The government eliminated a key requirement for importing medicines and aims to lower prices in pharmacies.

The sight of officials traveling abroad to inspect pharmaceutical factories— like Carla Vizzotti's visit to Russia during the pandemic to oversee the production of Sputnik V—seems like a thing of the past. The government of Javier Milei eliminated the requirement for ANMAT (National Administration of Drugs, Food and Medical Technology) technicians to conduct on-site inspections of foreign laboratories that export pharmaceutical products to Argentina.

The resolution aims to expedite the importation of medicines and expand the supply available in the country. According to the Executive branch, the change will allow more competitive products to enter the market and, consequently, lower prices in pharmacies , in a market that continues to show high prices despite the slowdown in inflation.

The measure repeals a requirement imposed in 2005, which stipulated that ANMAT (the Argentine National Administration of Drugs, Food and Medical Technology) had to certify Good Manufacturing Practices (GMP) on-site before authorizing the importation of a drug. From now on, the agency will be able to recognize certifications issued by “trusted” international health agencies , such as those of the Pan American Health Organization (PAHO ) or the member countries of Mercosur and the Pharmaceutical Inspection Co-operation Scheme ( PIC/S ).

Under the new system, if a foreign laboratory has a valid certification from one of these entities, on-site verifications will not be necessary . ANMAT (the Argentine National Administration of Drugs, Food and Medical Technology) may rely on existing reports and certificates, and will only order "virtual or on-site" inspections if it considers there to be health risks or doubts about the product's quality.

The Ministry of Health , headed by Mario Lugones , stated that the objective is “to avoid delays in authorizations and expedite procedures, without losing autonomy in decision-making.” However, the resolution was driven by the Ministry of Deregulation and State Transformation , led by Federico Sturzenegger , the official most closely associated with the government's deregulation agenda.

The announcement is part of a series of deregulatory reforms aimed at revitalizing key sectors of the economy. Days earlier, Sturzenegger had celebrated a similar measure for companies that import dental supplies, cosmetics, and hygiene products , which will no longer require prior inspection by ANMAT (the Argentine National Administration of Drugs, Food and Medical Technology) if they submit a sworn statement of compliance.

The former president of the Central Bank was also one of the driving forces behind the drug import program implemented by the province of Mendoza , under the administration of Alfredo Cornejo . Under this program, the province imports medications from India at discounts of up to 80% compared to local prices. The Mendoza model was seen as an experimental testing ground for a policy that is now being rolled out nationwide.

Although the government avoided addressing the issue of prices or quality, the decision has already generated concern within the Argentine pharmaceutical industry, which fears losing ground to international competition. Industry associations have not been officially notified of the new measure and, according to reports, are evaluating its technical and commercial impact.

Sources within the pharmaceutical industry warn that health controls could weaken , especially given the current climate in which ANMAT (the Argentine National Administration of Drugs, Food and Medical Technology) is facing scrutiny for its role in recent cases, such as that of HLB Pharma , implicated in the deaths of over 120 people from contaminated fentanyl.

Even so, government officials maintain that the new system will uphold international standards. “ The system is reliable because it is based on regulatory agencies with which we share technical criteria ,” sources close to Sturzenegger assert.

The government is betting that the increased flexibility will generate greater competition and a gradual decrease in prices , especially for the most commonly used medications, such as over-the-counter and prescription drugs. However, industry analysts warn that the effects could be delayed and will depend on the speed at which companies adapt to the new certification system.

The challenge will be balancing deregulation and health controls in a particularly sensitive area. While Milei promotes the logic of “free market,” the opposition is already anticipating requests for reports to learn the details of the technical criteria, as well as the risks associated with importing goods without on-site inspection.

For now, the measure already marks a turning point: it reinstates the logic of the 1990s , with more relaxed regulations and greater reliance on international standards. Those in the Casa Rosada (the Argentine presidential palace) are confident that this shift will help break the price monopoly that dominates the Argentine pharmaceutical market.