New Federal Laws on Covid-19 vaccines
12/03/2021
| In brief The Brazilian Federal Government published on March 10 the (a) Federal Law No. 14,124/2021, for providing for exceptional measures related to the acquisition of vaccines and other services related to Covid-19; and (b) Federal Law No. 14,125/2021, for providing for liability and adverse events of post-vaccination against Covid-19, and for the acquisition and distribution of vaccines by private entities and federative entities (State or Municipalities). More details Federal Law No. 14,124/2021 main purpose consists of establishing the regulatory framework for the acquisition of vaccines for Covid-19, providing that the government may execute agreements (or other similar instruments), with non-bidding requirements, to purchase Covid-19 vaccines even before the registration or the temporary authorization for emergency use from the National Health of Surveillance Agency (ANVISA). The waiver of the public tender procedure is foreseen and presumes the state of emergency and need of urgent attendance. The Law also provides for contracting of goods and services of logistics, technology information and communication, media and advertising, and training for the implementation of vaccination against Covid-19. The agreement for the acquisition of vaccines may establish certain special clauses, such as possibility of early payment, hypotheses of non-imposition of penalties, among others. Finally, ANVISA will provide an opinion on the exceptional and temporary authorization for the importation, distribution and authorization for emergency use of any vaccines and drugs against Covid-19, with clinical studies which has completed phase 3 or with the provisional results of one or more clinical studies. In addition, temporary authorization shall apply in case of equipment and health supplies subject to sanitary surveillance which do not have the definitive registration before ANVISA, provided the demonstration of registration for emergency use before other health authorities, such as FDA, EMA, HC, among others. Federal Law 14,125/2021 intends to expressly allow private entities and federative entities (State or Municipality) to directly purchase vaccines against Covid-19. While the immunization of priority groups is ongoing, purchased vaccines must be fully donated to the Unified Health System (“SUS”), in order to be used within the scope of the National Immunization Program (“PNI”). The description of all priority groups is in Annex I of the document available at https://bit.ly/2POg0bU. According to the most updated technical note issued by the Ministry of Health about the immunization of priority groups, the ongoing vaccination campaign has already reached approximately 10,2 million people from the priority groups, as follows: Health Workers (82.8%);Elderly people (60 years old or more) residing in long-term (institutionalized) institutions (100%);Individuals over 18 years of age with disabilities, residing in inclusive (institutionalized) homes (100%);Indigenous peoples living in indigenous lands aged 18 or over served by the Indigenous Health Care Subsystem (100% of the initial amount passed on by the Indigenous Health Secretariat – SESAI);Elderly aged 90 years and over (100%);Elderly people from 85 to 89 years old (100%); andElderly from 80 to 84 years old (70%)Once the immunization of the priority groups in concluded, private legal entities will be allowed to purchase, distribute and apply vaccines, provided that at least 50% of the doses are, mandatorily, donated to SUS. The remaining 50% must be used free of charge. Application must occur in duly licensed health establishments in order to ensure the appropriate safety conditions for patient’s and HCP’s health. Interested legal entities will need to provide to the Ministry of Health all information regarding the purchase, including the purchase and donation agreements, and regarding the application of the vaccines. Finally, Federal Law No. 14,125/2021 also provides that as long as the Public Health Emergency is declared, the Federal Government, States, Federal District and Municipalities are authorized to undertake the civil liability risks regarding post vaccination adverse events, provided that ANVISA has granted the product registration or the emergency use authorization. |
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