University of São Paulo: STF Ruling on Medicine Provision Outside SUS Set to Reduce Healthcare Legal Disputes
According to Gonzalo Vecina Neto, a professor in the Department of Management and Health at the School of Public Health (FSP) at the University of São Paulo and former president of the National Health Surveillance Agency (Anvisa), litigation in healthcare has become a common practice, especially in relation to medications prescribed by doctors who, despite their good intentions, may be prescribing medications without scientific support in some cases. “There are millions of lawsuits seeking the release of medications, many of which are not registered with Anvisa or have a registration that does not indicate that pathology, that is, they are not registered for that disease, which we call off- label use ,” he explains. This practice generates an annual cost of around R$10 billion, with no guarantee of efficacy or benefit to patients.
STF Decision
The new decision by the Supreme Federal Court reinforces the need for public policies based on scientific evidence. “The Constitution states that health is a citizen’s right, which must be achieved through the implementation of public policies. What Minister Gilmar Mendes did was exactly that. When a medicine is registered with Anvisa and it is prescribed for a specific condition that is listed in the medicine’s package insert, it must be distributed. When this happens, legal action is correct,” says Vecina Neto.
For him, this change could bring significant advances, as the Supreme Court’s decision binds the decisions of lower courts — causing a reduction in the number of lawsuits in the health sector —, since doctors who prescribe unregistered or off-label medications will need to present solid evidence to the Judiciary, such as rigorous clinical studies. “The judge will only be able to make the decision if the prescriber offers a set of data in evidence-based medicine, and of the highest quality, that is, double-blind, randomized studies, or meta-analyses,” he states.
Vecina Neto also clarifies that Anvisa is responsible for registering medicines, assessing their safety and efficacy. The National Commission for the Incorporation of Technologies into the SUS (Conitec) carries out the Health Technology Assessment (ATS), a process that analyzes whether a certain medicine should be incorporated into the public system, ensuring that only proven and effective treatments are offered to the population.