In 1992, during the UN Conference on Environment and Development (ECO 92), the Convention on Biological Diversity (CBD) was signed in Rio de Janeiro. As a signatory of the CBD, Brazil regulated its access to genetic resources and associated traditional knowledge through Provisional Measure (PM) No. 2186-16.

Such PM 2186-16 (a presidential decree not yet converted into permanent law, but having force of law) states the rules for the access to genetic resources and traditional knowledge when the purpose is to carry out scientific research, technological development or bioprospecting.

The PM establishes the Council for Management of Genetic Heritage (CGEN), the national authority responsible for coordinating the implementation of genetic heritage management policies.

In accordance with Article 31 of PM 2186-16, the applicant of a patent application which refers to a process or product obtained from samples of components of genetic heritage must specify the origin of the genetic material and/or associated traditional knowledge.

In order to comply with such rule, the Brazilian Patent Office issued Resolution 207/2009 which, briefly speaking, states that when an invention performed after June 30, 2000 resulted from access to samples of components of the Brazilian genetic heritage or associated traditional knowledge, a declaration disclosing the origin of the genetic material and the associated traditional knowledge, as well as the corresponding Access Authorization number, should be filed. 

The Brazilian PTO started issuing Office Actions during the examination of patent applications in the biotech, chemistry and pharma areas requesting such declaration.

If the invention does not involve the access to samples of components of the Brazilian genetic heritage or associated traditional knowledge carried out after June 30, 2000, a negative declaration should be filed.

Nowadays, there is no clear procedure established for requesting an authorization to access genetic heritage or associated traditional knowledge or how to share the benefits and profits obtained.

However, PM 2186-16 states that violation to its rules may be punishable by sanctions such as warning, fines and confiscation of products derived from samples of components of genetic heritage or associated traditional knowledge.

Based on this provision, the General Coordination for Environmental Monitoring –CGFIS from the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) began in April 2011 the second phase of Operation “Novos Rumos” for monitoring the access to genetic resources and associated traditional knowledge.

Unlike the first phase, in which sanctions were imposed to infringers searching to settle with the Council for Management of Genetic Heritage (CGEN), in this phase, the infringers who ignored the rules of access will be faced with heavier penalties.

Therefore, even though the need to develop forms of protection of genetic heritage and associated traditional knowledge has gained recognition in the last years, including the adoption of the Convention on Biological Diversity, a lot needs to be done to clarify the procedures involved in the access/use of such biological diversity in Brazil.