Análise crítica da legislação relacionada ao acesso à biodiversidade e repartição de benefícios e suas implicações na inovação biofarmacêutica

Abstract

The biodiversity has an important role for a countrys economy and it can be explored as a raw material for different industrial sectors or as information coming from biological resources. On the other hand, Biotechnology is recognized as a potential innovation source, whose products and processes are important tools for Brazils economic and industrial development. Public and private companies have interest on the many biotechnology applications, especially on health area, and the pharmaceutical industry is a pretty consistent example of this. An interesting way of exploring R&D on pharmaceutical area was to link technical biotechnology knowledge and biodiversity to develop new medicines. The biological diversity conservation became an internationally public discussion subject from 1980s mainly. The most expressive discussion happened in 1992, during the Rio 92, or known as United Nations Conference on Environment and Development, when the Convention on Biological Diversity (CBD) was established, which is the first international agreement on conservation and sustainable use of biodiversity. Brazil is one of its current 168 signatory countries. The CDB decisions became part of Brazilian legislation through Medida Provisória MP nº 2.186-16/2001. Its first edition was timely created in a context of biopiracy threat and, although it had 16 editions, the MP still presents unclear concepts and many gaps. This law has great influence over national R&D and countrys technological development and, because of the problems cited, people support that the access to genetic resources legislation is an obstacle for research development and, consequently, for the innovation in Brazil. The aim of this work is to analyze the legislation about access to genetic resources and benefits sharing, to highlight its fail points, how they interfere on R&D and innovation and propose solutions. The present study makes an analysis about the concepts presented by the legislations, as well the access authorizations process to genetic resource for scientific research, bioprospection and technological development, authorized by CGen and CNPq. Finally, using data from INPI, it was evaluated if the legislation is equally applied to national and foreign researchers and companies. It was found that the MP really has some mistakes regarding the biological concepts, which raise to misunderstanding and ambiguity. The other legal instruments, although developed trying to better explain them, still let many gaps. The slowness on CGens authorization access deliberations for bioprospecting and technological development interferes negatively on countrys scientific and technological development since it interferes directly on patents examination. This scenario interferes on patented technology transfer. Therefore, its urgent and necessary to provide a new law that substitutes the MP and restructure all the legislation of access to genetic resources and benefit sharing.