 |
In
1986, several small businessmen dedicated to agricultural agrochemicals
decided to found an organization to help them with the registration
of their products at the Ministry of Agriculture and represent
their views in the areas of industrial and economic policy.
Thus was born the Association of National Agrochemical Companies,
called AENDA for short. Other companies soon joined this first
group, consolidating and developing this associations’s
activities. |
AENDA is the principal
organization which pushed for registration by equivalence and this
concept totally changed the agricultural pesticide market in Brazil.
The fight to more rapidly implement registration by equivalence continues
because the evaluation of technical and formulated product dossiers
is still considered to be slow.
AENDA is an information
source for its members in real time and a place where the producers
of generic domissanitary and agricultural pesticides meet to discuss
their problems
AENDA, together with like
organizations, was co-responsible for the very successful Brazilian
programme for dealing with empty pesticide packaging; and is now active
in the question of the reevaluation of active ingredients, fighting
for the adoption of rational criteria which consider product cost/
benefit and the interests of the farmer.
AENDA, thoughout
the years, has been strongly involved in many different questions,
whether they be federal or state regulations, product application
and use, tributes and taxes, the patents’ system, import procedures,
etc., it being the forum where the producers of agricultural pesticides
and domissanitary products will find support for its problems and
claims and will act as a spokesman for this group before government
institutions.
| 1st
DECADE (1986 to 1996) |
These years were
marked by the environmental movement and noisy opposition to agricultural
pesticides. The country assimilated this new tendency to defend the
environment and founded IBAMA – The Brazilian Institute for
the Environment and Renewable Natural Resources, and under its orientation
Law 7.802 was written and promulgated in 1989, creating the term “agrotoxic”.
From this point in time, an overwhelming wave of environmental and
eco-toxicological norms, hurriedly and in a disorganized fashion,
resulted in the present legislation and caused a strong impact on
the business community since the demands and studies requested were
completely unknown in Brazil. Obviously, the smaller companies suffered
the most.
In this new environment, AENDA had a very important role, which included:
Convincing and stimulating Universities and Research Centres of the
need to carry out research and develop services in the areas of environmental
toxicology to give Brazil its own knowledge bases. It is worth noting
that the reaction was rapid and various centres started to deal with
a large demand generated by product registration. Private laboratories
were created later and, today, these are well-known in pesticide toxicology.
Besides these
worries and the costs necessary to fulfill these new norms, the members
still had to race against time because of the product “renewal”
date, a concept inherited from the old legislation. Many products
would be cancelled because of this. It was AENDA which first fought
for the end of “renewal”, under strong opposition from
IBAMA and the indifference of other sector organizations. The Association
appealed for the intervention of the Federal Attorney General and
the “renewal” was stopped.
Closing ranks
with other class and business organizations, such as AEASP, ANDEF
and SINDAG, in support of a programme for receiving and dealing with
empty pesticide packaging, one of the biggest demands of the environmental
movement. At the beginning of the 90s, we financed, together with
ANDEF, a pilot project in São Paulo and later the organizations
created INPEV – The National Institute for Empty Packaging Processing,
with proportional funds from all the companies working in the area.
This solution for the community was fundamental in reducing tensions
and improved the dialogue between those involved.
Closely following
the newly-implemented norms by IBAMA, or by the MINISTRY OF HEALTH
or by MAPA. A high point was the abolition of the heavy registration
taxes illegally established by IBAMA since this was done through a
ministerial directive, Ordinance nº 84 of 1996. During 1997,
1998 and 1999, the members were free of these obligations until the
government agency reformulated the taxes through Law nº 9.960
at the beginning of 2000, and this is also presently being contested
by the association
Dedicating a
lot of effort to MERCOSUL, by supporting CIAFA, AENDA’s equivalent
in Argentina which proposed the introduction of registration by similarity
in the region, a concept largely accepted in developed countries.
The concept is expressed in the statement: “Same chemistry,
same effects”. Therefore, it guarantees quality and avoids the
onerous repetition of toxicological, environmental, agronomical and
residue dossiers. Unfortunately, Argentina adopted this concept but
Brazil did not until the end of the 90s. This lack of cooperation
between governments forced AENDA to drop out of its partnership with
CIAFA, while at the same time, a Resolution permitting the free circulation
of products within MERCOSUL had been approved and Brazilian businessmen
were at a significant disadvantage.
