Change to pharmaceutical patent regulations opens the door to imports

Argentina flexibilized its regulation on pharmaceutical patents, eliminating a set of restrictions on foreign products that existed since 2012 and opening the door to imports.  The change was made as part of an agreement with the United States government. On Wednesday, the Argentine government overturned a 2012 resolution that established how pharmaceutical patents are analyzed and approved. Now, the National Institute of Intellectual Property will be in charge of processing the requests for patenting, analyzing each case individually, something it did before the resolution in question. The change means there will no longer be restrictions on certain categories of pharmaceutical and biotechnological products, which till now could only be patented by Argentine companies.  The elimination of those restrictions was a years-long demand from the U.S. The international pharmaceutical sector reportedly complained that the norm allowed for the proliferation of copycat products patented in Argentina. Part of the national pharma industry defended the regulation because it allowed them to develop their own generic versions of certain products, boosting the national industry and competitiveness, while providing cheaper versions of products. However, there will be no retroactive effect to the elimination of the restrictions, meaning that generic medications that are already being sold in the Argentine market will continue to be offered. Deregulation minister Federico Sturzenegger, who was behind the decision, said on X that it represents “a transcendental improvement regarding intellectual property” in Argentina. According to him, the 2012 resolution, approved during the government of Cristina Kirchner, “had made it very hard (if not impossible) to obtain a medical patent in Argentina,” which not only “violated the right to property” but also “delayed the arrival of innovating therapies to the country.” Sturzenegger said the decision puts Argentina in line with international standards on intellectual property and that, in exchange for the move, the U.S. will “open its entire domestic market to our pharmaceutical industry.” The American Chamber of Commerce in Argentina (AmCham) celebrated the decision, saying it will “boost innovation in healthcare, eliminating restrictions that for years limited pharmaceutical patents.” “Argentina is creating conditions to attract investment, developing knowledge and competing globally again,” AmCham said in an X post. “When predictability, investment and innovation connect, the result is clear: a more competitive economy, and a more robust health system.” The Industrial Chamber of Argentine Pharmaceutical Laboratories (CILFA, by its Spanish initials) said in a statement that they trust in the National Institute of Intellectual Property’s “competence and technical capability” to analyze patent requests “rigorously and on a scientific basis, granting patents for genuine pharmaceutical innovations.” “The issue goes beyond the private interests of the companies CILFA represents and affects, plain and simple, the public interest in health and access to medicines,” the chamber wrote. Cover photo credit: Roberto Sorin/Unsplash