Bolsonaro sanctions law that allows the incorporation of medicines into the SUS without Anvisa approval

President Jair Bolsonaro (PL) sanctioned a law that allows the incorporation of new technologies and medicines into the SUS (Unified Health System) for indications other than those approved by Anvisa (National Health Surveillance Agency).

According to the text, for drugs whose indication for use is different from that in the registration of the regulatory agency, approval by Conitec (National Commission for the Incorporation of Technologies in the SUS), the body responsible for updating the drugs in the SUS, is required.

Also according to the law, scientific evidence on efficacy, accuracy, effectiveness and safety will be observed, in addition to standardization in a protocol established by the Ministry of Health.

“The new measures guarantee greater access for the population to updated procedures for medical treatments. The proposal also represents an advance for patients who need therapeutic alternatives”, said the Palácio do Planalto, in a note.

Anvisa, in turn, stated, through a note, that it respects the legislative process. However, the agency points out that the application of the new law requires robust actions by the public authorities to reduce the risks to patients.

The agency also said that the new law points to the expansion of drugs and technologies through the so-called off-label use, that is, outside the conditions approved in the package insert, and that such expansion may result in an increase in unknown adverse events.

For patient safety, Anvisa says that strict control and monitoring is necessary, with the establishment of criteria based on scientific evidence and accountability of the public entity that establishes the incorporation of use not approved by the agency.

“The authorization and incorporation of use not provided for in the package insert, without the technical scientific support and adequate pharmacovigilance, obtained in the regular process of drug registration approval in Brazil, can result in a burden on the public health system and even on the operators of health plans, affecting the national health market”, he said in a note.

Anvisa added that it is already studying the adoption of regulatory measures for monitoring purposes, to protect public health.