not just for SARS-CoV-2 but other coronaviruses and other emerging viruses, and “all vaccines produced in these sites will be offered to all countries in the region. The benefit has to be a regional benefit.” Barbosa praised Cuba’s efforts in developing and offering vaccines “of high scientific quality” to the region. One Cuba-produced COVID-19 vaccine has been approved in six countries including Cuba, Mexico, Nicaragua, St. Vincent and the Grenadines, while a second has been approved by Cuba, Nicaragua and Venezuela.
 
Press conference, Press release
 
Uruguay launches ‘Health Intelligence Node’ to aid region
 
In March Uruguay’s government announced the creation of a “Health Intelligence Node” (Nodo de Inteligencia Sanitaria) that would facilitate information exchange among regional health authorities, citing “the need to generate health intelligence to support decision-making in health; the importance of making explicit the tacit knowledge of the organizations and a regional mandate to strengthen the horizontal cooperation between countries.”
 
The effort, supported by PAHO, Uruguay’s health ministry, and the office of its president, aims to leverage the successes of Uruguay’s health system and its strong early response to the COVID-19 pandemic, in which the country developed its own tests and testing strategies and imposed aggressive contact tracing. Last year Uruguay reported hosting or attending some 20 meetings with health officials, labs and hospitals in the region including in Belize, Brazil, and El Salvador; it plans to meet with officials in Chile, Colombia, Guyana and Peru this year. In mid-February Uruguay, along with Argentina, declared a national health emergency related to the detection of H5N1 avian influenza in wild bird species, and it has been proactive in the dissemination of surveillance reports, releasing regular public updates on findings.
 
Statement (Spanish)
FDA meetings hint at higher international profile for Argentina’s ANMAT
In recent weeks officials with the US Food and Drug Administration met with Argentina regulators, health officials and representatives of laboratories. At the top of the agenda was harmonization, with Argentinian officials expressing a desire for closer ties with FDA and higher stature in the international regulatory sphere.
On March 1, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) issued a statement saying that during a series of February meetings with FDA officials, “scenarios of international regulatory convergence” shared top billing with themes “of mutual interest in medicines, food products and medical products.”
 
Regional deputy director of FDA’s Office for Latin America, Michelle Rodríguez, said in the same statement that “for us, ANMAT has always been a priority agency,” noting that “one of its qualities has been and continues to be its work in relation to international regulatory convergence.” Further, Rodríguez said, despite a “stigma that Latin American countries cannot be part of international groups, Argentina is the first country in this region that achieves different memberships in these groups and it is something to be very proud of.”
 
ANMAT currently is an observer member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum (IMDRF). It seeks FDA’s support to attain full membership in both entities.
 
Statement 1, 2 (Spanish)
 
Argentina COVID vaccine trials advance
 
Argentine Health Minister Carla Vizzotti, who participated in the February meetings with FDA officials along with ANMAT head Manuel Limeres, said that the COVID-19 pandemic had strengthened the government’s resolve to “have a strong role in defining strategies of production, development and innovation.” Vizzotti also described Argentina’s private sector as a “strategic partner” in such efforts. Separately, the Argentine government announced March 6 that an Argentina-developed COVID-19 vaccine had entered phase 2/3 testing, with results expected by June.
 
Statement (Spanish)