**6. Regularization and conservation: Brazilian biodiversity law**

Biodiversity refers to the extent of a variety of resources within a natural system encompassing an extensive range of plants, animals, and microorganisms, as well as the genes they contain and the ecosystems that are made up of them. Biodiversity includes genetic differences within each species and the variety of ecosystems. In each ecosystem, living things form a community, interacting with each other [73]. The Earth possesses a unique feature: the possibility for life to exist. Millions of people and millions of other organisms such as plants, animals, protozoa, and fungi inhabit planet Earth. It is a fact that human actions have contributed to the devastation of biodiversity at a worrying rate. This loss of biodiversity affects the functioning of ecosystems and the ability to provide resources to society. In recent years, remarkable progress has been made toward understanding how biodiversity loss affects society and encouraging sustainable development [74].

The use of the term biodiversity first occurred in the 1980s, in a scenario of scientific-political initiatives impacting society for the richness of life on Earth and for issues aimed at environmental conservation. It emerged officially in 1992 and was formally enshrined in international policy when the United Nations Convention on

Biological Diversity (CBD) came into force in 1993. Brazil has competitive advantages over other countries of the globe in relation to its biodiversity, which allows the development of science and technology from research with its natural resources. Brazil, in turn, stands out in the creation of norms and public policies with the purpose of guaranteeing scientific prosperity based on sustainable development. Thus, Law No. 13.123/2015 has as its main objective to minimize the bureaucracy regarding access to genetic heritage and associated traditional knowledge. Law 13.123/2015, also known as the Brazilian Biodiversity Law, and its regulations are some of the instruments used by Brazil to achieve the goals established by the Convention on Biological Diversity (CBD), also relating to the Nagoya Protocol. These legal frameworks establish guidelines for access to biodiversity and associated traditional knowledge. In other words, it establishes the guidelines and recommendations for commercial relations between the country that provides genetic resources and the one that will eventually use these resources [75].

CBD was the first global treaty on biodiversity that came into force in 1993 and was ratified by Brazil in 1994. CBD provides for the need for a benefit-sharing mechanism and control of access to genetic heritage, guaranteeing nations' autonomy to deal with access to their genetic heritage. But points out that it would be unfair for the holders of this heritage not to obtain any kind of return on the commercial exploitation of their resources. The Nagoya Protocol was created by the CBD at its tenth meeting, which took place in 2010 in Nagoya, Japan, and came into force in 2014. Brazil ratified the Nagoya Protocol in 2021, joining 130 other countries [76].

**Figure 4.** *Legal requirements related to sustainable development practices.*

## *Alginate Extraction from Natural Resources Based on Legal Requirements: An Incentive… DOI: http://dx.doi.org/10.5772/intechopen.114217*

Law 13.123/2015 on access to Brazilian Biodiversity regulates the conduct of research and development with species originating or belonging to the Brazilian biodiversity and the sharing of benefits arising from this access. This Law has its origin associated with the most important international treaty for the protection of biodiversity, the Convention on Biological Diversity. Through Provisional Measure No. 2.186 of 2001, Brazil was a pioneer in regulating the rights and obligations associated with access to genetic heritage, associated traditional knowledge, and benefit sharing with respect to biodiversity. In order to legally facilitate access to genetic heritage and reduce bureaucratic obstacles to research and technological development, the Provisional Measure (which was in force since 2001) was replaced by Law 13.123/2015 [77]. **Figure 4** presents the interaction between the use of species belonging to Brazilian Biodiversity and legal requirements.

