Lawsuit to Speed Up Pesticide Registration in Brazil

Date:12-18-2023

In Brazil, the largest and most attractive pesticide market in the world, product registration process is quite slow and complex, and may take more than 12 years to evaluate generic formulated products (Formulated Products based on Equivalent Technical Products).

Some measures were adopted by the regulatory agencies in charge for pesticide registration to speed up evaluations. Among these, there is Anvisa’s Toxicology Petition System - Siptox, launched in October 2017, in which there were few adherences by registrant companies, and until now it is reason of registration rejections. Very recently, from 09/29/2023, another measure was the Joint Ordinance SDA MAPA - IBAMA - ANVISA No. 3, is still under discussion by agencies. Furthermore, Bill No. 1459/2022, also called the Pesticide Bill, which has been pending and discussed in the Legislature for more than 20 years, was forwarded by the Federal Senate for presidential sanction, and could be approved in 2023, if there would not have any vetoes.

According to a survey elaborated by AllierBrasil (2023), of the 168 registrations of generic Formulated Products approved in 2022, 52.38% demanded 6 years or more for approval. This time for approval has remained stable for the last four years, being much longer in years before that.

Notes:

FP Chemical: Chemical Formulated Product

FP/ETP: Chemical Formulated Product based on Equivalent Technical Product

Sources: Anvisa, Ibama, MAPA; adapted by AllierBrasil

The levels of pest and disease control can vary more quickly than the time for pesticide registration approvals, mainly due to the development of resistance in the biological targets against the molecules that are used. In a market worth US$ 20 billion per year, a delay in a product launch can be crucial for a company success or failure.

For this reason, 2022 had a record number of approvals of pesticide registration evaluations through court decision. Of the 168 registrations of Formulated Products based on Equivalent Technical Products, 60 were result of lawsuits, that is, more than a third of the approvals. Highlights to Rainbow (13.4%), Iharabras (13.4%), Adama (7.5%), Perterra (7.5%) and Syncrom (7.5%), which together totaled 49.3 % of the lawsuits, or 33 processes among 67.

Sources: Anvisa, Ibama, MAPA, Mazza & Manente de Almeida Advogados; adapted by AllierBrasil

The registration of Equivalent Formulated Products represented 90% of lawsuits, or 60 of the 67; 24 mixtures of active ingredients versus 43 of stand-alone products, with a total of 27 active ingredients. No lawsuit of technical products was identified in 2022.

The majority of the lawsuits had Anvisa and Ibama as defendants, 71.79%, while, for only Anvisa or Ibama, the percentage was 28.21% of the actions. The survey did not include lawsuits against the Ministry of Agriculture.

Notes:

FP: Chemical Formulated Product

NFP: New Chemical Formulated Product

FP/ETP: Chemical Formulated Product based on Equivalent Technical Product

Sources: Anvisa, Ibama, MAPA, Mazza & Manente de Almeida Advogados; adapted by AllierBrasil

According to the report ″Lawsuits, Decisions by Federal Court - 2022″, unpublished, elaborated by AllierBrasil and Mazza & Manente de Almeida Advogados, not all lawsuits are successful, especially in the case of the granting of injunctions by the Judiciary. Some Courts have a greater number of approvals, while the need for appeals to a second instance are more frequent in others.

In the same survey elaborated by AllierBrasil (2023), when comparing the time for registration approvals ″without lawsuits″ versus ″with lawsuits″, it is possible to demonstrate that lawsuits reduce significantly the time for pesticide registration approval.

Notes:

⁽¹⁾ Pesticide registration processes that followed a regular queue and processes that underwent legal action/lawsuits to speed up toxicological and environmental evaluations (all of the processes)

⁽²⁾ Pesticide registration processes that did not resort to lawsuits to speed up toxicological and environmental evaluations

Sources: Anvisa, Ibama, MAPA; adapted by AllierBrasil

The increase of lawsuits continues in 2023. For 2024, the Joint Ordinance No. 3 may speed up pesticide evaluations, but its procedures are still under discussion by the authorities. In regards to the much-discussed Pesticide Bill, it is still too early to predict whether the project will reduce the time for registration, even if it is sanctioned in whole, without any vetoes. 

This and other topics related to agribusiness, environment, biologicals, will be subject of lectures at the 2^nd Agrochemical Tradeshow São Paulo 2024 organized by AllierBrasil.