This Thursday (2) is the deadline for President Jair Bolsonaro (no party) to sanction the Bill (PL) 12/2021, which authorizes compulsory licenses for health supplies in situations of health emergency such as the pandemic of covid- 19.
Although the text by Senator Paulo Paim (PT-RS) is commonly called the PL of “breaking patents”, it is not a misappropriation. Compulsory licensing is provided for in Industrial Property Law 9,279/96 and was created to face possible abuses committed by patent holders.
The World Trade Organization (WTO) itself allows the adoption of this mechanism in cases of health emergency or public interest.
In 2007, for example, the Brazilian government compulsorily licensed one of the drugs in the Anti-Aids cocktail, Efavirenz, reducing the price of the drug to a third of what was negotiated by the US laboratory.
“Compulsory licenses have been proven to save lives. It is a legal, legitimate mechanism”, emphasizes Pedro Villardi, coordinator of the Working Group on Intellectual Property (GTPI) and a PhD in Human Sciences and Health from the Institute of Social Medicine of the State University of Rio de Janeiro (UERJ).
“PL 12/2021 manages to speed up this process and also brings other important devices. For example, the mandatory sharing of information necessary for the reproduction of technology. This would put Brazil in a very good position for the continuation of the fight against the pandemic”, completes the specialist.
If the project is sanctioned, the federal government must draw up a list of drugs of interest, with the participation of civil society and experts. In other words, if this is the assessment of the responsible group, Brazil could issue compulsory licenses even for Active Pharmaceutical Ingredient (IFA), one of the products that caused delays in the production and application of vaccines.
What if it doesn’t sanction?
Few laboratories control the production and distribution of immunizing agents in the world, preventing their reproduction through patents that guarantee a monopoly on intellectual property for 20 years or more.
Less than 30% of the Brazilian population took the two doses against the new coronavirus. Today, immunizing agents are in use from the laboratories Sinovac/Instituto Butantan (Coronavac), Astrazeneca/Oxford/Fiocruz, Pfizer and Janssen – the latter in a single dose. The Russian Sputnik vaccine is produced in the country by União Química and is awaiting authorization from the National Health Surveillance Agency (Anvisa).
The GTPI is coordinated by the Brazilian Interdisciplinary AIDS Association, founded by sociologist Herbert de Souza, Betinho, in 1987. Among the entities that make up the group and pressure the government to sanction the PL without vetoes, is the Brazilian Association of Public Health ( Abrasco).
If you do not determine the sanction or veto the PL, it will be tacitly sanctioned. If Bolsonaro vetoes some sections, these will be discussed again by Congress – and the bill would take longer to become law.
“This PL will allow Brazil to place more technologies in the public domain more quickly and allow Brazilian laboratories to have more information to reproduce these technologies”, emphasizes Villardi.
“This will allow Brazil to obtain supplies to fight covid-19 and other pandemics, such as medicines, vaccines and diagnostic kits, at lower prices and with greater availability.”
Even the United States, which has laboratories that have intellectual property rights for vaccines, have already taken a stand for the release of patents. Brazil did not defend compulsory licenses in any WTO meeting, causing discomfort among developing countries that are late with vaccination, such as India and South Africa.
Edition: Vivian Virissimo