In order to present and deepen a discussion on the legislation that governs the use of the Brazilian genetic heritage, researchers from Escola Bahiana de Medicina e Saúde Pública participated, on September 4, at Campus Cabula, in the seminar "The Impacts of the Biodiversity Law on R&D Activities and SisGen in practice", given by the advisor of the Vice-Presidency for Research and Biological Collections (VPPCB/Fiocruz), Aline Moraes.
Considering that the debate on the subject is important and necessary, Fiocruz has held several meetings for training and understanding of the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SisGen), as well as dedicated efforts to raise awareness of the units and their researchers on the Biodiversity Law (Law 13.123). SisGen is the electronic system that should be used by all researchers to register and authorize their activities. Failure to comply with the practices imposed by the Law results in high fines for the institution carrying out the research.
During the morning shift, a Fiocruz speaker presented Law 13.123/15, which came into effect since November 17, 2015, when he detailed each step of the aforementioned standard and the actions to be taken according to activity and responsibility, such as, for example , clarification on the registration of projects in SisGen, information on access to genetic heritage and on the Associated Traditional Knowledge (CTA), the difference between sending and sending material, the participation of foreign researchers, the sharing of benefits, among others.
In the afternoon shift, the researchers participating in the seminar had the guidance of Aline Moraes to get to know, in practice, SisGen and how to carry out the registration of projects.
The new law determines that projects carried out from June 30, 2000 to November 17, 2015 are registered, even if they have already been completed, and that projects that started before that date and are still in progress, are also registered. For the researcher and coordinator of NUPI, prof. Dr. Amancio José de Souza, the greatest difficulty that the Bahiana will face at this time will be to map the projects that really need to be registered, including those of researchers who continue in the Bahiana and those who are no longer at the institution, but who carried out research there. Another point to which he draws attention is the deadline, on November 5, which he considers to be another obstacle for people who do research. "We will articulate the entire capacity of the research network of the Bahiana – from the Dean of Research and Innovation and Extension to its various nuclei, including the legal nucleus, to give legal support to us and to our network of partners, such as Fiocruz. This committee does not intend to have a formal character, as we need it to work quickly, having the function of: contacting as many researchers as possible from the Bahiana; support people who are interested or need to register their projects and who are having difficulty, and help these researchers to define whether their projects are eligible for registration or not".
According to Aline Moraes, at this time, researchers must pay attention to the regularization of liabilities, mainly to research and bioprospecting activities that were carried out between June 30, 2000 and November 17, 2015, and also to the surveys carried out in 2015 until SinGen starts operating in 2016, as the deadline is November 5, 2018. "Researchers should also pay attention to patents. The requirements that are issued by the INPI (National Institute of Industrial Property) and the regularization of these projects to which these patents are linked, so as not to run the risk of losing these patents", says Aline. She says that the drafting of the new law was discussed and entered into public consultation, with contributions being sent: "If, on the one hand, the new law has improved in the sense that prior authorization was required and today there is only one registration, that is, a simpler procedure that can be done after starting the research activity, on the other hand, the very functioning of SinGen makes it difficult to complete". According to her, the greatest difficulty for researchers is to understand if they are within the scope of the law and register these projects in this unfriendly system. "Our expectation is that, with the new version, these problems will be resolved."