UNICAMP and the Genetic Heritage

In order to ensure that the scientific research and technological development activities carried out at the State University of Campinas comply with Law No. 13.123, of May 20, 2015, regulated by Decree No. 8.772, of May 11, In 2016, UNICAMP created a set of guidelines for its researchers, professors and managers.

According to the new legislation, access to the genetic heritage existing in the country or to associated traditional knowledge for the purpose of research or technological development and the economic exploitation of the finished product or reproductive material arising from this access will only be carried out upon registration, authorization or notification, and will be subject to inspection, restrictions and benefit sharing under the terms and conditions established in the Law and its regulation (art. 3 of Law No. 13.123/2015).

The following activities are subject to the requirements of the new Law:

1. Access to genetic heritage or associated traditional knowledge;
2. Remittance abroad of samples of genetic heritage; and
3. Economic exploitation of finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge carried out after the Law came into force.

Brief history: Regulation of Access to Biodiversity Genetic Resources
(international, national and institutional)

In 1987, the Governing Council of the United Nations Environment Program (UNEP), inaugurated the negotiations that culminated in the Convention on Biological Diversity - CBD, through the decision to convene a Working Group of Specialists in Biological Diversity, to reconcile the existing conventions related to the topic. At its first meeting, the Expert Group agreed on the need to develop an instrument with international parameters on Biological Diversity.

In 1989, another Group of Specialists in Biological Diversity was created to prepare an international legal instrument, aiming at the conservation and sustainable use of Biological Diversity resources, taking into account the need to protect associated traditional knowledge, to share costs and benefits between countries. developed and developing countries, as well as the perception that the conservation of biological diversity is in the common interest of humanity, and recognizing that States must have sovereign rights over their own biological resources that are responsible for their conservation and sustainable use .

In 1992, the CBD was approved and considered one of the main results of the United Nations Conference on Environment and Development – ​​CNUMAD, held in Rio de Janeiro, in June 1992 (RIO 92). The CBD is the world's leading forum for defining the legal and political framework for themes and issues related to biodiversity, where 168 countries were signatories and signed the CBD and 188 countries ratified it, according to the CBD website. Brazil was the first country to sign the CBD. In 1994, the Brazilian National Congress approved the CBD through Legislative Decree nº 2/1994. In 1998 this text was ratified by the Decree No. 2.519 / 1998, entering, therefore, the subject in the Brazilian legal system.

In 1995, the process of discussing national legislation had its milestone with the launch of the Bill (PL) no. 306/1995, by Senator Marina Silva. In 1998, Senator Osmar Dias approves in the Senate the substitutive PL No. 4.842/1998. In the same year, two other projects were presented in the Chamber of Deputies, the PL nº 4.579/1998 of the deputy Jacques Wagner and the nº 4.751/1998 authored by the Federal Executive, and the Executive's PL added a proposal for a Constitutional Amendment - EC 618/1998, which aimed to amend article 20 of the Federal Constitution/1988, in order to include the Genetic Heritage as an asset of the Union.

In 2000, the negotiation between a Brazilian social organization and a multinational pharmaceutical industry had a negative impact, due to the absence of a legal framework to support it. This scenario motivated the government to institute Provisional Measure (MP) No. 2.052 on June 29, 2000, based on PL 4.751/1998 and reissued until the supervenience of EC No. 32/2001, in force until the present day under No. 2.186 -16/2001.

In 2001, with the enactment of Decree No. 3.945/2001, Brazil regulated MP No. 2.186-16/2001 and began the process of implementing national legislation. In this year, the Genetic Heritage Management Council – CGEN was created with normative and deliberative attributions and, strictly composed of governmental bodies. The MP provides for prior authorization for scientific research, bioprospecting and technological development involving Access to Genetic Heritage and Associated Traditional Knowledge.

From 2001 to 2009, 71 CGEN meetings were held. The results related to the effort to make the understanding of the legal scope viable were the publication of Decrees, Technical Guidelines, Deliberations and Resolutions. Statistical data referring to authorizations granted for scientific research, bioprospecting and technological development that involve or not access to associated traditional knowledge reveal 76 authorizations and 101 accreditations of institutions/collections as trustees. 🇧🇷DPG internal bulletin September 2009 edition).

In 2003, there was a clear perception of all segments related to the topic (scientific and technological community, business, traditional communities, government and non-governmental organizations) of the non-adequacy of the MP's scope and the need to review the legal framework. New Preliminary Draft Law/APL was prepared by CGEN and sent by the MMA to the Civil House in November of the same year.

From 2004 to 2007, the matter was debated among the various Government Bodies under the articulation of the Civil House. At the end of 2007, the APL was opened for public consultation until July 2008. In the following 3 months, the results of the public consultation were consolidated and the planning of face-to-face consultations with traditional and local communities in different regions of the country was completed. In October 2008, the MMA withdraws the APL from the Civil House to prepare a new text.

In June 2009, UNICAMP, through the Dean of Research - PRP and in conjunction with the Attorney General's Office - PG and the Innovation Agency - INOVA, started a discussion process, with the objective of establishing an institutional strategy to adapt from the university to legislation that focuses on the topic of collection and use of genetic resources from Brazilian biodiversity and Associated Traditional Knowledge – CTA. After a meeting with the directors and representatives of the Units involved in the topic, it was decided to create a Working Group - WG formalized through the PRP Ordinance No. 004 of August 06, 2009 with the objective of guiding the professors, researchers and managers of UNICAMP, defining procedures and establishing guidelines and internal routines on the subject, whose work originated this site.

At the end of 2009, two APLs on the subject were sent to the Civil House: one authored by the MMA in partnership with the Ministry of Science and Technology - MCT and the other by the Ministry of Agriculture, Livestock and Supply - MAPA referring to genetic resources for agrobiodiversity.

At the end of 2010, the result of the work group was the development of this website, which was presented at a meeting to the Rector and all Unit directors and made available to the community. Currently, the Research Post-Rectory - PRP is concentrating its activities to meet the Resolution No. 35/2011, which deliberated on the regularization of activities of access to genetic heritage and/or associated traditional knowledge and its economic exploitation carried out in disagreement with Provisional Measure nº 2.186-16, of August 23, 2001 and other pertinent norms.

In September 2013, UNICAMP, through the Dean of Research - PRP, and in articulation with the Attorney General's Office - PG and the Innovation Agency - INOVA, in continuation of Support to the Unicamp community regarding compliance with the legislation pertinent to the use of genetic resources from Brazilian biodiversity and Associated Traditional Knowledge - CTA, decided to create a new "Group of Work and Monitoring of Genetic Heritage", formalized through the Internal Ordinance PRP/Nº 13/2013, with the objective of supporting scientific research activities, bioprospecting, technological development and didactic activities involving the Genetic Heritage, and which must comply with current legislation (Law 13.123/2015 and Decree 8.772/2016), which regulates the Collection, Access, Transport/Shipment of Component of the National Genetic Heritage and Access to Associated Traditional Knowledge.

In September 2017, on the occasion of the recertification of the Dean of Research (Deliberation CAD-274/2017), the Genetic Heritage Commission was created as a permanent body of the PRP structure, maintaining the function of supporting scientific research, bioprospecting, technological development and didactic activities involving the Genetic Heritage, and which must be in accordance with the the current legislation related to the collection, access, transport/shipment of a component of the national genetic heritage and access to associated traditional knowledge.

Any questions about the information contained in this site, the researcher should contact us by e-mail. cgen@mma.gov.br.

UNICAMP thanks Embrapa and Fiocruz, in the people Dr. Rosa Miriam Vasconcelos and Maria Celeste Emerick for their valuable contribution.