Out of 168 registrations of Formulated Products based on Equivalent Technical Products, 60 resulted from legal action, meaning more than one-third of approvals.
This statement comes from Flavio Hirata, an agronomist and expert in pesticide registration, and a partner at the consulting firm AllierBrasil.
In Brazil, he notes, the largest and most attractive agrochemical market in the world, the product registration process is quite slow, taking over 12 years for the evaluation of generic or equivalent products (Formulated Product based on Equivalent Technical Product).
According to a survey by AllierBrasil (2023), of the 168 registrations of generic Formulated Products approved in 2022, 52.38% took 6 years or more for approval.
This approval time has remained stable for the past four years, being much longer in previous years.
For this reason, Hirata points out that the year 2022 saw a record number of pesticide registration evaluations through legal actions.
“Highlighting the companies Rainbow (13.4%), Iharabras (13.4%), Adama (7.5%), Perterra (7.5%), and Syncrom (7.5%), which together accounted for 49.3% of legal actions, or 33 processes out of a total of 67, including all Chemical Formulated Products,” notes the expert.
According to him, the registration of Equivalent Formulated Products represented 90% of legal actions, or 60 out of 67 actions, with 24 mixtures of active ingredients against 43 isolated products, totaling 27 active ingredients.
No legal action was found related to technical products registered in 2022.
“The majority of actions had Anvisa and Ibama as defendants, 71.79%, while for only Anvisa or Ibama, the percentage was 28.21% of actions. The survey did not investigate actions against the Ministry of Agriculture,” emphasizes Hirata.
According to the unpublished report “Judicial Action, Decision by Federal Court – 2022,” prepared by AllierBrasil and Mazza & Manente de Almeida Advogados, not all legal action requests are successful, especially in obtaining injunctions, by the Judiciary.
Some Courts have a higher number of approvals, while in others, the appeal to the second instance is more frequent.
“In the same survey conducted by AllierBrasil (2023), when comparing the time for approval of registrations ‘without legal action’ versus ‘with legal action,’ it is possible to demonstrate that legal action significantly reduces the approval time,” states the expert.
“In 2023, there was a continued rise in companies turning to the court system and an uptick in the number of lawsuits being filed. For 2024, Joint Ordinance No. 3 may expedite the evaluation of registration processes, but the procedures are still being discussed by the authorities. Regarding the much-discussed Pesticide Bill (PL No. 1,459/2022), it is still too early to predict whether the project will reduce the registration time, even if it is fully sanctioned without any veto,” he concludes.
