The Compulsory Licence Debate Moves Forward in Brazil

On April 29th, on the same day the country reached the 400,000 mark of people killed by COVID-19, by 55 votes for to 19 against, the Brazilian Senate approved a legal bill enabling the use of compulsory licences (CL) during the COVID-19 pandemic. CLs are important legal measures provided for in the TRIPS Agreement that allows the suspension of patent monopolies under certain circumstances. While already enshrined within Brazilian law, this recent pandemic-specific CL legislation is seen by many as an important step to try to increase the availability of vaccines and other health technologies in the country, as the pandemic is at its most dramatic time Pharmaceutical industry representatives said that those who defended CL were opportunistic, and asserted that it would make more economic sense for them to sell their products in markets that did not break patents.


Throughout, Bolsonaro’s administration was against the bill, with pro-government senators offering inane excuses against compulsory licensing. During the vote, the Senator Carlos Viana, leader of the government in the Senate, said that World War I and World War II started because the USA and the UK issued CLs and Germany started the wars in retaliation.


Brazil is no stranger to the issuance of compulsory licenses. In Brazilian law, under the justification of public interest or national emergency the government can issue CLs. Brazil issued a CL once in 2007 for efavirenz, an antiretroviral used to treat HIV/AIDS infection. Within two years of importing a generic version from India, Brazil started local production of efavirenz. The savings for Brazil’s health system reached USD 100 million within the space of five years (2007-2011).


The question is: why did the Senate approve another bill on CLs if Brazil already had this legal provision enshrined in national law? This new bill had the objective of adjusting the CL current provisions to a pandemic context. We can point out three major changes: (a) the possibility of having CLs for many technologies simultaneously (versus a sporadic or case by case approach); (b) the possibility of CLs to be applied to products undergoing patent applications (rather than just subject to patents that had already been granted per previous law); and (c) sets up clearer rules as to the sharing of the necessary technical know-how by the patent holders or applicants.


Pursuant to the Senate’s approval on 29th April, the bill will now proceed to the House of Representatives for discussion. The timeline for approval is unclear – not only does the bill have to go through Standing Committees within the House of Representatives, but there are more than twenty other COVID-related CL bills presented by other parliamentarians also awaiting consideration. Out of these, Bill #1462/20 is particularly notable. According to this bill, during national health emergencies such as, but not limited to COVID-19, there should be no monopolies on essential health technologies. In other words, all essential health technologies should be put in public domain for the entire duration of the public health emergency.


These are all positive developments, although with the CL bill, it is extremely likely that the path in the House of Representatives will be harder. The President of the House, MP Arthur Lira, has already declared that he opposes compulsory licences and said he will not take the discussion to plenary discussion. Despite these potential obstacles, it is evident that the pandemic has awakened an urgency and a re-examination of the approach to patent law vis-à-vis emergencies. For Brazil, this may be a way out of the pandemic. And with the recent announcement of U.S. support for a TRIPS waiver, and declaration by African officials at the African Vaccine Manufacturing Summit that TRIPS was not working for Africa, it may well be that through Brazil and other countries, that we are witnessing a reverberation and the beginnings of a new global patent order.


Dr Pedro Villardi


Associate Consultant, Matahari Global