Intense debate
on tank mixes, since on the one hand the government wanted to define
rules and more tests for registration based on complaints from farmers
that agronomists could not issue the Agronomical Prescription because
these tank mixes were not described on the labels or inserts, and
on the other hand, the multinational companies who saw this as just
another obstacle for the generic companies. Based on regional research,
AENDA pointed out that this was not a subject for registration but
an international practice by farmers. Ordinance 67 was published in
1995, increasing the bureaucracy even more, which only permitted the
inclusion of a certain product mixed with another after the written
support by the registering company of the additional product. AENDA
began to denounce this “elitization” (which multinational
would permit the inclusion on its own brand label of a small or medium-sized
generic company?). In the second decade, AENDA’s opinion was
accepted.
Effectively participating
in the debates on state legislations created in the wake of Federal
Law 7.802/89. Mention should be made of discussions (and even judicial
proceedings in some cases) in Rio Grande do Sul, Paraná, Mato
Grosso, Mato Grosso do Sul, Espírito Santo, Minas Gerais, Santa
Catarina, Goiás and Rio de Janeiro.
| 2nd
DECADE (1996 to 2006) |
In the second
half of the 90s, the Ministry of Health set up ANVS – National
Agency of Sanitary Surveillance (later ANVISA), which incorporated
a series of activities and services of the Health Ministry. This agency
also started to emit directives and resolutions, increasing the registration
costs to unsustainable levels for small and medium-sized companies
and, once more, without distinguishing generic from new products.
Once again,
AENDA’s presence was of extreme importance through:
Forming a group
of associations when ANVISA was created by a Provisional Decree, and
coordinating an economic study which demonstrated to the government
the inequality of the registration taxes proposed (in our case, the
registration of household cleaning products and the evaluation of
phytosanitary processes). This group managed to get the authorities
to see sense and the subsequent Provisional Decrees incorporated a
discount for company size until the definitive law was promulgated.
Presentation to
the government and the community of the system of registration by
similarity, through advertisements, talks in the House of Deputies
and in the Senate, sending the academic community and various authorities,
various international opinions, the American legislation and FAOs
recommendations on the subject; as well as innumerable meeting with
Ministers, Executive Secretaries, Divisional Secretaries and Area
Managers of various government departments.
In
2000, the association managed to negotiate Resolution 104 with ANVISA,
which made the more expensive chronic toxicological tests unnecessary
for generic product registrations.
Also in 2000,
AENDA obtained support from the President’s Office, which issued
Inter-ministerial Ordinance 17 for revision of Decree 98.816/1990;
and coordinated the work so that the revision did, in fact, include
the fact of Similarity in the registration of generic products.
In 2002, this
intense fight was crowned with success with the publication of Decree
4074 which finally introduced into the Brazilian judicial regime the
concept of Similarity, under the denomination of Equivalency.
Still in 2002,
AENDA “negotiated” an agreement with ANDEF which allowed
the approval of Law 10.603, the Law of Proprietary Data, which was
fundamental for “unlocking” the Equivalency concept. The
concept of a New Chemical Entity (adopted in the TRIPS agreement and
“forgotten” in the Brazilian Patents Law) was established
at AENDA’s insistence and the new data added to a registration
dossier were only granted 1 year of protection and not the 5 years
proposed by LACPA (the international entity representing the multinationals).
Besides this, the Association managed to remove from the legal text
the system of financial compensation for the use of a dossier developed
by the company which had first launched a certain molecule into the
market, as had also been proposed by the LACPA.
Tank mixes: in
2002, the Government finally perceived that Ordinance 67/1995 on tank
mixes was an antidemocratic way of conducting registrations in this
case, as AENDA had been claiming, and revoked the registration of
products for tank mixes through Normative Instruction 46/2002.
In the period
between mid 2001 and the beginning of 2003, the Association was working
against the antidumping process involving GLYPHOSATE of Chinese origin,
promoted by MONSANTO and NORTOX. In spite of the wealth of information
presented by the members showing the inconsistency of the arguments
in favour of antidumping and the blatant injustice to the Brazilian
importers, the government imposed a 35.8% tax on imports from China.
However, AENDA’s actions through magazine and newspaper articles
and many meetings with Ministers and upper echelon civil servants
from various Ministries, left the government with the bitter feeling
of supporting a monopoly or duopoly for the principal pesticide used
in the country.
