MSF denounces setback in rights of clinical trial participants in Brazil

A decision made last month by the Brazilian Congress represents a major setback for clinical trial participants, limiting their right to receive for free the medications developed through the studies in which they took part.

This right was curtailed by a new law on research involving human subjects passed last year, which restricts the period during which the medication must be provided to a maximum of five years after it becomes commercially available. At the time, Doctors Without Borders (MSF) issued a statement requesting that this provision be vetoed, arguing that limiting post-trial access goes against public interest and violates the rights of research participants. President Luiz Inácio Lula da Silva vetoed the provision, but unfortunately Congress overturned the presidential veto at the end of last month.

"Overturning the veto was a serious setback, following a proposal from the pharmaceutical industry, especially considering that Brazil was once at the forefront of this issue, with one of the world’s most advanced legal frameworks," said Rachel Soeiro, regional Americas Coordinator for MSF Access.

“It must be made clear that clinical trial participants are not human guinea pigs and that their rights must be safeguarded above the economic interests of the research sponsors. Denying these people access to medicines they helped develop is simply unjust," she explained. Soeiro leads the regional division of MSF’s branch dedicated to expanding access to medicines and other medical technologies.

Before a new drug is approved for human use, it must undergo rigorous research processes that require volunteer participation. However, the results of these studies often do not translate into benefits for the general public—or even for the participants who directly contributed to the development of the medication.

Brazil has been a pioneer in guaranteeing the rights of participants in research involving human subjects, also known as clinical trials or clinical studies. Until recently, once a study concluded, the responsible parties were required to provide the medication to participants for an indefinite period, as long as it remained the best treatment option available to the patient.

Just last year, 70 requests for post-trial medication access were approved in Brazil, including treatments for diabetes, various cancers, rare diseases, autoimmune conditions, according to a report from the Clinical Trials Coordination of Anvisa, the Brazilian agency equivalent to US’s FDA.

Unsurprisingly, the new law originated from a proposal by Interfarma, the association representing the largest multinational pharmaceutical companies in Brazil. The pharmaceutical industry has a vested interest in restricting the rights of clinical trial participants, arguing that doing so would attract more research to the country.

In addition to limiting the provision of medications to no more than five years after their commercial release, the new law gives the researcher and sponsor the authority to decide whether participants will continue to have access. "This is a clear conflict of interest that puts participants’ rights at risk," warns the MSF Access regional coordinator.

The legal provision now awaits regulation by the Ministry of Health. Even though the law’s wording can no longer be changed, the regulation process can still establish more favorable criteria for research participants, such as introducing safeguards to mitigate conflicts of interest. "One possible improvement would be to create an independent review mechanism in cases where the researcher or sponsor deems the participant ineligible to receive the medication after the study ends," Soeiro explains.

Although it is now inevitable that the law will go into effect, there is no doubt limiting post-trial access constitutes a rollback in the rights of clinical trial participants and therefore violates the principle of non-retrogression enshrined in the Brazilian Constitution.

The new law also contradicts international standards to which Brazil is a signatory. One example is the Declaration of Helsinki, which established the principle of beneficence, requiring that the benefits of research outweigh the risks to participants and that post-trial access to medication must be ensured, among other obligations. The Declaration of Helsinki, which Brazil has historically championed, is universal in nature. Therefore, its principles must be applied equally in all countries.

Additionally, the right to “enjoy the benefits of scientific progress and its applications” is a human right established in Article 15 of the International Covenant on Economic, Social and Cultural Rights, a UN treaty which came into force in 1976 and to which Brazil is also a signatory.

Similarly, the restriction on post-trial access contradicts the principles of the recently approved Pandemic Agreement under the World Health Organization, which aims to guarantee post-trial access not only for clinical trial participants but also for at-risk communities.