Ana Cândida Sammarco

Mattos Filho, São Paulo

ana.sammarco@mattosfilho.com.br

Introduction

Since the beginning of the Covid-19 pandemic, many efforts have been mobilised for developing a vaccine that would enable countries worldwide to overcome the health emergency that has affected most of the globe since the beginning of 2020. These efforts culminated in a sequence of vaccine approvals between December 2020 and the present date. Following these authorisations, however, challenges regarding the operationalisation of a vaccination plan on a national level emerged in Brazil.

In the Brazilian context, the Federal Constitution determines that the Federal Government, states and municipalities have concurrent competence to legislate on health protection and defence,[1] as well as common competence to care for health and public assistance.[2] Even before the Covid-19 pandemic, the Brazilian Federal Government used to define the vaccination guidelines through a programme called the Brazilian National Immunization Program (Programa Nacional de Imunizações or PNI). By means of organising the vaccination nationally, this programme establishes schedules and public distribution considering the epidemiological situation, risk, vulnerability and social specificities.

The same logic applies to the vaccination against Covid-19, which is based on the Brazilian PNI. In this specific case, the Federal Government, through the Ministry of Health, established the Brazilian National Plan for the Operationalization of Vaccines Against Covid-19 (Plano Nacional de Operacionalização da Vacinação contra a COVID-19 or PNOVC). The instructions defined in the Brazilian PNOVC aim to support the states and municipalities in their vaccination efforts. The Brazilian PNOVC includes a list defining the priority groups in the vaccination process against Covid-19, which include health workers, people over 60 years old, indigenous populations, people with comorbidities and industrial workers.

In this context, our article comprises a summary of topics that stand out in the Brazilian legal and regulatory framework for a national immunisation plan, such as the nature of the authorisations being granted for the vaccines in Brazil, the rules for contracting with Brazilian governmental bodies, considerations on the purchase of vaccines by a private legal entity and the contribution of the Brazilian Healthcare Data Network (Rede Nacional de Dados em Saúde or RNDS) to the PNOVC.

The Brazilian legal and regulatory framework

Mechanisms currently in force to enable the supply of vaccines in Brazil

Currently, there are three mechanisms in place in the context of the Covid-19 vaccine supply: the Exceptional Authorization for Importation and Distribution (EAID); the Emergency Use Authorization (EUA); and the Marketing Authorization (MA). These are based on the publication of: (1) Law No 14,124/2021;[3] (2) Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária or Anvisa) Resolution No 475/2021;[4] and (3) Anvisa Resolution No 476/2021.[5]

The EAID is legally grounded in Anvisa Resolution No 476/2021, which disciplines the authorisation granted to importers exclusively for vaccines and medicines against Covid-19. For a license to be granted, the imported products must have at least completed Phase III clinical studies or have interim results from one or more clinical trials and a specific indication of the treatment or prevention of Covid-19 approved by the respective foreign health authority. The regulation allows the governmental bodies (Federal Government, states, municipalities and Federal District) to act as importers considering the purpose of using the vaccines to immunise the population through public programmes. As to the term, the EAID is a temporary and exceptional authorisation, and applicable only to batches indicated in the application for the license.

The EUA is based on Anvisa Resolution No 475/2021. As with the EAID, it is granted exclusively for vaccines against Covid-19. The authorisation is conceded after the completion of Phase III clinical trials or with interim results from one or more Phase 3 clinical trials. The EUA must be issued in the name of the importer or manufacturer, which can be any entity that has sanitary capacity in Brazil to import and/or manufacture medicines. It is also a temporary permit, which means that it can only be in force during a Public Health Emergency of National Importance declared by the Ministry of Health. The EUA may be modified, suspended or revoked by Anvisa at any time, and its application is limited to pre-defined targeted populations considering its use on an experimental basis.

Lastly, the MA is an authorisation disciplined by Anvisa Resolution No 55/2010. It is granted for products regulated by Anvisa, such as medicines, medical devices and health products after the completion of Phase III clinical trials. The permit must be issued in the name of the importer or manufacturer (an entity with sanitary capacity in Brazil). Differently from the other two authorisations, the MA is a definitive permit (ten-year term). Normally, from a regulatory perspective, there is the possibility of the commercialisation of a product that holds an MA. However, due to public health policies, there are currently legal barriers to commercialising vaccines against Covid-19 to the private sector.

Considerations on the purchase of vaccines by a private legal entity

Law No 14,125/2021 also authorises the acquisition of vaccines directly by private entities if they are fully donated to the Brazilian Public Healthcare System (Sistema Único de Saúde or SUS) to be used in the scope of the Brazilian PNI. According to this law, after the end of the immunisation of the priority groups defined by the Brazilian PNOVC, private legal entities may, in compliance with legal and sanitary requirements, acquire, distribute and administer vaccines, provided that at least 50 per cent of the doses are donated to SUS and the remaining amount is used free of charge.

A few organisations filed lawsuits against the Federal Government and Anvisa seeking the unconstitutionality of the donation of doses acquired by the private sector to SUS. For example, in March 2021, the Lower Court of the Federal District rendered a decision: (1) ruling out the requirement of full donation; and (2) declaring the unconstitutionality of the need to end the immunisation of priority groups so that private law legal entities can acquire and keep 50 per cent of doses to use free of charge. Therefore, it authorised the plaintiffs to immediately import vaccines against Covid-19 for exclusive immunisation of their associates and family members, through a company legally qualified to import medicines with Anvisa, without the need for full donation.

