Latin America Roundup: Colombia’s INVIMA at center of nation’s health-reform battle

In late March, Francisco Rossi stepped down as director of Colombia’s National Food and Drug Surveillance Institute (INVIMA) amid accusations that the agency was exacerbating ongoing medicines shortages in the country.

Rossi’s departure came amid a political battle over health reform in Colombia. The government is also seeking to replace the current network of privately run Health Promoting Entities (EPS), which are funded by the government and employee contributions and serve as intermediaries to healthcare providers, with a public system. Shortages of essential medications, ongoing for several years and mostly evident in institutional settings, have been used by both opponents and proponents of reform to justify their positions. INVIMA currently lists 169 medications for which shortages are occurring or at risk of occurring.

Industry groups claim INVIMA has maintained a backlog of more than 20,000 requests for authorizations and approvals since 2018, and that the medicines shortages are at least in part a result of delays involving active pharmaceutical ingredients (APIs), the vast majority of which are imported. Some trade groups have also claimed that as many as 1,200 APIs are in short supply in Colombia, while the government has acknowledged just 30 “priority” APIs to address.

In mid-March, Rossi told to Colombian legislators that the country’s current health minister, Carolina Corcho, had rejected shipments of low-cost pharmaceutical products because purchasing them would not represent a permanent solution to the shortages – rather, he argued, Colombia needed to strengthen its internal industrial capacity and rely less on imports. The comments caused an uproar. On 21 March, the country’s Attorney General announced an investigation into the Health Ministry and INVIMA over medications shortages. The next day, Rossi’s departure was reported, though he remains in government as an advisor on medicines to Corcho.

Colombia’s Health Ministry then issued a public statement attempting to explain the reasons for the shortages. Shortages were caused by myriad factors, the ministry said, including higher demand for certain classes of medicines; restrictions imposed by manufacturers in contracts with different EPS’s and pharmaceutical managers; incomplete or late deliveries; “regulatory requirements”; the backlog at INVIMA, and problems acquiring raw materials. The ministry also cited “loss of interest on the part of the industry in marketing certain products due to low profitability, even though they are essential for health care” and inadequate or late notifications by manufacturers of lack of availability.

In recent interviews with Colombian news outlets and healthcare sector analysts, Rossi has repeated many of these points, blaming market forces more than internal factors. But he did acknowledge the role of INVIMA, pointing to its byzantine fee system and a regulatory structure he has called unduly complex, “colonial,” slow and cumbersome to navigate. Pharmaceutical sovereignty has been a long running theme of Rossi’s, particularly since the COVID-19 pandemic, and he has rejected calls for increased harmonization with FDA and EMA, criticizing what he has described as these agencies’ industry-aligned focus on approvals of lucrative new products. Rossi has argued for simplifying Colombia’s pharmacopeia and in recent months heavily championed a proposed Latin American Medicines Agency, a project supported by Mexico and Cuba, as a way to increase availability of essential drugs and speed approvals in Latin American and Caribbean countries.

Statement (Spanish)

Mexico: COPFEPRIS makes show of speed, targets ‘irregular’ pharmacies

Mexico’s Federal Committee for Protection from Health Risks (COFEPRIS), announced on 27 March that it had in the two weeks prior registered a record 23 medicines and 153 devices, an increase of 30% and 42%, respectively, over the same period in 2022. “Agile regulation represents innovation that supports public health,” the agency said in a public statement.
COFERIS head Alejandro Svarch told Mexican press outlets that the agency would now publish reports detailing new authorizations every two weeks to boost awareness of the agency’s work and “how it effectively increases therapeutic options for patients.”

COFEPRIS also reported in April that it had stepped up vigilance along the US-Mexico border and was increasing oversight in the Mexican states of Baja California, Coahuila, Chihuahua, Nuevo León, Sonora and Tamaulipas. The agency said it was focusing on three areas: products destined for international trade, aesthetic surgery clinics and sale of irregular medications. On the last issue, the agency pledged to “regularly update the platform of irregular distributors,” and “intensify pharmacovigilance actions.” It also said it would increase surveillance of drug sales over the Internet and combine efforts “among competent authorities and sectors.” COFEPRIS revealed this month that it had identified seven online pharmacies in different areas of Mexico operating with dubious or insufficient documentation, or without physical storage sites available for inspection. In Mid-March, the U.S. Embassy in Mexico warned US citizens to exercise caution when purchasing pharmaceuticals in Mexico, citing the presence of counterfeit opioid painkillers tainted with fentanyl or methamphetamine. “Small, non-chain pharmacies” in border areas were especially suspect, the embassy advised.

COFEPRIS statements: Authorizations, Vigilance, Online Pharmacies (Spanish)

WHO may add anti-obesity drugs to essential medicines list

The World Health Organization (WHO) is considering adding anti-obesity medications to its next essential medicines list for the first time, according to news reports by Reuters. A formal request for the inclusion of GLP-1 receptor agonists, a class of drugs used in both diabetes and obesity, was submitted by four US-based researchers to WHO, whose Expert Committee on the Selection and Use of Essential Medicines will next meet in late April. The researchers argued in their submission that obesity, “once thought to be a problem of high income countries ... has become a rising issue in low- and middle- income countries,” and is responsible for an increasing share of global deaths. The WHO’s essential medicines list, updated every two years, is of particular importance to low and middle-income countries as it is meant to outline priority medications to be sold at prices within reach of their populations. The request noted that patents on the GLP-1 agonist liraglutide had expired in China and Japan and were set to expire in the US and Germany this year, meaning that lower-cost generic versions could likely emerge as early as 2024.

Petition to WHO (English)

Latin America Roundup: Colombia’s INVIMA at center of nation’s health-reform battle

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