Provides the tools for the control of access to the genetic resources of the Country and makes other provisions

The National Congress decrees:

CHAPTER I

GENERAL PROVISIONS

Article 1. It is incumbent on the State to preserve the diversity, the integrity and the sustainable use of the genetic patrimony of the Country and to oversee the entities engaged in research and manipulation of genetic materials, the following principles being observed:

I - sovereignty and inalienability of rights upon biological diversity and upon genetic resources existing in the national territory;

II - participation of the local communities and of the indigenous peoples in decisions aimed at giving access to the genetic resources in the areas they occupy;

III - national participation in the economic and social benefits deriving from the activities of access to Brazilian genetic resources, especially for the benefit of the local communities and of the indigenous peoples involved;

IV - priority, in the access to genetic resources, to undertakings being carried out within the national territory;

V - promotion of and support for the various forms of generation of knowledge and technologies with the Country, giving priority to strengthening the respective national capacity;

VI - protection and encouragement of cultural diversity, valuing the knowledge, innovations and practices of the local communities with respect to the conservation, use, management and exploitation of biological and genetic diversity;

VII - guarantee of the biosafety and of the environmental and food safety of the Country;

VIII - guarantee of individual and collective rights upon knowledge associated with biodiversity, in order for their protection and compensation to be duly acknowledged;

Article 2. The control and oversight of the access to genetic resources are aimed at the protection, conservation and sustainable use of the natural patrimony of the Country, the provisions of this Act being applied to all individuals and corporate bodies, either national or foreign, who extract, use, exploit, store, market, free or introduce genetic resources in the national territory.

Article 3. This Act applies to the inland, coastal, marine and island biological and genetic resources existing in the national territory, as well as to the migrating species which, for natural causes, are present in the national territory.

Article 4. This Act does not apply:

I - to the whole, the parts of the genetic components of human beings;

II - to the exchange of biological resources carried out by the local communities and by the indigenous peoples, among themselves, for their own purposes and based on their customary practices.

CHAPTER II

INSTITUTIONAL DUTIES

Article 5. To ensure compliance with the provisions of this Act, the State shall:

I - establish a committee made up of representatives of the Federal Government, the governments of the state and of the Federal District, the scientific community, non-governmental organizations and private companies, with a view to coordinating, assessing and ensuring the development of activities of preservation of diversity and of the integrity of the national genetic patrimony;

II - issue, within two years as of the publication of this Act, and update, every five years, a report about the degrees of threat to the national biodiversity and about the potential impacts of its deterioration upon sustainable development;

III - prepare technical and scientific guidelines for the establishment of priorities for the conservation of ecosystems, species and genes, based on factors such as the endemism, abundance and interrelationship of species, and their ecological value, as well as the possibilities of sustainable management;'

IV - establish, together with international agencies, local communities and non-governmental organizations, lists of genetic resources threatened by extinction or by deterioration, and of the places threatened by serious loss of biological diversity;

V - establish mechanisms to enable the control and disclosure of information regarding threats to the national biological diversity;

VI - develop plans, strategies and policies to conserve biological diversity and ensure the sustainable use of its component parts;

VII - monitor researches and inventories of the national biological diversity and develop a system to organize and maintain this information;

VIII - support the establishment and strengthening of conservation units so as to conserve species, habitats, representative ecosystems and the genetic variability within the species;

IX - control and prevent the introduction of exotic species in the national territory;

X - set up conditions to develop and strengthen activities of ex-situ conservation of the biological diversity of the Country;

XI - carry out studies aimed at modifying the calculation of the national accounts, so that they will reflect the economic losses deriving from the degradation of the biological resources and from the loss of biodiversity; and

XII - identify the priorities for the training of personnel prepared to protect, study and use biodiversity.

CHAPTER III

ACCESS TO GENETIC RESOURCES

Article 6. The activities of surveying and collecting resources of biological diversity carried out in the Brazilian territory shall be previously authorized by the competent authority, following the submission of a petition by the individual or corporate body involved, including, at least:

I - detailed and specific information about the resources to which access is desired, including their present and potential uses, their sustainability and the risks that may arise from such access;

II - detailed descriptions of the methods, techniques, collection systems and tools to be used;

III - precise location of the areas of access to the resources;

IV - information about the destination of the material collected and its possible future use;

Sole paragraph: Petitions requesting access to the territories of local communities, as well as those aimed at collection and research of resources of indigenous lands, shall be examined in accordance with rules to be issued within one hundred and eighty days as of the publication of this Act, the opinion of the populations involved and the participation of at least one member of the community in the activities carried out being ensured, in any event.

Article 7. The activities mentioned in the preceding article must be monitored by a Brazilian technical and scientific institution of well-known repute in the area being researched, especially assigned for that task by the competent authority.

