Latin America Roundup: Sanofi flu vaccine rollout delayed in Mexico

Production of a Mexico-made influenza vaccine from Sanofi is delayed despite originally being scheduled for availability in fall 2023, Mexican news outlets have reported. The reports say the Federal Commission for the Protection against Health Risks (COFEPRIS) has yet to give the go-ahead for antigens produced at one Sanofi plant in Mexico to be transported securely to another for formulation and packaging.

In recent years, the French pharmaceutical company has invested heavily in Mexico, including building new antigen manufacturing and packaging facilities. The Sanofi tetravalent vaccine flu vaccine has been touted as “100% made in Mexico,” where the company has pushed for a complete in-country production cycle to avoid exporting antigens to France and importing finished vaccines. According to reports, however, Sanofi has begun shipping Mexico-made flu antigens to France for packaging. The regulator has not publicly commented on the matter.

La Jornada article (Spanish)

Backlog prompts lawsuits for COFEPRIS

On 4 June, COFEPRIS announced it has made 179 authorization decisions on drugs, medical devices and clinical trials since mid-May. The agency said it approved 21 new medications, 151 devices and seven clinical trials. It also announced it had shut down six illegal distributors of pharmaceuticals.

The agency, meanwhile, is battling mounting legal challenges from members of regulated industry over its backlog, according to Mexican news reports. The industries most frequently using the courts to pressure the agency are industrial cannabis firms, vaccine makers, pesticide manufacturers and medical device makers, a situation detailed in a May column in the financial newspaper El Economista. COFEPRIS’s legal department is currently “headless,” according to health sector analyst Maribel Coronel, “and there is no one to establish a guideline or legal strategy to best face the wave of lawsuits and fines.”

COFEPRIS, El Economista (Spanish)

Takeda building digitalization center in Mexico

Japanese drugmaker Takeda announced last month that it was expanding its digital and data operations at its Mexico City headquarters. The new center, slated to begin operations this year, is Takeda’s second data hub globally; the first opened in Slovakia last year, and a third is being planned in Asia, according to an interview on a Mexican business channel with Girardo Vargas, the center’s director. In late May, Gabriele Ricci, the company’s chief data and technology officer, said in an interview with a Mexican newspaper that Takeda has sought marketing approval in Mexico for its quadrivalent dengue vaccine, now approved in Brazil and Argentina.

Interview (Spanish)

Colombia: Health reform delayed as political support dwindles

Congressional debate over a sweeping health reform plan that shifts management of public health funds from the private to public sector was scheduled for 6 June, but talks were suspended indefinitely on 5 June by the leader of Colombia’s Chamber of Representatives. In recent months both Colombia’s top regulator and its health minister have been replaced amid controversies over the proposed reforms, which are opposed by an umbrella organization of the country’s insurers and have seen attrition in political support.

Consultorsalud (Spanish)

Colombia to change IP rules resulting from publicly funded studies

On 19 May, Colombia’s congress passed into law a new national development plan that would make the Colombian state an owner of intellectual property resulting from “scientific, technology and innovation activities financed with public resources.” The change has uncertain significance for clinical trials of experimental agents in the country, however, pharmaceutical sovereignty and greater flexibility of IP rules have been oft-stated goals of the current government. According to the law, “in situations of declaration of public interest, the State reserves the right to obtain a non-exclusive and free license of these rights derived from projects financed with public resources ... In the same way, in the event of national security and defense reasons, the owner of the intellectual property rights must assign them to the State without any limitation and free of charge.”

National Development Plan (Spanish)

Colombia to harmonize cosmetics labeling with Bolivia, Ecuador and Peru.

Colombia’s food and medicines agency INVIMA announced on 5 June that it had hosted members of the Comunidad Andina trade block, which includes Colombia, Bolivia, Ecuador and Peru, and representatives of cosmetics makers, to advise on implementation of new rules harmonizing labeling of cosmetics products across these countries. The rules will be effective as of 17 December 2024.

INVIMA (Spanish)

Brazil’s ministry of health buys unregistered insulin to ease shortages

Brazil’s Ministry of Health has awarded contracts worth nearly $80 million for insulin and hemoglobin products that are not registered with the country’s National Health Surveillance Agency (ANVISA), according to several Brazilian news outlets. The products have been certified by regulators in other countries.

In recent years the government has authorized the emergency procurement of medicinal products not registered nationally in response to various shortages. Delivery of the insulin, manufactured in China, is expected to begin in July.

Metropoles, Folha de S.Paulo (Portuguese):

ANVISA approves surgical robot

Brazil’s ANVISA agency has approved the Honghu Orthopedic Surgical Robot, marketed in some countries as “SkyWalker,” following regulatory authorizations in China, the European Union and the United States. The robot, according to a statement by its manufacturer, the Shanghai-based MicroPort MedBot, uses CT imaging to guide surgeons in performing joint replacement surgeries with robotic arms. “After obtaining regulatory approval from ANVISA in Brazil, we will provide more comprehensive robotic surgical solutions for local surgeons and hospitals,” said Liu Yu, the company’s Executive Vice President and Chief Business Officer, in a statement.

Statement (English)

Argentina’s ANMAT hosts MERCOSUR regulators

Argentina’s medicines agency ANMAT hosted representatives of Southern Common Market, or MERCOSUR, a trade bloc that comprises Argentina, Brazil, Paraguay, Uruguay and Venezuela. The four-day meeting, which ended 1 June, focused on opportunities for regulatory coordination aimed at “strengthening the links of the MERCOSUR regulatory agencies,” according to a statement from ANMAT. Representatives from Brazil’s ANVISA, and Paraguay’s National Health Surveillance Directorate (DINAVISA) were among those in attendance.

ANMAT (Spanish)

Latin America Roundup: Sanofi flu vaccine rollout delayed in Mexico

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