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BRAZIL: An Introduction to Life Sciences

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Current political and economic background 

As we write this article, the most important health crisis experienced by humanity in the last hundred years is still ongoing. The year 2020 has been marked by social, economic and political devastation on a global level due to the COVID-19 pandemic. The World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Importance - the organisation's highest alert level, as provided for in the International Health Regulations (IHR) - on January 30, 2020. On March 11, 2020, the WHO characterised the outbreak caused by COVID-19 as a pandemic.

In Brazil, Law No. 13,979/2020, published on February 7, 2020, established measures to combat and contain the spread of the coronavirus, such as: social isolation, quarantine, mandatory laboratory tests and vaccinations, exceptional and temporary restriction of entry and exit from the country and interstate and inter-municipal locomotion, administrative requisition of goods and services, exceptional and temporary authorisation for import and distribution without the Brazilian Health Surveillance Agency (ANVISA) registration of products that are considered essential to the fight against the pandemic and other measures enacted by the federal, state and municipal governments.

Production chains were impacted to some extent: factories in the electronics sector had their production temporarily suspended due to the lack of components from China, the prices of main commodities exported by Brazil fell, the price of food rose and other supply chains were also affected. Consumer behaviour also created temporary and unusual demand for specific products.

According to the Quarterly Inflation Report published by the Central Bank on June 25th, the institution's official projection for retraction of the Gross Domestic Product (GDP) in 2020 was 6.4%.

At the very beginning of the crisis, bank credit for companies increased and the second half of March showed an increase in credit concessions. Considering consolidated monthly data, concessions financed with free resources for companies registered a growth of 59.6% in March - the highest monthly variation in the historical series, according to the Central Bank Quarterly Report.

The health crisis struck the country at a delicate moment. The economy had been showing signs of weakness, and COVID-19 added to the political uncertainty regarding the future of the Jair Bolsonaro administration. The pandemic also opened up issues such as high social inequality, hunger, unemployment and lack of basic sanitation in the country and intensified the debate about the role of the State in the economy and in the conduct of social policies.

It seems appropriate to mention, however, that if, on the one hand, the pandemic unveiled the enormous social gap existing in Brazil, it also highlighted the importance of the Brazilian Public Health System (known as SUS – Sistema Único de Saúde). Despite its undeniable limitations, SUS showed its capacity to provide basic assistance to the population and to care for the underprivileged. Attentive to the critical global scenario, Brazilian citizens have seen - regrettably through practical experience - the importance of the comprehensiveness and universality of SUS.

Finally, essential services continued to be guaranteed and provided to the population in order to prevent any potential stoppage of services from hampering the acquisition of goods that are essential to citizens and to combat COVID-19. Laws and regulations defined essential activities as a wide range of activities - from healthcare to audio and video broadcasting, cargo transportation, scientific and laboratory research related to the pandemic, and the collection, treatment and distribution of water.

Life Sciences: Impacts, developments and trends 

As the novel coronavirus continues to spread disease, death and catastrophe all over the world, virtually no economic sector has been spared the damage. Despite this, and amid the chaos of the global pandemic, the healthcare industry has not only persevered, but has made considerable profits. The pandemic reaffirmed the maxim “in every crisis lies an opportunity”.

The life sciences sector soon realised the strength of such maxim. The world, of course, has always needed pharmaceutical inputs, medicines and medical devices. However, to contain the novel coronavirus, there has been an unprecedented increase in demand for specific treatments, vaccines, hospital equipment and supplies, as well as tests to detect the disease. In this context, dozens of companies are now competing to produce items focusing on the crisis.

The health sector has faced a number of challenges and difficulties. The arguably unprecedented nature of a pandemic of such proportions led to a series of situations to which the government and its agencies, as well as the regulated sector and society in general, were not prepared nor equipped to quickly respond. Countless extraordinary measures are still being adopted to combat the crisis and to allow other routine processes to remain unaffected.

Among the countless acts enacted to combat the crisis, Law No. 13,979/2020 is certainly the most relevant, as it sets forth a non-exhaustive list of protective measures that should be adopted, concurrently, by the federal government, states and municipalities. Law No. 13,979/2020 assigned unprecedented police power to various bodies of the public administration and, as a result, many companies have faced questionable situations of restrictive measures of law (such as circulation and transportation of goods) and have relied on the judiciary to serve as a guardrail against arbitrariness.

ANVISA's performance has also been remarkable and intense. Aware of its fundamental role in the management of the Brazilian Health Surveillance System and in the safe release of new technologies to combat the pandemic (i.e. both to combat the virus directly, and to address the various secondary issues - diagnostic tests, hospital supplies, etc.), ANVISA has published several regulations to reduce the bureaucracy of procedures and speed up the analysis of matters related to the COVID-19 situation. The following are a few examples:

• RDC nº 348/2020, enacted in March, defined extraordinary and temporary criteria and procedures for expedited and simplified analysis of requests for registration, as well as registration amendments, of medicines, biological products and products for in vitro diagnosis.

• Technical Notice nº 14/2020, published in April, both relaxed and expedited clinical trial procedures and bioequivalence studies related to COVID-coping measures, with the objective of conducting efficient and quick research, without losing sight of participants’ safety and the principles of good clinical research practice.

• RDC nº 392/2020, published in May, defined the criteria and allowed extraordinary and temporary procedures to apply exceptionalities to specific requirements of Good Manufacturing and Import Practices for medicines and pharmaceutical supplies. According to the resolution, if a relation with the pandemic is evidenced, a company could be exceptionally and temporarily excused from compliance with reasonably controlled good practices requirements.

Many believe that the economic recovery needs to go beyond the conventional way of doing business, overcoming “business as usual”. As can be seen already, the pandemic forced a change in posture, mentality, processes and methodologies in society that, it is believed, will permanently impact the routine of companies, the life of citizens, the behaviour of consumers and the concerns of the public authorities, even after the pandemic crisis is overcome.

As we write our comments, scientists and regulators have started discussing the possibility of having a vaccine on the not-so-distant horizon. Assuming that overcoming the crisis is directly connected with the development of the vaccine, Brazil (through the federal government, states and public laboratories) has articulated agreements with foreign manufacturers and encouraged clinical trials in the national territory.

The most promising vaccines are in the final stage of development (Phase 3). Nevertheless, while optimists indicate the potential start of vaccination in the next few months, conservatives fear that the vaccine will only be available in mid-2021. The answer to this unsettling question remains with Chambers Latin America 2022.