Science and care are pillars of the development of society. It is for this reason that the 1988 Constitution established special protection for scientific research and considered health care a fundamental right.
Article published in this Leaf by the Minister of Health and the Secretary of the Ministry of Science, Technology and Innovation (“Brazil can become a leader in clinical research”, 11/13), but this was only one of these pillars. While it is commendable that the ministry has increased its investment in clinical research, it is worrying that the text does not take into account care for the most vulnerable – especially since recent history offers countless examples of how greed for scientific development has sacrificed human rights.
Contrary to what is claimed, the new law does not establish any guarantee that treatments developed with the participation of Brazilian patients will actually be made available in the country. If it promotes and facilitates research, as its enthusiasts say, it does so without establishing any guarantee of access to the Brazilian population.
Even more: before the new rule, research sponsors would have to guarantee access to the treatment developed for patients who participated in the study. With the new law, the obligation to provide post-study treatment is limited to five years; From then on, the cost is entirely transferred to the SUS – an arrangement that protects private interests and puts even more pressure on an already overstretched public budget.
The setback in patient protection is also recognized by the Federal Public Prosecutor’s Office, which, in its speech in ADI 7.875/DF, highlighted aspects of the law that violate the constitutional guarantees of research participants. Besides the AGU, the entities that participated in the creation of the SUS (like Abrasco, Rede Unida and Cebes), as well as universities like Unicamp and Unifep, agree that it is unconstitutional.
And even the National Health Council, with which the authors say they are in dialogue, approved a declaration that the clinical research law is unconstitutional and rolls back the rights of the most vulnerable. Dialogue, however, presupposes active listening and effective participation – not unilateral communication or processes that limit social participation, an aspect also unconstitutional in the new law.
Not surprisingly, entities representing the private clinical research sector were the primary enthusiasts; Historical collective health organizations, which also defend science in Brazilian health, have expressed an opposing position.
The song of scientific progress delights and hides its risks. This is why the Brazilian Society of Bioethics highlighted the risks for the fundamental rights of patients and SUS in ADI 7.875/DF, reported by Minister Cristiano Zanin. It is necessary for the STF and all civil society to be aware of the costs at which we will promote scientific progress, praying that it does not infringe on the fundamental rights of the most vulnerable.
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