In February 2015, the Brazilian law has been approved by the Deputy chamber and sent to the Senat for its approval on April 14th.
The main changes of the Brazilian framework compared to the previous text are the following:
- Prior authorization will be done electronically instead of passing by the CGEN;
- Benefit sharing arising from the use of the genetic resources will be monetary or non-monetary based on at least 1% of the annual benefits created by the commercialization of the finished products. It could be reduced to a minimum of 0,1% depending on sectoral negotiations.
- However, this aspect has been strongly discussed at the Senate. At the beginning, this would have been applied to accessed genetic resources that were key to the value of the finished product, but after the debate at the Senate, they modified the article to broader the scope to every genetic resources that enter into the composition of the finished product. Read more about the Senate discussion here.
- Benefit sharing arising from the use of traditional knowledge will be different whether the traditional knowledge has an identified origin or if it is the traditional knowledge is identified as spread.
- In the case of identified origin, the benefit would be negotiate freely between the user and the owner(s), but it should reach at least 50% of the amount shared for the use of the genetic resources. This benefit should be monetary and paid to a Fund created by the identified owner(s) in order them to remunerate (if relevant) other owners.
- In the case of spread traditional knowledge (non-identified origin), the project regulation says that the benefit should be the same as the one applied for access to genetic resources and paid to the National Fund.
- However, it foresees that if you access the genetic resources and the traditional knowledge to the same entity (community, etc.), you won’t pay double as you would be exempt of paying the benefit for access of the genetic resources but only for the traditional knowledge.
- The monetary benefits raised through the use of genetic resources should be paid to the National Fund.
- Only the finished product manufacturers would be the one who would pay the sharing of benefits. However, the ingredient suppliers for whom the regulation applies, would need to be registered for the access purposes and would be checked based on this registration.
- With regards to fines and non conformity with the proposed regulations, the fine would of a maximum of 10 millions of Reais instead of 50 millions. It foresees, as well, depending on cases (e.g. access to genetic resources without prior authorization), to reduce the fine up to 90% of the original amount and the final valor would be payable as benefit sharing.
Read more about the proposed regulation here.
As on April 14th the Senate made some amendments to the proposed text, it should go back to the Deputy Chamber before being send to the Presidency approval.
Despite all these changes, some key questions remain as for other regulations:
- What is considered as a genetic resources?
- When could we say that the associated traditional knowledge is of non-identifed origin (i.e. spread)?
- How Brazil will ensure traceability of all Brazilian genetic resources that are part of finished products worldwide?