2017 was a record year in agribusiness in Brazil. The bumper crop emerged as a pillar of the economy, exports of agricultural commodities and 405 approved registrations of agrochemicals by the Ministry of Agriculture far exceeded the 277 of the previous year.
The agrochemicals market in Brazil is one of the most concentrated in the world, and product registration has long been the biggest barrier to access. Taking into account the damming of the registration evaluations, the litigant companies followed several paths in order to have their registrations approved more quickly, ranging from lawsuits against the regulatory agencies, mainly ANVISA; political actions; lists of phytosanitary priorities; and, more recently, public consultation through the Chamber of Deputies - something unheard of until then, whose developments must occur during the course of this year.
Source: Ministry of Agriculture of Brazil.
The number of technical product registrations for tebuconazole and flutriafol, which total 32, is surprising. The market for these products has fallen dramatically as a result of the effectiveness of Asian soybean rust control, which has resulted in the exclusion of recommendations for control of this disease, but which may be a tool in mixtures with other products of different chemical groups.
Approved TPEs registrations such as thiamethoxam (13) and imidacloprid (7) from the neonicotinoid chemical group listed on reassessment by IBAMA, the regulatory agency responsible for the environment, have been evaluating their formulated products suspended for more than 5 years. Fipronil is the next active ingredient that will go into re-evaluation soon. With the approval of the processes of fipronil technical, a race begins for the approval of the respective products formulated with IBAMA, before the beginning of the revaluation, once after that, the evaluations of the processes will be suspended for a not determined period. This procedure has directly benefited companies that already have approved registrations, such as Syngenta, the sole holder of registrations based on thiamethoxam, with 24 formulated products.
Whereas acetamiprid is also of the same neonicotinoid chemical group and is not listed in the environmental revaluation, companies have focused on this product. There were 16 and 9 technical products and formulated products approved respectively. Based on the number of TPEs, an even greater number of formulated products should be expected in the coming years.
Generally speaking, generic product companies were the ones most approached with approved registrations. Also it is not possible to specify the sponsors of all the registrations, since many processes are under the ownership of consulting firms, such as AllierBrasil, for example, that on its behalf has 31 approvals, plus the processes on behalf of its clients, which make up the total of 36 approved registrations. Of the total of 405 approved registrations, approximately 25% are among the 10 largest companies in the industry.
More approved registrations tends to increase competition, which does not necessarily mean lower end user prices. This was identified in the AllierBrasil report "Brazilian Imports of Agrochemicals", where it was found that local distributors of glyphosate WG from China, for example, imported products from the same supplier in the same period, with price difference of up to 10%, which for glyphosate is quite sensitive.
All efforts are used to access one of the most attractive agrochemical markets in the world. Legal actions against regulatory agencies, which in 2017 had more than 100 judged based on this appeal, aims to anticipate the evaluation of the registration process. The evaluation of the process itself does not guarantee; however, the approval of the same, as reported in the report "Legal actions against regulatory agencies - Agrochemicals" prepared by AllierBrasil. Not infrequently, some lawsuits are dismissed. If, on the one hand, costs can be considered high, between US$ 20 thousand and US$ 40 thousand, this is compensated by the possibility of accessing the market within a few months after the judicial decision. Several companies, such as ALTA, AVGUST, BRA, CROPCHEM, IHARABRAS, SUMITOMO, among others, have used this legal instrument.
Another tool that expedited the evaluation of some processes were the phytosanitary priorities established by the Ministry of Agriculture. This procedure indicated as a priority some trademarks, instead of the active ingredients, benefiting only some companies. This means that, regardless of the date of the submission of the trademark chosen, the process goes to evaluation not taking into account the principle of anteriority. It is expected that another list of priorities will be published in 2018.
The record in registration approvals in 2017 does not decrease; however, the liability of the number of processes for evaluation. Only in the last quarter of 2017 more than 90 TPEs registration processes were filed. In addition, the number of processes filed is much higher than those approved.
The next steps in the regulatory area of agrochemicals are uncertain. There is a trend that companies that already have approved registrations are more benefited, that is, those that are already established in the market, as is the case of the cloning registration regulation recently approved by ANVISA. According to this new rule, the evaluations of the "clone-like" processes are streamlined, strengthening the companies that already have approved registrations, allowing the registration of several clones, and from there choose the more distributors as possible to commercialize their products, while other competing power companies that do not yet have approved registrations should wait between 6 and 10 years in the queue for evaluation.
The cloning regulation of ANVISA is a complex subject with several implications. Clones can become a big triumph in this battle of product registration and market access. To discuss this issue AllierBrasil is organizing the seminar "Pesticide Cloning Registration in Brazil, Regulation and Opportunities to Market Access" in Shanghai in March.
Very important actions that streamline registration approvals, or at least not to slow, often do not have the necessary attention of sponsors and / or registrants. The choice of suitable laboratories, adequate review of the tests and documents presented, delay in sending documents by the sponsor, and inconsistencies of any kind make a big difference in the result. There are cases of delays in the findings of assessments in more than 5 years as result of inconsistencies in the dossiers submitted, but may also lead to the rejection of the registration.