Sole paragraph: The institution assigned shall have joint and several liability for the fulfillment of the obligations undertaken by the individual or corporate body authorized to carry out the activities.

Article 8. The authorization issued by the competent authority shall include, in addition to the information provided by the petitioner, all of the other obligations to be fulfilled, especially:

I - observance of all other Brazilian rules, especially those regarding sanitary control, biosafety, protection of the environment and customs;

II - guarantee of unrestricted access for the Brazilian Government to the knowledge generated by and the information deriving from the activities carried out;

III - preferential guarantee for the Country to the use of the products obtained from the genetic resources investigated;

IV - guarantee of participation of the Country in the economic, social and environmental benefits of the products and processes obtained through the use of the genetic resources found in the Brazilian territory;

V - guarantee of the mandatory deposit of one specimen of each genetic resource to which access was given;

Article 9. It shall be incumbent upon the competent authority, together with the institution assigned to monitor the authorized activities, to monitor the observance of the provisions of the authorization and, specifically, to ensure that:

I - access is obtained exclusively to the authorized species;

II - the environmental conditions of the region where the activities are carried out are observed;

III - there is permanent direct participation of an expert from the supervising institution;

IV - a detailed account of the activities carried out and of the destination of the samples collected is presented;

V - one specimen of the collected sample is handed over to be conserved ex-situ.

Sole paragraph: The competent authority may also, when it deems necessary, demand the submission of a study of the environmental impact derived from the activities to be carried out.

Article 10. The competent authority may demand, from the individuals and corporate bodies authorized to carry out activities of surveying and collecting biological diversity resources, the payment of financial compensation to the State for such use.

Sole paragraph: The funds resulting from such payments shall be assigned to the National Environment Fund, created by Law No. 7.797, of July 10, 1989.

Article 11. The individuals and corporate bodies authorized to carry out activities of accessing Brazilian genetic resources are required to transmit to the competent authorities any information regarding the transportation of collected specimens, and they also have civil, criminal and administrative responsibility for the appropriate use or handling of such specimens, as well as for adverse effects upon the conservation and sustainable use of biological diversity.

Article 12. The authorization for access to genetic resources does not imply authorization to remit them abroad, in which case authorization must be previously requested and justified before the competent authority.

Sole paragraph: It is totally forbidden to remit single samples abroad without due regard to Article 8, item V, of this Act.

Article 13. The State may, when it deems necessary, establish restrictions to or prohibitions of access to the Brazilian genetic resources, especially in cases of:

I - endangered species, subspecies, lineages or varieties;

II - reasons of endemism or rarity;

III - vulnerable conditions of the structure or of the functioning of the ecosystems;

IV - adverse effects upon human health, or upon the quality of life or the cultural identity of the local communities;

V - environmental impacts which are undesirable or difficult to control, upon urban and rural ecosystems;

VI - danger of genetic erosion or loss of ecosystems, their resources or their components, because of undue or uncontrolled collection of germplasm;

VII - non-compliance with biosafety of food safety rules; and

VIII - use of resources for purposes contrary to national interests and to the agreements entered into by the Country.

Article 14. It is illegal to use genetic resources for purposes of research, conservation, or industrial or commercial operations, without the respective certificate of access.

Article 15. The rights upon genetic resources obtained or used in violation of this law shall not be recognized, and the certificates of intellectual property or similar certificates upon such resources or upon products or processes resulting from access under such circumstances shall not be considered valid.

Article 16. The introduction of specimens and genetic resources in the national territory shall depend on previous authorization and shall observe the following guidelines:

I - the introduction of an exotic specimen shall only be accepted if it is expected to yield evident and clearly defined benefits to the local communities;

II - the introduction of an exotic specimen shall only be accepted if no other native species is suitable for those objectives;

III - no exotic specimen may be deliberately introduced in any natural habitat, that is,m a habitat which has not been altered by man;

IV - no exotic specimen may be introduced in a semi-natural habitat, except for special reasons, and only when the operation has been submitted to a prior environmental impact study; and

V - the introduction of exotic specimens in highly altered habitats may only be carried out after its effects upon the natural and semi-natural habitats have been assessed by means of a previous environmental impact study.

CHAPTER IV

THE PROTECTION OF KNOWLEDGE

Article 17. The State recognizes and protects the rights of the local communities to benefit from their traditions and knowledge collectively, and to receive compensation for the conservation of biological and genetic resources, either by means of intellectual property rights or other mechanisms.

Sole paragraph: The protection of knowledge, innovations and practices developed through cumulative processes of biodiversity conservation and improvement, in which it is not possible to identify the person directly responsible for their generation, shall observe specific rules for collective intellectual property rights.

Article 18. Collective intellectual property rights represent the recognition of rights acquired along generations, including industrial property rights, copyright, improvement rights, secrets and others.

