CRO in Brazil - Opportunities and challenges in Brazil.
Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America. Divided into five regions, the country is the sixth largest pharmaceutical market in the world where regulatory compliance for clinical trials is upheld by an experienced and qualified workforce.
At first glance, these figures could be attractive to pharmaceutical and biotechnology companies. However, regulatory frameworks in Brazil are restrictive.
The regulatory process to approve clinical trials in the country requires approval by two entities, an ethical approval by CONEP (Comissão Nacional de Éticaem Pesquisa/National Ethics Commission) and a regulatory approval by ANVISA (Agência Nacional de Vigilância Sanitária/National Agency of Health Surveillance). Additionally, clinical trials require two ethical approvals, one by CONEP (as previously mentioned), which grants approvals at the national level and one at the local level by the institutional Ethics Committee (IEC).
Both bodies have to approve the same package. For multicenter studies, a selected site is assigned as the coordinator site to get the first approval by its local IEC, before the site is approved by CONEP. Once the final approval is released by CONEP, each one of the remaining sites must also submit the study to obtain the approval from the local IEC. The timeframe for all these steps usually takes 90 days.
The sponsor is responsible to apply the package describing the study and related supplies, such as the medication, lab tubes and any equipment or medical devices to ANVISA’s evaluation. This application can be started after the first local ethics approval at the coordinator site. Bear in mind, the approval letter could take over 12 months to be released.
Combining the double ethics and regulatory approvals, the total lead time could easily exceed 12 or even 18 months. As a result, this long timeline usually forces trials in Brazil to start later than in their foreign counterparts.
In order to change this environment, ANVISA opened a public consultation in 2014 where over 600 suggestions were received. Multiple rounds of discussions took place throughout 2014 with local players, which brought about steady progress, from a regulatory standpoint.
Based on new rules and timelines released by ANVISA in March 2015, upon receipt of the Drug Clinical Development Dossier (DDCM), ANVISA has 90 days to evaluate it. If there is no response after receipt the clinical trial can be started after the relevant ethical approval by CONEP. It means that Tacit approval is applicable and valid for Phase III studies with small molecules.
For Clinical Developments of Biological Products (including vaccines) and Clinical Developments in Phase I or Phase II, the DDCM evaluation occurs within 180 days after receipt of DDCM by ANVISA and the clinical trial may be initiated only after approval by ANVISA.
Brazil is one of the largest and most populous countries in the world, with a growing healthcare industry and a large pool of potential participants for clinical trials. However, like many countries, Brazil also faces challenges when it comes to conducting clinical trials, including regulatory issues, lack of infrastructure, and socioeconomic disparities. In this blog, we will explore the opportunities and challenges facing clinical trials in Brazil.
Opportunities:
- Large patient pool: Brazil has a large and diverse population, with over 200 million people. This means that there is a large potential pool of patients for clinical trials, particularly for diseases that are prevalent in Brazil, such as dengue fever and Chagas disease.
- Experienced researchers: Brazil has a well-established research community, with many experienced researchers in various fields. This expertise can be leveraged to conduct high-quality clinical trials.
- Lower costs: The cost of conducting clinical trials in Brazil is often lower than in other countries, due to lower labor costs and lower costs of living. This makes Brazil an attractive location for sponsors looking to conduct trials cost-effectively.
- Regulatory environment: The regulatory environment for clinical trials in Brazil has improved in recent years, with the creation of the Brazilian Health Regulatory Agency (ANVISA) and the National Council for Ethics in Research (CONEP). These agencies have made it easier for researchers to obtain regulatory approvals for clinical trials.
Challenges:
- Socioeconomic disparities: Brazil is a country with significant socioeconomic disparities, which can make it challenging to recruit patients for clinical trials. Many Brazilians live in poverty and lack access to healthcare, which can make it difficult for them to participate in trials.
- Infrastructure: While Brazil has a well-established research community, the country still lacks some of the necessary infrastructure for conducting clinical trials. This includes sufficient laboratory facilities and equipment, as well as trained staff to conduct and manage trials.
- Language barriers: While Portuguese is the official language of Brazil, many people in the country speak other languages, including indigenous languages. This can make it challenging to communicate with potential trial participants who do not speak Portuguese.
- Regulatory hurdles: While the regulatory environment for clinical trials in Brazil has improved, there are still challenges to obtaining regulatory approvals for trials. This includes navigating complex and sometimes conflicting regulations, as well as obtaining timely approvals from regulatory agencies.
Conclusion:
Brazil presents a significant opportunity for clinical trials, with a large and diverse patient population and an experienced research community. However, there are also challenges to conducting trials in Brazil, including socioeconomic disparities, infrastructure gaps, language barriers, and regulatory hurdles. Despite these challenges, with the right investment and support, Brazil has the potential to become a key player in the global clinical trial landscape.
