Latin America Roundup: EU, PAHO sign agreement to boost manufacturing, regulatory systems

On 18 July, the Pan American Health Organization (PAHO) and European Union announced a €3.8 million agreement to increase access to health technology in Latin America and the Caribbean. The program, to which PAHO will contribute €800,000, aims to “scale capacity in innovation and manufacturing of vaccines, medicines and other health technologies,” James Fitzgerald, PAHO’s Director of Health Systems and Services, said in a news release, adding that it would help the region become better prepared to “address regional health needs, including during times of pandemics.” The agreement comes under an EU initiative called Global Gateway, which aims to improve infrastructure, including healthcare infrastructure, in developing countries, using money raised in the private sector. The new agreement, PAHO said, “focuses in particular on strengthening regulatory frameworks technologies transfers,” and increasing manufacturing capacities “to enable … sustainable pharmaceutical production and private sector investment.”

PAHO (English)

Colombia: INVIMA backlog dates to 2013

The reported backlog at Colombia’s National Food and Drug Surveillance Institute (INVIMA) includes unprocessed requests from as long ago as 2013, according to El Colombiano. The newspaper looked at agency records to discern the number of pending requests for renewals of active pharmaceutical ingredients and found records for 2,685 ingredients, of which nearly a fifth date to 2018 or earlier. The 25 July report comes amid controversies over transparency at INVIMA, which in July claimed to have processed more than 10,000 requests in the first half of 2023. However, the agency offered few details on the processed requests, sparking complaints from industry groups and organizations including the Colombian Federation for Rare Diseases (FECOER), whose president, Diego Fernando Gil Cardozo, claimed in the same article that new orphan disease treatments take between a year and a half to four years to reach patients in Colombia due to the regulatory backlog.

El Colombiano (Spanish)

Former INVIMA official faces trial

A former INVIMA official has been arraigned over his alleged involvement in a ring that procured medications for cancer and rare diseases and modified their expiration dates, lot numbers and other records. The actions occurred between 2021 and 2023, prosecutors said during a 24 July hearing, following which the official, Sergio Fabián Suárez, was remanded to jail pending trial. Suárez is charged with intervening on 15 occasions to procure false documentation for costly oncology, HIV and rare-disease medicines that were expired, degraded, or otherwise out of compliance, in the service of a criminal network that imported and sold them across several regions of Colombia, according to news reports.

Semana (Spanish)

ANMAT weighs decentralized clinical trials

Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) in July issued a statement expressing guarded support for decentralized clinical trials, or trials in which data collection occurs at locations outside traditional clinical trial sites, including in participants’ homes. Such trials often rely on digital health technologies, such as activity trackers, other types of sensors or mobile-phone apps. In a 7 July statement on its web site, ANMAT wrote that the experience of the COVID-19 pandemic “has generated changes and new proposals that must be evaluated and analyzed, guaranteeing the safety, rights and dignity of trial participants, as well as the reliability of the data obtained through some of the new [trial] elements. That is why the need arises for regulatory agencies to express their position regarding this type of study.” ANMAT said that whenever a trial sponsor plans to submit an application in support of a trial with decentralized elements, “the sponsor must list them, attach their justification and a risk-benefit analysis ... which will be subject to consideration by the Administration.”

ANMAT (Spanish)

EL Salvador announces PPE inspection facility

El Salvador’s National Directorate of Medicines (DNM) has established, through a roughly $700,000 grant from PAHO, Central America’s first inspection lab for personal protective equipment. “This laboratory is going to verify if the gloves, syringes, masks or protective clothing fulfill requirements for protection. Our expectations are that this quality control verification service can be used for Central America, the Caribbean, the Dominican Republic and other countries,” commented Giovanni Escalante, El Salvador’s PAHO representative, in a press statement issued by the office of El Salvador’s president on Twitter.

Concerns about adequate PPE supplies have been high in the region since the COVID-19 pandemic, during which it faced dire, prolonged shortages due to lack of local manufacturing capacity and dependence on imports at a time of high demand and when some countries, including the United States, sought to restrict their export.
DNM (Spanish)

COFEPRIS approves 109 medical devices, advances case for Cuban COVID vaccine in children

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) announced that it had authorized 109 medical devices, among them diagnostic and therapeutic devices, in the first two weeks of July. It also approved 23 medicines, the agency said in a news release, including treatments for breast cancer, migraine and hypertension. In a separate announcement, the agency said its New Molecules Committee had given a favorable opinion on two Cuban-made COVID-19 vaccine products for use in children aged 5 and older, paving the way for potential emergency use authorization in that patient group. The vaccines, authorized for emergency adult use in Mexico in November 2022, have not been recommended by the World Health Organization.

COFEPRIS 1, 2 (Spanish)

Brazil court case touches on skinny labeling debate

A decision by a Brazilian court suggests that generic drug makers could market certain drugs for non-patented uses even as Brazil’s National Health Surveillance Agency (ANVISA) has yet to weigh in on the issue of carve-outs, or “skinny labeling.”

In 26 July analysis for Lexology, Tatiana Machado and Rob Rodrigues, of the Brazilian law firm Licks Attorneys, described a case brought by a Brazilian affiliate of the Indian generics manufacturer Sun Pharma, against the Brazilian subsidiary of Boehringer Ingelheim, in which a judge ordered Brazil’s patent office “to annotate that a second medical use patent” for the idiopathic pulmonary fibrosis treatment Ofev (nintedanib) “doesn’t prevent the manufacturing and/or selling of generic or brand-generic nintedanib-based drugs for other uses.”

The court’s decision, the analysts wrote, “doesn’t really change the status quo. After all, it only determined that the [patent office] annotates an undisputable fact about [the patent]: it can only be enforced against the manufacturing and selling of generic and brand-generic nintedanib-based drugs for the patented use. But these drugs will continue to have the same label as the reference-listed drug—which includes the patented use.”

So-called skinny labeling, which ANVISA is considering allowing, would allow generics companies to seek marketing approval only for unpatented uses of a compound, and avoid infringement of second-medical-use patents. However, Brazil currently stipulates that labeling for generic drugs must reflect all the same therapeutic indications as the reference-listed drug.

Lexology (English)

Latin America Roundup: EU, PAHO sign agreement to boost manufacturing, regulatory systems

Related topics

Recommended content

Welcome to the new RAPS Digital Experience