Angela Kung
Pinheiro Neto Advogados, São Paulo
akung@pn.com.br

Nicole Recchi Aun
Pinheiro Neto Advogados, São Paulo
naun@pn.com.br

Bruna do Rego Barros
Pinheiro Neto Advogados, São Paulo
​​​​​​​bbarros@pn.com.br

Background

The Covid-19 pandemic is not the first one in history, but can undoubtedly be seen as one of the most catastrophic public health crises in recent times, with striking economic, social and political effects. Several diseases have long plagued the world, such as the bubonic plague, better known as ‘Black Death’, in the 14th century, which took more than a hundred million lives, approximately 22% of the world population.^[1]

Smallpox^[2] in the mid-16th century, cholera in 1817 and Spanish flu in 1918, wiped out between 40 and 50 million people and infected more than a quarter of the world’s population (and, in 1968, the Hong Kong flu killed at least one million people alone). More recently, in 2009, swine flu killed 16,000 people.^[3]

Since the first records of Covid-19 cases in December 2019, there have been 212,357,898 confirmed cases, 4,439,843 deaths and 4,619,976,274 vaccine doses administered globally, according to the World Health Organization (WHO).^[4] Like similar viruses, the massive outbreak is widely understood as a zoonotic disease, originated, mutating and spreading from animals before infecting humans.

The immunisation campaign in Brazil

Brazil is one of the most affected countries by Covid-19, with the US the only country with more deaths. According to the Brazilian Ministry of Health (MoH), around 180,000 vaccine doses have been administered, considering first, second and single dose, which represents around 27% of full immunisation rate to date.^[5]

Brazil’s vaccination campaign has international prestige and recognition for historically making all WHO-recommended vaccines available free of charge to the entire population, under a universal healthcare access system. The MoH is in charge of the vaccination programme, and is known to provide fast distribution of vaccines throughout the states and municipalities in Brazilian annual vaccination campaigns. Nonetheless, MoH’s lack of planning and organisation failed the expectations for Covid-19 vaccination, putting significant hurdles for an effective response to the pandemic.

The first announced Covid-19 vaccine was administered in the United Kingdom on 8 December 2020.^[6] By that time, no vaccine had been approved by Brazil’s National Health Surveillance Agency (ANVISA). The first vaccine in Brazil was given on 17 January 2021 in São Paulo.^[7] In spite of the apparently short interval between UK and Brazil’s first jab, the Brazilian programme’s development lacked consistency and coordination over the following months, with a steady and dramatic growth in death toll, surges of cases and new variants, strained intensive care unit capacity, as well as on-and-off lockdowns exposing the population to uncertainty and vulnerability.

Under Law No 6,259 of 1975, the MoH is in charge of the Brazilian immunisation programme. Most recently, Law No 13,979 of 2020, which was issued specifically to define emergency measures to deal with the Covid-19 outbreak, vested the federal government with exclusive authority to tackle a number of public health implementation and enforcement measures, and the constitutionality of such exclusive jurisdiction was challenged at the Supreme Court.

The Supreme Court then held that the measures adopted by the federal government under said law do not exclude the constitutional mandate and autonomy of the other entities of the federation, which have concurrent jurisdiction on healthcare issues.^[8]

In the wake of such decision, given the failure of the MoH to promote a coordinated and timely federal vaccination campaign to contain the virus spread, some Brazilian states took the lead to implement their own programmes, which were previously concentrated and handled by the federal government within the national immunisation programme, bringing management and political disputes to the fore.

Such initiatives were discussed in Congress and, in March 2021, Law No 14,124 established that the National Plan for Vaccination should be observed, which was prepared, updated and coordinated at federal level by the MoH, also authorising states, municipalities and Federal District to purchase vaccines on a subsidiary basis from the federal government.^[9]

The private sector has also taken initiatives to speed up vaccination by attempting to purchase doses to vaccinate their own employees, but ethical and legal barriers, coupled with short supply issues, ended up undermining such initiatives, and Law No 14,125 of 2021 eventually established that only after complete immunisation of priority groups set out in the national immunisation programme would private entities be allowed to purchase, distribute and administer Covid-19 vaccines.

On the political front, vaccination priorities were overshadowed by constant strife over health policies, promotion of ineffective treatments, science denial and reliability of existing vaccines, coupled with uncoordinated financial and health assistance to more vulnerable states and municipalities, all of which is now under probe by a parliamentary inquiry for causing significant and harmful delays to immunisation of the population.

Further, on a behavioural perspective, a recent research showed that 94% of Brazilians have been already vaccinated or intend to be vaccinated with the first dose, which should facilitate the vaccine campaign development.^[10] Notwithstanding, the misinformation spread and the variety of vaccines and brands now available, triggering comparisons and selection of specific vaccines over others, ended up increasing vaccination refusal and hesitation rates, putting the success of the Brazilian immunisation programme at risk. Not surprisingly, while some hesitate, others ignore the priority order and try to skip the line for vaccine doses.

Such events became so often and disturbing that some states, including São Paulo, issued laws to penalise public servants and civilians involved in queue-jumping. At a national level, Bill No 25/2021 intends to criminalise the breach of immunisation measures, embezzlement involving vaccines, medicinal or therapeutic items, and corruption involving immunisation plans.^[11]

Thinking ahead

While the world was caught off guard by the pandemic in 2020, the time is ripe for looking ahead as experts suggest that Covid-19 may be endemic from now on. In addition, mutations and new surges are not yet contained and may give rise to similar events requiring prompt action and response.

We have learned the hard way that planning and defining policies backed by scientific-based evidences are the best strategies for dealing with outbreaks. Only after experimenting serious popularity impacts has the Brazilian government put actual efforts to pursue a sufficient vaccine supply for its population. Now it is important to tap into the knowledge and other resources acquired on an emergency basis to manage the use of ICU beds effectively as infection and hospitalisation rates decrease, to redeploy medical equipment from hospitals in big centres to those in smaller or most distant cities, to keep healthcare protocols updated with best evidence-based practices, and to monitor the probable causes for disease spreading (also fostering the development of efficient viral treatments).

As the pandemic is still unfolding and its legal, economic and social fallout and challenges are far from over, governance measures – coupled with effective communication, political leadership, investments in supply chain, tracking systems and prevention policies, such as mask wearing, social distancing and reopening measures and strategies – are not to be overlooked as they are critical to an effective vaccination programme, in Brazil or elsewhere.