Newsletter Edition 30 - November 2021


Debate points out that a compulsory license for medicines in Brazil can be innocuous

The modification in the rules of compulsory licensing of patents included in Law 14,200/2021 does not violate the principles of TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights), to which Brazil is a signatory, but it is an instrument not to be used, said the president-elect of ABPI, Gabriel Leonardos, on November 5th. Along with lawyer Gustavo Morais and Tyler Crowe, the manager of International Affairs at the GIPC (U.S. Chamber of Commerce’s Global Innovation Policy Center), Leonardos attended the third module of InterConnect, a series of virtual events promoted by Interfarma (Pharmaceutical Research Industry Association) to support parliamentarians on health issues. “The practical difficulties for compulsory licensing implementation in Brazil are huge”, said Leonardos.

Leonardos stated that the Compulsory License provided for in the legislation is a legitimate instrument but, Brazil would have to develop macroeconomic conditions to encourage the technology transfer and production of medicines. He recalled that only once, in 2007, this legal provision was adopted in the country, with Efavirenz, but its manufacture was only carried out three years later. “My criticism of this craving 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”.

In his presentation, Leonardos provided a brief background on patents, addressing patentability requirements, international treaties, the role of the BPTO (Brazilian Patent and Trademark Office), and aspects of legislation, among other matters. 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 removing incentives from the sustainable exploitation 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 Brazilian Constitution. What makes access to health infeasible is an ineffective public policy and not patents”, he explained.

Morais spoke about 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 fields, but it does not include medicines for human use, which is fundamental in the pharmaceutical field”, he stated. In turn, when addressing the importance of the global 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 robustly in several international IP treaties, and that is why companies may feel legal uncertainty in investing in the country”, he said.