The Federal Constitution establishes that it is the responsibility of the health surveillance authority to control medicines manufactured, sold and used in the country. Therefore, a law that contradicts decisions by the National Health Surveillance Agency (Anvisa) violates the right to health.
Based on the dissenting vote of Minister Edson Fachin, the Plenary of the Supreme Court, by seven votes to three, declared, on Thursday (10/14), the unconstitutionality of Law 13.454/2017, which authorizes the production, sale and consumption, under medical prescription in model B2, of the slimming drugs sibutramine, amfepramone, femproporex and mazindol.
The direct action of unconstitutionality was filed by the National Confederation of Health Workers (CNTS). 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.
The rapporteur of the case, Minister Nunes Marques, voted this Wednesday (13/10) for the declaration of constitutionality of the rule. According to him, the National Congress, based on the right to health and the support of doctors, can authorize the use of substances prohibited by Anvisa. The understanding was followed by ministers Alexandre de Moraes and Luís Roberto Barroso.
However, Edson Fachin’s dissenting vote prevailed for the declaration of unconstitutionality of the provisions of Law 13.454/2017. On Wednesday, the minister pointed out that, according to article 200, I, of the Federal Constitution, the Unified Health System is responsible for “controlling and inspecting procedures, products and substances of interest to health and participating in the production of medicines, equipment , immunobiologicals, blood products and other inputs”.
And Law 8080/1990 gave the health surveillance agency the powers to “control consumer goods that, directly or indirectly, are related to health, including all stages and processes, from production to consumption” (Article 6, paragraph 1, I).
As Fachin, Anvisa, by standardizing the rules of safety, quality and effectiveness, ensures the participation of companies and consumers in the drug market under more balanced conditions. For the minister, the agency’s powers derive from the constitutional text and aim to ensure the effectiveness of the right to health.
Anvisa’s decisions are “true achievements in terms of health protection” and cannot be superseded unless the rule that will revoke them does not guarantee equal protection, declared the magistrate, citing the principle of prohibiting retrogression.
“Thus, although it is not, in theory, impeded by the Legislative Power to regulate the marketing of a certain substance intended for human health, it is necessary that, under penalty of offense to the prohibition of retrogression, there must be meticulous regulation, indicating, for example, forms of presentation of the product, provisions regarding its validity and storage conditions, maximum dosage to be administered, among others”.
Fachin also cited the Supreme Court decision that declared the unconstitutionality of Law 13.269/2016, which allowed the distribution of phosphoethanolamine, known as the “cancer pill” — which was not approved by Anvisa. At the time, the ministers concluded that the State cannot authorize the offer of medication without respecting the minimum safety requirements, under penalty of disrespecting the fundamental right to health.
In this Thursday’s session, ministers Dias Toffoli, Carmen Lúcia, Ricardo Lewandowski, Rosa Weber, Gilmar Mendes and Luiz Fux followed the dissenting vote.
“A norm that puts the population in danger cannot be considered valid,” said Carmen Lúcia. According to her, the great problem of the poor is not obesity, but hunger. “And I don’t see public action to get around this problem.”
According to the principle of reserve administration, the Legislature cannot review administrative acts of the Executive in the strict performance of its constitutional attributions, highlighted Lewandowski. He declared that, in case of abuse, Congress has instruments to question Anvisa’s decisions, such as calling its leaders to provide clarifications or installing parliamentary inquiry commissions.
Gilmar Mendes, in turn, assessed that administrative decisions for the protection of life and health must comply with the standards of national and international technical entities. “It is not possible to flirt with the ‘sanitary earthworks’. There is no technical discretion, for example, to adopt a way known to be ineffective to fight an epidemic or to flatter hierarchical superiors”.
In Gilmar’s view, Law 13.454/2017 blocked Anvisa’s functional autonomy, since it prohibited the agency from issuing any technical judgment on slimming remedies sibutramine, amfepramone, femproporex and mazindol.
The president of the STF, Luiz Fux, pointed out that these drugs have several side effects. Thus, when enacting Law 13,454/2017, Congress irregularly replaced Anvisa in the exercise of administrative activity, generating deficient protection of the right to health.
CNTS challenged Law 13,454/2017, which authorizes the production, sale and consumption of slimming drugs (anorectics) sibutramine, amfepramone, femproporex and mazindol.
The CNTS argued that there was ample knowledge about the ineffectiveness of these drugs and their harmful side effects for patients. For the entity, the law disrespects individual rights and guarantees guaranteed by the Federal Constitution, such as the right to health (articles 6 and 196), safety and life (caput of article 5) and principles such as the dignity of the human person ( article 1, item III).
According to the confederation, 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, high blood pressure.
However, “without prior motivation and plausible administrative justification, or relevant public interest”, the then President of the Chamber of Deputies, Rodrigo Maia (DEM-RJ), in the exercise of the office of President of the Republic, sanctioned Law 13.454/2017, “authorizing the use of substances whose side effects and toxicity on the human body are unknown and put the population’s health at risk”.
The CNTS maintained that, given the growth of obesity in the country (the prevalence of the disease rose from 11.8% in 2006 to 18.9% in 2016, according to the Ministry of Health), there is great danger that a large contingent of Brazilians use these medications.
Thus, the entity asked for the declaration of the unconstitutionality of article 1 of the law and, consequently, of its entirety, given that article 2 deals only with the term clause.
Click here to read Edson Fachin’s vote
Click here to read Gilmar Mendes’ vote