The researcher or the person who accessed Brazilian biodiversity during their activities linked to Unicamp is responsible for:
- Preserve the diversity and integrity of the country's genetic heritage and supervise entities dedicated to research and manipulation of genetic material;
- Defend and preserve the environment for present and future generations.
- Complete your researcher registration and request a link to the State University of Campinas (CNPJ 46.068.425/0001-33). After enabling the link by the Pro-Rectory of Research, the other registrations can already be made.
- Only faculty members, researchers and employees of Unicamp can register at SisGen.
- Students and alumni must be registered on the advisor's team.
- It is also up to the researcher to keep the register updated regarding the composition of the team.
- Check whether the research activities fit the following definitions, contained in art. 2 of Law No. 13.123, of May 20, 2015:
- access to genetic heritage – research or technological development carried out on a sample of genetic heritage;
- research – activity, experimental or theoretical, carried out on the genetic heritage or associated traditional knowledge, with the objective of producing new knowledge, through a systematic process of knowledge construction that generates and tests hypotheses and theories, describes and interprets the foundations of phenomena and observable facts;
- technological development – systematic work on genetic heritage or on associated traditional knowledge, based on existing procedures, obtained through research or practical experience, carried out with the aim of developing new materials, products or devices, improving or developing new processes for economic exploitation .
If the activities fit the concepts presented, as well as the species object of the research fit as national genetic heritage (PG), that is, belong to the Brazilian biodiversity, it will be necessary to register in SisGen, as required by Law No. 13.123, of 2015 .
- Declare in the National System for the Management of Genetic Heritage and Associated Traditional Knowledge - SisGen (sisgen.gov.br), through the registration of access or remittance of genetic heritage or associated traditional knowledge, the following activities:
- access to genetic heritage or associated traditional knowledge within the country carried out by a national natural or legal person, public or private;
- access to genetic heritage or associated traditional knowledge by a legal entity headquartered abroad associated with a national scientific and technological research institution, public or private;
- access to genetic heritage or associated traditional knowledge carried out abroad by a national natural or legal person, public or private;
- remittance of a sample of genetic heritage abroad for the purpose of access, in the cases of items II and III of this caput; and
- sending a sample containing genetic heritage by a national, public or private legal entity, to provide services abroad as part of research or technological development.
- notification of finished product or reproductive material;
- access to genetic heritage or associated traditional knowledge and shipment abroad with the consent of the National Defense Council and the Navy Command;
- request for accreditation of institutions that maintain the collections ex situ containing samples of genetic heritage;
- request for access regularity certificates.
- Inform the following data in the SisGen registration:
- Access applicant data: user identification;
- Data on access (research and/or technological development): summary of activities; goals; application sector; expected or obtained results; responsible team, including partner institutions; period of activities;
- Data on the genetic heritage sample or access to associated traditional knowledge: identification of the genetic heritage at the strictest possible taxonomic level or associated traditional knowledge; identification of the origin of the genetic heritage, including georeferenced coordinates in degree, minute and second format, from the place where it was obtained in situ, even if they were obtained from ex situ sources or in silico🇧🇷 identification of the indigenous population, traditional community or traditional farmer who provide traditional knowledge, even if the knowledge was obtained from secondary sources; statement whether the genetic heritage is a traditional local or creole variety or a locally adapted or creole breed, or if the species is on an official list of endangered species;
- Access partnership data (if applicable): identification of national partnering institutions;
- Data on access carried out abroad: information from the institution based abroad associated with the national institution;
- Data on previous access (if applicable): registration number or previous authorization, in the case of genetic heritage or associated traditional knowledge accessed from research or technological development carried out after June 30, 2000;
- Data on secrecy: request for recognition of the legal hypothesis of secrecy;
- Data on associated traditional knowledge: identify sources for obtaining associated traditional knowledge; inform the georeferenced coordinate of the respective community, except in the case of associated traditional knowledge of unidentifiable origin; proof of obtaining prior informed consent.
- Keep accurate records of the information and documents listed in art. 22 of Decree No. 8.772, of 2016, for subsequent registration, in cases where access to or shipment of genetic heritage or associated traditional knowledge begins before the activity is registered.
- Provide all information related to the registration of access or shipment of genetic heritage or associated traditional knowledge, when requested by the PRP or NIT.
- Register for access or shipment of genetic heritage or associated traditional knowledge without fail before:
- of the shipment;
- The application for any intellectual property right;
- The commercialization of the intermediate product;
- Disclosure of final or partial results in scientific or communication media;
- Notification of finished product or reproductive material developed as a result of access.
