Patients who depend on imported medicines are facing growing delays in the sanitary clearance granted by Anvisa, Brazil's health regulatory agency. Cases gathered by the newspaper Folha de S.Paulo include a 6-year-old child waiting for a drug needed to start the conditioning chemotherapy ahead of a bone marrow transplant, and at least two patients with advanced cancer. According to patients and industry professionals heard by the newspaper, the difficulties intensified from September: processes that once took up to five business days now take from weeks to more than a month.
One of the cases is that of a 6-year-old boy, called Lucas by the newspaper, who is being treated for a rare autoimmune disease. According to his mother, Kiara Ferreira, the medicine arrived in Brazil on September 18 but remains under review by the agency. The family says it asked for priority clearance, without success. "There is no way to request urgency in a situation that is already urgent and involves a child's life," she told Folha.
The delay also affects real estate broker Andréa Baier, 60, who has advanced-stage melanoma with metastases in the lung and lymph nodes. She obtained access to immunotherapy through a court order, but the medicine arrived in Brazil in August and has not been released. "My life is at stake," she said. Retiree Genauro Bastos, 72, has spent more than 40 days without the drug that controls the symptoms of a neuroendocrine tumor with liver metastases. According to his daughter Juliana, he suffers daily nausea and vomiting and has difficulty eating.
An earlier Folha report had already detailed the case of lawyer Herberto Alfonso, 58, diagnosed in September 2025 with ocular melanoma with liver metastasis. He depends on Kimmtrak (tebentafusp), which is registered with Anvisa but whose imported shipment requires sanitary clearance. The medicine arrived in the country on September 26 and, according to the agency, the process has been under review since September 29. Alfonso says he filed formal complaints, turned to Anvisa's ombudsman and sent petitions to the CGU, the federal government's comptroller office, besides requesting priority.
"Even after explaining that this is continuous and urgent cancer treatment, the only guidance I receive is to wait for the normal processing. We are subjected to an excess of procedures, without an effective service channel capable of understanding the urgency of situations in which every day can make a difference," Alfonso told Folha.
What is confirmed and what remains unknown
When contacted, Anvisa confirms that an increase in requests over the past six months has raised the volume of processes under review, especially for medicines not registered in the country. The agency says medicines with a medical urgency indication are treated as priorities, but notes that "the high demand must be taken into account." Experts heard by Folha report dozens of stalled clearance processes, but the full scale of the problem is unknown: Anvisa did not say how many requests are awaiting review and did not answer, by the time the reports were published, the questions about the cases of Lucas, Baier and Bastos or about the pending issues blocking the release of their medicines.
What patients in the same situation can do
The paths taken by the patients heard by Folha point to some practical steps. The first is to formally request priority review, attaching a doctor's statement proving the urgency, since Anvisa itself says these cases receive preferential treatment. It is also possible to file complaints with the agency's ombudsman and with the CGU, as Alfonso did, keeping all protocol numbers. In extreme situations, going to court has worked: Baier obtained the right to treatment through a judge's order. Cancer patients and families of children in treatment should keep their medical team informed about the status of the import, so that therapeutic alternatives can be evaluated while clearance is pending.