On May 11, 2016 the Brazilian government published Decree No.
8,772, which regulates Law No. 13,123/2015, related to the access
of components of the Brazilian genetic heritage, protection of and
access to associated traditional knowledge and the sharing of
benefits for the conservation and sustainable use of Brazilian
This law defines genetic resources as "information
of genetic origin resulting from plant, animal, microbial species
or species of other nature, including substances derived from the
metabolism of these living beings," while traditional
knowledge relates to the "information or practice of
indigenous peoples, traditional communities and traditional
agriculture on the properties or direct or indirect uses of genetic
Decree No. 8,772 lists the following activities as being
subjected to the requirements of Law No. 13,123/2015: I) access to
genetic resources or associated traditional knowledge; II) shipment
abroad of genetic resources samples; and III) commercial
exploitation of finished products or reproductive material (plant
propagation or animal reproduction material of any genus, species
or cultivation resulting from sexual or asexual reproduction)
obtained from access to genetic resources or associated traditional
knowledge performed after the entry into force of Law No.
As we reported
previously in this blog, biodiversity Law No. 13,123/2015
revoked Provisional Measure No. 2186/2001, aimed at fighting
against biopiracy by ensuring that Brazilian indigenous communities
received enough compensation for scientific research involving
genetic resources of Brazilian biodiversity and traditional
Provisional Measure No. 2186/2001 was criticized as being
excessively bureaucratic, since it required prior authorization for
the access to national genetic resources or associated traditional
knowledge, which required the submission of documentation and
reports to the Board of Management of Genetic Heritage (CGEN),
causing delays and high costs for applicants.
Law No. 13,123/2015 established that access to genetic resources
must be requested through an electronic registry in a database,
which has been established by Decree No. 8,772 as the National
Genetic Heritage Management and Associated Traditional Knowledge
According to the Regulations set forth in Decree No. 8,772, the
registration in the SISGen must be done prior to: the sending of
material abroad, the application for any intellectual property
right, the marketing of intermediate products or the dissemination
of results in, for example, a scientific paper.
The new Regulations also establish the sharing of benefits
resulting from commercial exploitation of a finished product or
reproductive material resulting results from access to national
genetic heritage or associated traditional knowledge. The decree
specifies that the benefits can be a monetary or non-monetary
compensation, such as the launching of projects for conservation
and sustainable use of biodiversity or for the protection and
maintenance of knowledge, innovations and practices of indigenous
peoples, traditional communities and traditional farmers.
Additionally, Decree No. 8,772 clarifies that micro and small
companies, as well as traditional farmers and individual
entrepreneurs are exempt from benefit sharing.
The access to genetic resources or to associated traditional
knowledge (and the commercial exploitation of finished products or
reproductive material obtained therefrom) performed before June 30,
2000, are not subject to the requirements of Law No. 13,123/2015
and Decree No. 8,772/2016.
However, Decree No. 8,772/2016 has set a term of one year from
the establishment of the SISGen for the activities listed above
that were carried out under the previous legislation (Provisional
Measure No. 2186/2001) to be adjusted to the provisions of the Law
No. 13,123/2015. Additionally, in order for patent applications
filed while Provisional Measure No. 2186/2001 was in force to
comply with the new legislation, applicants will have to file a
SISGen registration or access authorization receipt.
The Brazilian National Sanitary Surveillance Agency (ANVISA) published Resolution No. 102 issuing new rules for the transfer of marketing authorizations of cosmetic, drug, tobacco, agrochemicals and health products...
Medical devices are any instrument, apparatus, application, material or article, including software, used by themselves or in tandem, and defined by the manufacturer to be used directly on human beings.
The primary legislation for the advertising of medicinal products is the General Health Law (Ley General de Salud) (HL), and its Regulations (Reglamento de la LGS en materia de Publicidad) (HLR).
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