At the beginning of this year, the National Health Surveillance Agency (Anvisa) launched a notice for a public competition, aiming to select 50 specialists in Health Regulation and Surveillance. However, this number is considered insufficient to restore the Agency's outdated staff, a reality that has persisted for some years.
In 2007, Anvisa had approximately 2,360 permanent employees; however, by December 2023, this number had reduced to 1,476, resulting in a deficit of 1,176 employees (44% reduction compared to 2007). Even at the peak of the number of employees in 2007, the number of employees was considered small compared to similar institutions around the world, such as the Food and Drug Administration (FDA), which had approximately 18 thousand professionals.
This shortage of servers, added to the increased volume of work and growing technical complexity, had a significant impact on the Agency's operations, becoming a cause for great concern.
However, it is important to recognize the efforts of Anvisa directors who work hard to maintain the agency's operations in a transparent and competent manner, and continue to rely on trained specialists who ensure the quality and safety of various products that society uses daily.
In addition to the competition, another recently announced initiative – highlighting Anvisa's recognition of its deficiencies and the active search for solutions – is the implementation of a new phase of the Online Optimized Analysis Project in the area of Biologicals.
On February 19th, 2024, the Agency established a task force dedicated to the consideration of all petitions that were filed between January 2022 and June 1, 2023 and that are awaiting analysis in the ordinary pharmaceutical technology post-registration queue.
The work of this task force is expected to last four months, a period that Anvisa believes is sufficient to carry out the analysis of petitions that have been awaiting evaluation for around two years. To make this process even more agile, experts will interact with companies online.
The Optimized Analysis Project was created in 2022, by the Biological Products Assessment Management (GPBIO), with the aim of optimizing and accelerating the analysis of post-registration petitions for the quality of biological products and, thus, reducing the process' queue.
Although it is a valid and noteworthy initiative, it is important to highlight that it may not solve the challenges that Anvisa has been facing for some years due to the lack of technicians. That is, although commendable, it is necessary to consider that this solution is not definitive, and that the creation of new task forces tends to occur in response to society's questions regarding the deadlines for analyzing various processes.
Another point to be considered: when the project was created, the five companies with the highest number of quality post-registration petitions waiting in the Agency's analysis queue were included, this means that the order in which the filed requests were entered was not followed, which could generate questions between companies and Anvisa.
We understand that this was an emergency measure and, in such circumstances, it is not always feasible to follow what the protocols determine. However, it is an issue that deserves reflection.
The experience was successful, leading the Agency to carry out a second phase of the project, between December 2022 and March 2023, now covering post-registration petitions for the efficacy and safety of biological products that had been filed by the 10th of December 2022, with additions based on OS 45/2018 or RDC 750/2022 standards.
These petitions were reallocated in a specific queue for treatment, resulting in a reduction in the analysis queue by more than 50% and maintaining control of the queue since then.
It is essential to emphasize again that Anvisa has worked and taken important steps to strengthen its capacity to act, allowing it to fulfill its mission of promoting and protecting the health of the Brazilian population, acting with scientific excellence in the regulation of products, services and environments subject to health surveillance, in collaboration with the Brazilian Unified Health System (SUS).
All initiatives to guarantee the health of Brazilians are worthy of recognition, especially when we consider that a two-year waiting period for analyzing a petition is unfeasible. How many important medicines could be in use, contributing to improving the health of many patients?
If the number of professionals is not expanded, both health protection and regulatory actions may become ineffective and insufficient. We cannot accept that an Agency that is one of the main regulatory bodies in the world, recognized by its peers for its efficiency and seriousness, is forced to adopt palliative measures to maintain the quality of the service it offers to the population.
It is time for society to join forces with Anvisa so that the necessary actions can be taken.
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