Brazil is one of the largest holders of biodiversity in the planet, and therefore it needs to keep holding a prominent position in the international scenario in regard to the sustainable and organized use of its genetic resources.

Although the concept of "genetic heritage" appears in article 225 of our Federal Constitution of 1988 and although the Convention on Biological Diversity of 1992 warded the subject off, the Provisional Measure 2186-16 plays a pivotal role as it became the crucial legal parameter in Brazil by virtue of the Constitutional Amendment 32 which made that Measure legally enforceable.

It is important to identify and understand the barriers and obstacles to the development and exploitation of such heritage.

The difficulty to interpret what is access to the genetic heritage; the requirement for the Public Authorities' prior authorization for access and collection; the requirement for previous consent of the owner of the area or place involved; and the requirement for sharing and fair and equitable division of the benefits arising out of the access, are illustrative examples of points in the legislation that generate not only doubts to those that intend to carry out research but also legal uncertainty to transactions, and, consequently, affect the technological development and innovation based on the use of the genetic heritage.

Currently the authority that essentially grants prior authorizations is the CGEN ("The Genetic Heritage Management Council").

We may understand, also under the technical guideline drawn up by the CGEN, that collection differs from access because access refers to the molecular level where the intent is to isolate and identify genetic data of an organism. Collection is the simple action of removing, expurgating or obtaining the organism in situ conditions.

Another controversial requirement is the prior consent of the owner of the involved area or place to the access. How to know in advance which is the place where the research will be conducted and the material will be collected?

As it is not possible to expect an exercise in futurology from the companies or interested parties, such requirement increases the cost of the transaction because it causes the need for multiple comings and goings from and to the place of the access to confirm if the area is the correct one and if it is adequate for the research.

In any context of innovation, ineffective and costly bureaucratic procedures inhibit the exploitation and development of creations and inventions by individuals.

Added to the ineffectiveness generated by the uncertainties in the rules laid down is the fact that the Provisional Measure ensured the owner of the area the right to be a party to a contract on use of genetic heritage and sharing of benefits.

This contract is a bilateral instrument between the party interested in accessing the genetic data or information and the provider that may be, among others, a community that has the possession of the genetic data or a traditional and special knowledge, which parties will share with the government the division of the benefits.

According to the Provisional Measure, in particular in regard to access for future commercial purposes, the fair and equitable distribution of the benefits must be provided for in such contract.

The lack of parameters for the understanding of "fair and equitable division of the benefits" creates in practice endless discussions and questioning between all those involved. Added to this is the enormous possibility of a mistaken identification of the owner of the accessed area, as controversies between communities over the ownership of a given area or even a given traditional knowledge associated with genetic information are quite common.

So many are the uncertainties that a potential investor or interested party will be likely to face that we should stress the role of the industrial property in the interaction with the Provisional Measure. Without understanding the balance between the intellectual property and the environment, we will incur the risk of hindering the scientific development based on political premises or malicious intents.

Article 8, paragraph 4, of the Provisional Measure 2186-16 establishes that "the protection ensured hereby will not affect, infringe or restrict intellectual property rights".

However, which is the level of interrelation and autonomy of the intellectual property rights, in particular those of industrial nature, in regard to products generated by access to genetic heritage under the Provisional Measure no. 2186-16?

The issue is controversial as it automatically polarizes two large groups: the group that holds the resource and the traditional knowledge and the group composed of more developed countries that intend to effectively use such assets/resources to develop new products and processes.

Even with the different legislations worldwide, concerning applications for patents abroad, it is consistent to conclude that those for the patent of a product or process in another country will be granted it if all requirements set in the industrial property law of such country are met.

Thus, it is coherent to understand that not rarely may be it possible to identify in other countries patents applied for by, and granted to, foreign companies whose subject resulted from past activities (at the beginning of the prospection and/or the field or scientific research) related to the use of, or access to, genetic material or traditional knowledge obtained in other countries.

How to regulate situations as that one described above remains a challenge, as it also affects the sovereignty of the countries.

Notwithstanding all challenges, aligning the principles of the Convention on Biological Diversity of 1992, the cultures of all participants, and the interests of each member state in the matter of the industrial property with a uniform legislation on the use of the genetic heritage and associated traditional knowledge will bring modernization and important changes that will benefit the whole community involved.

A correct creation and interpretation of uniform rules and their application to this area must be part of a strategic policy for the sustainable development of the world community.

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