- Evaluate when your activity deals with the Sending or Remittance of samples abroad, for the purposes of Law 13.123/15, considering:
- Remittance: the transfer of a genetic heritage sample to an institution located outside the country for the purpose of access, in which the responsibility for the sample is transferred to the recipient;
- Sending: consists of forwarding a sample that contains genetic heritage for the provision of services abroad as part of research or technological development in which the responsibility for the sample lies with the person who performs the access in Brazil.
- Carry out the registration of the genetic heritage sample shipment, filling out the SisGen electronic form with the following information:
- Identification:
- from the sender;
- of genetic heritage samples at the strictest possible taxonomic level; and
- the origin of the samples to be sent;
- Informations about:
- the type of sample and the form of packaging;
- the number of containers, volume or weight;
- the recipient institution abroad, including indication of legal representative and contact information; and
- overseas access activities, including objectives, intended uses and sector of application of the research or technological development project;
- Material Transfer Term - TTM, signed between the national natural or legal person and the legal entity headquartered abroad;
- Prior informed consent that expressly authorizes the shipment in the case of genetic heritage of traditional local or creole variety or locally adapted or creole breed for access in non-agricultural activities, when applicable.
- Identification:
- Register a Shipment by filling out the SisGen electronic form with the following information:
- Information about the recipient institution abroad, including contact information and indication of a legal representative;
- Information on the samples to be sent, containing the identification of the genetic heritage to be sent.
It is important to note that, for the purposes of Law 13.123/15, the provision of services abroad is considered to be the execution of tests or specialized technical activities carried out by the partner institution of the national institution responsible for access or contracted by it, for retribution or consideration.
- Attach together with the objects for sending the samples:
- The legal instrument;
- Prior informed consent, in case of sending a sample of genetic heritage of traditional local or creole variety or locally adapted or creole breed for access in non-agricultural activities, when applicable.
It is also important to note that the TTM will be signed by the researcher and the legal representative of the institution or whoever has been legally authorized (there is a need to prove this act).
- Obtain prior informed consent from the holder of associated traditional knowledge of identifiable origin, before accessing this knowledge, as provided for in art. 9 of Law No. 13.123 of 2015, through:
- Signature of the prior consent term;
- Audiovisual record of consent;
- Opinion of the competent official body; and
- Adhesion as provided for in a community protocol.
- Request authorization prior to access for the following cases:
- access to genetic heritage or associated traditional knowledge in an area indispensable to national security, which will take place after approval by the National Defense Council;
- access to genetic heritage or associated traditional knowledge in Brazilian jurisdictional waters, on the continental shelf and in the exclusive economic zone, which will take place after approval by the maritime authority.
- for the collection of genetic material from fauna and flora (in this case when the species appears on the list of endangered species), as well as entry into Federal Conservation Units. (For more information go to: http://www.icmbio.gov.br/sisbio/manual.html)
- Request and wait for the consent of the National Defense Council or the Navy Command, in cases where the access or shipment activities to be carried out in an area indispensable to national security, in Brazilian jurisdictional waters, on the continental shelf or in the exclusive economic zone, involve the participation of foreigners or foreign capital.
- Carry out a new registration when there is a change in the genetic heritage or associated traditional knowledge accessed or the purpose of access.
- Have skillful means to prove, in cases where the APG or CTA were completed before June 30, 2000 and the economic exploitation of the finished product resulting therefrom, that all stages of access were completed before June 30, 2000 such as :
- In the case of research: publication of an article in a scientific journal; communication in scientific events; patent filing; research completion report with a public funding agency or entity; publication of course conclusion work, master's dissertation, doctoral theses;
- In the case of technological development: patent filing; cultivar registration, product registration with public agencies; proof of commercialization of the product;
- In the case of economic exploitation of a finished product, in addition to the provisions above, the user must prove that access was sufficient to obtain the finished product that is the object of economic exploitation, that is, when no research or technological development activity has occurred after 30 of June 2000.
- Adequate and regularize the registration activities for accessing or sending genetic heritage or associated traditional knowledge carried out between June 30, 2000 and November 17, 2015, in disagreement with the legislation in force at the time:
- access to genetic heritage or associated traditional knowledge;
- access and economic exploitation of a product or process arising from access to genetic heritage or associated traditional knowledge, dealt with in Provisional Measure No. 2.186-16, of August 23, 2001;
- sending abroad a sample of genetic heritage; or
- dissemination, transmission or retransmission of data or information that integrate or constitute associated traditional knowledge.
For regularization, the Term of Commitment must be signed. In the event of access to genetic heritage or associated traditional knowledge solely for the purposes of scientific research, the user will be exempt from signing the Term of Commitment, regularizing it through registration or authorization of the activity, as the case may be.
