Medicines awaiting approval from Anvisa cause losses to the country, but what has been done to change this scenario?
At the end of 2023, the FarmaBrasil Group (which brings together some of the largest pharmaceutical industries in the country), carried out a survey that estimated that the medicines that are “on the waiting list”, awaiting approval from the National Health Surveillance Agency (Anvisa), corresponded to at a potential value of approximately R$17 billion. For this calculation, only medications that were in the queue and that had already started analysis were considered.
This assessment assumed that the medicines would enter the market in 2022, and used quantity and price data made available by the Medicines Market Regulation Chamber – such data contains the expected volume to be sold and the average unit value for each category.
As identified by the study, the category that was most impacted by the delay in Anvisa's analysis was biological medicines, whose potential value was around R$9 billion.
New and innovative medicines corresponded to R$4 billion, as well as generics and similar medicines, which also totaled R$4 billion. When analyzing the list of non-synthetic products, the estimate was approximately R$205 million, and herbal medicines were valued at R$31 million.
Finally, as calculated by FarmaBrasil, the time to eliminate the waiting list of medicines would be two years, considering that the agency maintained its current workforce and that no new requests were submitted during this period.
It is essential to emphasize that this is not just about medicines! Currently, Anvisa regulates sectors that represent more than 20% of the Brazilian Gross Domestic Product (GDP), including food, medicines, health products, cosmetics and others.
Despite this lengthy approval time, Anvisa has been increasing the annual number of published records since 2015. According to data presented by the entity at an event held at the end of 2023, at the Pharmaceutical Products Industries Union (Sindusfarma), by November of that same year, 333 records had already been published, covering generic, similar, new/innovative, herbal, specific, energized and cannabis-based products. In 2022, there were 266 publications; in 2021, there were 262. And the agency achieved these results despite a reduction of approximately 35% in the team of specialists responsible for analyzing records requests.
There are many criticisms related to the delay in analyzing medication records. It is also not uncommon - and even understandable - to make comparisons between the average time it takes for a registration to be approved by Anvisa and the American Food and Drug Administration (FDA). However, when making such a comparison, it is fair to consider that Anvisa has around 1,600 employees while the FDA has 19 thousand employees (2023 data).
Last year, after intense criticism from regulated sectors, the Federal Government approved a public competition to fill just 50 new vacancies. However, Anvisa's CEO, Antônio Barra Torres, acknowledged, at the time of the announcement, that the agency would need 1,300 new employees so that it could carry out its functions fully, free from problems arising from the shortage of labor.
It is clear that Anvisa spares no effort to fulfill its important role of preserving the health of the Brazilian population and meeting all demands. However, experts point out that the institution is operating at its limit and needs help.
It is essential that the government and competent authorities recognize the importance of investing in hiring a sufficient number of qualified personnel, so that the Agency can perform its functions effectively. To this end, companies that belong to sectors regulated by Anvisa must act assertively, to make sure the necessary improvements are implemented.
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