02/20/2026 | Gabriel Brito | OutraSaúde

https://outraspalavras.net/outrasaude/medicos-sem-fronteiras-em-defesa-da-etica-em-pesquisa/ 

Corporations want to use Brazilians as guinea pigs without having to face the consequences. An international organization joins an action seeking to contain the damage of a law that demolished the social control system of clinical studies. What is at stake?

After years of lobbying by the pharmaceutical industry, Law 14.784/23 was approved, which relaxes ethical standards in clinical research in Brazil. Driven by a right wing that undermined ethical notions during the pandemic, the new regulation has caused outrage among public health organizations and researchers in Brazil committed to the SUS (Brazilian Unified Health System).

At a time when the issue is fading from the spotlight, the organization Doctors Without Borders (MSF) decided to join the Direct Action of Unconstitutionality (ADI), created by the Brazilian Society of Bioethics (SBB) shortly after the law's approval, as amicus curiae, that is, an interested party.

“The central point is that the new law represents a setback in guaranteeing the rights of participants, in social participation and public governance, and in the sharing of benefits. This goes against commitments made by Brazil, for example, within the framework of the recently approved WHO Pandemic Agreement,” summarized Marcela Vieira, who works at MSF.

Speaking to Outra Saúde, the doctor reinforced the SBB's message that the law is a “victory for backwardness” in the regulation of clinical research in Brazil. This criticism is echoed by the entire social health movement in Brazil. Organizations such as Abrasco, Cebes, Frente pela Vida, the Brazilian Interdisciplinary AIDS Association (ABIA), and the Working Group on Intellectual Property (GTPI/Rebrip) had already joined the lawsuit now endorsed by Doctors Without Borders.

“It is an entire system of research ethics built in Brazil over decades, with broad social control and social participation, that is collapsing. Now, they are creating a Research Ethics Committee with much less social protection,” she added.

The collective resignation of 26 members of the National Research Ethics Council (Conep) corroborates Marcela Vieira's analysis, being the high point of the crisis that placed the government in an embarrassing position vis-à-vis sectors that supported it.

Neoliberalism or the right to health?
This is because Health Minister Alexandre Padilha adopted the traditional neoliberal discourse that changes in the rules would make the system more agile and attractive. But the modernizing discourse, like so many other reforms of similar ideological scope, is a mere fallacy that hides the obvious: the interests of capital.

“Whatever happens, the regression brought about by the enactment of Law 14.784/24 is clear. This regression, if the measures it proposes persist, especially the removal of social control from the SUS (Brazilian Unified Health System) in leading the ethical review process of research with human beings, will produce negative repercussions on the protection of research participants, the cornerstone of adequate regulation,” criticized Marisa Palácios, president of the SBB (Brazilian Society of Biology), in an article published alongside Reinaldo Guimarães, vice-president of Abrasco (Brazilian Association of Collective Health), and Marcia Bandini, of the National Health Council.

In practical terms, the law eliminates research ethics committees, which have a robust federative structure, and replaces them with the National Research Ethics System. But the coup is quite clear in excluding members of the National Health Council from its formation, which places businesspeople in the sector in a privileged position and disregards the very structure of the Ministry of Health and the federal Executive Branch. The new committee would be complemented by professionals of "notorious expertise," a rather vague term that would certainly vary according to the tastes of the rulers in power.

"We cannot accept that attracting research is based on reducing rights. People who participate are subjects of rights—not research inputs. Public trust and protection of participants are essential for the very legitimacy of the research and its results," added Marcela Vieira.

For both the doctor and other entities, the argument of making research more attractive in the country is empty. In the end, what is revealed is the intention to transfer research costs to the State. According to the law that was in force, volunteers had the right to share in the benefits of research; that is, if a new drug is developed and advances through the trial phases, those who contributed to its development have the right to receive it forever.

With the new law, the timeframe would be reduced to five years, which is often interrupted by a gap between the creation of a new drug and its effective availability on the market. The patient would then have to request it from the SUS (Brazilian public health system), which brings both economic and legal risks.

