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The modification in the rules of compulsory licensing of patents, included in Law 14200 / 2021, does not violate the principles of TRIPs – agreement on Aspects of International Law Related to Trade – to which Brazil is a signatory, but it is an instrument not to be used, said this Friday, 05, the vice president of ABPI – Brazilian Association of Intellectual Property, Gabriel Leonardos. He participated, along with the lawyer Gustavo Morais and the manager of International Affairs at GIPC, Tyler Crowe, in the third module of InterConnect, a series of virtual events promoted by Interfarma – Association of the Pharmaceutical Research Industry to subsidize parliamentarians on health issues. “The practical difficulties for the implementation of the compulsory license in Brazil are gigantic”, said Leonardos.

Leonardos, elected to the ABPI presidency for the 2022-2023 term, said that the Compulsory License, provided for in the legislation, is a legitimate instrument, but Brazil would have to develop macroeconomic conditions to encourage the transfer of technology and the production of medicines. He recalled that only once, in 2007, this device was adopted in the country, with Efavirenz, but its manufacture was only effective three years later. “My criticism of this eagerness for compulsory licenses is that in practice, under current conditions, it is useless,” he explained. Morais added: “The law will not be effective as it requires local manufacturing and involves products that are too complex to be manufactured in the short term.”

The vice president of ABPI, in his presentation, gave a brief background on patents, addressing, among others, patentability requirements, international treaties, the role of the INPI – National Institute of Industrial Property and aspects of legislation. In the item on Brazilian biodiversity, he criticized prohibitive items in the legislation. “It could be a shot in the foot: Brazil has the greatest diversity on the planet and (with the restrictions of the Law) we are taking incentives for the sustainable exploration of our biodiversity to bring state-of-the-art technology”, he said. He advocated universal access to health. “Access to health is a civilizing achievement of the 1988 Constitution. What makes access to health unfeasible is a deficient public policy, and not a patent,” he explained.

In his presentation, Morais noted the billion-dollar investments made by pharmaceutical companies in drug development and recalled that the data generated by clinical trials are subject to intellectual property protection. “In Brazil, protection is for ten years in the agrochemical, fertilizer and veterinary areas, but it does not include medicines for human use, which are fundamental in the pharmaceutical area,” he said. In turn, when addressing the importance of the world patent industry in his presentation, the GIPC representative informed that only 12% of drugs that reach the clinical trial stage in the United States are approved for commercialization by regulatory bodies. Crowe emphasized Brazil’s position on the world stage. “Brazil does not participate in a robust way in several international IP treaties and that is why companies may feel legal uncertainty in investing in the country,” he said.