Article type
Year
Abstract
Background: Publication bias affects decision-making and also violates the core of evidence-based medicine. It also causes damage to the population, since undisclosed information is, many times, related to efficacy and safety of interventions.
Objectives: To identify whether legal Brazilian system is able to control the selective publication of clinical trials.
Methods: We evaluated the Brazilian legal system seeking for solutions to the deadlock between the right to secrecy of the pharmaceutical industry and the right to health and information that protects citizens.
Results: The code of consumer protection (Federal Law 8.078/1990) establishes in its articles 6, II; 37; and 38, that every consumer has the right to full information about products for sale. Article 65 states that the government must keep supervision over the right to information. Article 66 provides that omitting information about any product, including medical supplies, is a crime. Under the Federal Constitution, Articles 6 and 196 guarantee the right to health for all citizens. Article 37 stipulates that the government must always be efficient. Article 5, XXXII, determines that the government must protect the consumer and Article 23, II, orders all local counties and federal states to be responsible for health protection.
Conclusions: The Brazilian legal system has instruments to control the selective publication of clinical trials. The country has a duty to ensure the effectiveness of the right to health and monitor the information provided by pharmaceutical industry. Public authorities that do not behave according to the law may be liable. The board of pharmaceutical industries may be convicted under the crime described in Article 66 of Law 8.078/90. Therefore, full information is a fundamental right of consumers. Supervision of that information is a duty of the government and the disclosure of complete data and information about medical supplies is a compulsory legal duty of pharmaceutical industry.
Objectives: To identify whether legal Brazilian system is able to control the selective publication of clinical trials.
Methods: We evaluated the Brazilian legal system seeking for solutions to the deadlock between the right to secrecy of the pharmaceutical industry and the right to health and information that protects citizens.
Results: The code of consumer protection (Federal Law 8.078/1990) establishes in its articles 6, II; 37; and 38, that every consumer has the right to full information about products for sale. Article 65 states that the government must keep supervision over the right to information. Article 66 provides that omitting information about any product, including medical supplies, is a crime. Under the Federal Constitution, Articles 6 and 196 guarantee the right to health for all citizens. Article 37 stipulates that the government must always be efficient. Article 5, XXXII, determines that the government must protect the consumer and Article 23, II, orders all local counties and federal states to be responsible for health protection.
Conclusions: The Brazilian legal system has instruments to control the selective publication of clinical trials. The country has a duty to ensure the effectiveness of the right to health and monitor the information provided by pharmaceutical industry. Public authorities that do not behave according to the law may be liable. The board of pharmaceutical industries may be convicted under the crime described in Article 66 of Law 8.078/90. Therefore, full information is a fundamental right of consumers. Supervision of that information is a duty of the government and the disclosure of complete data and information about medical supplies is a compulsory legal duty of pharmaceutical industry.