Safeguarding Biodiversity in South America – the Case of Brazil
by Moeller IP Advisors
From Amazonia to the Tropical Andes, the biodiversity of South America is incredible. It is not surprising to notice that many cases of biopiracy concern the natural resources of this continent. In 1986, American scientist Loren Miller’s patented the process for obtaining the ayahuasca vine, despite it had been known for centuries by the indigenous communities of the Amazon Rainforest. In 2000, the US company Pure World Botanicals filed and obtained 4 patents on the maca plant, that the indigenous communities of Peru already used for its medicinal qualities. More recently, a Japanese company patented a process to refine cupuaçu, a fruit similar to cocoa, that grows in the Brazilian Rainforest. How to protect South American genetic diversity and give space, at the same time, to the necessary scientific development?
Brazil Biodiversity Law
Brazil, one of the countries whose natural resources were the most exploited, tried to fight biopiracy by enacting a series of extremely strict rules contained in the Provisional Measure N. 2186/2001, aimed at limiting the use of native genetic materials. A new body, the Genetic Heritage Management Council – Cgen was created by the Ministry of Environment to deal with the implementation of the measure.
The old legislation provided that the access to the genetic resources had to be granted by the Federal Government, however, the authorization procedure could take up to a year. Unauthorized activities were fined by the Brazilian Institute of the Environment and Renewable Natural Resources and as a result, several patent applications were halted because of unpaid fines. The law also prevented Universities from effectively accessing the patrimony as any research performed without the previous authorization of the Genetic Heritage Management Council was deemed illegal.
Moreover, the rules failed to effectively compensate the indigenous communities for the use of the resources.
According to the new Biodiversity Law and the decree 8.772/2016, researchers, R&D bodies and national public or private companies, which intend to access the genetic resources or the traditional knowledge associated with them in order to develop new products, just need to register in an electronic database called the National System for the Management of Genetic Heritage (SISGen), without the need of a prior authorization.
Foreign companies can only apply if they are associated with Brazilian R&D private or public bodies as stated in Art. 12, inc.II. The registration has to occur before any disclosure of partial or final results of the research, before applying for any intellectual property right on those resources, and in a series of other cases as well. Currently, the SISGen is not yet available – as it was still under test as of April 2017;
The Environmental Ministry has stated that companies which have obtained an authorization under the PM 2186, will have a period of one year to complete their registration, from the publication of the SISGen.
Moreover, when a company accesses the traditional knowledge associated with the resources, it needs to obtain the prior consent of the relevant communities. If the company intends to commercially exploit a product which has been developed by accessing natural resources or associated traditional knowledge, it will need to reach a Compromise Agreement with the Ministry of Environment, notify the Brazilian authorities and then register it within the SISGen.
The Biodiversity law also creates the National Benefit Sharing Fund (FNRB) linked to the Environmental Ministry and states in art.20 and 21 that the Fund will collect between 0.1% and 1% of the revenues coming from the commercialisation a product manufactured from Brazilian genetic resources. According to article 24, when the revenues come from products which have been developed using traditional knowledge, they will be shared with the indigenous communities, on the basis of a mutual agreement.