Shortages of critical medicines and pharmaceuticals in Brazil

Marco Aurélio Torronteguy

TozziniFreire Advogados, São Paulo

mtorronteguy@tozzinifreire.com.br

In Brazil, the Brazilian health regulatory agency Anvisa, connected to the Ministry of Health, ensures public health protection through the sanitary control of products and services. All drugs in Brazil are regulated by Anvisa, and any commercial activity related to these products requires a marketing authorisation (MA) from the agency. As an MA holder, companies must comply with all Anvisa regulations, including the obligation to maintain product availability.

Anvisa mandates that MA holders report any interruption in drug supply, both temporary and definitive. Temporary discontinuation refers to a temporary suspension of manufacturing or importing drugs without intending to cancel or not renew the product registration. Definitive discontinuation means the MA holder intends to cancel or not renew the product registration.

According to Anvisa Resolution No 18/2014, manufacturers or importers of drugs must notify Anvisa of any supply discontinuation at least 180 days in advance. If the discontinuation of a medicine may cause a market shortage, the notification must be made 12 months in advance, and the regular supply of the drug must be ensured during this period. Reductions in drug quantities that may cause shortages must also be reported within 12 months. The MA holder must ensure the regular supply of their product during the mentioned periods. Unscheduled discontinuation of the manufacturing or importation of a drug due to unforeseen events impacting product quality, safety or efficacy must be reported within 72 hours.

Notifications to Anvisa must include specific documents, such as petition forms, reasons for discontinuation, countries where the product is marketed and assessments of therapeutic alternatives. Anvisa may request additional information as needed. To make the information available to the public, Anvisa provides an interactive list of products with reported discontinuations.

Non-compliance with these obligations can result in penalties, including warnings, fines, establishment interdiction and cancellation of the product's MA. Repeated non-compliance can lead to more severe penalties. Anvisa may also communicate with the Ministry of Health and consumer authorities, exposing companies to additional proceedings and reputational risks.

To reactivate the manufacturing or importation of the drug, the MA holder must simply notify Anvisa, provided there are no changes to the registered drug or its production process. If changes to the drug registration are required, reactivation will only be authorised after the approval of these post-registration petitions.

In the event of a market shortage risk, Anvisa is authorised to prioritise the administrative procedures for the registration and post-registration of substitute drugs. It is important to note that the sanitary regulation obliges Anvisa to cooperate with the Ministry of Health and consumer protection authorities to adopt measures to mitigate the impact on the population in cases of drug shortages or reduced quantities.

During the pandemic, Brazil faced significant challenges related to the shortage of medicines and medical devices. Anvisa played a crucial role in addressing these issues by requiring companies to report interruptions and, in some cases, to report the quantity of products available in stockpile. These measures were essential in managing the supply chain and ensuring the availability of essential medical products in the country.