RESUMO
Since 1931, and especially since the Nuremberg Code of 1947, an increasing number of declarations, regulations, norms, guidelines, laws, resolutions, and rules intended to create conditions for better protection of subjects participating in research studies have been published, although some have meant setbacks in the human rights of vulnerable populations. As such, violations of the dignity of experimental subjects in clinical trials continue. What researchers investigate and how the research is done, the quality and transparency of the data, and the analysis and the publication of results (of both raw and processed data) respond to the financial interests of the pharmaceutical companies, coming into permanent tension with bioethical principles and the needs of society. The active participation of civil society is necessary to make it so that pharmaceutical research, results and applications subordinate economic benefits to the protection of human rights.
Assuntos
Ensaios Clínicos como Assunto/ética , Experimentação Humana/ética , Violação de Direitos Humanos/ética , Cooperação Internacional , Pesquisa Farmacêutica/ética , Má Conduta Científica/ética , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Países em Desenvolvimento/economia , Europa (Continente) , Experimentação Humana/legislação & jurisprudência , Violação de Direitos Humanos/economia , Violação de Direitos Humanos/legislação & jurisprudência , Humanos , Cooperação Internacional/legislação & jurisprudência , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/legislação & jurisprudência , Má Conduta Científica/legislação & jurisprudência , Estados UnidosRESUMO
This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.