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Clinical Research in Brazil: there is still a lot of room to grow

In 2017, in Brazil resulted in around 1.95% of the total clinical studies carried out in the world, even though its population represents approximately 2.8% of the world population, this places the country as the 15th placed in the world research clinic ranking, while its population is the 5th largest population in the world and classified as the 7th largest pharmaceutical market in the world. This disconnect in terms percentage occurs mainly in function of three factors:

- Long and bureaucratic approval process by regulatory bodies. In the country, the approval time can exceed 10 months while in the reference countries in clinical research, this time varies between 3 to 6 months.

- Low education of patients and insufficient number of researchers.

- Investments in clinical research aimed at Latin America in general are still low, especially when considering local companies.

Among the factors listed above, it was identified that the main reason for the low performance of clinical studies in the country, is the issue of the long and bureaucratic approval process for studies and drugs. According to a survey carried out by Interfarma with 21 companies, about 242 studies have not been carried out in Brazil in the last 7 years, which represents approximately R$ 490 million that have stopped being invested in the country by only these companies, considering that the country exceeds 200 pharmaceutical companies, the amounts that are no longer invested in the country are even higher.

Another important aspect is the investment of the national pharmaceutical industry in clinical research, still reduced compared to the multinational pharmaceutical industry that generates innovation. According to a survey of the 2014 Innovation Survey conducted by IBGE, in partnership with the Ministry of Science, Technology and Innovation and FINEP (PINTEC), pharmaceutical manufacturers in the country invest an average of 2.25% of their net revenue in internal Research and Development activities. It can be interesting to compare with the investment media of the Multinational Pharmaceutical Industry that generates innovative products, which have disproportionately higher values: 10 to 17% of gross revenue (IFPMA).

In our experience in clinical research, we found that, in local projects, most of the cost of the project refers to payments to research centers, for the execution of health care and complementary exams inherent to the study, being proportional to the number of patients included and amounting to 50% of the expenses of a research project. The second largest expense, equivalent to approximately 40% of the value of a research project, refers to the Contract Research Organization (CRO) who prepare documents, are responsible for the execution, and audit of the studies. Often, these activities are internalized by companies, even though it is already clear that this does not reduce costs. The remaining 10% of research expenditures refer to fees, logistics and comparator medication, the production costs of the test medication are not counted here, although when the medication in use in the study is very sophisticated, this value may even represent the largest project investment.

Draft law 200 has been under discussion since 2015, was approved in 2017 by the Senate, and is now under analysis and approval by the Chamber of Deputies (now PL 7,082 / 2017). This law comes with the idea of ​​reducing bureaucracy in the analysis and approval for the execution of new clinical research projects in the country, in an attempt to bring the country closer to the deadlines practiced worldwide.

In summary, Brazil is able to advance more positions in the world ranking of clinical research and allocate a higher level of investments to the country once it increases the efficiency and speed in the approval of studies and products, and for that to happen, one of the main pillars is the reduction of bureaucracy in their approval processes, obviously without giving up the safety and monitoring of patients.

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