Article 19. The regulation of collective intellectual property rights shall take place within 1 (one) year as of the publication of this act, the following guidelines being observed:

I - identification of the types of intellectual property rights that are acknowledged in each case;

II - definition of the requirements and procedures for the recognition of a collective intellectual right and its ownership; and

III - definition of a system of collective registration, of procedures and of the rights and duties of the owner.

Article 20. It is ensured to the local communities the right not to allow the collection of biological and genetic resources and the access to traditional knowledge in their territories, as well as to demand restrictions upon such activities outside their territories, when it is proved that such activities threaten the integrity of their natural or cultural patrimony.

Article 21. Individual intellectual property rights, registered within or outside the Country, regarding biological or genetic resources, their by-products or respective processes, shall not be recognized when:

I - they use the collective knowledge of local communities; or

II - they have been obtained without the certificate of access and the permit to leave the Country.

Article 22. The State shall review the patents and other intellectual property rights registered outside the Country, which are based on national genetic resources, for the purpose of claiming the corresponding compensation or declaring them null and void.

CHAPTER V

TECHNOLOGY DEVELOPMENT AND TRANSFER

Article 23. The State shall promote and support the development of sustainable national technologies for the use in the improvement of autochthonous species, lineages and varieties, and shall give priority to the traditional practices and uses within the areas of the local communities, according to their desires.

Sole paragraph: For the aims of this article, the State shall promote the survey and evaluation of the traditional and local biotechnologies.

Article 24. The use of foreign biotechnologies will be permitted, whenever these comply with this Act and with other regulations on biosafety, and the interested party takes full responsibility for any damage to health, environment and local cultures, present or future, that may result therefrom.

Article 25. Arrangements shall be set up to guarantee and facilitate, for the national researchers, the access to and transfer of technologies that are relevant for the conservation and sustainable use of the biological diversity, or access to and transfer of those technologies that use genetic resources and that do not harm the environment and the culture of the Country.

Article 26. In the case of technologies which are subject to patents and other intellectual property rights, it shall be guaranteed that the access and the transfer shall be effected in such conditions as to guarantee an adequate protection to the intellectual property rights.

CHAPTER VI

ADMINISTRATIVE SANCTIONS

Article 27. The Executive Branch shall establish regulations containing the administrative sanctions that shall apply to those who violate this Act. The sanctions shall be, among others:

I - written admonishment;

II - preventive seizure of the collected resource, as well as of materials and of the equipment used in the unlawful action;

III - daily cumulative fine;

IV - suspension of the permit or licence for access to the resource;

V - revocation of the permit or licence for access to the resource; and

VI - definitive seizure of the collected resource, of the material and of the equipment used in the unlawful action.

Sole paragraph: The sanctions set forth by this article shall be applied without prejudice to the applicable civil and criminal proceedings.

CHAPTER VII

FINAL PROVISIONS

Article 28. The Executive Branch shall set forth regulations concerning this Act within 180 (one hundred and eighty) days from the day of its publication.

Article 29. The Act shall take effect on the date of its publication.

Article 30. All contrary provisions are hereby revoked.

JUSTIFICATION

The United Nations Conference of Environment and Development (UNCED) held in Rio de Janeiro in 1992 had two meanings which are interwoven and gaining in relevance both on the symbolic level and with regard to the geopolitics of the modern world. In the first place, the fact that the UNCED was held in Brazil stressed how much the issue under consideration - environment and development as a single and inseparable discussion - reflects our national dilemmas with respect to the future. Brazil is among the few countries of the world which have the so-called biological megadiversity, that is, important ecosystems, like tropical rain forests and cerrados, remaining at a level of integrity that is rare on a planet devastated by irresponsible human action. This characteristic, coupled to the size of our territory, should certainly be seen as a key element in the set of factors that have given weight in the configuration of international relations in a globalized context.

In the second place - and this should be viewed from the angle of what has been said above - in 1992, biodiversity obtained, clearly and definitively, the status of a critical and privileged arena in political and economic negotiations. It is not without reason that, the refusal of the United States, during UNCED, to sign the Convention on Biodiversity (as the Convention on Biological Diversity is better known) caused so much uproar and repercussion at the time. At the Conference it became clear, publicly, what was already known in specialized circles, biodiversity is power. The hot controversies that condition today's international relationships - of which the legal regulation of the genetic patenting is a paradigmatic example - related to the field of biodiversity.