In
2004, AENDA carried out a detailed study on the competition of pesticides
in Brazil based on 2003 data. The study separated the products into
categories: no competition, low competition and good competition.
The Secretariat for Accompanying Economic Matters of the Treasury
Department became interested and AENDA made an incisive presentation
to the technicians of that Secretariat. The importance of generic
products was finally accepted by that Ministry.
Since the end
of the 90’s, AENDA has being working to solution the problem
of the lack of pesticide registrations for the so-called “small
crops” and the implications for the Agronomic Prescription;
this problem has been aggravated by the successive cuts in active
ingredients promoted by ANVISA in the monographies. AENDA considered
as a solution the extrapolation of the Maximum Residue Limits of the
most important crops to the less important ones, within “similar”
crop groups, as recommended by the Codex Alimentarius. This solution
was promoted and, finally, in April 2006, the authorities edited a
modified version of this model for public consultation.
In this decade,
AENDA started to promote its ideas through printed bulletins, called
AENDA-NEWS. This name was maintained until 2001, when the layout was
modernized and it was printed in 4 colors under the new name, AENDA
OPINION. These editorials, by focusing on a single theme and in a
hard-hitting style, made history in the sector, and, without a doubt,
stimulated change in the registration system, which provided the advance
of the generic pesticides.
In this decade AENDA created a service of price collection, under
the operation of the Agricultural Economic Institute of Agriculture
Secretary in São Paulo. More than a 100 of most relevant brands
in the market had their prices systematically monitored and published
in the press. Besides, AENDA created an index of “exchange ratio”
between the agricultural product value and the value of the technical
basket of chemicals used in culture. This tool for economists and
farmers covered Cotton, Coffee, Sugar Cane, Beans, Oranges, Corn and
Soybean. This wide index was an innovation among the economic-scientific
agriculture.
| 3rd
DECADE (2006 to feb.2009) |
In 1996 many important
companies, such as ATANOR, AGRIPEC/NUFARM, CHEMINOVA, MILENIA, HELM,
SINON, left AENDA without explanations. There are rumors saying they
were forced by sources interested in stop AENDA’s success, because
of the threaten of the market been taken by hundreds of other companies.
Due to this sudden fall on its budget, AENDA decreased its structure
and had considerably retracted its actions with Government and general
public.
In spite of this AENDA continue vigilant to defend the generic
products:
In 2006 AENDA worked for the consolidation of the Equivalence regime,
certain this is the solution for rescuing the right that the generic
firms have to increase their product lines and, consequently, increase
competition. It allied itself with farmers’ organizations –
CAN and OCB, and from this alliance Decree 5.981 was born in December,
coordinated by the Casa Civil (Presidential Staff) with the 3 Ministries
involved. The main objective of this Decree is to make the registration
process more agile and to introduce improvements for the Equivalence
system.
In May 2007, Agriculture
Ministry published Normative Instruction no 18 which definitively
settled a long dispute over the necessity or not of presenting agronomic
efficacy tests to register a generic product recommended for the same
uses as a pre-existing product. These tests are not necessary. Once
again, AENDA’s position was accepted: “the objective
of the Equivalence Principle, in this case, is that agronomic knowledge
be widened by the generic companies, which should give priority to
their efficacy tests for new uses, in order to differentiate
their products”.
In 2007, AENDA
was invited by Industry Federation of São Paulo State-FIESP
to integrate the Conselho Superior do Agronegócio (Agribusiness
Superior Consel), for its important services to the Agricultural Inputs
sector.
In 2008, AENDA
launched a monthly report which analyses Patent Requests in Brazil.
This document allows the associates acknowledge every patent presented
to INPI (Brazilian Institute of the Industrial Property) that could
not be considered as Novelty or even Activity Inventiveness. This
enable the associates contest any patent that could jeopardize their
interests.
At the beginning
of 2008, when should had finished the antidumping right against the
Chinese herbicide GLYPHOSATE imports, the Brazilian government decided
to analyze an request postponement of 35,8% penalty over the import
price. AENDA, once more, presented solid proves that such postponement
could not be justified anyway and technically supported. In spite
of, the government had established a value of 11,7% and commenced
to work in a revision process. After that, AENDA immediately demonstrated
a mistake in the calculus and the government had to diminish the antidumping
barrier to 2,9%. During the revision process, AENDA presented new
data to cancel the antidumping. In February 2009, the Government decreased
the penalty to 2,1%.
