Through Decree 63/2024, published on 22 January 2024, in the Official Gazette of the Argentine Republic, progress began on the regulation of the Decree of Need and Urgency (DNU). DNU 70/23 regarding articles related to the prescription of medications and their commercialization. Likewise, work is also being done on upcoming regulations.
By said decree (https://www.boletinoficial.gob.ar/detalleAviso/primera/301967/20240122), the scope of the first regulatory decree was defined, establishing complementary measures for its better implementation, ensuring the conditions of health safety.
Through these measures, both the guiding principle of facilitating the use of generics and the conditions under which healthcare professionals authorized to prescribe medicinal specialties can issue them through an electronic system are established. Additionally, the conditions that must be met for the commercialization of over-the-counter medicinal specialties outside of pharmacies and for the dispatch of prescriptions by authorized drugstores are also specified.
The national government has reversed the changes it intended to implement through a decree (DNU), which aimed to prescribe medications by brand. From now on, doctors must specify the generic name or international common denomination, although they can also suggest a product from a specific laboratory/pharmaceutical company, which the pharmacist can substitute for a cheaper alternative upon the consumer's request.
In Argentina, it is not mandatory for the majority of generic drugs to provide evidence of bioavailability and bioequivalence. If doctors are restricted from suggesting a specific medication, there may be no guarantee that the patient will receive a product meeting the quality standards for therapeutic effectiveness.
Unlike other Latin American countries, national laboratories/pharmaceutical companies here hold a 50% market share. This is attributed to Argentine industrial policies predating the 1980s, tariffs, and a lack of understanding of the international patent protection system. Consequently, Argentine laboratories/pharmaceutical companies specialized in the production of replicas and generic drugs [1].
These policies likely favoured the growth of local pharmaceutical firms, shielding them from foreign competition and enabling specialization in the production of replica and generic drugs. Consequently, Argentine laboratories/pharmaceutical companies have thrived in manufacturing these types of medications, contributing significantly to their dominance in the national pharmaceutical market.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biopharmaceutical industry in Argentina in the 21st century [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 11]. Available from: www.gabionline.net/reports/biopharmaceutical-industry-in-argentina-in-the-21st-century
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