Law Authorizes Purchase of Vaccines by Municipalities and Private Companies

Sanctioned by the President of the Republic on March 10, Law No. 14,125 authorizes States, Municipalities, and the private sector to purchase COVID-19 vaccines. The law also establishes that buyers must assume potential risks related to civil liability for any adverse effects of the vaccines. Regarding the Federal Government, States, the Federal District, and Municipalities, these entities are allowed to provide guarantees or contract private insurance—either domestic or international—under one or more policies to cover such risks.

Private Sector Requirements

The private sector is only allowed to purchase vaccines provided the following conditions are met:

• The vaccine has temporary authorization for emergency use;

• It has exceptional and temporary authorization for importation and distribution; or

• It has been granted regulatory approval by Anvisa (Brazilian Health Regulatory Agency).

Distribution and Donation Requirements

In addition, doses purchased during the immunization of priority groups defined by the National Immunization Program (PNI) must be fully donated to the Unified Health System (SUS).

After this priority phase, companies that comply with all legal and health requirements will be allowed to purchase, distribute, and administer vaccines, provided that at least 50% of the purchased doses are mandatorily donated to the SUS, and the remaining doses are administered free of charge.

Administration of Vaccines

The acquired vaccines may be administered in any health facility or service that has an authorized injection room, as approved by the local health surveillance authority. All applicable regulatory requirements must be observed to ensure proper conditions for patient and healthcare professional safety.

Lopes Pinto Advogados remains available to provide further clarification if needed.