## **6.1 Biopiracy**

Biopiracy is characterized by the unauthorized use of biological resources and traditional knowledge belonging to other countries and their local and indigenous communities without sharing revenues obtained from the economic exploitation of these resources [78, 79]. Biopiracy is not just limited to medical development; it also happens in agriculture and many other industrial sectors. It occurs when researchers or development and research institutions access biological resources without official sanction, mostly from less developed countries or countries that do not have environmental laws for such activities. It is, therefore, a practice against sustainable development and against the genetic heritage of the country. The associated traditional knowledge has been used as a contribution to the pharmaceutical, phytotherapy, cosmetic, and agricultural and biological pesticide industries, among others. Protection of associated traditional knowledge has the potential to improve the performance of the economies of many developing countries by making their biological wealth

**Figure 5.** *Harms related to the practice of biopiracy.*

more commercially available and increasing exports of traditional knowledge-related products. This knowledge is the heritage of indigenous and local communities that are being exploited on a large scale without making a share of the profit [73]. Thus, this exploitation of genetic heritage linked to communities' traditional knowledge is often used in ways that result in biopiracy. **Figure 5** provides a brief description of the biopiracy process and possible damage caused to the country of origin of the species.

The practices of biopiracy, are businesses that can involve millions. In this sense, Brazil is one of the biggest targets of biopiracy, due to the interest of other countries in its vast biodiversity. A lot of companies and developed countries make huge profits using the biological properties of native and endemic plants from developing countries; on the other hand, they get nothing in return. The damage and inconvenience that the country is subjected to, related to the practice of biopiracy, knowledge, and bioproducts, until 2017, were evaluated in losses of R\$33.3 billion per year. These losses would be linked not only to the illegal trade in plants and animals but also to the monetary loss from not receiving royalties from the patenting of active pharmaceutical and cosmetic ingredients obtained from Brazilian biodiversity and associated traditional knowledge, which, based on these practices, were registered in other countries. As it is considered an illegal activity under the national laws of many countries, the genetic heritage that has been illegally accessed can be used in various innovation processes around the world, and due to the lack of integration of international systems, it is almost impossible to trace raw materials and consequently identify the origin of biopiracy [80]. This practice has been a concern for countries with vast biodiversity, such as Brazil. Meanwhile, it is expected that with legal regulations, international treaties, and conventions, it will be possible to trace the origin of bioprospecting and access to genetic heritage. And thus combat this crime against the conservation and biodiversity of countries.

#### **6.2 Enforcement of the law to access Brazilian genetic heritage**

Access to genetic heritage (GH) and/or associated traditional knowledge (ATK) to GH, has been regulated in Brazil since 2001 (through Provisional Measure No. 2.186/2001). Law 13.123/2015 determined significant changes regarding the access to Brazilian Biodiversity, mainly on the rules of sharing benefits obtained for the conservation and sustainable use of biodiversity, the access to technology and technology transfer, the exploitation of products or reproductive material of GH or ATK and the remittance abroad of part or all of the living or dead organism part of GH access. Thus, SISGEN (National System of Genetic Heritage Management), was created by Decree No. 8772/2016, is an electronic system maintained by the executive secretariat of CGEN (Genetic Heritage Management Council) in order to assist the user to register processes of access to GH or ATK, in order to request authorization for access to the country's GH or ATK, carry out shipment of GH samples abroad, notification of finished product among other provisions set out in Law 13.123/2015 [80].

Therefore, the use of products of the metabolism of living organisms resulting from access to the GH existing in the national territory is within the scope of the legal requirements related to the abovementioned Law. Thus, in order to carry out scientific research and/or economic exploitation, shipment, and access to ATK from organisms that are considered part of the Brazilian PG and/or product of the metabolism of these organisms, it is necessary to register in SISGEN according to the activity to be performed. Otherwise, the user will be subject to the legal implications set forth in the Law, including fines for noncompliance with the legal requirements related

*Alginate Extraction from Natural Resources Based on Legal Requirements: An Incentive… DOI: http://dx.doi.org/10.5772/intechopen.114217*

to access to the Brazilian GH. Thus, the activities of extraction of alginate, which is considered a product of the metabolism of living organisms, which are obtained or isolated in Brazilian territory, found *in situ* conditions in the national territory, continental shelf, territorial sea, and exclusive economic zone, are within the scope of Law 13.123/2015, therefore, subject to the legal implications of the country, being essential to register the respective activities in SISGEN, before CGEN [4].
