Latin America Roundup: AMLAC effort gains interest from Argentina, Chile and Brazil

The effort to bring about a regional Latin American regulatory agency gained ground in recent weeks, with declarations of interest from regulatory authorities in Argentina, Chile and Brazil.

The push to form a Latin American and Caribbean Medicines Agency (AMLAC) gained momentum earlier this year as a three-country initiative spearheaded by regulatory agency heads in Mexico, Colombia and Cuba. After a 15-16 June meeting in Bogota, Colombia, regulators from Argentina, Chile and Brazil committed to join discussions on the formation of a new regional authority. The next steps following the Bogota meeting, according to a tweet from Colombia’s medicines agency, INVIMA, include creating a “regional school of health regulation” to improve members’ scientific and technical capacities, forming working groups to set priorities and a future meeting in mid-July in Washington, DC.

A consistent theme of the AMLAC discussions has been bolstering regional self-sufficiency for drugs and medical devices, by supporting manufacturing and increasing flexibility toward intellectual property. Its proponents, the most outspoken of whom has been Alejandro Svarch, head of Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS), have cited the difficulties Latin American countries have faced procuring vaccines during the COVID-19 pandemic and persistent drug shortages, as having inspired the effort. In a video published June 15, Svarch lauded the participating agencies for joining the fight “against indifference and inequality” that impedes regional self-sufficiency in medicines and devices. Svarch also expressed the need to build more confidence among the different regulatory agencies.

AMLAC’s proponents have often used political rhetoric of “struggle,” “solidarity” and the “hegemony” of foreign and corporate interests as necessitating the agency. Much of the news coverage of AMLAC to date has come from politically aligned outlets, such as the Venezuelan broadcaster TeleSur. But the participation of all six of Latin America’s national regulatory authorities of regional reference suggests that the effort’s appeal may be becoming less ideological and more practical as support for it broadens. “Regulatory harmonization matters to public health. The dream of AMLAC has to be realized calmly but willfully to make it a reality,” commented Heriberto Garcia, head of Chile’s National Medicines Agency (ANAMED), a newcomer to the effort.

COFEPRIS statement (Spanish)

Dominican medicines agency splits from health ministry

The Dominican Republic’s medicines agency, DIGEMAPS, has separated from the country’s Ministry of Health, in a move that will allow it financial and administrative independence. On 5 June, the country’s president Luis Abinader, in a formal decree, declared DIGEMAPS to be its own entity, with the objective of improving the efficiency and quality of its services as the country’s regulator of medicines and medical devices, foods, cosmetics and other products for human use. The change is expected to take six months to fully execute, and will be led by Leandro José Villanueva, a former vice minister of health who has been chosen to head the independent DIGEMAPS.

The move was immediately lauded by the Dominican pharmaceutical trade association, INFADOMI. “We are confident that with a stronger regulator, not only at the local level, but also at the regional level, our industry can be recognized as … on par with other countries with which we are equivalent in terms of quality and innovation,” the group’s president Ludwig García, told the Dominican newspaper El Nuevo Diario. Garcia affirmed that in recent years, the Dominican pharmaceutical industry has experienced high growth, with its medications marketed in 20 countries across the region. Such growth has been made possible thanks to strong government support, García said.

Diario Libre, El Nuevo Diario (Spanish)

Anti-fentanyl law tasks COFEPRIS with authentication, tracking of chemical precursors

A Mexican federal law aims to place tighter vigilance on chemicals that can be used in the production of illegal fentanyl, while imposing harsher penalties for violators.

Under the new law, which came into force in May, any person or entity importing or working with these precursor chemicals – which are also used in legal drugs, cosmetics, and cleaning products – must report information on their activities to COFEPRIS annually. They must register any regulated activities within 24 hours with the agency’s new online tracking platform, SISUS, which logs the type and amount of chemical and allows for tracing of its movements.

Several government entities are empowered to enforce the law, including Mexico’s Navy. Customs offices that can import and export chemical precursors are more limited than before, and only COFEPRIS has the authority to verify the chemicals.

Importantly, the law comes with serious sanctions for violators, including up to 15 years in prison for anyone who deviates a precursor from its intended use or makes use of it to produce synthetic drugs; and up to 10 years for anyone illegally possessing chemical precursors or machines to produce pills or capsules. Further amendments to the law can be made through October 30.

SISUS explanatory video (English and Spanish)

New vector lab in Uruguay to fight outbreaks

Uruguay’s health ministry has announced the opening of a new laboratory focused on “identifying and breeding the most important vectors for public health,” according to a statement issued 12 June. The center, which also counts support from the Pan American Health Organization and other international entities, will focus primarily on the Aedes aegypti mosquitos that transmit dengue, chikungunya, zika and yellow fever, helping to identify disease outbreaks and test control strategies. In 2020 Uruguay, after more than a century without local dengue transmission, saw its first local outbreak; this year has seen further cases of local transmission, as well as more extensive local transmission of chikungunya virus.

Statement (Spanish)

Ecuador suspends manufacturer

On 10 June, Ecuador’s Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), announced a ban on the sale, distribution and production of medicinal products by Ginsberg Ecuador, a Quito-based firm that since produced a wide range of active pharmaceutical ingredients and medicines, including more than 700 licensed products. The regulator told local press that the suspension was related to reporting violations but did not provide additional details. According to news reports, Ginsberg was cited by ARCSA last year over alerts concerning the quality of its products, and the agency suspended its Good Manufacturing Practices certification for one plant.

Twitter (Spanish)

Latin America Roundup: AMLAC effort gains interest from Argentina, Chile and Brazil

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