The trade agreement with the United States has a full impact on the pharmaceutical laboratory sector. Because it facilitates the introduction of new patents In addition, he explains that to control the quality of these products, the approval of the local regulatory body will not be necessary, but rather the approval of the Food and Drug Administration (FDA) will be sufficient.
Indeed, one of the points referring to this issue, in the Joint Declaration on the Framework of Agreement between the United States and Argentina on Reciprocal Trade and Investment, is that which is consistent with “Standards and Conformity Assessment.” It is noted here that “Argentina will allow the entry of US products that comply with applicable US or international standardsOr US technical regulations or US or international conformity assessment procedures, without additional conformity assessment requirements, we will continue to remove non-tariff barriers affecting trade in priority areas.
At the same time, it is noted that “Argentina will accept the import of vehicles manufactured in the United States that comply with Federal Motor Vehicle Safety Standards and US emissions standards.” We will accept US Food and Drug Administration (FDA) certifications and prior marketing authorizations for medical devices and pharmaceutical products..
Another point that affects the pharmaceutical industry is that which refers to “intellectual property”. In this sense, the text states: “Argentina has taken action against an important and notorious regional market for counterfeit products and counterfeit medicines.” We will continue to strengthen law enforcement against counterfeiting and piracy, including in the digital environment“.
It was also emphasized here that “Argentina has committed to addressing the structural challenges identified in the document Office of the United States Trade Representative Special Report No. 301 of 2025which include patentability criteria, Delays in patent processing And geographical indications and working to harmonize its intellectual property system with international standards.
When asked about this issue, the chamber that brings together national laboratories, “Silva,” said: “The declarations indicate the foundations of a framework agreement, the full content of which will be known with the final text of the agreement. Therefore, until this happens, it will be difficult to predict its effects on the sector.
Silva added:We support a trade agreement that promotes trade and investment, in terms of reciprocity with regard to health regulation of pharmaceutical products.This lays the foundations for greater competition, access to medicines and balanced intellectual property.
Meanwhile, from the Business Chamber of Pharmaceutical Laboratories (Kuberala), they expressed their interest “Analyze (the agreement) carefully.” Before commenting.
For their part, the foreign laboratories grouped in Kemi (Argentine Chamber of Medical Specialties) did not comment on the conclusion of this memorandum.
This topic was posted by Nation In April. In that note, Francisco Oliveira mentioned that The United States has tightened its claims on Argentine pharmaceutical patents. Reference was also made to Special Report No. 301, which has been in preparation since 1989 and owes its name to the famous “Section 301” of the US Trade Act, passed in 1974, which allows that country’s trade representative to take action against foreign countries engaging in unfair or discriminatory trade practices.
According to what was published at the time, the most important issue was the pharmaceutical sector. In the above-mentioned report, one paragraph described the difficulties faced by foreign companies, as interpreted by the US authorities, in patenting their products in Argentina. This is a recurring topic of conversation between Argentina and the United States since Donald Trump announced increased tariffs on the entire world.
The North American Trade Bureau said this: “A major flaw of the legal framework is the overly broad restrictions on patentable subject matter.including patent examination guidelines that automatically reject applications for classes of pharmaceutical inventions that are patentable in other jurisdictions.”
But there was also another indication that existing barriers for foreign companies when patenting products in the country could be removed. Federico Sturzenegger, Minister of Deregulation, drafted a draft decree at the beginning of the year proposing to overturn this decision.
This decision, which can be rescinded under the new agreement, is restrictive and, with the exception of Venezuela, unique in the region. In general, in most of the 76 countries that have legislation to protect the industry’s intellectual property, objections to patents are filed after they are issued. In Argentina, on the other hand, the rule in question allows them even to disagree.
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