Latin America Roundup: El Salvador seeks to raise licensing, renewal fees for drugs

El Salvador’s executive branch has proposed legislative changes that would oblige the country’s regulatory agency, the National Directorate of Medicines (DNM), to increase fees related to all categories of drug licensing and renewal.

The fees jump from $500 to up to $3,000 for a new registration of an imported non-generic drug product, according to press reports, while renewals would cost $600, up from the current listed fee of $86. An additional therapeutic indication would cost $420, up from $25. The change, which is opposed by pharmaceutical industry representatives in El Salvador, was presented on 25 August to Salvadoran legislators, though it has yet to be formally debated or published online. The office of El Salvador president Nayib Bukele issued no written statement concerning the proposed fee hikes; however, representatives of Bukele’s office confirmed its request for across-the-board hikes to the newspaper La Prensa Grafica, saying that sufficient economic resources are needed for the regulatory agency to “guarantee safety, quality and effectiveness of the products subject to regulation.” The reported new fees, while higher than current ones, are not especially high by global standards, which a 2017 analysis found to be all over the map, with registrations of a new non-generic drug product costing $100 or less in some Southeast Asian countries to more than $300,000 in Canada and Europe. Even among lower and middle- income countries, fees ranged widely, with some countries, like Brazil, charging more than $50,000 for licensing new agents.

La Prensa Grafica (Spanish)

INVIMA simplifies fee schedule

Colombia’s National Food and Drug Surveillance Institute (INVIMA) has streamlined its complex fee system for drug renewals, registrations, and other service categories, halving its 925 former fee categories to 464. The new fee schedule or manual, adopted and published in August, represents a key advance in streamlining INVIMA’s processes for the registration and renewal of medicines. In addition to reducing the number of fee categories, the new manual is easier and faster to search, the agency said in a news statement, and contains clearer descriptions of its categories, “helping users avoid errors in selection and payment.” INVIMA’s fee system has been criticized by industry groups and its own leadership, including former acting director Francisco Rossi, for provoking unnecessary confusion and delays.

INVIMA (Spanish)

COFEPRIS warns of irregular lots of Hepatitis B vaccine

Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) said on 10 September that it had detected a possibly falsified Hepatitis B vaccine in circulation in the country. Specific lot numbers of the product, labeled Probivac-B, were found not to conform with packaging information. The mislabeled vaccine represents “a risk to the health of the population, because the manufacturing, handling and storage conditions are unknown, so its safety, quality and effectiveness are not guaranteed.” Probivac-branded hepatitis B vaccines, manufactured by the Mexican firm Probiomed, have been approved and available in Mexico since at least 2019.

COFEPRIS has increased the frequency of its numbers of alerts about falsified, mislabeled or adulterated medications over the past three years, a May 2023 analysis by the newspaper Expansion Politica revealed; in 2020 it issued only 12 such alerts, most about pirated products, while the first five months of 2023 saw more than 30. The COVID-19 epidemic prompted COFEPRIS to issue alerts related to pirated COVID vaccines. Despite enhanced pharmacovigilance and a greater push to publicize results of investigations, the problem of pirated medications remains endemic in Mexico, so much so that in the spring of 2023 the agency published an entire illustrated magazine dedicated to the phenomenon, explaining its pharmacovigilance strategies and concepts such as medication production chains and how irregularities are identified.

COFEPRIS (Spanish)

Ecuador confiscates unregistered OTC medical devices

Ecuador’s Regulatory, Control and Surveillance National Agency (ARSCA) identified some 600 medical devices not registered with the agency for sale in the city of Cuenca, according to a press report in the Cuenca newspaper El Mercurio. The sales occurred in online outlets such as Mercado Libre (the region’s equivalent of Amazon.com), and products were confiscated in operations by other agencies, including police. The unlicensed products included blood pressure monitors, stethoscopes, otoscopes, oximeters, nebulizers, tuning forks, suture kits and glucometer strips.

El Mercurio

Brazil: New laws require transparency on public drug stocks; tighter rules sought for coverage of advanced therapies

On 24 August the Brazilian government mandated that states and municipalities distributing drugs to public pharmacies must post accessible data on their websites about those pharmacies’ drug stocks, allowing citizens an easier look at where shortages are occurring. The issue of citizen access to drug availability data came into sharp relief during the COVID-19 pandemic, during which information about drugs and vaccines could only be accessed by way of cumbersome petitions using Brazil’s freedom of information laws, according to an analysis in Lexology by lawyers with the Brazilian firm Licks Attorneys.

A court case filed in 2022 prompted the change, the attorneys wrote, adding that the new rule “directly affects the population relying on government-supplied medicines,” who often face “difficulty accessing such medicines due to a lack of distribution planning.” In a separate analysis published 5 September, the Licks Attorneys described an ongoing debate in Brazil over how so-called advanced therapies – high-tech, high-cost medications requiring ongoing monitoring, such as advanced cellular therapy products and gene therapies – should be covered by private insurance. Brazil’s National Agency for Supplementary Health, which regulates private insurance, is seeking “specific and stricter” new rules governing the inclusion of these therapies on lists of covered procedures, according to the authors.

Lexology

Latin America Roundup: El Salvador seeks to raise licensing, renewal fees for drugs

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