Angela Kung

Pinheiro Neto Advogados, São Paulo

akung@pn.com.br

Nicole Recchi Aun

Pinheiro Neto Advogados, São Paulo

naun@pn.com.br

Julia de Castro Kesselring

Pinheiro Neto Advogados, São Paulo

jkesselring@pn.com.br

Anna Luiza Bertin Henrique

Pinheiro Neto Advogados, São Paulo

ahenrique@pn.com.br

Giuliana Garcia Maruca

Pinheiro Neto Advogados, São Paulo

gmaruca@pn.com.br

Introduction

Brazil is one of the largest countries with a universal health system, which is structured and organised through the National Health System (Sistema Único de Saúde or SUS). Vaccination rights are one of the cornerstones of universal access to health, representing at the same time a constitutional right and a legal duty of the Brazilian Government.

As a general rule under Decree No 78,231/1976, the Ministry of Health (MoH) centralises the management of vaccination programmes, including purchase, supply and distribution, through the Brazilian National Immunization Program (Programa Nacional de Imunizações or PNI), while states and municipal secretaries of health are responsible for the local implementation of the vaccination programme and application of vaccines.

Within the PNI, the MoH is responsible for defining vaccines that are mandatory for the population, pursuant to Law No 6,259/1975. States, municipalities and the Federal District also have jurisdiction to define mandatory vaccines for their respective territories. Even though the possibility of defining mandatory vaccines was already covered by PNI, the Brazilian Federal Government issued Law No 13,979/2020 authorising public authorities to establish compulsory vaccination and other prophylactic measures, among other measures to fight against Covid-19.

Consequently, discussions on the appropriate interpretation of mandatory vaccines were intensified and escalated to the Supreme Court of Brazil, which has recently issued a decision in the sense that local authorities can impose restrictive measures for citizens that refuse vaccination (eg, fine or circulation restraints), but cannot forcibly immunise the population.

Law No 14,124/2021

The special circumstances surrounding the Covid-19 pandemic and the urgent need for vaccines to fight the disease required a review of PNI regular standards, and resulted in the enactment of Law No 14,124/2021. Among other provisions, Law No 14,124/2021 authorised states, cities and the Federal District to directly purchase vaccines and manage Covid-19 immunisation programmes in case the MoH fails to do so.

Law No 14,124/2021 has also posed limitations to the acquisition of vaccines by the private sector, which has been subject to criticism and public scrutiny. In summary, under the law, the private sector is currently not allowed to purchase Covid-19 vaccines to be privately applied to third parties until the complete immunisation of all priority groups by SUS and, thereafter, the law requires the donation of 50 per cent of any purchased vaccines to the SUS.

The Brazilian Congress is currently revisiting such legal requirements, and amendments to this law should be expected shortly. If and when states, cities, the Federal District and private entities import vaccines, either registered with the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária or Anvisa) or authorised under the emergency use regulation, the procedures of Resolution RDC No 476/2021 will have to be observed.

Emergency use authorisation

In addition to Law No 14,124/2021, the Brazilian Federal Government issued additional laws and regulations aiming to expedite access to vaccines for the Brazilian population. In this sense, Anvisa published Resolution RDC No 475/2021 to establish requirements in order for companies to apply for emergency use authorisation of vaccines.

The emergency use authorisation modality exceptionally authorises the use of unregistered vaccines with Anvisa in MoH programmes. In order to apply for emergency use authorisation of vaccines, companies must hold the applicable licenses and authorisations to manufacture and/or import pharmaceutical products, and the application must be supported by complete clinical trials or clinical trials under phase III. Based on such an exceptional regime, the applicant company must undertake to conclude the clinical development of the Covid-19 vaccine, present the respective results to Anvisa and apply for the definitive sanitary registration. In order to grant the emergency use authorisation, Anvisa relies on reports of the sanitary registrations or emergency use authorisations granted by one of the following international authorities: Food and Drug Administration (FDA) (United States), European Medicines Agency (EMA) (European Union), Pharmaceuticals and Medical Devices Agency (PMDA) (Japan), National Medical Products Administration (NMPA) (China), Medicines and Healthcare Products Regulatory Agency (MHRA) (United Kingdom), Ministry of Health of the Russian Federation (Russia), Central Drugs Standard Control Organisation (CDSCO) (India), Korea Disease Control and Prevention Agency (KDCA) (Republic of Korea), Health Canada (HC) (Canada), Therapeutic Goods Administration (TGA) (Australia), Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) (Argentina), or other foreign health authorities acknowledged by the World Health Organization (WHO) or International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Covid-19 vaccines in Brazil

Finally, it is interesting to note the status of Covid-19 vaccines authorised to be used in Brazil. On 23 February 2021. Laboratórios Pfizer Ltda obtained the definitive registration for the vaccine COMIRNATY™ and AstraZeneca do Brasil Ltda and Fundação Oswaldo Cruz (Fiocruz) obtained the definitive registration for the vaccines Vacina Covid19 Recombinante and Vacina Covid19 Recombinante Fiocruz, respectively, on 12 March 2021.

The vaccine Coronavac developed by Sinovac Biotech, Ltd, and manufactured in Brazil in partnership with Instituto Butantan, the public laboratory in the State of São Paulo, and the vaccine Ad26.COV2.S developed by Janssen Pharmaceutical, Inc (the pharmaceutical company of the Johnson & Johnson group), received emergency use authorisation from Anvisa.

Finally, União Química Farmacêutica Nacional S/A applied for emergency use authorisation from Anvisa for the vaccine developed by the Russian laboratory Instituto Gamaleya, known as Sputnik V, whose documentation is still under analysis by Anvisa.