“In fact, the new regulatory program established by Article 33, VII, of Law 14.874/2024 creates a financial burden on the Unified Health System: that of covering the treatment costs for patients who are subjects of post-study clinical research, which, until then, was nonexistent,” criticized the health law attorney Fernando Aith, in an article in which he points out the risks of even greater judicialization of health in Brazil.

Hauntings
For specialists, the cost of sharing the benefits of research with volunteers is usually very low for companies. Furthermore, by making regulation more vulnerable to economic interests, the specter of nefarious experiments returns to haunt the country.

One of these was intensely experienced by Minister Alexandre Padilha himself, who was at the center of a debate that included the decisive participation of CONEP: the case of the unauthorized use of proxalutamide during the pandemic. The use of the drug, intended for cancer treatment, in patients with coronavirus in Manaus was one of the scandals of the COVID-19 health crisis. Its use was requested by endocrinologist Flávio Cadegiani for his clinic in Brasília and expanded without authorization to other states. The product had never been licensed in Brazil by Anvisa (Brazilian Health Regulatory Agency), and its illegal application ended with an investigation by the Public Prosecutor's Office that linked it to 200 deaths. Cadegiani was eventually indicted in the final report of the Pandemic CPI (Parliamentary Commission of Inquiry).

“We are facing, perhaps, the biggest ethical-scientific scandal in the history of Brazilian medicine. And certainly one of the biggest scandals seen by this CONEP (National Research Ethics Committee), which has existed since 1997. I am absolutely shocked. How could someone do this to lives?” protested then-Deputy Padilha in November 2021, at the peak of the Pandemic CPI investigations.

In addition to this scandal, there are other historical events of clinical trials without guaranteed information for volunteers who, in practice, become guinea pigs, as reported in a report by Outra Saúde last November.

“It’s important to remember that people do this voluntarily, hoping for a medication that can actually improve their lives. The new law diminishes their confidence in participating in clinical trials. There is a long-term effect that is very difficult to measure now, but which seems dangerous.”

Marcela Vieira's comment questions the very belief in the industry, as the reduction of ethical parameters may inadvertently hinder people's participation in clinical trials.

However, by leaving its regulation in the hands of a committee dominated by the sector's market, it is worth questioning whether measures such as payment for participation will be permitted, which opens the door to the exploitation of economically vulnerable people.

The recent case of the “iris sale” shows that such a possibility is not mere speculation. The World project, by OpenAI, the artificial intelligence giant owned by Sam Altman, scanned the irises of at least 115,000 Brazilians in 2024. Suspended by the courts, the collection of biological data represents a profound ethical dilemma and, even so, was accepted by ordinary citizens in exchange for about 300 reais. Even so, the money could only be redeemed by downloading the company's app, which increased its already monumental market value.

This paradigmatic case related to new digital technologies adds to similar episodes that have had serious repercussions on public health, such as the sale of blood by untested donors. In both Brazil and England, this practice caused thousands of HIV/AIDS and hepatitis infections.

The Dispute Over Ethics
“The hope is that the ADI (Direct Action of Unconstitutionality) will prosper and, in the meantime, that the decree will be revised, reintegrating CONEP (National Research Ethics Committee) into the new model. It is also essential to strengthen the entities that represent research participants so that they continue to demand their rights,” argued Dirceu Greco, physician and former president of the SBB (Brazilian Society of Biology), in an interview with the portal of the Faculty of Medicine of UFMG (Federal University of Minas Gerais).

President Lula vetoed several articles of the law, but Congress overturned the vetoes last year, and his final decree firmly established Big Pharma's influence on research ethics in the country. Despite the defeat, the legal action brought by organizations dedicated to defending health and the SUS (Brazilian public health system) was not supported by government bodies that could have taken the matter to court.

At some point, the Supreme Federal Court (STF), which has become the central protagonist in ethical debates and questions due to its ministers' involvement in businesses outside their official duties, will have to analyze ADI 7875. The election year suggests that the risk of a complete downgrading of ethical standards may become a reality.

Marcela Vieira is emphatic in stating that there is nothing good on the horizon: “reducing the rights of participants is not the way forward. The law treats people as guinea pigs, not as subjects of rights. This will reduce confidence in participating in the system.”