Law 13,454/17, which authorizes the production, sale and consumption of the anorectics sibutramine, amfepramone, femproporex and mazindol, the famous slimming remedies, is unconstitutional. So decided the STF ministers, by majority, in a plenary session this Thursday, 14.
The action was filed by the CNTS – National Confederation of Health Workers to challenge Law 13,454/17, which authorized the production, sale and consumption, under medical prescription, of the anorectics sibutramine, amfepramone, femproporex and mazindol. The contested provision read as follows:
Art. 1 The production, sale and consumption, under medical prescription in model B2, of the anorectics sibutramine, amfepramone, femproporex and mazindol are authorized.
According to the entity, the toxicity of these drugs to the human body is unknown, and Anvisa, as an inspection body for the efficacy and safety of anorectics, recommends their ban in the country.
According to the Confederation’s arguments, Anvisa proposed, in 2011, the withdrawal from the market of sibutramine and other substances, amphetamine anorectics, due to their serious adverse effects, such as physical and psychological dependence, anxiety, tachycardia, and arterial hypertension. However, “without prior motivation and plausible administrative justification, or relevant public interest”, the president of the Chamber of Deputies, Rodrigo Maia, in the exercise of the office of president of the Republic, sanctioned the law.
- Winning chain – against the sale/consumption of anorectics
Edson Fachin voted to recognize the unconstitutionality of the law and judge the action fully valid. The minister noted that the judiciary must have “technical deference” to decisions by regulatory agencies on infra-constitutional rules, in accordance with the Constitution.
“Can the National Congress authorize the production of a substance that could potentially affect human health, dispensing with registration?”, asked the minister. Edson Fachin asserted that the action of the State, through the Legislative power, cannot authorize the release of substance, without the minimum observance of the control standards published by the Legislative power itself.
the ministers Toffoli days, Ricardo Lewandowski, Gilmar Mendes, Luiz Fux and the ministers Carmen Lucia and Pink Weber followed the vote of divergence in the sense of the unconstitutionality of the commercialization of these remedies.
- Overdue current – in favor of the sale/consumption of anorectics
Yesterday afternoon, voted Nunes Marques, reporter. The minister noted that obesity is a major public health problem in Brazil: “there are 529 obesity-related comorbidities,” he pointed out. Nunes Marques stated that the poor and obese Brazilian population does not have a pharmacological option to fight obesity, as the remedies for this problem are very expensive.
“Poverty aggravates obesity. The elimination of any alternative treatment for obesity, especially if it is a cheap alternative, brings severe effects to the poorest (…) The ban on the production and sale of anorectics harms thousands of patients who actually need this drug.”
Regarding the 2011 opinion of Anvisa (against anorectics), the minister noted that the resolution of the autarchy, when voting on the bill that gave rise to the contested law, was already suspended by means of decree 273/14.
In this sense, the rapporteur concluded that the decision of the National Congress did not imply the indiscriminate approval of substances for medicinal use. For the minister, what the National Congress did was to annul an administrative act by Anvisa that seemed unfounded, “notably taking into account the opinion of medical entities”.
“Brazilian society cannot do without the only control mechanisms over Anvisa’s acts of empire, especially when they are contrary to the country’s interests.”
Finally, Nunes Marques asserted that, instead of prohibiting the use of anorectics, “we should think about a more effective control and fight for their use to be made rationally”. Thus, the rapporteur dismissed the action to validate the law that authorized the sale and consumption of weight-loss drugs.
“The legislative measure is fully compatible with the Constitution, although it does not prevent that, as new evidence emerges, the Agency may again withdraw such substances from the market.”
Subsequently, the minister voted Alexandre de Moraes. Right at the beginning of his vote, the minister understood that the National Confederation of Health Workers has no active legitimacy to propose the action: “it does not represent the doctors, the only ones that the law allowed the prescription of this medicine”.
Having overcome this issue, Moraes understood that it was indeed an option for Anvisa to totally abolish the possibility of medicines, but it was an “unreasonable” option, there was an excess, for the minister.
“The total elimination of effective drugs from obesity modalities puts thousands of people who do not have access to other drugs at risk. The law corrected an excess of normative act.”
Luis Roberto Barroso aligned with the rapporteur’s understanding. For the minister, the law expresses a medical consensus that was formed in debate in the National Congress. The minister stressed, however, that there can be no harm to Anvisa, so that it can, yes, return to the issue, provided that there are new elements (evidence-based medicine) in several lines, which would lead to a new ban .
“Law 13,454/17 is compatible with the Constitution, with no exemption from registration with Anvisa, nor from other health surveillance actions.”