At the end of May of this year, the new law for clinical research was finally sanctioned. By defining the rights and duties of all parties involved in a clinical trial, brazilian science finally begins to pave the necessary path to advance and leverage its development as an industry.
It took about seven years of debates and several changes to finally obtain presidential sanction.
But after all, why did clinical research law need to change?
National Overview
According to 2023 data from World Health Organization (WHO) observatory, Brazil is in 17th position in the world ranking of clinical trials. Despite being the leader when it comes to South America, of the total research in progress in the world, only 2.57% is being carried out in Brazil.
One of the elements that allowed this position - although not so high, yet significant - is the rich ethnic diversity that the country has. In this sense, it is worth noting that a study with a wide ethnic variety makes it possible to study the performance of a medication or therapy with more assertiveness, since it takes into account the genetic inheritances of each group, as well as their cultural and behavioral habits. On the contrary, a substance may have its efficacy or effectiveness limited to groups from a few regions of the planet.
Among other corroborating aspects, it is possible to mention:
- Brazil has the highest GDP in Latin America;
- It is the 12th largest GDP in the world;
- The 7th largest population in the world;
- It is the 7th largest pharmaceutical market on the planet;
- Well-established health systems (public and private);
- Lower labor cost.
The costs of clinical research in Brazil
According to the report "The importance of Clinical Research for Brazil", published in 2022 by Interfarma (Pharmaceutical Research Industry Association), among the nine countries most relevant to the scientific scene, the only countries in Latin America to be included in the chart are Brazil and Argentina.
As can be seen, the brazilian territory has a great competitive advantage because it has lower costs than in Argentina, Russia, Poland, USA, Germany, Belgium and the United Kingdom. Also according to the report, the costs of oncology research (which is, worldwide, one of the niches that receive the most investment for research) can be reduced by up to 45% when carried out in Brazil, when compared to the leading countries in clinical research.
Brazil x World
However, Brazil has the potential for much more and that is precisely what the new clinical research framework is trying to unlock: to boost the country to be among the top ten in the world ranking.
In the first image below, it is possible to observe the performance of clinical trials around the world over the years from 1999 to 2021. In table A, there is the number of clinical trials conducted per year and by region of the world; on the other hand, in table B, the analysis is made from those with the highest income to those with the lowest.
In the second image, the orange line highlights only the performance of the American continent (without differentiating between north, center and south).
Finally, in the figure below is table C, which lists the countries with the highest number of clinical trials by country or area. As indicated at the beginning of this edition, Brazil appears in 17th position.
Main obstacles of the old brazilian regulation
Working with science is not simple. There are several segments working through many stages to achieve what we call clinical research. In Brazil, a series of obstacles end up making the scientific market less competitive when compared to leading countries.
To initiate a clinical study, proposals must go through three instances: the National Health Surveillance Agency (Anvisa), the Research Ethics Committee (CEP), and the National Research Ethics Commission (CONEP). The analysis is necessary to ensure the safety and ethics of the research.
However, the problem starts with too much burocracy. It is a reality in which study projects take an average of eight months, according to ABRACRO (Brazilian Association of Representative Clinical Research Organizations), to be analyzed and, if it complies with the guidelines, be approved.
This deadline is one of the first elements holding back brazilian scientific competitiveness, since the most common — when compared to other countries — is for a study to be approved within about two months. According to data from IQVIA, in 2018, for example, the average time required for a clinical research project to be evaluated and approved was:
- 32 days in the United States;
- 62 days in Poland;
- 86 days in Mexico;
- 113 days in Argentina;
- And 215 days in Brazil.
To think about competitiveness, we need to think through the logic of the industry. In short, we can say that it works like this: pharmaceutical companies choose the target therapy to be studied and sponsor the research to take place. Then, the number of participants needed for each stage is stipulated — if we are talking about diabetes, for example, the ideal is to have at least 10 thousand participants from the most varied ethnic profiles.
To comply with this requirement, the countries that will be part of the study are selected, and this is the moment of conflict, because the projects undergo an extensive period of processing between the instances until finally being approved.
If, on the one hand, Brazil has advantages, the regulations — until then — did not provide sufficient legal certainty and the approval time delayed the completion of studies.
The new legislation
The project that began as Bill 6007/2023 now appears in the news as Law 14.874/24 and finally offers greater legal certainty for carrying out research with human beings.
With the new legislation, 56 legal and scientific terms were defined, which helped define the term 'clinical research' as “scientific procedures developed systematically to evaluate the action, safety, and efficacy of drugs, verify the distribution of disease risk factors, and assess the effects of factors or states on health”.
Stages
Among the decisions, the National System of Ethics in Clinical Research with Human Beings was created. The new system will be responsible for editing standards, evaluating and accrediting all those involved in clinical trials and must represent a single instance. Thus, thanks to the unified structure, project analysis must be faster and reach a maximum period of 180 days. In addition, its regulation will be carried out by the Executive Branch.
