ACCESS AND BENEFIT SHARING LEGISLATION AND THE BRAZILIAN BRCs MANUELA DA SILVA - FIOCRUZ OSWALDO CRUZ FOUNDATION BRAZIL
NEW BRAZILIAN ABS LAW - 13.123/15
LAW Nº 13.123, FROM 20 OF MAI 2015 After 6 months from the publication in the Official Gazette (21.05.15) the law will enter into force Regulates the section II of 1 and 4 of article 225 of the Federal Constitution, Article 1, point j of Article 8, point c of Article 10, Article 15 and 3 and 4 of Article 16 of the Convention on Biological Diversity, promulgated by Decree No. 2519 of 16 March 1998, provides for access to genetic resources, on the protection and access to associated traditional knowledge and the benefit sharing for conservation and sustainable use of biodiversity; revokes the Provisional Measure 2.186/16, 23 August 2001, and take other measures.
SCOPE OF THE LAW 13.123/15 THE LAW COVERS THE ACTIVITY OF RESEARCH TECHNOLOGICAL DEVELOPMENT ECONOMIC EXPLOITATION FROM THE ACCESS OF GENETIC RESOURCES FROM THE ACCESS OF ASSOCIATED TRADITIONAL KNOWLEDGE FINISHED PRODUCT OR REPRODUCTIVE MATERIAL
SCOPE OF THE LAW 13.123/15 DIFERENTLY FROM THE CURRENT LEGISLATION, THE NEW LAW: REACHES ALL RESEARCH (EXPERIMENTAL OR THEORETICAL) CONDUCTED WITH THE BRAZILIAN BIODIVERSITY SUCH AS: TAXONOMY PHYLOGENY EPIDEMIOLOGY INVENTORIES ECOLOGICAL STUDIES BIOGEOGRAPHY
ACTIVITIES THAT ARE SUBJECT TO THE LAW I. Access to genetic resources and associated traditional knowledge; II. III. Shipment abroad of genetic resources Economic exploitation of finished product or reproductive material from access to genetic resources and associated traditional knowledge
FOR COMPLYING WITH THE LAW REGISTRATION DURING THE PHASE RESEARCH TECHNOLOGICAL DEVELOPMENT NOTIFICATION BEFORE ECONOMIC EXPLOITATION
REGISTRATION The registration should be conducted prior to: Shipment; Request of any intellectual property right; Commercialization of any intermediate product; Release of results, final or partial, in scientific circles or scientific communication; Notification of finished product or reproductive material developed as a result of the access
NOTIFICATION For economic exploitation will be required: I - Notification of the finished product or the reproductive material to the National Competent Authority (CGen) II - Presentation of the benefit-sharing agreement within 1 year from the time of notification of the finished product or reproductive materials
REGISTRATION, NOTIFICATION AND AUTHORIZATION CGEN WILL CREATE AND MAINTAIN ELECTRONIC SYSTEMS FOR: ACCESS TO GENETIC RESOURCE REGISTRATION ACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE SHIPPING GENETIC RESOURCE NOTIFICATION FINISHED PRODUCT REPRODUCTIVE MATERIAL
CERTIFICATE OF ACCESS REGULARITY ADMINISTRATIVE ACT BY WHICH THE NATIONAL COMPETENT AUTHORITY DECLARES THAT ACCESS TO GENETIC RESOURCES ACCESS TO ASSOCIATED TRADITIONAL KNOWLEDGE MET THE REQUIREMENTS OF THE LAW
SHIPMENT OF GENETIC RESOURCE REGISTRATION FOR SHIPMENT ABROAD MUST BE PERFORMED PRIOR SHIPMENT AND DEPENDS: SIGNATURE OF MATERIAL TRANSFER AGREEMENT - MTA INFORMATION ON THE INTENDED USE
SHIPMENT OF GENETIC RESOURCE SHIPPING WILL BE REGISTERED IN CASES WHERE ACCESS TO GENETIC RESOURCES ARE CONDUCTED BY: INTERNATIONAL ORGANIZATION THAT IS ASSOCIATED TO NATIONAL INSTITUTION (PUBLIC OR PRIVATE) NATIONAL INDIVIDUAL OR LEGAL ENTITY (PUBLIC OR PRIVATE) THAT IS ABROAD SHIPPING WILL ALSO BE REGISTERED IN THE CASE OF: SHIPPING GENETIC RESOURCE BY NATIONAL LEGAL ENTITY (PUBLIC OR PRIVATE) FOR SERVICES ABROAD (e.g. DNA SEQUENCING)
RESEARCH BY FOREIGNERS BRAZILIAN BIODIVERSITY CAN ONLY BE ACCESSED BY FOREIGN INSTITUTION (LEGAL ENTITY LOCATED ABROAD) in partnership with BRAZILIAN INSTITUTION (PUBLIC OR PRIVATE) THAT, FOR ALL LEGAL PURPOSES, WILL BE RESPONSIBLE FOR THE ACTIVITIES OF ACCESS TO GENETIC RESOURCES AS WELL AS FOR THE REGISTRATION
