The Minister of Health, Marcelo Queiroga, defended Law No. 14,313/2022, which allows the SUS (Unified Health System) to prescribe and apply medicines with off-label use, that is, outside the package insert, even without Anvisa’s approval (Agência National Health Surveillance). This Wednesday (23), the minister stressed that the legislation is an old demand that aims to expand the supply of medicines to the Brazilian population.
“There are several drugs whose indication on the leaflet does not cover certain diseases that need to be treated in the Unified Health System. The Ministry of Health had already requested the expansion of the use of these medications with Anvisa, and there was a divergence between the legal advisors. The solution came through legislative action, the law passed in the National Congress, that is, an advance for SUS”, defended Queiroga.
The minister mentioned the drug Tacrolimus, which, according to the package insert, is prescribed to prevent kidney transplant rejection. “There was a demand to expand to heart transplantation, which was stopped for years, until an industry asked for expansion to use the heart, but there was still a lack of liver and lung. Now, with this legislation, it is possible to expand the use of this drug and others more”, he exemplified.
Anvisa, however, considers that the new law, by authorizing the incorporation of off-label use without technical-scientific support and adequate pharmacovigilance, “may result in a burden on the public health system and even on health plan operators, affecting the national sanitary market”.
In order to adapt to the new law, the agency stated that it is studying the adoption of regulatory measures in order to guarantee monitoring and, therefore, the protection of the population’s health. “Anvisa clarifies, initially, that it respects the constitutional legislative process established in Brazil. However, it points out that the application of the new law needs robust actions by the public power to reduce the risks to patients”, he said, in an official note, charging, still , “responsibility of the public entity that comes to establish the incorporation of use not approved by Anvisa, and clear and transparent procedures must be adopted”.
In Queiroga’s assessment, attention to the procedure will not be neglected, since it will be up to Conitec (National Commission for the Incorporation of Technologies) to make the recommendation, if there is no opinion from Anvisa. “Conitec will carry out the analysis, which will use strict criteria. How is it going to allow medicines without scientific proof? in Brazil” and that Anvisa needs to respect the new legislation. “What is law is law, let it be fulfilled.”
Under the new rule, in addition to Conitec’s opinion, the drug to be incorporated must demonstrate scientific evidence on efficacy, effectiveness and safety for the new use. Drugs must be acquired through international multilateral organizations, such as PAHO (Pan American Health Organization), and must respect economic evaluation. The standardization of the protocol will be prepared by the Ministry of Health, to assist in the analysis.