New biobank and biorepository
According to National Health Council, as of March 2023, Brazil had 88 biobanks approved by CEP/CONEP. With the creation of a new system, the country also gains a new biobank and a biorepository that should gather materials for non-commercial research.
Although the name suggests that they are synonymous, the biobank and the biorepository represent different objectives and responsibilities for the collection and storage of biological materials. While one deals with broader objectives, the other is aimed at specific projects, which include the project researcher as one of those responsible for storage.
Compensation
Under the new rules, granting financial advantages to participants remains prohibited. However, there are exceptions, such as in cases where an individual considered healthy participates in bioequivalence tests. On the other hand, the reimbursement of expenses such as transportation, food, and material delivery was authorized.
Responsibilities
With regard to responsibilities, the responsibilities of sponsors and researchers were defined, as well as guidelines for the manufacture, import, or export of the studied products. Finally, rules are also established for publicity and standards to ensure monitoring and transparency.
Vetos
Another change - and one that generated some controversy - was the reduction in the time it took to supply drugs to trial participants. In theory, the supply of drugs will continue without a definitive deadline to end.
This is because, among President Lula's vetoes is Art. 33, item VI, which would allow the sale of experimental drugs to study participants five years after the end of the study.
However, point VI was rejected for the following explanation: “It is not appropriate to interrupt the right to post-study access to research participants, since it is a right acquired, by justice, neither in the commercial availability of the drug nor availability in the public health network, which would mean transferring to taxpayers the responsibility of the sponsor to provide post-study access”.
On the other hand, according to the Brazilian constitution and the dynamics of the three powers, there is still the possibility of overturning the veto over the next few months.
The second veto, on the other hand, concerns the 3rd paragraph of Art. 24. The excerpt required that the Public Prosecutor's Office be informed about the participation of indigenous people in the research. However, it was vetoed for violating the principle of equality and for pointing to “a possible situation of state protection in relation to indigenous peoples, a condition that has already been overcome by legislation”. You can better understand vetoes by clicking here.
Economic potential for Brazil
Steady-state
To understand the economic potential of clinical trials in Brazil, Interfarma's 2022 report is based on the idea of “steady-state”, whose concept is: a condition in which the variables of a system do not change over time.
Thus, the analysis indicates that, in Brazil, the average expenditure per ongoing clinical trial is usually 2.4 million dollars. Applying this value in oncology, the estimated average value is $1 million dollars. Considering this information, it is also estimated that, if there were an additional investment of 315 million dollars, it would be possible to expand the number of clinical studies, starting from 238 for 540 studies. In the words of the researchers: “This increase would accumulate year after year, until reaching a steady-state of entry and termination of these studies, equivalent to the average time spent conducting a clinical study”.
In addition, the Interfarma finding suggests that the global average duration of clinical trials is 26 months - when already in progress, excluding pre-development phases.
Possible indirect impacts
With regard to indirect impacts in economic activity, a report entitled”Biopharmaceutical Industry-Sponsored Clinical Trials - Impact on State Economies”, prepared in 2015 by Pharmaceutical Research and Manufacturers of America (PhRMA), points out that the pharmaceutical industry invested around $10 billion to conduct clinical studies in the United States in 2013, which generated an estimated positive economic impact of around $25 billion. In the view of the Interfarma researchers, “if we apply this same reasoning to the Brazilian context, we can conclude that the total economic impact could reach R$5 billion”.
In addition, the expansion of access promoted by the nature of clinical studies may entail a reduction in drug costs for the government. This is because, according to a study conducted by the Turkish Ministry of Health — in partnership with the Universities of Istanbul and Hacettepe —, it highlighted that an investment of US$107 million, carried out between the years 2006 and 2010, resulted in a minimum savings of $311 million during the same period, thanks to the access offered to 14,370 patients to clinical studies.
In this case, we are talking only about drug treatment, but there is still the possibility of reducing expenses associated with hospitalization and lack of productivity of patients. “Expanding the scope of analysis, we can see the growth of clinical research as a balancing vector of the health sector's trade balance, as the increase in international investments is accompanied by a lower import of scientific and technological knowledge,” say the researchers in the Interfarma report.
Brazilian experience
In addition, a study by Aliança Pesquisa Clínica Brasil, published in 2015, evaluated 46 clinical studies in Brazil and points out that, of these, 18 were discontinued due to delays in the necessary approvals — all studies were sponsored by the industry and were submitted between the years 2007 and 2013.
As a result, the data suggest that about 530 brazilian patients stopped participating in these 18 studies, reflecting a loss of access to treatments that may have generated expenses of around $15 million for the Brazilian health sector (the analysis took into account costs with patients, medications, administrative expenses, and other supplies).
Finally, with the new clinical research milestone, Brazil can reach the 10th position in the world ranking, in addition to attracting around 3 to 5 billion reais in investments each year.
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