Priority should be given to regularizing access to genetic heritage or associated traditional knowledge over the last five years. The instrument for this regularization is the term of commitment available at http://www.mma.gov.br/patrimonio-genetico/reparticao-de-beneficios-eregularizacao/termo-de-compromisso.
For guidance on registration, access the SisGen Manual – MMA.
- Check whether the activity to be registered fits into any of the hypotheses in which the deadline for regularization has not yet started, as indicated in the Table “Deadlines applicable for registration of access to the PG or CTA carried out between 17/11/2015 and 05/11/2017 or after 05/11/2017”.
Licensee Responsibilities
The institution or company that licenses Unicamp technologies resulting from access to the PG or CTA will be responsible for sharing benefits, observing:
- product notification consisting of the declaratory instrument that precedes the start of the activity of economic exploitation of the finished product or reproductive material arising from access to genetic heritage or associated traditional knowledge, in which the user declares compliance with the requirements of this Law and indicates the benefit-sharing modality, when applicable, to be established in the benefit-sharing agreement, pursuant to article 2, item XIX of Law no. 13.123/2015;
- benefit sharing will only occur when a product is sold, and no longer when there is a prospect of use;
- Only finished product manufacturers will be required to share benefits, intermediate product manufacturers being exempt;
- In the case of reproductive material (agro), only the producer of the reproductive material must share benefits.
- Benefit sharing (at the user's discretion) may be monetary or non-monetary;
- When a single finished product is the result of different accesses, these will not be considered cumulatively for the calculation of benefit sharing;
- The sharing of benefits will be allocated to a Fund (National Fund for Sharing Benefits).
Responsibilities of the NIT
The NIT and the PRP are responsible for:
- Disseminate, promote and support culture related to genetic heritage.
- For managing patents involving research involving access to genetic heritage.
Penalties
For the sanctions provided for in Law 13.123/15 and Decree 8.772/16 resulting from administrative infractions and non-compliance with the legislation, without prejudice to the applicable criminal and civil responsibilities, such as:
- Warning;
- Penalty fee;
- Seizure:
- of the samples that contain the accessed genetic heritage;
- the instruments used in obtaining or processing the genetic heritage or associated traditional knowledge accessed;
- products derived from access to genetic heritage or associated traditional knowledge;
- of the products obtained from information on associated traditional knowledge;
- Temporary suspension of the manufacture and sale of the finished product or reproductive material derived from access to genetic heritage or associated traditional knowledge until regularization;
- Embargo of the specific activity related to the infraction;
- Partial or total interdiction of the establishment, activity or enterprise;
- Suspension of certificate or authorization;
- Cancellation of certificate or authorization.
The fine will be arbitrated by the competent authority, per infraction, and may vary:
- From BRL 1.000,00 to BRL 100.000,00 when the infraction is committed by a natural person; or
- From BRL 10.000,00 to BRL 10.000.000,00 when the infraction is committed by a legal entity, or with its competition.
For the purposes of ICTs, it is interesting to know specifically the following penalties in cases of irregular use of access to genetic heritage or associated traditional knowledge: Lack of prior registration for remittance: minimum fine of R$ 20.000, and maximum of R$ 100.000,00, in the case of an individual and a minimum fine of BRL 100.000,00 and a maximum fine of BRL 10.000.000,00 for legal entities;
Applying for Intellectual Property rights (in Brazil or abroad) without prior registration: a minimum fine of R$3.000,00 and a maximum of R$30.000,00 in the case of an individual. Minimum fine of R$20.000,00 and maximum fine of R$10.000.000,00 for legal entities;
Disclosing research results without prior registration: a minimum fine of R$ 1.000,00 and a maximum of R$ 20.000,00 in the case of an individual. Minimum fine of BRL 50.000,00 and maximum fine of BRL 500.000,00 for legal entities;
Access associated traditional knowledge of identifiable origin without obtaining prior informed consent: a minimum fine of R$20.000,00 and a maximum of R$100.000,00 in the case of an individual. Minimum fine of BRL 100.000,00 and maximum fine of BRL 10.000.000,00 for other legal entities;
Failure to indicate the origin of associated traditional knowledge of identifiable origin in publications, uses, explorations and disclosures of access results: minimum fine of BRL 1.000,00 and maximum of BRL 10.000,00 in the case of an individual. Minimum fine of BRL 10.000,00 and maximum fine of BRL 500.000,00 for other legal entities;
Failure to adapt or regularize within the terms of the law: a minimum fine of R$ 1.000,00 and a maximum of R$ 10.000,00 in the case of an individual. Minimum fine of BRL 10.000,00 and maximum fine of BRL 10.000.000,00 for legal entities.