On March 10, 2021, the Brazilian President sanctioned Law 14,125/2021, which provides for civil liability related to adverse events in post-vaccination against Covid-19, as well as providing for the acquisition and commercialization of vaccines by private legal entities.
1. Civil Liability for Post-Vaccination Adverse Events
Law 14,125/2021 establishes that the Federal Government, States, Federal District and Municipalities are authorized, for as long as the period of public health emergency persists, to acquire vaccines and to assume the risks regarding civil liability related to post-vaccination adverse events, under the terms of the agreement for the acquisition or supply of vaccines entered into between public authorities and the pharmaceutical laboratories, provided that the Brazilian Health Surveillance Agency (“ANVISA”) has granted the respective registration or temporary authorization for emergency use.
The Federal Government, States, Federal District and Municipalities are allowed to constitute guarantees or contract private insurance to cover the risks related to civil liability, while the Federal Executive Branch may institute its own administrative procedure for evaluating demands related to post-vaccination adverse events. It is important to highlight that the assumption of risk regarding civil liability referred to in the Law is restricted to acquisitions made by each public entity.
2. Acquisition of Vaccines by Private Legal Entities
In accordance with Article 2 of the Law, private legal entities may directly acquire Covid-19 vaccines that have temporary authorization for emergency use, exceptional and temporary authorization for importation and distribution, or sanitary registration granted by ANVISA (Brazilian FDA), provided that they are fully donated to the Brazilian National Health System (Sistema Único de Saúde – SUS), in order to be used within the National Immunization Program (Programa Nacional de Imunizações – PNI), of the Ministry of Health.
Only after the immunization of the priority groups established in the National Immunization Plan for vaccination against Covid-19 is completed, will private legal entities be able to distribute and administer vaccines, provided that at least fifty per cent (50%) of the doses are mandatorily donated to the SUS and the remaining doses are uitilized free of charge, which can include the administration of doses free of charge to the entities’ employees.
The health and sanitary requirements for the acquisition, distribution and administration of the vaccine doses must be met, following which the referred vaccines can be applied in any establishment or health service that contains a room for the administering of of injectables authorized by the local health surveillance service. In addition, private legal entities must provide to the Ministry of Health all the information relating to the acquisition, including the donation and purchase contracts, as well as relating to the administering of the vaccines against Covid-19.
Demarest’s Public and Regulatory Law team is closely monitoring the vaccination-related matters to assist its clients in actions to combat Covid-19 and is available to answer any questions about the new Law 14.125/2021.