RESEARCH BY FOREIGNERS NATIONAL COUNCIL FOR SCIENTIFIC AND TECHNOLOGICAL DEVELOPMENT Authorization's Request for Collecting and Research (Scientific Expeditions) http://www.cnpq.br/web/guest/in-english-summary
BENEFIT SHARING CLEAR AND FIXED RULES FOR BENEFIT SHARING WERE ESTABLISHED, THAT CAN BE: MONETARY, WITH THE PERCENTAGE OF 1% FIXED OR NON MONETARY ONLY THE MANUFACTURER OF THE FINISHED PRODUCT OR THE PRODUCER OF THE REPRODUCTIVE MATERIAL WILL BE SUBJECT TO BENEFIT-SHARING, REGARDLESS OF WHO PERFORMED PREVIOUSLY THE ACCESS
BENEFIT SHARING THE NON MONETARY BENEFIT SHARING MAY BE: a) Projects for conservation, sustainable use of biodiversity, protection and maintenance of knowledge, innovations and practices of traditional knowledge holders; b) Technology transfer; c) Making product available in the public domain, unprotected by intellectual property rights or technological restrictions; d) Licensing products free of charge; e) Training of human resources on issues related to conservation and sustainable use of genetic resources or associated traditional knowledge; f) Free distribution of products in programs of social interest.
BENEFIT SHARING The payments from the benefit sharing and fines due to noncompliance of the Law shall be deposited in the National Fund of Benefit Sharing - FNRB, under the Ministry of Environment responsibility and established in order to support genetic resources and associated traditional knowledge as well as to promote its use in a sustainable way.
BENEFIT SHARING The monetary funds deposited in the National Fund of Benefit Sharing (FNRB) arising from economic exploitation of finished product or reproductive material obtained from the access to: Genetic Resources from ex situ Collections will be partially intended for the benefit of these collections Associated Traditional Knowledge will be used exclusively for the benefit of traditional knowledge holders
BENEFIT SHARING Through the National Fund of Benefit Sharing the National Program of Benefit Sharing PNRB will be established in order to promote, among others: Conservation of biological diversity Survey and inventory of genetic resources Recovery, creation and maintenance of ex situ collections Training of human resources associated with the use and conservation of genetic resources and associated traditional knowledge Support for the efforts of indigenous peoples, traditional communities and traditional farmers in the sustainable management and conservation of genetic resources
NATIONAL COMPETENT AUTHORITY - GENETIC HERITAGE MANAGEMENT COUNCIL (CGEN) CGen will consist of representatives from bodies and entities of the federal public administration that are competent on the various actions of this law with maximum participation of 60% and the representation of civil society in at least 40% of the members, with parity ensured among: Business sector Academia Indigenous peoples, traditional communities and traditional farmers CGEN currently consists of: 9 ministries 10 federal organizations including research institutions and government organizations that represent traditional communities
BEST PRACTICE FOR BRAZILIAN BRCs - Registration of access of genetic resources during research and technological development in order to obtain the certificate of access regularity - Registration before shipping genetic resources - Maintain records to track the acquisition, supply and commercial use of genetic resources - Supply genetic resources with identified and legal origin (PIC and/or MTA from depositors or from other culture collections) - Supply genetic resources together with MTA - Supply genetic resources for commercial use under a MAT
THANK YOU! Manuela da Silva manueladasilva@fiocruz.br FIOCRUZ FUNDAÇÃO OSWALDO CRUZ HEALTH MINISTRY