The global pandemic has certainly impacted regulation all around the world. Travel restrictions, social distancing measures, and economic policies are only some examples of regulatory responses that can be observed at the various governance levels. Drug regulation, more specifically, has been particularly controversial regarding medicaments that could allegedly be used in the treatment of COVID-19. This is the case of chloroquine (CQ) and hydroxychloroquine (HCQ), two drugs that were virtually unknown for most of the world’s population until the beginning of the pandemic.
Both drugs became known to the public when different countries began testing its application to treat COVID-19. Even though it was clear that they had been applied experimentally, it rapidly became a strategy against the virus in different parts of the globe. The Brazilian government has been a relentless supporter of CQ and HCQ. Certainly, other countries have equally championed the use of these drugs (most notably, the US). Nevertheless, the effects of political polarization and the executive’s position on regulatory agencies have been particularly striking in Brazil.
Jair Bolsonaro, the president of Brazil, has been overly vocal about the use of CQ to treat COVID-19 and promote the “protection of jobs and lives.” Thus, the Brazilian government has been putting its hopes in CQ to reduce the virus mortality and allow the economy to keep flowing. As will be shown below, the political struggle to defend these medicaments has only created further instabilities in the government, with deleterious consequences to the Brazilian population.
The public debate on CQ and HCQ intensified as Brazil registered its first COVID-19 death on March 17. The first reaction of Anvisa (National Sanitary Surveillance Agency, the Brazilian health regulatory agency) was to clarify that studies on the application of chloroquine to treat COVID-19 had not been conclusive to support its authorization. Nevertheless, the US government’s support for the drug and the repercussions on social media induced people to buy CQeven when they did not have any COVID-19 symptoms. To avoid the undersupply of CQ and HCQ, Anvisa released Resolution 351, making mandatory a prescription to the purchase of these drugs, and Resolution 352, requiring a special authorization to export CQ and its chemical components. Therefore, Anvisa’s first regulatory reactions were directed to control CQ usage and assure its domestic supply.
The Brazilian Health Ministry, however, had a different response. On March 25, it released a note authorizing the use of CQ and HCQ as an adjuvant medicament in the treatment of severe cases of COVID-19. Luiz Henrique Mandetta, then Health Minister, advised that, despite the lack of evidence regarding the medicaments’ efficacy, the Ministry would make the drug available to doctors who desired to use it. Bolsonaro praised these regulatory changes and, a few days later, announced that the pharmaceutical laboratory of the Brazilian army would start producing CQ.
Despite this initial success, Bolsonaro faced difficulties in promoting CQ as a strategy to deal with the pandemic. It became clear that Anvisa would not loosen regulation without proof of efficacy, and further regulatory changes in the Health Ministry faced objections. The disagreements between Mandetta and Bolsonaro concerning social isolation and the use of CQ and HCQ increased the tensions in the federal administration, which ultimately led to Mandetta’s resignationon April 16. In his last pronouncement as Minister, he criticized the political use of CQ and the spread of fake news concerning the efficacy of the drug.
Nelson Teich took over the position but had the enormous challenge of providing a solution to the growing number of COVID-19 cases. Even though political disagreements were the core reason for the change in Health Minister, Teich and Bolsonaro’s positions still differed significantly. Since Bolsonaro insisted on making the use of CQ more flexible and relaxing the social distancing measures, Teich was being pressured to accept regulatory changes with which he did not agree. He resigned on May 15 as the death toll reached 14,817. Possibly avoiding more political conflicts, Bolsonaro nominated General Eduardo Pazuello acting Health Minister.
Without an official Health Minister, the Bolsonaro government approved the administration of CQ and HCQ even in the initial stages of the disease. However, this regulation has a strong political character as it explicitly says that there is no scientific evidence of CQ and HCQ efficacy against COVID-19. Plus, it makes the administration of these drugs discretionary to health professionals, and only when the patient signs a consent form. Apart from having almost no regulatory impact, the protocol also faced criticism from different members of civil society and research institutes.
The resignation of two Health Ministers underscores that the interest in authorizing CQ and HCQ to treat COVID-19 was beyond scientific evidence or regulatory prudency. On the contrary, it was a political agenda, inciting tensions between the part of the population that supports the government and the one against it, replicating the polarized dynamic seen during the 2018 elections. Bolsonaro’s support to CQ not only shifts the government’s resources away from efficient regulatory and policy responses to the pandemic but also sends the wrong message to the Brazilian population. In fact, despite the Anvisa regulation to ensure the domestic supply of the CQ and HCQ, patients treating other diseases struggle with undersupply.
Regardless of the actual efficacy of CQ and HCQ to combat COVID-19, the case of Brazil emblematic shows how regulation is politically shaped, and that autonomous regulatory bodies remain indispensable. Nevertheless, it is essential to acknowledge that, if empirically proved, CQ could be an excellent treatment to COVID-19, especially considering that it can be cheaply produced as a generic medicament, different from other drugs (such as Remdesivir). However, scientific evidence must be clear so that regulatory agencies can decide better.
Amidst declarations of leaving the World Health Organization and corruption accusations, the death toll in Brazil surpassed 60,000. Still, Brazil remains without an official Minister of Health for more than a month and no appropriate regulatory responses to overcome this crisis.
Alexandre San Martim Portes is a PhD Candidate at the School of Regulation and Global Governance (RegNet), Australian National University. Email: firstname.lastname@example.org