Thus, some of the concerns and statements of consciousness and principles found in the Preamble to the Convention on Biological Diversity (approved by the National Congress in February of 1994 and took effect at the end of the same year) which are listed below, should be interpreted with hope but also with shrewdness:

m the importance of the biological diversity for evolution and for maintaining life sustaining systems of the biosphere;

m the sovereignty of the States over their own biological resources;

m the responsibility of the States for the conservation of their biological diversity and for the use of their biological resources in a sustainable manner;

m the urgent need to develop scientific, technical and institutional capacities with regard to biological diversity to provide the basic understanding upon which to plan and implement appropriate measures;

m the overriding priority of developing countries is the economic and social development and the eradication of poverty; and

m the conservation and sustainable use of biological diversity is of critical importance for meeting food, health and other needs of the growing world population, for which purpose access to and sharing of both genetic resources and technologies are essential.

The objectives of the Convention, set forth in its Article 1, summarize the points of the Preamble.

the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.

Thus, it can be seen that the great points of the issue are set and agreed by the world community. However, the fuzzy areas are obvious: the complexities and contradictions hidden under the ambiguity of the words that express value judgement still not guaranteed in practice, in spite of the generic and diplomatic consensus about them. If we desire to carry out our intentions, it is necessary to act, to begin with, by defining the starting points for a practical positioning in the balance between verifiable intentions and interests in the area of biodiversity.

Our situation - of a country especially endowed with biological diversity resources - should be seen as an asset for the solving of important internal problems, especially those related to extreme poverty and hunger, and, at the same time, for the establishment of a strong and positive reference in the scope of international relationships. Therefore, it is an extremely relevant task, both for society and for its representatives, to dedicate to biodiversity the political, technical and institutional effort that it requires as a strategic lever for the construction of our nation.

To this end, the necessary steps must be taken for the discussion, which already occurs in certain segments, to extend to the area of judicial and institutional changed that are vital for the use of our biodiversity in a responsible and sustainable manner, in view of the interests of our population and the consistent actions that Brazil should have in the international scene. The further we go in the debate and the more objective the instruments that we have to tackle this issue become, the lease we will be exposed to chance, to parochial decisions and to mistaken or rash policies.

Thus, the decision to present this bill means a contribution to create a concrete arena for discussion and decision-making relative to one of the vital aspects of the biodiversity issue, namely, the access to genetic resources, the subject of a specific topic in the Biodiversity Convention, which, in its Article 15, item 1, states: "Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation.

With regard to this, Prof. Ennio Candotti, ex-president of the Brazilian Society for the Advancement of Science (SBPC), in a debate reproduced in the document "Eco-92: Primeira Avaliaçäo da Conferência" (UNCED - First Evaluation of the Conference), is reported as saying:

Until now, the right over the genetic heritage was not defined; it oscillated between common heritage of humankind, with free access, and heritage with limited access, granted out of benevolence by the countries that sheltered it. Today, there is no more place for benevolence. We must establish a specific judicial instrument, and the Congress should define the necessary laws to protect this heritage.

In addition, it must be pointed out that the Brazilian Constitution of 1988 already provided for such a definition, in its Chapter VI - Environment, article 225. In paragraph 1, item II, it is stated that it is incumbent upon the Government to: "preserve the diversity and integrity of the genetic patrimony of the country and to control entities engaged in research and manipulation of genetic materials".

The bill now being presented takes into account the vastness of the issue and its complex nature; this is so in part due to the fact that the regulation of genetic resources in the whole world is very recent and is still limited to very few countries. The bill focuses, in its general principles, directives and basic rules, on the access to national genetic resources. We are aware that, on this foundation, a long trail must be followed in the National Congress for a comprehensive and profound exchange of knowledge and opinions, among scientists, researchers and technicians, segments of the population directly interested and non-governmental organizations, that have accumulated important experience on the subject. The best end product, which we hope will result from the consideration of this bill, is a productive and responsible consensus in favour of the Brazilian society, in the direction of an affirmative and positive participation of Brazil in the international scene.

The bill is divided in seven chapters. The first two deal with general principles and institutional duties to guarantee what is provided for in the bill. Chapter III deals with the access to genetic resources. Described here are the necessary conditions for the request, by a natural or legal entity, of authorization to survey and collect biological diversity resources in the Brazilian territory, with exception to the special rights of the directly affected communities, including Indian communities. This chapter also specifies the safeguards to the national interest and those of technical-scientific and environmental nature, that should be complied with.

Chapter IV deals with the protection of knowledge, involving the rights of traditional communities. Chapter V regulates the development and transfer of technology. Chapters VI and VII deal with administrative sanctions and final provisions.

The bill used several research sources, among them the legislation of other countries, papers from international conferences, as well as consultations with several segments of society and national and foreign scientists and experts.

In view of the importance of the issue dealt with here, we expect from you, honourable Senators, support and contributions to enable us in this House to establish an open and fruitful debate on this particular issue, that will yield a collective result that is important for the Country.

Hall of Sessions, October 26, 1995

Senator Marina Silva