New law should boost clinical research in Brazil
By Paulo Fernandes, consultant, board member of the Brazilian Clinical Research Alliance
As the largest country in Latin America, Brazil offers unique strengths such as its diverse population, efficient patient recruitment and high-quality data, which make it a very attractive location for conducting clinical trials. With recent improvements in legislation and regulatory frameworks, Brazil will further strengthen its role and that of Latin America in the global clinical research landscape.
The effect of the Brazilian Clinical Research Law 14.874/24
Approved by Brazilian President Luiz Inácio Lula da Silva in May 2024 and set to come into force 90 days after approval, Law 14.874/24 aims to streamline the clinical trial review process, reduce bureaucratic obstacles, and improve the predictability of the review, particularly in relation to timelines. By providing a clearer and more efficient regulatory pathway, the law can attract more investment and encourage innovation in the sector, both from global and local pharmaceutical and biotechnology companies. The expected improvements in timelines will make Brazil an even more attractive location for global clinical trials. The law establishes that the Brazilian Regulatory Authority will have 90 business days to respond to clinical trial requests; it simplifies the ethics review process, relying only on the review of local ethics committees before trials can begin; and it adds clearer rules to existing regulations that directly improve the country’s viability.
Defense of clinical research
The new law is supported by the well-established Brazilian association of CROs, ABRACRO, which has been supporting the clinical research ecosystem for the past 18 years. Recently, ABRACRO has been advocating for better regulatory frameworks and promoting the development of the clinical trials workforce in the country. ABRACRO has taken a proactive role in fostering public discussion on the new law, fostering interactions with regulators from ANVISA, central and local ethics committees, as well as other industry associations such as Sindusfarma (the Brazilian Pharmaceutical Industry Association), Interfarma (the Brazilian Research-Based Pharmaceutical Industry Association), Grupo Farma Brasil (the Brazilian Research-Based Pharmaceutical Industry Association) and Abiquifi (the Brazilian Pharmaceutical Industry Association - focused on APIs).
About seven years ago, ABRACRO created its first extension course on conducting clinical research and has been promoting these courses within the ecosystem. This initiative supports the entry of new professionals and the training and retraining of those already working in the area of clinical trials. In addition, some of these courses are offered to professionals from public institutions, free of charge or at a discount, to support their updating, which improves the overall quality of service provision based on a deeper understanding of ethics, their individual roles, etc. The member companies and the association's efforts have built a solid foundation for the future.
Diversity and recruitment continue to be Brazil’s main strengths
Brazil’s most significant advantage in clinical trials has traditionally been its ability to accelerate enrollment in global clinical trials, often allowing time spent during the regulatory phase (under the old framework) to be recouped with rapid enrollment. The positive enrollment is the result of a number of factors, including the strong relationship between trial physicians and their patients, a country where access to the latest and most advanced technological treatments is not yet widespread, and the collective desire for better healthcare for all. Combined with the continued push by regulators, including the FDA through its November 2020 Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry, for greater enrollment diversity, this potential enhances the country’s attractiveness for clinical trials.
With a significant advantage in terms of population diversity, more than 50% of Brazil's population has multiple ethnic origins, 61% of its population is concentrated in urban areas, with almost 40 cities with more than 500,000 inhabitants, and a high global rate of technological adoption places Brazil as the first country in Latin America, according to the IMD World Digital Competitiveness Ranking for 2022. Data on the global burden of diseases in the country is in line with global data, with oncology being one of the most prevalent diseases today, a sad but growing trend.
Population diversity allows researchers to collect more comprehensive and reliable data, which is crucial for developing new treatments and medical interventions that support the introduction of safer products to the market and serve more patients more quickly. By efficiently recruiting patients from a variety of demographic backgrounds, clinical trials in Brazil can produce inclusive and comprehensive results, benefiting global health outcomes.
High quality data and centers
Brazilian clinical trial centers maintain high standards and rigorously adhere to protocols, resulting in the production of high-quality data. The country has a network of well-equipped research centers with experienced professionals and continues to improve its capacity to train new professionals for clinical research. This existing infrastructure supports the execution of complex clinical trials, ensuring reliable and accurate results.
Brazil has a long history in several therapeutic areas and has recently seen an increase in the number of clinical trials for cell and gene therapy. ANVISA, the country’s regulatory authority, has played a crucial role in regulating the evaluation and implementation of such technologies that ultimately help patients, for example with the publication in 2020 of the Resolution of the Collegiate Board - RDC no. 338 exclusively on Advanced Therapies Medicinal Products or its publication in 2023 of a specific guidance document for the sector called Guide of considerations on non-clinical biodistribution studies with gene therapy products - Guide 70/2023 - version 1 in addition to multiple webinars and meetings with the regulated sector to discuss advances in the field and its regulations.
Clinical research sector expanding in Latin America
The changes extend beyond Brazil, highlighting the potential of Latin America as a whole. Recent developments in Argentina demonstrate the growing potential for clinical research in the region. Argentina has seen significant growth in clinical trials, with a 79% increase in the number of trials between 2017 and 2021 and a 130% increase in clinical R&D investment during the same period, according to the local association of pharmaceutical companies and CROs, CAEME/CAOIC. This growth was the result of government changes made a few years ago that promoted a less bureaucratic, more predictable and faster regulatory environment.
Furthermore, Colombia and Mexico also play important roles in the clinical research landscape in Latin America. Both countries have numerous clinical research sites with robust infrastructures, allowing for efficient recruitment of participants in various therapeutic areas, including internal medicine, vaccines, and oncology, among others. In Colombia, with over 50 million inhabitants, there are more than 130 active clinical research sites that have received direct GCP inspections from INVIMA, its regulatory authority. Mexico has made significant progress in aligning its regulatory framework with international standards, particularly through its active participation in initiatives such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). This alignment has improved the quality and reliability of clinical trial data, fostering greater trust between sponsors and investigators.
Existing centers in Colombia and Mexico, supported by experienced professionals and an increasing focus on regulatory compliance, further enhance the region’s attractiveness as a clinical trial location. Enhancements to existing capabilities and positive historical regulatory oversight results demonstrate Latin America’s potential to become a major hub for clinical research, offering an attractive environment for global clinical trials and investment in innovation.
Conclusion
Brazil is at the forefront of clinical research, offering significant advantages such as a diverse population, high-quality data, and efficient patient recruitment. Recent legislative advances further cement Brazil’s new opportunities. As these changes come into effect, we can expect significant positive impacts on the clinical research landscape in Brazil, making it an even more attractive location for conducting cutting-edge medical research. With simultaneous growth in countries such as Argentina, the opportunity for clinical research across Latin America will expand, presenting a promising future for the region’s contribution to global health advancements.
Originally published in Clinical Leader - https://www.clinicalleader.com/doc/new-law-expected-to-boost-clinical-research-in-brazil-0001
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