The history of Equivalence Registration System is already presenting
a relative success. By the end of 2008, the registration numbers were:
-- 88 registers of Equivalent Technical Products was based on 39 active
ingredients
-- 82 registers of “Equivalent Formulated Products” was
formulated with 26 active ingredients
-- Register requests of Technical Products which were being evaluated,
added more 36 at the 39 first active ingredients.
AMATEUR GARDENING – AENDA was the principal
instigator of the movement in favour of the registration of household
pest control products for flower pots and domestic gardens to replace
products with agricultural registration. From this arose Directive
322/1997, legislation which, besides regulating the registration of
these products in accordance with the Law of Medicine and Sanitary
Drugs, also permitted a more effective supervision of sales
DIRECTIVES
AND RESOLUTIONS – AENDA also effectively participated
in other important pieces of legislation through its dialogue with
the Government and other entities, as in the case of the Resolutions
on the GEL formulation and containers with a trigger-type mechanism.
HOUSEHOLD
PESTICIDE PRODUCTS OR AGROCHEMICALS – The association
had to really work hard so that household pesticide products were
not considered agrochemicals, as was wrongly established in Decree
4074/2002. Legal opinions were elaborated and distributed throughout
the various instances of Government. A solution to this case is still
pending, although, fortunately, household pesticide products continue
to be registered according to Law 6.360/1976, the Medicine and Sanitary
Drugs Law.
PROFESSIONAL
GARDENING – After the insistence of AENDA and ABAS
for various years to widen Amateur Gardening, ANVISA published Public
Consultation nº 46/2005, to regulate the registration and use
of products in parks, avenues, sports grounds and other typically
urban situations.
TAXES
ACCORDING TO COMPANY SIZE – As already mentioned in
the Chapter “The 2nd Decade”, AENDA coordinates a common
approach with other entities for the reduction of taxes. An economist
was contracted who surveyed the impacts in small and medium-sized
companies and the study convinced the Health Ministry to change the
rules by introducing discounts for company size.
BANNING
OF CHLORPYRIPHOS – Due to incidents with intoxications
in Rio Grande do Sul, the Public Prosecutor’s Office opened
a lawsuit involving ANVISA and the product manufacturers. AENDA took
part in the lawsuit in order to defend its members’ interests.
There were 2 years of struggle, with injunctions for and against;
innumerable hearings with ANVISA but the latter was forced to cancel
the product registrations for the household pest control area. The
judicial process is still pending.
POST-GRADUATE
COURSE IN HOUSEHOLD CLEANERS – AENDA and ABAS, with
the support of ANVISA and CRQ, organized the 1st Post-graduate Course
in Brazil in TECHNOLOGY OF HOUSEHOLD CLEANING PRODUCTS. The course
started in October 2005 and lasted for 18 months.
Integrant of Federal Ministerial and State Chambers and Thematic Committees.
DATABASE: Registration of Products, Registers in process, Alterations
in the Registers,
Legislations, Monographs, State Product Cadasters and Sectorial Politics
Data.
AENDA's NEWS REPORT (NOTÍCIAS DA AENDA): Monthly information
about the
pesticide sector in Brazil.
INTERNATIONAL PRODUCT NEWS (NOVIDADES EM PRODUTOS): Monthly report
about products on the world.
SIGNALS OF AENDA – YELLOW AND RED (SINAIS DA AENDA): International
news
about menaces to the products, including the revaluations activities
Courses promotion, Lectures and Technical Meetings.
Lectures accomplishment in the Parliament, Ministries, Universities,
Unions and Rural
Federations, Companies, etc.
Participation in Congresses, Seminars, Fairs and Several Events.
Constant interaction with others entities.
SITE www.aenda.org.br, with
some pages:
*
Who we are
*
Companies associate list
*
Papers (AENDA during the year publish some papers in defense of the
generic)
*
Competition (list of all registered products classified by its market
offer)
*
Prices (Link with Research Institutes that collect Formulated Products
prices)
* Products
(Catalog of all products registered according to its use)
*
Equivalence (chronological table of all Equivalents Technical Products
registered and their
derivative Formulated Products)
*
Legislation (Main legal Acts regarding Agrochemicals and Indoor Products)
*
Packages (It shows educational folders and lists by State every point
to return empty
packages)
*
Link’s (it shows other websites related to the sector)
*
Contact us
