Editor’s note: Kestener, Granja e Vieira Sociedade de Advogados is a high-end boutique featuring in Band 1 in Chambers’ Life Sciences ranking. Leading partner Beatriz Kestener, who has been ranked in Band 1 since 2011, is a major force in the market and a key figure advising on matters before Brazil’s regulators and sanitary authorities. She co-authors the overview below with partner Rubens Granja, who also features in Chambers’ rankings and is also experienced assisting with sophisticated life sciences matters.
Life Sciences in Brazil
In our last article, we were in the middle of the COVID-19 health crisis, in a critical period in which the Government had to adopt emergency measures and decisive positions to mitigate the damages that the pandemic, then at its height, was causing to the Brazilian population.
In the last year, the Government has had to review outdated rules, while the health sector has had to adjust their services to reach a population in isolation at home. At the time of that publication, COVID-19 vaccines were in development by the pharmaceutical companies, and the date when the vaccines would begin to be marketed and applied was still uncertain.
Thanks to the vaccines, many countries have already managed to control and prevent the spread of the disease in their territories, some even eliminating sanitary containment measures such as the use of masks and the prohibition of large gatherings. In contrast, Brazil is still struggling to combat the spread of the virus and striving to curb the number of deaths caused by COVID-19. The political agenda and personal positions of current President Jair Bolsonaro complicate the adoption of a unified and efficient policy to fight the pandemic in the country.
Still struggling with the worst humanitarian crisis experienced by the country, the Federal Government had been promising measures to encourage the sustained growth of the economy in the coming years, such as administrative reform, tax reform, the New Bankruptcy Law and the privatization of state-owned companies. It also has been seeking to establish regulatory frameworks that strengthen legal certainty, improve the business environment, and expand investments in various sectors, such as oil and gas, infrastructure, sanitation and bioeconomy.
The global pharmaceutical industry has focused its efforts to develop and supply vaccines against COVID-19. In the last article, the first vaccines were forecast to be available in Brazil in early 2021. The expectation has been met, but at a very slow pace.
By early June 2021, Brazil had applied at least one dose to 23% of the Brazilian population. This places the country 72nd in the vaccination ranking of 190 nations and territories according to Brazilian BBC News – a modest position, to say the least, if compared with other countries in Latin America such as Uruguay and Argentina, especially considering that Brazil has always been recognized worldwide for its ability to implement public policies on mass vaccination.
The first vaccine applied in the country was CoronaVac under the emergency use authorization pathway created by ANVISA in 2020. It was developed by Sinovac Biotech, Ltd, and manufactured in Brazil in partnership with Butantan Institute (an important public laboratory in the State of São Paulo, responsible for the production of immunization agents).Since then, other vaccines have emerged and have been gradually authorized by ANVISA, either for emergency use such as Janssen Pharmaceutical, Inc’s (the pharmaceutical division of Johnson & Johnson), or those with a sanitary registration granted by ANVISA such as Pfizer’s (developed in partnership with BioNTech) and AstraZeneca’s (developed in partnership with Oxford University and, locally, with Fundação Oswaldo Cruz - Fiocruz).
Despite the efforts of the pharmaceutical industry, Brazilian institutes, and the Brazilian government to develop, supply and apply the vaccines, complete vaccination in Brazil is expected only in 2022.
Relevant changes to public purchase rulesIn the legislative scenario, the Brazilian Government has published different laws during the years of 2020 and 2021, driven by movements started by the pharmaceutical industry, public activists, and politicians to achieve the urgent need for vaccines. For the purpose of this article, it is important to mention Law No. 14,124/2021, which provided for exceptional measures relating to the acquisition of vaccines and supplies; the contracting of goods and services in logistics, information and communication technology; social communication and advertising; and training for vaccination against COVID-19 under the Brazilian Immunization Operational Plan. The direct and indirect public administration entities were authorized to enter into contracts or other similar instruments, with no need to bid, to acquire vaccines and supplies intended for vaccination against COVID-19, even though this occurred prior to the sanitary registration or to the temporary authorization for emergency use by ANVISA.
Likewise, the new regulatory framework for public bidding and contracting with the enactment of Law No. 14,133/2021, in force since April 1, 2021, allows for, as a general rule, the possibility of shorter bidding processes for any public purchase carried out by the Ministry of Health with procedural deadlines cut by half, optimizing the supply of goods and services within the scope of the SUS (Brazilian Unified Health System), regardless of the pandemic.
Trends in the health sector
Just as the companies are reinventing themselves and optimizing their activities to reduce the impacts of COVID-19 in their results, the health sector is also moving in the same direction.
To adapt and adjust to the current reality of the health sector, many entities that provide health-related services are now investing in high-quality personalized services. Among the current trends, we highlight the most relevant ones with likely staying power in the market.
Under the health service net, telemedicine has always been viewed as an essential component of medical care given the size and complexity of Brazil and its health system. Since Brazil is the fifth largest country in the world, it is a reality that a segment of its population does not have direct access to health services, especially groups of people located in peripheral areas. In this context, telemedicine services, although widely regulated by the Federal Council of Medicine, were developed.Among the restrictions imposed by the ethical and medical standards, as a rule, (i) telemedicine services must be carried out exceptionally, only for cases where in-person treatment would not be possible and (ii) the first medical appointment should be done preferably in person. The COVID-19 pandemic changed those standards: the Brazilian Government published legislation authorizing the provision of telemedicine services in any circumstance during the pandemic. In this case, the physician is responsible for applying the same standards as in the physical appointments. However, these more open rules for telemedicine have a deadline: they will be authorized only for as long as the pandemic lasts.
Physicians are also now allowed to issue digital prescriptions, doing away with the need to present a physical prescription for acquisition of medicines. This fact boosted the creation of start-up companies that focus on developing processes, systems and software related to this field.
Considering that telemedicine services have met with some success and expanded access to consumers and patients, we expect that the rules applicable to the area will be revised by the Federal Council of Medicine, aiming at improving their use even after the current health crisis.
Besides the technology applied for provision of health services, the COVID-19 pandemic also boosted the use of technology in the commercialization of health products. Companies are investing in the electronic commercialization of products, and the sector most positively affected was the beauty one. Although the sector expected some decrease in sales due to quarantine restrictions imposed by the Government, in fact online sales increased substantially during the year 2020, and some companies are considering closing their physical stores to invest in e-commerce.
At least from a legal and regulatory point of view, despite all the misfortune that the COVID-19 pandemic has represented, much has been tested and learned. The unprecedented pandemic has turned out to be a living laboratory for the health sector, allowing us to rethink strategies and public policies, understand their reach and limits, and finally, improve as a society.