The plenary of the Federal Supreme Court (STF) decided today (14), by 7 to 3, to overthrow the Law 13,454 / 2017, which authorized the production, sale and consumption of four anorectic substances, that is, capable of inhibiting appetite and inducing weight loss.
Known as “weight loss pills”, because they are marketed in this format, the substances sibutramine, amfepramone, femproporex and mazindol, which act on the brain, had their use approved in Brazil by Congress even after a resolution by the National Health Surveillance Agency ( Anvisa) have imposed a series of restrictions on substances.
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The law was sanctioned in June 2017 by the then president of the Chamber, Rodrigo Maia, who was temporarily acting as President of the Republic. At the time, Anvisa itself released a statement regretting the sanction, which for the agency brought “great risk to the health of the population”.
The substances femproporex, mazindol and amfepramone, for example, have been restricted in Europe and the United States since the 1990s. Sibutramine, in turn, has regulated use in some countries, albeit with restrictions. Before the law, Anvisa already allowed the controlled sale of the substance by previously authorized manufacturers.
The law that released the sale of the four substances was questioned in the Supreme by the National Confederation of Health Workers (CNTS), for whom there was no plausible justification for the sanction. The entity claimed that there is a high risk to the population due to the serious adverse effects of substances, which can include physical and psychological dependence, anxiety, tachycardia and arterial hypertension, among others.
The Supreme agreed with the arguments and declared the law unconstitutional. For most ministers, the norm had an excessively succinct wording, with only two articles, and gave space to the interpretation that medicines with these active principles would not need to pass through the sieve and receive the sanitary registration of Anvisa, which would be unconstitutional, in the view of most of the Court.
In the opinion of Minister Edson Fachin, who prevailed in the judgment, the Legislature could even authorize the production and sale of the substances, as long as it followed the technical criteria used by Anvisa when analyzing the risks to public health. What did not happen in the specific case, according to the minister.
“Thus, the action of the State through the Legislative Power could not, without a very high burden of undue inertia or damage by omission to the protection of health by the regulatory agency, authorize the release of substances without the minimum observance of the prescribed control standards in law and conveyed through the resolutions of Anvisa”, said Fachin.
The minister was followed by ministers Carmen Lúcia, Rosa Weber, Ricardo Lewandowski, Luiz Fux, Dias Toffoli and Gilmar Mendes, who pointed out that in the justifications for the bill, which resulted in the release, there was no mention of technical aspects.
Justices Kassio Nunes Marques, rapporteur, and Luís Roberto Barroso and Alexandre de Moraes were defeated in the judgment. For them, Congress has the power to authorize the sale of medicines even without ANVISA’s approval, since lawmakers are even capable of inspecting the acts of regulatory agencies.
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