The trade agreement between Argentina and the United States, announced this Thursday, consists of several points that are directly related to the trade agreement. pharmaceutical industry. One relates to the future role of the National Agency for Medicines, Food and Medical Technology (ANMAT), which will partially continue to exist. subject to approval What you receive from the Food and Drug Administration (FDA). The other is pharmaceutical patents.
Regarding the first point, the U.S. Embassy said in a statement that Argentina accepts “certificates from FDA and FDA.” prior marketing approval This goes hand in hand with a tariff chapter that says, “Argentina provides preferential market access for U.S. exports.” certain medicines”, and there are no further details at this time.
Regarding intellectual property, the agreement states that “Argentina alsol 2025 Special 301 Report Includes U.S. Trade Representative standards Patentabilitydelays in granting patents, delays in geographical indications, and the need to work to bring the intellectual property system into line with international standards.”It should not be forgotten that this report caused a lot of noise in foreign research institutions in April 2024.
clarion Three of the most important chambers of the pharmaceutical industry in Argentina and the local pharmaceutical industry, which gather existing laboratories, were consulted on this issue. They are two nations: Argentina Chamber of Pharmaceutical Laboratories (CILFA) and Chamber of Pharmaceutical Laboratories (Cooperala). And what represents it is foreign research instituteArgentine Chamber of Pharmaceutical Specialties (CAEME).
From CILFA, they were cautious after learning the first guidelines of the trade agreement, stating: “The announcement refers to the basis of the framework agreement, the full contents of which will be known in the final text of the agreement. Therefore, until this happens, its impact will be difficult to predict In this field. ”
But they added: “We are in favor of trade agreements that promote trade and investment. Reciprocity in regulation This will result in greater competition, access to medicines, Balanced intellectual property“On the other hand, the Cooperara side requested not to comment for the time being even if they received inquiries.” clarion.
Meanwhile, CAEME, the chamber that would a priori benefit most from the agreement, elaborated in detail in a statement. So they celebrate the news and declare: important stepAnd they said, “To the agreement, FDA standards Intended for certification and pre-authorization of medical devices and drugs. This increases speed Access to innovation” avoids duplicate processes and improves the efficiency of the health registration process.
They particularly highlight the “positive signals sent by both governments.” Strengthening the intellectual property systemis an essential pillar for the development of knowledge-based industries. ” And they added, “We highly appreciate the efforts envisaged to address the deficiencies identified in the Special 301 report, including the review of standards.” Patentability limitations and adapting local systems to higher global standards. ”
Finally, they point out that: “This progress is A more predictable systemaligns with international regulatory frameworks, allows for more effective protection of innovative products, and promotes the export of local inventions and products. stimulate investment in research Developments in strategic areas such as pharmaceuticals, agricultural biotechnology and entrepreneurship. ”
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