Banca de DEFESA: LARISSA PIEROZAN
Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.STUDENT : LARISSA PIEROZAN
DATE: 08/12/2025
TIME: 10:00
LOCAL: https://meet.google.com/xnh-ckbf-vjz
TITLE:
“AGRO É POP, AGRO É TECH, AGRO É TUDO”: an analysis of the protection of test data submitted to government entities for approval of the marketing of pesticides.
KEY WORDS:
Pesticides; Intellectual Property; Undisclosed Information.
PAGES: 129
BIG AREA: Ciências Sociais Aplicadas
AREA: Direito
SUBÁREA: Direitos Especiais
SUMMARY:
Test data protection is crucial for organizations that develop products that require state approval for commercialization. Their protection originates in the chapter on confidential information under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). At the national level, protection is ensured through the prohibition of unfair competition, specifically against the disclosure, exploitation, or use of such data without the authorization of its holder (art. 195, XIV, of Law 9,279/1996). The scope of this protection is debated in relation to the commercialization of generic products, which may obtain registration through a simplified procedure by demonstrating equivalence with the reference product that submitted the complete test data. In the area of pesticides, legislation provides for an exclusive use period for the data submitted for the approval of these products. Thus, third parties seeking to register a generic pesticide must redo the tests if they do not have authorization from the holder of the reference pesticide during the protection period. Although there is literature on the protection of test data for pesticides, it limits itself to presenting the legal aspects of the protection granted. In this context, several questions arise: how is test data protected? Are all data protected? Can they be made public, and if so, by what procedures? How is their confidentiality ensured? How do organizations make use of these test data? Do they use them beyond their function as a requirement for registering a pesticide? Therefore, the objective of this research is to understand how test data submitted to government entities for the approval of pesticide commercialization in Brazil are protected, while also investigating the economic and strategic value of these data for the organizations that produce them. To achieve this objective, a qualitative and exploratory approach was adopted, developed in two stages: (i) data collection, through documentary research and semi-structured interviews; and (ii) analysis and interpretation of the collected material. Law 10,603/2002 provides for the protection of test data; however, it contains open-ended terms, requiring regulation regarding its implementation. It was concluded that there is a lack of internal rules within government entities for applying the legislation and for formalizing consolidated understandings among the three entities involved. This is particularly true for the Ministry of Agriculture (Mapa), which is the entity with the fewest relevant documents on undisclosed information. Despite this, European resolutions provide non-exhaustive lists of what may or may not be considered confidential information, which may serve as guiding principles. A lack of definition was identified concerning the procedures to be adopted for disclosing protected information when necessary to safeguard the public. Nonetheless, there are initiatives by government entities to disclose information once the protection period ends. Finally, these test data hold importance beyond being a requirement for obtaining registration; they may impact decision-making processes, such as in public policy formation. Thus, there is a clear need for further studies and governmental actions regarding undisclosed information.
COMMITTEE MEMBERS:
Presidente - KELLY LISSANDRA BRUCH - UFRGS
Externa à Instituição - CLAUDIA INÊS CHAMAS - Fiocruz - RJ
Externa à Instituição - PATRICIA DE OLIVEIRA AREAS - UNIVILLE
Externo à Instituição - DANIEL ALVES LEASTRO