INFO KGV | LIFE SCIENCES MARCH 2021
COVID-19: Government authorised to assume civil liability related to post-COVID-19 vaccination adverse events
Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno, Bruno Fontes Muniz and Brenda Costacurta Ohnuki, Kestener Granja and Vieira Advogados
On 10 March 2021, Law No 14,125/2021 (Portuguese language) was published, authorising the Federal Government, States, the Federal District and Municipalities to assume civil liability related to the post-COVID-19 vaccination adverse events. The assumption of civil liability by the Public Administration was a recurring issue raised by manufacturers in vaccine acquisition deals.
While acquiring the vaccines, the public entities will be able to execute private insurance agreements, with national or international companies, to cover possible liabilities related the abovementioned adverse events.
Private legal entities will also be able to directly purchase COVID-19 vaccines, however their destination and use will be conditional on the vaccination of priority groups determined by the national immunisation programme, which states:
- While the vaccination of priority groups is ongoing, all vaccines must be donated to the Brazilian Public Health System (SUS).
- After the vaccination of the priority groups has been completed, at least 50% of the purchased doses by the private legal entity must be donated to SUS.
Private legal entities must provide the Ministry of Health with all information related to the acquisition of COVID-19 vaccines, including purchase and donation contracts, in a timely and detailed manner.
COVID-19: Brazilian government authorised to join COVAX Facility
Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno, Bruno Fontes Muniz and Brenda Costacurta Ohnuki, Kestener Granja and Vieira Advogados
On 2 March 2021, the Federal Executive Branch of Brazil was authorised by Law No 14,121/2021 (Portuguese language) to join the COVID-19 Global Access Facility (COVAX Facility), an international alliance bringing together governments and manufacturers in order to help developing countries access COVID-19 vaccines, led by the World Health Organization and GAVI, the Vaccine Alliance.
The law enables the Federal government to acquire safe and effective COVID-19 vaccines upon agreements governed by the contractual terms established by the alliance. The Brazilian public bidding and contracting rules are therefore not applicable to the acquisitions.
Brazil’s adherence to the global instrument does not imply mandatory vaccine acquisition and does not constitute an impediment to Brazil’s adherence to other vaccine acquisition mechanisms.
Law No 14,121/2021 entered into force on 2 March 2021.
COVID-19: Anvisa temporarily prohibits personal importation of certain drugs
Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno, Bruno Fontes Muniz and Brenda Costacurta Ohnuki, Kestener Granja and Vieira Advogados
On 17 March 2021, the Brazilian Health Surveillance Agency (Anvisa) published Resolution RDC No 479/2021 (Portuguese language), which temporarily prohibits individuals from importing vaccines and hyperimmune sera, as well as other products that require special temperature, humidity and luminosity conditions for transportation and warehousing.
Personal importation is normally carried out by post, courier express or accompanied baggage. Through these routes, the sanitary controls of commercial distribution chains that are regularly inspected by Anvisa are not necessarily followed and this can increase risk for patients. For example, the constant temperature fluctuation during personal importation can affect not only the quality and effectiveness of products but can also lead to changes that cause unpredictable risks, compromising patient safety.
Anvisa is aiming to mitigate the health risks related to personal importation. The Agency has already identified cases of counterfeit drugs in Brazil, which were imported through this mechanism.
Due to the COVID-19 pandemic, the importation by individuals of such products and the corresponding challenges on pharmacovigilance have also risen.
The prohibition does not impact importation by private health clinics, which are still subject to a strict control of health surveillance.
The Resolution entered into force on the date of its publication and will remain in effect as long as the public health emergency related to the COVID-19 pandemic is recognised by the Ministry of Health.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
