By Luciana Murad Costa, lawyer at Bhering Cabral Advogados*
In recent years, Brazil has gained prominence in the global landscape of clinical trials, ranking among the 20 leading countries in this field, according to data from Anvisa.
Favourable factors that make the country an attractive location for such studies include the ethnic and genetic diversity of its population, competitive costs compared to other jurisdictions, the technical excellence of national research centres, and a conducive regulatory environment.
Industry stakeholders point out that Brazil is well positioned to achieve even greater relevance in the global clinical trials scenario, attracting international investment, stimulating scientific advancement, and delivering direct benefits to the population. However, regulatory hurdles still hinder the full exploitation of this potential.
Also referred to as clinical trials, these studies are scientific investigations involving human participants designed to assess the action, safety, and efficacy of medicines, techniques, procedures, or medical devices prior to market release. They represent a necessary preliminary stage for new drugs, vaccines, and therapies to reach the population.
Most clinical studies are concentrated in oncology, infectious, rare, or chronic diseases, and gene therapies. In addition to enabling the development of new treatments, clinical trials provide patients with early access to innovative alternatives and contribute to scientific and technological advancement in the country.
The clinical trial ecosystem includes the sponsor, generally represented by the pharmaceutical industry; the research centre, being the institution where the study is conducted; the investigator or researcher, the physician responsible for the conduct of the study and for participants’ safety; and the patient, who voluntarily and without remuneration agrees to participate.
For a clinical trial to be conducted in Brazil, its protocol must undergo rigorous technical and ethical assessments, requiring prior approval from Anvisa, which verifies compliance with Good Clinical Practice guidelines, and from Research Ethics Committees (CEPs), which are responsible for reviewing ethical aspects and safeguarding participants’ rights, safety, and well-being.
However, bureaucracy and delays in the approval process often acted as barriers, prompting foreign sponsors to relocate studies to other jurisdictions.
Against this backdrop, the enactment of Law No. 14,874 of 18 May 2024, the legal framework for research involving human subjects in Brazil, represented a significant step forward. It aligned national rules with international Good Clinical Practice standards, streamlined and simplified the approval of research protocols, and introduced greater predictability by setting maximum review periods.
Although Law No. 14,874/2024 is about to complete its first year of validity, its guidelines have not yet been fully implemented, as several provisions still depend on regulatory acts by the Executive to be effective, such as the functioning of the National System of Ethics in Human Research, the accreditation of ethical review bodies, and the list of documents required for protocol submission.
Recently, the National Congress overturned the presidential veto to certain provisions of the Clinical Trials Law, reinstating, among other aspects, the possibility of discontinuing the free supply of medication to patients in the post-study period, five years after its entry into the market. The veto had been justified by concerns over participants’ interests, by creating an indefinite obligation for sponsors to continue supplying medication after the study concluded. Although controversial, this obligation was regarded by sponsors as a significant burden and a deterrent to conducting clinical trials in Brazil.
The core challenge lies in promoting scientific innovation and encouraging clinical research without neglecting participant protection. Regulation must simultaneously foster the development of new therapies within the country, attract international sponsors, and uphold ethical standards, safety, and participants’ rights.
In light of this promising growth scenario, yet with gaps in regulation for the full application of Law No. 14,874/2024, contracts to be executed between national research centres, investigators, and sponsors demand heightened attention—particularly considering that most sponsors are major foreign pharmaceutical companies. Clear contractual provisions regarding the parties’ obligations, allocation of responsibilities, remuneration criteria, insurance, governing law and jurisdiction, record retention periods, data protection, and intellectual property are critical aspects for effective contractual management in such projects.
*Originally published by Medicina S/A