Facing this decision, on 30 March 2021, the Federal Government presented a Motion for Suspension of Preliminary Injunction aiming for the suspension of the effects of a few decisions rendered by the Lower Court, including the decision mentioned above. On 7 April 2021, the Court of Appeals granted the motion filed by the Federal Government and suspended the decisions rendered by the Lower Court. The topic of the acquisition of vaccines by private entities will probably continue to be judicially discussed as long as the priority groups of the Brazilian PNOVC last, considering that the supply of vaccines is still scarce.

On the federal level, it is important to highlight the discussion of the Bill of Law No 948/2021, which encompasses the allowance to purchase vaccines without the obligation for the private sector to donate them to SUS. On 7 April 2021, the House of Representatives concluded the voting process on Federal Bill No 948/2021. It approved substitute wording, which allows private companies to purchase vaccines for the free immunisation of their employees, as long as they donate the same number of doses purchased to SUS. Now it will be sent to the Federal Senate, which will make its decision soon. If Federal Bill No 948/2021 is approved and sanctioned without vetoes, there is a risk that its constitutionality will be challenged in court.

Rules for contracting with Brazilian governmental bodies

In Brazil, as a rule, when contracting with governmental bodies, a bidding process is mandatory as determined by Law No 8,666/1993.[6] Its dispositions are, in general, more protective towards the public administration. Nevertheless, in the context of Covid-19, considering Law No 14,124/2021 and Law No 14,125/2021,[7] which were recently enacted, some exceptions are stated to facilitate the immunisation of the Brazilian population, as follows.

Law No 14,124/2021 authorises the governmental authorities to execute contracts without a bidding process to purchase vaccines and supplies for the combat of Covid-19 even before the issuance of an MA or EUA by Anvisa; and contract goods and services to facilitate the implementation of Covid-19 vaccination measures. The absence of a bidding process, however, does not dismiss the need for an administrative process, which shall include technical elements regarding the choice of the supplier and the price reasoning.

The agreement can establish the following special provisions if they represent an indispensable condition for obtaining the good and assuring the service: (1) anticipated payment including the possibility of losing the prepaid value; (2) hypothesis of the non-imposition of penalties to the supplier; and/or (3) other indispensable conditions with due justification.

Additionally, Law No 14,125/2021 establishes that, while the Public Health Emergency of National Importance lasts, the Federal Government, states and municipalities are authorised to purchase vaccines against Covid-19 and assume civil responsibility for adverse post-vaccination events once Anvisa has granted the MA or EUA to the product. In this scenario, the governmental bodies are authorised to constitute warrantees and hire private insurance coverage for the assumed.

Contribution of the RNDS to the PNOVC

The Brazilian RNDS is a digital platform created by the Brazilian National Health System’s Computer Department ('DATASUS') to enhance the interoperability of health data between all stakeholders, including patients, managers, pharmacies, health services and professionals, laboratories, health insurance providers and others.

In the context of the public health emergency, since March 2020, the RNDS has allowed for notifications and results of Covid-19 laboratory tests to be integrated, as well as the release of results to patients – available on its portal or the ConecteSUS app.

Considering the need for the strict monitoring of vaccine application data and any possible adverse events during this new stage in the fight against the pandemic, the RNDS is now playing an important role in the operationalisation of the immunisation strategy, enabling the integration of information between different areas of the national healthcare network, and facilitating the transition and continuity of patient care between the public and private sectors. The platform also enables citizens to access their digital vaccine records and national vaccination certificates, while permitting accredited health professionals to access their patient’s electronic medical records.

If implemented in compliance with ethical, health and data protection regulations, the initiative should generate unprecedented and highly valuable analysis, not only for fighting the Covid-19 pandemic but also for improving the Brazilian PNI overall, which has incorporated a total of 14 vaccines to date.

Established by Ordinance GM/MS No 1434/2020,[8] the RNDS is considered to be a fundamental part of Brazil’s digital health strategy. It is based on guidelines provided by the National Policy of Information Technology and Health Information,[9] the e-Health Strategy,[10] and the Digital Health Action, Monitoring and Evaluation Plan for Brazil.[11] To sustain momentum, the Ministry of Health recently issued the Brazilian National Digital Health Strategy,[12] which is an action plan for the digitalisation of both public and private healthcare systems over the next eight years.

In the long term, the RNDS should be established as a repository for patients’ health data, using blockchain technology to address issues of security, performance, access and scalability. By 2028, the Ministry of Health intends to have all levels of healthcare information integrated into this digital platform, so it can be used as a tool for innovation, information and improvement of healthcare.

Final considerations

Operationalising a national vaccination plan with time constraints derived from an unprecedented health emergency is certainly not an easy task. In this context, the regulations analysed above indicate the attempt to deal with an extreme situation that requires innovation – both technological and legal. In the long run, these innovations may represent a great opportunity for governmental authorities, industry players and society in general to understand what works in practice and what can be improved.

Notes